chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling abnormal, Full blood count normal, Grip strength decreased, Hypoaesthesia
Clinical narrative: She was given the flu shot on 10/13/15 and started reacting to it shortly afterwards. Her arm started to feel numb from her shoulder down to her fingertips. She couldn't grasp anything in her left hand. Strange feeling went up her left side of her neck into the left side of her jaw. That lasted for two days. After two days she had diarrhea.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Metabolic function test
Clinical narrative: She was given the flu shot on 10/13/15 and started reacting to it shortly afterwards. Her arm started to feel numb from her shoulder down to her fingertips. She couldn't grasp anything in her left hand. Strange feeling went up her left side of her neck into the left side of her jaw. That lasted for two days. After two days she had diarrhea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Severe chills from 8:30 PM to 11:00 PM, vomiting from 9:30 PM to 10:00 PM, fever from 11:00 PM to 3 AM.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, hot and raised morning following vaccine. Seen 10-23-15 - area is 8 x  cm pink area wthn 2 x 3 area of induration and deeper redness in center. No fluid - tx - BENADRYL and ice.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Fever up to 103, cough, congestion and some sore throat 1 day after receiving vaccine. Seen on 11-12-15, sx consistent with URI no tx.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt described prolonged pain at the injection site, lasting roughly 3 weeks post admin. No other symptoms present.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient here for urgent care on 11/17/2015, reported rash with pain on upper left arm after receiving PREVNAR 13 shot recently. Skin comment: (L) deltoid = erythema, warm patch irreg 4x 5 cm. Mild soft tissue swelling. Non tender.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 10-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-SEP-2015, the patient received an improperly stored dose od VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 30-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLUR3, PNC13
Symptoms: Influenza, Pneumonia
Clinical narrative: My mom was given a flu shot and pneumonia shot at the same time! 2 weeks after the shot she had flu symptoms and pneumonia symptoms.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Basophil count increased, Fatigue, Feeling abnormal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Had pain in her left arm that extends in her neck and shoulders. Extremely tired and achy. Received physical therapy x2, used theraputty at home.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Metabolic function test normal, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Had pain in her left arm that extends in her neck and shoulders. Extremely tired and achy. Received physical therapy x2, used theraputty at home.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity, Red blood cell count normal, White blood cell count increased
Clinical narrative: Had pain in her left arm that extends in her neck and shoulders. Extremely tired and achy. Received physical therapy x2, used theraputty at home.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Erythema, Myalgia, Peripheral swelling, Skin warm
Clinical narrative: Severe swelling of entire arm. Hot red. Severe muscle pain. Continued for weeks.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest X-ray abnormal, Chest pain, Musculoskeletal chest pain
Clinical narrative: Sudden onset reproducible chest pain (chest wall pain).
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Bursitis, Drug administered at inappropriate site, Injection site pain, Injection site reaction
Clinical narrative: Patient had complaints following her flu injection of severe left shoulder pain present for a month prior to seeking treatment.  Unable to lift her arm without significant pain.  Affected daily activities.  Went to see an orthopedic who diagnosed her with Lt subacromial bursitis with secondary rotator cuff dysfunction secondary to post flu vaccine reaction and likely high placement. She was given a steroid injection with significant pain improvement.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rotator cuff syndrome, Vaccination complication
Clinical narrative: Patient had complaints following her flu injection of severe left shoulder pain present for a month prior to seeking treatment.  Unable to lift her arm without significant pain.  Affected daily activities.  Went to see an orthopedic who diagnosed her with Lt subacromial bursitis with secondary rotator cuff dysfunction secondary to post flu vaccine reaction and likely high placement. She was given a steroid injection with significant pain improvement.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Cough, Ear infection, Respiratory tract infection, Sneezing, Wheezing
Clinical narrative: Congestion, sneezing, wheezing, coughing, ear infection.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose influenza vaccine instead of the age appropriate vaccine for influenza due to error in pulling stock.
Age: 24.0
Sex: F
Vaccine: FLUN4
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea vomiting.  Several episodes of emesis over 30-45 minutes.  Spontaneously resolved.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Induration, Pain in extremity, Skin warm, Sleep disorder, Swelling
Clinical narrative: Onset of pain and swelling on right arm which grew large, hot and very indurated over entire upper arm lateral, anterior and posterior per patient. Lasted 1 week. She was unable to sleep with arm at side due to swelling. Did not seek medical care.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 14-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose and frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received patients received improperly stored doses of VAQTA, lot # L007559, expiration date 01-JUN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has bee received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 12-OCT-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot #, dose and route unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # and dose unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. 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 medical assistant refers to an unknown number of patients of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the unknown number of patients were inadvertently vaccinated with M-M- R II LOT # K010319, expiration date 22-JUL-2015 (dose, strength, dose number, administration route were not reported), that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacist via a publics representative referring to a 60 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 25-OCT-2015 the patient was vaccinated with ZOSTAVAX (strength, dosage, frequency and route unspecified). On an unspecified date in 2015 (reported as "over a two week period following ZOSTAVAX"), the patient had an "increasing progression" of swelling at the injections. On an unspecified date in 2015 the patient experienced an unspecified "itchy" irritation at the injection site. Additionally the pharmacist also reported that the patient experienced an unspecified rash on the breast and abdomen. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored doses of GARDASIL, lot # K008931, exp. 04-MAR-2017; K010215, exp. 05-MAY-2017; K016966, exp. 10-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects are reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral, lot # reported as L008054, expiration date: 30-NOV-2016, (dosage was not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-AUG-2008, the patient was vaccinated with the first dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiry date were not reported). On 13-NOV-2015 (reported as "today"), the patient was in the office to receive the second dose of hepatitis A vaccine (manufacturer unknown) (dose, route, lot # and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-OCT-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, lot # J011272, expiration date: 21-APR-2016 (dosage, and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Product quality issue, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of therapeutic response decreased in a 62-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017. This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017 and ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017. On 7th January 2015, the patient received the 1st dose of ENGERIX B adult. On 4th March 2015, the patient received the 2nd dose of ENGERIX B adult. On 8th July 2015, the patient received the 3rd dose of ENGERIX B adult (intramuscular). On 4th March 2015, not applicable after receiving ENGERIX B adult and ENGERIX B adult, an unknown time after receiving ENGERIX B adult and not applicable after receiving ENGERIX B adult and ENGERIX B adult, the patient experienced drug dose administration interval too long. On 8th July 2015, the patient experienced drug dose administration interval too short. On September 2015, the patient experienced therapeutic response decreased. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapeutic response decreased, drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Addition details were provided as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B tires following vaccination with ENGERIX B (see cases US2015GSK136759, US2015GSK136758, US2015135763, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titers. All the seven patients were new hires at the company and so the reporter was following them. The patients were vaccinated at the same clinic by the complaint reporter or one of her nurses. This case concerned to the patient number 2. On 4th March 2015, the patient received 2nd dose of ENGERIX B adult, which led to lengthening of the vaccination schedule. On 8th July 2015, the patient received 3rd dose of ENGERIX B adult, which led to shortening of the vaccination schedule. On 10th September 2015, 246 days after receiving 1st dose of ENGERIX B adult, 190 days after receiving 2nd dose of ENGERIX B adult and 64 days after receiving 3rd dose of ENGERIX B adult, the patient underwent laboratory test for Hepatitis B antibodies which read as borderline leading to low seroconversion to hepatitis B vaccine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Hyperhidrosis, Malaise, Nausea, Pallor
Clinical narrative: Patient received his first shot of GARDASIL 9 at 9:15am. Patient was scheduled to have bloodwork drawn after having this shot. After about 5 minutes of waiting in the room, I went back into the room to check on patient, and Mom said that the patient became nauseous, sweaty, and feeling ill. The patient did have a pale pallor. Patient was laying down when I went in. At this time I measured the patient's blood pressure, and received 122/76 manually in his left arm sitting. Fingerstick blood sugar was 93, fasting. Patient stated he had not eaten any breakfast this morning. Dr. instructed patient to hold off having bloodwork done until next week. Mom and patient verbalized understanding. Patient was given peanut butter crackers and a can of coca cola in office. At 9:40am the patient stated he was feeling better. Mom asked if the patient should be kept home from school today, informed that was up to her. Mom and patient decided to stay home from school today. Advised them to get a note for school from the front desk. Mom and patient verbalized understanding.
Sex: F
Vaccine: HPV4
Symptoms: HIV test negative, Maternal exposure before pregnancy
Clinical narrative: Information has been received from the author of the literature article titled above. Human papillomavirus (HPV) was a common sexually transmitted infection and the causative agent for cervical cancer, a frequently occurring malignant disease among women in developing countries. The reporter assessed GARDASIL provision to female entertainment and sex workers (FESW). The study population consisted of a convenience sample of 220 FESW, who participated in the Study which was a prospective study conducted from August 2009 to August 2010 on the prevalence and incidence of sexually transmitted inflections (STis) and HIV, sexual behaviours, reproductive health practices, drug use, and sociocultural determinants of HIV infection amongst FESW. At baseline, only 23.65 of the study population (N=52) had heard of HPV. Of the 220 women participating in the YWHS-2 study, 192 returned at three months and 191 completed the pre-vaccination knowledge and attitude survey. On 192 participants attending the first quarterly cohort visit where vaccine was offered, 149 (78%) were eligible for vaccination (HIV negative); HIV-positive (n=32) and pregnant (n=11) women were excluded. Out of the 149 women who received the first dose of the vaccine, 138 (92.6%) returned in two months and 11 (7.4%) women were lost to follow up. Of the 138, three women had become pregnant and were ineligible to continued the vaccine series. For the third and last vaccine administered at month six, 123 (91.1%) women of the 135 who had received the second vaccine returned, and 118 received the third and final dose. Five additional women had become pregnant during the interim period and were not eligible for the final vaccine visit. The overall vaccine series completion rate among vaccine initiates was 79.2%. Women who reported use of amphetamine-type stimulants had significantly and independently lower odds at vaccine completion (adjusted odds ratio [AOR] 0.24; 95% confidence interval [C1] 0.08, 0.69). New pregnancies also had an impact on vaccine completion: 5.4% (8/149, 5.4%) who started the series had to stop due to new pregnancy. Results demonstrated the effectiveness of a simple education intervention designed to increase human papillomavirus knowledge and the feasibility of unsuccessful human papillomavirus vaccine in a population that was often difficult to engage in preventive health care. This case refers to 3 female patients of unknown age who was enrolled in the YWHS-2 study On unknown dates the patients received the first dose of GARDASIL (lot#, dose and route not reported). On unknown dates (in two months after vaccinations) the patients became pregnancy and were ineligible to continue the vaccine series. The pregnancy outcome was not reported. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Bronchoalveolar lavage abnormal, Bronchoscopy abnormal, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Breathing difficulty, cough requiring hospitalization.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza B virus test positive, Interstitial lung disease
Clinical narrative: Breathing difficulty, cough requiring hospitalization.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm hot to touch, swollen, sever pain, difficulty moving arm.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Neck pain, Pain in extremity, Throat irritation, Tremor
Clinical narrative: Complained of pain radiating down right arm and up to neck. Began sweating and shaking and feeling like her throat was itching.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: I was 38 weeks pregnant. My baby's heart stopped beating. He was pronounced dead less than 24hrs after I got the flu shot.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of drug administration, Injection site mass
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 year old female patient. The patient had on pertinent medical history and did not present any allergies. There was no information about the patient's concurrent conditions provided. On 09-NOV-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD subcutaneous injection, 0.5 ml, administered intramuscularly instead of subcutaneously in the left thigh, albumin status rHA, lot # L025204, expiration date 07-JAN-2017. Concomitant therapies included KINRIX vaccine, administered on the same day in different area of the left thigh. On an unknown date in approximately November 2015, the patient experienced a lump at the (Oka-Merck) PROQUAD injection site. The patient sought medical attention and was scheduled for an in-office visit. There was no treatment administered, since the patient had been seen by the time of the report. The outcome of injection site lump was reported as not recovered by the time of report. The relatedness between the injection site lump and the suspect vaccine was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 3 year old male patient who was vaccinated. Concurrent conditions and medical history were not reported. On 07NOV2015 the same physician ordered that the patient should be vaccinated for pneumococcus and receives a dose of PNEUMOVAX. On the same date the patient was vaccinated. Despite that it is not sure if the patient received PNEUMOVAX23 (lot #, dose, frequency and route of administration were not provided) or PREVNAR. On an unspecified date the patient's chart showed that he received PREVNAR instead of PNEUMOVAX23. The reporter stated that he does not believe that the patient experienced a wrong vaccine administration as the product confusion. This information could not be verified. No adverse effects were reported. The outcome of the adverse event is unknown. The relatedness between the wrong drug administration is not related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K007822, expiration date 15-AUG-2015, dose, strength, vaccination site, route unspecified). The pharmacist stated that, PNEUMOVAX 23 did not have any previous temperature excursions and it was supported with in-house post-expiry data. No adverse symptoms were reported. Product quality complaint (PQC) was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 year old patient of unknown gender. No concomitants medications were reported. No medical history, allergies or drug reactions were reported. On 04-NOV-2015 the patient was vaccinated with 0.5 ml dose of VAQTA (Lot number: L028666, expiration date: 04-NOV-2016), intramuscularly. The patient inadvertently was administered a pediatric dose of VAQTA instead of the recommended adult dose. Lab diagnostic studies were not reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II; (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several  reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II; (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of 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 was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. ON 01-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified patient of unknown age and gender. On 02-NOV-2015 the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD (lot # L009208, expiration date 17-SEP-2016, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II, (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a male patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date 30th June 2016). On 10th November 2015, the patient received FLUARIX QUADRIVALENT .5 ml. ON 10th November 2015, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hemorrhage and injection site swelling. On an unknown date, the outcome of the injection site hemorrhage and injection site swelling were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 10th November 2015, immediately after receiving a dose of FLUARIX QUADRIVALENT and while the needle was being withdrawn, the patient's arm began to squirt out the blood and a small bump appeared at the injection site of the patient. The healthcare professional initially called to inquire about this being a possible side effect or adverse reaction of the product. The reporter also stated that, she did not feel comfortable providing more information regarding the incident at this time and would just prefer to speak further regarding the possibility of the adverse reaction being caused by the product. No further information was reported regarding the incident.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 16-SEP-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Activities of daily living impaired, Dehydration, Headache, Pyrexia, White blood cell count increased
Clinical narrative: Fever of 99.5 and headache. Sent home from school. On 11/8/2015 continued to have fever. Was taken to local ER. Given IV fluids for dehydration and sent home.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Complained of pain on left arm at injection site, radiating down arm and up left side of neck.
Age: 3.0
Sex: M
Vaccine: FLUN4, MMRV
Symptoms: Peripheral swelling, Rash erythematous, Urticaria
Clinical narrative: RED SWOLLEN PATCHES DIAGNOSED IN ER AS HIVES, TREATED WITH BENADRYL AND STEROIDS. RETURNED TO ER 11/17/2015 FOR SWOLLEN FEET AGAIN DIAGNOSED AS HIVES.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a 0.5 mL dose of influenza vaccine when age called for a 0.25 mL dose.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose and route of administration were not reported) )incorrect product storage). No adverse effects were reported. Follow up information has been received from the Licensed Practical Nurse (initial reported as Licensed Vocational Nurse) during a telephone call on 13-NOV-2015 concerning one of the multiple patients of unknown age and gender. On 08-JUL-2015, the patient vaccinated with the improperly stored RECOMBIVAX HB. Additional information has been requested. Patients information, products, events and narrative were updated.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. No relevant medical history or concurrent conditions were reported. On 31-OCT-2015 the patient was vaccinated with VARIVAX (Merck) (dose, route, lot# and expiration date not reported). On unknown dates in November 2015 (reported as "about a week-and-a-half" after the administration of VARIVAX (Merck) the patient developed induration, erythema and pain at the injection site. There was no rash. The patient sought medical attention by presenting to the pharmacist. The outcome of the events was not recovered. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The pharmacist reported that on unknown dates the patients "might" have received doses of improperly stored ZOSTAVAX (lot#, dose and route were unknown). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1511USA009275 and 1511USA009326). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from the medical assistant (also reported as healthcare worker) refers to an unspecified patient of unspecified age and gender. Medical history and concurrent conditions were not reported. On 16-NOV-2015 (reported as today), a patient was inadvertently vaccinated an expired dose of VARIVAX (Merck) injection (confirmed lot number: H015558 and expiry date: 16-AUG-2014) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information is not expected, because there was no consent for further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 23-AUG-2015, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Ocular hyperaemia, Palpitations, Throat tightness
Clinical narrative: Eyes bloodshot, throat tightness, headache, chills, palpitations.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Choking, Intussusception, Laboratory test normal, Retching
Clinical narrative: 11/13/15 PE. Child had gagging/choking episode after RV5 with short apnea episode < 30 sec. Again gag/choking episode after inject. 4 mo IMS. Observed 90 min in clinic. 11/15/15 ER with emesis after every feed. Pt admitted for observation abd US showed intussusception. Reduced with GASTROGRAFIN. Dsch 11/16/15.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: 11/13/15 PE. Child had gagging/choking episode after RV5 with short apnea episode < 30 sec. Again gag/choking episode after inject. 4 mo IMS. Observed 90 min in clinic. 11/15/15 ER with emesis after every feed. Pt admitted for observation abd US showed intussusception. Reduced with GASTROGRAFIN. Dsch 11/16/15.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blepharospasm, Dizziness, Fatigue, Pallor
Clinical narrative: A few hours after vaccination - pale, fatigued - eyes were twitching - 12-16 hours later - dizzy - pale and eyes were twitching again.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.8
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.5 mL dose of influenza vaccine when should have recieved 0.25 mL dose based on patient's age.