chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema
Clinical narrative: Upon follow-up information received on 23 March 2015, the case was upgraded to serious due to the addition of the event intrauterine growth restriction. Initial unsolicited pregnancy report received from a healthcare professional on 22 January 2015. A 28-year-old female patient had received first dose of ADACEL, (batch number C4714AA, expiry date was 08 August 2017) and administered subcutaneously in left tricep on 19 January 2015. The patient had no illness at the time of vaccination and pre-existing allergies, birth defects and medical conditions were not reported. The patient was 31 weeks pregnant at the time of vaccination. The last menstrual period date was 26 May 2015 and expected date of delivery date is March 2015. The patient was in her third trimester of pregnancy. The patient did not receive any treatment for infertility. It was reported that the vaccine was administered subcutaneously instead of intramuscular route resulting in inappropriate route of vaccination. On 21 January 2015, 2 days after vaccination, the patient developed redness at the injection site. The patient was evaluated by the physician on 21 January 2015. Complementary investigations were not reported. The physician prescribed BENADRYL as corrective treatment. At the time of this report, the outcome was unknown. Follow-up information received for this unsolicited pregnancy case on 23 March 2015 from a healthcare professional. The route of administration for the dose of ADACEL received on 19 January 2015 was reported as intramuscular (previously reported as subcutaneous, inappropriate route of vaccination). The patient experienced local inflammation reaction that resolved with BENADRYL and icing of the area. The patient declined genetic testings. She gave birth to a single male live baby (vaginal delivery). Labor was induced for suspected intrauterine growth restriction at 38 weeks of gestation. The newborn's weight was 5 lbs and 8 oz. He did not present any congenital abnormality. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Amnesia, Chest discomfort, Chest pain, Consciousness fluctuating, Fatigue
Clinical narrative: Pt rec'd Tdap vaccine 3-16-15. Within 5 minutes, she c/o unusual taste in mouth, followed by blurred vision, lethargy, tightness in throat. BP decreased 81/50. EPIPEN given x2, BP increased to 122/76. 911 called, transported pt to hospital, adm x 2 days.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Intensive care, Palpitations, Throat tightness
Clinical narrative: Pt rec'd Tdap vaccine 3-16-15. Within 5 minutes, she c/o unusual taste in mouth, followed by blurred vision, lethargy, tightness in throat. BP decreased 81/50. EPIPEN given x2, BP increased to 122/76. 911 called, transported pt to hospital, adm x 2 days.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vision blurred
Clinical narrative: Pt rec'd Tdap vaccine 3-16-15. Within 5 minutes, she c/o unusual taste in mouth, followed by blurred vision, lethargy, tightness in throat. BP decreased 81/50. EPIPEN given x2, BP increased to 122/76. 911 called, transported pt to hospital, adm x 2 days.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood pressure decreased, Blood pressure increased, Dysgeusia, Lethargy, Throat tightness
Clinical narrative: Pt rec'd Tdap vaccine 3-16-15. Within 5 minutes, she c/o unusual taste in mouth, followed by blurred vision, lethargy, tightness in throat. BP decreased 81/50. EPIPEN given x2, BP increased to 122/76. 911 called, transported pt to hospital, adm x 2 days.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Thyroid disorder, X-ray normal
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Pain, X-ray normal
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Limb discomfort, Musculoskeletal pain
Clinical narrative: Pain with movement decreased range of motion. The hospital refuses to believe that the flu shot could cause this. They gave me steroids told me to do home exercises. Sent me to a neurologist to check for nerve damage. Sent me to a private doctor and this doctor also believes that a flu shot can't cause this. Doctors and administers of the flu shot should be educated. The student went way too high on my shoulder. I told them the very next day.
Age: 26.0
Sex: M
Vaccine: DTP
Symptoms: Chills, Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Chills, body aches, nausea, vomiting then diarrhea continued until Monday.
Age: 68.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient states that her arm started swelling the night of the injections and the next morning it was red and swollen.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Chills, Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: Fever, chills, shivers, nausea, fatigue, "tight breathing", tachycardia.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Tachycardia
Clinical narrative: Fever, chills, shivers, nausea, fatigue, "tight breathing", tachycardia.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness, swelling, heat at injection site and extending over a larger area of triceps area.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Approx. 6 hours after vaccine was administered (Pnemovax 23) patient c/o fever, soreness around injection site and nausea. On 3/27/2015 around 2:00 pm L arm had become red and somewhat swollen. Erythema widespread around injection site as well as mild swelling. 3/28/2015 Patient seeked treatment at acute care clinic. C/o increased redness, fever, pain, and itching. Tx. was Kenalog IM injection, and antibx. and anti itch RX's if needed. FYI - Patient had received a Prevnar 13 vaccine via IM route to L arm 8 weeks prior to this vaccine.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Approx. 6 hours after vaccine was administered (Pnemovax 23) patient c/o fever, soreness around injection site and nausea. On 3/27/2015 around 2:00 pm L arm had become red and somewhat swollen. Erythema widespread around injection site as well as mild swelling. 3/28/2015 Patient seeked treatment at acute care clinic. C/o increased redness, fever, pain, and itching. Tx. was Kenalog IM injection, and antibx. and anti itch RX's if needed. FYI - Patient had received a Prevnar 13 vaccine via IM route to L arm 8 weeks prior to this vaccine.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pain on the shoulder after I took the flu shot from pharmacy. This is the first time I having this pain.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Body temperature decreased, Cyanosis, Dyspnoea, Intensive care
Clinical narrative: Pt was transferred from living center (LC) to ED and then to ICU 4 days after he received a flu shot. He was noted to be lethargic, nail beds and lips were blue, respirations labored, BS 321, B/P 98/58, P 82, T 96.8, R 22. He was transferred to general medicine floor the next day and then back to LC 2 days later. The LC physician reported that the flu shot has caused him to be admitted to the hospital the last 3 years d/t hypotension, etc. Nausea, vomiting and hypotension. Sodium chloride.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lethargy
Clinical narrative: Pt was transferred from living center (LC) to ED and then to ICU 4 days after he received a flu shot. He was noted to be lethargic, nail beds and lips were blue, respirations labored, BS 321, B/P 98/58, P 82, T 96.8, R 22. He was transferred to general medicine floor the next day and then back to LC 2 days later. The LC physician reported that the flu shot has caused him to be admitted to the hospital the last 3 years d/t hypotension, etc. Nausea, vomiting and hypotension. Sodium chloride.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Cyanosis, Dyspnoea, Intensive care, Lethargy
Clinical narrative: Pt was transferred from living center (LC) to ED and then to ICU 4 days after he received a flu shot. He was noted to be lethargic, nail beds and lips were blue, respirations labored, BS 321, B/P 98/58, P 82, T 96.8, R 22. He was transferred to general medicine floor the next day and then back to LC 2 days later. The LC physician reported that the flu shot has caused him to be admitted to the hospital the last 3 years d/t hypotension, etc. Nausea, vomiting and hypotension. Sodium chloride.
Age: 85.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nail discolouration
Clinical narrative: Pt was transferred from living center (LC) to ED and then to ICU 4 days after he received a flu shot. He was noted to be lethargic, nail beds and lips were blue, respirations labored, BS 321, B/P 98/58, P 82, T 96.8, R 22. He was transferred to general medicine floor the next day and then back to LC 2 days later. The LC physician reported that the flu shot has caused him to be admitted to the hospital the last 3 years d/t hypotension, etc. Nausea, vomiting and hypotension. Sodium chloride.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored ROTATEQ. No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an immunization official healthcare worker referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, frequency, and lot# were not reported), which were stored improperly. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MENB
Symptoms: Abortion spontaneous, Blood test abnormal, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Case number PHEH2015US005313, is an initial spontaneous report from a consumer (patient) received on 17 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015 and a follow up received from nurse on 20 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358730) on 26 Mar 2015. This report refers to a 29 years old female pregnant patient. Past medical history included Graves' disease. Concomitant medications included propylthiouracil and prenatal vitamins. The patient was vaccinated with BEXSERO (batch number: unknown) on 24 Feb 2015. On 04 Mar 2015, the patient underwent blood test which confirmed non-viable (not further specified). The patient's pregnancy was confirmed by quantitative lab work (possible chemical pregnancy). However, no ultrasound was done to confirm the pregnancy. The patient's last menstrual period (LMP) was on 28 Jan 2015 and expected date of delivery (EDD) was 04 Nov 2015. On 08 Mar 2015, the patient had a miscarriage. The patient's pregnancy was not associated with any contraception failure and the patient did not discontinue any drugs due to the pregnancy. The patient had now recovered and was now having regular menses. Seriousness and causality of the events was not reported. Seriousness assessment of miscarriage was upgraded based on the NVS-IMS list. On the basis of the review performed it is possible to confirm that BEXSERO manufacturing process is under control. From a technical and quality point of view, neither any objection nor discrepancy has been identified nor was any cause identified for the reported adverse event. Non-significant follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015: Updated QA reference number. Follow up received from nurse on 20 Mar 2015: updated patient demographics, medical history, concomitant medications, LMP, EDD and other clinically relevant information in the narrative. Follow-up information received from the Quality Assurance Department (reference number: 358730) on 26 Mar 2015: Updated BEXSERO batch review report.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Inflammation, Pain, Pruritus
Clinical narrative: Round painful itchy rash about the size of a silver dollar, possibly larger. Red inflamed swollen like a large fist. Hot, itchy, very painful, incredibly itchy. It's been 98 hours now and the swelling it down some, but the rash, swelling, pain, itching are all present, just to a lesser degree. The main pain and swelling were from 12 hours after until 86 hours after.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Rash pruritic, Swelling
Clinical narrative: Round painful itchy rash about the size of a silver dollar, possibly larger. Red inflamed swollen like a large fist. Hot, itchy, very painful, incredibly itchy. It's been 98 hours now and the swelling it down some, but the rash, swelling, pain, itching are all present, just to a lesser degree. The main pain and swelling were from 12 hours after until 86 hours after.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Induration, Pain
Clinical narrative: Redness, swelling, pain, firmness, numbness in hand/arm, warmth.
Age: 28.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Swelling
Clinical narrative: Redness, swelling, pain, firmness, numbness in hand/arm, warmth.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: NAUSEA, chills, fever, arm pain. Lasted until 03/30/2015 at 8:00 AM.  Treated with Tylenol and ibuprofen.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: Injection hurt going in and needle coming out., it was given in my Left upper arm very high. Has hurt ever since.  Arm has hurt lifting arm up to put tee shirt on and when I cross over my Left arm to the right.  Pain has decrease about 75%. I can still feel discomfort on the upper inward side of arm and at injection site. I took naproxen for 10 days at night, helped some. Used heat some I have continued my everyday activities. I feel using it would be better.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site discomfort, Injection site pain, Pain in extremity
Clinical narrative: Injection hurt going in and needle coming out., it was given in my Left upper arm very high. Has hurt ever since.  Arm has hurt lifting arm up to put tee shirt on and when I cross over my Left arm to the right.  Pain has decrease about 75%. I can still feel discomfort on the upper inward side of arm and at injection site. I took naproxen for 10 days at night, helped some. Used heat some I have continued my everyday activities. I feel using it would be better.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA and vomiting.  Lasted until 03/30/2015 at 8:00 AM.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Exfoliative rash, Injection site pruritus, Rash erythematous
Clinical narrative: Patient states the injection site started itching the night after the vaccine was administered. Subsequently, a rash (scaly and red) formed within 3 days after administration. The size of the rash was approximately 1.5 cm x 1 cm.
Age: 39.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Complaining of hives and itching both arms upon waking.  Noted itching of throat 1-2 hours post vaccination.  Took Benadryl with some relief.  Hive not noted anywhere but arms. Recommended she go to Urgent Care or her PCP.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Client developed cellulitis. Saw MD on 3/18/15. Treated with antibiotics. Resolving on 3/19/15.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis
Clinical narrative: Client developed cellulitis. Saw MD on 3/18/15. Treated with antibiotics. Resolving on 3/19/15.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Welt at injections site that itches.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, MNQ, VARCEL
Symptoms: Incorrect product formulation administered
Clinical narrative: An ActHIB (Haemophilus b conjugate vaccine) was mixed with a Meningococcal (Menactra vaccine) and given to the patient together.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Her arm began hurting after injection on Friday, but on Saturday, she began to have localized swelling.  On Sunday 03/29/15, the circumference of her whole upper arm was edematous, hot to touch and erythematous.  She was seen in clinic followed by the emergency room.  She was treated with Keflex.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea, Malaise, Pyrexia
Clinical narrative: Patient received the MMR vaccine at the pediatrician's recommendation on March 4th, 2015. On the ninth day following the shot, March 13th, she developed a fever and seemed 'not well', then started having diarrhea the next morning, March 14th. She had a fever most of March 13th-15th, and it lingered on and off through the 17th. The diarrhea was extremely foul and runny and around 10+ times a day from March 14th-March 16th. It has remained runny and FOUL, (I know that diarrhea doesn't smell good, but this is the worst I've ever smelled, and I have 3 children and have taken care of them when sick for 13 years now, this smells different) still, but since the 17th, it's only 1-4 times per day. We've tried the BRAT diet, and it didn't help, plus she's become picky about food, so I'm basically feeding her whatever she will eat. When I called the nurse advice line, I was told 'She probably just picked up a virus, just let it run it's course.' ... There are 5 people in my house, and no one else has been sick. At all.  I have not taken her to a hospital yet for this, because it doesn't seem to be life-threatening, however, if her docotor or someone doesn't help me get her straightened out soon, or it doesn't just clear up on it's own, I will be taking her for testing. Going on 3 weeks of diarrhea for such a little child, I know she can't possibly be absorbing any nutrients at this point.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Patient received the MMR vaccine at the pediatrician's recommendation on March 4th, 2015. On the ninth day following the shot, March 13th, she developed a fever and seemed 'not well', then started having diarrhea the next morning, March 14th. She had a fever most of March 13th-15th, and it lingered on and off through the 17th. The diarrhea was extremely foul and runny and around 10+ times a day from March 14th-March 16th. It has remained runny and FOUL, (I know that diarrhea doesn't smell good, but this is the worst I've ever smelled, and I have 3 children and have taken care of them when sick for 13 years now, this smells different) still, but since the 17th, it's only 1-4 times per day. We've tried the BRAT diet, and it didn't help, plus she's become picky about food, so I'm basically feeding her whatever she will eat. When I called the nurse advice line, I was told 'She probably just picked up a virus, just let it run it's course.' ... There are 5 people in my house, and no one else has been sick. At all.  I have not taken her to a hospital yet for this, because it doesn't seem to be life-threatening, however, if her docotor or someone doesn't help me get her straightened out soon, or it doesn't just clear up on it's own, I will be taking her for testing. Going on 3 weeks of diarrhea for such a little child, I know she can't possibly be absorbing any nutrients at this point.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Full blood count, Haematocrit
Clinical narrative: Mother noticed some swelling around the injection site where he was complaining of pain as well.  The next day, he developed a fever Tmax 102F.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Haemoglobin, Injection site pain, Injection site swelling, Platelet count, Pyrexia
Clinical narrative: Mother noticed some swelling around the injection site where he was complaining of pain as well.  The next day, he developed a fever Tmax 102F.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Local swelling, Pain
Clinical narrative: Localized swelling, erythema, pain, induration.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called to say she had swelling, itching and redness to left arm from injection site to elbow. Pt denied airway involvement or other systemic symptoms.  Pt instructed to seek evaluation at the Immediate Care Center.  Pt waited until 3/28 at approximately 10:30 AM to seek treatment.  Pt received Benadryl and was instructed to continue Benadryl as she is allergic to corticosteriods.  Pt states similar reaction several years ago to tetanus toxoid.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Arm started to get sore in my muscles on front and back of arm. Pain in using and raising my arm. Pain is still present as of today Took Ibuprofen, tried BLUE-EMU. Some headaches not all the time.  I usually don't get headaches. Pain is from my shoulder to my elbow. How long are these systems suppose to last?  They do not subside and gets worse as I use my arm.  Hard to raise my arm shoulder high or above. Have not been to the doctor yet because I didn't think that there was anything to be done.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: After 3rd Gardasil vaccination my daughter came down with body aches, joint pains, generally not feeling well, nausea, vomiting, chills, chest pain, congestion, slight fever, shortness of breath, extreme fatigue - 4 days later (3/27/2015) cough and greater congestion - 6 days later (3/29/2015) redness in both eyes with no itching or oozing, just red - 7 days (3/30/2015) greater cough and laryngitis. She has been more fatigued since the first injection.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Laryngitis, Malaise, Nausea, Ocular hyperaemia
Clinical narrative: After 3rd Gardasil vaccination my daughter came down with body aches, joint pains, generally not feeling well, nausea, vomiting, chills, chest pain, congestion, slight fever, shortness of breath, extreme fatigue - 4 days later (3/27/2015) cough and greater congestion - 6 days later (3/29/2015) redness in both eyes with no itching or oozing, just red - 7 days (3/30/2015) greater cough and laryngitis. She has been more fatigued since the first injection.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Vomiting, White blood cell count increased
Clinical narrative: After 3rd Gardasil vaccination my daughter came down with body aches, joint pains, generally not feeling well, nausea, vomiting, chills, chest pain, congestion, slight fever, shortness of breath, extreme fatigue - 4 days later (3/27/2015) cough and greater congestion - 6 days later (3/29/2015) redness in both eyes with no itching or oozing, just red - 7 days (3/30/2015) greater cough and laryngitis. She has been more fatigued since the first injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT STATED THAT HER ARM STARTED TO SWELL IN THE AREA INJECTED, IT BECAME RED, AND STARTED TO BECOME ITCHY.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Memory impairment, Muscle contractions involuntary, Speech disorder
Clinical narrative: Moments after receiving the vaccine (#3 of 3 in the series), patient fell backwards, arms and hands curled up into her chest and started babbling. Her eyes remained open the entire time. This only lasted for about 20 seconds. After the event, patient did not recollect any of it.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Blisters in area of vaccine (approx. 2" dia of blisters) plus localized swelling approx. 4" wide and 7" long. All in area of injection on right arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Eyelid oedema, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: 03/27/15 red bump at injection site with a headache, 03/30/15 mild nausea and headache, eyes "puffy underneath".
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Slight fever (with arm soreness common with injection). Taking ibuprofen.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Vomiting
Clinical narrative: Intussusception of the colon and vomiting.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: The day right after my flu shot was given in top of left shoulder-pointing down. I had sharp pain in the shoulder. I could not raise the left arm to change my clothes by myself nor could I sleep except sitting up.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: The day right after my flu shot was given in top of left shoulder-pointing down. I had sharp pain in the shoulder. I could not raise the left arm to change my clothes by myself nor could I sleep except sitting up.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Myalgia
Clinical narrative: Muscle pain redness at the injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Difficult IM vaccine injection resulted in immediate (L) deltoid pain w/radiation to (L) hand. Severe for 4 days, persistent to present (5 mos.) orthopedic consult -> local injection of triamcinolone and Bup/vacaine, followed by 3 wks of arm exercises. Symptoms worsened PT referral-> unable to provide beneficial treatment; Referred back to orthopedics for follow-up care.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Per nursing vaccination note 9/19/14: Swelling of left upper arm immediately post shot.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Local reaction, Pruritus, Swelling
Clinical narrative: Large local reaction to Tdap. Swelling, itchy, burning to the area.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Mobility decreased, Neck pain, Pain
Clinical narrative: Very painful arm. Red, swollen, radiating pain into neck. Chills, aches. Could not use arm x 3 days. Today-sxs resolved.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Very painful arm. Red, swollen, radiating pain into neck. Chills, aches. Could not use arm x 3 days. Today-sxs resolved.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Foaming at mouth, Salivary hypersecretion
Clinical narrative: Pt had some 'frothing' or hypersalivation after last (2 mo) vaccines lasted 2-3 hrs and started 3h after shots.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of RECOMBIVAX HB (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to RECOMBIVAX HB. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014262, MARRS # 1503USA014263, MARRS # 1503USA014264 and MARRS # 1503USA014265). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Register Nurse refers to unspecified number of patients of unknown age and gender. On an unkonwn date, the patients were vaccinated with GARDASIL (dose, strength, frequency and lot number were not reported), which since 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 26-MAR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006191 and expiration date on 02-FEB-2015, dose 0.5 ml, intramuscular. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Accidental exposure to product, Needle issue, No adverse event, Underdose
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB, strength: 2.5mcg/0.5 ml (lot#, expiration date, route and dose were not reported). The nurse reported the patient only received a partial dose of RECOMBIVAX HB since there was leakage around the needle and a "drop" of RECOMBIVAX HB dose fell on the patient's leg. No adverse effects reported. No product quality complaint was involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the 2 doses of improperly stored MMR II which were not supported were administered to 2 unspecified patients. No adverse effects reported. The outcome of reported events is unknown. No product quality complaint was involved. This case is linked to the case 1503USA013941 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2015, the patients were vaccinated with improperly stored VAQTA (dose, frequency and indicatrion were not provided). No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to several unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with supported vaccine products post excursion, VARIVAX lot# K007781, expiration date 28-MAY-2016 (dose and route were not reported). No adverse effects reported. There was no concomitant medication provided. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored VAQTA. No adverse effects were reported. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a 75 year old female patient. On an unknown date the patient was vaccinated with one dose of ZOSTAVAX (dose, route and lot# unknown) for prevention of shingles. On an unknown date the patient was diagnosed with a mild case of shingles after receiving ZOSTAVAX. The patient made office visit on an unspecified date and received acyclovir (unspecified dose/frequency and manufacturer) as treatment. Outcome of shingles was reported as recovered on an unknown date. This is one of two reports received from the same reporter. Additional information is not expected as the physician refuse to be contacted.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date, the patient was inadvertently administered a dose of VAQTA (lot# H012642; expiration date: 16-APR-2015), 0.5 ml, intramuscular. Concomitant therapies were not reported. The C.M.A stated that this VAQTA had been improperly stored. No adverse effects were reported and product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age (over 65 years old). Information about patient's current condition or medical history was not reported. The nurse reported that the patient received his first dose of ZOSTAVAX (lot# not reported, 0.65ml, subcutaneously) on 25-MAR-2014 and then inadvertently was administered a second dose of ZOSTAVAX (lot# not reported, 0.65ml, subcutaneously) on 27-MAR-2015. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a health professional refers to a 65 year old female patient. Patient's pertinent medical history included seizures. Drug reactions/allergies were unspecified. On 26-MAR-2015 the patient was administered with ZOSTAVAX, .65 ml (lot # L002422, expiry date: 23-APR-2016) for routine vaccination. Concomitant therapies included DILANTIN. The patient experienced dizziness on 26-MAR-2015 following the administered of ZOSTAVAX. The patient sought medical attention and went to the pharmacy. Lab diagnostic studies were unspecified. Treatment given for the event was unspecified. Outcome of the event was not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of ROTATEQ (lot # and expiry date unspecified ) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to ROTATEQ. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014263, MARRS # 1503USA014264 and MARRS # 1503USA014265). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of with PROQUAD (Merck) (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to PROQUAD (Merck). This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS # 1503USA014263 ad MARRS # 1503USA014265). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of (Oka/Merck) VARIVAX (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to (Oka/Merck) VARIVAX. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS # 1503USA014263 and MARRS # 1503USA014264. 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 health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of GARDASIL (lot # and expiry date unspecified) which were improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS #1503USA014263, MARRS # 1503USA014264 and MARRS # 1503USA014265). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Rash
Clinical narrative: Skin rash and arm swelling.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Feeling hot, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Per ER Attending Note 12/12/14: Patient is a 60 year old male with (R) shoulder pain and swelling after a PNEUMOVAX shot 2 days ago. Felt hot and itchy yesterday. Had some chills overnight. Today seemed more painful and comes to the ED now. Denies other rash. No CP or SOB. Otherwise doing ok. Acetaminophen 2 tablets tab prn, diphenhydramine 25-50 mg prn.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 26-MAR-2015 was vaccinated with an improperly stored dose of VAQTA 25/0.5 (units not provided), intramuscular, lot # K005958 and expiration date on 09-FEB-2017, 0.5 ml, intramuscular. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of MMR II (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to MMR II. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS # 1503USA014264 and MARRS # 1503USA014265. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: This staff reports she received the varicella vaccine 2-6-15 and for about a month has noticed a sensitivity over the left forehead when she touches this area.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Urticaria
Clinical narrative: 3 hours after shot, got hives on midsection and shoulder. Persisted on face (mostly on) for 3 weeks as of now intense muscle soreness in neck and lower back started 3/24/15.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Axillary pain, Back pain, Chest pain, Herpes zoster, Pruritus
Clinical narrative: Patient received MMRV in office on 3/10/15. On 3/18/15 or 3/20/15 patient noticed painful/itchy area on back and mother began applying hydrocortisone. Appeared to spread under arm and to chest. Patient seen 3/28/14 and diagnosed with shingles. Patient given Rx of ZOVARIX to start if painful, but right now continues to just itch.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referred to several unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PROQUAD 0.5 ml, subcutaneously, lot# reported as K020749 and expiration date 30-APR-2016. There was no concomitant medication provided. No adverse effects reported. This is one of two reports from same source. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: PNC13
Symptoms: Abdominal distension, Dizziness, Pain in extremity
Clinical narrative: Light headed. Arm pain. Dizziness. Gas pain.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Haematocrit normal
Clinical narrative: Patient w/ hematochezia x 4 weeks.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist via other company Pfizer, refers to a 64 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date a year ago, the patient was vaccinated with PNEUMOVAX23 (Lot # and dose were not reported). The patient had a knot at the injection site which lasted 3 months. The outcome was unknown. The reporter did not provide the relatedness of the event with PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 24-SEP-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On 03-MAR-2015, the patient was vaccinated with second dose of GARDASIL (lot number, dose, frequency and route unspecified) which was outside the vaccination recommendations. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect product was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician via company representative referring to a male patient of unknown age. Concurrent conditions, medical history of the patient were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route unspecified). Concomitant therapies were not reported. On an unknown date the patient experienced cellulitis, after receiving ZOSTAVAX. At the time of the report, the event outcome was reported as recovering. No product quality complaint (PQC) involved. The relatedness between the vent and therapy with ZOSTAVAX was not reported. Additional information has been requested.