chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient received the PNEUMOVAX 23 vaccine on 11/6/18 from me. On 11/7/18 she started having localized allergic reaction symptoms. She has experienced itching, a red, swollen area with heat at the injection site as big as the palm of her hand plus her fingers, and red blotches going down the upper half of her arm. These symptoms starting clearing up a little on their own on 11/9/18 and she saw Dr. on 11/9/18. He prescribed a MEDROL DOSE pack and triamcinolone and she is to start treatment on 11/9/18. She is not upset and is very understanding. I apologized to her and asked if she can come in to show me the site so I can make sure she is improving. Due to weather she is coming to the pharmacy for me to see the site on 11/12/18.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: The patient received the PNEUMOVAX 23 vaccine on 11/6/18 from me. On 11/7/18 she started having localized allergic reaction symptoms. She has experienced itching, a red, swollen area with heat at the injection site as big as the palm of her hand plus her fingers, and red blotches going down the upper half of her arm. These symptoms starting clearing up a little on their own on 11/9/18 and she saw Dr. on 11/9/18. He prescribed a MEDROL DOSE pack and triamcinolone and she is to start treatment on 11/9/18. She is not upset and is very understanding. I apologized to her and asked if she can come in to show me the site so I can make sure she is improving. Due to weather she is coming to the pharmacy for me to see the site on 11/12/18.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Local reaction, Rash macular
Clinical narrative: The patient received the PNEUMOVAX 23 vaccine on 11/6/18 from me. On 11/7/18 she started having localized allergic reaction symptoms. She has experienced itching, a red, swollen area with heat at the injection site as big as the palm of her hand plus her fingers, and red blotches going down the upper half of her arm. These symptoms starting clearing up a little on their own on 11/9/18 and she saw Dr. on 11/9/18. He prescribed a MEDROL DOSE pack and triamcinolone and she is to start treatment on 11/9/18. She is not upset and is very understanding. I apologized to her and asked if she can come in to show me the site so I can make sure she is improving. Due to weather she is coming to the pharmacy for me to see the site on 11/12/18.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Bloody discharge, Haemoptysis, Otorrhoea, Sputum discoloured
Clinical narrative: Patient came into the pharmacy on 11/8/18 at 9:08am and stated that after she go the flu shot she has been coughing up blood and in her left ear there was blood in it. She stated that the phlegm is green to dark red in color. I advised the patient to go to urgent care to get it checked and she agreed. Pt states she is feeling otherwise fine.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphonia, Glassy eyes, Malaise, Ocular hyperaemia, Pyrexia
Clinical narrative: He came home and soon after had a high fever. He fell asleep and it was becoming troubling how hard I had to work to wake him up and keep him awake. Once he started to come to he opened his eyes and had glossy red eyes and just looked sick from his body reacting to this shot. He had a deep raspy voice since then as well. I'm curious about the reason my son received a flu shot administered by a volunteer. 1. Without having a signed consent, 2. Without checking his file to see if he had a medical or religious exception, 3. They were using a different child's medical paperwork from a different class. 4. The principal said oh sorry normally I do them all but this year we had a volunteer do them. We will have to change it next year. 5. The majority of the human rights start with medical and I don't know what can be done but we were also charged the fee for it. I am not okay with this in anyway. My thinking is not so much a legality issue, but I have extensive experience and knowledge of the medical world. Patient's rights, laws regarding administration of a vaccine or medication. If you understand what I am so upset about it is just the tip of the iceberg. If my lifestyle is based on religious freedom, or my life choices as a medical provider they put in my son, based on a whole other child's contradictions I have to make sure it does not happen to anyone else. I hope the people who are responsible understand the possibilities for a department investigation into this carelessness of assault physically, spiritually and emotionally. I have to go to the public and we have to demand results from the school district because I entrusted the school to my son's safety and well-being. They violated that then weren't even capable of producing much more than an oops sorry wrong boy. No accountability whatsoever to the thinking and actions that put a volunteer in charge of my son's life and physical health. If we form a more functional use for the flu shot vaccine, I'd consider the use of it. The uncertainty of the first batches made that season for a specific area is primarily a guessing game. I am so sicken by this assault of my poor 6 year old. Assault not only on his little tiny physical body, but worse the mental effect it's creating. I haven't seen him in this zombie like state before. The unknown measure of changes and possible damages to his natural biological and neurological functionality.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: He came home and soon after had a high fever. He fell asleep and it was becoming troubling how hard I had to work to wake him up and keep him awake. Once he started to come to he opened his eyes and had glossy red eyes and just looked sick from his body reacting to this shot. He had a deep raspy voice since then as well. I'm curious about the reason my son received a flu shot administered by a volunteer. 1. Without having a signed consent, 2. Without checking his file to see if he had a medical or religious exception, 3. They were using a different child's medical paperwork from a different class. 4. The principal said oh sorry normally I do them all but this year we had a volunteer do them. We will have to change it next year. 5. The majority of the human rights start with medical and I don't know what can be done but we were also charged the fee for it. I am not okay with this in anyway. My thinking is not so much a legality issue, but I have extensive experience and knowledge of the medical world. Patient's rights, laws regarding administration of a vaccine or medication. If you understand what I am so upset about it is just the tip of the iceberg. If my lifestyle is based on religious freedom, or my life choices as a medical provider they put in my son, based on a whole other child's contradictions I have to make sure it does not happen to anyone else. I hope the people who are responsible understand the possibilities for a department investigation into this carelessness of assault physically, spiritually and emotionally. I have to go to the public and we have to demand results from the school district because I entrusted the school to my son's safety and well-being. They violated that then weren't even capable of producing much more than an oops sorry wrong boy. No accountability whatsoever to the thinking and actions that put a volunteer in charge of my son's life and physical health. If we form a more functional use for the flu shot vaccine, I'd consider the use of it. The uncertainty of the first batches made that season for a specific area is primarily a guessing game. I am so sicken by this assault of my poor 6 year old. Assault not only on his little tiny physical body, but worse the mental effect it's creating. I haven't seen him in this zombie like state before. The unknown measure of changes and possible damages to his natural biological and neurological functionality.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pyrexia, Tremor
Clinical narrative: Fever, shaking, joint pain, fatigue.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Fatigue, Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: ARMS ACHE, BILATERAL HAND SWELLING, BLISTERING ON HANDS, FATIGUE.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Aphonia, Diarrhoea
Clinical narrative: Pt lost her voice and developed diarrhea, which lasted 24 hours.
Sex: M
Vaccine: PPV
Symptoms: Exposure via skin contact, No adverse event, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a pharmacist, who is also a male patient of unknown age who reports on himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-OCT-2018, the pharmacist had accidental exposure of PNEUMOVAX 23 lot# R007721 with expiration date on 01-MAR-2020, to his face and his mouth, while he was drawing up PNEUMOVAX 23 from vial. No adverse effect was reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a consumer of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was not certain which vaccine received and reported that received three doses of PNEUMOVAX 23 for prophylaxis, or PREVNAR 13 (strength, dose, frequency, route, lot number and expiration date were not reported). The patient did not experience any reaction.
Sex: M
Vaccine: PPV, TDAP, TYP
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from an unspecified source via a company representative and refers to a 18 year old male patient. The patient did not have any concurrent conditions, relevant medical history or drug reactions or allergies. Concomitant therapies included BOOSTRIX and an unspecified typhoid vaccine. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose, frequency, lot number and expiration date were not reported) for vaccination for mission. On an unknown date, the patient experienced cellulitis and, due to that, he was hospitalized. It was reported that the patient sought medical attention and an unspecified treatment was received for his cellulitis, however, no laboratory diagnostic studies were performed. It was also reported that no discharge date from the hospital was reported. At the reporting time, the patient had not recovered from cellulitis. The reporter did not provide a causal relationship between the event cellulitis and PNEUMOVAX 23. Upon internal review, the event cellulitis was considered to be medically significant.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-OCT-2018, the patient was inadvertently vaccinated with GARDASIL 9 for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 24-OCT-2014, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about November 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine maintenance and for the prevention of shingles. After receiving ZOSTAVAX the patient began to experience severe pain in her right eye and headaches. Shortly thereafter; she broke out in a rash on her forehead, right side of her head, right eye, and down her neck. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from herpes zoster and followed up with a specialist regarding issues with her right eye. Upon internal review ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 10 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002372:Original Case : 1811USA002232 US-009507513-1811USA002374:Original Case : 1811USA002232 US-009507513-1811USA002375:Original Case : 1811USA002232 US-009507513-1811USA002371:Original Case : 1811USA002232 US-009507513-1811USA002373:Original Case : 1811USA002232.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 17 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 4 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002375:Original Case : 1811USA002232 US-009507513-1811USA002373:Original Case : 1811USA002232 US-009507513-1811USA002374:Original Case : 1811USA002232 US-009507513-1811USA002371:Original Case : 1811USA002232 US-009507513-1811USA002232:Original Case : 1811USA002232.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 14 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002375: Original Case: 1811USA002232; US-009507513-1811USA002232: Original Case: 1811USA002232; US-009507513-1811USA002374: Original Case: 1811USA002232; US-009507513-1811USA002371: Original Case: 1811USA002232; US-009507513-1811USA002372: Original Case: 1811USA002232.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 8 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002375:Original Case : 1811USA002232 US-009507513-1811USA002373:Original Case : 1811USA002232 US-009507513-1811USA002232:Original Case : 1811USA002232 US-009507513-1811USA002371:Original Case : 1811USA002232 US-009507513-1811USA002372:Original Case : 1811USA002232.
Sex: F
Vaccine: FLU4
Symptoms: Bursa injury, Hypoaesthesia, Injected limb mobility decreased, Paraesthesia, Product administered at inappropriate site
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 26-Oct-2018, concerns a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: YF39107, expiry date: 30-Jun-2019, route of administration and anatomical location: not reported). The reporter believed that it had hit the bursa (coded as vaccine administered at inappropriate site and bursa injury). On the same day after vaccination, the patient was not able to lift her arm past the shoulder and experienced numbness and tingling in extremities. On an unspecified date the patient went to the doctor and got steroids which was helping her. At the time of this report the patient was recovering from the event. The reporter assessed the case as non-serious. This case was crossed linked with case number: 201804876 due to same reporter.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local site reaction to DTaP on the upper left thigh. the area is circular and red. There is minimal warmth. Local site reaction to DTaP on the upper left thigh. The area is circular and red. There is minimal warmth.
Age: 7.0
Sex: F
Vaccine: DT, IPV
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Td was not supposed to be given. Was given in error. Patient complained of leg soreness for a day and then it went away.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt's 12mo immunizations were not loaded in the state immunization registry which resulted in pt receiving her 12 mo immunizations on 11/08/2018. She received a 2nd set of her 12 mo immunizations(Hep A, MMR, Varicella). Mother was notified as well as employee with the State. ****Child did not have an adverse reaction to any of the immunizations given.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Muscle spasms, Seizure
Clinical narrative: That night, eyes turned in, seizures, muscle spasms that lasted for 5 days. When they called the hospital, they told not to bring the baby in unless there was a high fever. Took baby to the doctor on Monday, showed her the videos; she did not think anything was wrong. Checked with his colleagues, told her that is was normal. Took patient to doctor 2 months later and was referred to eye surgeon.  Surgeon wanted to have surgery immediately but parents refused. Patient stills sees eye doctor until today. After 6 months, parents left the practice and went to new doctor. So far, parents have only received a referral to eye doctor, but no testing or prescribed medication. Parent has plenty of photos and videos about spasms and seizures to share as needed. Last doctor visit was on October 4th.    Received 18 month vaccines on 1/23/18.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Aggression, Aphasia, Autism spectrum disorder, Eye disorder, Loss of personal independence in daily activities
Clinical narrative: Pt was sent to health department for vaccines. After the vaccine stopped talking, feeding himself, recurrent temper tantrums, not responding. On his 2 year checkup he was diagnosed with severe autism. Went to run an ADOS test today and send doctor also wants to ran a brain scan. Still has recurring appointments with eye doctor; eye still wanders and goes in and out.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt was sent to health department for vaccines. After the vaccine stopped talking, feeding himself, recurrent temper tantrums, not responding. On his 2 year checkup he was diagnosed with severe autism. Went to run an ADOS test today and send doctor also wants to ran a brain scan. Still has recurring appointments with eye doctor; eye still wanders and goes in and out.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Impaired work ability, Injection site erythema
Clinical narrative: With 1st and 2nd dose had all listed side effects. Intense enough to miss 1 day of work. Dizziness, light headedness, temperature 100.7 F, chills, body aches, pain, tenderness, redness at injection site. Lasts 3 days. Submitted for your statistics.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: With 1st and 2nd dose had all listed side effects. Intense enough to miss 1 day of work. Dizziness, light headedness, temperature 100.7 F, chills, body aches, pain, tenderness, redness at injection site. Lasts 3 days. Submitted for your statistics.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient called and stated he had a throbbing pain in the arm where the vaccine was administered.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was outdated. No adverse reactions have been noted or reported.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Two days after injection, 11/2/18, woke up with a mild, itchy rash starting on her hands and feet. By late morning rash encompassed her lower extremities to her buttocks and across her hands with diffuse scattering onto the forearms. At the time of exam, 11/5/18 the rash had not spread and seemed to be improving. Treated with Benadryl at bedtime and Claritin during the day with no topicals. Continue conservative care and consider topical if unchanged. Follow up with provider on 11/9/18.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Within 4 minutes of injection, patient's left side of neck became red, itchy, and began spreading down onto the chest.
Age: 39.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Hypophagia, Injected limb mobility decreased
Clinical narrative: Pt returned to clinic (11/08/18) 2 days after receiving vaccines. Pt has been having severe arm pain within 6 hr after PNEUMOVAX and flu shot. Pain is unbearable, per the pt. She can't raise her arm (left). She has fever 100.5. Feeling body aches and severe HA. She has nausea and can barely eat. She is keeping liquids down. She is having chills and sweating. No notable sick contacts. No muscle weakness, paralysis, tingling. Discussed complications of vaccine reactions. Treatment: ICE for 20 min Q2-3 hrs while awake Elevation of extremity Ibuprofen 400-600 mg Q6hrs PRN pain or swelling Prednisone 40 mg given in office. Continue 40 mg Daily for 1 more day, then 20 mg daily for 3 days. Zyrtec 10 mg daily Zantac 150 mg BID Outcome: Pt feels slightly better today (11/09/18). Discussed her progress by phone.
Age: 39.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt returned to clinic (11/08/18) 2 days after receiving vaccines. Pt has been having severe arm pain within 6 hr after PNEUMOVAX and flu shot. Pain is unbearable, per the pt. She can't raise her arm (left). She has fever 100.5. Feeling body aches and severe HA. She has nausea and can barely eat. She is keeping liquids down. She is having chills and sweating. No notable sick contacts. No muscle weakness, paralysis, tingling. Discussed complications of vaccine reactions. Treatment: ICE for 20 min Q2-3 hrs while awake Elevation of extremity Ibuprofen 400-600 mg Q6hrs PRN pain or swelling Prednisone 40 mg given in office. Continue 40 mg Daily for 1 more day, then 20 mg daily for 3 days. Zyrtec 10 mg daily Zantac 150 mg BID Outcome: Pt feels slightly better today (11/09/18). Discussed her progress by phone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Gave the injection on 11/5/18, rash started on the 6 and 7. Red patch rash about 3 inch by 2 inches with small watery looking bumps at injection site. Patient said the fluid inside the bump did not bust. Just a little itchy. She felt like a flu-like symptoms for 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Nausea, Pain, Vomiting
Clinical narrative: Nausea, vomiting, abdominal pain, headache, body aches, Headache started within 2 hours of receiving vaccine. Nausea, vomiting, abdominal pain, body aches and headache the day after. Given ZOFRAN. Today 11/9/2018 is starting to feel better.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Toe walking
Clinical narrative: Mom noticed a little swelling about 2 hours after the vaccine. The swelling noted to be significantly increased yesterday. Swelling from groin to just below knee cap. No redness, No c/o pain. Pt walking on his toes, left leg only, yesterday which he never does.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pain, Pain in jaw
Clinical narrative: I had significant pain in my left jaw joint, especially when I opened and closed my mouth. The intense pain came in waves like it was spasming. The pain was a 6.5 out of 10. Ibuprofen didn't stop the pain. It lasted for about 10 hours and affected my sleep. By the morning, it had resolved after taking one 350 mg Vicoden. I was not informed which type of Tdap booster vaccine that I was given. I have received tetanus booster shots every ten years for my entire life, and I have never had a reaction like this one. I couldn't find any information on the internet about an adverse side effect to the Tdap that includes a side effect that affects the jaw like lockjaw, so I thought I should report it.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: REDNESS AND SWELLING UNDER THE RIGHT ARM. ABOUT A DOLLARBILL SIZE RAISED AREA. PT PURCHASED BENADRYL ON 11/09/18. PT STATED THAT THE REDNESS HAD GONE DOWN SINCE 11/07/18.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Swelling
Clinical narrative: Per patient she had swelling with the PNEUMOVAX 23 that resolved in 4 days.
Age: 23.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 23-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in April 2018, the patient was vaccinated with PROQUAD for prophylaxis (dose, frequency, lot #, and expiration date were not reported). The patient was inadvertently vaccinated as her titers for measles, mumps, rubella and varicella were all negative. Adverse effects were not reported. Outcome of event was not reported.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Unable to get up to the bathroom D/T the shaking.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Swelling, Vomiting
Clinical narrative: Per chart review: JUN 07, 2017 at 14:15 'Verbal contact via telephone with client. Patient calling to report swelling and emesis x1 past PREVNAR 13 injection. Does not c/o tongue swelling, et difficulty breathing. Patient states that there is no redness or warmth to injection site.' Nausea vomiting.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Skin warm
Clinical narrative: Swelling, redness, hot to touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Soreness, after midnight the fever and shivering started. Pain more at the site and some nausea.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Lip swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: Swelling of eyelids, lips and tongue, dizziness, chills.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Significant swelling and erythema of arm from acromion process to below biceps; radiating pain down back and chest.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash erythematous, Rash papular
Clinical narrative: 12.5 x 9.6 cm area of erythema, warmth and mild swelling. Erythematous papular rash noted on the outer edges.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: 22yr old female with history of splenectomy (2012) post MVA presented to PCP for annual visit on 11/6. Patient was uncertain if PNEUMOVAX vaccine had been previously administered. MD ordered for Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23), Tuberculin PPD Test (Order 398485110), and Flu vaccine, age 6 mo, 0.5 mL dose, preservative free, IM (QUADRIVALENT). RMA prepared and administered the following: influenza vaccine (Lot # TM9Z5) IM to patient's right deltoid, tuberculin PPD 0.1mL intradermally to patient's left arm (LOT # C5474BA) and PNEUMOVAX vaccine (LOT # R018731) IM to patient's left deltoid. On 11/8, patient contacted office and complained that arm receiving PNEUMOVAX vaccine was "tender to touch with red raised areas noted/warmth near injection site. Pt has been taking tylenol for pain."  Patient seen MD 11/9 for follow up. MD noted "Erythematous, blotchy 2 x 3 cm area of erythema noted on right upper extremity proximal to injection site. Irregular borders". Patient denied fever, chills, drainage or burning. MD concerned for cellulitis who prescribed cephalexin 500mg PO Q6H. PPD read (negative) as well. Patient instructed to continue to take Tylenol or motrin as needed.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tuberculin test negative
Clinical narrative: 22yr old female with history of splenectomy (2012) post MVA presented to PCP for annual visit on 11/6. Patient was uncertain if PNEUMOVAX vaccine had been previously administered. MD ordered for Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23), Tuberculin PPD Test (Order 398485110), and Flu vaccine, age 6 mo, 0.5 mL dose, preservative free, IM (QUADRIVALENT). RMA prepared and administered the following: influenza vaccine (Lot # TM9Z5) IM to patient's right deltoid, tuberculin PPD 0.1mL intradermally to patient's left arm (LOT # C5474BA) and PNEUMOVAX vaccine (LOT # R018731) IM to patient's left deltoid. On 11/8, patient contacted office and complained that arm receiving PNEUMOVAX vaccine was "tender to touch with red raised areas noted/warmth near injection site. Pt has been taking tylenol for pain."  Patient seen MD 11/9 for follow up. MD noted "Erythematous, blotchy 2 x 3 cm area of erythema noted on right upper extremity proximal to injection site. Irregular borders". Patient denied fever, chills, drainage or burning. MD concerned for cellulitis who prescribed cephalexin 500mg PO Q6H. PPD read (negative) as well. Patient instructed to continue to take Tylenol or motrin as needed.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia
Clinical narrative: Severe chills lasting 6-8 hrs. Severe headache lasting 6 hrs- insomnia.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 24 hours after immunization, patient experienced chills, aches, and a fever. He is still symptomatic 2 days later. Has been alternating ibuprofen and Tylenol with minimal relief. Wife wanted this reported to VAERS even though it was explained that this was likely not caused by the shot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Disorientation, Nausea, Pain
Clinical narrative: Fever, chills, nausea, aches, disorientation, loss of balance. Began the night of the 6th of November; continues on the 9th.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, aches, disorientation, loss of balance. Began the night of the 6th of November; continues on the 9th.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Product quality issue
Clinical narrative: I have cellulitis The emergency room doctor said It was due to the medication at that injection site. I am now on antibiotic's for the next seven days also they gave me a shot in the ER of the antibiotic.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Syncope
Clinical narrative: Patient instructed to stay seated on exam table after HPV #1 as routine. About 5 minutes later she had very brief few seconds of syncope/near syncope. Was placed supine w/legs raised and elevated. Almost immediately she was completely alert and oriented. VS wnl. No head or any other injury sustained. Patient monitored after episode and did well.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient states, "I got my flu shot on 10/26/2018 and 5 days later developed chills, headache and a fever as high as 100.4. It lasted 3-4 days. I saw my doctor who put me on Tamiflu for 3 days."  Denies current symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness & swelling at injection site, very sore arm, headache and chills during the first night and following day, some slight body aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Redness & swelling at injection site, very sore arm, headache and chills during the first night and following day, some slight body aches.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Per Dr on 11/08/2018, Mom calls reporting fever rectally 103.1 after 6 mo shots (not given at clinic as he was post-circ). No rash and not acting unwell. No URI sx. "didn't do well with last shots", low grade fever and fussy at 4 mo. TYLENOL and ibuprofen now recommended, then alternating every 4 for TYLENOL and 6 for ibuprofen.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, White blood cell count normal
Clinical narrative: Right upper arm swollen, painful, erythematous.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: High fever, vomiting, fatigue, difficulty breathing due to worsening congestion.
Age: 48.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, TDAP, TYP
Symptoms: Feeling hot, Flushing, Rash generalised, Rash papular
Clinical narrative: 11/7/18 Returns for #2 TWINRIX. Reports that mid morning on 10/29/18 during a meeting at work, began to feel flushed and a rash appeared starting at chest and moved up, but was most prevalent in chest area. The rash then proceeded to move all over her body. States rash was even into the genital area and did also cover legs and arms. Felt feverish but did not take temperature but definitely felt warm for a day or two. Was very itching and describes as red raised rash. Symptoms lasted for four days and then recovered fully.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: 8 cm circular well-circumscribed area of mild edema and erythema around the influenza vaccination site. It is not tender. He moves his shoulder well but has some mildly increased discomfort with movement. There is no streaking anywhere. There is no fluctuance. He has full sensation throughout the left upper extremity. Differential diagnosis includes moderate local reaction to influenza vaccine versus cellulitis. He likely had a similar toxic local reaction last year that was more severe than his current. Should the pain increase or he develop any fevers or of any questions or concerns that this may be more of an infectious scenario that he should return for reevaluation. For now, recommended symptomatic management with ice and rest and observation.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site infection
Clinical narrative: Patient developed a skin infection at site of administration.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: No adverse event, Product preparation issue, Wrong product administered
Clinical narrative: Patient was given incorrect vaccine. She was due for PEDIARIX and was given KINRIX instead. KINRIX is a vaccine intended for 4 - 6 years olds. There were no adverse effects just wrong dosing given. Pt was also due for ROTARIX, which is a 2 part vaccine given orally. You should mix the diluent with the powder in the vial. So the child only got the diluent. That makes this baby behind on her Rota immunizations.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nasopharyngitis, Pain, Pyrexia, Rash
Clinical narrative: FULL TRUNK RASH STARTED WITHIN HOURS. ACHES, FEVER CHILLS WITHIN 6-8 HOURS. UPPER RESPIRATORY SYMPTOMS (SEVERE COLD) WITH 24HRS.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Respiratory symptom
Clinical narrative: FULL TRUNK RASH STARTED WITHIN HOURS. ACHES, FEVER CHILLS WITHIN 6-8 HOURS. UPPER RESPIRATORY SYMPTOMS (SEVERE COLD) WITH 24HRS.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia, Upper respiratory tract infection
Clinical narrative: FULL TRUNK RASH STARTED WITHIN HOURS. ACHES, FEVER CHILLS WITHIN 6-8 HOURS. UPPER RESPIRATORY SYMPTOMS (SEVERE COLD) WITH 24HRS.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Viral rash
Clinical narrative: FULL TRUNK RASH STARTED WITHIN HOURS. ACHES, FEVER CHILLS WITHIN 6-8 HOURS. UPPER RESPIRATORY SYMPTOMS (SEVERE COLD) WITH 24HRS.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Death, Eye injury, Scleral disorder
Clinical narrative: I've noticed, she was not acting like her normal self when I took her to the doctor four days before she passed. I explained to the doctor about these mysterious spots that had shown up on the white part of the eye. The doctor diagnosed it as a eye injury, gave me antibiotics and sent us home. She died four days later. I feel the spots could have been her brain hemorrhaging.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 11-OCT-2018, the patient was vaccinated with one dose of M-M-R II not valid lot number reported as N026829, expiration date 27-SEP-2019 (route of administration was not reported). In the same office visit, the patient was vaccinated with PROQUAD lot number R007682, expiration date 11-SEP-2019 (route of administration was not reported) (overdose, inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 18-year-old female patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in 2012 (when the patient was 12 years old), she was vaccinated with first dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 12-OCT-2018, the patient wanted to know if she could complete the series with GARDASIL 9. No adverse symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Mumps, Mumps antibody test negative, Vaccination failure
Clinical narrative: This literature marketed report as received from authors of the literature article refers to 4 children of unknown gender (exact age was not provided). It was assumed, that the patients were immunologically naive to mumps antigens, and that the children did not have circulating maternal IgG antibodies. In relation to first dose of M-M-R II, sera used to analysis were collected from these children at four visits resulting in the following overlapping time frames: 0.5 to 6 months, 3 to 8 months, 5 to 10 months, 1.7 to 2.7 years, and 4.0 to 5.3 years post-vaccination. On unknown dates (when the patients were at age 14 to 18 months), the patients were vaccinated with the first dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided). The second dose of the vaccine was given 5 to 6 months later. On unknown dates, serum analysis revealed low avidity results after the second dose of M-M-R II. The authors stated, that it was unlikely that these 4 low-avidity results were due to mumps virus infections in individuals with two-dose primary vaccine failure, due to the low mumps virus circulation at the time. The outcome of vaccination failure and low-avidity results after vaccination was not provided. The authors considered the events to be related to M-M-R II.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Vaccine given high on upper arm. The following day, felt worsening deep arm pain exacerbated by attempts to lift arm laterally away from body. Was in hospital that night (11/4/18) for IV antibiotics due to cellulitis after cat bite/scratches of opposite (left) arm and received IV pain medication for that. The following 2 nights woken due to pain in right arm. Currently, avoiding movements that might cause pain and preferentially using my left arm/hand.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Skin warm
Clinical narrative: Right arm joints swollen and painful from shoulder to hand, hot to touch and unable to raise right arm above head.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site discomfort, Nausea, Pyrexia
Clinical narrative: Fever of 103-104 degrees, nausea, HA, chills, and slight soreness at injection site.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Chromaturia, Limb discomfort
Clinical narrative: Pt received FLUZONE HD and PNEUMOVAX on 10/23/18. His arms were both very sore that evening, lasting for 2.5 days. On Thursday he started to see urine was getting dark yellow. On Friday morning, urine was very pink/red. Then, every urination after that was light red/pink. The color of the urine returned to normal on Friday evening. Friday afternoon, went to see his wife's doctor, no bloodwork done. No abdominal pain. Pt had bloodwork done on 10/29/18, lab tests did not show any abnormalities. Since then, pt has also had a ultrasound and CT scan to check for stones, tests did not find any abnormalities. Pt is scheduled for a cystoscope exam. This is patient's first time receiving FLUZONE HD and PNEUMOVAX. Also his first time receiving 2 shots at the same visit.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Conjunctival hyperaemia, Rhinorrhoea, Swelling of eyelid
Clinical narrative: Puffy eyelids, particularly the right eyelid, without erythema to the eyelid, injected conjunctivae (right more than left), runny nose.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Eye movement disorder
Clinical narrative: At 18 month Well visit mother recalled that 2-3 days after varicella vaccine extreme eye deviation occured - worse than typical. Self resolved. Mother reported that his ophthamologist "did not know " if the vaccine caused this.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Report of pain, swelling, redness persistent 2 days after injections in left arm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Loss of consciousness, Pyrexia
Clinical narrative: Patient states felt reaction at site the evening of immunization, about 7 hours after getting vaccine stated she had a low fever. Morning after immunization patient states she passed out at home while in her kitchen.