chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included gabapentin (Neurontin), simvastatin, estrogens conjugated (Premarin) and levothyroxine sodium (Synthroid). On 21st May 2018, the patient received SHINGRIX. On 22nd May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and insomnia. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the insomnia was not recovered/not resolved. The reporter considered the headache and insomnia to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced headache the day after a SHINGRIX injection. The headache lasted a few days and then resolved. The patient also reported that beginning the day after the injection, she had experienced insomnia which was unresolved. The patient had denied permission to contact their physician.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Injection site erythema, Oral mucosal blistering
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, shivering, cold sweat and blistering of mouth. On an unknown date, the outcome of the injection site erythema and cold sweat were unknown and the outcome of the shivering and blistering of mouth were recovering/resolving. It was unknown if the reporter considered the injection site erythema, shivering, cold sweat and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at injection site, shivers, cold sweats and mouth blisters a couple days after receiving the SHINGRIX vaccine in the right deltoid. The patient was still having the symptoms however was recovering. No further information was reported regarding the event.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 adult male patient who received SHINGRIX (batch number T5242, expiry date April 2019) for prophylaxis. On 3rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was complaining of his forearm bothering him, as it was achy and sore.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.  It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The Field representative called to report adverse events that three different patients experienced on SHINGRIX as reported to her by the nurse. As per the field representative one of the the patient's husband went in to get the SHINGRIX and experienced some side effects with the SHINGRIX vaccine. No further details were provided as far as what kind of adverse event the patient experienced. The field representative had very limited information. Attempted to call nurse twice to get further information on the events but was not able to reach her. She also stated that nurse had reported the event to VAERS. This was 1 of 3 cases, reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rigors in a 62-year-old male patient who received Shingrix (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Concomitant products included Venlafaxine, Aspirin, Wellbutrin Xl, Atorvastatin, Brilinta, Metoprolol Succin and Omega Fatty Acid. On 9th February 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced rigors. On an unknown date, the outcome of the rigors was recovered/resolved. The reporter considered the rigors to be related to Shingrix. Additional details were provided as follows: The patient was administered Shingrix in the left arm. The patient experienced severe rigors with first dose of Shingrix. The reaction lasted for about 12 hours approximately. This case was linked to the case US2018GSK072776, reported by the same reporter for the same patient who experienced same event after the 2nd dose. Follow up was received by a physician on 1st June 2018: The reporter's contact details were updated. The patient's demographic details were updated. The VAERS details were updated. Sender's Comments: US2018GSK069429: Previous VAERS submission in paper format.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, pain and shoulder pain. On an unknown date, the outcome of the fever and pain were recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the fever, pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a fever and achiness for 2 to 3 days. The patient was scheduled for a cortisone shot for painful shoulder in one week (6th June 2018) after the vaccine was given. The patient was asking, whether that would be safe or should she wait longer.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of generalized aching in a 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced generalized aching. On an unknown date, the outcome of the generalized aching was recovering/resolving. It was unknown if the reporter considered the generalized aching to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the physician's assistant (PA). The reporter stated that the patient called and said a day after she got Shingrix vaccine she got achey all over and she said she had been slowly getting better but it had been 3 weeks and she still had it. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Injection site erythema, Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cough in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives. The patient was treated with salbutamol sulphate (Albuterol). On an unknown date, the outcome of the cough was not recovered/not resolved and the outcome of the pain and stiffness were recovered/resolved and the outcome of the chest abnormal feeling of, fever, injection site erythema and hives were unknown. It was unknown if the reporter considered the cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives to be related to SHINGRIX. Additional details were provided as follows: The reporter did not know batch number of SHINGRIX. The age at vaccination was not reported, but the patient could be 64 or 65 years old. The patient post vaccination was achy and stiff for three days and then was fine. The patient had weird feeling in chest and a cough and she was still coughing using albuterol and fever. The patient had redness at injection site and hive on leg. The patient wanted to get the next shot of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cough in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives. The patient was treated with salbutamol sulphate (Albuterol). On an unknown date, the outcome of the cough was not recovered/not resolved and the outcome of the pain and stiffness were recovered/resolved and the outcome of the chest abnormal feeling of, fever, injection site erythema and hives were unknown. It was unknown if the reporter considered the cough, pain, stiffness, chest abnormal feeling of, fever, injection site erythema and hives to be related to SHINGRIX. Additional details were provided as follows: The reporter did not know batch number of SHINGRIX. The age at vaccination was not reported, but the patient could be 64 or 65 years old. The patient post vaccination was achy and stiff for three days and then was fine. The patient had weird feeling in chest and a cough and she was still coughing using albuterol and fever. The patient had redness at injection site and hive on leg. The patient wanted to get the next shot of SHINGRIX.
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Chills, Swelling
Clinical narrative: This case was reported by a physician via other and described the occurrence of swelling in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVNAR for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and PREVNAR at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and chills. On an unknown date, the outcome of the swelling and chills were recovering/resolving. The reporter considered the swelling and chills to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. An attendee (doctor) at primed conference mentioned that after vaccination with SHINGRIX it resulted in adverse events that were mostly resolved. They did not specify when exactly they received the dose. This case has been linked with the case US2018GSK103584, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patients experienced fever, headache, malaise, myalgia, nausea and vomiting. On an unknown date, the outcome of the fever, headache, malaise, myalgia, nausea and vomiting were unknown.  It was unknown if the reporter considered the fever, headache, malaise, myalgia, nausea and vomiting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter had some questions about length of immunity and side effects. The reporter had a few patients in their last office with fairly severe reactions like high fever, headache (HA), malaise, myalgias, nausea or vomiting (N or V) after receiving BEXSERO. The reporter had patients most days.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of fever in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patients experienced fever, headache, malaise, myalgia, nausea and vomiting. On an unknown date, the outcome of the fever, headache, malaise, myalgia, nausea and vomiting were unknown.  It was unknown if the reporter considered the fever, headache, malaise, myalgia, nausea and vomiting to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter had some questions about length of immunity and side effects. The reporter had a few patients in their last office with fairly severe reactions like high fever, headache (HA), malaise, myalgias, nausea or vomiting (N or V) after receiving BEXSERO. The reporter had patients most days.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Zoster vaccine with an associated reaction of pain. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was unknown when, the vaccine was given or when pain abated. The patient did rate pain as 8 by 10 but the patient was fine at the time of reporting. The health care professional stated she had zoster previously and this pain was better than having zoster.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Malaise, Nausea
Clinical narrative: Within 24 hours developed sever arm pain with large, hot red area below injection site, as well as high fever (102 degrees), chills, nausea, malaise, body aches. Most resolved within 48 hours EXCEPT the arm pain and hot red area below injection site which are still present 1 week post injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Within 24 hours developed sever arm pain with large, hot red area below injection site, as well as high fever (102 degrees), chills, nausea, malaise, body aches. Most resolved within 48 hours EXCEPT the arm pain and hot red area below injection site which are still present 1 week post injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash, Rash pruritic
Clinical narrative: Pt developed a local as well as an itchy rash on her arms, legs, torso.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Ear infection, Malaise, Weight decreased
Clinical narrative: Mom reports after completing Screening Checklist for Contraindications to Vaccines for Children and Teens (Immunization Action Coalition) "she got her shots on Tuesday and then by early Saturday morning she had "severe diarrhea" "lost weight" "went through 4 bags of diapers with diarrhea episode lasting into the next week; "took her to see Dr. on Monday 04/16/18" "unsure if vaccine related" babe continued to be ill and was taken back to Dr. on Thursday 04/19/18 and diagnosed with ear infection at that time" Mom also reported "family history of intussusception" "babe had sister with epilepsy, dad and brother have "Tourettes"Mom reports that babe is well today, however vaccinations withheld at this time. Awaiting response from Immunization Division. Babe was "full-term C-Section delivery' birth weight 6lbs, 19 1/2 In; last month (May) weight per mom was 10.13 lbs. Babe is breast/bottle fed- per mom. Babe appeared alert, made eye contact and smiles to verbal stimulation.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Syncope
Clinical narrative: Fainted for about 30 seconds, took about 15 minutes before he felt ok enough to walk out, headache and tingling/numb arms after coming to. This lasted for about an hour.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash on right side of chest, vesicular fluid filled tiny vesicles.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 68-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX23, (lot # M041686 , expiration date 20-MAY-2018), (dose, frequency and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 18 year old healthy and normal male patient. The patient has none concurrent conditions, medical history or concomitant medications. Merck Sterile diluent was used. On 23-MAY-2018, the patient was vaccinated with his first dose of VARIVAX (lot # M038226 with expiration date 07-SEP-2018), subcutaneously for school purposes (dose not reported). On 06-JUN-2018, the parents reported the pharmacist that the patient developed chickenpox on an unspecified time post vaccination (varicella). The pharmacist prescribed the patient acyclovir (manufacturer unknown) as treatment. No laboratory diagnostic studies were performed. The outcome of varicella and the causal relationship between varicella and therapy with VARIVAX was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-OCT-2008, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In February 2016, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JUN-2008, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2011, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-NOV-2013, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed bacitracin/polymixin ointment and tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-APR-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-FEB-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles along with shingles affecting the right eye. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Upon internal review, shingles affecting the right eye was determined to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Local reaction, Pyrexia, Rash, Swelling
Clinical narrative: Saw swelling fever NA. E/R. Localized reaction to Lf thigh - E/R. Report seen today 6-12/2018. Rash pant size 4x4" - No Induration Negative warm, Negative swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase normal, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Patient received SHINGRIX vaccine on March 26, 2018. He called his primary care provider's office on April 3, 2018 complaining of soreness in his right arm/shoulder area that started approximately 2 days after the injection. Icing the area, acetaminophen, and ibuprofen were ineffective to alleviate the pain. Patient made an appointment to see his provider on April 5, 2018 to have the injection site evaluated. The provider noted no swelling, reddening or tenderness of the injection site area. On April 13, 2018, patient went to ER due to worsening right and left shoulder pain radiating towards his neck. On May 22, 2018, patient called his primary care provider again to tell him the pain had not subsided. He had a cortisone shot which did not alleviate the pain. Patient is currently awaiting an MRI to see if there is any damage to the injection site area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain, Peripheral swelling
Clinical narrative: Swollen arm, nausea, chills, body aches, flu like.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: I don't know the details of the vaccine. I started feeling chills and shivering. That got worse as the night wore on. I took some tylenol. When I woke up about 6AM I was much improved but not 100%.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain all over, headache, slight fever.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR
Symptoms: Allergy to vaccine, Antibody test, Anxiety, Aphasia, Asthma
Clinical narrative: Child developed hives all over the trunk. Blistering type. Happened during two separate vaccination appointments. The second time was worse. Believed to be an allergy to one of the vaccines. Child stopped speaking completely within a 1-2 week period. Before vaccination was developing speech at the appropriate rate. Did not resume any speaking until 3 1/2 years old after intensive speech therapy. Referred to specialists and behavioral clinic. Child has SPD. Child has "unknown anxiety". Child concurrently treated for difficulty breathing--asthma diagnosis. Child has ADHD. Multiple vaccines at once, multiple times--unsure of lot numbers or types.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR
Symptoms: Attention deficit/hyperactivity disorder, Blister, Condition aggravated, Dyspnoea, Electroencephalogram
Clinical narrative: Child developed hives all over the trunk. Blistering type. Happened during two separate vaccination appointments. The second time was worse. Believed to be an allergy to one of the vaccines. Child stopped speaking completely within a 1-2 week period. Before vaccination was developing speech at the appropriate rate. Did not resume any speaking until 3 1/2 years old after intensive speech therapy. Referred to specialists and behavioral clinic. Child has SPD. Child has "unknown anxiety". Child concurrently treated for difficulty breathing--asthma diagnosis. Child has ADHD. Multiple vaccines at once, multiple times--unsure of lot numbers or types.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR
Symptoms: Schizotypal personality disorder, Urticaria
Clinical narrative: Child developed hives all over the trunk. Blistering type. Happened during two separate vaccination appointments. The second time was worse. Believed to be an allergy to one of the vaccines. Child stopped speaking completely within a 1-2 week period. Before vaccination was developing speech at the appropriate rate. Did not resume any speaking until 3 1/2 years old after intensive speech therapy. Referred to specialists and behavioral clinic. Child has SPD. Child has "unknown anxiety". Child concurrently treated for difficulty breathing--asthma diagnosis. Child has ADHD. Multiple vaccines at once, multiple times--unsure of lot numbers or types.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain
Clinical narrative: Ear ache.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Arthropathy, Blood test normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Death, Grip strength decreased
Clinical narrative: By October 8th patient felt extreme shoulder pain. On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical. Diagnosis: frozen shoulder. Five additional appointments - condition appointments-condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain spread throughout body, limb weakness, weight loss, could not hold eating utensils. Doctor and Physical Therapist Providers both recommended neurology group/no appt. until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active, robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and at his last appointment on January 3rd, 2018, he registered 150 pounds. He could not hold a fork or juice glass. Both Dr. and Therapist said they could no longer help him and recommended the Neurologist Neurologists the first week in January. His appointment was set for February 3rd and he called every day to see if there was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance took him to the Hospital hospital where he died within one hour. Therapist said from his first appointment, on November 15th, that the cause was the flu shot. All symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a strong man who had never been hospitalized since a tonsillectomy at age 5 who dies from a vaccination designed to keep him healthy. What are the statistics of death from a flu shot? What compensation for wrongful death is covered by the FDA? Pharmacy certainly shuns responsibility for having an inexperienced girl administer the shot. I think there should be a precise warning given at the time of the shot, shot as opposed to the generic list of possible side effects. We wasted months treating a frozen should shoulder rather than see seeing a neurologist. I have saved all receipts and reports in my file. And you are welcome to verify husband's patient's physical condition from any of the 136 units in our condo who saw him walking daily, fishing, playing tennis, etc. You can also check with our neighbors who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination he drove 1600 miles (with overnight stops along the way, of course). I will, and do, miss my loving husband of fifty three years-as years - as do our children and his twin sister. It is a difficult time for all of us.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: By October 8th patient felt extreme shoulder pain. On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical. Diagnosis: frozen shoulder. Five additional appointments - condition appointments-condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain spread throughout body, limb weakness, weight loss, could not hold eating utensils. Doctor and Physical Therapist Providers both recommended neurology group/no appt. until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active, robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and at his last appointment on January 3rd, 2018, he registered 150 pounds. He could not hold a fork or juice glass. Both Dr. and Therapist said they could no longer help him and recommended the Neurologist Neurologists the first week in January. His appointment was set for February 3rd and he called every day to see if there was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance took him to the Hospital hospital where he died within one hour. Therapist said from his first appointment, on November 15th, that the cause was the flu shot. All symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a strong man who had never been hospitalized since a tonsillectomy at age 5 who dies from a vaccination designed to keep him healthy. What are the statistics of death from a flu shot? What compensation for wrongful death is covered by the FDA? Pharmacy certainly shuns responsibility for having an inexperienced girl administer the shot. I think there should be a precise warning given at the time of the shot, shot as opposed to the generic list of possible side effects. We wasted months treating a frozen should shoulder rather than see seeing a neurologist. I have saved all receipts and reports in my file. And you are welcome to verify husband's patient's physical condition from any of the 136 units in our condo who saw him walking daily, fishing, playing tennis, etc. You can also check with our neighbors who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination he drove 1600 miles (with overnight stops along the way, of course). I will, and do, miss my loving husband of fifty three years-as years - as do our children and his twin sister. It is a difficult time for all of us.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Resuscitation, Vaccination complication, Weight decreased
Clinical narrative: By October 8th patient felt extreme shoulder pain. On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical. Diagnosis: frozen shoulder. Five additional appointments - condition appointments-condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain spread throughout body, limb weakness, weight loss, could not hold eating utensils. Doctor and Physical Therapist Providers both recommended neurology group/no appt. until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active, robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and at his last appointment on January 3rd, 2018, he registered 150 pounds. He could not hold a fork or juice glass. Both Dr. and Therapist said they could no longer help him and recommended the Neurologist Neurologists the first week in January. His appointment was set for February 3rd and he called every day to see if there was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance took him to the Hospital hospital where he died within one hour. Therapist said from his first appointment, on November 15th, that the cause was the flu shot. All symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a strong man who had never been hospitalized since a tonsillectomy at age 5 who dies from a vaccination designed to keep him healthy. What are the statistics of death from a flu shot? What compensation for wrongful death is covered by the FDA? Pharmacy certainly shuns responsibility for having an inexperienced girl administer the shot. I think there should be a precise warning given at the time of the shot, shot as opposed to the generic list of possible side effects. We wasted months treating a frozen should shoulder rather than see seeing a neurologist. I have saved all receipts and reports in my file. And you are welcome to verify husband's patient's physical condition from any of the 136 units in our condo who saw him walking daily, fishing, playing tennis, etc. You can also check with our neighbors who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination he drove 1600 miles (with overnight stops along the way, of course). I will, and do, miss my loving husband of fifty three years-as years - as do our children and his twin sister. It is a difficult time for all of us.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Insomnia, Nausea
Clinical narrative: Patient reported nausea, vomiting, diarrhea, headaches, fever, chills, pain in arm, and insomnia. This has been going on for the last 4-5 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Patient reported nausea, vomiting, diarrhea, headaches, fever, chills, pain in arm, and insomnia. This has been going on for the last 4-5 days.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Heart rate increased, Hypotension, Leukocytosis, Lung infiltration
Clinical narrative: Pt received vaccine on 5/16/18 and was feeling fine. Next morning pt woke up feeling weak, had low BP and high heart rate. Pt was hospitalized for 2 days. Diagnosed w/pneumonia and sepsis w/mild leukocytosis, (R) lung infiltrate.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Sepsis
Clinical narrative: Pt received vaccine on 5/16/18 and was feeling fine. Next morning pt woke up feeling weak, had low BP and high heart rate. Pt was hospitalized for 2 days. Diagnosed w/pneumonia and sepsis w/mild leukocytosis, (R) lung infiltrate.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy welt on LT side of back, approximately 1/3" long, resembling poison oak. Welt double within approximately 2 days. Applying OTC cortisone cream, then calamine lotion 1-2 x/day, calmed the itch. I eventually searched internet for shingles/images-welt looked very similar.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear haemorrhage, Neuralgia, Rash
Clinical narrative: Outbreak on face, neck, ear, eye, scalp, lips. Nerve pain in ear, on face, in mouth, on scalp and neck. Blood in ear. Office visits: May 15, May 22, June 6, 2018 - prescribed antibiotics, ear drops, nerve pain - gabapentin.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: 2 days after getting the vaccines in his thighs- a rash developed on his thighs- the next day the rash spread down his entire legs on both sides- the following day the rash gets better.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyskinesia, Eye movement disorder, Pallor, Syncope
Clinical narrative: Pallor, fainting episode, eye rolling movement to right, brief jerking movement upper limbs 5 secs. Patient placed supine with knees flexed and recovered in 2 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Local reaction, Rash erythematous
Clinical narrative: 4 cm diameter erythematous circular rash- started 1 day after DTaP vaccine. Started on KEFLEX in case cellulitis although seems more due local reaction.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Condition aggravated, Fatigue, Pain in extremity, Post polio syndrome
Clinical narrative: Greatly exacerbated post polio syndrome. Pain (bursitis and tendonitis) in lt arm. Fatigue - such that couldn't get out of bed in a.m. in bed most of day (extremely unusual - tho' typically takes 2 naps/day). No treatment. Back to baseline by 4th day (in terms of 'outcome').
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendonitis
Clinical narrative: Greatly exacerbated post polio syndrome. Pain (bursitis and tendonitis) in lt arm. Fatigue - such that couldn't get out of bed in a.m. in bed most of day (extremely unusual - tho' typically takes 2 naps/day). No treatment. Back to baseline by 4th day (in terms of 'outcome').
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with VAQTA lot # N005605 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the patient was administered an expired dose of VAQTA. The outcome of the event was unknown. Causal relationship between and VAQTA was not provided.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse via a company representative regarding at least 10 unspecified patients. The patients' medical history, allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patients were vaccinated with M-M-R II (dose, frequency, strength, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patients produced negative titers (antibody test negative). It was unknown if a treatment was given for the adverse event. The outcome regarding the antibody test negative was unknown. The relatedness between the event and M-M-R II was not provided. Furthermore, no product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included sterile diluent. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, frequency and route were unknown) lot # N028445 for prophylaxis. The temperature excursion was registered, without Digital Data Logger, between 6 Fahrenheit degrees and 14 Fahrenheit degrees along 1 hour and 13 minutes.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an adult patient (reported as approximately 27 or 28 years old) of unknown gender. The patient's medical history, concomitant medication and concurrent conditions were not reported; the patient had previously received 2 doses of M-M-R II when the patient was a child. The reporter stated that an unspecified physician wanted the patient to be vaccinated again two doses of the above mentioned vaccine (Inappropriate schedule of drug administration) (Inappropriate schedule of drug administration). On an unknown date in 2017, the patient was vaccinated again with a dose of M-M-R II (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Furthermore, no adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 28-JAN-2015, the patient was vaccinated with first dose of VAQTA (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. On 23-JUL-2015, the patient was vaccinated with second dose of VAQTA (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. The reporter stated that the second dose was administered too early. No adverse effects were reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to currently 15 year old patient of unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. In approximately 2016, also reported as "2 years ago", a 13-year-old patient received first dose of a GARDASIL 9 for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 06-JUN-2018, a 15-year-old patient came to the office for the second dose GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) in the series. No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JUN-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.