chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Client had Flu imm. on 10/5/18 with subsequent cont. achy/sharp (L) shoulder pain, currently rated 5/10 with movement of shoulder and with sleeping. Denies N/T/LOP but did have upper arm pain. Rx with ice without relief. Client is (R) handed. Pain with Abduction and arm crossing over chest. No prior shoulder inj. DO.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pain in jaw
Clinical narrative: Developed swelling, redness of right deltoid area. Appears to have surrounding bruising. Denies any arthralgia or decreased ROM. Complaints of right sided jaw ache. No noted lymph node swelling.  Patient used ice to the area and will utilize Ibuprofen and continue with as needed Claritin.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Injection site swelling, Respiration abnormal, Vaccination complication
Clinical narrative: Patient brother came in on 10/17/18 and stated that patient had a bad reaction to flu shot and patient went to ER for swollen left arm that has spread to her left side. Patient brother stated that MD stated that area is clogged and infected, and if it burst to bring patient back to ER. Patient brother stated that it is affecting her breathing, and MD wrote an Rx for doxycycline, MEDROL DOSE PACK, and albuterol HFA inhaler.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pain in extremity
Clinical narrative: Patient presented to pharmacy at 10:42 am on 10/18/2018 with a slight malaise, and a sore left arm with a warm, raised red area in the upper arm region. No other side effects to the vaccine were reported. I recommended icing the affected area and taking ibuprofen/acetaminophen for the pain/inflammation.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Client states that her left upper arm swelled and was painful for one day. She reports this is how she always reacts to flu vaccine. She used cold compresses and took advil.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Malaise, Pyrexia, Vomiting
Clinical narrative: Patient began to feel feverish the day following vaccination and experienced vomiting and chills, general unwell feeling for 2-3 days following dose.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Middle insomnia, Myalgia, Pain in extremity, Restless legs syndrome
Clinical narrative: My 14 yr old daughter and I went to get our flu shots at our local pharmacy last Friday, 10/12/2018. That night I slept fine till about 2 am or so and woke with what I call RLS, Restless legs. I could not get back to sleep for a hour or so and was very restless. I am in good shape with no health issues and workout regularly. The day after the Vaccine my entire legs were sore, not the joints, but the muscles. It was I had done a all event of leg exercises and dehydrated and cramped my calf muscles. My calfs hurt the worst all day, but the quads also were sore. I stayed busy all day, but the muscles were still sore all that day. My Daughter who is 14 and in perfect health woke Sunday, 10/14/2018 and told me her legs were killing her. I asked is it the muscles and she said it was. I had not said anything about my pains the day before after getting the vaccine and did not mention it to her. She kept complaining about her leg muscles most Sunday being very sore. Myself on Sunday had only mild pains left. Neither of us went to a doctor for treatment and by Monday I was pretty much over it.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Difficulty moving arm, muscle pain in entire body, headache, fatigue, fever > 102 F, nausea, dizziness.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Difficulty moving arm, muscle pain in entire body, headache, fatigue, fever > 102 F, nausea, dizziness.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Malaise
Clinical narrative: Patient came over and said she didn't feel well. Said she was feeling warm and light headed. Had her sit and observed and spoke to her asking questions about her symptoms. She started to feel well. Kept observing in store over 20 min. She felt better by that time.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Pyrexia, Rash, Streptococcus test negative, Urine analysis normal
Clinical narrative: Day after shot developed high fever (Tmax 104.3F), vomited once, develop rash next day. Fever lasted 3-4 days.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Day after shot developed high fever (Tmax 104.3F), vomited once, develop rash next day. Fever lasted 3-4 days.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pericarditis
Clinical narrative: Patient stated that she went to the Emergency Room the next day and had pericarditis.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Heart rate irregular, Throat irritation
Clinical narrative: Pt felt that he had an irregular heartbeat which led to a bit of anxiety. He felt that he was having a tickle in his throat. After taking an alprazolam, pt was feeling better and did not need to call 911 or go to ER.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Cranial nerve palsies multiple, Laboratory test, Visual impairment
Clinical narrative: 3rd, 4th,5th and 6th Cranial nerve palsies. 98% Resolved overtime 3 years later still have residual visual disturbances.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I can't provide the detail on the vaccine (above) administered except it was the one for seniors. Patient 74 year old Male. After my normal visit with my Primary Care Doctor. On Monday morning October 15th? I had both blood work done and this years Senior -Inactivated Influenza Vaccine administered by nurse. Within two days I have now come down with both a sore throat which has morphed into a full blown cold (my assumption) with associated symptoms. I am reporting this because of the paper work given to be by my provider (VACCINE INFORMATION STATEMENT) regarding the shot administered. I fully understand it may have nothing to do with the vaccine but thought I would report it to you. Thank you, Sent to both Doctor and to (VAERS).
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dyspnoea, Erythema, Injection site erythema
Clinical narrative: Redness at injection site, down left arm, left axilla and partial chest wall. Pt. stated redness improving. Pt reported slight shortness of breath.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Patient called at 11:00AM 10-18-18 and asked to speak to a pharmacist regarding the pain in her left arm that has occurred since the administration of her flu shot on 10-7-2018. The patient states that her arm is extremely sore and painful to the point of causing restricted mobility and loss of sleep. Stated she thinks pharmacist may have hit a nerve when administering the vaccination. Patient had tried TYLENOL and ibuprofen OTC with no effect. Patient was advised to contact and discuss situation wit her personal physician and informed that a report would be file describing her condition.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain, Peripheral swelling, Tenderness
Clinical narrative: The morning after the shot patient noticed redness and a little soreness, she looked this morning and arm is really inflamed red and radiating down arm. There is a swollen area antecubital and it is very sore to the touch.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, headache, chills.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: States on 10/03/2018 around 8 am received a influenza vaccination. States below the shot she has a "poking pain". She also has redness and warmth 2 inches below the injection site. States it was larger but improved. Has tried ice and has helped.
Age: 64.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: When the injection was administered, there was intense pain in my shoulder. The pain lasted for a few hours, and then subsided to a minor dull ache over the next several days. On approximately 10/16/18, my left upper arm/shoulder started having a stronger dull ache and I experienced limited range of motion. In the following two days, the pain increased with any left arm movement, and my range of motion became more limited. The night of 10/17/18, my upper arm/shoulder was in great pain with very limited range of motion, and I had trouble sleeping. I slept better on my left side, where the pain was. When trying to sleep on my right side, the pain was worse, almost feeling as if my shoulder was not strong enough to carry the weight  of my arm.
Age: 64.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: When the injection was administered, there was intense pain in my shoulder. The pain lasted for a few hours, and then subsided to a minor dull ache over the next several days. On approximately 10/16/18, my left upper arm/shoulder started having a stronger dull ache and I experienced limited range of motion. In the following two days, the pain increased with any left arm movement, and my range of motion became more limited. The night of 10/17/18, my upper arm/shoulder was in great pain with very limited range of motion, and I had trouble sleeping. I slept better on my left side, where the pain was. When trying to sleep on my right side, the pain was worse, almost feeling as if my shoulder was not strong enough to carry the weight  of my arm.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site pain, Pyrexia
Clinical narrative: Tenderness, soreness, in left shoulder. Chills and fever day after shot was given. Redness on skin surface about six inches long, 3 inches wide.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, Swelling, at deltoid that began the next day with pain rated 2 on 1-10 scale. Pain, redness, and swelling extended from deltoid down to elbow and lasted 5 days before resolution.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On or about 25-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in December 2015 (reported as on or about 17-DEC-2015), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not specified). On an unknown date in December 2015 (reported as on or about 22-DEC-2015), the patient was treated for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-MAR-2010, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-APR-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 04-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2014 (reported as later in 2014), the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset on an unspecified date in approximately 2014). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 30-NOV-2012 the patient was inoculated with ZOSTAVAX vaccine at a physician office for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016 the patient was treated by a physician for onset of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 04-AUG-2011 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015 the patient was treated by a physician at a medical clinic for onset of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic cirrhosis, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015 the patient was treated at a hospital onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Wheezing
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4-year-old male patient with congenital heart disease and primary pulmonary hypertension. The patient had no known drug reactions/allergies. The concomitant medications were not provided. On 21-AUG-2015, the patient was vaccinated with the first dose of measles, Oka-Merck PROQUAD subcutaneously (exact dose, lot # and expiration date were not reported) for prevention of measles, mumps, rubella and varicella. There were no adverse reactions after the first dose administration. On 15-OCT-2018, the patient was vaccinated with the second dose of Oka-Merck PROQUAD recombinant Human albumin (rHA), subcutaneously, lot # R014354 and expiration date: 18-NOV-2019 for prophylaxis. On 15-OCT-2018, immediately following administration, he went into anaphylaxis and was wheezing in the office. As a treatment BENADRYL intramuscularly (IM) was given and the patient was on oxygen before the ambulance arrived. In the ambulance the patient got steroids. He was transported and admitted to the medical center to the observation unit on 15-OCT-2018. The outcome of anaphylactic reaction was unknown. The causality assessment between measles, Oka-Merck) PROQUAD and the event was not provided. The reporter considered the event of anaphylaxis to be life threatening. Upon internal review, the event of anaphylaxis was considered to be medically significant because it required treatment with oxygen.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about late 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed a painful rash. The patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about late 2017, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date shortly after receiving ZOSTAVAX, the patient developed a painful rash. In response to these complaints, on an unknown date, the patient presented to a physician and was diagnosed as suffering from the shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Peripheral swelling
Clinical narrative: Arm is has knot in it and is swollen. TYLENOL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Vomiting
Clinical narrative: Chills and vomiting.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling hot, Lethargy
Clinical narrative: Extreme Nausea and lethargy throughout the next day. Vomited multiple times in the morning.  Felt warm, but did not take temperature. Diarrhea in the evening. Sense of nausea persisted. Very tired and slept when not in the bathroom. Felt lightheaded, but no longer nauseated today (the subsequent day). Diarrhea persists.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Extreme Nausea and lethargy throughout the next day. Vomited multiple times in the morning.  Felt warm, but did not take temperature. Diarrhea in the evening. Sense of nausea persisted. Very tired and slept when not in the bathroom. Felt lightheaded, but no longer nauseated today (the subsequent day). Diarrhea persists.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, tender, red and warm.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Injection site pain
Clinical narrative: Chills, fatgiue, major achiness in all bones, joints . . . slept 11 hours felt rotten . . . expect to be fine except for injection-site muscular soreness by tomorrow.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Chills, fatgiue, major achiness in all bones, joints . . . slept 11 hours felt rotten . . . expect to be fine except for injection-site muscular soreness by tomorrow.
Age: 11.0
Sex: M
Vaccine: DTAP, FLU4, HPV9, MENB
Symptoms: Headache, Nausea, Pallor, Retching, Syncope
Clinical narrative: He got very pale sick to his stomach and started dry heaving. Fainted for a few seconds and then came to. Slept for 1.5 hours then woke up  with a very bad headache and vomited. Went back to sleep for 3 hours and work up feeling normal again. Ate, had color, active... all seemed well.
Age: 11.0
Sex: M
Vaccine: DTAP, FLU4, HPV9, MENB
Symptoms: Vomiting
Clinical narrative: He got very pale sick to his stomach and started dry heaving. Fainted for a few seconds and then came to. Slept for 1.5 hours then woke up  with a very bad headache and vomited. Went back to sleep for 3 hours and work up feeling normal again. Ate, had color, active... all seemed well.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient got vaccine 3 weeks ago. She came to the pharmacy to complain that she is not able to lift her arm or move her arm and her left hand is stiff. Employee, who did the Flu shot referred the patient to see the doctor.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Lymphadenopathy, Malaise
Clinical narrative: After receiving the vaccine earlier in the day, Patient had trouble sleeping that night and just "wasn't feeling well". While showering she was shaving her right axillary area and noticed swelling. She felt that her lymph nodes were what had swelled. Upon examination, moderate swelling noted in the axillary area with no redness and no warmth to the touch. Patient denied any fevers or chills. Her only complaint was not feeling well, "run down" and visible as well as palpable swelling.
Age: 65.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Asthenia, Chills, Ear congestion, Headache, Neck pain
Clinical narrative: Patient reports fever of 102 F and cold chills by 5pm the evening of 10/15/18, over the next two days the patient reports chest congestion, ear congestion on the left side, soreness in the left arm and left side of neck, headache, and general lack of energy and strength. She began taking Tylenol when the fever started, and maintained a fever of 100 F or below for the next two days. Patient came to the pharmacy the morning of 10/18/18 to report her signs and symptoms.
Age: 65.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient reports fever of 102 F and cold chills by 5pm the evening of 10/15/18, over the next two days the patient reports chest congestion, ear congestion on the left side, soreness in the left arm and left side of neck, headache, and general lack of energy and strength. She began taking Tylenol when the fever started, and maintained a fever of 100 F or below for the next two days. Patient came to the pharmacy the morning of 10/18/18 to report her signs and symptoms.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: PATIENT FELT HEAT AROUND INJECTION SITE THAT EVENING OF INJECTION, WENT TO EMERGENCY ROOM NEXT DAY WHERE THEY OUTLINED CELLULITIS AND IT WAS SHOWN TO WORSEN. PATIENT TREATED FOR CELLULITIS. UNKNOWN DURATION.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: Pain in arm was much more than expected almost immediately. Within 2 hours area around injection site had swollen and become painful and hot to touch. Muscular and joint pain started and I had fever of just under 100F. Within several hours, fever had risen to almost 102F. Flu-like symptoms of intense fatigue, muscle and joint pain, headaches, weakness, and loss of appetite set in before the end of the night. These symptoms lasted for 5 days causing me to miss work for most of the following week. Fever persisted at 101-102 for most of the time, dropping to just under 100 by late the following Tuesday and to 99 on Wednesday - by evening it was normal and I went to work the next day, Thursday, for the first time since the prior Friday.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain in arm was much more than expected almost immediately. Within 2 hours area around injection site had swollen and become painful and hot to touch. Muscular and joint pain started and I had fever of just under 100F. Within several hours, fever had risen to almost 102F. Flu-like symptoms of intense fatigue, muscle and joint pain, headaches, weakness, and loss of appetite set in before the end of the night. These symptoms lasted for 5 days causing me to miss work for most of the following week. Fever persisted at 101-102 for most of the time, dropping to just under 100 by late the following Tuesday and to 99 on Wednesday - by evening it was normal and I went to work the next day, Thursday, for the first time since the prior Friday.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm was much more than expected almost immediately. Within 2 hours area around injection site had swollen and become painful and hot to touch. Muscular and joint pain started and I had fever of just under 100F. Within several hours, fever had risen to almost 102F. Flu-like symptoms of intense fatigue, muscle and joint pain, headaches, weakness, and loss of appetite set in before the end of the night. These symptoms lasted for 5 days causing me to miss work for most of the following week. Fever persisted at 101-102 for most of the time, dropping to just under 100 by late the following Tuesday and to 99 on Wednesday - by evening it was normal and I went to work the next day, Thursday, for the first time since the prior Friday.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Hypotonia, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: 12 hrs after vaccinations, abrupt onset of severe vomiting and diarrhea and soon became limp, unresponsive and pale. Occurred while on commercial jet- almost diverted for medical care. Episode lasted 20 minutes. No addnl vomiting or diarrhea. Symptoms thought to be 2ndary to ROTATEQ vaccine.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Patient's husband came in stated that patient was experiencing muscle pain and hives around the area of injection. Spoke with employee at Dr's office who instructed the patient to use Benadryl and a warm compress and if symptoms do not go away within 24 hours to call their office to follow up.  I gave this information to the patient's husband who acknowledged his understanding of what to do.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain
Clinical narrative: Pain at injection site, no swelling. Noticed numbness lateral arm and weakness in grasp. Numbness unchanged but weakness and pain improved as of 10/05/2018.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in January 2013 (reported as on or about 04-JAN-2013), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in August 2016 (reported as on or about 26-AUG-2016), the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-NOV-2012, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). On or about 28-DEC-2012, the patient was inoculated the second time with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-NOV-2012, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed Acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-OCT-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-MAY-2014, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUN-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-DEC-2013, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-SEP-2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-AUG-2016, the patient was treated by the same physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-DEC-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 22-JAN-2016, the patient was treated by a health professional for the onset of a vesicular rash which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and tramadol for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016 (reported as later in 2016), the patient was treated for herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an 11-year-old female patient. No information regarding the patient's medical history was provided. She used mometasone furoate (NASONEX) for seasonal allergies (it was unknown if she was taking the drug when the vaccines were administered). On 11-OCT-2018, the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm, lot # R008163, expiration date 18-NOV-2020 for prophylaxis; MENACTRA in the right arm, ADACEL in the left arm and influenza virus vaccine (unspecified) in the left arm. Within minutes after receiving four vaccines, the patient experienced a systematic bilateral rash on upper part of her body, which was described as a red, blotchy shirt". The patient was given diphenhydramine hydrochloride (BENADRYL) and the Emergency Medical Service (EMS) was called. The patient's blood pressure, oxygen levels and temperature were monitored and they were all good. The patient seemed to be recovering so the parents declined to use EMS. The patient was taken home about one hour after vaccination. Causality assessment between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 27-SEP-2018 (one week before the patient got a second dose only seven days after the first dose), the patient was vaccinated with first dose of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 04-OCT-2018 (reported as one week ago) the patient was inadvertently administered a second dose of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported) only seven days after the first dose (Vaccination error, Inappropriate schedule of drug administration). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster on an unspecified date. Later in 2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, pain, suffering and other damages. The outcome of the events was unknown. Vaccination failure, emotional distress, injury and herpes zoster were considered to be related to ZOSTAVAX.