chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Patient received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192699, 2019SA193109, 2019SA193112, 2019SA193105, 2019SA193110, 2019SA193111, 2019SA193107, 2019SA193106, 2019SA192700 and 2019SA192698 (Same reporter).  This case involves female patient of an unknown age who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via unknown route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: excursion on shipping Tenivac; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a female patient of unknown age who was vaccinated with a dose of  vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which had excursion on shipping, (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. It was reported that Time 7/9/19 received 7/11/2019 (2 days).  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Daptacel was given to a patient/ No AE; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 32 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the right thigh on 19-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect route of product administration
Clinical narrative: administered an ActHIB vaccine subcutaneously instead of Intramuscular; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI988AA, expiry date- 03-Oct-2020 via subcutaneous route instead of intramuscular in the left thigh On 19-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation via subcutaneous route; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath, wheezing started on sunday the 20th.  Patient used the ventolin inhaler and it did not improve symptoms.   On Tuesday  the 23rd the patient went to urgent care and was given a steroid injection and prescription for prednisone.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Local reaction
Clinical narrative: She developed redness on the injection site on her Left thigh on 7/21/19.  Started Tylenol yesterday. The redness is not going away.  No fever.  She is acting fine.   She had MMRV on the left thigh given on 7/15/19/ They are leaving  tomorrow. I reassured the mother that patient has a local reaction to the MMR. Give her Benadryl 2.5 ml q 6hrs x 2-3 days. - diphenhydrAMINE (BENADRYL 2.5 MG/ML) 12.5 MG/5ML Syrup; Take 2.5 mL by mouth four times daily as needed for swelling/pruritis for up to 3 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pruritus generalised, Rash
Clinical narrative: Patient stated she felt tired and sick the day after (7/23/19) receiving her first dose of Shingrix.  She woke up the next morning (7/24/19) with a rash on face, head, and neck.  She also stated she was itching all over.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Depressed mood, Fatigue, Learning disorder, Loss of personal independence in daily activities
Clinical narrative: My son got the vaccine Bexsero before going to college. He was an amazing student and after getting this vaccine, since I can't relate his situation to anything else, he started having memory problems, he had to drop the university due to this. After researching what may have been the cause, this is the only chain I can tie with his lack of energy, mood swings, and memory problems.. My son was an A honor student at high school, learned Russian by himself, aside from German, English and Spanish. He was in a Magnet Engeneering program and now he is feeling more than depress and sad because he can't even solve an small problem!  I urge you to consider my e mail. I will continue investigating this and will urge you to give me a solution since the only event related to his problem is this vaccine which he got right before entering the university where all the problems started.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Memory impairment, Mood swings
Clinical narrative: My son got the vaccine Bexsero before going to college. He was an amazing student and after getting this vaccine, since I can't relate his situation to anything else, he started having memory problems, he had to drop the university due to this. After researching what may have been the cause, this is the only chain I can tie with his lack of energy, mood swings, and memory problems.. My son was an A honor student at high school, learned Russian by himself, aside from German, English and Spanish. He was in a Magnet Engeneering program and now he is feeling more than depress and sad because he can't even solve an small problem!  I urge you to consider my e mail. I will continue investigating this and will urge you to give me a solution since the only event related to his problem is this vaccine which he got right before entering the university where all the problems started.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Patient described severe muscle pain and joint pain that lasted for months after injection but has now gone  away. The patient states still having occasional pain in hands but says also has arthritis in hands so that could be related.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client started having some swelling on  Tuesday morning and by Tuesday evening it was even more swollen, warm, and red but not running a temperature. Mom called childs PCP and made an appointment for Wednesday morning. By Wednesday morning childs whole upper arm was swollen, red and warm to touch but still no fever. PCP stated that she didn't think it was cellulitis but couldn't for sure say if vaccine reaction and stated to monitor for temperature, SOB, and any other side effects, but in the meantime apply benadryll and icy hot topically.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient went to the pharmacy to state that the area where the vaccine was administered was inflamed and painful. We encouraged him to go to the doctor to be evaluated. Patient went to the doctor. The doctor prescribed the antibiotic Ciprofloxacin 500 mg tablet to take twice a day. The patient was called days later for follow-up and patient stated that he feels better and he no longer has pain in the affected area.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fatigue, Nausea, Vision blurred
Clinical narrative: MOTHER COMPLAINT THAT PATIENT FELT NAUSEATED, LIGHT HEADED, TIRED AND HAD BLURRED VISION 2 DAYS AFTER RECEIVING VACCINES.    NO FEVER.  INSTRUCTED TO FOLLOW UP WITH PCP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Pyrexia, Rash macular
Clinical narrative: Pt complained of fever on and off, splotchy red areas on arm and burning/tingling sensation in immunized arm.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Muscle spasms, Myalgia
Clinical narrative: Patient's husband came in on 7/24/19, said patient  had fever, chills, stomach pains, leg cramps, muscle aches all over, and headache. We recommended that he take patient to Urgent Care.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient's husband came in on 7/24/19, said patient  had fever, chills, stomach pains, leg cramps, muscle aches all over, and headache. We recommended that he take patient to Urgent Care.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash erythematous, Vaccination site reaction
Clinical narrative: PATIENT CAME IN THE PHARMACY 2 DAYS POST SHOT NUMBER 2 IN THE SERIES WITH A RED RASH AT THE SITE OF THE VACCINATION.  THE SITE WAS RED, WARM TO THE TOUCH, AND HARD.  NO DIFFICULTY BREATHING, OR SIGNS OF anaphylactic REACTION.  PATIENT HAS BEEN TAKING TYLENOL AND APPLYING ICE TO THE SITE SINCE DOSE ADMINISTRATION.  SHE HAD NO SIDE EFFECTS TO THE FIRST SHOT
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient called and reported redness, itching, small patch hives, fever (>100 degrees Fahrenheit). Injection was in left arm. Patient was instructed to follow up with PCP if symptoms ongoing or worsen within 7 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Trismus
Clinical narrative: Patient called the pharmacy and reported that her jaw was locking up on the right side, which is where she claims the vaccine was given.  Patient said it felt like a muscle spasm. Patient was incouraged to seek medical attention, but status is unknown at this time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chest discomfort, Chills, Fatigue, Hyperhidrosis
Clinical narrative: patient came in today 07/24 and was asking about adverse effects of the vaccine. she listed some adverse effects she had experienced and most of them were listed in the package as normal or expected adverse effects such as sweating, fatigue, muscle aches, fever and shivering. she said she had no GI issues, but said the events did not start until the next day in the evening.  the one thing she did report which is not listed is bone aches, I asked the patient if she thought maybe this was just muscle aches which are normal but she said it was pretty bad "bone pain" and also reported some chest tightness. I asked patient if it was bad enough she needed medical attention or if she called her md and she said not that it was not that bad but it took about 3 days to get better, at this point she said she was much better but wanted to make sure this was ok and was not sure if she needed to let us know. patient still wants to get second dose.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: patient came in today 07/24 and was asking about adverse effects of the vaccine. she listed some adverse effects she had experienced and most of them were listed in the package as normal or expected adverse effects such as sweating, fatigue, muscle aches, fever and shivering. she said she had no GI issues, but said the events did not start until the next day in the evening.  the one thing she did report which is not listed is bone aches, I asked the patient if she thought maybe this was just muscle aches which are normal but she said it was pretty bad "bone pain" and also reported some chest tightness. I asked patient if it was bad enough she needed medical attention or if she called her md and she said not that it was not that bad but it took about 3 days to get better, at this point she said she was much better but wanted to make sure this was ok and was not sure if she needed to let us know. patient still wants to get second dose.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: PATIENT SEEMED TO FAINT AND/OR HAD A POSSIBLE SEIZURE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patietn reported red circle appeared on arm around injection site. It was about 2-3 inches in diameter. It produced heat. It was also firm to the touch.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hyperaesthesia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Despite moving my arm frequently as recommended, arm pain started early afternoon, fever of 101 that night, all over aches and sensitivity, weakness. Fever subsided by early afternoon next day and all symptoms were gone by evening next day.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle pain, chills, fever
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oral mucosal eruption, Oropharyngeal pain, Rash erythematous, Tongue eruption
Clinical narrative: Saturday 7/20/19: woke up with sore throat in the morning and fatigue  Sunday 7/21/19: still sore throat, fatigue lessened  Monday 7/22/19: still sore, no fatigue  Tuesday 7/23/19: no sore throat  Wednesday (today) 7/24/19: has red sores/bumps on back of tongue, top of mouth, throat
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient got shot, two days later arm became hot and red then two days later arm was sore and this lasted around a week, then for 1 more week arm became itchy and warm but redness went away the reaction lasted till 7-17-19
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever and fatigue the night of the morning vaccine. Dizziness, fatigue and nausea (including vomiting) the following day.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dry mouth, Fall, Head injury
Clinical narrative: Patient received HPV,MCV4,TDAP after receiving vaccines patient stated he felt normal. Patient stood up to leave and with in seconds felt his mouth dry and fell to the floor and hit his head on the counter. Ambulance was called and patient was being observed and cared for until the arrival of EMT to be transported to the Emergency Room.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Patient experienced 36 hours of fever, fatigue, nausea, body aches
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Tremor
Clinical narrative: Patient experienced tremor and back pain about 45 minutes after injection of pneumovax 23. Injection was given on 07/17/2019 and when patient report the event to the pharmacist at 07/24/19, all his adverse reaction had been resolved.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Injection site inflammation, Peripheral swelling
Clinical narrative: Patient states that she experienced inflammation at the site of injection about 3 hours after receiving vaccination.  She also stated that she had sweating at night and her left arm was swollen red in the morning after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: Patient states that 5 days after receiving her shingrix vaccine she developed rash and itching that moved from one part of the body to other including her legs and arms.  She took  benadryl 25mg tablets that helped her control rash temporarily but rash came back the next day. She states that she also suffers from eczema and this rash could be because of eczema. She notified her primary doctor.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Stupor
Clinical narrative: Fatigue, torpor, muscle pain, shivering, pain at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Headache, Nausea
Clinical narrative: Nausea, dizziness, throbbing headache. Bedridden the whole day following the vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: I had chills, stomach pain, nausea, muscular pain and pain at site of  injection.   Tylenol and Tums decreased the symptoms temporarily.  I felt better approximately 16 hours after symptoms began, although my arm is still very tender to touch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: I had chills, stomach pain, nausea, muscular pain and pain at site of  injection.   Tylenol and Tums decreased the symptoms temporarily.  I felt better approximately 16 hours after symptoms began, although my arm is still very tender to touch.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Disorientation, Dizziness, Fall, Gait disturbance
Clinical narrative: Dizziness, mental disorientation, loss of balance, falls, muscle weakness (arms and legs) had to use hand rails up and down stairs, progressing for 2 months, slowly recovery over next 2+ months, short stumbling steps.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Neurological examination normal
Clinical narrative: Dizziness, mental disorientation, loss of balance, falls, muscle weakness (arms and legs) had to use hand rails up and down stairs, progressing for 2 months, slowly recovery over next 2+ months, short stumbling steps.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HEPA, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No symptoms. Contacted by pediatrician 3 months later to Alert us to the wrong vaccine given.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site rash, Pyrexia
Clinical narrative: Developed a fever over the weekend, up to 101 degrees F. Noticed a red rash at injection site that continued to grow over the weekend to cover an area about the size of a grapefruit. It was considerably enflamed.  Her PCP ended up calling in Rx for Clindamycin thinking some sort of cellulitis had developed.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: soreness and painful and rash on 1st day then stomach cramping, feverbarely under 100, blood red swollen 6 inches on the area o f the vaccine and hot to feel and couldnt touch
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: soreness and painful and rash on 1st day then stomach cramping, feverbarely under 100, blood red swollen 6 inches on the area o f the vaccine and hot to feel and couldnt touch
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Erythema, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: soreness and painful and rash on 1st day then stomach cramping, feverbarely under 100, blood red swollen 6 inches on the area o f the vaccine and hot to feel and couldnt touch
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: soreness and painful and rash on 1st day then stomach cramping, feverbarely under 100, blood red swollen 6 inches on the area o f the vaccine and hot to feel and couldnt touch
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain upper, Night sweats, Pain of skin, Rash
Clinical narrative: Patient called clinic on 7/18/19 c/o night sweats, rash and feeling of a "knot" in stomach as well as tenderness of skin. Spoke with physician on 7/19/19 and all symptoms had resolved. (Report delayed as reported out of office until 7/22/19)
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: & chills
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Shortly after receiving his first HPV vaccine,  patient fainted twice within 30 minutes.  Patient came around both times within 30  seconds.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Disorientation, Hypersomnia, Pyrexia
Clinical narrative: fever chills excessive sleep (i.e, 19 hours for next 24 hours) disorientation
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: arm swelling, redness, warmth, itching started 7/22/19. over last 2 days swelling, warmth of arm, redness, itching have increased. Keflex QID x10days 250mg
Age: 11.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (R) upper arm w/ erythema, edema & warmth
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Vaccination site cellulitis
Clinical narrative: 2 x 3 cm area of redness, induration, warmth at injection site on (R) thigh
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Myalgia, Neck pain, Pain of skin, Peripheral swelling
Clinical narrative: Fever today Tmax-101 degrees F with neck pain + muscle aches "sunburn" like feeling on her face + posterior trunk areas, (L) arm swollen with redness + tenderness to touch
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Tenderness
Clinical narrative: Fever today Tmax-101 degrees F with neck pain + muscle aches "sunburn" like feeling on her face + posterior trunk areas, (L) arm swollen with redness + tenderness to touch
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Aldolase increased, Biopsy skin abnormal, Blood creatine phosphokinase increased, Dermatomyositis, Rash
Clinical narrative: developed rash 4 days after his immunizations: Diagnosed with juvenile Dermatomyositis (JDM) She has been referred to Pediatric Rheumatology. She has an appointment on 7/26/19. Anticipate she will be admitted & will start treatment at that time.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Child developed 101'F fever, vomited yesterday, diarrhea
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives three days after vaccine given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: Patient has erythema of the injection site and itching rash.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt says that her arm is still sore from a Shingrix vaccine that was given on 11/18/18. She pointed to her deltoid, so there is no reason to believe that it was administered abnormally.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Pain, Pyrexia
Clinical narrative: SWOLLEN INJECTION SITE, FLU LIKE CONDITION, BODY ACHE, FEVER 102.0
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Antibody test, Blood glucose, Glycosylated haemoglobin increased, Insulin C-peptide, Type 1 diabetes mellitus
Clinical narrative: ANTIBODY TEST; Blood sugar; A1C of 12.1; Insulin C-peptide; Type 1 diabetes mellitus; This report was identified from a line listing obtained on request by the Company from the FDA (agency# 794773) under the Freedom of Information Act, referring to a 17 years old male patient. The patient's current illnesses included Aspergers. The patient's other medications included loratadine (CLARITIN), multi-vitamins (unspecified), cyanocobalamin (reported as B12). Historical condition and prior vaccinations were not reported.   On 13-MAR-2013, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis and the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (strength, dose, route, lot#, expiration date and indication were not reported).  In March 2014 (reported as 1 year after vaccination), the patient began to have symptoms of Type 1 Diabetes. Diagnosis of Type 1 Diabetes was on 20-JAN-2015 with Glycated hemoglobin (A1C) of 12.1 (unit unspecified) (glycosylated haemoglobin increased), which means the patient had Type 1 Diabetes undiagnosed for 3 months if not longer. On 20-JAN-2015, the patient had Type 1 Diabetes Antibody tests, insulin C-peptide, and blood sugar level test, the results were not provided. All the events caused hospitalization, disability and were life threatening.      The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.   Follow-up information has been received from the FDA (agency# 794773) under the Freedom of Information Act, on 03-JUL-2019. Reporter information was updated. Age at vaccination was updated as 17 years old. Hence the patient's age was updated as 19 years old. Ethnic group and facility information was updated. The patient had allergy to sulfa drugs. The patient had never has an adverse event following any previous vaccine. The patient visited physician office and emergency room. Duration of hospitalization was updated as 1 day.  Follow up information was received from a medical assistant on 18-JUL-2019. The reporter was unable to assist the call. The reporter stated the events and vaccination were long ago and there was no patient identifier available at the time of the call.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient called and reported redness, itching, small patch hives, fever (greater than 100 degrees Fahrenheit).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Musculoskeletal stiffness, Pain in extremity, Rheumatoid arthritis, Skin warm
Clinical narrative: This was my first pregnancy. I was 7 months pregnant and went to immediate care to get a flu shot. Called OB and immediate care today for specific dates. Called OB on 11/11/16 complaining of Rheumatoid Arthritis symptoms. Hot to touch, pain and extreme stiffness in hands/fingers. Didn't make the correlation until I found studies confirming the strong link between vaccinations and RA.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Pt reports big blister forming 1 inch below the injection site about the size 3inx6in, sensitive to touch rather like a shingles outbreak. It's been almost 1 week and the blister is just going down. Tylenol and icing has helped.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Nausea, Rash
Clinical narrative: Felt intense fatigue and malaise accompanied by chills and nausea . Small rash on my left hip.
Sex: F
Vaccine: HIBV
Symptoms: Blood albumin decreased, Blood immunoglobulin M decreased, Blood potassium decreased, Extra dose administered, Full blood count
Clinical narrative: Multiple myeloma; The patient was administered an additional dose of PEDVAX HlB; The patient was administered an additional dose of PEDVAX HlB; The patient was administered another dose of PEDVAX HlB; This spontaneous report was received from a nurse concerning a 52 year old female patient. The patient's concurrent conditions included family history neoplasm of the gastrointestinal tract, mood disorder, high cholesterol, gastrooesophageal reflux disease (GERD), sleep apnea and hypothyroidism. The patient's drug reactions/allergies included morphine. The patient's concomitant medications included multiple unspecified medications. On unknown dates (many years ago), the patient "may" have been administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as prophylaxis (formulations, strength, dose, routes of administration, lot numbers and expiration dates were not reported).    On an unspecified date (also reported as 15-JUL-2019, conflicting information), she developed multiple myeloma (plasma cell myeloma). The reporter could not confirm if the multiple myeloma occurred prior to of after receiving the first doses of the suspect vaccine (number of doses unspecified).   On 09-MAY-2018, the patient had a stem cell transplant as treatment for multiple myeloma also reported as no treatment was given for the event, conflicting information.  On 17-APR-2019, another dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was administered, intramuscular, lot # R021083, expiration date 13-JUN-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). On 17-JUN-2019, the patient had the following test performed: complete blood count (CBC), comprehensive Metabolic Panel (CMP) and immunoglobulin, and the results showed potassium, albumin, red blood cells, hemoglobin and hematocrit (HNH) and  immunoglobulin M (IGM) were low. On 11-JUL-2019 , she received an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscular, lot # R027329, expiration date 12-JUL-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). The patient sought for medical attention and followed closely with the surgeon.  At the time of the report, the patient had not recovered from plasma cell myeloma. The causal relationship between the event and therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was not reported. Upon internal review the event plasma cell myeloma was determined to be medically significant.
Sex: F
Vaccine: HIBV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Immunoglobulins, Metabolic function test, Plasma cell myeloma
Clinical narrative: Multiple myeloma; The patient was administered an additional dose of PEDVAX HlB; The patient was administered an additional dose of PEDVAX HlB; The patient was administered another dose of PEDVAX HlB; This spontaneous report was received from a nurse concerning a 52 year old female patient. The patient's concurrent conditions included family history neoplasm of the gastrointestinal tract, mood disorder, high cholesterol, gastrooesophageal reflux disease (GERD), sleep apnea and hypothyroidism. The patient's drug reactions/allergies included morphine. The patient's concomitant medications included multiple unspecified medications. On unknown dates (many years ago), the patient "may" have been administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as prophylaxis (formulations, strength, dose, routes of administration, lot numbers and expiration dates were not reported).    On an unspecified date (also reported as 15-JUL-2019, conflicting information), she developed multiple myeloma (plasma cell myeloma). The reporter could not confirm if the multiple myeloma occurred prior to of after receiving the first doses of the suspect vaccine (number of doses unspecified).   On 09-MAY-2018, the patient had a stem cell transplant as treatment for multiple myeloma also reported as no treatment was given for the event, conflicting information.  On 17-APR-2019, another dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was administered, intramuscular, lot # R021083, expiration date 13-JUN-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). On 17-JUN-2019, the patient had the following test performed: complete blood count (CBC), comprehensive Metabolic Panel (CMP) and immunoglobulin, and the results showed potassium, albumin, red blood cells, hemoglobin and hematocrit (HNH) and  immunoglobulin M (IGM) were low. On 11-JUL-2019 , she received an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscular, lot # R027329, expiration date 12-JUL-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). The patient sought for medical attention and followed closely with the surgeon.  At the time of the report, the patient had not recovered from plasma cell myeloma. The causal relationship between the event and therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was not reported. Upon internal review the event plasma cell myeloma was determined to be medically significant.
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Red blood cell count decreased, Stem cell transplant
Clinical narrative: Multiple myeloma; The patient was administered an additional dose of PEDVAX HlB; The patient was administered an additional dose of PEDVAX HlB; The patient was administered another dose of PEDVAX HlB; This spontaneous report was received from a nurse concerning a 52 year old female patient. The patient's concurrent conditions included family history neoplasm of the gastrointestinal tract, mood disorder, high cholesterol, gastrooesophageal reflux disease (GERD), sleep apnea and hypothyroidism. The patient's drug reactions/allergies included morphine. The patient's concomitant medications included multiple unspecified medications. On unknown dates (many years ago), the patient "may" have been administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as prophylaxis (formulations, strength, dose, routes of administration, lot numbers and expiration dates were not reported).    On an unspecified date (also reported as 15-JUL-2019, conflicting information), she developed multiple myeloma (plasma cell myeloma). The reporter could not confirm if the multiple myeloma occurred prior to of after receiving the first doses of the suspect vaccine (number of doses unspecified).   On 09-MAY-2018, the patient had a stem cell transplant as treatment for multiple myeloma also reported as no treatment was given for the event, conflicting information.  On 17-APR-2019, another dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was administered, intramuscular, lot # R021083, expiration date 13-JUN-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). On 17-JUN-2019, the patient had the following test performed: complete blood count (CBC), comprehensive Metabolic Panel (CMP) and immunoglobulin, and the results showed potassium, albumin, red blood cells, hemoglobin and hematocrit (HNH) and  immunoglobulin M (IGM) were low. On 11-JUL-2019 , she received an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscular, lot # R027329, expiration date 12-JUL-2021 as update vaccinations post stem cell transplant (extra dose administered, product administered to patient of inappropriate age) (dose and strength were not reported). The patient sought for medical attention and followed closely with the surgeon.  At the time of the report, the patient had not recovered from plasma cell myeloma. The causal relationship between the event and therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was not reported. Upon internal review the event plasma cell myeloma was determined to be medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; inadverdently administered expired dose of VARIVAX; This spontaneous report was received from a nurse prescriber referring to a 02-year-old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 17-JUL-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N017396, expiry date: 07-JUN-2019) (anatomical location and route were not reported) for prophylaxis (expired product administered). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) (lot#R032351, expiry date: 02-JUN-2021). No adverse effects were reported (no adverse event). No PQC was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-JAN-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpetic zoster keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpetic Zoster Keratitis. On an unspecified date, the patient was treated by a healthcare provider for herpetic zoster keratitis. The outcome of the event herpetic zoster keratitis was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event herpetic zoster keratitis was determined to be medically significant.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: bells palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced bells palsy. On an unspecified date, the patient was treated by a physician for bells palsy. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event bells palsy was determined to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: developed no titers from the vaccine; This spontaneous report was received from a consumer (patient's mother) referring to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form) (strength, route and lot number with expiration date were not reported) as prophylaxis. On an unknown date, the patient developed no titers from vaccine (varicella virus test negative). The reporter did not clarify what no titers meant. The outcome of varicella virus test negative was unknown. Reporter did not provide any causality of the event with respect to the suspect drug.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 29-MAY-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported; Patient returned to the office and was administered additional doses of MMRII and VARlVAX simultaneously on 7/12/2019.; one unidentified patient was administered one dose of MMR II on 5/24/2019 and then one dose of VARlVAX on 6/7/2019; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 24-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1, 1 dosage form (dose number, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis and then on 07-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) dose 1, 1 dosage form (dose number, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the varicella virus vaccine live (oka/merck)(VARIVAX) was administered before the 28 day minimal interval between live vaccines. On 12-JUL-2019, the patient returned to the office and was administered simustaneusly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 2 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) dose 2 (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. No adverse effects reported.  This is a non-valid report due to lack of patient's identifiers.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).