chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unspecified date the patient was administered GARDASIL 9 (dose, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 06-JUL-2015, the patient was vaccinated with unspecified improperly stored doses of MMR II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 02-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. 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 24 May 2013. A patient (No information was provided regarding the patient) was inadvertently administered expired dose MENACTRA vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 40 year old male patient with asthma (diagnosed prior to receiving VARIVAX (Merck) and no drug reactions or allergies. Within the past five years, the patient received two doses of VARIVAX (Merck) (dose, route of administration, lot number, interval were not reported), on unknown dates. Concomitant therapy included SYMBICORT. The physician stated that the patient had titers drawn on 24-JUL-2015 for "school" and the results of the titers were "insufficient". Outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 07-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot number was reported as L009208, expiry date: 17-SEP-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. 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 licensed vocational nurse refers to 3 patients of unknown age and gender. The patients medical history, drug reactions or allergies and concurrent conditions were not reported. On 04-AUG-2015 the patients were administered with a dose of an improperly stored VARIVAX (Merck), lot number K021486, expiry date 03-NOV-2016, (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a male patient of unknown age. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025765, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 May 2013. It was reported that the patient was administered a dose of MENACTRA on 03 May 2013 and then again on 05 May 2013. No adverse event was reported. 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 23 May 2013. It was reported that an expired dose of MENACTRA was administered to an 18-year-old patient. 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 23 May 2013. A patient was administered a booster dose of MENACTRA vaccine as that had expired in January 2013. No information was provided regarding the patient. 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 22 May 2013. It was reported that a dose of MENACTRA that had expired on 07 May 2013 was administered. No information was provided regarding the patient. 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 23 May 2015. A patient received an expired dose of MENACTRA. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Adverse event, Expired product administered
Clinical narrative: Initial report received on 26 September 2013 from a nurse. A female patients whose age, medical history and concomitant medicaitons were not reported, received a dose of MENACTRA vaccine (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received the MENACTRA. The nurse reported that she had a severe reaction a week after receiving her shot. She said her arm had a baseball growing out of it. She called her doctor to report the issue, only to find out the product has been expired since May 2013. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Initial report received from healthcare professional on 12 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received MENACTRA (lot number and expiration date unknown) (route, site and dose number not reported) on an unknown date. On an unknown date, stated staff member inadvertently stuck self with needle which had been used to withdraw MENACTRA from vial, stated no reaction noted at site was just calling to see if would have any possible reaction. No actual clinical data. Would monitor patient as would any vaccine, will need to follow own facility policy for needle stick, and please call us back if patient would have any reaction. No MIS AE filled since no reaction. Not a PC since was stuck with needle after withdrawing MENACTRA vaccine from vial into own plastic syringe without difficulty and incurred needle stick when "recapping" needle. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Age: 60.0
Sex: U
Vaccine: MNQ
Symptoms: Pruritus
Clinical narrative: Initial information received from another manufacturer on 23 December 2013. This information was received from a healthcare professional (pharmacist). A 60-year old patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of Meningitis vaccine from unknown manufacturer (Route, dose number, lot number and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed severe itching on unspecified areas of body. Laboratory investigations were not reported. The patient was treated with unspecified antihistamine injection. On an unspecified date, the patient had recovered from the event. 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 11 July 2013. It was reported that, 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: U
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 08 July 2013. It was reported that during administration of MENACTRA vaccine the patient pulled away and had received only half dose. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017), (dose and route of administration were not reported). Concomitant medications were not provided. No adverse symptoms were reported. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 53 year old patient of unknown gender. No medical history and concurrent conditions reported. On 27-JUL-2015, the 53 years old patient was vaccinated with PROQUAD (Merck) lot # K018144, expire date 10-APR-2015 (dose, route not reported) which outside of the recommendations in the PROQUAD (Merck) prescribing information. No adverse effects reported. No product quality complaints reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Healthcare Worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 06-AUG-2015, the patient was vaccinated with ZOSTAVAX instead of PNEUMOVAX 23. Concomitant therapies included acyclovir. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site discolouration
Clinical narrative: Initial report received from a healthcare professional on 31 July 2013. This case is invalid as individual patients identifiers are missing. Three patients whose date of birth, gender and age at the time of event were not reported, had received an intramuscular dose of MENACTRA vaccine (Lot number: U4584BA, dose number and anatomical site were unknown) on 31 July 2013. On 31 July 2013, same days after vaccination, the patients experienced black circles around injection site. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none. Follow-up information received from a healthcare professional on 27 August 2013: A 20-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of MENACTRA vaccine (Lot number: U4584BA, dose number and anatomical site were unknown) on 31 July 2013. The patient had not received any vaccine 4 weeks before administration of MENACTRA. On 31 July 2013, on the same days of vaccination, the patients experienced black circle around injection site. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from event. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Red blood cell abnormality, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 15 August 2013. An 11-year-old female patient had received an intramuscular dose of MENACTRA vaccine (lot number: U4648AA, site of administration was not reported) on 13 August 2013. The patient had no significant medical history or illness at time of vaccination. The patient's concomitant medications were not reported. On 13 August 2013, the patient had developed redness and swelling over whole deltoid area and it was hot to touch. The patient was seen by a healthcare professional. No laboratory investigations were done and the patient was prescribed allergy medications (unspecified) as corrective treatment. At the time of this report, the patient had not recovered from events. List of documents held by the sender: None. Follow up information received from healthcare professional on 17 October 2013. The patient received vaccine on left arm. The patient's symptoms subsided and swelling decreased with medications. The patient has not returned to clinic for further evaluation.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial overdose report received from a healthcare professional on 12 August 2013. It was reported, that a patient (No information was provided regarding the patient) received two doses of MENACTRA on the same day. 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 06 August 2013. A patient (No information was provided regarding the patient) received an expired dose of MENACTRA. 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 05 August 2013. A patient (No information was provided regarding the patient) was administered an expired dose of MENACTRA. 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 06 August 2013. An expired dose of MENACTRA vaccine was 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: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 August 2013. A patient (no information was provided regarding the patient) had received a dose of MENACTRA vaccine that had expired in February (year not specified). No adverse event was 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 05 September 2013. It was reported that 2 doses of MENACTRA were administered to a patient within 10 days. (No information was provided regarding the patient). 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 profsesional on 09 September 2013. An expired dose of MENACTRA was given to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Urticaria
Clinical narrative: Bruising welts
Age: 35.0
Sex: F
Vaccine: MMRV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's husband referring to his wife a 35 year old patient. There was no pertinent medical history or drug allergies/drug reactions. On approximately 24-JUL-2015 reported as "two weeks ago", the patient was vaccinated with PROQUAD (Merck), subcutaneous injection (dose, lot# and expiration date not provided). There was no concomitant medication described. The reporter stated that, it was recently confirmed (unspecified date) that the patient was pregnant which was considered as an exposure during pregnancy. Last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. No adverse effects were reported. At the time of the report, the outcome of exposure during pregnancy was unknown. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via Poison and Drug Center (PDC) refers to a patient of unknown gender between the age of 6 years and 12 years old. The patient's relevant medical history, past drug history and concomitant medications were unknown. On 26-May-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions 5.3 degrees Celsius for 2 hours and 8 minutes. On 02-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K014798 and expiration date 12-MAR-2016) via injection (dose, frequency and indication were unknown). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continues on PROQUAD (Merck). This is one of the eight reports received from the same source. 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 and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 07-AUG-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, subcutaneously, expiration date 20-AUG-2016 (strength, dose, lot # were not provided) which was inadvertently reconstituted with sterile diluent (Merck), lot H021469, expiration date 31-MAY-2015. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 02-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 25 year old patient of unknown gender. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, frequency, lot#, expire date not reported). No concomitant medications reported. On an unknown date the patient experienced herpes zoster after receiving VARIVAX (Merck). The outcome of herpes zoster was unknown. This is one of the two report from the same reporter. (MARRS#1508USA005043). Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 10 year old child patient of unknown gender. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route, frequency, lot#, expire date not reported). No concomitant medications reported. On an unknown date the patient experienced herpes zoster after receiving VARIVAX (Merck). The outcome of herpes zoster was unknown. This is one of two report from the same reporter. (MARRS# 1507USA013566). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown dates the patients were administered improperly stored doses of GARDASIL (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecific number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered improperly stored doses of PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecific number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered improperly stored doses of COMVAX (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports reported by the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Blister, Rash maculo-papular
Clinical narrative: Pt with start of maculopapular rash on face, chest, back and arms. Starting to show vesicles. Concern for chickenpox.
Sex: U
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: This case was reported in a literature article and described the occurrence of seizure in a infant unk subject who received Flu seasonal TIV Dresden. On an unknown date, less than a week after receiving Flu seasonal TIV Dresden, the subject developed seizure. Serious criteria included GSK medically significant. The outcome of seizure was unknown. The investigator considered that there was a reasonable possibility that the seizure may have been caused by Flu seasonal TIV Dresden. Additional information received: This case was reported in a literature article and it described the occurrence of seizures in a child of unspecified gender between 6 and 59 months of age who had received an unspecified trivalent vaccine (manufacturers unknown). This case was identified after searching a large insurer database for medical claims. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date in the 2010-2011 influenza season, the patient received at least 1 dose of an unspecified trivalent vaccine (dosage, administration route and site unknown; batch number not provided). On an unspecified date, either the day of the vaccine administration or the following day, the patient suffered seizures. The diagnosis was confirmed by the authors after reviewing the patient's medical records. Treatment was unknown. The outcome of the event was unspecified at the time of reporting. The authors commented that the event had been temporarily associated with seasonal influenza vaccine previously. The authors concluded that "we utilized a claims-based data source to evaluate the safety of trivalent influenza vaccines and H1N1 vaccines. We ultimately found no increased outcome risk following 998,881 trivalent influenza vaccines and 538,257 H1N1 vaccine doses administered in the 2009-2010 season, and 1,158,932 trivalent influenza vaccine doses in the 2010-2011 season. The large number of vaccines in this health plans' database allowed for precise risk estimates of most outcomes, although claims profile reviews were critical in excluding cases with alternate explanations. This study adds to the body of evidence supporting the safety of influenza vaccines". This case is 1 of the 3 valid cases reported in the same literature article (see case US2015GSK116277).
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Muscular weakness, Trigger finger
Clinical narrative: ARTHRITIC ONSET TO LEFT HAND OF INJECTED ARM. TRIGGER FINGER ONSET TO PINKY FINGER. WEAKNESS OF LEFT HAND. AS OF 8/13/2015 CONDITIONS HAVE NOT IMPROVED.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Hypersensitivity, Middle insomnia, Pruritus generalised, Swelling face
Clinical narrative: I woke up in my sleep scratching myself all over my body. The left side of my face was swollen.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain at injection site left arm. Numbness in all 5 fingers with burning pain radiating from injection site down the arm under the elbow and into the ring finger and pinky finger from time of injection for about 6 months. Treatment ibuprofen ice/warm soaks applied to arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swelling and redness at injection site approximately 4 inches in diameter. Pain and heat accompanied at injection site.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Patient reported that the arm in which she had received the injection was "itchy" early Wednesday. The injection site was also red and hard to the touch. I offered her a loratadine tablet to help with the itching until she could leave work. The itching did not resolve in the afternoon and spread to her eyes. She visited the local emergency room where she was told she had cellulitis of the injection site, along with an allergic reaction to some component of the vaccine. She was treated with IM diphenhydramine and oral antibiotics and steroids. Her symptoms were subsiding the next day.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient reported that the arm in which she had received the injection was "itchy" early Wednesday. The injection site was also red and hard to the touch. I offered her a loratadine tablet to help with the itching until she could leave work. The itching did not resolve in the afternoon and spread to her eyes. She visited the local emergency room where she was told she had cellulitis of the injection site, along with an allergic reaction to some component of the vaccine. She was treated with IM diphenhydramine and oral antibiotics and steroids. Her symptoms were subsiding the next day.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: NO reaction reported. Vaccines were inadvertently administered due to human error. Shot record was pre-stamped for vaccines that had been administered exactly 1 year prior to current visit (08/12/14). Nurse saw the dates and thought it was 08/12/15, and accidentally administered Tdap, Varicella, MCV4, and Hepatitis A. Patient also received HPV9, which was the intended vaccine. After administration, mother of patient asked about the number of shots, and that is when the error was realized. Mother asked about possible adverse reactions. Nurse advised her to monitor her daughter for any changes, and to inform the Health Dept. if any occurrence should happen. Patient did not show any signs of reaction, but report is being made in an abundance of caution.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a 78 year old male patient. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number and expiration date not reported). Concomitant therapy was not reported. On an unknown date in 2015, the patient experienced flu like symptoms after receiving ZOSTAVAX including achiness and dizziness. The patient went to the emergency room at an unspecified hospital on an unknown date in 2015. However, it was unspecified if the patient was admitted into the hospital. The patient recovered on an unknown date in 2015. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave VZV and MMRV vacine to child. No reaction, called CDC and parent after realising error. Reported to provider, site coordinator and HR of company.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Over the course of a week started getting more tired, aching, head aches.  By end of 2nd week sleeping all the time, joint pain stiffness, headaches, stomach ache, chills can't work. By 3rd week Sleeping 16 to 20 hours per day extreme stiff, aching in muscles and joints losing weight, general ill feeling.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersomnia, Impaired work ability, Joint stiffness, Malaise, Musculoskeletal stiffness
Clinical narrative: Over the course of a week started getting more tired, aching, head aches.  By end of 2nd week sleeping all the time, joint pain stiffness, headaches, stomach ache, chills can't work. By 3rd week Sleeping 16 to 20 hours per day extreme stiff, aching in muscles and joints losing weight, general ill feeling.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain, Weight decreased
Clinical narrative: Over the course of a week started getting more tired, aching, head aches.  By end of 2nd week sleeping all the time, joint pain stiffness, headaches, stomach ache, chills can't work. By 3rd week Sleeping 16 to 20 hours per day extreme stiff, aching in muscles and joints losing weight, general ill feeling.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Vision blurred
Clinical narrative: Blurriness in one eye, with migraine in frontal area.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Company was having their annual flu shots for all the employee's. They were set up with several stations and hundreds of people were feeding through the flu shot stations. When it was my turn, I went to the next available person. It was a male EMS guy. He rubbed the alcohol swab on my arm and injected the flu shot in my right arm. The needle going in was more painful than in the past, but when he pulled it out of my arm, it hurt so bad! Instantly, I could feel the pain radiating down my arm. About an hour later I could not move my arm very much. I noticed the band-aide that he put on my arm was really high on my shoulder. I pulled the band-aide off to see the needle hole. I was shocked at how high he placed the shot in my arm. I waited a few days hoping the pain would go away. The pain never went away, it only got worse. I went to the clinic at work and told them what happened. They started me on some NSAIDS and told me to come back for follow up. I came back with no relief. I was instructed to continue the NSAIDS and do some arm exercises at home. Again, I came back with no relief. Finally, they referred me to an outside Orthopedic Surgeon who gave me a Cortisone shot and then made me go through physical therapy. After the physical therapy was done (and the Cortisone shots was still effective), I was told to come back if the pain returned once the shot wore off. Well the pain came back and I went back to see the doctor. An MRI was ordered and now I am in the process of preparing for shoulder surgery.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 10-year-old male patient who received FLUARIX QUADRIVALENT (batch number TP225, expiry date 30th June 2014). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On 9th October 2013, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and swelling arm. The patient was treated with antibiotics unknown. On an unknown date, the outcome of the cellulitis of arm and swelling arm were unknown. The reporter considered the cellulitis of arm and swelling arm to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follow: Vaccine Service Rep reported that HCP received the vaccine FLUARIX QIV. Pt. reports swelling of the arm. Pt. went to the ER and doctors diagnosed as cellulitis. Pt. received antibiotics. Correction following the clarification received on 13 August 2015: This case was reported by a nurse via call center representative and not by a consumer as previously reported.
Age: 1.43
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, Product label confusion, Wrong drug administered
Clinical narrative: Unkown at this time.
Age: 1.23
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Vaccination site rash
Clinical narrative: Rash on left thigh area of vaccine.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: Hives on arms, chest, underarms, and back up neck and onto scalp. Fever of 101-102 degrees and severe headache.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, for 7 days, still having symptoms.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 3:45PM in the County Department of Public Health hallway, child experienced syncope related to administered vaccines: TDAP, MCV4, HPV#1.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, hives, and itching that developed 72 hours after receiving immunizations. Symptoms have resolved with the use of Benadryl, but returned x 3-4 days.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient received the vaccine on (8/08/2015). Irregular border of swelling near the injection site on the left deltoid muscle (proximal lateral).  The site is approximately 3 inch in diameter and 1/16 inch elevation on 8/12/2015, patient reports that it has worsened today (8/13/2015) and increased to 2 swelling sites connecting each other, each site is approximately 3 inches in diameter on 8/13/2015. It is red, elevated, warm to touch and tender. Patient reports that it hurts when she tries to work using left arm muscle, and it is painful when she sleeps on her side. Patient has tried Ibuprofen and it did not work for the pain. The injection site is on her left arm.
Age: 43.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Body temperature increased, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: Severe Pain in right arm (arm that vaccine was given) that I could not lift or move my arm. I felt like I had the flu-temperature of 102.7, very bad headache, severe pain all over body, freezing cold and wrapped in blankets (it was 95 degrees F outside and my air conditioner was shut off), I had sinus pain, throat pain, terrible fatigue and dizziness when not laying down. This went on severe with fluctuating temperature for three days.
Age: 43.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Influenza, Injected limb mobility decreased, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Severe Pain in right arm (arm that vaccine was given) that I could not lift or move my arm. I felt like I had the flu-temperature of 102.7, very bad headache, severe pain all over body, freezing cold and wrapped in blankets (it was 95 degrees F outside and my air conditioner was shut off), I had sinus pain, throat pain, terrible fatigue and dizziness when not laying down. This went on severe with fluctuating temperature for three days.
Age: 43.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Sinus headache
Clinical narrative: Severe Pain in right arm (arm that vaccine was given) that I could not lift or move my arm. I felt like I had the flu-temperature of 102.7, very bad headache, severe pain all over body, freezing cold and wrapped in blankets (it was 95 degrees F outside and my air conditioner was shut off), I had sinus pain, throat pain, terrible fatigue and dizziness when not laying down. This went on severe with fluctuating temperature for three days.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Decreased appetite, Lethargy, Pyrexia, Swelling face
Clinical narrative: Dad reported lethargy, decreased appetite, and fever up to 102.7 began on the evening of the 10th and swelling in the jaw and face began after noon on the 11th.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head abnormal, Confusional state, Head injury, Loss of consciousness, Syncope
Clinical narrative: Mother reported that patient collapsed outside health department shortly after vaccination administration. Mother reported child lost consciousness and hit her head when she fell- reported child was confused when she regained consciousness. EMS was called and suggested patient may have had a seizure. Patient was brought to local hospital for assessment. CT scan was performed, found abnormal pons region. Patient was referred for MRI.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Asthenia, Delirium, Dizziness, Malaise, Pyrexia
Clinical narrative: Patient received vaccine at approximately 2 PM on 8/11/2015. Pt reported not feeling well starting at 8 PM that evening. Proceeded to throw up, feel feverish (no temp taken until 8/12/15 at 10:00 AM and at that time was 102 F). Felt weak, dizzy, and "delirious". Took Ibuprofen at midnight on 8/12/2-15 and Tylenol at 10:00 AM on 8/12/15. Mother called pt's PCP and spoke with a nurse about illness. Did not bring child in for treatment. Child recovered and was "much better" as of 8/13/15.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient received vaccine at approximately 2 PM on 8/11/2015. Pt reported not feeling well starting at 8 PM that evening. Proceeded to throw up, feel feverish (no temp taken until 8/12/15 at 10:00 AM and at that time was 102 F). Felt weak, dizzy, and "delirious". Took Ibuprofen at midnight on 8/12/2-15 and Tylenol at 10:00 AM on 8/12/15. Mother called pt's PCP and spoke with a nurse about illness. Did not bring child in for treatment. Child recovered and was "much better" as of 8/13/15.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered at inappropriate site
Clinical narrative: Patient received MMR vaccine 0.5ml in Right tricep. Seen by provider following vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Local red itchy area with 2 inch diameter at site of reaction.   Told her to watch reaction site at this point.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Legs turned bright red from thighs to feet. Received Benadryl.
Age: 27.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE. FEELING OF WARMTH IN FACE.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Mother reports the child has swelling the size of a softball on the Right arm where receiving the vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Eye pruritus, Eye swelling
Clinical narrative: Patient reports mild swelling around both eyes, as well as itching and irritation. No other areas affected, no trouble breathing, no other symptoms. She has been taking Benadryl since symptoms started. Patient says after 20 hours, symptoms have not resolved. She will continue to monitor. She hasn't tried any new makeup or food recently but she was gardening on 8/12 and forgot to wear gloves.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Confusional state, Memory impairment, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient said she remembers getting her vaccination. She had trouble remembering what year she was born.  I questioned her about that and she said she was having a really stressful day.  She had a water line broke at home and she had tons to get done. After she had the vaccination she took a seat on the bench outside the pharmacy.  After she had been seated a while.  We noticed she was talking on her phone.  She said that she was really confused and couldn't remember why she was at pharmacy.  She called her son, he came and took her to the hospital.  She was told that she was having a stroke.
Age: 17.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Abasia, Asthenia, Blood glucose normal, Hyperhidrosis, Neurological examination normal
Clinical narrative: Pt became faint. Possible vasovagal. After several attempts pt did was not able to sit up or stand without becoming diaphoretic again. Observed over 60" then with Fathers consent called medix to transport to local hospital. Vital signs remained stable, pt was alert and oriented but was pale weak and diaphoretic. Unable to ambulate. Neuro check was negative. Blood sugar was 104. We had given pt juice prior to inj and then following the second near syncope episode.
Age: 17.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Pallor, Presyncope, Syncope
Clinical narrative: Pt became faint. Possible vasovagal. After several attempts pt did was not able to sit up or stand without becoming diaphoretic again. Observed over 60" then with Fathers consent called medix to transport to local hospital. Vital signs remained stable, pt was alert and oriented but was pale weak and diaphoretic. Unable to ambulate. Neuro check was negative. Blood sugar was 104. We had given pt juice prior to inj and then following the second near syncope episode.
Age: 42.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Low grade fever.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Patient called today 8/13/15 stated that at the injection site of her right arm is redness, swelling, and she can not move her arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Malaise, Nausea
Clinical narrative: Sore, red arm at injection site.  Continued into next day, very red arm, feeling of sickness, nausea, dizzy, entire arm is sore.  Felt feverish, but had no fever. Took tramadol.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore, red arm at injection site.  Continued into next day, very red arm, feeling of sickness, nausea, dizzy, entire arm is sore.  Felt feverish, but had no fever. Took tramadol.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pruritus generalised, Urticaria
Clinical narrative: HIVES EVERY WHERE: ITCHING, RED AND PAINFUL AND ITCHING AT INJECTION SITE.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Back pain, Chills, Infection, Inflammation
Clinical narrative: Fever 103, chills, fever continued to the next day. On 07/10/2015 started feeling pain in joint all over whole body, especially legs and hands, lower back pain. On 07/13/2015 went to emergency room, blood count for white blood cells --370. Pain in joints and muscles, swollen lymph nodes. Pain in joints and muscles continued during next weeks. Blood test from 07/22/2015 SED rate 80.  Inflammation due to a infection.  Referal to X ray. Pain in joints. Blood test shows rheumatoid  factor.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Fever 103, chills, fever continued to the next day. On 07/10/2015 started feeling pain in joint all over whole body, especially legs and hands, lower back pain. On 07/13/2015 went to emergency room, blood count for white blood cells --370. Pain in joints and muscles, swollen lymph nodes. Pain in joints and muscles continued during next weeks. Blood test from 07/22/2015 SED rate 80.  Inflammation due to a infection.  Referal to X ray. Pain in joints. Blood test shows rheumatoid  factor.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rheumatoid factor positive, White blood cell count decreased
Clinical narrative: Fever 103, chills, fever continued to the next day. On 07/10/2015 started feeling pain in joint all over whole body, especially legs and hands, lower back pain. On 07/13/2015 went to emergency room, blood count for white blood cells --370. Pain in joints and muscles, swollen lymph nodes. Pain in joints and muscles continued during next weeks. Blood test from 07/22/2015 SED rate 80.  Inflammation due to a infection.  Referal to X ray. Pain in joints. Blood test shows rheumatoid  factor.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dystonia, Hyperventilation, Paraesthesia, Syncope
Clinical narrative: THE PATIENT TOLD HER MOTHER SHE FELT FAINT.  SHE THEN FAINTED BUT NEVER LOST CONSCIOUSNESS.  SHE BEGAN TO HYPERVENTILATE AND COMPLAINED OF TINGLING IN HER HANDS AND FEET.  SHE THEN COMPLAINED OF DYSTONIA IN HER HANDS.  THE EMS TOOK HER TO THEIR VAN.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Hypoaesthesia, Nausea, Nerve stimulation test, Nuclear magnetic resonance imaging brain
Clinical narrative: Sudden numbness in both legs from the knee down, nausea, fatigue, then on July 7, 2015 arms went numb, extreme fatigue followed.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging spinal, Vascular test
Clinical narrative: Sudden numbness in both legs from the knee down, nausea, fatigue, then on July 7, 2015 arms went numb, extreme fatigue followed.