chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin burning sensation, Somnolence
Clinical narrative: Sore arm/Achy /Pain in arm; Warm/Feeling of warmth; arm was red from the injection site/red arm; Itched; Rash; painful rash / Raised rash; Unable to sleep; Scabs; Red bumps; Itchy bumps; Burned; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the left arm at around 5:30pm. Less than an hour, the patient experienced sore arm. The patient stated that, her arm was red from the injection site down to her elbow and approximately four inches in width, the redness changed to a rash which she described as raised, red bumps that itch. The patient could not sleep for a week because it was so painful. The patient stated that, the area involved has reduced in size and is appearing to resolve. There was discrepancy between the outcome reported in the structured field and the outcome reported in the source document (recovered or recovered with sequel) for all events.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received 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 unknown.   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 patient received Shingrix and she felt ill after receiving the vaccine. The reporter was not sure if this event occurred after dose 1 or 2 and was not sure how many doses of Shingrix the patient had received.  The reporter did not wish to provide any additional information regarding this patient or event and requested for no follow up regarding this event.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at the injection site.  On day two, pain and hot to the touch along with a large red swollen patch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Chills, Eye discharge, Eye pruritus, Influenza like illness
Clinical narrative: I had fever, chills and nausea throughout the night (after midnight) after receiving the vaccine that morning. Definitely flu like symptoms.  The next day, I felt like I had jabbing sensations in my right eye.  That eye also had some drainage (similar to what you would feel with a bad cold) and itchy.  That afternoon, I had the weird sensation of being able to "feel" the right side of my face. It felt like something was going to happen. It reminded me of how it felt when I had shingles in that area years ago. By the 3rd day, things seem to have resolved themselves.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Sensory disturbance
Clinical narrative: I had fever, chills and nausea throughout the night (after midnight) after receiving the vaccine that morning. Definitely flu like symptoms.  The next day, I felt like I had jabbing sensations in my right eye.  That eye also had some drainage (similar to what you would feel with a bad cold) and itchy.  That afternoon, I had the weird sensation of being able to "feel" the right side of my face. It felt like something was going to happen. It reminded me of how it felt when I had shingles in that area years ago. By the 3rd day, things seem to have resolved themselves.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, nausea, extreme muscle pain, fever, headache
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site bruising, Injection site movement impairment
Clinical narrative: after receiving shot patient ended up in the hospital same night due to not being able to move her right leg. Mom says the immunization left her leg bruised, as well.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chest pain, Diaphragmalgia, Dyspnoea, Fatigue
Clinical narrative: 7/5 woke with mild weakness and sensitivity to touch on left jaw shoulder upper arm and side: disappeared by evening 7/6 1:30 AM woke with tightness to throat. easier to breath sitting up. weakness and mild pain moved down chest to diaphram caused strain and  weakness in  breathing, throat clear, elevated respiration, went to emergency room at Hospital, Doctor seemed unfamiliar with side effects of vaccine sent me home, right side of diaphram slowly cleared 3:00 pm Sunday 7/7  1:00 AM left side of diaphram cleared breathing returned to normal bt a spot weakness ans d pain continued to move  around left side of upper body until about 4:00 AM. All clear by 6:30 AM. tired and sore for several days
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Respiratory rate increased, Tenderness, Throat tightness
Clinical narrative: 7/5 woke with mild weakness and sensitivity to touch on left jaw shoulder upper arm and side: disappeared by evening 7/6 1:30 AM woke with tightness to throat. easier to breath sitting up. weakness and mild pain moved down chest to diaphram caused strain and  weakness in  breathing, throat clear, elevated respiration, went to emergency room at Hospital, Doctor seemed unfamiliar with side effects of vaccine sent me home, right side of diaphram slowly cleared 3:00 pm Sunday 7/7  1:00 AM left side of diaphram cleared breathing returned to normal bt a spot weakness ans d pain continued to move  around left side of upper body until about 4:00 AM. All clear by 6:30 AM. tired and sore for several days
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Patient received Pneumovax 23 into left arm and Shingrix into right arm, around 6:40 pm on 7/18/19.  Patient awoke during the night after (early am 7/19/19 feeling nauseous, but was able to go back to sleep.  Upon awaking in morning 7/19/19 - left arm was swollen, red, and hot to the touch in an area about the size of her hand. Patient states that the arm was very stiff and sore and that she could barely move her left arm. Pt did report stinging on injection at time shot was given, but no other trouble until awoke in the morning.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received Pneumovax 23 into left arm and Shingrix into right arm, around 6:40 pm on 7/18/19.  Patient awoke during the night after (early am 7/19/19 feeling nauseous, but was able to go back to sleep.  Upon awaking in morning 7/19/19 - left arm was swollen, red, and hot to the touch in an area about the size of her hand. Patient states that the arm was very stiff and sore and that she could barely move her left arm. Pt did report stinging on injection at time shot was given, but no other trouble until awoke in the morning.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased, Pain, Suicidal ideation
Clinical narrative: For 2 days after receiving vaccine he stated he couldn't move. He was in bed other than to go to the bathroom with severe body aches. Stated his thinking was foggy "in la la land". After starting to get his strength back, about 4 days later, he felt so terrible that he started having thoughts of suicide. "I could have gotten a gun and shot myself" He stated he even looked at the glass patio door and wondered how hard he would have to hit it to finish himself off. Stated he was eating right, some grains and protein as well as drinking extra fluids.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Contusion, Immunoglobulin therapy, Increased tendency to bruise, Platelet count decreased
Clinical narrative: easy bruising up and down the arm/the patients platelet count was "7,000" and dropped to "2,000"; This spontaneous report was received from a physician via company representative and refers to a 17-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) subcutaneous injection, dose 1, lot # R030806 and expiration date 24-OCT-2020 (formulation, exact dose, route of administration were not reported, site of administration was not confirmed, reported as left or right arm) for prophylaxis.  On 07-JUL-2019, the patient experienced easy bruising up and down the arm (not confirmed if the bruising was on the same arm the injection was administered into). On 07-JUL-2019, she was admitted to the hospital and her platelet count was 7.000 and dropped to 2.000 (units not provided). As treatment she was administered a dose of IVIG (Intravenous Immune Globulin), and a second dose 24 hours later. On 10-JUL-2019, it was noted that patient's platelet count stabilized at 20.000 (units not provided) and she was discharged from the hospital. The outcome of platelet count decreased was reported as recovered/resolved on 10-JUL-2019. No causality assessment was provided by the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope episode that lasted a few seconds; This spontaneous report as received from a physician via a company representative refers to a 21-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In July 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient had a syncope episode that lasted a few seconds. The symptoms remained for about 30 minutes. The patient was then released from a medical care after he was up on his feet. The patient was still alive. The patient did not pass away.  The outcome of the event and the relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.  Upon internal review, the event of syncope was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: acute cerebrovascular accident in the left posterior frontal cortex; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 22-APR-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an acute cerebrovascular accident in the left posterior frontal cortex. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experience mental and emotional distress due to resulting physical limitations, and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The causality assessment between the event and the zoster vaccine live (ZOSTAVAX) was reported as related.  The event of acute cerebrovascular accident in the left posterior frontal cortex was considered to be disabling.  Upon internal review, the event of acute cerebrovascular accident in the left posterior frontal cortex was determined to be medically significant.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number S002503 with expiration date in 23-JUL-2020 (strength, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (C) to 8 C (-3 C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008643: US-009507513-1906USA010325: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA008903: US-009507513-1907USA011954:
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Myalgia, Pain
Clinical narrative: Achy; Muscle aches; Flu like symptoms; Soreness at injection site; felt crummy/ felt like they were coming down with; This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The veterinarian on the line reporting following the Shingrix vaccine the patient had 24-48 hours of feeling achy, had muscle aches, flu-like symptoms, soreness at the injection site, felt crummy and felt like they were coming down with something. Related to Patient. Adverse event filed for contact as well. No further information captured regarding husband. This case linked with US2019AMR125734 and US2019AMR125759, reported by same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Hyperhidrosis, Night sweats, Somnolence
Clinical narrative: fatigue; falling asleep; Condition aggravated; Night sweat; heavy sweating; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified, fatigue and dizziness.   On 8th July 2019, the patient received the 2nd dose of Shingrix. On 9th July 2019, 1 days after receiving Shingrix, the patient experienced fatigue, sleepiness and condition aggravated. In July 2019, the patient experienced heavy sweating and night sweat. On an unknown date, the outcome of the fatigue, heavy sweating, sleepiness, night sweat and condition aggravated were unknown.   It was unknown if the reporter considered the fatigue, heavy sweating, sleepiness, night sweat and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received his second injection of Shingrix Monday morning. The patient felt fine within 3 to 4 hours of the shot but that night and next night experienced heavy sweating during the night. It was so bad he had to change his clothes.  The patient Also experienced heavy fatigue. The patient was falling asleep in a golf cart.  The healthcare provider neglected to inform him of the name of the drug and any side effects when they administered the shot. The reporter knew about the brand name when they called the night nurse at local Kaiser-Permanente.  The reporter asked if it was common practice for healthcare providers to not disclose either the name brand and side effects at injection. Also, these side effects pretty normal (as per GSK website) or are these cause for concern considering he already has a heart condition?  The pharmacist reported that the clinical trials, the most common adverse reactions were pain, redness, and swelling at the injection site. The most common general adverse events were myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms. The reporter asked do you have guidance as to whether the HCP should have advised him of these events ahead of the injection and provide him the name of the drug.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Skin irritation
Clinical narrative: oval shaped irritation area presented on abdomen; two small blistery spots on belly or trunk area; This case was reported by a physician via sales rep and described the occurrence of blister in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date unknown) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix. On 2nd January 2019, immediately after receiving Shingrix, the patient experienced blister. On 6th January 2019, the patient experienced skin irritation. On an unknown date, the outcome of the blister was recovered/resolved and the outcome of the skin irritation was unknown.   It was unknown if the reporter considered the blister and skin irritation to be related to Shingrix.  Additional details were provided as follows: The physician reported that male patient received first dose of Shingrix and shortly afterward developed two small blistery spots on the belly or trunk area. Follow up report received from physician on 12th July 2019: The patient also reported that 2"x3" oval shaped irritation area presented on abdomen. No Blisters were reported. The case has been linked to the case US2019124742, reported by same reporter for same patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Breast pain, Breast swelling, Fatigue, Middle insomnia
Clinical narrative: sharp pain in left breast; swelling of the left breast on the outside; fatigue; joint pain; This case was reported by a consumer via call center representative and described the occurrence of breast pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphangiectasia (below the breasts across upper ribcage).   On 8th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, several hours after receiving Shingrix, the patient experienced breast pain, breast swelling, fatigue and joint pain. On an unknown date, the outcome of the breast pain, breast swelling, fatigue and joint pain were unknown.   It was unknown if the reporter considered the breast pain, breast swelling, fatigue and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccination on her left arm. The patient received Shingrix and awakened in the night by sharp pain in left breast. There was swelling of the left breast on the outside. The patient had experienced fatigue and joint pain also.  The patient asked should she be concerned or would this just go away in a couple of days.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal, Tachycardia
Clinical narrative: Tachycardia; This case was reported by a other health professional via call center representative and described the occurrence of tachycardia in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   The patient's past medical history included atrial fibrillation.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, 1 days after receiving Shingrix, the patient experienced tachycardia. On an unknown date, the outcome of the tachycardia was recovered/resolved.   The reporter considered the tachycardia to be unrelated to Shingrix.  Additional information received were as follows: The medical assistant on the line to reported that the patient received their first Shingrix and went to the urgent care and had an EKG (Electrocardiogram), the next day and was diagnosed with tachycardia with a heart rate that went up to 104 beats per minutes. The patient's heart rate was fast but otherwise he was feeling fine. Exactly when the events started or resolved were unknown. The medical assistant reported that the MD seem to thought that the tachycaardia may not had been due to Shingrix, as patient had a history of atrial fibrillation.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 information received were as follows: This cazse case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced sore arm. The reporter did not consent to follow up. No additional information was provided. This case has been linked with US2019125959, reported by the same reporter.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Instillation site paraesthesia, Muscular weakness, Pain in extremity
Clinical narrative: weak arm; unable to lift arm; sore arm; sensation of the "liquid from the shot moving down inside arm"; This case was reported by a other health professional via call center representative and described the occurrence of instillation site abnormal sensation in a 46-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Havrix adult (intramuscular). On 7th July 2019, 52 days after receiving Havrix adult, the patient experienced pain in arm. On 8th July 2019, the patient experienced weakness of arms and injected limb mobility decreased. In July 2019, the patient experienced instillation site abnormal sensation. On an unknown date, the outcome of the instillation site abnormal sensation, pain in arm, weakness of arms and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the instillation site abnormal sensation, pain in arm, weakness of arms and injected limb mobility decreased to be related to Havrix adult.  Additional details were provided as follows: The patient was the pharmacy technician and reporter. The patient received dose of Havriix adult in right arm. 1 week after vaccination with Havrix adult, the patient experienced instillation site abnormal sensation. The patient reported that, the past sunday, from the date of reporting, she woke up and injection arm was very sore and that on the next day she was unable to lift that arm it was so sore and weak. On the day of reporting, the patient visited to the physician, and would have follow up tests to try and determine the issue. Emergency room visit required. The patient consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: upper left arm pain/Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On 8th June 2019, 1 days 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 batch number and expiry date of Shingrix was not reported. The patient reported that, after vaccination with Shingrix, he had been experiencing intermittent pain while laying down at night in his upper left arm where he got the shot, and the pain was 3 on the pain scale of 1-10. The patient reported that, his arm was sore on the first day, 4 on pain scale of 1-10 and on second day the pain had decreased to 2. The patint stated that, he would not be getting 2nd dose of Shingrix. The patient did not consent to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: left thigh swollen for 2-3 hours
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Polymerase chain reaction, Rash generalised, Varicella virus test positive
Clinical narrative: Patient was given VIS sheet prior to administration of Vaccination,patient reviewed in front of RN but denied any issues with information on VIS. Vaccine was administered due to a negative Varicella titer drawn on 3-11-19. Patient started to break out in a rash to her body 3 weeks after Vaccination also with localized irritation, erythema to site of injection.
Age: 6.0
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I contacted the CDC and was informed of this vaccination of Kinrix,  that Kinrix can only be used on patients who have been / are on time for their vaccines. Anyone who is on a catch up schedule should not be considered for kinrix. I called to see what would be the best way to go about this and their recommendations. They are only approved for the 5th dose of Dtap and the 4th dose of Polio. So the last dose.  This dose will be counted without error per CDC recommendations.  Pt did NOT have a reaction, this was a immunization error with a multidose given and not each individually
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Erythema, Immediate post-injection reaction, Injection site pain
Clinical narrative: It hurt right away. Even the needle unlike the 1st dose. Red, swelling, pain, fever later the same night. Shivering. Stomach pain. Everything hurts. Can?t lay on left side. The 1st needle I wouldn?t even have known I had one. With this one I have every side effect that is listed.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: It hurt right away. Even the needle unlike the 1st dose. Red, swelling, pain, fever later the same night. Shivering. Stomach pain. Everything hurts. Can?t lay on left side. The 1st needle I wouldn?t even have known I had one. With this one I have every side effect that is listed.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Flushing, Hypertension
Clinical narrative: Shortness of breath, chest tightness, flushed face, severe back spasms, and hypertension (178/85) almost immediately after vaccination
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Shortness of breath, chest tightness, flushed face, severe back spasms, and hypertension (178/85) almost immediately after vaccination
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Facial pain, Fatigue
Clinical narrative: 07-16-19 - Left side of face, arm, hand numb and painful within 30 minutes of vaccine (has not cleared up as 07-19-19.)  Fever started 07-16-19, chills, body aches, muscle aches, fatigue (has not cleared up as of 07-19-19.)  07-19-19: Left arm (not where the injection site was) now has multiple red painful patches - was burning in that area the day before.  Left side of stomach area now burning like my arm was, expecting patches to form based on my arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: 07-16-19 - Left side of face, arm, hand numb and painful within 30 minutes of vaccine (has not cleared up as 07-19-19.)  Fever started 07-16-19, chills, body aches, muscle aches, fatigue (has not cleared up as of 07-19-19.)  07-19-19: Left arm (not where the injection site was) now has multiple red painful patches - was burning in that area the day before.  Left side of stomach area now burning like my arm was, expecting patches to form based on my arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Laboratory test normal, Myalgia, Pain
Clinical narrative: worsening diffuse body pain/arthralgia/myalgia about two weeks after vaccine given. had started with this pain post-viral may 2018 did have  worsening of pain had occurred in july 2018 after 1st dose of HPV 9 given on 7/24/2018.
Age: 20.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; On 29-NOV-2013 at age 20 years, patient received the first dose of the HPV vaccination series, GARDASIL Quadrivalent/ the patient received the second dose in the HPV vaccination series on 23-MAY-2019 and it was GARDASIL 9.; On 29-NOV-2013 at age 20 years, patient received the first dose of the HPV vaccination series, GARDASIL Quadrivalent/ the patient received the second dose in the HPV vaccination series on 23-MAY-2019 and it was GARDASIL 9.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 29-NOV-2013, at age of 20 years, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the first dose of the human papillomavirus (HPV) vaccination series) (dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis. On 23-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (the second dose of the HPV vaccination series) (dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: did not return for her subsequent doses of GARDASIL-9 after the initial dose; No adverse effects were reported in the patient; Information has been received from a physician referring to female patient of unknown age. The patient's medical history, drug Reactions/Allergies and concomitant medication were not reported.  On an unknown date, the patient vaccinated with her initial dose HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot#, expiration date, and strength were not reported) for prophylaxis.  At the time of reporting, the physician reported that the patient in the office did not return for her subsequent doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) after the initial dose (Inappropriate schedule of product administration). No adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Herpes zoster, Sialoadenitis
Clinical narrative: Sialadenitis; difficulty swallowing; herpes zoster (shingles); Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 10-NOV-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster (shingles), sialadenitis and difficulty swallowing. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations, and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was reported as related.  The events of herpes zoster (shingles), sialadenitis and difficulty swallowing were considered to be disabling.  Upon internal review, the event of sialadenitis was determined to be medically significant.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; administered a dose of improperly stored varivax; This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown.   On an unknown date in July 2019 (reported as within the last 2 weeks), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength and route of administration were unknown) (lot # R019235 with Expiration date: 04-JUL-2020 or lot # S005084 with Expiration date: 19-FEB-2021) for prophylaxis which was reconstituted with properly stored sterile diluent(STERILE DILUENT) (Lot # N028746, Expiration date: 17-MAR-2020). It was reported that the varicella virus vaccine live (oka/merck)(VARIVAX) was stored at -14 degree celsius to -10 degree celsius (-14.17 celsius) for 30 minutes (product storage error). There was no previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Off label use
Clinical narrative: interferon alfa and recombinant HPV-9 valent vaccine used for treatment of juvenile-onset recurrent respiratory papillomatosis;   This literature marketed report has been received from the authors of a published literature article and refers to a 27-year-old male patient. His concurrent conditions included non-smoking. No information regarding patient's medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient started therapy with interferon alfa-2b (manufacturer unknown) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (for both suspects strength, dose, frequency, route of administration, lot# and expiration date were not provided) both for juvenile-onset recurrent respiratory papillomatosis (considered as off label use).  This is one of the two reports received from the authors of the same published literature article.; Sender's Comments:  US-009507513-1907USA003577:
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Heart rate increased, Pain in extremity
Clinical narrative: increased in blood sugar; Condition aggravated; soreness; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and atrial fibrillation (on pacemaker). Concomitant products included evolocumab (Repatha) and liraglutide (Victoza).   On 5th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, heart rate increased and condition aggravated. On 6th July 2019, the patient experienced blood sugar increased. On 6th July 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the heart rate increased and blood sugar increased were not recovered/not resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the pain in arm, heart rate increased, blood sugar increased and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient had pre-existing diagnosis of type 2 DM-well controlled and diagnosis of atrial fibrillation on pacemaker which was well controlled.  The patient received the 1st dose of the Shingrix vaccine in her right arm. The patient reported right arm soreness which resolved on 6th July 2019. After receiving the Shingrix vaccine, same day, the patient started experiencing increase in heart rate which is still elevated.  The patient stated on her fasting blood sugar was elevated at 135 which increased to 161 the next day and still elevated.  The patient stated base line was usually below a 100.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: appears Shingles rash; appears Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix. On 4th July 2019, 3 days after receiving Shingrix, the patient experienced shingles and rash zosteriform. On an unknown date, the outcome of the shingles and rash zosteriform were unknown.   It was unknown if the reporter considered the shingles and rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix on an unknown arm. The patient appeared as Shingles rash. The reporter wanted to know, how to proceed with the 2nd dose of the Shingrix vaccine. The reporter was unable to provide patient and vaccine details. This case has been linked with case US2019123786, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fat necrosis, Injection site erythema, Injection site indentation, Muscle atrophy
Clinical narrative: muscle atrophy; Fat necrosis; divot at the injection site; erythema; Arm swelling; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 13th February 2019, the patient received the 2nd dose of Shingrix. On 14th February 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and extensive swelling of vaccinated limb. On an unknown date, the patient experienced muscle atrophy, fat necrosis and injection site indentation. On an unknown date, the outcome of the injection site erythema and extensive swelling of vaccinated limb were recovered/resolved and the outcome of the muscle atrophy, fat necrosis and injection site indentation were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, extensive swelling of vaccinated limb, muscle atrophy, fat necrosis and injection site indentation to be related to Shingrix.  Additional details were provided as follows: The patient received her second dose and the next day experienced swelling from her shoulder down to her elbow on the left side that lasted a month. The reporter described it as erythema from shoulder to elbow. These events were resolved. The patient described as fat necrosis or possible muscle atrophy that has produced a divot at the injection site. The reporter had consented to follow up.
Age: 50.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: swelling at injection site; bruising at injection site; itchiness at injection site; swelling at injection site; bruising at injection site; itchiness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In March 2019, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On 5th July 2019, the patient received Boostrix. In July 2019, not applicable after receiving Fluarix Quadrivalent 2018-2019 season and less than a week after receiving Boostrix, the patient experienced injection site swelling, injection site bruising and injection site itching. On an unknown date, the patient experienced injection site swelling, injection site bruising and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site bruising and injection site itching were recovered/resolved and the outcome of the injection site swelling, injection site bruising and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site bruising and injection site itching to be related to Fluarix Quadrivalent 2018-2019 season. It was unknown if the reporter considered the injection site swelling, injection site bruising and injection site itching to be related to Boostrix.   Additional details were provided as follows: The case was reported by patient who was a psychologist  The patient received Fluarix dose and experienced swelling, bruising and itchiness at the injection site that lasted for about 2 weeks and resolved. The patient reported that she had a tetanus booster shot on 5th July 2019 (unsure of the brand name) and less than a week after vaccination, she experienced the same reactions which had not yet resolved. As per narrative brand name of tetanus booster dose was unknown but in the source document boostrix was reported, hence captured as per source document.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Myalgia, Pain
Clinical narrative: Muscle aches; Flu like symptoms/felt like they were coming down with; Soreness at injection site; felt crummy; Achy; This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on unknown date, refer case US2019124837).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The veterinarian on the line reporting following the Shingrix vaccine the patient had 24-48 hours of feeling achy, had muscle aches, flu-like symptoms, soreness at the injection site, felt crummy and felt like they were coming down with something. Related to Patient. Adverse event filed for contact as well. No further information captured regarding husband. This case linked with US2019AMR125734 and US2019124837, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic benefit; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she had a friend who described that her mother experienced a reduction in post herpetic neuralgia from a shingles outbreak after receiving the Shingrix vaccine, which led to unexpected therapeutic effect. The reporter was unable to provide any additional information. This was one of the 4 cases, reported by the same reporter. This case has been linked with cases US2019125910, US2019125912, US2019125907, reported by the same reporter.