chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: 3 days after got the SHINGRIX shot, patient developed rash all over the front body. The rash got better after patient took a tablet of BENADRYL 25 mg.
Age: 60.0
Sex: M
Vaccine: HPV9, VARZOS
Symptoms: Anti-thyroid antibody, Chills, Decreased appetite, Epstein-Barr virus test negative, Fatigue
Clinical narrative: I experienced flu-like symptom starting one day after injection which continued for approximately six weeks. Those symptoms included fever, chills, headache, night sweats, nausea, fatigue, lack of appetite and muscle pain. Two days after symptoms began, I spoke with my primary care physician and related my condition to him. He thought the symptoms would go away after a day or two. During this time, my current physician relocated. Two weeks later, symptoms continued. I contacted the physician's office and spoke with a nurse. I was told the symptoms were likely because of the injection and that they would go away. Four weeks later, symptoms continued. I went to an urgent care unit in my neighborhood. The attending physician was at a loss and could not help. Two days later, I saw a nurse practitioner at my physician's office. He suggested TYLENOL and ibuprofen. One week later, I saw a new physician and he prescribed a steroid for a period of five days. Five days later, symptoms began to subside. Seven weeks after injection, health returned to normal.
Age: 60.0
Sex: M
Vaccine: HPV9, VARZOS
Symptoms: Headache, Hepatitis viral test negative, Influenza like illness, Mononucleosis heterophile test negative, Myalgia
Clinical narrative: I experienced flu-like symptom starting one day after injection which continued for approximately six weeks. Those symptoms included fever, chills, headache, night sweats, nausea, fatigue, lack of appetite and muscle pain. Two days after symptoms began, I spoke with my primary care physician and related my condition to him. He thought the symptoms would go away after a day or two. During this time, my current physician relocated. Two weeks later, symptoms continued. I contacted the physician's office and spoke with a nurse. I was told the symptoms were likely because of the injection and that they would go away. Four weeks later, symptoms continued. I went to an urgent care unit in my neighborhood. The attending physician was at a loss and could not help. Two days later, I saw a nurse practitioner at my physician's office. He suggested TYLENOL and ibuprofen. One week later, I saw a new physician and he prescribed a steroid for a period of five days. Five days later, symptoms began to subside. Seven weeks after injection, health returned to normal.
Age: 60.0
Sex: M
Vaccine: HPV9, VARZOS
Symptoms: Nausea, Night sweats, Pyrexia, Varicella virus test negative
Clinical narrative: I experienced flu-like symptom starting one day after injection which continued for approximately six weeks. Those symptoms included fever, chills, headache, night sweats, nausea, fatigue, lack of appetite and muscle pain. Two days after symptoms began, I spoke with my primary care physician and related my condition to him. He thought the symptoms would go away after a day or two. During this time, my current physician relocated. Two weeks later, symptoms continued. I contacted the physician's office and spoke with a nurse. I was told the symptoms were likely because of the injection and that they would go away. Four weeks later, symptoms continued. I went to an urgent care unit in my neighborhood. The attending physician was at a loss and could not help. Two days later, I saw a nurse practitioner at my physician's office. He suggested TYLENOL and ibuprofen. One week later, I saw a new physician and he prescribed a steroid for a period of five days. Five days later, symptoms began to subside. Seven weeks after injection, health returned to normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cardiovascular evaluation, Dizziness, Feeling hot, Musculoskeletal disorder
Clinical narrative: I received the 2nd shingles vaccine in the series. 2 hrs later the pain was so extreme that I went to the ER. I have never experienced such pain. I have swelling and still very little use of my arm. I am also experiencing dizziness, hot and cold extremes and weakness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral coldness, Peripheral swelling
Clinical narrative: I received the 2nd shingles vaccine in the series. 2 hrs later the pain was so extreme that I went to the ER. I have never experienced such pain. I have swelling and still very little use of my arm. I am also experiencing dizziness, hot and cold extremes and weakness.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Infection
Clinical narrative: Patient's significant other has contacted the patient advocate on 8/1/18 because patient is admitted to hospital. Patient's significant other stated that the patient has a flesh-eating bacterium or a cyst from the shots he received from the hospital on Monday 7/30/18. The cause of the infection is unknown at this time. Per chart review, patient received SHINGRIX vaccine by GSK (lot # 3AF9E 2/2/21) and PNEUMOVAX vaccine by Merck (lot # R009408 3/7/20) on Monday 7/30/18.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Abscess, C-reactive protein abnormal, Infection, Injection site pain, Insomnia
Clinical narrative: Patient's significant other has contacted the patient advocate on 8/1/18 because patient is admitted to hospital. Patient's significant other stated that the patient has a flesh-eating bacterium or a cyst from the shots he received from the hospital on Monday 7/30/18. The cause of the infection is unknown at this time. Per chart review, patient received SHINGRIX vaccine by GSK (lot # 3AF9E 2/2/21) and PNEUMOVAX vaccine by Merck (lot # R009408 3/7/20) on Monday 7/30/18.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site, White blood cell count increased
Clinical narrative: Patient's significant other has contacted the patient advocate on 8/1/18 because patient is admitted to hospital. Patient's significant other stated that the patient has a flesh-eating bacterium or a cyst from the shots he received from the hospital on Monday 7/30/18. The cause of the infection is unknown at this time. Per chart review, patient received SHINGRIX vaccine by GSK (lot # 3AF9E 2/2/21) and PNEUMOVAX vaccine by Merck (lot # R009408 3/7/20) on Monday 7/30/18.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient was given vaccines on 8/7/18 and later in day her mom called with concern of a lot of pain and swelling. Swelling continued to next day but decrease in pain 8/9/18 saw pt with 5-6 inches area of erythema, redness and pain.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Rash
Clinical narrative: Developed rash within 24 hours of req. vaccines. No difficulty breathing - seen at ER on 7/25/18 was given prednisone - followed up in office on 7/27/18 - rash resolved - see attached visit. 7/25/18 - given prednisone at ED - hyper. After Rx given - didn't fill prednisone. Rash on chest. Did have a loose BM and played in grass. Rash is gone now. No respiratory difficulty. Pic looks like an enteroviral rash.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient received first dose of SHINGRIX 08/02/2018, about 48 hours later patient experienced severe swelling in her arms that progressed to her legs and she also developed a rash on her arms and lower legs initially that migrated up to her upper thighs. Patient was instructed to take BENADRYL and IBU by Rph on 08/04/2018. Patient saw primary care provider 08/06/2018 at which time she received a prescription for prednisone to help reduce the swelling and pain. Patient is being monitored by her physician who has told her to not take the second dose of SHINGRIX.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain, Sleep disorder
Clinical narrative: Dears Sirs: At 68 I lead a very sedentary life, working part-time sitting in front of a computer. I do not lift anything heavy than a bag of groceries or participate in any sports. In fact I do nothing that would cause a muscle strain. I had the first dose of the SHINGRIX vaccine on 05/29/18. The side effect that I experienced was pain throughout my deltoid. Even taking NSAIDs the pain was there at rest and pretty bad every time that I had to flex the deltoid, and interfered with my sleep at night. A few days later I saw my GP for another matter, and he said that the pain would go away in a few more days. After two months I was still in pain. I went to my GP and described the pain in my deltoid as a 3-4 at rest, and an 8 whenever I had to use my arm that caused flexing of the deltoid. He put me on a two week regimen of steroids. This greatly diminished the pain, but not totally. After the two week supply of the steroids ran out, the pain came back. His next step was to put me on a stronger steroid. Once again, when the two week supply ran out, the deltoid pain came back. It has now been almost three and one-half months, and the pain in my deltoid is still there, and the second shot is due, which I am not looking forward to it. Both my GP and I believe that this vaccine did some sort of permanent damage to my deltoid muscle. I cannot be on steroids forever. All I want is for the pain to stop. It is greatly interfering with my daily life, and has caused me to use my left arm less and less. This is worrisome because I fear that it will atrophy. This should not be happening. Thank you for your consideration.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscle injury
Clinical narrative: Dears Sirs: At 68 I lead a very sedentary life, working part-time sitting in front of a computer. I do not lift anything heavy than a bag of groceries or participate in any sports. In fact I do nothing that would cause a muscle strain. I had the first dose of the SHINGRIX vaccine on 05/29/18. The side effect that I experienced was pain throughout my deltoid. Even taking NSAIDs the pain was there at rest and pretty bad every time that I had to flex the deltoid, and interfered with my sleep at night. A few days later I saw my GP for another matter, and he said that the pain would go away in a few more days. After two months I was still in pain. I went to my GP and described the pain in my deltoid as a 3-4 at rest, and an 8 whenever I had to use my arm that caused flexing of the deltoid. He put me on a two week regimen of steroids. This greatly diminished the pain, but not totally. After the two week supply of the steroids ran out, the pain came back. His next step was to put me on a stronger steroid. Once again, when the two week supply ran out, the deltoid pain came back. It has now been almost three and one-half months, and the pain in my deltoid is still there, and the second shot is due, which I am not looking forward to it. Both my GP and I believe that this vaccine did some sort of permanent damage to my deltoid muscle. I cannot be on steroids forever. All I want is for the pain to stop. It is greatly interfering with my daily life, and has caused me to use my left arm less and less. This is worrisome because I fear that it will atrophy. This should not be happening. Thank you for your consideration.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine increased, Condition aggravated, Fibromyalgia, Glomerular filtration rate decreased, Headache
Clinical narrative: Had vaccine on 7/29/18. Side effects of headache have persisted along with terrible aggravation of my FMG. Had renal panel 7/29/18. My creatinine went up to 1.3 and EGFR dropped from 60 to 40. Often feel a sleepiness I cannot explain. I am not diabetic, no HTN, no prior renal issues. Do not take any meds to explain changes.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Had vaccine on 7/29/18. Side effects of headache have persisted along with terrible aggravation of my FMG. Had renal panel 7/29/18. My creatinine went up to 1.3 and EGFR dropped from 60 to 40. Often feel a sleepiness I cannot explain. I am not diabetic, no HTN, no prior renal issues. Do not take any meds to explain changes.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Fatigue, arm (L) pain, swelling, heat at site of injection began evening after vaccination. Muscle aches 1 day after vaccination. Began subsiding 2-3 days later.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain, headache, chills, muscular aches R-arm, adverse affects in both vaccines, R arm.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Computerised tomogram normal, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Severe swelling, redness and pain at injection site. Difficulty moving arm from severe pain. Seen ER - elevated WBC, CT nl. Saw hand/shoulder ortho - vaccine reaction diagnosis.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Neutrophil percentage increased, Product administered at inappropriate site, White blood cell count increased
Clinical narrative: Severe swelling, redness and pain at injection site. Difficulty moving arm from severe pain. Seen ER - elevated WBC, CT nl. Saw hand/shoulder ortho - vaccine reaction diagnosis.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain (R) arm and headache.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: Infant found about 5AM 4-27-18, in its bed, deceased. Coroner states autopsy suspects death about 2AM 4-27-2018.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a TDaP instead of a DTaP. Called public health and spoke w/them. She stated that since it's her 4th series, she will not need an additional vaccine. Dr. spoke w/father and understood. Nursing supervisor, was notified as well.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MENB
Symptoms: Head injury, Syncope, X-ray
Clinical narrative: Pt fainted 5 min after receiving vaccine and hit her head.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Day after the vaccine had localized swelling to left arm and low grade fever to 100-100.9. Next day (2 days after vaccine administered) arm became very red, swollen and tender and pain with arm movement. Area of redness x 10 cm encircling 3/4 of the arm width. No more fever. Patient came to clinic on 2nd day after vaccine administered, Adverse event has NOT resolved yet.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Nausea
Clinical narrative: I got the SHINGRIX vaccine on Tuesday afternoon. During the night I woke up with bad muscle aches, joint pain, shivers and nausea. It lasted for 24 hours.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Morning after receiving immunizations he had onset of swelling, redness, itchiness at the injection sites on both arms. He received immunizations on the 8/6, and after was on the right and HPV and Tdap on the left. Worsened yesterday, looked very red and swollen. Mom was using ice packs, giving benadryl. Not seeming to help. Today finally starting to go down, not as red. No more itching. There was no systemic symptoms at any time. Physical Exam:  Skin:  Left lateral upper arm with 11.5 x 9.5 cm area of blanching erythema that is Non-Tender, mildly edematous. There is small 2-3 cm area of induration right at vaccine site. Right lateral arm has 9.5 by 8 cm area if lighter Non-Tender blanching pinkness that is mildly edematous. No induration. NO hives, no rash anywhere else.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Vaccination site induration
Clinical narrative: Morning after receiving immunizations he had onset of swelling, redness, itchiness at the injection sites on both arms. He received immunizations on the 8/6, and after was on the right and HPV and Tdap on the left. Worsened yesterday, looked very red and swollen. Mom was using ice packs, giving benadryl. Not seeming to help. Today finally starting to go down, not as red. No more itching. There was no systemic symptoms at any time. Physical Exam:  Skin:  Left lateral upper arm with 11.5 x 9.5 cm area of blanching erythema that is Non-Tender, mildly edematous. There is small 2-3 cm area of induration right at vaccine site. Right lateral arm has 9.5 by 8 cm area if lighter Non-Tender blanching pinkness that is mildly edematous. No induration. NO hives, no rash anywhere else.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Diarrhoea, Lethargy
Clinical narrative: This date, 12/20/17 was the 6th time patient had received a vaccination. Each vaccination listed she had the same adverse reaction. She had diarrhea for three days each time. She also was uncharacteristically inconsolable in between being uncharacteristically lethargic. This was reported to our pediatrician each time in person and at times also in writing. After the sixth time occurring at her 12 month appointment, we again expressed our concerns. Our pediatrician then suggested perhaps holding off for a while before continuing. But did not report or inform us how to report. I only discovered this recently via word of mouth.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Cyanosis, Respiratory arrest
Clinical narrative: Stopped breathing & turned blue. I know it was Hep B but I don't know Lot # or any other information.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Disturbance in attention, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever of 100.5°F, injection point pain (extending to the elbow), general malaise, and difficulty concentrating lasting over 24 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Pain, large swelling of bicep area, redness, itching, slight fever following day. Back to normal 8/10/2018.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, chills, fever; lasted most of the night.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist and refers to a patient (age and gender unknown). Information about medical history, current condition and concomitant therapy was unknown. On 12-JUL-2018, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (route, strength and frequency were unknown; Lot number N037669 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date: 09-MAY-2018) for prophylaxis (expired product administered). No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a physician, concerning a 5 year old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included M-M-R II and sterile diluent. On 20-JUL-2018, the patient was inadvertently vaccinated with ZOSTAVAX lot # M041086, intramuscular in the left deltoid (dose and frequency were not provided) (discrepant information also reported that lot # N021172 with expiration date was administered subcutaneously 0.65 ml once on an unknown date) for prophylaxis instead of VARIVAX (dose, frequency, route, lot number and expiration date were not provided). The reporter stated that the patient was seen 2 weeks later and no issues noted. Additionally, on the same date the patient was also vaccinated with QUADRACEL dose 4, intramuscularly in the left deltoid arm, lot number CS325BA. The patient experienced pain in arm that lasted 3 or 4 days where ZOSTAVAX and QUADRACEL were administered. The outcome of pain in arm was reported as recovered. The causal relationship between pain in arm and the therapies was not assessed.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative, concerning an adult female patient of unknown age. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 30-JUL-2018, the patient was vaccinated with VARIVAX injection (strength, dose, route, frequency, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 19-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261 US-009507513-1808USA004371: Original Case : 1808USA001261 US-009507513-1808USA004372: Original Case : 1808USA001261 US-009507513-1808USA004373: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261; US-009507513-1808USA004379.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a consumer (patient's wife who was enrolled in Market Research Program) referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot, batch# number and route of administration was not reported) for prophylaxis. On an unknown date, 3 days after vaccination the patient experienced pneumonia and was hospitalized. The outcome of pneumonia was unknown. Causality assessment was not reported. Upon internal review, pneumonia was determined to be medically significant.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 30-JUL-2018, the patient received PROQUAD, subcutaneously, lot number R002936, expiration date on 29-JUL-2019 for prophylaxis (strength, dose number and anatomical location were not reported). There was no adverse effect reported.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an 18 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with Oka-Merck PROQUAD lot # N019826, expiration date 09-JAN-2019 (route, dose and frequency were not reported) for prophylaxis (Drug administered to patient of inappropriate age) along with an sterile diluent. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 16 year old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Approximately in 2013, when the patient was 11 years old, the patient was vaccinated with GARDASIL for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).  On 03-AUG-2018, the patient was in the physician's office in order to receive GARDASIL 9 as second dose in human papilloma virus (HPV) series. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or about 02-AUG-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In approximately 2014, the patient was treated herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated an improperly stored dose of LIQUID PEDVAXHIB (strength, dose, route of administration and anatomical location were not reported) lot # N014944 and expiration date: 06-MAR-2020, indicated for prophylaxis.     No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (8.8 degrees Celsius) for 5 hours and 15 minutes on unspecified dates. There were no previous excursions reported. Medical Assistant was not sure why the refrigerator went out of range. This is one of several reports received from the same reporter (MARRS#: 1808USA004222).; Sender's Comments: US-009507513-1808USA004222:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 17 year old male patient. Information regarding the patient's concurrent conditions, pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. On an unknown date, when the patient was 12 years old, he was vaccinated with GARDASIL (Lot #, expiration date, dose, anatomical location and route of administration were not provided) for prophylaxis. On an unknown date, when the patient was 17 years old, he received the second dose of the series; GARDASIL 9 (Lot #, expiration date, dose, anatomical location and route of administration were not provided) for prophylaxis. The reporting physician stated that this was longer than recommended interval (inappropriate schedule of vaccine administration). No adverse effects reported.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a currently 20 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On 08-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 per intramuscular route, for prophylaxis (dose, lot number and expiration date were not reported). The patient became pregnant with last menstrual period of 13-JUN-2018 and estimated date of delivery of 20-MAR-2019. At the time of the report, the patient was 8 weeks pregnant. The patient did not seek medical attention. She did not received any treatment and no laboratory test were performed.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N032569, expiry date: 18-JUN-2019, orally for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). No adverse effects reported. The temperature excursion and time frame for ROTATEQ was between 9°C to 25°C (13.4°C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004219: US-009507513-1808USA004192.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated an improperly stored dose of PEDVAXHIB (strength, dose, route of administration and anatomical location were not reported) lot # N014944 and expiration date: 06-MAR-2020, indicated for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (8.8 degrees Celsius) for 5 hours and 15 minutes on unspecified dates. There were no previous excursions reported. Medical Assistant was not sure why the refrigerator went out of range. This is one of several reports received from the same reporter (MARRS#:1808USA004064). Sender's Comments: US-009507513-1808USA004064.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist via Poison & Drug Center refers to a 14 year old male patient. The patient started Oka/Merck VARIVAX on an unknown date years ago for vaccination. The patient's concomitant medications, medical history and relevant labs were unknown. On 08-AUG-2018, the patient was vaccinated with expired Oka/Merck VARIVAX (lot # M025864 with expiry date of 24-MAY-2018) 0.5 ml, subcutaneously on the arm(frequency reported as once) for prophylaxis. As of 08-AUG-2018 it was unknown if the patient will continue Oka/Merck VARIVAX and the outcome of expired vaccine administration was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA001261:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-AUG-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 6 degree Fahrenheit (F) to 14 F for 30 minutes on 01-AUG-2018. There was previous temperature excursion reported: 15 F to 46 F for 14 hours on 16-JUN-2018. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA00126.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Incorrect dose administered, Injection site pain
Clinical narrative: Received information on a spontaneous report on 23JAN2018 and 25JAN2018 from personnel. The physician reported that on 23JAN2018, a patient received 5ml of BIOTHRAX vaccine rather than the prescribed 0.5ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the site, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Sex: M
Vaccine: ANTH
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information received on 16MAY2018. The official reported that a patient received his 6-month dose of BIOTHRAX 2 months earlier than scheduled. No adverse events were noted. No further information is expected.
Sex: U
Vaccine: ANTH
Symptoms: Booster dose missed, No adverse event
Clinical narrative: Information received from a physician on 05JUL2018. The physician reported that a patient has not maintained the boosters yearly. No adverse events were noted. No further information is expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: SHINGRIX 1st shot. Terrible arm pain, the worst I've ever had with a shot. I also had achy back pain from that shoulder to the base of my neck. Had to put arm in and out of sling, aspirins, and iced it for two days. The pain in the arm started about 4 hrs after shot and continued to get worst through the day. I don't believerI slept that night do to the slightest movement cause the arm to hurt so much. It took about days to really feel better. Certainly not wanting to go through this again.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Rash pustular, Skin lesion
Clinical narrative: Patient developed blister lesions and some pustules on the left face and left arm and left breast.  On the breast she had itching and burning. All lesions resolved in 3 days except still has some small pustules on the left breast now (8/10/18).
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine administered in error. Notified the Dept of Health and they advised us on her plan - will need another MENACTRA booster prior to college (up to 18 years old).
Age: 31.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site mass, Injection site warmth
Clinical narrative: Hard lump under skin at injection site. Site is inflamed, red and warm to the touch. Symptoms appeared 2 weeks following administration of vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms of redness, heat, swelling, and pain of right arm just below the injection site of KINRIX at approx. 7pm on the date of the injection. Symptoms progressed down the arm nearing the elbow at the time of assessment which was 8/9/18 at approx. 3:30pm. Child was evaluated in clinic and above symptoms noted were present. Child guarding arm and reluctant to allow nursing staff to assess. Mother was encouraged to used cold packs, otc pain reliever, and otc anti-histamine. Spoke with mother 8/10/18 at 8:40am, she reports child is sleeping and is slightly improved, denies fever.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Asthenia, Back pain, CSF test normal, Chest X-ray normal
Clinical narrative: Next day pt felt achy, chest, back, felt dizzy, sharp chest pain, weak, mild nausea, felt like face was drooping, no fever at time, felt very weak, had bad headache, stomach ache, mostly upper epigastric area, no emesis, no rash, had diarrhea, to ED (had fever that night, and next am, none since) 8-6 - admitted x 2 days- normal CT brain, normal CSF, ultrasound kidneys normal, CXR normal, positive rapid strep but had no sore throat, no adenopathy, no rash - released on KEFLEX, TYLENOL, omeprazole, had normal urine culture - after release presents today still some achiness, no weakness in gait, normal exam, but for upper chest wall costochondritis features.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest pain, Computerised tomogram head normal, Costochondritis, Culture urine negative, Diarrhoea
Clinical narrative: Next day pt felt achy, chest, back, felt dizzy, sharp chest pain, weak, mild nausea, felt like face was drooping, no fever at time, felt very weak, had bad headache, stomach ache, mostly upper epigastric area, no emesis, no rash, had diarrhea, to ED (had fever that night, and next am, none since) 8-6 - admitted x 2 days- normal CT brain, normal CSF, ultrasound kidneys normal, CXR normal, positive rapid strep but had no sore throat, no adenopathy, no rash - released on KEFLEX, TYLENOL, omeprazole, had normal urine culture - after release presents today still some achiness, no weakness in gait, normal exam, but for upper chest wall costochondritis features.