chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram abdomen normal, Lipase normal, Liver function test normal, Muscle spasms, Ultrasound abdomen 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.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Vaginal haemorrhage, White blood cell count 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.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT RECEIVED VACCINE 9/14/18 CALLED PHARMACY 9/15/18 SAID SHE WAS EXPERIENCING REDNESS EXTENDING DOWN ARM, WARMTH AND SWELLING IN THE FINGERS AND SHE SAID SHE HAD ALREADY TAKEN BENADRYL AND IBUPROFEN. A COLD COMPRESS WAS SUGGESTED IN ADDITION. CHECKED ON PATIENT AGAIN 9/16/18 AND SHE REPORTED NO IMPROVEMENT AND SAID SHE WOULD BE SEEING HER PRIMARY CARE DOCTOR ON 9/17/18. AFTER SEEING PRIMARY MD 9/17/18 SHE CAME BY PHARMACY ARM REMAINED RED WIDESPREAD EVEN SOME BELOW ELBOW AND REPORTED SWELLING OF FINGERS. PRIMARY MD PRESCRIBED 5 DAYS OF PREDNISONE THERAPY.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received Zoster (SHINGRIX) on 09/14/18. Today, 09/17/18, she came in to the pharmacy to report injection site reaction, swelling, erythema, tenderness, pain and soreness right after receiving the shot. Today, she states that she is feeling a lot better and just wanted to know if this was normal. Patient appeared to be satisfied after I told her that it is possible to have an injection site reaction. Also, the reaction was resolving and she was feeling better. She left the pharmacy satisfied with the way I handle it. I promised to check in on her in a couple of days.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Chest discomfort, Chills, Fatigue, Musculoskeletal stiffness
Clinical narrative: After receiving the shot in left arm, about an hour later my arm started to get sore, felt body chills, neck and low back pain/stiffness, chest felt funny. My son also complained about his arm hurting. I felt tired and stayed down for the day I received the shot and the next day I stayed mostly in bed.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: After receiving the shot in left arm, about an hour later my arm started to get sore, felt body chills, neck and low back pain/stiffness, chest felt funny. My son also complained about his arm hurting. I felt tired and stayed down for the day I received the shot and the next day I stayed mostly in bed.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reported swollen, redness, and warmth on her arm the day after vaccine. Possible fever, but never confirmed it with a thermometer. The second day the swelling had gone done but still red. Patient iced the area, which seemed to help.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Muscular pain, strong enough to immobilize left arm and partially immobilize left elbow from around 6-7 pm. The next morning, the arm was sore but moveable, but temp was over 102. Mostly ok by evening. No previous reaction to any shot.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Mobility decreased, Syncope
Clinical narrative: After receiving vaccines in the morning at 10:00 AM, Patient stated that later that night around 11:00 PM he got up to head to bed and collapsed to the floor stating that he lost all mobility in his legs and unable to move to get to the phone. Stated that it took him until about 3:00 AM to get to make it to his bed. Came in to let us known about event and ask if anyone else have reported having reactions like this to vaccines. Patient stated that he was feeling much better now but having a little numbness still.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Got the 1st of 2 shingles vaccine, injection site sore and swollen. Tired too.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site pain, Oedema, Pain, Soft tissue swelling
Clinical narrative: She has SHINGRIX injection with pain at injection site (expected) Left deltoid however within two hours significant soft tissue edema left axilla with pain 10/10. Pain was to degree she consider ER visit. She applied ice, then heat. On examination no lymphadenopathy and now mild soft tissue swelling with pain 6/10. This is her second injection.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Bilateral welts appearing 3-4 days after SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reports having whole body hives since receiving the shot. Started two days post immunization.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Muscle spasms, Nausea, Pain
Clinical narrative: Painful cramping, nausea and some diarrhea after GARDASIL 9 vaccine. 14 year old boy. Started the next day and carried over another day.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea
Clinical narrative: Had SHINGRIX Zoster shot on 9/11/18. On 9/12/18 suffered from diarrhea, chills, and severe rigors.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever and pain, chills, flu-like symptoms.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Pain in jaw, Pyrexia, Swelling
Clinical narrative: Local swelling on the right, low grade fever, intense chills, shaking, jaw and head pain.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Tremor
Clinical narrative: Local swelling on the right, low grade fever, intense chills, shaking, jaw and head pain.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Red, swollen, itchy warm to the touch. No fever, sore when lay on or touch. Quarter size of rash took a BENADRYL this am. Patient said the adverse symptoms did not happen until last Friday morning on Sept. 14, 2018, patient received the PREVNAR 13 on Sept. 7, 2018, Monday.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Red, swollen, itchy warm to the touch. No fever, sore when lay on or touch. Quarter size of rash took a BENADRYL this am. Patient said the adverse symptoms did not happen until last Friday morning on Sept. 14, 2018, patient received the PREVNAR 13 on Sept. 7, 2018, Monday.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient received quadrivalent flu shot and caregiver reported two days later patient was treated in ED for hives - unknown if flu shot was the culprit however given the time frame and the lack of any other changes in patient's medical history recently chances that flu shot caused hives in this patient are more likely. Patient received flu shot every year in years previous without any reportable adverse effects.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oral mucosal blistering, Stomatitis
Clinical narrative: 7/23 - initial RXN: soreness/redness/swelling at injection site. 7/25 - began developing blisters in mouth which worsened over time. 7/30 - reported RXN to clinic. Saw Sr. MD provider Dr. who reported might be related to vaccine from 7/23. No follow up by clinic. Pt. never received contraindication screen before vaccine or VIS. I am writing to share some more details about this report of a vaccine adverse reaction report that happened for my daughter after a 2nd dose of HPV in this clinic in July of 2018. Unclear if clinic sent in a VAERS report. 7/23/18 This HPV-9 vaccine was given in the Clinic lab area. The initial ordering provider for initial HPV vaccine order 5/24/18, was our new PCP. Unfortunately Dr. was not present in the building at the time of this second vaccine administration. No covering provider is listed, so I provided you with the Medical Director for this program, who is ultimately responsible for care provided by medical team who provide these vaccines at this clinic. When patient seen 7/30/18 MD verbalized unable to verify if RXN was not vaccine related. Related to who the person who gave the actual vaccine administered by. The person who recorded in my daughter's chart under "Given by" is illegally recorded as this person was only present in the room and did not give this injection. The person who gave this HPV 9-valent was a "student" the name as reported only by her first name. This name is not listed anywhere on her notes. Related failure to assess for contraindications before giving immunization: No VIS was given before this vaccine was given which is required by Federal Law. No question was asked about if this patient could be pregnant or will become pregnant within 28 days of this vaccine. Unfortunately false documentation to this question in chart. Thank you, Please call me for further questions.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Syncope
Clinical narrative: Child waited in office 15 minutes post vaccine and just after leaving the office, did not feel well. Mom had him sit on the floor then child fainted. Brought back into exam room for evaluation by MD.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Injection site pain, Nausea
Clinical narrative: R arm pain over deltoid with swelling edema and erythema; improving had 1 episode of N/with vomiting and 1 loose stool.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: R arm pain over deltoid with swelling edema and erythema; improving had 1 episode of N/with vomiting and 1 loose stool.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, hot to the touch and swollen at injection site.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Feeling abnormal, Pallor, Throat tightness
Clinical narrative: Patient received HPV and Hep A vaccines in office and was waiting in office following injection. Patient began feeling "funny", became pale. C/o throat feeling tight. Patient was given 25 mg BENADRYL p.o. and followed by epinephrine auto-injection of 0.3 mg. EMT squad was called and pt transported to hospital. Observed at Hosp. and released to home.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: About 5 minutes after given the GARDASIL 9, patient confirmed of dizziness and later became pale. Patient was asked to lie down and after 15 minutes recovered completely.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: Before bed patient realized that his arm was swollen, red and sensitive to touch (w/ shirt or hand). Patient took TYLENOL to try to ease the pain.
Age: 1.75
Sex: F
Vaccine: FLU4, HEPA, MMR
Symptoms: Cough, Diarrhoea, Faeces discoloured, Vomiting
Clinical narrative: Mom called back about one hour ago. Child has had 3-4 yellow runny stools since leaving office. Asked Mom if child had been sick recently or anyone else in the home. Mom states child had vomited 4 times this am, two that Mom did not see but Dad did and the other two were mostly mucous and that child seem to have a cough. Advised Mom that perhaps the loose stools are sx. of a "stomach bug" or gastroenteritis which frequently starts with vomiting. The vomiting usually subsides and loose stools begin. Mom states stools have been yellow and very loose. There has been no fever. Advised to monitor liquid intake and follow bland diet as in Bananas, crackers, jello, white grape or pear juice. Advised if sx. worse to call back.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Pt began reaction on 9/10/18 in PM with body aches, chills, fever, stomach upset. This occurred for 36 hours - pt. is still having headaches to day from the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: Flu like symptoms, chills. Per patient, his doctor told him he could take pain relief (TYLENOL or Ibuprofen) and that the symptoms would pass.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per MD notes: (R) upper arm red, swelling and pain.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypersomnia, Somnolence
Clinical narrative: 9-4-18 Tuesday, had flu shot in the afternoon. Went to bed 11:PM to 8AM. I couldn't wake up. Went back to bed by 8:10 AM and slept until midnight, only getting up twice to go to the bathroom. Back to bed 1 AM and slept until 10:30 AM on Thursday 9-6-18. Never had anything like that happen to me before. I was fine after that. Not sick before or after all that sleeping. It was scary. I did not eat nor drink during all that time. I never smoked, always was a non-drinker. I am 77 years old and other than acid reflux, I am physically fine. I am just reporting this as something highly unusual. I did not go to a doctor. Flu shot was given in my right shoulder. I slept 32 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Diarrhoea, Vomiting
Clinical narrative: I had a temperature of 101.1 from midnight until 5:00pm. I also was vomiting and had diarrhea during that time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received 1s dose of SHINGRIX, Hours after vaccine at injection site, patient noticed redness, slight swelling and warmth at and around injection site. Redness, soreness and warmth persisted for about 5 days before resolving. Patient stated they used ice on affected arm to control side effects.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain down left arm and between fingers of left hand.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None. Patient given HIB # 5 and PCV # 5 in error.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient states arm became red approximately 3 inches below injection site. Went to Urgent Care on 9/13/2018 and was diagnosed with cellulitis.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term 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 or about 13-JAN-2012, the patient was treated at an Urgent Care 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUL-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance 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. On or about 04-AUG-2012, the patient was treated by a physician 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 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.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Seizure, Tinnitus
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Hypoacusis, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Seizure, Tinnitus, Tremor, Urinary incontinence
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Hypoacusis, Loss of consciousness, Nervousness, Product storage error, Seizure
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Tinnitus, Urinary incontinence
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a company representative referring to a 17 year old male patient. The patient's concurrent conditions, drug reactions/allergies and medical history were reported as none. There was no concomitant medication reported. On 31-AUG-2018 at 04:10 PM, the patient was vaccinated with the first dose of GARDASIL 9 administered intramuscular in the right deltoid (lot # N026812, expiration date 22-JUN-2020) for Human Papilomavirus prevention. Later, on that same date at 04:11 PM, the patient received a dose of HAVRIX anatomical location and route were not reported (lot # 32G52, expiration date not reported) for prophylaxis. The reporter mentioned that immediately upon withdrawing the needle that contained the HAVRIX, the patient started seizing and shaking, he was very stiff, he urinated on himself, and his eyes rolled back. The apparent seizure stopped within seconds. Upon becoming conscious after the seizure, the patient reported ringing in his ears and trouble hearing. The patient's blood pressure at that time was 90/60 (units not provided) and his heart rate was 110 (units not provided). The patient received unspecified treatment for the adverse event. No lab diagnostic test were performed. The nurse recommended the patient to go to the Emergency Room for evaluation and treatment, but it was unknown if the patient went. It was also informed that the patient recovered from all symptoms before he left the office. The causality assessment between the suspect therapies GARDASIL 9 and HAVRIX with the events was not provided. Upon internal review, seizure was considered as a medically significant event.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 68-year-old female patient who received Shingrix (batch number 7X3EJ, expiry date 5th December 2020) for prophylaxis. On 29th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th August 2018, less than a day after receiving Shingrix, the patient experienced injection site reaction and injection site pain. On 31st August 2018, the patient experienced swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm. On an unknown date, the outcome of the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, injection site pain, skin warm and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received the 1st dose of Shingrix on right arm. The patient reported that she experienced stiffness and pain at her injection site. Also, the patient reported that she experienced pain on her left arm, left elbow swelling, left arm hot to touch, difficulty lifting with her left arm, and both hands cramping. The patient reported that she went to urgent care to seek medical attention. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with US2018163083, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site pain, Injection site reaction, Joint swelling, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 68-year-old female patient who received Shingrix (batch number 7X3EJ, expiry date 5th December 2020) for prophylaxis. On 29th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th August 2018, less than a day after receiving Shingrix, the patient experienced injection site reaction and injection site pain. On 31st August 2018, the patient experienced swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm. On an unknown date, the outcome of the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, injection site pain, skin warm and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received the 1st dose of Shingrix on right arm. The patient reported that she experienced stiffness and pain at her injection site. Also, the patient reported that she experienced pain on her left arm, left elbow swelling, left arm hot to touch, difficulty lifting with her left arm, and both hands cramping. The patient reported that she went to urgent care to seek medical attention. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with US2018163083, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 68-year-old female patient who received Shingrix (batch number 7X3EJ, expiry date 5th December 2020) for prophylaxis. On 29th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th August 2018, less than a day after receiving Shingrix, the patient experienced injection site reaction and injection site pain. On 31st August 2018, the patient experienced swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm. On an unknown date, the outcome of the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, skin warm and pain in arm were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site reaction, swelling of elbows, cramp in hand, contusion, mobility decreased, injection site pain, skin warm and pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received the 1st dose of Shingrix on right arm. The patient reported that she experienced stiffness and pain at her injection site. Also, the patient reported that she experienced pain on her left arm, left elbow swelling, left arm hot to touch, difficulty lifting with her left arm, and both hands cramping. The patient reported that she went to urgent care to seek medical attention. The patient planned to continue follow-up with her physician on an unknown date. This case has been linked with US2018163083, reported by same reporter.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 87 year old female patient. The patient's pertinent medical history was not reported. The patient's drug reactions/allergies included codeine allergy. Her concurrent conditions included Waldenstrom's macroglobulinaemia and osteoporosis. On an unknown date, the patient was vaccinated with a shot of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (route of administration, lot # and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified). It was stated that the patient experienced pneumonia (captured in MARRS 1809USA005005). On 06-AUG-2018, the patient started therapy with fidaxomicin (DIFICID) 200 mg tablets,1 tablet  twice daily, per oral, for 10 days, for clostridium difficile infection (lot # and expiration date were not reported). Concomitant therapies included apixaban (ELIQUIS), metoprolol, iron supplement, and vitamin D. On 15-AUG-2018, the patient completed treatment with fidaxomicin(DIFICID). On 07-SEP-2018, the patient saw a physician who noted that the patient tested positive for clostridium difficile (drug ineffective), with formed stool  described as "one part antibodies, another part that tests activities of the bacteria". No treatment was given for the event. At the time of reporting, the outcome of the event was reported as not recovered. The causality assessment between the event and the suspect therapies was not provided.; Sender's Comments: US-009507513-1809USA005005:
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Clostridium difficile infection, Clostridium test positive, Drug ineffective
Clinical narrative: This spontaneous report was received from the patient's daughter referring to a 87 year old female patient. The patient's pertinent medical history was not reported. The patient's drug reactions/allergies included codeine allergy. Her concurrent conditions included Waldenstrom's macroglobulinaemia and osteoporosis. On an unknown date, the patient was vaccinated with a shot of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (route of administration, lot # and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified). It was stated that the patient experienced pneumonia (captured in MARRS 1809USA005005). On 06-AUG-2018, the patient started therapy with fidaxomicin (DIFICID) 200 mg tablets,1 tablet  twice daily, per oral, for 10 days, for clostridium difficile infection (lot # and expiration date were not reported). Concomitant therapies included apixaban (ELIQUIS), metoprolol, iron supplement, and vitamin D. On 15-AUG-2018, the patient completed treatment with fidaxomicin(DIFICID). On 07-SEP-2018, the patient saw a physician who noted that the patient tested positive for clostridium difficile (drug ineffective), with formed stool  described as "one part antibodies, another part that tests activities of the bacteria". No treatment was given for the event. At the time of reporting, the outcome of the event was reported as not recovered. The causality assessment between the event and the suspect therapies was not provided.; Sender's Comments: US-009507513-1809USA005005:
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Burning sensation, Fatigue, Initial insomnia, Pain
Clinical narrative: Within 8 hours of the Pneumonia vaccine, I had body aches and a 100 temperature. This lasted 3 days. Then I felt serious fatigue the fourth day. I slept for 24 hours. It still was not enough. On the fifth day, my arms and legs felt like they were burning. Days 6, 7, 8, 9, 10, 11, 12, 13, 14, I would lay in bed for 4 hours before I could fall asleep. The burning sensation in my arms and legs continued. Day 15, 16, 17, as I write this hurts less.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: Within 8 hours of the Pneumonia vaccine, I had body aches and a 100 temperature. This lasted 3 days. Then I felt serious fatigue the fourth day. I slept for 24 hours. It still was not enough. On the fifth day, my arms and legs felt like they were burning. Days 6, 7, 8, 9, 10, 11, 12, 13, 14, I would lay in bed for 4 hours before I could fall asleep. The burning sensation in my arms and legs continued. Day 15, 16, 17, as I write this hurts less.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Patient called office to report after receiving her Flu Vaccine (FLUBLOK) Left Deltoid at our Flu clinic on 9/14/2018 at 6:30am from our RN, she went home and went to sleep after working night shift. When she awoke she states she had an all over body rash of hives, that was very itchy. She reported yesterday Monday 9/17/2018 she did not seek treatment and does not wish to seek treatment for the rash at this time, the rash was resolving. She did state she wants to report this reaction. Patient stated she has had the flu vaccine every year and never had a problem or reaction before. She does not believe she has had the FLUBLOK prior to this dose. Patient states she has no known allergies and is generally healthy.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 21 year old female patient with hypersensitivity to amoxicillin. The patient had no concomitant medications or pertinent medical history. On 15-OCT-1997, the patient was vaccinated with the first dose of M-M-R II, she received the second dose of this vaccine on 17-JUL-2002, for prophylaxis (dose, anatomical site, route of administration, lot number and expiration date were not reported). Sterile diluent (MERCK STERILE DILUENT) was used for reconstitution, however, it was not specified which of the doses were reconstituted with it. On 20-JUL-2018, the patient had titers drawn, which showed she was positive for immunity of rubella but she was negative for immunity of measles and mumps. The patient sought medical attention, however, she did not receive any treatment for the events. At the time of the report the patient had not recovered from the events. The causality assessment between the events and the therapy with M-M-R II was not reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: This spontaneous report was received from a medical assistant at physician's office referring to a 25 year old female patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 26-AUG-2018 the patient was vaccinated with GARDASIL 9 lot # R002345, expiration date 16-NOV-2020, 1 dosage form, intramuscularly at an unspecified injection site of the left arm for prophylaxis. On 26-AUG-2018, 4 hours after the injection, the patient developed redness and itching at the injection site and on the neck and chest. On 04-SEP-2018, the patient returned to physician's office for medical treatment, but  no treatment was given for the events. No lab diagnostics/studies was performed. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a currently 12 year old male patient. The patient had no concomitant medications, medical history and no drug reactions/allergies. Information about the patient's concurrent conditions was not provided. On 24-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # reported as "M026306 with an expiration date in 30-APR-2018"), intramuscularly, for "prevention of HPV" (prophylaxis) (dose, strength and frequency were not provided). Moreover, on 31-AUG-2018 the patient was vaccinated with the second dose of GARDASIL 9 (lot # N032284 with an expiration date in 22-SEP-2020), intramuscular in the left deltoid for prophylaxis (dose, strength and frequency were not provided). On an unspecified date in September 2018 (reported as "On an unspecified date after 08/31/2018"), the patient developed a rash, redness, and itching at the injection site (Left Deltoid). Additionally, on 05-SEP-2018, the patient went to the physician's office and was prescribed with Prednisone 20mg (dose: 2 tablets by mouth once daily for 7 days) and hydroxyzine 25mg (dose 1 tablet by mouth four times a day for 3 days). Finally, it was reported that there were no laboratories performed to the patient. At the time of reporting, the outcome of injection site rash, injection site pruritus and injection site erythema was reported as resolving. The causal relationship between GARDASIL 9 and the reported events was not provided. Lot number M026306 is an invalid lot number for GARDASIL 9.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from a male consumer of unknown age, who refered to himself. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for shingles prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). It was reported, that the vaccination failed and the patient had to have a booster vaccine in 60 days (vaccination failure). The outcome of the event was not reported. The causality for the event was not reported. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1809USA005291: