chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received 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 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 details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional reported that the patients have some reactions after receiving the 1st dose that makes them hesitant to get the 2nd dose. The healthcare professional was not comfortable giving patients information. The healthcare professional was a student on rotation so not able to provide long term data from the pharmacy's patients, but assured that they have documented correctly and reported as needed. The healthcare professional looked for data or resources to answer questions came from providers rather than patients. The healthcare professional did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a female patient who received 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 itchy rash and skin irritation. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash and skin irritation were unknown. It was unknown if the reporter considered the itchy rash and skin irritation to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform email. The age at vaccination was not reported. The healthcare professional reported that the patient came to their store for the 2nd dose of SHINGRIX and reported an event happened to her after her 1st dose of SHINGRIX. The patient stated that mosquito bites never bothered her before, but since she had received 1st dose of SHINGRIX, she felt that mosquito bites had been very irritating. The patient used hydrocortisone to relieve the itchiness. No further details were reported regarding the event. The healthcare professional did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a adult female patient who received 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician assistant stated that, after receiving SHINGRIX, the patient felt ill for 24 to 49 hours. SHINGRIX was administered in a local pharmacy, not in this office. No details were available or reported for this case.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season).  On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. On the same day, the patient also received an unspecified flu shot on the opposite arm (right arm) but there were no events associated with the flu shot. Later in the day after vaccination with SHINGRIX, the patient experienced redness, pain and arm soreness at the injection site. The redness on the left arm was described as about 3 inches in circumference. The contact details of the physician was provided. The reporter had given consent for follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Insomnia, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received SHINGRIX. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and vaccine administered at inappropriate site. In June 2018, the patient experienced sleeplessness. On an unknown date, the outcome of the injection site pain, injection site erythema and sleeplessness were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The nurse reported the case for herself. The reporting nurse received a dose of SHINGRIX which was reportedly administered too far below the deltoid, which led to vaccine administered at inappropriate site. The patient experienced local injection site pain and redness (3-4 inches in diameter), and it started resolving seven days later. Less than a week after receiving SHINGRIX, the patient could not sleep due to pain. The nurse did not have lot number or expiration of vaccine. It was not known if this had been reported before. The reporter had consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash pruritic, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site erythema, injection site swelling, itchy rash, pustular rash and scab were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab to be related to SHINGRIX. Additional information received as follows: On 17th or 18th October 2018, in morning, the patient had the shot of SHINGRIX. The patient was not sure of the exact date. In afternoon, the patient experienced redness, soreness and swelling at the injection site after receiving the shot in the morning. Eight to ten days later she noticed a few bumps behind her knee that looked like 3-4 bug bites. They were itchy. They appeared on her stomach too. After a day or 2 they produced little puss heads and then they scabbed over. A few recently appeared on the back of her arms, on front and back of her neck and on her right foot. She stated that they come and go. The reporter gave consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site erythema, injection site swelling, itchy rash, pustular rash and scab were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, itchy rash, pustular rash and scab to be related to SHINGRIX. Additional information received as follows: On 17th or 18th October 2018, in morning, the patient had the shot of SHINGRIX. The patient was not sure of the exact date. In afternoon, the patient experienced redness, soreness and swelling at the injection site after receiving the shot in the morning. Eight to ten days later she noticed a few bumps behind her knee that looked like 3-4 bug bites. They were itchy. They appeared on her stomach too. After a day or 2 they produced little puss heads and then they scabbed over. A few recently appeared on the back of her arms, on front and back of her neck and on her right foot. She stated that they come and go. The reporter gave consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) and (batch number 293AT, expiry date 27th February 2021) for prophylaxis. On 27th August 2018, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On 27th August 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, myalgia upper extremities and joint range of motion decreased. The patient was treated with anti-inflammatory/antirheumatic products and Heat Therapy. On an unknown date, the outcome of the pain in arm, myalgia upper extremities and joint range of motion decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, myalgia upper extremities and joint range of motion decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient began experiencing arm pain immediately after receipt of SHINGRIX. The muscle pain had been severe enough to interfere with range of motion. Anti-inflammatories and heat were tried with minimal improvement. At the time of reporting, the patient was undergoing physical therapy to help alleviate symptoms. The healthcare professional (HCP) did not feel comfortable providing patient's demographics. The reporter did not give consent to be followed up. The HCP would follow up after discussion with the patient if she changes her mind.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Influenza vaccine for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis and Influenza vaccine for prophylaxis. The patient's past medical history included chickenpox (as a child, severe case). On an unknown date, the patient received Influenza vaccine at an unknown dose, Influenza vaccine at an unknown dose and Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine and not applicable after receiving Influenza vaccine and Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, vaccination failure (serious criteria GSK medically significant), influenza and fever. On an unknown date, the outcome of the vaccination failure and vaccination failure were unknown and the outcome of the influenza, influenza and fever were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza, vaccination failure and influenza to be related to Influenza vaccine. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. It was unknown if the reporter considered the fever to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. Twice in the past she got the flu after getting the flu vaccine and though the illness was shorter that it otherwise would have been because of the vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for influenza, time to onset for event and laboratory confirmation for influenza were not provided. The patient regularly gets the flu vaccine and usually has a low grade fever afterwards. The patient had denied permission to contact their physician. This case has been linked with the case US2018195484, reported by same reporter for same patient.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who received a dose of FLUBLOK QIV (batch number: QSAA1811, Expiry date: 30-Jun-2020) rather than FLUZONE (batch number and expiry date was not reported) (dose, dose in series, route and site of administration were not reported for both the vaccines) on 16-Nov-2018. The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as He did not receive any other vaccines that day. It was a case of actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4, PPV, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a patient who was vaccinated with FLUBLOK QIV (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. It was also reported that, vaccine PNEUMOVAX, ADACEL (batch number, expiration date, dose, route and site of administration was not reported) was also delayed in transit and therefore no longer viable with vaccine. The patient's medical history and concomitant medications were not reported.  It was an actual medication error due to incorrect product storage as Flublok, Adacel and Pneumovax were delayed in transit and were no longer viable. Customer Service transferred call to Nurse Consultant as this Customer/Pharmacy tech is reporting that Flublok was given to a patient from the vaccine shipment that was delayed in transit and therefore no longer viable.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 months (reported as 13.5 months)-old female patient who was vaccinated with 0.5 ml FLUZONE (Lot number: UJ005AD, expiry date: 30-Jun-2019) via intramuscular route in right thigh, on 18-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a patient (age and gender not reported) who received vaccination with 0.5 ml FLUZONE QUADRIVALENT (batch number UT6290MA, expiry date 30 June 2019, route and site of administration were not reported) on 18 Nov 2018. Patient had not received concomitant. It was a case of actual medication error due to Incorrect product storage as patient received FLUZONE QUAD after it was exposed to a high of 33.54 degrees Celsius. It was not reported if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient had the PENTACEL liquid part but not the powder part of the vaccine, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient also received ROTATEQ, PREVNAR 13 and HEPATITIS B VACCINE as concomitant medication. On an unknown date, the patient received a dose of suspect PENTACEL lot C5447AB, expiry date- 15-Nov-2019 via unknown route. It was a case of actual medication error due to inappropriate reconstitution technique. (Other relevant tests included no lab test.) Final diagnosis was gave the PENTACEL liquid part but not the powder part of the vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for gave the PENTACEL liquid part but not the powder part of the vaccine.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Erythema, Injection site rash, Pain, Swelling
Clinical narrative: Injection site rash, noticed 3 days ago from PCV 13 - Recommended hydrocortisone 1% topical and OTC oral Claritin. Instructed to watch for worsening symptoms, increased redness, swelling, pain, and  anaphylaxis.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Patient developed redness, swelling, and inflammation in the right arm after administration of the PNEUMOVAX 23 vaccine.  She said it started at site of injection then moved down her arm past her elbow.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient developed redness, swelling, and inflammation in the right arm after administration of the PNEUMOVAX 23 vaccine.  She said it started at site of injection then moved down her arm past her elbow.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain, Pyrexia
Clinical narrative: I am unsure about the vaccine type and #. I was not provided with this information. 4 days after the vaccine, given in my right arm, the right side of my neck because painful to touch and motion. It feels as if it is swollen with water. To the touch, it is lumpy. The lymph nodes from behind my ear, down my neck, along my collar bone and in my arm pit (all on the right side) are swollen and painful. My nose is runny, I have a fever and am achy.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Swelling
Clinical narrative: I am unsure about the vaccine type and #. I was not provided with this information. 4 days after the vaccine, given in my right arm, the right side of my neck because painful to touch and motion. It feels as if it is swollen with water. To the touch, it is lumpy. The lymph nodes from behind my ear, down my neck, along my collar bone and in my arm pit (all on the right side) are swollen and painful. My nose is runny, I have a fever and am achy.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reported side effects of whole body aches within 24 hours of second dose and it lasted about 24 hours.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Cough, Feeling hot, Head discomfort
Clinical narrative: On 11/20/18, Patient stated that at about 0900 pm he had the chills, took his temp because he was feeling warm and it was 102.0. Patient stated it went up to 103. He did not take any medication for the fever, he applied a cold towel to his head and covered himself with a blanket and the fever broke. This morning his temperature was 98.1 but has started with a cough and feels pressure in his head. He stated he has had the flu shot for 10 years and has never had side effects like he is having this time. Same day, patient stated that his fever is waxing and waning and goes from 99 to 102. Patient is concerned that he continues to have a fever. Appointment made for tomorrow morning. Patient was encouraged to go to ER if he became worse overnight. Patient is unsure if he will go to ER. Patient stated he took 2 TYLENOL for fever and will continue to monitor his symptoms and is staying hydrated. 11/21/18, Patient saw physician and diagnosed with post-injection cellulitis and arthus reaction. Patient given cephalexin 1000 mg PO TID.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Type III immune complex mediated reaction
Clinical narrative: On 11/20/18, Patient stated that at about 0900 pm he had the chills, took his temp because he was feeling warm and it was 102.0. Patient stated it went up to 103. He did not take any medication for the fever, he applied a cold towel to his head and covered himself with a blanket and the fever broke. This morning his temperature was 98.1 but has started with a cough and feels pressure in his head. He stated he has had the flu shot for 10 years and has never had side effects like he is having this time. Same day, patient stated that his fever is waxing and waning and goes from 99 to 102. Patient is concerned that he continues to have a fever. Appointment made for tomorrow morning. Patient was encouraged to go to ER if he became worse overnight. Patient is unsure if he will go to ER. Patient stated he took 2 TYLENOL for fever and will continue to monitor his symptoms and is staying hydrated. 11/21/18, Patient saw physician and diagnosed with post-injection cellulitis and arthus reaction. Patient given cephalexin 1000 mg PO TID.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Night sweats
Clinical narrative: Patient came in to the pharmacy on 11/23/18 complaining of right knee pain. Patient started having pain in her right knee on 11/14/18 and it has persisted despite taking OTC ibuprofen. Patient also has sweating at nighttime and feels tired. Patient does not have any fever. Patient was advised to consult her doctor for further analysis on 11/23/18.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: Same symptoms are reported for first vaccine in the series (VAERS ID 760259, E number 142387), but worse.  Severe chills, shivering, also achy, headache, a quite a bit of pain in my arm at the injection site (by comparison I just got a flu shot and had no pain whatsoever at the injection site).  Symptoms lasted for almost 24 hours.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Electroencephalogram abnormal, Seizure
Clinical narrative: Received the flu vaccine with my 15 year old daughter. She has experienced no symtoms. I had a series of not previously ever experienced  seizures. 2 back to back. Was taken via ambulance to the hospital. Checked out and then it happened again on the way home from the hospital. I was admitted two days and given meds there. Now I'm on Keppra 500 mg 2x a day. The only thing I changed was the flue shot. I have never had a seizure in my life. Is there a link?
Age: 53.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site inflammation, Injection site warmth, Malaise
Clinical narrative: Lots of fever, inflammation in the right immunization area, malaise in the body, patient had to go to the doctor for medical assistance, ANCEF was administered.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Headache, Malaise, Nausea, Vomiting
Clinical narrative: 11/1/18 note: Pt c/o nausea w/o vomiting, malaise, and mild HA (3-410) one day after receiving flu immunization.
Age: 77.0
Sex: M
Vaccine: HEPA
Symptoms: Bilevel positive airway pressure, Cardiac failure, Cardiogenic shock, Death, Dyspnoea
Clinical narrative: 77M with a history of chronic systolic heart failure from ischemic cardiomyopathy, NYHA Class III, EF <20%. He was in clinic this AM for regular follow up. Has been doing well, at baseline for last few weeks. Did well at cardiology appt. Given hepatitis A vaccine while in clinic, no other new meds. Called back to cardiology appointment 3 hours after returning home to report he was not feeling well and was becoming progressively short of air. Patient was instructed to report to ED for evaluation. Patient presented to ED where he was noted to be hypoxic. Trialed briefly on bipap but then intubated given work of breathing and hypoxia. Patient was transferred to the ICU with a primary diagnosis of Acute Hypoxic Respiratory Failure. HF decompensation was suspected, with role of hepatitis A vaccine unclear. Patient continued to deteriorate and by 11pm that same evening developed cardiogenic shock. Patient's wife made patient a DNR in event of cardiac arrest, and patient expired that evening at 11: 29 pm. Norepinephrine per titration protocol, vasopressin per titration protocol, epinephrine 1 mg once.
Age: 77.0
Sex: M
Vaccine: HEPA
Symptoms: Endotracheal intubation, General physical health deterioration, Hypoxia, Intensive care, Malaise
Clinical narrative: 77M with a history of chronic systolic heart failure from ischemic cardiomyopathy, NYHA Class III, EF <20%. He was in clinic this AM for regular follow up. Has been doing well, at baseline for last few weeks. Did well at cardiology appt. Given hepatitis A vaccine while in clinic, no other new meds. Called back to cardiology appointment 3 hours after returning home to report he was not feeling well and was becoming progressively short of air. Patient was instructed to report to ED for evaluation. Patient presented to ED where he was noted to be hypoxic. Trialed briefly on bipap but then intubated given work of breathing and hypoxia. Patient was transferred to the ICU with a primary diagnosis of Acute Hypoxic Respiratory Failure. HF decompensation was suspected, with role of hepatitis A vaccine unclear. Patient continued to deteriorate and by 11pm that same evening developed cardiogenic shock. Patient's wife made patient a DNR in event of cardiac arrest, and patient expired that evening at 11: 29 pm. Norepinephrine per titration protocol, vasopressin per titration protocol, epinephrine 1 mg once.
Age: 77.0
Sex: M
Vaccine: HEPA
Symptoms: Respiratory failure
Clinical narrative: 77M with a history of chronic systolic heart failure from ischemic cardiomyopathy, NYHA Class III, EF <20%. He was in clinic this AM for regular follow up. Has been doing well, at baseline for last few weeks. Did well at cardiology appt. Given hepatitis A vaccine while in clinic, no other new meds. Called back to cardiology appointment 3 hours after returning home to report he was not feeling well and was becoming progressively short of air. Patient was instructed to report to ED for evaluation. Patient presented to ED where he was noted to be hypoxic. Trialed briefly on bipap but then intubated given work of breathing and hypoxia. Patient was transferred to the ICU with a primary diagnosis of Acute Hypoxic Respiratory Failure. HF decompensation was suspected, with role of hepatitis A vaccine unclear. Patient continued to deteriorate and by 11pm that same evening developed cardiogenic shock. Patient's wife made patient a DNR in event of cardiac arrest, and patient expired that evening at 11: 29 pm. Norepinephrine per titration protocol, vasopressin per titration protocol, epinephrine 1 mg once.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Nervousness
Clinical narrative: The patient felt shaky and flushed. She also felt dizzy. We treated pt with 25 mg of BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In December 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles (herpes zoster) and in June 2013, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the outcome of herpes zoster, pain, condition aggravated emotional distress and vaccination failure was unknown. The reporter considered herpes zoster, pain, condition aggravated emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about 2014, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles in or about 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise, Meningitis viral, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included influenza and meningitis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), viral meningitis (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, viral meningitis and influenza were unknown. It was unknown if the reporter considered the vaccination failure, viral meningitis and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were received as follows: The patient had meningitis in the past, causes the patient zero thought because none of the vaccine could stop meningitis. The patient had flu without the vaccine. The patient was sick for few days at home. After vaccination with Influenza vaccine, the patient was ended up with viral meningitis. Flu vaccine didn't even stop it. Influenza vaccine may not prevent the flu but it would make flu easier to get over. This case was considered as suspected vaccination failure case since time to onset was unknown at the time reporting. Flu with Influenza vaccine ended up in hospital for a few days.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date in 2016, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood albumin normal, Blood calcium increased, Blood thyroid stimulating hormone normal, Headache, Metabolic function test
Clinical narrative: On 11/5/18, was seen in family practice clinic and reported that she had gotten the flu shot and the next day woke with bad headache. Took TYLENOL and ALEVE. Called the clinic and was prescribed meloxicam and didn't help. Had cataract surgery in 2012 which resolved the cloudiness in her eyes. Has had cloudiness in eyes come back off and on since August 2018. Vision has not been worse with her current headache. No photophobia. No vomiting. No recent nasal congestion. Often gets sinus infection in winter. Pain is a 9. Worse since last week. History of migraines 5-6 times a year, usually on days of high humidity. Her migraine pain is also behind her right eye. Takes ADVIL for that pain and headaches usually take 2-3 days to go away. Referred to ophthalmology and was seen 11/7/18. They reported that APD, normal color testing. Due to mild temporal pallor of both optic nerves, patient will need HVF 24-2 and OCT RNFL in the future. They recommended MRI of brain and orbits which were done 11/12/18.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Optic atrophy, Protein total normal, Vision blurred
Clinical narrative: On 11/5/18, was seen in family practice clinic and reported that she had gotten the flu shot and the next day woke with bad headache. Took TYLENOL and ALEVE. Called the clinic and was prescribed meloxicam and didn't help. Had cataract surgery in 2012 which resolved the cloudiness in her eyes. Has had cloudiness in eyes come back off and on since August 2018. Vision has not been worse with her current headache. No photophobia. No vomiting. No recent nasal congestion. Often gets sinus infection in winter. Pain is a 9. Worse since last week. History of migraines 5-6 times a year, usually on days of high humidity. Her migraine pain is also behind her right eye. Takes ADVIL for that pain and headaches usually take 2-3 days to go away. Referred to ophthalmology and was seen 11/7/18. They reported that APD, normal color testing. Due to mild temporal pallor of both optic nerves, patient will need HVF 24-2 and OCT RNFL in the future. They recommended MRI of brain and orbits which were done 11/12/18.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extremely sore for two days after vaccination and continuing sharp pain when arm lifted above shoulder or placed behind back and dull pain in bed until now (a month after injection). Details: When received injection, I was seated in a regular chair and the NP was standing. At the time, I felt the shot was very high on my shoulder (the left one, in which almost 15 years ago I'd had a rotator cuff injury that had completely healed). The nurse also seemed to withdraw the syringe very quickly? I noticed several drops of vaccine beading from the needle after it was placed on the examination table while she put on a bandaid. The injection site was unusually painful for two days, and I used a heating pad and tried not to use it. After that, the constant pain disappeared, but it has remain slightly sore at the injection site and the whole shoulder is quite painful when I raise my arm, especially angled over my head to take off clothing or behind my back to remove my bra. The pain and angles are similar to what I experienced with rotator cuff, as is the fact that it is more uncomfortable in bed. It also seems to "creak" on movement more than the other shoulder. I am absolutely positive I did NOTHING to injure my right shoulder, as I am very careful about joints, since I am active and wish to remain that way.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Vision blurred
Clinical narrative: Dizziness, problems walking like I am drunk. Vision slightly blurred. No treatment left message with my doctor, his office will be open Monday Nov. 26, 2018,
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient stated that approximately 2 hours after administration, she began to feel excruciating pain in her left arm and shoulder where it was no longer functional. She went into the ER later that night and received 5 tablets of Norco 5-325 and exercises to do to maintain shoulder flexibility. She can no longer do daily activities like dressing herself. She can no longer hold her 3-month-old granddaughter because her left arm is too weak.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Encephalitis viral, Feeling abnormal, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: I am a physician with many years of experience, former medical school professor, and widely published biological scientist. I have never had an adverse reaction to any drug or vaccine before SHINGRIX and am in good health. My adverse effects from this vaccine were extremely severe! Two days after receiving it I developed severe flu-like symptoms including bronchitis with wheezing. Within the next few days I developed a viral encephalitis that seriously impaired by ability to think (especially creatively), to move quickly, or to carry out most of my normal functions. I felt like I had aged about 25 years in a few days. This lasted for about two weeks and was deeply frightening. Another side effect was an almost complete loss of sexual function. These symptoms were treated with valacyclovir at full therapeutic doses for several weeks, and gradually decreased. I am not sure that even now 2 months later I have been restored to full health. I have discussed my symptoms with several other people, including other physicians, who have received this vaccine and some of them reported similar hard-to-describe but clear cut impairments of mental function. I BELIEVE THIS VACCINE IS DANGEROUS AND IT SHOULD BE REMOVED FROM THE MARKET UNTIL A DETAILED REASSESSMENT OF ITS ADVERSE EFFECTS IS COMPLETED. I have no economic or other hidden interest in making the above statement, but I am convinced on the basis of about 50 years of experience in medicine and medical research that this live modified virus is a threat to public health and that its advantages, if any, over the prior shingles vaccine in shingles prevention are more than outweighed by its obvious frequent and in some cases VERY severe adverse reactions. I hope you will pay careful attention to this communication.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Male sexual dysfunction, Mental impairment, Vaccination complication, Wheezing
Clinical narrative: I am a physician with many years of experience, former medical school professor, and widely published biological scientist. I have never had an adverse reaction to any drug or vaccine before SHINGRIX and am in good health. My adverse effects from this vaccine were extremely severe! Two days after receiving it I developed severe flu-like symptoms including bronchitis with wheezing. Within the next few days I developed a viral encephalitis that seriously impaired by ability to think (especially creatively), to move quickly, or to carry out most of my normal functions. I felt like I had aged about 25 years in a few days. This lasted for about two weeks and was deeply frightening. Another side effect was an almost complete loss of sexual function. These symptoms were treated with valacyclovir at full therapeutic doses for several weeks, and gradually decreased. I am not sure that even now 2 months later I have been restored to full health. I have discussed my symptoms with several other people, including other physicians, who have received this vaccine and some of them reported similar hard-to-describe but clear cut impairments of mental function. I BELIEVE THIS VACCINE IS DANGEROUS AND IT SHOULD BE REMOVED FROM THE MARKET UNTIL A DETAILED REASSESSMENT OF ITS ADVERSE EFFECTS IS COMPLETED. I have no economic or other hidden interest in making the above statement, but I am convinced on the basis of about 50 years of experience in medicine and medical research that this live modified virus is a threat to public health and that its advantages, if any, over the prior shingles vaccine in shingles prevention are more than outweighed by its obvious frequent and in some cases VERY severe adverse reactions. I hope you will pay careful attention to this communication.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Feeling cold, Mobility decreased, Nausea, Pain
Clinical narrative: Around 8pm, my left arm began to hurt a lot and I almost passed out. I felt dizzy, nauseous, and started blacking out. The pain in my arm continued to increase throughout the evening - extreme pain shooting up my neck, through my shoulder and down my arm. I was also incredibly cold. This continued through the entire night. The next day I could not move my arm at all. I visited the urgent care center and contacted my doctor who said it sounded like I had a vigorous immune response to the pneumonia vaccine. It took several days to regain the use of my my arm.  However, today it continues to be uncomfortably sore and achy (especially at night) and there are certain movements that cause me pain. My doctor has suggested waiting 4-6 weeks for things to heal. NOTE: I don't know which brand/type of Influenza vaccine I recieved that day - the notes I have say Influenza Preservative Free Quadravalent - which wasn't an option listed above.