chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial unsolicited report received from a pharmacist on 18 November 2014. A 78-year-old female patient, whose medical history and concomitant medications were unknown, received FLUZONE HD (lot number U5042CA) on 03 November 2014. One day post-vaccination, on 04 November 2014, she experienced a headache and her blood pressure "went up and then down". The patient informed the reporter that she had been hospitalized for three days but that no cause had been found for her symptoms. The symptoms recovered on an unspecified date. According to the patient, she "was having follow-up done for possible cardiac issues". Documents held by sender: None.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Tic
Clinical narrative: Initial unsolicited case received from a consumer (the patient's parent) on 18 November 2014. A 8-year-old male patient, with a reported medical history of facial and body tics, had received an intramuscular dose of FLUZONE, (batch number UI189AB) in the left deltoid on 15 November 2014. The patient had no identified illness at the time of vaccination. On 17 November 2014, i.e. 2 days post vaccination, the patient developed facial tics; he was "shaking his head yes and no (not in relation to a conversation) and opening his mouth for no reason". The parent reported that the tics were more exacerbated and very obvious since vaccination. The patient had facial and body tics in the past: parent reported that before vaccination, "they were very mild". At the time of the report, patient was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Initial unsolicited case received from a healthcare professional on 17 November 2014. It pertains to 2 of 3 patients reported from the same facility who experienced adverse events following vaccination; the other patient is captured in case number 2014SA159421. Two patients, genders and ages not reported, received FLUZONE ID, (lot numbers and date of vaccination not reported). They subsequently reported numbness and tingling in their arms with loss of grip strength. Only one of the patients had seen a primary care physician, who felt it was an injection site issue and instructed the patient to follow-up in a few months. Another had not yet seen a physician and was scheduled to follow-up with a physician later that month. It was not clear which of the three total patients reported had been seen by physicians. The patients were not ill at the time of vaccination, and laboratory data was reported as unknown. The patients had not recovered. Documents held by sender: None.
Age: 2.0
Sex: M
Vaccine: DT
Symptoms: Asthma, Bronchial hyperreactivity, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 30 July 2014. Additional information received for this unsolicited case on 21 November 2014 resulted in the case being upgraded to serious. A 32-month-old male patient, whose medical history and concomitant medications were not reported, had received intramuscular dose of DT Pediatric, batch number: C4161AA (dose number was not reported) in left deltoid on 24 July 2014. It was reported that on 25 July 2014, one day after receiving DT Pediatric vaccine, the patient experienced redness, swelling and puffiness of his left arm from shoulder to the wrist with limited range of motion over the course of 4 days post vaccination. The physician prescribed amoxicillin and MOTRIN as a corrective treatment with no laboratory investigations. It was reported that, the symptoms were resolving with improvement of symptoms with only slight swelling. As per reporter, no further physician evaluation required. At the time of this report, the outcome was recovering. Documents held by sender: none. Follow up information received from healthcare professional on 06 Oct 2014. It was reported that patient had amoxicillin 200 for 5 days (handwritten). The outcome of all events was reported as recovered. Additional information was received from the patient's parent on 21 November 2014. The patient had received the vaccine on 24 July 2014 at 7:00pm, and symptoms started on 24 July 2014 at 9:00pm. Ten days after vaccination, the patient experienced an asthma attack and was subsequently diagnosed with reactive airway disease. He was currently on multiple medications per the parent. These events had not recovered. Additionally, the parent provided more information regarding the state where the vaccine had been administered.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Communication disorder, Condition aggravated, Disorientation, Laboratory test, Speech disorder
Clinical narrative: Initial unsolicited case received on 18 November 2014 from a consumer who is the patient's daughter. An 85 year old female patient with a history of allergies to penicillin and latex and a medical history of stroke, glaucoma, acid reflux and a diagnosis of Alzheimer's was vaccinated on 09 October 2014 with FLUZONE HIGH DOSE, lot number route and site of administration were not reported. Forty-eight hours later, the past was "lucid", knew people, places, events around her and was speaking in full sentences for 2 1/2 weeks after vaccination until 27 October 2014. The patient had been diagnosed with Alzheimer's and has been in a skilled care of residential living facility. The patient has not spoken in full sentences and did not communicate or always know people and surroundings. The reporter thinks her mom may have something other than Alzheimer's and that testing procedure for diagnosis for Alzheimer's "did not accurately reflect her status". The caller declined to provide a healthcare provider contact and wants no one other than herself to be contacted. The patient outcome is unknown. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Head injury, Hypotension, Incorrect dose administered
Clinical narrative: This spontaneous report was received from the patient's mother refers to a 17 year old female patient. The patient had allergy to penicillin. On 07-JUL-2011 the patient was vaccinated with the first dose of GARDASIL; on 15-AUG-2011 the patient was vaccinated with the second dose of GARDASIL; and on 09-APR-2012 the patient was vaccinated with the third dose of GARDASIL. On 01-DEC-2014 the patient went to a physician visit for a routine sports physical examination and was vaccinated with GARDASIL, one injection, intramuscular in the arm, (strength, lot number and expiration date were not reported). Concomitant therapies included unspecified flu shot in the other arm on the same day GARDASIL was administered. The reporter stated that the patient was given a 4th dose of GARDASIL in error, because the patient already completed the three dose series of GARDASIL and this should had been in her medical records. On 01-DEC-2014, after being administered the fourth dose of GARDASIL, the patient "fainted", hit her head, and was unconscious for about one minute near the front desk. The patient was immediately rushed to the Emergency Room for further testing and observation. The patient showed signs of low blood pressure and she vomited. Electrocardiogram (EKG), labwork and computerised tomogram (CAT) scan were performed, results were not provided. The patient was treated with fluids. No further information was provided. The outcome of fainted, hit her head, unconscious for about one minute, signs of low blood pressure and vomited were unknown. Upon internal review the event unconscious was considered serious due to medically significant. Additional information is not expected, because contact information was not provided.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Laboratory test, Loss of consciousness, Syncope, Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother refers to a 17 year old female patient. The patient had allergy to penicillin. On 07-JUL-2011 the patient was vaccinated with the first dose of GARDASIL; on 15-AUG-2011 the patient was vaccinated with the second dose of GARDASIL; and on 09-APR-2012 the patient was vaccinated with the third dose of GARDASIL. On 01-DEC-2014 the patient went to a physician visit for a routine sports physical examination and was vaccinated with GARDASIL, one injection, intramuscular in the arm, (strength, lot number and expiration date were not reported). Concomitant therapies included unspecified flu shot in the other arm on the same day GARDASIL was administered. The reporter stated that the patient was given a 4th dose of GARDASIL in error, because the patient already completed the three dose series of GARDASIL and this should had been in her medical records. On 01-DEC-2014, after being administered the fourth dose of GARDASIL, the patient "fainted", hit her head, and was unconscious for about one minute near the front desk. The patient was immediately rushed to the Emergency Room for further testing and observation. The patient showed signs of low blood pressure and she vomited. Electrocardiogram (EKG), labwork and computerised tomogram (CAT) scan were performed, results were not provided. The patient was treated with fluids. No further information was provided. The outcome of fainted, hit her head, unconscious for about one minute, signs of low blood pressure and vomited were unknown. Upon internal review the event unconscious was considered serious due to medically significant. Additional information is not expected, because contact information was not provided.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Head injury, Hypotension, Laboratory test
Clinical narrative: This spontaneous report was received from the patient's mother refers to a 17 year old female patient. The patient had allergy to penicillin. On 07-JUL-2011 the patient was vaccinated with the first dose of GARDASIL; on 15-AUG-2011 the patient was vaccinated with the second dose of GARDASIL; and on 09-APR-2012 the patient was vaccinated with the third dose of GARDASIL. On 01-DEC-2014 the patient went to a physician visit for a routine sports physical examination and was vaccinated with GARDASIL, one injection, intramuscular in the arm, (strength, lot number and expiration date were not reported). Concomitant therapies included unspecified flu shot in the other arm on the same day GARDASIL was administered. The reporter stated that the patient was given a 4th dose of GARDASIL in error, because the patient already completed the three dose series of GARDASIL and this should had been in her medical records. On 01-DEC-2014, after being administered the fourth dose of GARDASIL, the patient "fainted", hit her head, and was unconscious for about one minute near the front desk. The patient was immediately rushed to the Emergency Room for further testing and observation. The patient showed signs of low blood pressure and she vomited. Electrocardiogram (EKG), labwork and computerised tomogram (CAT) scan were performed, results were not provided. The patient was treated with fluids. No further information was provided. The outcome of fainted, hit her head, unconscious for about one minute, signs of low blood pressure and vomited were unknown. Upon internal review the event unconscious was considered serious due to medically significant. Additional information is not expected, because contact information was not provided.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Loss of consciousness, Syncope, Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother refers to a 17 year old female patient. The patient had allergy to penicillin. On 07-JUL-2011 the patient was vaccinated with the first dose of GARDASIL; on 15-AUG-2011 the patient was vaccinated with the second dose of GARDASIL; and on 09-APR-2012 the patient was vaccinated with the third dose of GARDASIL. On 01-DEC-2014 the patient went to a physician visit for a routine sports physical examination and was vaccinated with GARDASIL, one injection, intramuscular in the arm, (strength, lot number and expiration date were not reported). Concomitant therapies included unspecified flu shot in the other arm on the same day GARDASIL was administered. The reporter stated that the patient was given a 4th dose of GARDASIL in error, because the patient already completed the three dose series of GARDASIL and this should had been in her medical records. On 01-DEC-2014, after being administered the fourth dose of GARDASIL, the patient "fainted", hit her head, and was unconscious for about one minute near the front desk. The patient was immediately rushed to the Emergency Room for further testing and observation. The patient showed signs of low blood pressure and she vomited. Electrocardiogram (EKG), labwork and computerised tomogram (CAT) scan were performed, results were not provided. The patient was treated with fluids. No further information was provided. The outcome of fainted, hit her head, unconscious for about one minute, signs of low blood pressure and vomited were unknown. Upon internal review the event unconscious was considered serious due to medically significant. Additional information is not expected, because contact information was not provided.
Sex: U
Vaccine: DTAPIPV
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylaxis in a child patient who received KINRIX (batch number 9AB77, expiry date unknown). Concurrent medical conditions included milk allergy. On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to KINRIX.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 0905 immediately following the influenza vaccination he had an area of induration, warmth and erythema at the injection site. Given diphenhydramine 25mg. Within 7-10 minutes post injection he only had induration remaining.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood test normal, Cardiac stress test normal, Chest X-ray normal, Electrocardiogram normal, Headache
Clinical narrative: Symptoms start 10/24/14: sore throat, headache, swollen neck glands, pain in right shoulder/torso. Symptoms subsided 11/25/14.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Lymphadenopathy, Mononucleosis heterophile test negative, Musculoskeletal pain, Oropharyngeal pain
Clinical narrative: Symptoms start 10/24/14: sore throat, headache, swollen neck glands, pain in right shoulder/torso. Symptoms subsided 11/25/14.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Face injury, Syncope
Clinical narrative: Patient came to the pharmacy, accompanied by his father, to request the quadrivalent flu vaccine. He mentioned that he does not fare well with needles but wanted the vaccine anyway. After the vaccine was administered, he was given a bottle of water and asked to sit for a few minutes to see how he feels. After sitting for a few minutes, he felt weak so he laid down on the floor with his feet up on the chair for a few minutes and then sat back up on the chair for a few more minutes until he felt he was okay to leave. After he left the pharmacy and crossed the street, he felt lightheaded and fainted. He came out of it quickly, took a couple steps and fainted again. He came out of it and continue to go home. He fainted again when he reached the front entrance of his building and injured his chin as a result of his fall. His father helped him into the lobby and called down his mother for help. He laid down and rested until he felt a little better. Then they took him to the hospital to treat his injuries. His mother called today (11/26/14) to report the event and said that he is now okay.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain, Rotator cuff syndrome
Clinical narrative: Pain in right shoulder after flu vaccine that resulted in limited range of motion. Progressively became worse. Vaccine given high in arm. MRI - shoulder impingement syndrome.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Developed (L) shoulder pain after receiving a flu vaccine - was given high in the arm.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Following flu shot developed deltoid pain/deep aching, usually 2-3/10 on pain scale, some movement 6-7/10/ Declined medical treatment.
Age: 47.0
Sex: F
Vaccine: FLUR3
Symptoms: Dysphonia, Hypersensitivity, Pruritus, Rash
Clinical narrative: Itching, rash, raspy voice, anaphylactic. Due to hx of numerous allergies (possibly eggs as well) was give FLUCELVAX and, had her wait in waiting room for 20 min. At about 15 min after vaccine given-started to develop s/s.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Became short of breath after receiving a flu vaccine - taken to ER.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Burning down (L) arm after receiving flu vaccine continues to have pain, especially in the morning after sleeping on arm. Declined treatment. Given high in arm.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neuralgia, Radiculitis brachial
Clinical narrative: Verbal report from employee: Diagnosed with Brachial Neuritis. Has stiff neck and arm, nerve pain and spasms. On steroids and FLEXERIL.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain (L) shoulder. Vaccine given high on arm.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Lg reddened area approximately 60 mm in circumference at injection site. Slightly sore. No treatment. EE to use warm compresses and ibuprofen at home.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain
Clinical narrative: Felt painful after injection throughout night. Swelling left neck in a.m.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness (L) deltoid. Started suddenly having chills, vomiting, headache and sever "thirst". He could not get warm enough. Start on same day that he received vaccine 12/1/14 at 1000pm - 4 am. Fell asleep at 4 am.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Insomnia, Thirst, Vomiting
Clinical narrative: Redness and soreness (L) deltoid. Started suddenly having chills, vomiting, headache and sever "thirst". He could not get warm enough. Start on same day that he received vaccine 12/1/14 at 1000pm - 4 am. Fell asleep at 4 am.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient experiencing prolonged and more severe injection site pain. Still not resolved. today.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Pt states they had SOB, redness, swelling, body aches, fever.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Myelitis transverse
Clinical narrative: No signs of adverse events or reactions after administration of the flu vaccine or the T-dap on 11/14/14. It was reported by agency infection control RN the patient was dx with Transverse Myelitis 2 weeks after administration.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Pink rash flat, non-palpable, Not warm onset 12/1/14. No treatment. MD uncertain if related to vaccine, parents certain it is.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient got vaccine on 10-14-14. Pain started in the evening and has remained since. Unable to use left arm without pain. Was seen by a doctor and was told to use cold compress but did not relieve pain. Pain at injection site remains.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Rash
Clinical narrative: Pt developed rash on both arms. Feels warm but not sure if feverish. Took BENADEYL and feel better.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Feeling abnormal, Malaise, Nasal congestion, Rhinorrhoea
Clinical narrative: This case was reported by other health professional and described the occurrence of sick in a female patient who received FLULAVAL 2014-2015 season. On 10th October 2014, the patient received FluLaval 2014-2015 season. In October 2014, unknown after receiving FluLaval 2014-2015 season, the patient experienced sick, stuffy nose, running nose and bad feeling. On an unknown date, the patient experienced recurrent cough. On an unknown date, the outcome of the sick, recurrent cough, stuffy nose and bad feeling were unknown. It was unknown if the reporter considered the sick, recurrent cough, stuffy nose, running nose and bad feeling to be related to FluLaval 2014-2015 season.  Patient received the tri flu shot.
Age: 41.0
Sex: M
Vaccine: FLUN4
Symptoms: Dyspnoea, Rash, Throat tightness
Clinical narrative: Patient described that he felt like his throat was closing and was having SOB. Patient had an acute rash. Called ambulance for transfer to ER.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Muscle spasms, Pain
Clinical narrative: Stated tricep hurt very had when given. By evening arm was tight and sore-knew that could be expected. No redness or swelling. Bad pain in arm, tried to lift arm and bad pain shot down arm. States had spasms in arm when injected-wondered if it hit nerve or something? A few days ago so bad could not lift arm. Went to ER. 11/30/14 and was given pain pills that did not help. On 12/2/14 went to PMD-put on non steroidal to loosen arm up 12/3/14 arm loosening up today-has more movement-if lifts high-very painful still.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Stated tricep hurt very had when given. By evening arm was tight and sore-knew that could be expected. No redness or swelling. Bad pain in arm, tried to lift arm and bad pain shot down arm. States had spasms in arm when injected-wondered if it hit nerve or something? A few days ago so bad could not lift arm. Went to ER. 11/30/14 and was given pain pills that did not help. On 12/2/14 went to PMD-put on non steroidal to loosen arm up 12/3/14 arm loosening up today-has more movement-if lifts high-very painful still.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 (also reported as on an unspecified date in last winter), the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration was not provided), to prevent shingles. No concomitants were reported. The pharmacist reported that "within a week" of a patient receiving ZOSTAVAX, two sisters of the patient developed shingles. The pharmacist was unsure if the patient that received ZOSTAVAX developed any adverse reactions or if the two sisters came in contact with the patient after the patient received ZOSTAVAX. No product quality complaint (PQC) was involved. Action taken with respect to ZOSTAVAX was not applicable. Outcome of event was unknown. Causality was not provided. The pharmacist did not have any further information. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no pertinent medical history or drug reactions/allergies. On 10-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K007986, 09-MAR-2015) (dose and route not reported). There was no concomitant medication. On 10-NOV-2014, the patient developed a 4-5 inch are of swelling and redness at the injection site after administration of ZOSTAVAX. The area of reaction was painful and itchy. No lab test was performed. The patient self-treated with unspecified topical anti-itch cream and antibiotic cream applied to the area of reaction. The patient sought medical attention via calling the pharmacist. The pharmacist suggested to the patient to take ADVIL. At the time of reporting, the patient had not recovered from the events. The causality between the events and ZOSTAVAX was not reported. Additional information is not expected, as the physician asked not to be contacted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient did not have pertinent medical history. The patient had drug reaction to codeine result in hives. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K003603, expiration date 20-MAR-2015, dose 0.65 ml) subcutaneous in the left arm for vaccination. None concomitant therapies were reported. On  11-NOV-2014 in the evening, the patient experienced injection site redness, chills and hardened area in left arm from elbow to armpit. As of 14-NOV-2014, patient's adverse effect had resolved somewhat but not completely, so she sought medical attention with pharmacist for recommendation for treatment. Ibuprofen was given for treatment of the adverse event. None lab diagnostics studies were performed. Action taken for ZOSTAVAX was not applicable. The relationship between all event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 months old patient of unknown gender. On 08-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant regarding a patient of unknown age and gender. On 07-NOV-2014 the patient was vaccinated with an expired dose of MMR II (lot # H018949, expiration date 18-OCT-2014) (dose and route not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information is not expected because the reporter cannot be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of who was about 65 to 70 years of age. No medical history was reported. On 18-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose and frequency not provided). The concomitant therapy included anticoagulant (unspecified). The patient who received ZOSTAVAX contacted a pharmacy on 20-NOV-2014, complaining of "a golf-sized area of raised, red skin". The pharmacist had not directly observed this injection-site reaction, but he states that the patient reproted that surrounding the "golf-ball-sized area" was an area of dark pink skin "about the size of a tennis ball." The pharmacist contacted the service call center inquiring about what was considered "a typical injection-site reaction" for ZOSTAVAX. He reproted that he was not in the pharmacy with which the patient made contact. He state that he would be seeing the patient on 21-NOV-2014, and that he would be able to provide more details at that time because he would be having access to the patient's information. The pharmacist reported that He did not know whether or not the patient was developing a rash. The outcome of the events was unknown. The Causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 18-NOV-2014 the patient received an expired dose of PNEUMOVAX 23 (lot # J004332, expiration date: 26-SEP-2014, route of administration, anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported. Further information was not provided. Product quality complaint (PQC) was not involved. Additional information is not expected because there was no consent for follow-up.
Sex: U
Vaccine: VARCEL
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. On 05-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous, lot number and expiration date were not reported) which was improperly stored. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female 70 year old patient. On 20-NOv-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K007988; expiry: 03-SEP-2015, dose: 0.65 ml, subcutaneous in the left deltoid region. No concomitant medications were reported. A patient visited the pharmacy on Saturday, 29-NOV-2014, and showed the pharmacist that the injection site where she received a dose of ZOSTAVAX is warm, red, and swollen. The patient reported that she "feels fine otherwise." The patient did not receive any other vaccinations on the day she received ZOSTAVAX, nor has she received any vaccinations since she received ZOSTAVAX. The patient reported that she "suddenly noticed" that her injection site was warm, red, and swollen on 29-NOV-2014. The patient had not informed her physician about this injection site ear to be developing a rash. There was no treatment given for the events. Action taken was unknown. The outcome of the patient's injection site was warm, red and swollen was reported as recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 41 year old patient. On 26-NOV-2014 (also reported as today) the patient was vaccinated with PROQUAD (lot # K000710, expiration date 16-JUL-2015, 0.5 ml dose, subcutaneously in the left arm) rather than M-M-R II. The patient had not experienced any adverse effects. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Hypertension, Peripheral swelling
Clinical narrative: Hypertension and swelling of arm.
Age: 0.09
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 week old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 23-OCT-2014, the patient was vaccinated with first dose of RECOMBIVAX HB (dose, frequency, lot number and route unspecified). On 25-NOV-2014 the patient was vaccinated with second dose of expired RECOMBIVAX HB (lot number: H010380 with expiry date of 18-NOV-2014) (dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Myalgia, Rash
Clinical narrative: Myalgia, skin rash, rash and erythema multiform.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, induration - 2.8 cm x 3.3 cm on anterior aspect of (L) thigh. Non-tender. Mother advised to do warm soaks.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history, relevant concomitant medication, and past drug history were unknown. On 26-NOV-2014, the pharmacy had a power outage and the temperature in the refrigerator reached 77 degrees for up to 9 hours. On 28-NOV-2014, a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K009874, expiration date: 19-MAR-2016) that was stored in the refrigerator was administered to a patient. It was unknown if there was relevant lab data. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker regarding a 8 year and 10 month old patient of unknown gender who on 29-OCT-2014 was vaccinated with a dose of GARDASIL intramuscular (dose, lot # and expiration date not reported). No known adverse effects. It was unknown if the patient sought medical attention. 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 nurse practitioner refers to a unknown number of patients of unknown age and unknown gender. Patient concurrent conditions and relevant medical history was not reported. On an unknown date unknown number of patients were vaccinated with improperly stored GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was unknown. This case is linked to #1412USA001450 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date unknown number of patients were vaccinated with improperly stored PEDVAXHIB (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PEDVAXHIB was unknown. This case is linked to # 1412USA001369 via same reporter link. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node swelling.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to her 13 year old daughter. No pertinent medical history of the patient was reported. On 11-AUG-2014, the patient was administered with the first dose of GARDASIL intramuscularly (strength, lot number, expiry date and site of administration were not reported). On 06-OCT-2014, the patient received the second dose of GARDASIL. On 08-NOV-2014 the patient was vaccinated with the third dose GARDASIL, intramuscular. There was no concomitant medications reported. It was reported that on 08-NOV-2014, the third dose of GARDASIL was administered out of sequence, without waiting for the six months between the second and third doses. The vaccine was administered by an unspecified nurse at the practice. The patient did not experience any side effects from GARDASIL. The doctor suggested that the patient could get an additional dose of GARDASIL after the patient had reached the 6 months point. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena
Clinical narrative: This spontaneous report was received from a other health professional (dentist) refers to a female patient of unknown age. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, therapy route, lot # and expiry date not reported). Concomitant medications were not reported. In 2014 (reported as unspecified date earlier in the year) the patient experienced seizure like symptoms on an unspecified date, after receiving GARDASIL. No product quality complaint (PQC) was reported. Outcome of the event was not reported. Causality assessment was not provided. This is one of the several reports received from the same source (MARRS #1412USA001509). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a other health professional (dentist) refers to a female patient of unknown age. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, frequency, therapy route, lot # and expiry date not reported). On an unknown date the patient experienced fainting on an unspecified date after receiving GARDASIL. Outcome of the event was not reported. Causality assessment was not provided. This is one of the several reports received from the same source (MARRS #1412USA001433). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Back of (L) arm, red, bruised, swollen painful. Could not move. Missed 2 days of work. Swelling extended to her (L) armpit and back. Had picture on her cell phone.
Age: 41.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site swelling, Oedema peripheral, Swelling
Clinical narrative: Back of (L) arm, red, bruised, swollen painful. Could not move. Missed 2 days of work. Swelling extended to her (L) armpit and back. Had picture on her cell phone.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 3 patients of unknown demographics. The patients pertinent medical history was not reported. On an unknown date the patients received improperly stored ZOSTAVAX. No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the 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 as received from a Nurse refers to a 3 patients of unknown demographics. The patients pertinent medical history was not reported. On an unknown date the patients received improperly stored VARIVAX (Merck). No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 3 patients of unknown demographics. The patients pertinent medical history was not reported. On an unknown date the patients received improperly stored RECOMBIVAX HB. No adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Convulsion, Eye movement disorder, Tremor
Clinical narrative: Approx 20 hrs after vaccines had temp of 101 and seizure with shaking and eyes rolling back in head. Lasted few minutes. Mom gave TYLENOL and is otherwise well.
Age: 1.06
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Erythema, Oropharyngeal pain, Peripheral swelling, Pruritus
Clinical narrative: Patient presents with rash. No history of fever, sore throat, and cough. The rash is involving the upper extremity. The character is described as pruritic, red and warm. Had Tdap 3 days ago. Starting next day arm was red, swollen, itchy, slightly improved today. No medication given, no fever.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient presents with rash. No history of fever, sore throat, and cough. The rash is involving the upper extremity. The character is described as pruritic, red and warm. Had Tdap 3 days ago. Starting next day arm was red, swollen, itchy, slightly improved today. No medication given, no fever.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist, as part of the rebate patient support program, refers to a female patient of unknown age with hypertension, thyroid issues and gastrointestinal (GI) tract malfunction. At the time of this report the patient had no known allergies. On  07-NOV-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K010648, expiration date 30-OCT-2015, 0.65 ml, subcutaneous in the left arm (dose number was unspecified). Concomitant therapies were unspecified (also reported as "nothing immunosuppressive"). On an unknown date in 2014 (a couple days ago), the patient experienced red spots on her skin, on her legs, stomach, arms and head. The reporter stated that had not observed these red spots. The reporter also stated that a phone call from the patient's son was received, reporting that the patient had been itching and had low grade fever. Treatments given for the adverse events were unspecified. The patient sought medical attention by calling physician but no one had returned the phone call. The pharmacist did not know of the patient developing shingles. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 28-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II, lot # H014988, expiration date 08-AUG-2014, (dose, dose number, route and anatomical location were unspecified). Dose supported. No concomitant therapies were reported. No adverse experience reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous repot as received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported.  The pharmacist informed that on 07-NOV-2014, the patient was vaccinated with dose of M-M-R II (injection, lot# K004948, expiration date: 04-APR-2016 (route and dosage were not reported). That underwent an unsupported temperature excursion. No adverse effects were reported.  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 nurse refers to 13 patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with doses of improperly stored of GARDASIL (strength, dosage, route, lot number and expiration date 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.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (strength, dosage, route, lot number and expiration date 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: 66.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Hypertension, Tremor
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a regulatory authority and concerns a 66 year old female: US 9215. The subject's weight was not reported. The subject's concurrent conditions included upset stomach. The subject had a drug history of mycin and penicillin allergy. The subject received typhoid vaccine oral ty21a (capsule, hard, oral; batch 120601B), 4th dose on 12-DEC-1991 as a prophylactic vaccination. Concomitant medications included terfenadine and acetylsalicylic acid. On an unspecified date, the subject experienced high blood pressure, shaking and was extremely weak. The subject required an emergency room/ doctor's visit. The subject recovered from the events of high blood pressure, shaking and being extremely weak on an unspecified date. Action taken with typhoid vaccine oral ty21a was not applicable. Company causality was assessed as not related. This report was serious (medically significant).
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Local swelling, Pyrexia
Clinical narrative: 9/22/14 patient received PNEUMOVAX in left arm as she has asthma history. Pt dvlpd red bump enlarging with fever and heat and pain 12 cm x 11 cm. Red hot tender area. Diagnosed w/cellulitis.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: 9/22/14 patient received PNEUMOVAX in left arm as she has asthma history. Pt dvlpd red bump enlarging with fever and heat and pain 12 cm x 11 cm. Red hot tender area. Diagnosed w/cellulitis.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: 9/22/14 patient received PNEUMOVAX in left arm as she has asthma history. Pt dvlpd red bump enlarging with fever and heat and pain 12 cm x 11 cm. Red hot tender area. Diagnosed w/cellulitis.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain in extremity, Sleep disorder
Clinical narrative: Severe aching pain in arm and shoulder of injection site (left arm). As the day progressed, so did the pain. Unable to sleep on left side or use arm without the pain worsening. Unable to sleep due to pain. Ibuprofen used for pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Bronchitis, Chest X-ray, Cough, Sinusitis
Clinical narrative: Start with cough, 11/07/2014 went to emergency facility, diagnose bronchitis gave me Prednsone, Claritin and albuterol. Cough continue after treatment went to a generalist diagnosed sinusitis. Give me some nasal decongestant, antibiotics, send to take a head xray an refer me to a OTORHINOLARYNGO SPECIALIST HE CHECK ME gave me Alegra and Singulair. Feel a little better but the cough still prevailed until today 12/04/2014.