chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Sensory disturbance, Tonic clonic movements
Clinical narrative: mmunization record reviewed, HPV, menactra and Tdap immunizations recommended.   Screening reviewed - no contraindications/precautions.     Consent obtained and VIS provided - client's questions answered.  Immunizations administered under Standing Orders as in Orders.   Client observed for adverse reactions -  adverse reaction response:  Patient entered the exam room and went to sit on the exam table.  Writer showed patient's mother the vaccine and verified that the HPV, Menactra and Tdap were in the syrnges and ready for administration.  Patient was nervous and reluctant to take off jacket.  With encouragement from her mother and writer, patient removed her jacket.  Both arms were tense and she was holding on to the left side of the exam table.  With encouragment from writer and patient's mother patient let go of table and attempted to relax. She recieved the menactra vaccine to her left arm IM and giggled saying it didn't hurt that bad.  Writer administered the Tdap in the Left Deltoid at which time, patient said, 'oh that hurt." She then puffed out her cheeks which looked like she was holding her breath, she stiffened and then she became flaccid with eyes open and was laid on her back on the exam table by her mother and this writer.  She turned slightly to her right, facing her mother, tonic clonic movement was noted in both arms and legs as well as her head.  Patient's eyes were open. This lasted 40 seconds.  She was breathing and her mucus membrane color remained pink. after 20 seconds patient raised her head and said what happened.  She was distressed and started crying.  She said her face felt like it was buzzing.  Writer called for assistance and offered patient support and a popcycle which she ate slowly.  She took drank some water as well. She did not become naseaus nor was she incontent of urine or stool.  Mother declined to have the HPV vaccine given.  At 0945, Writer notified Dr. via telephone, Dr. wanted patient observed for 20 minutes and if there was a concern by writer or patient mother, Dr. recommended patient go to urgent care.   BP was 104/60 pulse 62 and  Respirations 18.  Patient repoted that she felt dizzy after the second shot and it was reported that patient had not eaten today.   Patient and mother were given verbal support and reasurrance by writer.  Patient's mother reported that patient's grandmother had a seizure diagnosis, took medications which controled the seizures.   Patient got down from table, walking around in the exam room, she denied visual changes or feeling dizzy, she denied light, sound or color changes before the episode.  She stated she felt okay.  Mother stated she wanted to take her daughter to the ED for evaluation.   Writer informed the mother and patient that due to this episode the PHO would not be able to give her anymore vaccines, but that she could recieve any additional vaccines at a providers office if approved by the provider.  Both mother and daughter left the clinic without further incident.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Swelling and redness at injection site, fever of 101.5, loss of appetite, aching muscles and joints, rash, better after two days but still have low grade fever of 99.5
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Swelling and redness at injection site, fever of 101.5, loss of appetite, aching muscles and joints, rash, better after two days but still have low grade fever of 99.5
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine on Wednesday 8.14.19 at 0930. No reaction at the time.  Monday 8.19.19 patient arm became  red, swollen and hot at the injection site. Pain radiated down to elbow and up to neck and headache. Patient reports feeling fatigued and generally unwell. This is persisting today still - 8.21.19.  Patient  states injection site reaction was still increasing in size on Tuesday 8.20.19 - with redness extending over upper arm.  Today - 8.21.19 injection site reaction is approx 20mm, and it warm, red and painful to touch.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Malaise, Neck pain, Pain
Clinical narrative: Patient received vaccine on Wednesday 8.14.19 at 0930. No reaction at the time.  Monday 8.19.19 patient arm became  red, swollen and hot at the injection site. Pain radiated down to elbow and up to neck and headache. Patient reports feeling fatigued and generally unwell. This is persisting today still - 8.21.19.  Patient  states injection site reaction was still increasing in size on Tuesday 8.20.19 - with redness extending over upper arm.  Today - 8.21.19 injection site reaction is approx 20mm, and it warm, red and painful to touch.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: 18 patients received single dose of HPV vaccine; This literature marketed report has been received from the authors of a published literature article, and refers to 18 female patients of an unknown age. No information regarding patients' pertinent medical history, drug reactions or allergies and concomitant medications was reported. The patients took part in the study from March 2012 to December 2014.  On an unknown date, the patients were vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis or with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The patients received single dose regimen of the suspect vaccine (considered as inappropriate schedule of vaccine administration).  A copy of the published article is attached as further documentation of the patients' experience.   This is one of two reports derived from the same literature article (cross referenced with # 1908USA007784).; Sender's Comments:  US-009507513-1908USA007784:
Sex: U
Vaccine: VARZOS
Symptoms: Keratoplasty, Ophthalmic herpes zoster, Post herpetic neuralgia, Viral uveitis
Clinical narrative: Herpes Zoster Opthalmicus/Zoster Keratits; Zoster Uveitis; Post Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Herpes Zoster Opthalmicus of the right eye, Zoster Keratitis, Zoster Uveitis and Post Herpetic Neuralgia. As a result of Plaintiffs injuries to the right eye, Plaintiff ultimately was required to have Descemet Membrane Endothelial Keratoplasty of the right eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the events of viral uveitis and ophthalmic herpes zoster were considered to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: 34 patients received only two doses of HPV vaccine; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 34 female patients of an unknown age. No information regarding patients' pertinent medical history, drug reactions or allergies and concomitant medications was reported. The patients took part in Home Human Papillomaviruses (HPV) or Pap Examination study from March 2012 to December 2014.  On an unknown dates, the patients were vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis or with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown dates, the patients were vaccinated with the second dose of suspect vaccine. They received only two doses regimen of the suspect vaccine (considered as inappropriate schedule of vaccine administration).  A copy of the published article is attached as further documentation of the patients' experience.   This is one of two reports derived from the same literature article (cross referenced with MARRS# 1908USA000166).; Sender's Comments:  US-009507513-1908USA000166:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: redness at the injection site; swelling at the injection site; fever; joint pain; flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, joint pain and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling, fever, joint pain and influenza-like symptoms were recovered/resolved.   The reporter considered the injection site erythema to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, fever, joint pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The reporting licensed practical nurse was the concerned patient. The age at vaccination was not reported but it could be 69 years or 70 years. The lot number was unknown. The patient also had a low fever of 100 degree F, joint pain and flu like symptoms that lasted 3 days. The patient was not hospitalized. This case has been linked with US2019146763, reported by the same reporter.      Lab Comments: On an unknonw date, the patient's body temperature was recorded as 100 degree F.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Comparison of intensity of adverse events per dose; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The registered pharmacist reported that most patients who do get the second dose of Shingrix, the adverse events were not as bad as with dose 1 but sometimes just as bad and sometimes worse. No further details were provided by registered pharmacist. The reporter gave permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Shingrix rash at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The caller reported that the patient had a rash around the injection site for about 1 week after receiving Shingrix. The reporter did not consent to follow up. The caller refused to give any further information about the patient or the vaccine.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: red at injection site; hard at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 25-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA147, expiry date 31st May 2020) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Menveo. In August 2019, less than a week after receiving Menveo, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Menveo.  Additional details were provided as follows: The office manager reported that the patient returned at the time of reporting after receiving a Menveo vaccination. The patient left arm was red and hard at injection site.  The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Impaired work ability
Clinical narrative: Lt. tricep/bicep area - swollen, warm, hard nodule, red 6x8cm started 7/25/19 then fever 99-100 degrees, myalgias, arthralgias, weakness, dizziness and nausea with fatigue about 4pm later that day; symptoms continued through 7/26/19 early evening and resolved except for tender hard nodule at vaccine site.  This Tdap was given through Employee Health.  This patient is a physician on staff.  She had to miss a day of work due to this vaccine.  Another employee who received a Tdap from the SAME LOT NUMBER also had unusually severe reaction (reported separately) and also had to miss work.  This is unusual.  I have given over 100 Tdaps this past year and these two cases are the only rather severe reactions.  Maybe a coincidence??  Just thought I should report.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Lt. tricep/bicep area - swollen, warm, hard nodule, red 6x8cm started 7/25/19 then fever 99-100 degrees, myalgias, arthralgias, weakness, dizziness and nausea with fatigue about 4pm later that day; symptoms continued through 7/26/19 early evening and resolved except for tender hard nodule at vaccine site.  This Tdap was given through Employee Health.  This patient is a physician on staff.  She had to miss a day of work due to this vaccine.  Another employee who received a Tdap from the SAME LOT NUMBER also had unusually severe reaction (reported separately) and also had to miss work.  This is unusual.  I have given over 100 Tdaps this past year and these two cases are the only rather severe reactions.  Maybe a coincidence??  Just thought I should report.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Lt. tricep/bicep area - swollen, warm, hard nodule, red 6x8cm started 7/25/19 then fever 99-100 degrees, myalgias, arthralgias, weakness, dizziness and nausea with fatigue about 4pm later that day; symptoms continued through 7/26/19 early evening and resolved except for tender hard nodule at vaccine site.  This Tdap was given through Employee Health.  This patient is a physician on staff.  She had to miss a day of work due to this vaccine.  Another employee who received a Tdap from the SAME LOT NUMBER also had unusually severe reaction (reported separately) and also had to miss work.  This is unusual.  I have given over 100 Tdaps this past year and these two cases are the only rather severe reactions.  Maybe a coincidence??  Just thought I should report.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Neck pain
Clinical narrative: arm sore since injection day flu like symptoms for the past 2 days (chills, sweats) 8/19 evening soreness  in neck began 8/21 AM woke up with horrible headache
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: arm sore since injection day flu like symptoms for the past 2 days (chills, sweats) 8/19 evening soreness  in neck began 8/21 AM woke up with horrible headache
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, X-ray limb
Clinical narrative: Injection hurt more than normal.  Shoulder pain started immediately after and has never gone away. Hurts shoulder to move arm to left (shutting car door, putting on jacket, etc.) and while sleeping
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Pain, redness, and swelling on right arm and chest.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Feeling cold, Hyperhidrosis, Pain in extremity
Clinical narrative: From the patient: "On 7/23/19 started with chills; as the day progressed I was freezing while at work.  By the time I got home at 5pm I was freezing and running a fever of 101, and by 6pm my fever was 102.4.  I took 800mg of Motrin at 5pm and 1500mg of Tylenol at 7pm then 800mg at 9 then tylenol at 11pm.  My fever remained around 102 - still freezing.  Sometime in the night I woke wet with sweat and fever broke.  I called and spoke to doctor on call from my family Dr's office around 9:30a.  She said it was rare to have a side effect but stated if no other symptoms such as cough or sore throat then it may not be viral.  I had no other symptoms.  My arm was sore but no extreme pain or swelling.  The next day I was very weak.  I returned to work on 7/25/2019."  This patient was given her Tdap through Employee Health.  This was the second employee who had an unusual adverse reaction from this same lot #.  (Other already was reported separately) It is rare that my Tdap recipients have more than a "sore arm".
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: From the patient: "On 7/23/19 started with chills; as the day progressed I was freezing while at work.  By the time I got home at 5pm I was freezing and running a fever of 101, and by 6pm my fever was 102.4.  I took 800mg of Motrin at 5pm and 1500mg of Tylenol at 7pm then 800mg at 9 then tylenol at 11pm.  My fever remained around 102 - still freezing.  Sometime in the night I woke wet with sweat and fever broke.  I called and spoke to doctor on call from my family Dr's office around 9:30a.  She said it was rare to have a side effect but stated if no other symptoms such as cough or sore throat then it may not be viral.  I had no other symptoms.  My arm was sore but no extreme pain or swelling.  The next day I was very weak.  I returned to work on 7/25/2019."  This patient was given her Tdap through Employee Health.  This was the second employee who had an unusual adverse reaction from this same lot #.  (Other already was reported separately) It is rare that my Tdap recipients have more than a "sore arm".
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: fever; tiredness; arm pain, redness, swelling at injection site starting 12 hours after injection and lasting for 36 hours.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Patient called and states visible knot at injection site, no bruising, not red, not hot to the touch, just a raised area.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Syncope, Tonic convulsion
Clinical narrative: syncope with loss of consciousness and tonic seizure for 3-4 seconds
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling of (L) lower extremity, mainly the foot, with mild redness 12.5 mg Benedryl POx 1 alternated heat and ice 6 mg Decadron IM x 1
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Body temperature increased, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: 8-9-19 pain in left arm where she got injection. Decreased range of motion of shoulder and swelling of left chest. Low grade temp of 99. Pain with using arm to apply pressure like holding lof of bread to cut it.
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site pain, Joint range of motion decreased, Pain, Red blood cell sedimentation rate normal
Clinical narrative: 8-9-19 pain in left arm where she got injection. Decreased range of motion of shoulder and swelling of left chest. Low grade temp of 99. Pain with using arm to apply pressure like holding lof of bread to cut it.
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Troponin normal, X-ray limb normal
Clinical narrative: 8-9-19 pain in left arm where she got injection. Decreased range of motion of shoulder and swelling of left chest. Low grade temp of 99. Pain with using arm to apply pressure like holding lof of bread to cut it.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: 3 Hours after Vaccine Pain in Arm & fever. Nausea, Chills, fatigue, light Headed - Pain in Right Arm Ice, Ibuprofen, return if fever continues or worsening
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: 3 Hours after Vaccine Pain in Arm & fever. Nausea, Chills, fatigue, light Headed - Pain in Right Arm Ice, Ibuprofen, return if fever continues or worsening
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Anger, Feeling abnormal, Headache, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Pt. reports approximately 2 hours after receiving vaccine developed headache that is still present today. Other descriptions includes not feeling right & unable to iron tablecloth that she was supposed to help sister with. After laying down got up feeling unusually strong and angry. Also having spasms in back and ovaries.
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Ovarian disorder
Clinical narrative: Pt. reports approximately 2 hours after receiving vaccine developed headache that is still present today. Other descriptions includes not feeling right & unable to iron tablecloth that she was supposed to help sister with. After laying down got up feeling unusually strong and angry. Also having spasms in back and ovaries.
Age: 46.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Asthenia, Blood test, Headache, Malaise, Somnolence
Clinical narrative: Pt. reports approximately 2 hours after receiving vaccine developed headache that is still present today. Other descriptions includes not feeling right & unable to iron tablecloth that she was supposed to help sister with. After laying down got up feeling unusually strong and angry. Also having spasms in back and ovaries.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Rash, Rash papular, Rash pruritic
Clinical narrative: Rash - nearly confluent pink tiny papules, from (L) thigh to (L) flank & (L) arm , mildly itchy
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Back pain, Burning sensation, Headache, Immediate post-injection reaction
Clinical narrative: Patient Recived her Men B vaccine yesterday around 9:30 AM Pt states her arm felt weird immediately and she could feel it travel down her arm. Over the course of the next few hours. She developed a headache, Nausea, upper back Pain - burning sensation & C/O weakness and a lack of strength overall. Pt was able to Participate in soccer practice
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Sensory disturbance
Clinical narrative: Patient Recived her Men B vaccine yesterday around 9:30 AM Pt states her arm felt weird immediately and she could feel it travel down her arm. Over the course of the next few hours. She developed a headache, Nausea, upper back Pain - burning sensation & C/O weakness and a lack of strength overall. Pt was able to Participate in soccer practice
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Patient reports having deafness in left ear (unclear exact date of onset) after first Shingrix injection. Patient visited a doctor in a different network and was prescribed oral prednisone (dose and length of treatment unknown).  Patient says deafness resolved in after a total of 9 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Malaise, Pain in extremity
Clinical narrative: The night he got the injection the patient states he felt very hot and ill. He did not have a fever, and by the next morning he felt fine. He states his left arm was very sore for 3 days, but not red or swollen, and at this time he has no pain or discomfort.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Pain in extremity
Clinical narrative: REDDNESS AND EDEMA AT INJECTION SITE. PAINFUL TO USE ARM
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: On day 1, within an hour of the injection, she had a hard time lifting her arm. It was extremely painful and it lasted for 2 days. Then, she had a localized swelling which was hot from the shoulder to the elbow, which still persists currently, intermittently every now and then. She was given a Medrol dosepack for the inflammation, but had to d/c it because it made her dizzy and shaky. She took food with it and still experienced these symptoms. She experienced a headache for 3-4 days, but no fever/chills. She did notify the doctor.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # N019608, expiration date: 09-JUL-2019 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with expired sterile diluent (MERCK) lot number N006322, expiration date: 11-JUL-2019 (exact dose, injection site, route of administration and indication were not provided). No temperature excursion had  occurred. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Loss of consciousness, Nausea, Seizure like phenomena
Clinical narrative: experienced nausea, headache, and then passed out with seizure like activity following GARDASIL 9 vaccination; experienced nausea, headache, and then passed out with seizure like activity following GARDASIL 9 vaccination; experienced nausea, headache, and then passed out with seizure like activity following GARDASIL 9 vaccination; experienced nausea, headache, and then passed out with seizure like activity following GARDASIL 9 vaccination; This spontaneous report was received from  the patient's mother referring to a 17 years old female patient with no known allergies.   The patient was born with one kidney. The patient's medical history was not provided.      On 12-AUG-2019, the patient was vaccinated with the "1st dose of the three-dose regimen" of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on an unspecified arm (dose, frequency, route, lot# and expiration date were not provided) for HPV. Concomitant therapies included unspecified meningitis vaccine shot administered simultaneously.  On the same date, the patient experienced nausea, headache, and then passed out (loss of consciousness) with seizure like activity following HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination." On an unspecified date, routine lab work was performed but the results were not provided.  No treatment was prescribed for the event.  Later on the same date, the patient recovered from loss of consciousness, headache, nausea and seizure.    The causal relationship between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, loss of consciousness and seizure were considered medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: developed hives 3-4 days after being administered the dose of GARDASIL 9 which started on the patient's arms and then spread to the rest of her body.; This spontaneous report was received from a nurse, via a company representative, and refers to a 21-year-old female patient, who was not pregnant. The patient had no pertinent medical history, concomitant therapies, drug reactions or allergies.  On an unknown date in June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #, expiry date, exact dose and injection site were not provided) as a prevention of human papillomavirus (HPV) cancer. On an unknown date in 2019 (reported as 3-4 days after inoculation), she developed hives, which started on her arms and then spread to the rest of her body. On an unknown date in 2019, the patient called the doctor office due to the event and was given advice to go to an emergency room (ER), whether the rash got worse. No specific treatment was given at that time. She did not need to go to the ER as the rash cleared up on its own, on an unknown date in 2019.  The causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: seizures after receiving first dose of GARDASIL 9; This spontaneous report was received from a nurse prescriber (also reported as physician) via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot number and expiration date were not reported) for prophylaxis.  After receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced seizures. The outcome of the event was not reported. Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.    Upon internal review, the event seizures was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis viral, Deafness neurosensory, Dizziness, Tinnitus
Clinical narrative: bilateral sensorineural hearing loss; dizziness,; tinnitus; viral conjunctivitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-AUG-2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in August 2019 (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered bilateral sensorineural hearing loss, dizziness, tinnitus, and viral conjunctivitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the event of bilateral sensorineural hearing loss was considered to be medically significant.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; upset stomach; fever; severe headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gastric infection (for 24 hours).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 hrs after receiving Shingrix, the patient experienced chills, upset stomach, fever, headache and nausea. On an unknown date, the outcome of the chills, upset stomach, fever, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the chills, upset stomach, fever, headache and nausea to be related to Shingrix.  Additional information received were as follows: The patient asked regarding the side effects of fever, chills and upset stomach typically how soon after the shot do they appear and how long do they last. At around 6:00 pm, the patient received Shingrix. At around 5:00 am, on next day of vaccination, the patient experience fever, chills, severe headache and nausea, which lasted about 23 hours with the headache and nausea ceasing about the same time. The patient was not sure whether this was due to the vaccine or a 24 hour stomach bug.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Rheumatoid arthritis flare up; This case was reported in a literature article and described the occurrence of rheumatoid arthritis flare up in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant) and rheumatoid arthritis flare up (serious criteria GSK medically significant). The subject was treated with glucocorticoids nos (Glucocorticoids). On an unknown date, the outcome of the rheumatoid arthritis flare up was recovered/resolved and the outcome of the rheumatoid arthritis flare up was unknown.   The reporter considered the rheumatoid arthritis flare up to be possibly related to Shingles vaccine. The reporter considered the rheumatoid arthritis flare up to be possibly related to Shingles vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of flare in a patient of unspecified age and gender, who was vaccinated with unspecified zoster recombinant adjuvanted vaccine (manufacturer unknown) for prophylaxis. The patient was part of retrospective chart review that aimed to study the impact of the new zoster recombinant adjuvanted (ZRA) vaccine in rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRD) patients and to measure the risk of flare and incidence of side effects between 01 February 2018 and 20 January 2019. The patient had rheumatoid arthritis. No information on patient's medical history, family history, concurrent condition was provided. On an unspecified date between 01 February 2018 and 20 January 2019, the patient received 1st and 2nd dose of unspecified zoster recombinant adjuvanted vaccine (administration route and site unspecified, batch number not provided). The age of vaccination was not provided. On an unspecified date, within 12 weeks of vaccination, the patient developed flare after 1st and 2nd dose of vaccine. Treatment was unknown. [In this study, all the flares were mild, self-limited, responded to treatment with low dose glucocorticoids, and did not warrant a change in immunosuppressive therapy].  The outcome of the event was not reported. The authors' stated, "In our experience with 300 patients who received the new ZRA (207 RA and 93 SRD) in 2018-2019, the incidence of disease flares was less than or equal to 3% and of side effects was 15% which is reassuring. Both flares and side effects were mild, self-limited, and did not require a change in disease-modifying anti-rheumatic drugs (DMARD) therapy.
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative.  A 17-years-old male patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination the patient experienced headache that was so severe that the patient went to the emergency room (ER). Clinical outcome of the adverse event was unknown at time of this report.   The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Inflammation
Clinical narrative: Arm became inflamed after injection; This is a spontaneous report from a contactable physician via Pfizer sales representative. A female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe) via unspecified route of administration in the arm on unspecified date at single dose for immunization. Patient had no relevant medical history (none). Concomitant medications were not reported. The physician reported that a patient received a dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein); and patient arm became very inflamed after injection on unspecified date. She went back to the office a week later and she was fine. Outcome of the event was reported as recovering.  Information on batch number has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Anxiety, Dyspnoea, Hypersensitivity, Malaise, Nausea
Clinical narrative: Patient developed allergic reaction to immunizations given in office 8/19/2019. Patient started to not feel well after MA administered vaccines (hepatitis A and Shingrix) and became nauseated, short of breath and anxious. Patient was reporting that she felt like her throat was shutting. 911 was called as patient was placed on nonrebreather at 8L. Patient given diphenhydramine 50mg IM along with dexamethasone 4mg IM. Patient then given EPIPEN 0.3mg IM injection into left thigh. Patient's HR 55 and O2 saturation 99%. Patient then transported to the hospital with EMS. Dr. at bedside giving verbal orders for medication and treatment plan.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient developed allergic reaction to immunizations given in office 8/19/2019. Patient started to not feel well after MA administered vaccines (hepatitis A and Shingrix) and became nauseated, short of breath and anxious. Patient was reporting that she felt like her throat was shutting. 911 was called as patient was placed on nonrebreather at 8L. Patient given diphenhydramine 50mg IM along with dexamethasone 4mg IM. Patient then given EPIPEN 0.3mg IM injection into left thigh. Patient's HR 55 and O2 saturation 99%. Patient then transported to the hospital with EMS. Dr. at bedside giving verbal orders for medication and treatment plan.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Allergic reaction to throat. Difficulty breathing.  School nurse administer 25mg of Benadryl, then I took patient to the ER. She was then given a shot of Prednisone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain, redness, swelling at injection site, 103 fever, chills, aches
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain, redness, swelling at injection site, 103 fever, chills, aches
Age: 38.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness, redness, swelling in left arm at injection site. Fatigue, headache, nausea, diarrhea, muscle pain.
Age: 38.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site swelling, Myalgia, Nausea
Clinical narrative: Soreness, redness, swelling in left arm at injection site. Fatigue, headache, nausea, diarrhea, muscle pain.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient had redness and swelling at the site of injection which self resolved over 4-5 days. Noted significant pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pain
Clinical narrative: Patient given last vaccine of HPV at 11:53am,  Patient was fine until approximately 11:58 am when patient stated that she had throbbing, then passed out, mom caught her and we laid her onto the floor. Had help come in with ice packs-ice packs placed on forehead and neck.  Pillow put under head. Patient up and talking now.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hyperhidrosis, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, sweating, sore throat, muscle soreness, headache
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: swelling, sore
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Nausea, Pallor, Syncope
Clinical narrative: HPV shot was given to my daughter around 8:30 to 8:45 am on August 21st. After the shot was given my daughter said that she thought she may faint, and right after that her head fell on the desk and she fainted. We the medical assistant(MA) and myself grabbed patient and started to put her on the floor as we were straightening her out she became very stiff and her arms went out and were stiff as a board. As the MA yelled for help and we were getting her on the floor her eyes rolled into the back of her head. I asked if I should call 911, but no one confirmed we just had several people in the office by then and they tried waking my daughter. She did come too shortly after that and was out of it but responded when asked if she could hear me. The office took her blood pressure after she came too and was able to sit up. It was within range but I don't remember what it was. Shortly after that we were able to get her to the chair. Her color was very pail and it took a long time before that came back. She was given two juices boxes and some string cheese. She only ate a few bites of the cheese and said she wasn't hungry. I asked her what she was feeling and she said I think I'm going to throw up. It was shortly after that she threw up all of the juice she drank and cheese. It wasn't until then she was starting to feel better and color was coming back into her face. She said she was starting to feel better. They took her blood pressure again it was good. We stayed at the office until her color was better and she felt good. (About 2 hours total) Once we got home she laid down and slept for 3 hours straight.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: HPV shot was given to my daughter around 8:30 to 8:45 am on August 21st. After the shot was given my daughter said that she thought she may faint, and right after that her head fell on the desk and she fainted. We the medical assistant(MA) and myself grabbed patient and started to put her on the floor as we were straightening her out she became very stiff and her arms went out and were stiff as a board. As the MA yelled for help and we were getting her on the floor her eyes rolled into the back of her head. I asked if I should call 911, but no one confirmed we just had several people in the office by then and they tried waking my daughter. She did come too shortly after that and was out of it but responded when asked if she could hear me. The office took her blood pressure after she came too and was able to sit up. It was within range but I don't remember what it was. Shortly after that we were able to get her to the chair. Her color was very pail and it took a long time before that came back. She was given two juices boxes and some string cheese. She only ate a few bites of the cheese and said she wasn't hungry. I asked her what she was feeling and she said I think I'm going to throw up. It was shortly after that she threw up all of the juice she drank and cheese. It wasn't until then she was starting to feel better and color was coming back into her face. She said she was starting to feel better. They took her blood pressure again it was good. We stayed at the office until her color was better and she felt good. (About 2 hours total) Once we got home she laid down and slept for 3 hours straight.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Full blood count normal, Peripheral swelling, Tenderness
Clinical narrative: Patient developed a cellulits from the injections. Her arm was red and swollen, tender to touch 20cmx9cm area.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: pt broke out in rash on arm....notified us at te pharmacy 8/21/19 at which point rash was clearing
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient became very lightheaded, pale, nauseous and sweaty.  We had her lie down and applied a cold compress and elevated her feet.  Her blood pressure dropped to 68/41 with pulse of 70.   A physician assessed her symptoms and recommended monitoring her vital signs until patient felt better.  Her blood pressure continued to improve and approximately an hour after receiving the vaccines her blood pressure measured 92/59 and her pulse was 90.  She felt much better and left the clinic.