chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Rash
Clinical narrative: This spontaneous report was received from a physician referring to a 68 year old female patient without drug reactions or allergies. The patient's medical history included high blood pressure and breast cancer. On 29-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot number, expiration date, dose, route and anatomical location were not reported. Concomitant therapies included Atenolol and Amlodipine. On 31-OCT-2015, the patient broke out in a rash in right arm and had one rash like spot on left arm, she noted that her rash was painful and she was not able to sleep (insomnia). On 03-NOV-2015, the patient went to the physician's office and she was diagnosed with Shingles from receipt of the vaccine. As treatment, the physician wrote a prescription for 1 gram of VALTREX twice daily for five days. At the time of the report, the outcome of Shingles and insomnia was reported as not recovered/not resolved. There was not a product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Rash, Varicella
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old male patient. On 09-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 09-OCT-2015, the patient received another dose of ZOSTAVAX (dose, route and lot # not reported). In October 2015, the patient experienced a rash on his face and both sides of his arm. On 23-OCT-2015, the patient was seen by a physician and he was diagnosed with chicken pox. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. There were no medical history and concurrent conditions reported for the patients. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases 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 pharmacist and refers to multiple unspecified patients of unknown age and gender. There were no medical history and concurrent conditions reported for the patients. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of MMR II (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram normal, Injected limb mobility decreased, Injection site pain, X-ray normal
Clinical narrative: 09/07/14 - Flu shot administered at pharmacy at 9:17 a.m. followed by extreme pain within the hour. Left arm was totally immobile. Notified pharmacy at 10:00 a.m. the same day. Total immobility lasted approximately four to six weeks. After that period of time, the pain became limited to the area from elbow to shoulder with the most pain in the deltoid muscle. 10/07/14, 10/14/14 and 10/21/14-Received massage therapy. These sessions did not relieve the pain. 11/10/14-Office visit with Dr. Had an Xray of left arm, including deltoid muscle, which showed no results. Dr. ordered pain patches with lidocaine and muscle relaxers (Tizanidine) on the same day. Once again, these did nothing to relieve the pain. 03/31/15, 04/02/15 and 04/16/15-Received acupuncture treatments. These treatments did nothing to lessen the pain. 05/27/15-Consult with Dr. He still did not know what could be done to alleviate the pain in the deltoid muscle. 07/23/15-Had an EMG test done by orthopedic. Dr. did not find anything and ordered physical therapy. 08/31/15 and 09/02/15-Received physical therapy. I also did "at home" physical therapy. These treatments were painful and yielded no results. As of this date (11/09/15), I am still experiencing pain in the deltoid muscle of my left arm but feel it is about 65% to 75% better since 09/07/14.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL, DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Oxygen saturation decreased, Respiratory rate increased, Wheezing
Clinical narrative: 4-5 minutes after the vaccines were administered, patient started having a lot of salivation, redness on his face and he started to complain that he couldn't breathe. When the Dr arrived, he was given Albuterol in nebulization + an Epinephrine shot. Office called Ambulance and patient was taken to ER, where he was stabilized. He was given another shot of Epinephrine + Solumedrol (Anti-Histamine). We spent 4 hours at the ER, and then he was discharged.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL, DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Salivary hypersecretion, Tryptase increased
Clinical narrative: 4-5 minutes after the vaccines were administered, patient started having a lot of salivation, redness on his face and he started to complain that he couldn't breathe. When the Dr arrived, he was given Albuterol in nebulization + an Epinephrine shot. Office called Ambulance and patient was taken to ER, where he was stabilized. He was given another shot of Epinephrine + Solumedrol (Anti-Histamine). We spent 4 hours at the ER, and then he was discharged.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Ear pain, Headache, Influenza virus test negative, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Body aches, fever, pain that radiated up right arm from injection site to ear and jaw, stiff neck, vertigo, headache.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Pain, Pain in jaw, Vertigo
Clinical narrative: Body aches, fever, pain that radiated up right arm from injection site to ear and jaw, stiff neck, vertigo, headache.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Ear pain, Headache, Influenza virus test negative, Injection site pain
Clinical narrative: Body aches, fever 100.7, vertigo, Headache, pain radiating from injection site up to ear, pale, weakness.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pallor, Pyrexia, Vertigo
Clinical narrative: Body aches, fever 100.7, vertigo, Headache, pain radiating from injection site up to ear, pale, weakness.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Weight bearing difficulty
Clinical narrative: Arm stiff and sore. Can't lift arm higher than shoulder. Can't bear weight on arm or lift anything with left arm.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Injection site erythema, Myalgia, Vaccination site nodule
Clinical narrative: Extreme pain in muscles in legs and arms. Large knot at vaccination site as well as red and very warm. Headaches and chills but no fever.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site warmth
Clinical narrative: Extreme pain in muscles in legs and arms. Large knot at vaccination site as well as red and very warm. Headaches and chills but no fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Allergy test, Blood test normal, Cough, Dyspnoea
Clinical narrative: Slowly developed a dry cough. Initially thought was start of a cold but this cough over several weeks deepened and was a continual spasms of a deep unproductive cough.  No other symptoms other than occas sore throat and some sinus drainage (I also have seasonal allergies, dust, etc. which started to kick in towards Oct.)   Went to the doctor and urgent care at least 3 x.  Was in the bronchial and according to drs, not in the lungs (did not do an xray).  I was so bad I could not do my daily activities but remained in my bedroom with humidifier and air cleaner going.  No meds helped and it is still lingering a bit in my bronchials.  I have been to a new allergist also who does not see a relationship to allergies unless it was a reaction to the PREVNAR 13 vaccine. No way for him to tell.  I feel this is directly related to the vaccine (either ingredients or my immune systems response to same or something I don't know about the vaccine and me) since I have never in my life, at 65, having gone through plenty of illnesses and health challenges, had this type of a cough not a cough this persistent and severe.  It seemed more like what I would think of as a "whooping cough" (which I have been vaccinated against about 2 months earlier with a tetanus shot with no known negative response).  I would just cough and cough until I couldn't catch my breath (asthma has been ruled out). Treatment was really to try to loosen the cough.  Nothing really worked.  Eventually guaifenesin helped a bit, took fluticasone propionate, cough syrups, amoxicillin 10 day, and 10 day Levaquin.  I am still coughing occas. each day with a bit of loosened mucus.  Only 1 or 2 x a day usually.  This has been about 8 weeks now.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Paranasal sinus hypersecretion
Clinical narrative: Slowly developed a dry cough. Initially thought was start of a cold but this cough over several weeks deepened and was a continual spasms of a deep unproductive cough.  No other symptoms other than occas sore throat and some sinus drainage (I also have seasonal allergies, dust, etc. which started to kick in towards Oct.)   Went to the doctor and urgent care at least 3 x.  Was in the bronchial and according to drs, not in the lungs (did not do an xray).  I was so bad I could not do my daily activities but remained in my bedroom with humidifier and air cleaner going.  No meds helped and it is still lingering a bit in my bronchials.  I have been to a new allergist also who does not see a relationship to allergies unless it was a reaction to the PREVNAR 13 vaccine. No way for him to tell.  I feel this is directly related to the vaccine (either ingredients or my immune systems response to same or something I don't know about the vaccine and me) since I have never in my life, at 65, having gone through plenty of illnesses and health challenges, had this type of a cough not a cough this persistent and severe.  It seemed more like what I would think of as a "whooping cough" (which I have been vaccinated against about 2 months earlier with a tetanus shot with no known negative response).  I would just cough and cough until I couldn't catch my breath (asthma has been ruled out). Treatment was really to try to loosen the cough.  Nothing really worked.  Eventually guaifenesin helped a bit, took fluticasone propionate, cough syrups, amoxicillin 10 day, and 10 day Levaquin.  I am still coughing occas. each day with a bit of loosened mucus.  Only 1 or 2 x a day usually.  This has been about 8 weeks now.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Herpes zoster, Pleurisy
Clinical narrative: Started having chest pain. Went to the ED on 11/14/15 and diagnosed with pleurisy.  On Monday, 11/16/2015, broke out with shingles.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe joint pain and body aches, high fever (103+) nauseated, severe headache.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle soreness, limited use of shoulder muscle.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Headache, Injection site pain, Rash
Clinical narrative: Patient complains of headache, pain in arm where injection was given, rash on same arm, slightly short of breath.  Day 3 with same symptoms.  Pt advised to take Benadryl, call PCP, and go to ER if face or mouth swells of breathing becomes difficult.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blepharospasm, Hypoaesthesia
Clinical narrative: Facial numbness and eye twitching x 8 hours (until went to sleep). Resolved upon waking. No Treatment necessary.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood test, Cardiac flutter, Chest X-ray, Chills
Clinical narrative: Fever, chills, excessive sweating, joint pain, racing heart, heart fluttering, general felt AWFUL.  What sent me to the ER were the heart palpatations...sleeplessness.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Hyperhidrosis, Insomnia, Palpitations, Pyrexia
Clinical narrative: Fever, chills, excessive sweating, joint pain, racing heart, heart fluttering, general felt AWFUL.  What sent me to the ER were the heart palpatations...sleeplessness.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Urine analysis
Clinical narrative: Fever, chills, excessive sweating, joint pain, racing heart, heart fluttering, general felt AWFUL.  What sent me to the ER were the heart palpatations...sleeplessness.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site urticaria
Clinical narrative: Patient had significant bleeding at injection site. After bleeding stopped, a dime sized welt was observed at the injection site. On 11/14/15, the patient reported that she has a 3" bruise at the injection site and pain that radiates the length of her arm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain
Clinical narrative: She developed R should pain, arm numbness and difficulty with grasp.  It has slowly improved but she still has symptoms periodically. (per MD note)
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: Woke up with extreme pain in my left shoulder, unable to use that arm, felt shaky ans sick to my stomach.  Went to my Dr after about 2 weeks with the shoulder still swollen, quite painful and range of motion still limited.  Started anti inflammatory med and physical therapy, returned in August still having pain and motion problems, had an MRI noting severe bursitis and a tear in the shoulder.  Was given a steroid shot that helped, but the shoulder is still painful and I have been told there is an impingement.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nervousness, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: Woke up with extreme pain in my left shoulder, unable to use that arm, felt shaky ans sick to my stomach.  Went to my Dr after about 2 weeks with the shoulder still swollen, quite painful and range of motion still limited.  Started anti inflammatory med and physical therapy, returned in August still having pain and motion problems, had an MRI noting severe bursitis and a tear in the shoulder.  Was given a steroid shot that helped, but the shoulder is still painful and I have been told there is an impingement.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tenderness
Clinical narrative: Client woke up with tenderness. Rash on upper left side of back consistent with shingles rash.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient returned to the clinic today and reported the symptoms to me, onset was next day with chills, fever (unk), body aches, very sore injection site, very tender to touch, red, swollen.  Symptoms last 36 hours.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient returned to the clinic today and reported the symptoms to me, onset was next day with chills, fever (unk), body aches, very sore injection site, very tender to touch, red, swollen.  Symptoms last 36 hours.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: Extreme Dizziness (fell twice - no injuries) Lasted past Midnight. Rest. Will report this to my MD on Monday.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received the high-dose flu shot and Prevnar on the same day and requested them in the same arm.  She came back on 11/12/15 because her arm near her elbow (not where she was vaccinated) was swollen slightly, red, and warm to the touch.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: PATIENT THOUGHT HER HAND WAS SWOLLEN. HER ARM AT INJECTION SITE WAS NOT RED OR SWOLLEN. I COULD NOT TELL IF HER HAND WAS SWOLLEN OR NOT, BUT SHE WAS CONCERNED IT WAS FROM VACCINE.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Patient called in the morning and stated his arm was swelling. He said it was from the pneumonia vaccine at the time. However, his girlfriend called back in the afternoon and stated it was his right arm which is where he received a flu shot. She said he had a rash spread down to his elbow. I advised them to go to the ER or urgent care.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Hyperhidrosis, Lethargy, Presyncope
Clinical narrative: Became lethargic, sweaty, almost fainted but father carried her to a chair.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported breaking out with large Shingles rash on arm where vaccine was administered.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Redness, hives around injection site measuring about 2 inches in diameter, itching and the area is swollen. Patient states pain since initial injection but that it increased this morning after waking and that's when itching started. He took off bandaid ten min post injection.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Started as severe pain in upper left shoulder. Loss of range of motion, cannot lift, pull with arm. Have trouble sleeping at night waking up with arm pain. Cannot do normal activities without pain. Very bothersome.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Chemical taste in mouth; recalled similar symptoms after taking now-forgotten antibiotics ~decade ago. Persisted throughout the day, after eating, brushing, etc.
Age: 1.5
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Abnormal behaviour, Blood test, Computerised tomogram, Decreased appetite, Emotional distress
Clinical narrative: Screaming and arching back, dead eyes inconsolable, low grade fever, not sleeping or eating, not acting herself, not using her words.
Age: 1.5
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Insomnia, Opisthotonus, Pyrexia, Screaming, Speech disorder
Clinical narrative: Screaming and arching back, dead eyes inconsolable, low grade fever, not sleeping or eating, not acting herself, not using her words.
Age: 1.5
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Staring
Clinical narrative: Screaming and arching back, dead eyes inconsolable, low grade fever, not sleeping or eating, not acting herself, not using her words.
Sex: F
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a consumer regarding a female patient (reporter's friend's young daughter) of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (lot# unspecified). No concomitant medications were reported. Since vaccination with GARDASIL, the patient now had seizures. No Product Quality Complaint (PQC) was reported. The outcome of seizures was not reported. Causality assessment was not provided. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen, reddish color upper right arm and feels "hot" according to pt.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Pain, weakness, numbness in (L) arm. Pt states vaccine solution burned while administered.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness, swelling, itching at vaccine site (L) deltoid.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Pruritus
Clinical narrative: Itchy patches of discomfort/misery; after adjusting variables, pt has decided started right after and must be due to immunization. Will now try hydrocortisone and BENARYL cream.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Patient developed rashes in the back day after the shot was administered. Rash was itchy and eventually went away after 2-3 days.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Induration
Clinical narrative: 4 cm induration - none erythema, no exudate, no lymph nodes.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL. Approximately on 06-NOV-2015, reported as "is currently in the office", the patient received a second dose of GARDASIL 9. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-SEP-2015, the patient was vaccinated with improperly stored dose of (Merck) PROQUAD (lot # K013867, expiration date 05-MAR-2016) (dose and route of administration were not provided). No adverse effect was reported. 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 refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route of administration were not reported, lot # reported as K02504 with expiration date: 22-JUL-2016). No adverse effects were reported. This is one of 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 multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were not reported, lot # J014855 with expiration date: 16-APR-2016 and K010216 with expiration date: 12-MAY-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician referring to a 13 year old patient of unknown gender. On 05-NOV-2015 the patient was vaccinated with GARDASIL 9 (dose was not reported, lot # L011846 with expiration date: 16-JUN-2017, intramuscularly in the gluteal muscle). The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ dose was not reported, lot # L004453 with expiration date: 16-APR-2015 and K010222 with expiration date: 12-MAY-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Merck) VARIVAX (dose, route, lot # and expiration date were not reported). There were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding multiple unspecified patients of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Merck) PROQUAD, (dose, route, lot # and expiration date were not reported). There were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medication and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not provided). The syringe used to draw up the GARDASIL from the vial and injection the patient "leaked" and the patient did not receive the full dose of GARDASIL. It was verified this was not a product quality complaint (PQC). No adverse effect was reported. The outcome of medical device complication was unknown. The relatedness between medical device complication and GARDASIL was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 52 year old female patient with chronic obstructive pulmonary disease (COPD). No information regarding the patient's concomitant medication and drug reactions or allergies was reported. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (strength, dose, route of administration, lot # and expiration date were not provided). On the same date, the patient was vaccinated with influenza virus vaccine (unspecified) in the arm (strength, dose, route of administration, lot # and expiration date were not provided). No indication was given as to which arm or the timing of the 2 shots. Later on 06-NOV-2015, the patient returned to the nurse practitioner's office and complained of "warm and swollen arm".  On 09-NOV-2015, the patient returned to the nurse practitioner's office and her arm was still "red and swollen" (onset date of arm's redness estimated to November 2015). It was unspecified if the patient received the treatment and had lab diagnostics studies performed. The patient notified the nurse practitioner that she was feeling better and recovering from the events. The patient sought medical attention. The relatedness between the events and PNEUMOVAX 23 and influenza virus vaccine (unspecified) was not reported. 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 pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 26-AUG-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.  Patient details: suspect therapy, event data and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of M-M-R II injection, lot # K002527, expiration date 18-FEB-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of (Merck) PROQUAD injection, lot # K009891, expiration date 11-JAN-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-SEP-2015 a 13 year old patient was vaccinated with (Merck) PROQUAD (strength, dose, frequency were not reported) (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On an unknown date the patients was vaccinated with improperly stored (Merck) PROQUAD (strength, dose, frequency and route were not reported) lot # L030586 with an expiry date of 10-FEB-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports 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 healthcare worker refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On an unknown date the patients was vaccinated with improperly stored (Merck) VARIVAX (strength, dose, frequency and route were not reported) lot # L023594 with an expiry date of 26-JUN-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports 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 physician refers to a 20 patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # L017144 with expiration date: 13-MAY-2017). No adverse effects reported. Additional information is not expected. The reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # K022990, expiration date- 04-MAY-2016. No adverse event was reported. The outcome of the event was unknown. 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: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # K002746, expiration date 09-DEC-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 26-AUG-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash pustular
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old male patient. The patient's concurrent conditions included high blood pressure and high blood cholesterol. The patient had shingles in the past. On 14-OCT-2015, the patient was vaccinated with ZOSTAVAX lot # L012478, (Expiry date 10-JUL-2016) dose 0.65 ml, tablet, subcutaneous. Concomitant therapies included sterile diluent (lot # K024557, (Expiry date 10-OCT-2016), hydrochlorothiazide (HCTZ), CRESTOR, lisinopril, omeprazole and HYTRIN. On 15-OCT-2015 the patient developed a rash "ovular, 2 inches across by 1 inch with pustules at the edges that are flat and dry, not like usual shingles he had in the past". It was reported that the patient received AFLURIA (lot # U55806, Expiry date 18-JUN-2016), on 14-OCT-2015, same day as ZOSTAVAX was administered in the opposite arm. The patient sought medical attention contacted the pharmacist. The outcome of rash was not known. Causality assessment was not provided. There was no product quality complaint filed. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician via a company representative referring to a 4 years old male patient. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was mistakenly vaccinated with a dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported) which was outside the recommendations Per the prescribing information of GARDASIL 9 (off-label use and inappropriate schedule of drug administration). Concomitant drug was not reported. Outcome of the events and the causality were not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a health worker referring to a patient of unknown age and gender. On 28-MAY-2015, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, strength, lot # and expiration date unknown). On 29-OCT-2015 the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, strength unknown, lot # L017265, expiration date: 10-FEB-2017) (extra dose administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of ROTATEQ orally, lot # K022990, expiration date 26-JUN-2016 (dose was not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of patients received improperly stored doses of VARIVAX injection, lot # K009757, expiration date 09-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of the 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 pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 10-SEP-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of PNEUMOVAX 23 injection, prefilled syringe, lot # K020215, expiration date 15-MAY-2016 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-AUG-2015, the patient was vaccinated with a dose (it was unspecified which dose in series it was) of improperly stored GARDASIL lot # J006850, expiration date 31-MAR-2016 (strength, dose and route of administration were not provided). On 16-OCT-2015, the patient was vaccinated with and additional dose (it was unspecified which dose in series it was) of improperly stored GARDASIL (lot # J006850, expiration date 31-MAR-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 12-SEP-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # K021030, expiration date: 22-JUN-2016 (dose, route and site of administration were not reported). NO adverse effects were reported. Follow up information has been received from the pharmacist on 09-NOV-2015. On 03-SEP-2015, the patient was vaccinated with dose of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy, event data and narrative were updated.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Musculoskeletal disorder
Clinical narrative: Extreme soreness at injection site (unable to use arm); headache.
Age: 1.24
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Rash
Clinical narrative: RASH DEVELOPED AROUND NOSE/MOUTH AND SPREAD TO UNDER EYES. STILL WON'T GO AWAY. NO TREATMENT HAS HELPED.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Eye pruritus, Malaise, Pain, Productive cough, Rhinitis
Clinical narrative: Cough productive, diffuse body aches, coryza, itchy eyes, severe malaise.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Chills, Hyperhidrosis, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fever 101, sore stiff arm where shot was given. 6 days after shot given fever 101 returned, chills, severe muscle pain, sweating while sleeping. 10 days later severe shoulder bursitis of left side (same side as injection).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 101, sore stiff arm where shot was given. 6 days after shot given fever 101 returned, chills, severe muscle pain, sweating while sleeping. 10 days later severe shoulder bursitis of left side (same side as injection).
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Onset of shingles.
Age: 0.41
Sex: M
Vaccine: DTAP
Symptoms: Febrile convulsion, Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever started the evening of 11/12/2015, noticed swelling, redness and lump at sight of injection in the morning of 11/13/2015, fever peaked around 4:30 am on 11/14/2015, at 8:30 am he had a seizure, paramedics called and evaluated at hospital febrile seizure confirmed.
Age: 0.41
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Low grade fever started the evening of 11/12/2015, noticed swelling, redness and lump at sight of injection in the morning of 11/13/2015, fever peaked around 4:30 am on 11/14/2015, at 8:30 am he had a seizure, paramedics called and evaluated at hospital febrile seizure confirmed.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, over all body aches, headache, fatigue, pain and swelling at site of injection, red rash at site of injection ~1 inch diameter day 1: day 2 thru day 5 fever, severe body muscle and joint aches and pain, severe headache, chills, severe fatigue and muscle weakness, difficulty breathing: day 4 elevated heart rate to 165 BPM, for 48 hours: by day three rash around injection site covered back of arm from shoulder to elbow and around both sides: day 6 arm rash gone but large hard lump on arm at injection site ~ 4" diameter: day 8 body fatigue resolved and other symptoms resolved but hard lump on arm persistent ~  4" diameter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Fever, over all body aches, headache, fatigue, pain and swelling at site of injection, red rash at site of injection ~1 inch diameter day 1: day 2 thru day 5 fever, severe body muscle and joint aches and pain, severe headache, chills, severe fatigue and muscle weakness, difficulty breathing: day 4 elevated heart rate to 165 BPM, for 48 hours: by day three rash around injection site covered back of arm from shoulder to elbow and around both sides: day 6 arm rash gone but large hard lump on arm at injection site ~ 4" diameter: day 8 body fatigue resolved and other symptoms resolved but hard lump on arm persistent ~  4" diameter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Muscular weakness, Myalgia, Pain
Clinical narrative: Fever, over all body aches, headache, fatigue, pain and swelling at site of injection, red rash at site of injection ~1 inch diameter day 1: day 2 thru day 5 fever, severe body muscle and joint aches and pain, severe headache, chills, severe fatigue and muscle weakness, difficulty breathing: day 4 elevated heart rate to 165 BPM, for 48 hours: by day three rash around injection site covered back of arm from shoulder to elbow and around both sides: day 6 arm rash gone but large hard lump on arm at injection site ~ 4" diameter: day 8 body fatigue resolved and other symptoms resolved but hard lump on arm persistent ~  4" diameter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, over all body aches, headache, fatigue, pain and swelling at site of injection, red rash at site of injection ~1 inch diameter day 1: day 2 thru day 5 fever, severe body muscle and joint aches and pain, severe headache, chills, severe fatigue and muscle weakness, difficulty breathing: day 4 elevated heart rate to 165 BPM, for 48 hours: by day three rash around injection site covered back of arm from shoulder to elbow and around both sides: day 6 arm rash gone but large hard lump on arm at injection site ~ 4" diameter: day 8 body fatigue resolved and other symptoms resolved but hard lump on arm persistent ~  4" diameter.