chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 04-MAR-2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), on 04-SEP-2013, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 79-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 12-APR-2014, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In 2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Injection site pain; redness; headaches; left side neck pain; shoulder pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th December 2019, refer case US2020AMR033929).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, neck pain and shoulder pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the headache, neck pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, till the time of reporting experiencing headache, neck pain and shoulder pain. The patient had injection site pain and redness and would nearly gone till the time of reporting. For the tollerence of 1st dose refer case US2020AMR033929, reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Injection site pain; redness; headaches; left side neck pain; shoulder pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th December 2019, refer case US2020AMR033929).   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, neck pain and shoulder pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the headache, neck pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, neck pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, till the time of reporting experiencing headache, neck pain and shoulder pain. The patient had injection site pain and redness and would nearly gone till the time of reporting. For the tollerence of 1st dose refer case US2020AMR033929, reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Fast heart beat; shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased and shortness of breath. On an unknown date, the outcome of the heart rate increased and shortness of breath were unknown.   It was unknown if the reporter considered the heart rate increased and shortness of breath to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient wanted to know how long did it take for side effects to happen.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 102; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included still's disease (auto immune diease).   On 20th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had a fever of 102 degree F after vaccination with Shingrix.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles after the first dose of Shingrix; patient received the first dose of Shingrix 1 year ago, and did not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported a patient received the first dose of Shingrix 1 year ago, and did not received the second dose yet, which led to incomplete course of vaccination.  Also, the patient developed Shingles 5 months ago. The HCP asked how to proceed with the second shot. HCP provided consent to be contacted for the follow-up of this case.
Sex: U
Vaccine: HEPAB, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Twinrix at an unknown dose. On an unknown date, unknown after receiving Shingrix and Twinrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix and Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per Shingrix vaccine indication. The patient had a fever after Twinrix or Shingrix vaccination. The reporter was not sure about which vaccine was administered by patient. The reporter did not consent to follow up. This case has been linked with US2020039898, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Carnett's sign positive, Chills, Muscle rupture, Rib fracture
Clinical narrative: tear in his rectus abdominus; worst rigors of his life; abdominal pain; broken rib; positive carnetts sign; This case was reported by a physician via call center representative and described the occurrence of torn muscle in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020 10:00, the patient received the 2nd dose of Shingrix. On 9th March 2020 22:00, 12 hrs after receiving Shingrix, the patient experienced torn muscle (serious criteria GSK medically significant), rigors, abdominal pain and rib fracture. In March 2020, the patient experienced carnett's sign positive. The patient was treated with naproxen. On an unknown date, the outcome of the torn muscle, abdominal pain, carnett's sign positive and rib fracture were recovering/resolving and the outcome of the rigors was recovered/resolved.   It was unknown if the reporter considered the torn muscle, abdominal pain, carnett's sign positive and rib fracture to be related to Shingrix. The reporter considered the rigors to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient developed worst rigors of his life and took Naproxen which helped get the rigors under control.  The patient then developed abdominal pain on the right side which he believed was caused by a broken rib and a tear in his rectus abdominus, caused by the rigors.  The patient has been taking Naproxen 3-4 times a day and was slowly getting better.  The reporter consented to follow up. The reporter did not have the lot or expiry date for vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: - 6 mo old female was walked in for 6mo vaccines, Pediarix #3, PCV#3, influenza #1 and Rotateq #3 were required. Pt had already completed their 6 mo well visit  previously. Staff contacted me approx 15 min after vaccine given and stated that pt was having a localized reaction at the injection site of  the Pediarix vaccine on the L thigh. Exam showed erythema with several wheals grouped around and extending out from injection site. Pt was calm and not in acute distress. mild erythema seen at injection sites on the R thigh but no hives. No edema of leg or feet , no drooling or wheezing. Vitals and wt were immediately obtained. Vital were in normal range. weight verified and a dose of benadryl (3.5 ml ) given orally at 1542 by Nurse given and tolerated well. Pt remained stable and w/o progression of urticarial lesions or other reactions following administration of the benadryl. 20 min after benadryl given hives were resolved and pt doing well. Lungs CTA, HR RRR and normal cap refill and no edema. Pt was observed for 45 min after benadryl given and was able to discharge home . Education regarding allergic reactions d/w parent. If additional hives start in the next 24hrs oral benadryl can be given, s/s of progressing and serious allergic reactions reviewed with parent and instructions to RT ER given to parent. Pt is considered allergic to Pediarix vaccine now and information relayed to mom.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Dizziness, Fall, Feeling cold, Head injury
Clinical narrative: The patient was sitting on the bed and fell backwards and hit the back of her head. She started having a seizure for 5 minutes, head to the side, arms/hands twitching and passed out. After 5 min or so patient was conscious and started she felt dizzy, cold, right arm numb and complained of back pain.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Loss of consciousness, Muscle twitching, Posture abnormal, Seizure
Clinical narrative: The patient was sitting on the bed and fell backwards and hit the back of her head. She started having a seizure for 5 minutes, head to the side, arms/hands twitching and passed out. After 5 min or so patient was conscious and started she felt dizzy, cold, right arm numb and complained of back pain.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Patient states that a month after administration she felt tenderness in center of right deltoid. She also states a month after adminstration she feels soreness when she pulls her arm back or up. Again, she points to center of right deltoid. She has not seeked medical attention because she says it is not necessary at this point. She only wanted to let me know about tenderness and soreness in center of deltoid.
Age: 50.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal swelling, Respiratory depression, Syncope
Clinical narrative: RespDepression, Syncope & DYSPNEA; SWELLING OF THROAT DIPHENHYDRAMINE 25 MG ONCE, METHYLPREDNISOLONE 125 MG ONCE, ALBUTEROL 1 neb by inhalation now
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Delirium, Myalgia, Nausea, Pyrexia
Clinical narrative: Confusion, Myalgia, Fever, Nausea Vomiting & DELIRIUM
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Confusion, Myalgia, Fever, Nausea Vomiting & DELIRIUM
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: body aches; fever; chills; emesis; This spontaneous report was received from a health care professional via Food and Drug Administration (FDA) and refers to an 17-year-old female patient. It was reported that the patient had no allergies to medications, food or other products. She also did not have any concurrent conditions. Her concomitant vaccines included third dose of poliovirus vaccine inactivated (vero) (IPOL) and second dose of meningococcal acyw conj vaccine (crm197) (MENVEO). No other information regarding the patient's medical history, concomitant medications was provided.  On 25-APR-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the left arm, lot # R026716, expiration date 30-MAY-2021 (strength, dose, frequency was not provided) for prophylaxis. On the same day, the patient experienced fever, chills, body aches, emesis. It was reported that the patient recovered from the events on 27-APR-2019 (reported as lasted for 2 days).  The causality assessment between the events and of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow-up information was received from the health care professional on 19-MAR-2020. It was specified that the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid. Additionally details of vaccine administration and patient's demographics were provided.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; a shipment of PNEUMOV AX 23 was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The report considers one patient and one combination product. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   The reporter informed that a shipment of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was due to be delivered on 26-FEB-2020, but was not deliver until 27-FEB-2020. On 09-MAR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S029542, expiration date 10-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose was from the late shipment. The patient experienced no symptoms. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. manufactureraddress:; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: shingles; allergic reaction; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 50-year-old (also reported as 61-year-old, conflicting information) female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 19-OCT-2015, the patient was caused to suffer an allergic reaction, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. She is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct , and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered allergic reaction and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient contacted me about one week ago and states that her shoulder has been in pain since the vaccine.  States that she tried icing it and taking medicine for the pain but it still persists.  Patient was visiting and has now returned to home.
Age: 29.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, extreme headache, chills, fever.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient was given Meningitis B vaccine at the age of 11.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: Beginning the day after the injection the patient developed severe leg weakness. He was unable to get out of bed unaided. This resolved in 1 day without intervention
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Magnetic resonance imaging, Magnetic resonance imaging neck, Ophthalmological examination abnormal, Optic ischaemic neuropathy
Clinical narrative: I continually thought my glasses were dirty. on 10-31-2019 I saw purple flashes in my left eye. Then I could not see from that eye. It was like looking through bubbles. I called my eye doctor. He did an examination and determined that it was not glocoma, cataracs any other eye issue. He said that my optic nerve had ruptured. He referred me to an opthomologist . I then had bloodwork, MRI, doppler Peripheral Veno. I also had a sleep study test. He said I have non-arteritic ischemic optic neuropathy. I will return to him in June for a field of view test. My distance vision is slowly improving. I cannot read with my good eye covered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Optic nerve injury, Photopsia, Scan with contrast, Sleep study, Ultrasound Doppler
Clinical narrative: I continually thought my glasses were dirty. on 10-31-2019 I saw purple flashes in my left eye. Then I could not see from that eye. It was like looking through bubbles. I called my eye doctor. He did an examination and determined that it was not glocoma, cataracs any other eye issue. He said that my optic nerve had ruptured. He referred me to an opthomologist . I then had bloodwork, MRI, doppler Peripheral Veno. I also had a sleep study test. He said I have non-arteritic ischemic optic neuropathy. I will return to him in June for a field of view test. My distance vision is slowly improving. I cannot read with my good eye covered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: I continually thought my glasses were dirty. on 10-31-2019 I saw purple flashes in my left eye. Then I could not see from that eye. It was like looking through bubbles. I called my eye doctor. He did an examination and determined that it was not glocoma, cataracs any other eye issue. He said that my optic nerve had ruptured. He referred me to an opthomologist . I then had bloodwork, MRI, doppler Peripheral Veno. I also had a sleep study test. He said I have non-arteritic ischemic optic neuropathy. I will return to him in June for a field of view test. My distance vision is slowly improving. I cannot read with my good eye covered.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Blood test normal, Urticaria
Clinical narrative: hives occurred the same night i received my flu shot, took benadryl to stop hives and contacted primary care doctor that gave me the flu shot, doctor told me to for two weeks to take 10mg of zyrtec daily and 200mg of tagamet twice daily. Hives became less severe, but still continued to show up. Hives can be anywhere on elbows, wrists, forearm, hips, spine, eyes, lips, back of knee/leg, ankles. Went back to primary care doctor and had blood drawn but results were normal and hives continued daily. Went to get a second opinion from another primary care doctor in December 2019, she prescribed prednisone for 5 days and that stopped the hives completely for a couple weeks.  Then at the beginning of 2020 hives began to show up in the same places. Went to an allergist in January 2020 who told me to take Allegra, Xyzal, Benadryl or a combination of those to stop the hives when they occur. Hives continue occur 5-6 times a week in the same spots.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: injection was administered too low in the arm. Patient had a localized red aura around the injection site. It did not looked infected or inflamed.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever - 101 (high) , vomiting (2-3 times) body aches, chills, headache. Lasted approximately 60 hours
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, X-ray normal
Clinical narrative: PATIENT IS REPORTING A DEEP MUSCULAR PAIN IN HER RIGHT ARM SINCE THE FLU SHOT WAS GIVEN IN OCTOBER WITH NOT MUCH RELIEF. THE PAIN IS GREATER WHEN SHE MOVES HER ARM IN A CERTAIN WAY OR WHEN SHE LAYS ON IT AT NIGHT. SHE WENT TO HER PRIMARY CARE PHYSICIAN WHO GAVE HER AN XRAY. THE XRAY WAS CLEAR. THE PHYSICAN RECOMMENDED A FEW SESSIONS OF PHYSICAL THERAPY FOR THE PATIENT TO PREVENT FROZEN SHOULDER. THE PATIENT DID 3 TO 4 SESSIONS OF PHYSICAL THERAPY AND IT SEEMED TO HELP HER PAIN
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Her arm felt hot and was swollen for 5 days. She did not seek additional care. Happened to stop by pharmacy and mentioned se to us.
Age: 53.0
Sex: F
Vaccine: HIBV, VARZOS
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Hyperhidrosis, Injection site erythema
Clinical narrative: 03/06/2020 - redness, swelling, and itching at injection sites. Lasted through 03/09/2020. 03/19/2020 -  at 8 am, rapid onset of malaise and dry cough. 03/20/2020 -  symptoms worsened with addition of body ache, fever post ibuprofen of 100.4, pleuritic pain with inhalation, and body sweats. 03/22/2020 - no fever. other symptoms continued (malaise, body ache, pleuritic pain with inhalation, dry cough). 03/23/2020 - malaise, body ache, pleuritic pain with inhalation, dry cough. and, Dyspnea when speaking. Started azithromycin, amoxicillin, and cough med with codeine following results of CXR. 03/24/2020 - malaise improving. Pleuritic pain, dry cough, and dyspnea when speaking persist. 03/25/2020 - Pleuritic pain, dry cough, and dyspnea while speaking have decreased in severity, however, they persist.
Age: 53.0
Sex: F
Vaccine: HIBV, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pain, Pleuritic pain
Clinical narrative: 03/06/2020 - redness, swelling, and itching at injection sites. Lasted through 03/09/2020. 03/19/2020 -  at 8 am, rapid onset of malaise and dry cough. 03/20/2020 -  symptoms worsened with addition of body ache, fever post ibuprofen of 100.4, pleuritic pain with inhalation, and body sweats. 03/22/2020 - no fever. other symptoms continued (malaise, body ache, pleuritic pain with inhalation, dry cough). 03/23/2020 - malaise, body ache, pleuritic pain with inhalation, dry cough. and, Dyspnea when speaking. Started azithromycin, amoxicillin, and cough med with codeine following results of CXR. 03/24/2020 - malaise improving. Pleuritic pain, dry cough, and dyspnea when speaking persist. 03/25/2020 - Pleuritic pain, dry cough, and dyspnea while speaking have decreased in severity, however, they persist.
Age: 53.0
Sex: F
Vaccine: HIBV, VARZOS
Symptoms: Pneumonia, Pyrexia, Respiratory viral panel, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: 03/06/2020 - redness, swelling, and itching at injection sites. Lasted through 03/09/2020. 03/19/2020 -  at 8 am, rapid onset of malaise and dry cough. 03/20/2020 -  symptoms worsened with addition of body ache, fever post ibuprofen of 100.4, pleuritic pain with inhalation, and body sweats. 03/22/2020 - no fever. other symptoms continued (malaise, body ache, pleuritic pain with inhalation, dry cough). 03/23/2020 - malaise, body ache, pleuritic pain with inhalation, dry cough. and, Dyspnea when speaking. Started azithromycin, amoxicillin, and cough med with codeine following results of CXR. 03/24/2020 - malaise improving. Pleuritic pain, dry cough, and dyspnea when speaking persist. 03/25/2020 - Pleuritic pain, dry cough, and dyspnea while speaking have decreased in severity, however, they persist.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Pain, Somnolence
Clinical narrative: Mostly a lot of fatigue and drowsiness with some mild body ache. They began later on day of shot and lingered for a good 10 days before beginning to subside. Completely gone in 14 days total. Didn't really feel bad, just wanted to nap a lot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Headache (severe), Nausea, Chills.  These all started Saturday evening and lasted into Sunday. Patient was unable to get out of bed on Sunday.  On Monday, she felt better but still had headache (less severe) and it lasted into Tuesday.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Full blood count normal, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid soreness, swollen, hard to move and tender to touch 5 x 7 cm indurated mod Tender.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Local reaction
Clinical narrative: Left deltoid soreness, swollen, hard to move and tender to touch 5 x 7 cm indurated mod Tender.
Age: 75.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: & SWELLING
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: & SWELLING OF ARM
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: & arm swelling
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Patient received a Shingrix Vaccine 2-27-2020 Shortly afterwards she contracted reactive ShiNgles iN her eye. 500mg Valacyclovir oNce daily presribed
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 75-year-old male patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 08-JUN-2011, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a medical center (MC) for prophylaxis. As a result of his receipt or zoster vaccine live (ZOSTAVAX), on 08-JUN-2012, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), he had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions he requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, he requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. He also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. He has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Flatulence
Clinical narrative: ABDOMINAL DISCOMFORT, DISTENSION AND PAIN; FLATULENCE/ SEMI BLOATING SENSATION; ABDOMINAL DISCOMFORT, DISTENSION AND PAIN; ABDOMINAL DISCOMFORT, DISTENSION AND PAIN; This spontaneous case (789481-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by a consumer via health authority It describes a 26-year-old female consumer who experienced abdominal discomfort, distension and pain, flatulence/ semi bloating sensation, while being on oral Vivotif (lot no: 3003215) for an unknown indication.   Case report: The consumer took the two doses of Vivotif. On 02-Dec-2018, after taking the second dose, she experienced abdominal discomfort, distension and pain. She also felt flatulence with bloating sensation.  The consumer was allergic to peanut butter, nuts and related products.  Action taken with Vivotif was unknown.   The clinical outcome of the events abdominal discomfort, distension and pain, flatulence/ semi bloating sensation was unknown.  Company's Comment: In this case, it was reported that a 26-year-old female consumer experienced abdominal discomfort, distension and pain, flatulence/ semi bloating sensation, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, the events are confounded by patient's history of allergy to peanut butter, nuts and related products.; Sender's Comments: Company's Comment: In this case, it was reported that a 26-year-old female consumer experienced abdominal discomfort, distension and pain, flatulence/ semi bloating sensation, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, the events are confounded by patient's past history of allergy to peanut butter, nuts and related products.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: DIARRHOEA; STOMACH PAIN; This spontaneous case (796046-1) was extracted through VAERS database on 26-Apr-2019. The case was reported by a consumer. It describes a 24-year-old female consumer who had extreme diarrhea and stomach pain, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 26-Dec-2018. On 27-Dec-2018, she had extreme diarrhea and stomach pain.  The consumer's medical history included Herpes simplex viruses (HSV), cold sores, and scoliosis. She also had allergy to nuts, which caused anaphylactic reaction.  Concomitant medication at the time of events included oral acyclovir (400 mg) and oral ranitidine (150 mg).  Action taken with Vivotif was unknown.  The consumer had recovered from the events diarrhea and stomach pain.  Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea and stomach pain after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and stomach pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH CRAMPING; This spontaneous case (798406-1) was extracted through VAERS database on 26-Apr-2019. This case was reported by a consumer. It describes a 17-year-old female consumer who experienced stomach cramping, after the administration of oral Vivotif (lot number: 3003220) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 24-Jan-2019 and within two hours of taking the first dose, she experienced severe stomach cramping which continue until an analgesic was taken Advil (ibuprofen: 400 mg) but it again started on the next day.  The consumer had no past medical history and allergy.  The consumer had no concomitant medication.  The consumer had no laboratory tests.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events of stomach cramping.  Company's Comment: In this case, it was reported that the consumer experienced stomach cramping, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach cramping is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  experienced stomach cramping, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach cramping is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: FLU4, TYP
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAIN; This spontaneous case (798408-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by a consumer via health authority. It describes an 11-year-old male consumer who experienced stomach pain, while being on oral Vivotif (lot no: 3003220) and intramuscular Fluzone quadrivalent (influenza virus vaccine) (lot no: UJO28AB) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 24-Jan-2019 and within two hours, he experienced severe stomach pain which occurred intermittently. The pain had subsided by 6 pm and it did not affect his appetite.   The consumer experienced measles rash and fever as an infant following the administration of MMR (measles, mumps, and rubella) vaccine.  Action taken with Vivotif and Fluzone quadrivalent was unknown.   The consumer had recovered from event of stomach pain.  Company's Comment: In this case, it was reported that a 11-year-old male consumer experienced stomach pain, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. Additionally, co-administration of intramuscular Fluzone quadrivalent (influenza virus vaccine) also provides a plausible explanation for the reported events; Sender's Comments: Company's Comment: In this case, it was reported that a 11-year-old male consumer experienced stomach pain, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. Additionally, co-administration of intramuscular Fluzone quadrivalent (influenza virus vaccine) also provides a plausible explanation for the reported events
Sex: F
Vaccine: TYP
Symptoms: Drug hypersensitivity, Dysphagia, Erythema, Heart rate decreased, Malaise
Clinical narrative: LOW PULSE; DIFFICULT TO SWALLOW; HIVES LIKE RED SPOTS; UNWELL; ITCHY; HIVES LIKE RED SPOTS; This spontaneous case report (801055-1) was extracted through VAERS database on 24-May-2019. The case was reported by a nurse. It describes a 50-year-old female consumer who felt unwell, itchy, hives like red spots, difficult to swallow, and low pulse, after the administration of oral Vivotif (lot no: 3003239) for an unknown indication.   Case report: The consumer took the first two doses of Vivotif on 04-Feb-2019 and 06-Feb-2019, respectively. On 07-Feb-2019 in the afternoon, she started to feel unwell and itchy. By the evening, she noticed rash, 5-10 hives like red spots. She felt itchy. She took Benadryl (diphenhydramine) for it. At midnight, she woke up having a difficult time to swallow. She had a low pulse (about 40). On 08-Feb-2019, she again took Benadryl.   The consumer's medical history included bad reactions (not specified) to tetanus 10 years ago for which she went to the hospital.  Action taken with Vivotif was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the female consumer felt unwell and experienced itch, hives like red spots, difficulty to swallow, and low pulse following the intake of Vivotif. The events appear to be due hypersensitivity to Vivotif and hence, in view of a temporal relationship the causality has been assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the female consumer felt unwell and experienced itch, hives like red spots, difficulty to swallow, and low pulse following the intake of Vivotif. The events appear to be due hypersensitivity to Vivotif and hence, in view of a temporal relationship the causality has been assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: LOW PULSE; DIFFICULT TO SWALLOW; HIVES LIKE RED SPOTS; UNWELL; ITCHY; HIVES LIKE RED SPOTS; This spontaneous case report (801055-1) was extracted through VAERS database on 24-May-2019. The case was reported by a nurse. It describes a 50-year-old female consumer who felt unwell, itchy, hives like red spots, difficult to swallow, and low pulse, after the administration of oral Vivotif (lot no: 3003239) for an unknown indication.   Case report: The consumer took the first two doses of Vivotif on 04-Feb-2019 and 06-Feb-2019, respectively. On 07-Feb-2019 in the afternoon, she started to feel unwell and itchy. By the evening, she noticed rash, 5-10 hives like red spots. She felt itchy. She took Benadryl (diphenhydramine) for it. At midnight, she woke up having a difficult time to swallow. She had a low pulse (about 40). On 08-Feb-2019, she again took Benadryl.   The consumer's medical history included bad reactions (not specified) to tetanus 10 years ago for which she went to the hospital.  Action taken with Vivotif was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the female consumer felt unwell and experienced itch, hives like red spots, difficulty to swallow, and low pulse following the intake of Vivotif. The events appear to be due hypersensitivity to Vivotif and hence, in view of a temporal relationship the causality has been assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the female consumer felt unwell and experienced itch, hives like red spots, difficulty to swallow, and low pulse following the intake of Vivotif. The events appear to be due hypersensitivity to Vivotif and hence, in view of a temporal relationship the causality has been assessed as possible.