chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Vomiting
Clinical narrative: This case was reported by a contact via call center representative and described the occurrence of diarrhea in a 52-year-old male patient who received BOOSTRIX (batch number 87PC3?, expiry date 12th SEPTEMBER 2016). On 27th FEBRUARY 2015 10:00, the patient received BOOSTRIX. On 27th FEBRUARY 2015, less than a day after receiving BOOSTRIX, the patient experienced fatigue, vomiting, urine color abnormal, gas pain and eating disorder. On 27th FEBRUARY 2015 11:45, the patient experienced diarrhea and abdominal cramp. On 28th FEBRUARY 2015, the outcome of the vomiting was recovered/resolved. On 1st MARCH 2015, the outcome of the diarrhea, abdominal cramp, fatigue, urine color abnormal, gas pain and eating disorder were recovered/resolved.  The reporter considered the diarrhea, abdominal cramp, fatigue, vomiting, urine color abnormal, gas pain and eating disorder to be possibly related to BOOSTRIX. Additional information received: Reporter which is a GSK employee stated that all symptoms were suspected to be related to the BOOSTRIX vaccine that her husband received. He immediately reported the symptoms to his doctor who unfortunately did not follow up.
Sex: M
Vaccine: TDAP
Symptoms: Injection site haematoma, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a adult male patient who received BOOSTRIX. On 13th MAY 2015, the patient received BOOSTRIX. On 13th MAY 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong injection technique. In MAY 2015, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage and wrong injection technique were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to BOOSTRIX. Additional details were reported as follows. The pharmacist administered BOOSTRIX with a 18 G needle (vs a 25 G). Subsequently, less than a week after vaccination, the patient bled and  he felt the vaccine leaked out.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site erythema, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. No pertinent medical history was reported. On 31-MAR-2015, the patient was vaccinated with ZOSTAVAX Vial (lot # K020185 and expiration date 27-JAN-2016), dose 0.65 ml, subcutaneous. Concomitant therapies included SYNTHROID. On 02-APR-2015, the patient experienced contusion, pruritus, redness at the injection site, the redness also extended  down to her elbow. Patient sought medical attention. On an unspecified date, the patient was seen by her unspecified physician for evaluation and was provided with an unspecified treatment. Symptoms were still present, however, they were improving. The pharmacist denied that any rash, lesions, spots, papules or blisters were present and reported that the red area was not raised at all. Action taken was not applicable. The outcome of events was recovering/resolving. Causality was not assessed by the 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 demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX injection (strength, dose, route and site of administration, lot # and expiry date were unspecified). No concomitant medications were reported. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed herpes zoster, reported to ED on 5/10/15 after receiving Zostavax on 5/4/15.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at injection site, warm and itchy 11 mm x 17 mm after physical exercise.
Sex: U
Vaccine: HIBV
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 demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB injection (strength, dose, route and site of administration, lot # and expiry date were unspecified). No concomitant medications were reported. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of improperly stored ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, lot # and expiry date were unspecified). No concomitant medications were reported. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cardiac pacemaker insertion, Disability, Dizziness, Drug interaction
Clinical narrative: It was 2005 and got TBI as a result. I  had the pneumonia vaccine and everything was fine. I'm a little slow and it's been hell trying to nail down what happened. It was the next time I had a couple drags off a joint of pot. I said, 2 drags is enough, I have to get some fresh air. I sat in my open car, engine off. I lit a cigarette then, felt my legs were funny, so I flexed the muscles in them to make them feel better. I felt strong confusion coming on so, I got out to watch the mechanic to give my brain something to focus on. Then, I felt like I'm getting no air. Was I breathing?? It didn't seem so, so I breathed on purpose. The air was going in and out fine but, there was no oxygen in it. I felt like I was drowning and there was no way out. My brain was going into a frenzy trying to figure it out. Maybe I'm hyperventilating? So I stopped and my lungs did not take over on their own. The ultimate sensation of fear and no thought process about getting on the ground for safety, in which I was trained. I saw black. They said I stiffened up and fell straight back like a tree. They couldn't catch me in time. I woke up in the ambulance in unsurvivable pain to my head. They put a pacemaker in me cause my rate was slow and they couldn't find anything else. As my brain healed and I was able to walk 2 weeks later but, not very well. My heart rate returned to normal and since I've had no need for the pacemaker. Months later, I took a drag off a joint and oh my God! A flashback reaction? I got down on the ground right away. Person says, what are you doing? It came on again. Is the ground moving? I'm so dizzy. I feel like I'm drowning again. I still am a lite smoker and can jog and swim without breathing problems. But the pot felt like it suddenly closed all the intake cells in my lungs. I passed out for a minute then, woke up covered in sweat. It's like since the vaccine, I have an unbelievable bad allergic reaction to pot. I'm disability now. I never regained my sense of smell or my hierarchy brain functions that made me who I was. Resigned my career after 2 1/2 years of struggling to save it. Everywhere I went after that, they were like, we gotta get that guy out of here! Thanks, I hope this helps to put a warning not to smoke pot after getting shot for some people.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Fall, Fear, Feeling abnormal, Headache
Clinical narrative: It was 2005 and got TBI as a result. I  had the pneumonia vaccine and everything was fine. I'm a little slow and it's been hell trying to nail down what happened. It was the next time I had a couple drags off a joint of pot. I said, 2 drags is enough, I have to get some fresh air. I sat in my open car, engine off. I lit a cigarette then, felt my legs were funny, so I flexed the muscles in them to make them feel better. I felt strong confusion coming on so, I got out to watch the mechanic to give my brain something to focus on. Then, I felt like I'm getting no air. Was I breathing?? It didn't seem so, so I breathed on purpose. The air was going in and out fine but, there was no oxygen in it. I felt like I was drowning and there was no way out. My brain was going into a frenzy trying to figure it out. Maybe I'm hyperventilating? So I stopped and my lungs did not take over on their own. The ultimate sensation of fear and no thought process about getting on the ground for safety, in which I was trained. I saw black. They said I stiffened up and fell straight back like a tree. They couldn't catch me in time. I woke up in the ambulance in unsurvivable pain to my head. They put a pacemaker in me cause my rate was slow and they couldn't find anything else. As my brain healed and I was able to walk 2 weeks later but, not very well. My heart rate returned to normal and since I've had no need for the pacemaker. Months later, I took a drag off a joint and oh my God! A flashback reaction? I got down on the ground right away. Person says, what are you doing? It came on again. Is the ground moving? I'm so dizzy. I feel like I'm drowning again. I still am a lite smoker and can jog and swim without breathing problems. But the pot felt like it suddenly closed all the intake cells in my lungs. I passed out for a minute then, woke up covered in sweat. It's like since the vaccine, I have an unbelievable bad allergic reaction to pot. I'm disability now. I never regained my sense of smell or my hierarchy brain functions that made me who I was. Resigned my career after 2 1/2 years of struggling to save it. Everywhere I went after that, they were like, we gotta get that guy out of here! Thanks, I hope this helps to put a warning not to smoke pot after getting shot for some people.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Heart rate decreased, Hyperhidrosis, Hypersensitivity, Hyposmia, Loss of consciousness
Clinical narrative: It was 2005 and got TBI as a result. I  had the pneumonia vaccine and everything was fine. I'm a little slow and it's been hell trying to nail down what happened. It was the next time I had a couple drags off a joint of pot. I said, 2 drags is enough, I have to get some fresh air. I sat in my open car, engine off. I lit a cigarette then, felt my legs were funny, so I flexed the muscles in them to make them feel better. I felt strong confusion coming on so, I got out to watch the mechanic to give my brain something to focus on. Then, I felt like I'm getting no air. Was I breathing?? It didn't seem so, so I breathed on purpose. The air was going in and out fine but, there was no oxygen in it. I felt like I was drowning and there was no way out. My brain was going into a frenzy trying to figure it out. Maybe I'm hyperventilating? So I stopped and my lungs did not take over on their own. The ultimate sensation of fear and no thought process about getting on the ground for safety, in which I was trained. I saw black. They said I stiffened up and fell straight back like a tree. They couldn't catch me in time. I woke up in the ambulance in unsurvivable pain to my head. They put a pacemaker in me cause my rate was slow and they couldn't find anything else. As my brain healed and I was able to walk 2 weeks later but, not very well. My heart rate returned to normal and since I've had no need for the pacemaker. Months later, I took a drag off a joint and oh my God! A flashback reaction? I got down on the ground right away. Person says, what are you doing? It came on again. Is the ground moving? I'm so dizzy. I feel like I'm drowning again. I still am a lite smoker and can jog and swim without breathing problems. But the pot felt like it suddenly closed all the intake cells in my lungs. I passed out for a minute then, woke up covered in sweat. It's like since the vaccine, I have an unbelievable bad allergic reaction to pot. I'm disability now. I never regained my sense of smell or my hierarchy brain functions that made me who I was. Resigned my career after 2 1/2 years of struggling to save it. Everywhere I went after that, they were like, we gotta get that guy out of here! Thanks, I hope this helps to put a warning not to smoke pot after getting shot for some people.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Visual impairment
Clinical narrative: It was 2005 and got TBI as a result. I  had the pneumonia vaccine and everything was fine. I'm a little slow and it's been hell trying to nail down what happened. It was the next time I had a couple drags off a joint of pot. I said, 2 drags is enough, I have to get some fresh air. I sat in my open car, engine off. I lit a cigarette then, felt my legs were funny, so I flexed the muscles in them to make them feel better. I felt strong confusion coming on so, I got out to watch the mechanic to give my brain something to focus on. Then, I felt like I'm getting no air. Was I breathing?? It didn't seem so, so I breathed on purpose. The air was going in and out fine but, there was no oxygen in it. I felt like I was drowning and there was no way out. My brain was going into a frenzy trying to figure it out. Maybe I'm hyperventilating? So I stopped and my lungs did not take over on their own. The ultimate sensation of fear and no thought process about getting on the ground for safety, in which I was trained. I saw black. They said I stiffened up and fell straight back like a tree. They couldn't catch me in time. I woke up in the ambulance in unsurvivable pain to my head. They put a pacemaker in me cause my rate was slow and they couldn't find anything else. As my brain healed and I was able to walk 2 weeks later but, not very well. My heart rate returned to normal and since I've had no need for the pacemaker. Months later, I took a drag off a joint and oh my God! A flashback reaction? I got down on the ground right away. Person says, what are you doing? It came on again. Is the ground moving? I'm so dizzy. I feel like I'm drowning again. I still am a lite smoker and can jog and swim without breathing problems. But the pot felt like it suddenly closed all the intake cells in my lungs. I passed out for a minute then, woke up covered in sweat. It's like since the vaccine, I have an unbelievable bad allergic reaction to pot. I'm disability now. I never regained my sense of smell or my hierarchy brain functions that made me who I was. Resigned my career after 2 1/2 years of struggling to save it. Everywhere I went after that, they were like, we gotta get that guy out of here! Thanks, I hope this helps to put a warning not to smoke pot after getting shot for some people.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Pain in extremity
Clinical narrative: Redness/'hard knot' (5X5cm), hot to the touch at injection site, pink and swelling around injection site (10X15cm), pain in arm running down into hand.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised large circle around injection site. Possible cellulitis.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Client fainted after her vaccines were given. She was lowered to the floor and and became conscious after 30 seconds. She then was then monitored for 40 mins. Client was offered water and crackers. Her mother was notified and came to drive the client home.
Age: 56.0
Sex: M
Vaccine: HEPAB, MMR, TDAP, TYP
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: C/o symmetric hand/wrist/ankle pain. Pain feels like a deep ache.  No rash, no sob, no respiratory symptoms.  Saw Urgent Care this morning 5/21/15.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Neuralgia, Pain in extremity, Urticaria
Clinical narrative: Pain on hip and leg started on 5/12 and continued on 5/13. 5/18 broke out with hives. 5/18 had doctor visit and visually confirmed with shingles. For shingles prescribed Acyclovir 200 mg and for nerve ending and pain Gabapentin and antibiotic Cephalexin 500 mg 3x/day. Improvement is not enough yet that is noticeable.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Skin warm, Swelling
Clinical narrative: Redness, swelling, felt warm to the touch, arm felt "heavy".
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Pruritus, Swelling
Clinical narrative: Redness around site of injection which spreaded farther down her arm each day. Slight swelling and very slight itching. No pain.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion, Postictal state
Clinical narrative: Had febrile seizure lasting at least 1 min with 5 min post-ictal phase.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at shot site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Nausea, Urticaria
Clinical narrative: HIVES, ABDOMINAL PAIN AND NAUSEA. RELIEVED WITH BENADRYL BUT PERSISTING 48HR AFTER VACCINE IF STOP GIVING BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site urticaria
Clinical narrative: A red circle appeared around the injection site with red welts or bumps and is extremely sore and sensitive and warm to touch and a small bruise in the center.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: A red circle appeared around the injection site with red welts or bumps and is extremely sore and sensitive and warm to touch and a small bruise in the center.
Age: 12.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Macule, Papule, Pruritus, Urticaria
Clinical narrative: Urticarial rash that started from the face and trunk and spread to the whole body. Started as small papules, increased in size to macules and developed into hives. It is itchy. No fever and no mucosal involvement.
Age: 12.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Pityriasis rosea, Rash generalised
Clinical narrative: Urticarial rash that started from the face and trunk and spread to the whole body. Started as small papules, increased in size to macules and developed into hives. It is itchy. No fever and no mucosal involvement.
Age: 80.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Inflammation, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Arm pain, inflammation, left arm hot, arm red x 3", neck pain, difficulty moving arm due to pain.
Age: 80.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Skin warm
Clinical narrative: Arm pain, inflammation, left arm hot, arm red x 3", neck pain, difficulty moving arm due to pain.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date sicne 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # J005078, expiration date: 20-SEP-2015) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. This is one of several reports 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of (Oka/Merck) VARIVAX (route, dose and lot # not reported). The temperature excursion for (Oka/Merck) VARIVA was unsupported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash, Skin warm
Clinical narrative: 70mm rash on (L) arm. Warm and painful to the touch.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red on the area where she got the vaccine.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: She received shot on 5/12. Presented to pharmacy 5/21 with app. 5" round rash (circular) on arm where shot was given. Said it has looked like that since she got the shot.
Age: 65.0
Sex: F
Vaccine: PNC13, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Injection given on 5/14/15. Patient call 5/18/15 with pain in arm. 5/20/15 seen in clinic. Arm painful and swollen.
Age: 65.0
Sex: F
Vaccine: PNC13, PPV, PPV
Symptoms: Movement disorder
Clinical narrative: Injection given on 5/14/15. Patient call 5/18/15 with pain in arm. 5/20/15 seen in clinic. Arm painful and swollen.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Swelling at injection site. Pain Redness Itching. Treating with TYLENOL/Ibuprofen/BENADRYL.
Age: 1.14
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Rash starting on trunk 5/20/15. Papular no vesicles, no scabbing. Fever 5/16 and 5/17/15.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm redness, swelling > 10 inches.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Left shoulder pain with impaired range of motion. Pain described as dull and burning.
Age: 1.79
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right upper thigh with area of erythema that is approximately 12 cm x 8 cm. It is slightly warm and appears a little tender. No significant induration.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at injection site, itching. Cool compresses and Tylenol.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Miliaria, Rash generalised, Urticaria
Clinical narrative: Received HPV #3 on 5-19-15. On 5-20-15 at night patient noticed rash on arm she received immunization. On 5-21-15 rash to arm, neck, face and back. Mom reports looks like "hives" like "Heat Rash".
Age: 73.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swollen at injection site. Redness is down from injection site to elbow and warm to touch. 1 pt, he only experienced soreness and redness on day of injection, and worst starting 3 days ago.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt had pneumococcal vaccine on 5/4 and states it's heating up, how long is this supposed to last? Pt states area on left upper arm is red, 2 1/2 in diameter, itchy and hot to touch. Denies fever. Pt has been applying ice to area since yesterday and it is not getting any better and localized skin rash (some swelling, itching, itching and redness). Cephalexin 500 mg QID, Cetirizine 5 mg everyday.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unregistered number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly doses of ZOSTAVAX (route, dose and lot # not reported). The temperature excursion for ZOSTAVAX was unsupported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. 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 medical assistant concerning multiple unspecified patients (demographics unknown). On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Merck) PROQUAD (route, dose and lot # not reported). The temperature excursion for the (Merck) PROQUAD was unsupported with in house stability data. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with 7 doses of (Merck) PROQUAD, lot # K022447, expiration date 13-MAY-2016 (dose and route not provided). The temperature excursion with (Merck) PROQUAD was supported with in-house stability data. No adverse symptoms were reported. 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: Information has been received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with 7 doses of (Oka/Merck) VARIVAX, lot # K007781, expiration date 28-MAY-2016 (dose and route not  provided). The temperature excursion with (Oka/Merck) VARIVAX was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-MAY-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # not provided), when he was indicated for ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (dose#, dose, strength and lot # were not reported, intramuscular). The patient experienced "fatigue" on unspecified date after injection of GARDASIL. The patient had called doctor's office for medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant via field representative referring to an 18 year old female patient. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (route, lot#, strength and dose were unknown) on 12-NOV-2014, 24-MAR-2015 and 19-MAY-2015, respectively (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information is not expected as the medical assistant didn't want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product physical issue
Clinical narrative: This spontaneous report as received from a healthcare worker (pharmacy technician) refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. The healthcare worker reported a "particular" (product physical issue), in a reconstituted vial of ZOSTAVAX lot number and expiry date were not reported. So on an unknown date, that caused the patient to miss their vaccination. No adverse effects reported. PQC had been filed. There was no concomitant medication provided. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Indurated abey on deltoid 2" in diameter, tender to the touch, mild erythema.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of redness to L deltoid to axillae area warm to touch 5cm redness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis, Herpes zoster, Pain
Clinical narrative: Bad pain left leg on 5/12, 5/13, 5/14 treating with BIOFREEZE. 5/14 in evening noticed that shingles broke out on left buttocks so put cortisone 5/15 went to urgent care and diagnosed with shingles. Given VALTREX (generic), CIPRO 500 mg for bladder, phenazopyridine 200 mg. Bladder infection did not clear up after 2 days as usual. Husband also broke up in shingles. Went to doctor on 5/18 doctor confirmed it was shingles and changed bladder medication to doxy-cycl-hycl 100 mg. As of today bladder improving but not a lot. For the shingles had pain on various parts of body and it looks like they are clearing down.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Throat irritation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 5-year-old female patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014). Co-suspect products included MMR and varicella virus vaccine. On 30th March 2015, the patient received KINRIX .5 ml, MMR and varicella vaccine. On 30th March 2015, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. In April 2015, the patient experienced injection site lump, injection site erythema, injection site tenderness, fever and burning in throat. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site tenderness were recovering/resolving and the outcome of the fever, burning in throat and expired vaccine used were unknown. The reporter considered the injection site lump, injection site erythema, injection site tenderness and fever to be probably related to KINRIX. It was unknown if the reporter considered the burning in throat and expired vaccine used to be related to KINRIX. Additional details were reported as follows: The child was healthy without any medication. The expired dose of KINRIX was given in the left deltoid. The MMR vaccine was given in the left arm, the varicella vaccine was given in the right arm. The patient developed a softball sized lump 3 days following the vaccination on the left deltoid (KINRIX's injection site). Within the week of vaccination, the patient also developed redness and tenderness on KINRIX's injection site as well as fever and burning throat. Five days after vaccination, the patient visited the emergency room. She was sent home and had to be monitored by her mother. Seven days after vaccination, a follow-up was done with the home physician. The injection site reactions were resolving.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Expired product administered, Injection site erythema, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 5-year-old female patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014). Co-suspect products included MMR and varicella virus vaccine. On 30th March 2015, the patient received KINRIX .5 ml, MMR and varicella vaccine. On 30th March 2015, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. In April 2015, the patient experienced injection site lump, injection site erythema, injection site tenderness, fever and burning in throat. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site tenderness were recovering/resolving and the outcome of the fever, burning in throat and expired vaccine used were unknown. The reporter considered the injection site lump, injection site erythema, injection site tenderness and fever to be probably related to KINRIX. It was unknown if the reporter considered the burning in throat and expired vaccine used to be related to KINRIX. Additional details were reported as follows: The child was healthy without any medication. The expired dose of KINRIX was given in the left deltoid. The MMR vaccine was given in the left arm, the varicella vaccine was given in the right arm. The patient developed a softball sized lump 3 days following the vaccination on the left deltoid (KINRIX's injection site). Within the week of vaccination, the patient also developed redness and tenderness on KINRIX's injection site as well as fever and burning throat. Five days after vaccination, the patient visited the emergency room. She was sent home and had to be monitored by her mother. Seven days after vaccination, a follow-up was done with the home physician. The injection site reactions were resolving.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Throat irritation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 5-year-old female patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014). Co-suspect products included MMR and varicella virus vaccine. On 30th March 2015, the patient received KINRIX .5 ml, MMR and varicella vaccine. On 30th March 2015, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. In April 2015, the patient experienced injection site lump, injection site erythema, injection site tenderness, fever and burning in throat. On an unknown date, the outcome of the injection site lump, injection site erythema and injection site tenderness were recovering/resolving and the outcome of the fever, burning in throat and expired vaccine used were unknown. The reporter considered the injection site lump, injection site erythema, injection site tenderness and fever to be probably related to KINRIX. It was unknown if the reporter considered the burning in throat and expired vaccine used to be related to KINRIX. Additional details were reported as follows: The child was healthy without any medication. The expired dose of KINRIX was given in the left deltoid. The MMR vaccine was given in the left arm, the varicella vaccine was given in the right arm. The patient developed a softball sized lump 3 days following the vaccination on the left deltoid (KINRIX's injection site). Within the week of vaccination, the patient also developed redness and tenderness on KINRIX's injection site as well as fever and burning throat. Five days after vaccination, the patient visited the emergency room. She was sent home and had to be monitored by her mother. Seven days after vaccination, a follow-up was done with the home physician. The injection site reactions were resolving.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring, Cardiac stress test, Dizziness, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Pertinent medical history was unspecified and there were no drug reactions/allergies. On an unspecified date sometime in October 2014, the patient received GARDASIL injection (dose/frequency, lot #, expiry date unspecified) (patient also reported that she could not confirm if she received GARDASIL or GARDASIL 9). Concomitant medications were unspecified. The patient reported that she experienced syncope and a medicinal-induced seizure, after receiving an initial dose of GARDASIL. The patient sought medical attention and she reported that sometime in November 2014, she was seen at an unspecified emergency room. She was not hospitalized. Tilt-table test, 24-hour heart monitor test, stress test and electrocardiogram (EKG) were performed on unspecified dates and result of these tests were not provided. No treatment was provided for the adverse events. Therapy with GARDASIL was discontinued sometime in 2014. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Seizure, Syncope, Tilt table test
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Pertinent medical history was unspecified and there were no drug reactions/allergies. On an unspecified date sometime in October 2014, the patient received GARDASIL injection (dose/frequency, lot #, expiry date unspecified) (patient also reported that she could not confirm if she received GARDASIL or GARDASIL 9). Concomitant medications were unspecified. The patient reported that she experienced syncope and a medicinal-induced seizure, after receiving an initial dose of GARDASIL. The patient sought medical attention and she reported that sometime in November 2014, she was seen at an unspecified emergency room. She was not hospitalized. Tilt-table test, 24-hour heart monitor test, stress test and electrocardiogram (EKG) were performed on unspecified dates and result of these tests were not provided. No treatment was provided for the adverse events. Therapy with GARDASIL was discontinued sometime in 2014. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac monitoring, Cardiac stress test, Electrocardiogram, Seizure, Syncope
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Pertinent medical history was unspecified and there were no drug reactions/allergies. On an unspecified date sometime in October 2014, the patient received GARDASIL injection (dose/frequency, lot #, expiry date unspecified) (patient also reported that she could not confirm if she received GARDASIL or GARDASIL 9). Concomitant medications were unspecified. The patient reported that she experienced syncope and a medicinal-induced seizure, after receiving an initial dose of GARDASIL. The patient sought medical attention and she reported that sometime in November 2014, she was seen at an unspecified emergency room. She was not hospitalized. Tilt-table test, 24-hour heart monitor test, stress test and electrocardiogram (EKG) were performed on unspecified dates and result of these tests were not provided. No treatment was provided for the adverse events. Therapy with GARDASIL was discontinued sometime in 2014. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tilt table test
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. Pertinent medical history was unspecified and there were no drug reactions/allergies. On an unspecified date sometime in October 2014, the patient received GARDASIL injection (dose/frequency, lot #, expiry date unspecified) (patient also reported that she could not confirm if she received GARDASIL or GARDASIL 9). Concomitant medications were unspecified. The patient reported that she experienced syncope and a medicinal-induced seizure, after receiving an initial dose of GARDASIL. The patient sought medical attention and she reported that sometime in November 2014, she was seen at an unspecified emergency room. She was not hospitalized. Tilt-table test, 24-hour heart monitor test, stress test and electrocardiogram (EKG) were performed on unspecified dates and result of these tests were not provided. No treatment was provided for the adverse events. Therapy with GARDASIL was discontinued sometime in 2014. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: IPV
Symptoms: Eye movement disorder, Seizure, Unresponsive to stimuli
Clinical narrative: Out of nowhere he had a seizure. It was a cluster of seizures, 3 in a row. Eyes rolled backwards into his head. Unresponsive. Lasted approximately 9 seconds. Fully recovered. No treatment required.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Influenza like illness, Injection site rash, Nausea, Rash
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 11 year old female patient. The patient's concurrent condition included asthma. There was none of drug reactions or allergies reported. Concomitant therapies included SINGULAIR and oxycarbonate. On 15-MAY-2015 the patient was vaccinated with a dose of GARDASIL (lot#, strength, dose and frequency were not reported). On the same day, after receiving vaccine, the patient experienced nausea, bumps at the injection site, flu-like symptoms, inability to speak, dizziness and rash. The patient sought medical attention by phone call to health professional office on 15-MAY-2015. She was treated with ADVIL. None of lab diagnostics studies were performed. Therapy with GARDASIL was discontinued. The outcome of the patient's events was reported as recovering/resolving. The relatedness between therapy with GARDASIL and the patient's events was not reported. Upon internal review the inability to speak was coded to aphonia and considered as medically significant event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 11 year old female patient. The patient's concurrent condition included asthma. There was none of drug reactions or allergies reported. Concomitant therapies included SINGULAIR and oxycarbonate. On 15-MAY-2015 the patient was vaccinated with a dose of GARDASIL (lot#, strength, dose and frequency were not reported). On the same day, after receiving vaccine, the patient experienced nausea, bumps at the injection site, flu-like symptoms, inability to speak, dizziness and rash. The patient sought medical attention by phone call to health professional office on 15-MAY-2015. She was treated with ADVIL. None of lab diagnostics studies were performed. Therapy with GARDASIL was discontinued. The outcome of the patient's events was reported as recovering/resolving. The relatedness between therapy with GARDASIL and the patient's events was not reported. Upon internal review the inability to speak was coded to aphonia and considered as medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates ("a few weeks ago") the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # K015312, expiration date 17-DEC-2015) subcutaneously. No adverse effects reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dysphagia, Eyelid ptosis, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness to feet, hands, and tongue, abnormal sensation in trunk with twisting movements, left eye droop, dysphagia, and fatigue.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Sensory disturbance
Clinical narrative: Numbness to feet, hands, and tongue, abnormal sensation in trunk with twisting movements, left eye droop, dysphagia, and fatigue.
Age: 28.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives broke out all over arms, legs, abdomen - two nights in a row, only at night. Disappearing by 10am for the most part.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 23-APR-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 60's. The patient's current conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU, subcutaneously (unknown strength and dose) to prevent shingles. Concomitant therapies were not reported. On an unknown date, the patient experienced, "itchy and painful rash that looked like shingles around the injection site after receiving ZOSTAVAX". The patient sought medical attention and visited pharmacist. The patient received lidocaine as treatment in response to the events. The outcome of the events was reported as recovered (unknown date). There was no product quality complaint involved. Causality assessment was not reported. 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 Certified Medical Assistant refers to a patient of unknown age and gender. On 27-APR-2015, the patient was vaccinated with one dose of (Oka-Merck) PROQUAD that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 16-APR-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.