chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Rec. vaccine 12 N 12/8/14. 830pm N and V. Temp 102. 9pm upper left arm swollen, red, hot to touch.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Rec. vaccine 12 N 12/8/14. 830pm N and V. Temp 102. 9pm upper left arm swollen, red, hot to touch.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient husband came in and said pt complained left arm pain. Also spoke about a rash in adbomen/ribs on 11/03/14 - Advised patient to go to Emergency Room. Patient husband came back and said arm is still hurting but never went to see MD. 11/17/14 vaccine give 10/20/14 when pt 64. Before vaccine given, patient complained of arm pain.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Crepitations, Injected limb mobility decreased, Injection site pain, Weight bearing difficulty
Clinical narrative: Pain in upper arm where shot was administered. Some cracking sounds. Unable to sleep on left side or lift heavy objects. Movement of arm constrained.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Starting a couple days after the vaccine, there has been a mild pain in my left arm under the vaccine site. Skin is not affected. It lasted for a long time and only in the last few days is going away. I told the pharmacist a couple weeks ago and he recommended I take 3 tablets of ibuprofen twice a day, which I did for a few days and it helped. Now when I feel a little pain I take ibuprofen. It is feeling much better but I wanted to report it. I am marking "patient recovered" as "unknown" for now, but I think I am almost completely recovered.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Local swelling
Clinical narrative: SIGNIFICANT LOCAL ERYTHEMA AND SWELLING.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site injury, Limb discomfort, Middle insomnia
Clinical narrative: Patients left arm was sore and uncomfortable, woke her up during sleep. When looked at it site purple and red from elbow to shoulder. Family MD determined a vessel was nicked during injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vascular injury
Clinical narrative: Patients left arm was sore and uncomfortable, woke her up during sleep. When looked at it site purple and red from elbow to shoulder. Family MD determined a vessel was nicked during injection.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Gait disturbance, Neck pain, Spinal pain
Clinical narrative: I noticed soreness in my spine and slight neck pain. By the next day the pain was worse in my back and concentrated in my lower back and neck. By the third day I could barely walk because of the pain in my lower back. There is also pain in my neck. I am taking Naprosyn now, so I don't know the ultimate outcome.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling on L upper arm. No noted generalized rashes. No respiratory distress. MD made. MD reassured pt mom. Pt was assessed by MD.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Patient has had continued pain and MRI as well as physical therapy.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Body temperature increased, Dizziness, Feeling hot, Nausea
Clinical narrative: 4:30 P child noted to stomach ache and nausea, felt warm. The following morning noted T103.1, continued c/o stomach, nausea, slight dizziness. Symptoms seemed to resolve over 24 hours.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified number of patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were administered improperly stored doses of ROTATEQ (dose and frequency were not reported). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. 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 medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of ROTATEQ (dose, frequency, and lot # were not reported, orally) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUR3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Woke up from sleep with itching on left upper arm, went to bathroom and saw red arm.  Took Benadryl until I fell back asleep.  Reported to employee health services for follow up on 12/18/2014, saw provider for red, itchy, whelped areas on left deltoid.  Prescription for prednisone given.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient received Fluarix quad vaccine on 11/02/14. She called on 12/18 concerned that she still has pain in her arm and wanted to know if its from vaccine. She has not seen a doctor yet.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Burning sensation, Herpes zoster, Pruritus
Clinical narrative: 2 days after flu vaccine developed itching, burning and blisters to L scalp. Diagnosed with herpes zoster.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm pain at vaccination site with redness, extreme swelling, and warmth from shoulder to elbow.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased
Clinical narrative: Patient believes that the shot was not injected into her deltoid muscle, but "higher up near the bone and entered the joint fluid between her bones." She claims that this resulted in her losing range of motion in her arm and required her to seek physical therapy.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: AS PER EMPLOYEE 1 1/2HRS AFTER INJECTION EMPLOYEE STARTED TO FEEL DIZZY AND LIGHTHEADED. EMPLOYEE STATES SHE LAID DOWN AND WENT TO SLEEP. SYMPTOMS RESOLVED THE FOLLOWING MORNING.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site pain, X-ray limb normal
Clinical narrative: Person stated he had no problems when flu shot was administered, painless and no complications, after several days it the shoulder area where shot was given was very sore and got black and blue, his entire shoulder area remained black and blue for several weeks and now 2 months later is still very sore. He had a doctor X-ray shoulder to see if he had done something to it and x-ray came back normal. He has had the flu shot every year for 20+ years and has never had a reaction before.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Blood glucose normal, Full blood count normal, Gait disturbance, Metabolic function test normal
Clinical narrative: Patient was not given his usual Concerta am dose. He was giggly, had a "drunken" gait and erratic behavior. After eating his behavior was normal for him. Later in the afternoon during PE he again has a similar gait when escorted to the nurse's office but when held by a staff person he had full strength in all extremities to attempt to get away from her.  Physical exam in this office was normal. He spoke clearly.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Patient was not given his usual Concerta am dose. He was giggly, had a "drunken" gait and erratic behavior. After eating his behavior was normal for him. Later in the afternoon during PE he again has a similar gait when escorted to the nurse's office but when held by a staff person he had full strength in all extremities to attempt to get away from her.  Physical exam in this office was normal. He spoke clearly.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Severe swelling and pain at site of injection x2.  Initially received vaccination 1 dose of vaccine in June and developed severe swelling and pain requiring medical attention.  Upon second dose on 12/08/2014, patient redeveloped similar symptom of severe swelling and pain which pt described as worse than first.  Patient treated with antibiotics and pain medication.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Redness noted by parent.  Still red next day at 3:00 pm.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Myalgia
Clinical narrative: It has been four weeks since getting flu shot.  Muscle pain continues and seems to be getting worse at the injection site on left arm.  Have been getting flu shots for 25 years and never had any king of adverse reaction at all.  Pain at injection site would always go away after a day or two. Not this time?  Something is just not right this time?  Have not been to a doctor yet.  But plan on going first of year if not better.  The flu shot I received was suppose to protect against 4 strains of the flu.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Leukocytoclastic vasculitis, Rash, Skin graft
Clinical narrative: Chest pain, rash, general joint pain, leading to skin necrosis.  Diagnosed as leukocytoclastic vasculitis.  Extensive skin grafts to repair damage on both legs and feet.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Skin necrosis
Clinical narrative: Chest pain, rash, general joint pain, leading to skin necrosis.  Diagnosed as leukocytoclastic vasculitis.  Extensive skin grafts to repair damage on both legs and feet.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient woke up the next day to swollen red and tender area at injection site appr 3 x 2.5 inches. Patient came to pharmacy 12-14-14 pharmacist recommended Benadryl which brought itch, redness and swelling under control. Spoke to the patient 12-18-14 all is well except for slight tenderness at site all swelling and redness subsided.
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a other health professional and described the occurrence of passed out in a male patient who received FLUARIX. On an unknown date, the patient received FLUARIX .5 ml. On an unknown date, 15 min after receiving FLUARIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. The reporter considered the passed out to be unrelated to FLUARIX. Additional details provided: The patient was about to get blood drawn and the reporter thought that the event occurred because the patient saw the needle for the blood draw. The reporter does not believe the event was not related to the FLUARIX. She did not have more information.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experienced prolonged pain and soreness on upper right arm where it was vaccinated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Patient stated that 4 hours after receiving vaccine she experienced shakiness for 45 minutes and then she experienced severe vomiting for one day. She went to urgent care and she was treated for dehydration with IV medications.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm sore, swollen, red area "size of hand", warm to touch, small number of petechiae and area blanches.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Petechiae
Clinical narrative: Upper left arm sore, swollen, red area "size of hand", warm to touch, small number of petechiae and area blanches.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 5 cm red warm area on (L) arm at injection site, site feeling itchy. No fever, no hives, SOB. Ice pack, BENADRYL, azithromycin as site tender and warm, TYLENOL. If no improvement - patient to go to emergency room.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Emotional distress
Clinical narrative: Mom reports that baby was inconsolable for about 7 hours about 8 hours post vaccination. Mom did give TYLENOL when baby would not calm down and baby did settle down after that. No fever or redness at sites.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Neck pain
Clinical narrative: Bruise in area of injection pain from injection to shoulder up to back of neck.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Malaise, Myalgia
Clinical narrative: T101.4, malaise, severe myalgias w/i 12  hours of vaccine.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness and swelling of right deltoid. Exam reveals 8 cm x 10 cm swelling - erythemia, and enduration. No fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Pain in extremity, Peripheral swelling, Tenderness, Upper extremity mass
Clinical narrative: Patient reportds severe brusing at/near the site of injection. Patient reports arm pain, tenderness and swelling, persisting to present day. Patient says she feels there is a "mass" in the arm.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Onset: one day after flu shot. Patient feel "drag-down", fatigue, nausea and vomting for 3 days. Vomit 1 time per day. Increase water intake and say in bed. Recovered on the 4th day.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Employee states noticed swelling and redness on upper (L) arm today from the flu vaccine received on 12-1-14.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Pain in area vaccinated is causing limited movement with pain when arm is jolted or abrupt movement of body (ie shock from stepping down from a curb) will cause pain in the upper arm where vaccinated which makes me stop moving any further.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Pain in area vaccinated is causing limited movement with pain when arm is jolted or abrupt movement of body (ie shock from stepping down from a curb) will cause pain in the upper arm where vaccinated which makes me stop moving any further.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a health professional refers to a 78 year old male patient. The patient's pertinent medical history included hypertension. In 2008 (reported as six years ago), the patient was administered PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). In September 2014 (reported as 3 months ago), the patient was vaccinated with another dose of PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). In 2014 (reported as shortly after), the patient experienced fever and body ache. The outcome of body ache and fever was reported as recovered/resolved on an unspecified date in 2014. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Discomfort, Erythema, Local swelling, Pain, Pruritus
Clinical narrative: C/O large area swelling, redness and pain with itching. BENADRYL used for discomfort. Pt could not tolerate ice.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Dizziness, Hyperhidrosis, Nausea, Tremor, Vomiting
Clinical narrative: Dizziness, nausea, shaking, emesis, diaphoresis.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Vaccination site rash
Clinical narrative: Started as rash on vaccine site, then rash turned into blisters and opened. Had to go to urgent care to see doctor.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old male patient. On 01-JUL-2014, the patient was vaccinated with the first dose (Oka/Merck) VARIVAX lot # J012376, expiration date 03-OCT-2015, 0.5 ml, subcutaneous. On 12-AUG-2014, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (lot # and expiration date were not reported), 0.5 ml, subcutaneous. On 22-SEP-2014, the patient was mistakenly vaccinated with the third dose of (Oka/Merck) VARIVAX lot # J013728, expiration date 30-OCT-2015, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 70mm redness and 30mm induration at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient. The patient's concurrent conditions included hypothyroidism. None drug reactions or allergies were reported. On 08-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot #, expiration date were not reported). Concomitant therapies included SYNTHROID. On 08-DEC-2014, the patient experienced redness at her site on injection on her left lateral deltoid area. The physician reported that the area of redness was progressing to the size of approximately 20 cm by 5 cm. On 12-DEC-2014, area appeared to raised. The physician could not determine, at the time of this report, if the patient was developing a rash. The physician reported that the patient denied pain, she did not have fever, body aches and any other symptoms. The physician reported the reddened area was not warm to the touch or indurated. The physician has prescribed to the patient ROCEPHIN and KEFLEX, which did not seem to have any effect. The patient had none lab diagnostic studies performed. The patient sought medical attention. The outcome of event was reported as not recovered. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a other healthcare professional via other company refers to 4 patients of unknown age and unknown gender. The patients current conditions and medical history was not reported. On an unknown date the 4 patients were vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported) (lot # J013394) that had been exposed to temperatures outside of the required temperature range and the efficacy of the product outside the temperature range has not been established. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot# not reported). No concomitant medications reported. The medical assistant has reported that over the last 30 days (approximately from the 09-NOV-2014) an unknown number of doses of VARIVAX (Merck) which underwent a supported temperature excursion had been administered to the patients. No adverse effects reported. No treatment was given for the adverse event. Product quality complaint was not reported. This is one of the several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown demographics. The patient's relevant medical history, concomitant medications and past drug histories were unknown. On 09-DEC-2014, the patient was vaccinated with a dose of GARDASIL injection (lot # K005881, expiry date: 14-JUL-2014; strength, dose and route of administration unspecified), that had been through a temperature excursion on this day and possibly a past temperature excursion. It was unknown if the GARDASIL was first, second or third injection of the series. It is unknown if there was any relevant laboratory data. As of 09-DEC-2014 it was unknown if the patient will continue to receive the GARDASIL. This is one of several reports from the same source. Additional information has been requested.
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. On 17-DEC-2014 the patient was inadvertently administered with an expired dose of PNEUMOVAX 23, (dose, route and lot number not reported). The expiration date was reported as 20-NOV-2014. No adverse effects reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema
Clinical narrative: This spontaneous report was received from a other health professional refers to a 48 year old male patient with sleep apnea, diabetes and hypertension. The patient's medical history included hypercholesterolemia. On 25-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409; expiry: 6) intramuscular. Concomitant therapies included benazepril hydrochloride and omeprazole (manufacturer unknown). On 26-NOV-2014 (also reported as within 2 days prior to 28-NOV-2014), after receiving the dose, patient experienced erythema at the injection site and chills. The erythema was diagnosed as possible cellulitis. As a result, patient was started on cephalexin (manufacturer unspecified). Patient's present status was unspecified. Lab diagnostics studies performed was none. Patient sought medical attention and called had an office visit. There was no product quality complaint (PQC) involved. The outcome of possible cellulitis and chills is unknown. Causality assessment was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old female patient with painful menstruations and familial risk (history of aluminum and nickel allergy). On 19-NOV-2014, the patient was vaccinated with a first dose of GARDASIL, .5 ml intramuscular in the left arm, Lot # K009202 and expiration date on 17-DEC-2016. Reporter also mentioned that the patient was prescribed MICROGESTIN on 19-NOV-2014, however the patient had discontinued it (unspecified reason). It was reported that one day and a half after vaccine administration, approximately on 20-NOV-2014, the patient developed a headache and shortness of breath. The patient also developed a numbness of her hands and ankles. The patient went to the emergency room where patient had multiple tests (chest and lung x-ray) and all results were negative. The patient stated that she was had never been tested for allergies so it was not known if the patient was allergic to aluminum and nickel. The patient sought medical attention at emergency room. At the time of the report, the patient had not recovered from the events. The relatedness between the event and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of VARIVAX (Merck) (dose, frequency, route of administration and lot # were not reported) that were exposed to a temperature excursion since 02-NOV-2014 (exact dates not provided) which was unknown to be supported or not supported at that time. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On 23-SEP-2014, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular (lot/batch number was not reported). It was reported that the patient received the first two doses of GARDASIL 0.5 ml, intramuscular (lot/batch number was not reported) on 18-MAR-2014 and 31-JUL-2014. On an unknown date (reported as after receiving the 3rd dose), it was learned that the patient was pregnant. The patient became pregnant with last menstrual period (LMP) reported as of 08-SEP-2014 and estimated due date (EDD) of 15-JUN-2015, calculated based on reported LMP. On an unknown date, unspecified pregnancy test was completed (results were not provided). It was reported that the patient sought medical attention by reporting pregnancy to Health Care Professional (HCP) office. At the time of the report, the pregnancy outcome was unknown. 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 medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of PROQUAD (dose, frequency, route of administration and lot # were not reported) that were exposed to a temperature excursion since 02-NOV-2014 (exact dates not provided) which was unknown to be supported or not supported at that time. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients. On unknown date, patient were vaccinated with a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). The medical assistant reported that in the past there had been an unspecified number of patients who have experienced pain at the injection site when GARDASIL was administered. The reporter had no other information on these patients. The patient's outcome, and the relatedness between the event and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, pain, swelling (R) thigh after receiving KINRIX.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient received the PREVNAR 13 on 12/9/14 at approx. 8:45 AM. She reports that her left upper arm started to swell, with a red rash spreading to upper part of shoulder later that afternoon. No pain at site, no restriction in shoulder ROM, slight itching. No reaction to her last Pneumococcal vaccination. Was seen by another provider on 12/16/14, and treated with antibiotics for 5 days. Patient in the process of recovering. Caller her 12/17 at 3 PM and patient states that she seem to be improving at the injection site on left arm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patient's medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not 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 as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unspecified dates in 2014, the patients were vaccinated with doses of PEDVAXHIB (dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. 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 medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. In approximately 2014, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequently, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality compliant (PQC) was not involved. This is 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 receivd from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified number of patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were administered improperly stored doses of PNEUMOVAX 23 (dose and frequency were not reported). No adverse events were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with PROQUAD (Merck), (lot#, dose, route not reported). No concomitant medications reported. The medical assistant has reported that over the last 30 days (approximately from the 09-NOV-2014) an unknown number of doses of PROQUAD (Merck) which underwent a supported temperature excursion had been administered to the patients. No adverse effects reported. No treatment was given for the adverse event. Product quality complaint was not reported. This is one of the several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thi spontaneous report as received from a registered nurse refers to a patient with unknown age and gender. On an unknown date the patient received a dose of improperly stored (Oka/Merck) VARIVAX (1 dose). No adverse effects reported. It was not specified if the patient sought for medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Employee was feeling dizziness, lightheaded,nausea, clammy. Vitals were BP-133/86, Pulse-82, Temp-98.7. Employee rested on exam table for about 30 minutes and drank fluids. Employee stated feeling better at that time.
Sex: U
Vaccine: HBHEPB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been receivd from a registered nurse concerning a patient of unknown age and gender. On 16-MAR-2007 the patient was vaccinated with a first dose of unspecified Hepatitis B vaccine (manufacturer unknown) (dose, lot #, expiration date and route not reported). On 30-APR-2007 the patient was vaccinated with a second dose of COMVAX (lot # and expiration date not reported) 0.5 ml, intramuscular. On 31-JUL-2007 the patient received third dose of COMVAX (lot # and expiration date not reported) 0.5 ml, intramuscular. The patient received doses of Hepatitis B on a shorter than recommended schedule. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: L arm (injection site) induration (6 x 7 cm) with large inflammatory reaction (pain/erythema) without evidence of infection.
Sex: U
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from an other health professional on 20-NOV-2014 refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (Lot # 4387514). The clinic reported the patient had a reaction. The patient developed a hot red swollen rash. The outcome of developed a hot red swollen rash is unknown. The product was noted to be disposed of , however, the rest of the inventory was turned to branch. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Feeling hot, Urticaria
Clinical narrative: Client stated "I started to feel feverish in my hands and ears tightness in my chest and then hives." His father is a nurse practitioner. Client called him and he gave him a steroid shot. Client felt better.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL (strength, route, dose, lot, batch # and expiration date not reported). Concomitant therapies were not reported. On an unknown date the patient was administered the second dose of GARDASIL, 3 years after the first dose of GARDASIL. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected because physician did not want to be contacted.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a company representative refers to a 11 year old male patient. On an unknown date the patient was vaccinated with GARDASIL lot # K008621, expiry date: 04-MAR-2017 (also reported as 20-MAR-2017). It was reported that this product was exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range was not established. No allergic reaction was observed. No medical attention was needed. Outcome of the event was not reported. Causality assessment was not provided. This is one of several reports from the same source (MARRS # 1412USA009297). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a company representative refers to a 8 year old female patient. On an unknown date the patient was vaccinated with GARDASIL lot # K008621, expiry date: 04-MAR-2017 (also reported as 20-MAR-2017). It was reported that this product was exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range was not established. No allergic reaction was observed. No medical attention was needed. Outcome of the event was not reported. Causality assessment was not provided. This is one of several reports received from the same source (MARRS # 1412USA003042). Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Contusion, Ecchymosis, Erythema, Injection site pain
Clinical narrative: Reaction to pneumonia shot. Patient is here because he is having a reaction to a pneumonia shot, L arm swollen, sore in shoulder and elbow, had shot on 12/15. Soreness started at injection site that night. Started 12/16 sl swelling L inner forearm, bruise on L forearm started with redness around and then ecchymosis around bruise progressed. No fever. Arm hurts to use it or lie on it at night. Hurts to use shoulder. No sx of fever. Patient reports no fever, no night sweats, no significant weight gain, no significant weight loss, and no exercise intolerance. He reports no difficulty hearing and no ear pain. He reports no frequent nosebleeds, no nose/sinus problems, and no rhinorrhea. He reports no sore throat, no bleeding gums, no snoring, no dry mouth, no mouth ulcers, no oral abnormalities, and no teeth problems. He reports no chest pain, no arm pain on exertion, no shortness of breath when walking, no shortness of breath when lying down, no palpitations, no know heart murmur, and no leg swelling. He reports no cough, no wheezing, no shortness of breath, and no coughing up blood. He reports no abdominal pain, no vomiting, normal appetite, no diarrhea, not vomiting blood, no nausea, no acid reflux, and no constipation. He reports no depression, no sleep disturbances, feeling safe in relationship, and no alcohol abuse.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Peripheral swelling
Clinical narrative: Reaction to pneumonia shot. Patient is here because he is having a reaction to a pneumonia shot, L arm swollen, sore in shoulder and elbow, had shot on 12/15. Soreness started at injection site that night. Started 12/16 sl swelling L inner forearm, bruise on L forearm started with redness around and then ecchymosis around bruise progressed. No fever. Arm hurts to use it or lie on it at night. Hurts to use shoulder. No sx of fever. Patient reports no fever, no night sweats, no significant weight gain, no significant weight loss, and no exercise intolerance. He reports no difficulty hearing and no ear pain. He reports no frequent nosebleeds, no nose/sinus problems, and no rhinorrhea. He reports no sore throat, no bleeding gums, no snoring, no dry mouth, no mouth ulcers, no oral abnormalities, and no teeth problems. He reports no chest pain, no arm pain on exertion, no shortness of breath when walking, no shortness of breath when lying down, no palpitations, no know heart murmur, and no leg swelling. He reports no cough, no wheezing, no shortness of breath, and no coughing up blood. He reports no abdominal pain, no vomiting, normal appetite, no diarrhea, not vomiting blood, no nausea, no acid reflux, and no constipation. He reports no depression, no sleep disturbances, feeling safe in relationship, and no alcohol abuse.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history, drug reactions or allergies were not reported. On 21-NOV-2014 the reporter stated that the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose number was not reported) lot # J004332, expiration date 26-SEP-2014, 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse experience was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot# K009876, expiry date 19-MAR-2016, dose, route and frequency were not provided). On an unknown date the patient experienced redness at the injection site and the surrounding area was "hot". The patient didn't seek for medical attention. The outcome of the events was not provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Dyspnoea, Mass, Papule, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old female patient with asthma. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot # K014835, expiration date: 14-DEC-2014, subcutaneous in the arm (as the prescribing information). Concomitant therapies included ADVAIR. On 03-DEC-2014 the patient experienced shortness of breath, asthma attacks and a red sensitive "slabbish" rash on the entire injection arm that began as papules after receiving ZOSTAVAX. The pharmacist reported that the patient used her already prescribed unspecified short-acting beta-agonists (SABA) medications for treatment of the asthma attacks; any other treatment was unspecified. The outcome of the events was reported as recovering/resolving. The reporter considered asthma attack to be life threatening. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old female patient with asthma. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot # K014835, expiration date: 14-DEC-2014, subcutaneous in the arm (as the prescribing information). Concomitant therapies included ADVAIR. On 03-DEC-2014 the patient experienced shortness of breath, asthma attacks and a red sensitive "slabbish" rash on the entire injection arm that began as papules after receiving ZOSTAVAX. The pharmacist reported that the patient used her already prescribed unspecified short-acting beta-agonists (SABA) medications for treatment of the asthma attacks; any other treatment was unspecified. The outcome of the events was reported as recovering/resolving. The reporter considered asthma attack to be life threatening. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Condition aggravated, Dyspnoea, Hyperaesthesia, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old female patient with asthma. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot # K014835, expiration date: 14-DEC-2014, subcutaneous in the arm (as the prescribing information). Concomitant therapies included ADVAIR. On 03-DEC-2014 the patient experienced shortness of breath, asthma attacks and a red sensitive "slabbish" rash on the entire injection arm that began as papules after receiving ZOSTAVAX. The pharmacist reported that the patient used her already prescribed unspecified short-acting beta-agonists (SABA) medications for treatment of the asthma attacks; any other treatment was unspecified. The outcome of the events was reported as recovering/resolving. The reporter considered asthma attack to be life threatening. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Papule, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old female patient with asthma. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot # K014835, expiration date: 14-DEC-2014, subcutaneous in the arm (as the prescribing information). Concomitant therapies included ADVAIR. On 03-DEC-2014 the patient experienced shortness of breath, asthma attacks and a red sensitive "slabbish" rash on the entire injection arm that began as papules after receiving ZOSTAVAX. The pharmacist reported that the patient used her already prescribed unspecified short-acting beta-agonists (SABA) medications for treatment of the asthma attacks; any other treatment was unspecified. The outcome of the events was reported as recovering/resolving. The reporter considered asthma attack to be life threatening. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site swelling
Clinical narrative: Significant pain upon injection. Nurse said it felt "hard" to get needle in. Arm remained swollen (hard knot) and sore for over a week and then I experienced decrease of right arm motion (unable to lift arm out from side more than 20-30 degrees. Increase in upper arm pain to point it was hard sleeping. Could not lie on arm.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Significant pain upon injection. Nurse said it felt "hard" to get needle in. Arm remained swollen (hard knot) and sore for over a week and then I experienced decrease of right arm motion (unable to lift arm out from side more than 20-30 degrees. Increase in upper arm pain to point it was hard sleeping. Could not lie on arm.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Local swelling, Nodule, Pain in extremity
Clinical narrative: Significant pain upon injection. Nurse said it felt "hard" to get needle in. Arm remained swollen (hard knot) and sore for over a week and then I experienced decrease of right arm motion (unable to lift arm out from side more than 20-30 degrees. Increase in upper arm pain to point it was hard sleeping. Could not lie on arm.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain of skin, Paraesthesia, Peripheral coldness
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 year old female patient with asthma and breast cancer. The patient had no allergies or drug reactions. On 19-NOV-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular, 1 dose, dosage and dose number unknown; lot number reported as: K005402 EXP 07-NOV-2015). Concomitant therapies included DULERA and an unspecified rescue inhaler. On 22-NOV-2014, the patient felt "cold", tingling sensation (like BENGAY), and pain to the touch "like nerve pain" down her right arm, chest, abdomen, and the entire right side of her body, which was the same side on which she was vaccinated. The patient sought medical attention (nurse practitioner office visit) but received no treatment. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.