chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site warmth, Pyrexia, Rash
Clinical narrative: Patient was afebrile and presented for a well-child visit. Approx. 15 minutes after receiving vaccines patient spiked a fever of 102.0 and had localized heat to the injection area of the left thigh. Mother reports a fine raised rash under bottom lip as well. This was not visualized by RN and is gone at time of completing this report.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN ARM.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Influenza like illness, Pyrexia, Tremor
Clinical narrative: Patient received the high dose flu vaccine on September 13 2018. A few hours after the shot, the patient started having flu like symptoms including fever, sweats, and shakes. This continued into the evening until ambulance was contacted and she was brought to hospital. Patient was admitted to hospital around 1130pm that evening and stayed until her discharge midday on Sep 15th. She was placed under observation due to her flu like symptoms. Patient does have a history of COPD.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction, Rash erythematous
Clinical narrative: 10 cm localized reaction with red raised rash 3 days after vaccine. No vesicles yet, but looks like it is forming some.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Numbness on side of face absent of rash. The following day the numbness had extended to the opposite side of her face covering cheeks and chin and had developed a red rash on her chin. At this point she visited her PCP and was prescribed Valacyclovir to take 1 tablet three times daily for 7 days. She admitted she only took 3 to 4 tablets whenever she though of it and did not finish the prescription.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given PENTACEL and HIB on the same day. He was given the PENTACEL with 28 days for Dtap. Pt was not due for vaccines.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Gait disturbance, Joint stiffness
Clinical narrative: Arm swolen and bright red, approx. 10 inch circumference, extremely sore. One week later, half that size, dark purple, itchy. Upon rising on 9/11, entire body extremely achy, joints very stiff and painful.  Had to call for husband to help me walk and get seated. Could not even pour coffee. Could barely move. Took NSAID, which helped. Extreme fatigue for two days. Diarrhea followed two days later for two days. First shot only caused only a minor sore arm and minor fatique for one day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swolen and bright red, approx. 10 inch circumference, extremely sore. One week later, half that size, dark purple, itchy. Upon rising on 9/11, entire body extremely achy, joints very stiff and painful.  Had to call for husband to help me walk and get seated. Could not even pour coffee. Could barely move. Took NSAID, which helped. Extreme fatigue for two days. Diarrhea followed two days later for two days. First shot only caused only a minor sore arm and minor fatique for one day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin discolouration, Skin reaction
Clinical narrative: Arm swolen and bright red, approx. 10 inch circumference, extremely sore. One week later, half that size, dark purple, itchy. Upon rising on 9/11, entire body extremely achy, joints very stiff and painful.  Had to call for husband to help me walk and get seated. Could not even pour coffee. Could barely move. Took NSAID, which helped. Extreme fatigue for two days. Diarrhea followed two days later for two days. First shot only caused only a minor sore arm and minor fatique for one day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling, Rash
Clinical narrative: Patient received the shot on 7/13/18 and got this reaction 3 days later on 7/16/18. Her got swollen legs and ankles/ also got rash on stomach and arms. Called doctor who gave her a steroid shot which resolved the issue.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Hyperhidrosis, Influenza like illness, Pyrexia, Tremor
Clinical narrative: Patient received the shot on 9/13/18. That afternoon he reported that he had flu like symptoms suich as fever, shakes, sweats, temperature, that increased in intensity throughout the afternoon.  Late that evening he contacted his primary doctor to report the ongoing side effects. The PCP reported that if he felt that bad to contact the ambulance and be seen at the hospital. The patient contacted that ambulance and was seen at hospital arriving around 1130Pm on 9/13. He was discharged the following morning around 6:30am when his symptoms started to decrease.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Last week she mentioned to me that soon after her flu shot last year she developed shoulder pain. Went through physical therapy and is still doing exercises at home.
Age: 16.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Lethargy, Neck pain, Skin warm
Clinical narrative: Day after vaccinations received, Mom states patient "felt warm" (temp not taken) and lethargic and also neck started to hurt; he also developed a red, raised rash "right where the Tdap was given" at injection site (left deltoid), which is now, on 9/17/18 spreading and has reached his elbow and covers quite a bit of his upper arm. His neck continues to be sore and Mom states no injuries known. Encouraged to take him to PCP.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Electrocardiogram normal, Fear of death, Feeling abnormal, Hyperhidrosis
Clinical narrative: During the night after vaccine, I got up 3-4 times to urinate. The last time about 5-5:30 a.m. I felt nauseous, then terribly nauseous. Barely made the 8-10 steps to a chair where I had to lay my head on a table. Then became profusely sweaty all over my body. I suspected heart attack although no chest or other pain. This feeling of death subsided after 15-20 minutes. Then was very weak. At that point I decided to be checked out at ER, Hospital .
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nocturia, White blood cell count increased
Clinical narrative: During the night after vaccine, I got up 3-4 times to urinate. The last time about 5-5:30 a.m. I felt nauseous, then terribly nauseous. Barely made the 8-10 steps to a chair where I had to lay my head on a table. Then became profusely sweaty all over my body. I suspected heart attack although no chest or other pain. This feeling of death subsided after 15-20 minutes. Then was very weak. At that point I decided to be checked out at ER, Hospital .
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Condition aggravated, Diarrhoea
Clinical narrative: Starting around 2 pm, flu-symptoms, joint pain. Headache, fatigue, upset stomach, nausea, fever of 99.8, skin rash: left arm from injection site to elbow and both side of abdomen, at around 10 pm woke up with severe abdominal cramps and had really bad diarrhea for 2 hours. Since I have many allergies I took 50mg of BENADRYL, I call my pharmacist, he confirmed that I was having a reaction to the vaccine, he recommended that I continue with BENADRYL and ALEVE for the fever, I was sick for 5 or 6 days, and these reactions triggered a flare up of my fibromyalgia, I am still dealing with the flare up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Fibromyalgia, Headache, Influenza, Injection site rash
Clinical narrative: Starting around 2 pm, flu-symptoms, joint pain. Headache, fatigue, upset stomach, nausea, fever of 99.8, skin rash: left arm from injection site to elbow and both side of abdomen, at around 10 pm woke up with severe abdominal cramps and had really bad diarrhea for 2 hours. Since I have many allergies I took 50mg of BENADRYL, I call my pharmacist, he confirmed that I was having a reaction to the vaccine, he recommended that I continue with BENADRYL and ALEVE for the fever, I was sick for 5 or 6 days, and these reactions triggered a flare up of my fibromyalgia, I am still dealing with the flare up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia, Rash, Vaccination complication
Clinical narrative: Starting around 2 pm, flu-symptoms, joint pain. Headache, fatigue, upset stomach, nausea, fever of 99.8, skin rash: left arm from injection site to elbow and both side of abdomen, at around 10 pm woke up with severe abdominal cramps and had really bad diarrhea for 2 hours. Since I have many allergies I took 50mg of BENADRYL, I call my pharmacist, he confirmed that I was having a reaction to the vaccine, he recommended that I continue with BENADRYL and ALEVE for the fever, I was sick for 5 or 6 days, and these reactions triggered a flare up of my fibromyalgia, I am still dealing with the flare up.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Immobile, Laboratory test
Clinical narrative: One week following Shingles and Flu vaccines, developed severe and constant pain in joints throughout body, including shoulders, neck, angles, knees, elbows, wrists, hands, and pelvis; severe swelling of feet and hands; immobility; lack of strength; chills. Added to existing treatment regiment, noted above, ibuprofren, hydrocodone, Cyclobenzaprine, Burber Panella, NAC, Resveratrol, Magnesium Malate, topical CBD balm. Symptoms continue regarding pain, immobility, and lack of strength; lesser chills. Pain medication somewhat alleviates pain.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: One week following Shingles and Flu vaccines, developed severe and constant pain in joints throughout body, including shoulders, neck, angles, knees, elbows, wrists, hands, and pelvis; severe swelling of feet and hands; immobility; lack of strength; chills. Added to existing treatment regiment, noted above, ibuprofren, hydrocodone, Cyclobenzaprine, Burber Panella, NAC, Resveratrol, Magnesium Malate, topical CBD balm. Symptoms continue regarding pain, immobility, and lack of strength; lesser chills. Pain medication somewhat alleviates pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Trunk rash.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: Large localized reaction of Left arm migrating down to Left elbow with swelling started 9/16/2018. Has been slowly improving until time of appointment.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: C/o tingling & arms & legs X approximately 12 days. No weakness. Intermittent. B/L upper ext from elbows to hands, B/L lower ext from knees to feet.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: HIVES ON BODY AND HEAD.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to an adult.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Rash, Urticaria
Clinical narrative: Patient reported feeling hot in her face and upper body, having a rash or hives, and flushing. Patient denied shortness of breath or swelling. Patient went home and took a BENADRYL, then came back to the pharmacy to report what had happened. Patient's symptoms had started to subside, but patient was instructed to take a second BENADRYL and stay in our waiting room to be monitored. Patient's primary care was called. Her blood pressure was 138/85 and her temperature was 98.1 F. Patient was sent home after 30 minutes had passed with a thermometer and instructions to call her PCP if she has a fever, and to call 911 if she feels shortness of breath or swelling in her mouth/face/throat.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called clinic at 2:44PM to report that her right deltoid had some mild itching, she removed the Band-Aids and noted that her deltoid was red warm and had raised area about 3 inches in diameter. No fever or breathing symptoms. Patient advised by provider to put cool compresses to site and take BENADRYL per boxed directions to help with the symptoms, patient to go to ER immediately if any breathing symptoms or wheezing starts.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia, Rash
Clinical narrative: Mom called on 9/11/2018 stating pt broke out in rash and also had red swollen knot where MMRV was given. She wasn't sure if from vaccine or if he was getting sick. Also had fever. She took child to ER and was Dx viral. Child also teething. Child has had off and on fever since 9/9/2018.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Streptococcus test negative, Teething, Viral infection
Clinical narrative: Mom called on 9/11/2018 stating pt broke out in rash and also had red swollen knot where MMRV was given. She wasn't sure if from vaccine or if he was getting sick. Also had fever. She took child to ER and was Dx viral. Child also teething. Child has had off and on fever since 9/9/2018.
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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine 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 of herpes zoster or shingles. In 2016, the patient was treated by a physician 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 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: Decreased immune responsiveness, 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-AUG-2013, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a persistent severe 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 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-SEP-2016, the patient was treated at a dermatology office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
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 07-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine for the intended purpose of prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed and was diagnosed with shingles on two separate occasions. As a result of the shingles outbreaks, the patient has developed and continues to suffer from and seek treatment  for persistent severe post herpetic neuralgia. As a direct and proximate result of ZOSTAVAX vaccine, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was unknown. Causality assessment was related. Post herpetic neuralgia, persistent strain of herpes zoster and vaccine did not prevent shingles as intended were considered disabling. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 20 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Suspected to have precipitated Guillain-Barre, one practitioner also said abscessed tooth may have something to do with.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Since getting the shot in September of 2017, I continue to experience muscular pain in the muscle of my upper left arm when moving it. I do not have free movement, it is stiff and requires more effort to move it and when I do so, it is very painful.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site nodule, Injection site warmth, Somnolence
Clinical narrative: Knot size of ping pong ball formed at injection site noticed Sunday morning (36 hours post injection). Heat and redness at site of injection along with the knot. Starting at 8 pm Friday evening, lasting thru Sunday morning patient experienced excessive sleepiness and fatigue.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site mass, Injection site pain
Clinical narrative: Lump formed at injection, pain developed and spread from site of injection to under arm area. Not relieved by cold compresses or ibuprofen.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Ear pain, Fatigue, Headache
Clinical narrative: He stated that he had hives on neck and upper chest starting 3-4 hours after vaccination. They lasted about 20 minutes and went away. He also had an earache, headache, diarrhea, dizziness and extreme fatigue. The symptoms "come and go" and last about 20 minutes at a time. All symptoms started 3-4 hours after vaccination.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: He stated that he had hives on neck and upper chest starting 3-4 hours after vaccination. They lasted about 20 minutes and went away. He also had an earache, headache, diarrhea, dizziness and extreme fatigue. The symptoms "come and go" and last about 20 minutes at a time. All symptoms started 3-4 hours after vaccination.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash white center.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms beginning about 6 hours after vaccination and lasting 5 days. Fatigue, muscle and joint pain, fever for 3 days (mostly low-grade but 102.5 for a number of hours even after administration of ibuprofen). No respiratory symptoms whatsoever. No GI symptoms.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given two PCV13 vaccines a year apart.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered KINRIX, a vaccination indicated for 4-6 years of age. Patient is only 4 months of age. No negative reaction so far. Appropriate measures taken (called pharmacy, called manufacturer, advised provider and patient's parent, etc.).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Injection site discolouration, Injection site pain
Clinical narrative: 8/15/2018: Needle felt like a hot iron going in the skin. Zoster burn non-stop. Local area pain, swelling, feverish, red, hot to the touch. Swelling the size of 1.5 inches in diameter. Used ice, BENADRYL and TYLENOL 8/16-18/2018. Low grade fever 100degrees, body aches, glands swollen on entire left side of body (neck, armpit, groin), nausea & headache. 8/19-31/2018. Swelling increased in size to 3.5 inches in diameter, painful to touch, fiery, light headache, use ice & TYLENOL. 8/28/2018- 9/11/2018 painful watery blister in left ear after the 11th went away and started peeling, used ice, BENADRYL, rubbing alcohol, and hydrogen peroxide and TYLENOL. 9/1/2018-9/14/2018 injection site turned black and started peeling circle 3.5 inches in diameter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: 8/15/2018: Needle felt like a hot iron going in the skin. Zoster burn non-stop. Local area pain, swelling, feverish, red, hot to the touch. Swelling the size of 1.5 inches in diameter. Used ice, BENADRYL and TYLENOL 8/16-18/2018. Low grade fever 100degrees, body aches, glands swollen on entire left side of body (neck, armpit, groin), nausea & headache. 8/19-31/2018. Swelling increased in size to 3.5 inches in diameter, painful to touch, fiery, light headache, use ice & TYLENOL. 8/28/2018- 9/11/2018 painful watery blister in left ear after the 11th went away and started peeling, used ice, BENADRYL, rubbing alcohol, and hydrogen peroxide and TYLENOL. 9/1/2018-9/14/2018 injection site turned black and started peeling circle 3.5 inches in diameter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin warm, Swelling
Clinical narrative: 8/15/2018: Needle felt like a hot iron going in the skin. Zoster burn non-stop. Local area pain, swelling, feverish, red, hot to the touch. Swelling the size of 1.5 inches in diameter. Used ice, BENADRYL and TYLENOL 8/16-18/2018. Low grade fever 100degrees, body aches, glands swollen on entire left side of body (neck, armpit, groin), nausea & headache. 8/19-31/2018. Swelling increased in size to 3.5 inches in diameter, painful to touch, fiery, light headache, use ice & TYLENOL. 8/28/2018- 9/11/2018 painful watery blister in left ear after the 11th went away and started peeling, used ice, BENADRYL, rubbing alcohol, and hydrogen peroxide and TYLENOL. 9/1/2018-9/14/2018 injection site turned black and started peeling circle 3.5 inches in diameter.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Nasal congestion, Throat irritation
Clinical narrative: Day after the flu shot I got a scratchy throat, the day after that I had a stuffy nose for the next two days, now the fourth day after I'm coming down with a cough. I took the shot b/c I have a newborn and now she's sick too. 5 weeks old.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Fatigue, Insomnia, Poor quality sleep
Clinical narrative: Restless night couldn't sleep or find comfortable position. Fatigue. Third day now getting better i think.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: L shoulder swollen and painful. No SOB, dizziness. Some numbness in L anterior arm. Recommended NSAIDs, BENADRYL and if needed prednisone Erx done.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: PATIENT HAD WIDESPREAD, BRIGHT RED, PIN-PRICK LOOKING RASH ON LEGS, ARMS, BUTTOCKS. PATIENT SAID IT WAS VERY ITCHY. SAW PHYSICIAN TODAY 9-17-18 AND WAS RECOMMENDED BENADRYL.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Within 36-48 hours after receiving SHINGRIX, arm receiving SHINGRIX swelled to twice its normal size and patient had fever, severe arthralgias and myalgias and spent 3 days in bed.
Age: 81.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, headache.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Basal cell carcinoma, Injection site erythema, Injection site scar, Laboratory test abnormal
Clinical narrative: Patient states that he got redness at injection site, and a small scar developed at the flu injection site. The patient states states the injection site has stayed red for the last 3 years, and that his dermatologist has been monitoring it for last couple of years. Patient also states that the area now has tested positive for basal cell carcinoma and has been directed to have the area surgically removed.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient came in pharmacy on 09/14/2018 complaining of large red spots on her back. Patient stated that she started feeling itchy after receiving the shot (on 09/10/2018) but ignored it until 09/14/2018. Advised patient to take BENADRYL and follow up with PCP. Patient was going to see the doctor on 09/15/2018.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site rash, Pain, Rash
Clinical narrative: September 9, 2018: Extreme fatigue. Mild headache. Mildly achy. September 10, 2018: Rash at site of injection. Rash in front of neck and whole left side of neck, rash on lower part of sternum. September 11, 2018: Rash started to resolve. September 12, 2018: Rash mostly gone.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Increased tendency to bruise, Injection site erythema, Pain
Clinical narrative: 1 DAY AFTER IMMUNIZATION, PT STATED SHE FELT SORENESS. 2-3 DAYS POST SHOT NOTICED REDNESS AT INJECTION AND INCREASE IN BRUISING ON SKIN AND AT TIME OF OBERSVATION SIZE SLIGHT BIGGER THAN HALF-DOLLAR COIN. STILL SORE. PT TAKING TYLENOL AND COLD COMPRESS FOR PAIN RELIEF.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had a sore bump at the injection site. Painful to touch. Redness.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen and red area and it is hot to the touch where the vaccine was given.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Fatigue, Injection site swelling, Peripheral swelling
Clinical narrative: Chills, swelling of arm/injection site, feeling tired and run down.
Age: 28.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Electrocardiogram normal, Feeling hot, Heart rate decreased, Hypotension, Nausea
Clinical narrative: Patient fainted shortly after receiving vaccinations. Woke up quickly but felt hot and nauseated. Called 911. EMS evaluated blood pressure, heart rate, and did an EKG. Blood pressure and Heart rate were both originally low, EKG normal. EMS continued to monitor and BP and HR returned to normal. Patient drank some water and was able to go home.
Age: 28.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after receiving vaccinations. Woke up quickly but felt hot and nauseated. Called 911. EMS evaluated blood pressure, heart rate, and did an EKG. Blood pressure and Heart rate were both originally low, EKG normal. EMS continued to monitor and BP and HR returned to normal. Patient drank some water and was able to go home.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATED ARM VERY SORE AND COULD NOT LIFT IT UP REDNESS AT SITE OF INJECTION AND SWOLLEN.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Swelling of the arm around the injection site. Red rash with 2 streaks running to just above the elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, felt sick.
Age: 31.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pain and reduced mobility of LUE started soon after vaccine administration. Pt thought it was due to the tetanus vaccine however the pain continued. Pt experiencing pain with abduction, extension of LUE, has difficulty raising hands above head. Pt is icing and using NSAIDs with some relief. Currently complaining of pain and reduced mobility day 8 post injections. Vaccine was given close to greater tubercule of humerus. Pictures available for documentation.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discolouration, Peripheral swelling, Pruritus
Clinical narrative: Black and blue at injection site, arm swollen and itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise, Pallor
Clinical narrative: Extremely painful at site of shot. Today only moderate pain. Feeling generally unwell, uncharacteristically pale, and tired today.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Amylase normal, Arthralgia, Blood creatinine normal
Clinical narrative: I received the first dose in the series on June 4th in the morning. One week later, I had two sores in my mouth on my gum line in the back of my mouth next to my molars. I have never had mouth sores before and have always been healthy. I felt that this could be related to the vaccine in that it ramped up my immune system and it seemed as though it might have caused it to attack the healthy cells in my body. The sores healed in a few weeks. After the second dose on 8/3, about a week later I started to experience stomach pains in the evening. It started on 8/10 in the evening. I felt it was probably indigestion as it passed a few hours later. I had slight stomach pain at night the following week, but nothing notable. On 8/17, I had severe stomach pain after supper again that passed after a few hours. On Sunday 8/18, the pain was severe and excruciating. It started at around 7pm and continued for about 6 hours as severe pain. Around 1am it started to subside. The following day I had slight cramping all day, but was able to go to work. This cycle repeated each night with the severe stomach/abdominal pain starting at 7-8pm and subsiding at about 1-2am. I had to lie in a ball with a heat pad on my abdomen the pain was so bad. During the day it would be better. By 8/23, I could no longer deal with the pain and needed to be seen by my primary provider. The thought was it could be my gallbladder. I had to do an abdominal ultrasound and lab work. Later that day a CT scan. I was forced to stay home from work to get all this testing done and was lucky to get it done in one day. The stomach pain continued that night again. On 8/24, the stomach pain was better and I did not have an episode that evening. On 8/25, I had an episode during the day that lasted about 6 hours. That was the last bad episode. Since then, the stomach pain has been hit or miss, but always mild. I do continue to have joint pain now. It has been the worst in my knees. That is what I have noticed since the stomach pain has subsided. It may have also been an issue during that time frame, but the stomach pain far exceeded any other pain I might have experienced. Also, starting on 8/24, I experienced vaginal bleeding. I did do a return visit to my provider. We decided that the bleeding was likely due to the stress that my body was under. I am on birth control and this bleeding was in the middle of my cycle.