chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mouth ulceration
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of hypersensitivity (and other events after receiving 1st dose on 16th April 2018, refer case US2018143007). On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced mouth ulcer, sore mouth and eating disorder. On an unknown date, the patient experienced allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, shivering and fever. The patient was treated with BENADRYL and ALEVE. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the allergic reaction, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the right arm. The patient experienced similar adverse events with the 2nd dose as that after receiving the 1st dose, with some additional events. The patient stated that she could hardly move, felt terrible, hard to even get out of her bed. The patient experienced ulcers in the mouth, where one was at the roof and the other at the back behind the molars. The patient also stated that it was difficult for her to eat with the ulcers. The patient experienced itchiness after vaccination with both the doses. The patient took BENADRYL for itching and for the other events she took ALEVE. At the time of reporting, the patient stated that the events were better but not completely resolved. The patient also stated that, the patient had redness and swelling at the injection site 6 days after the shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Myalgia, Oral pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of hypersensitivity (and other events after receiving 1st dose on 16th April 2018, refer case US2018143007). On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced mouth ulcer, sore mouth and eating disorder. On an unknown date, the patient experienced allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, shivering and fever. The patient was treated with BENADRYL and ALEVE. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the allergic reaction, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the right arm. The patient experienced similar adverse events with the 2nd dose as that after receiving the 1st dose, with some additional events. The patient stated that she could hardly move, felt terrible, hard to even get out of her bed. The patient experienced ulcers in the mouth, where one was at the roof and the other at the back behind the molars. The patient also stated that it was difficult for her to eat with the ulcers. The patient experienced itchiness after vaccination with both the doses. The patient took BENADRYL for itching and for the other events she took ALEVE. At the time of reporting, the patient stated that the events were better but not completely resolved. The patient also stated that, the patient had redness and swelling at the injection site 6 days after the shot.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Patient showed picture of arm with bandage still applied. Erythema, pain and redness over lower portion of deltoid beginning at lower portion of bandage and extending in direction of elbow. Estimate about 2.5 in. by 3 in. area. No anaphylaxis or pruritus. No hives. Limited to local area. Full recovery in 2 days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Myalgia, Peripheral swelling
Clinical narrative: Fatigue, muscular aches - arm swollen significantly. Slepts more than 24 hours over 1 1/2 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Sore, itchy arm. Itching lasts up to today 08/15/18 (17 days).
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nervousness, Pallor, Syncope
Clinical narrative: Per Mother patient stated she was starting to feel light headed after receiving vaccine and fainted. Mother grabbed patient and helped lower her to exam table. Patient alert and oriented when RN re-entered room. Patient states she was a little nervous for vaccine and felt weak but didn't know what happened and thought she was dreaming. Gave patient Sprite to drink, states she is beginning to feel better. Dr. notified and evaluated patient. Had patient lay on exam table and rest for 15 more minutes. Color returning. Mother driving patient home. Alert note added to patient's chart re: syncope w/ vaccines.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hunger, Hypersomnia, Hypophagia, Injection site pain
Clinical narrative: The next day after receiving 2nd dose of SHINGRIX, patient reported having significant general malaise, excessive tiredness, sleeping more than usual, and some nausea during 24 hour period after receiving vaccination. Patient also reporting having significant soreness in arm at injection site, not feeling hungry, not eating as usual. Patient did say symptoms improved significantly the next day (48 hours after vaccination). Patient also stated that reaction/symptoms after receiving 2nd dose of SHINGRIX seemed much worse than after receiving 1st dose of SHINGRIX.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: The next day after receiving 2nd dose of SHINGRIX, patient reported having significant general malaise, excessive tiredness, sleeping more than usual, and some nausea during 24 hour period after receiving vaccination. Patient also reporting having significant soreness in arm at injection site, not feeling hungry, not eating as usual. Patient did say symptoms improved significantly the next day (48 hours after vaccination). Patient also stated that reaction/symptoms after receiving 2nd dose of SHINGRIX seemed much worse than after receiving 1st dose of SHINGRIX.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Cough, Dysphagia, Feeling of body temperature change, Pulse abnormal, Salivary hypersecretion
Clinical narrative: Pt was administered Anthrax vaccine 0.5ml to right arm at 3:14pm. Shortly after, pt began coughing while in waiting room. Pt then stated at this time that she coughed last time she received both the Typhoid and Anthrax vaccine on 6/6/18 but that it lasted for about five minutes. We continued to monitor pt and noted that cough was becoming worse with time. At 3:30pm pt was brought back to treatment room and vital signs were taken as: BP 130/90 HR 87 while sitting radial pulse noted to be weak and thready, RR was difficult to assess due to frequent coughing. No local reaction noted to injection site. After a few minutes, pt then informed she was feeling "mouth watery" "difficulty to swallow" and "hot and cold." Pt was placed on 100% NRB 15L with no improvement. 911 was called by another service member. EPIPEN 0.3mg was given IM to left thigh at 3:36pm. Pt noted to cough slightly less and informed that swallowing felt better. VS taken at 1541 as: BP 120/82 HR 114 Spo2 99% on 4L NC, RR continued to be difficult to assess due to frequent coughing. Coughing then produced to get worse. Second dose EPIPEN given IM to right thigh at 1542. Ambulance team arrived at this time. Report was given and pt transferred to local  hospital.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Neck pain
Clinical narrative: Sore neck all sides for 2 weeks TYLENOL 100 m 4 x daily for week and 500 after.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Local circumferential injection site reaction with swelling, mild warmth, and mild hyperemia. Approx 8 cm diameter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Very sore upper arm, difficulty raising arm, fatigue, and for an hour or two after all nausea. Upper arm problem is continuing on the 2nd day.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: Full seizure that lasted a full minute about 15 minutes after the injection.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: Patient received shingles vaccine and had swelling and bruising and arm pain on the underside of his arm and elbow below the injection site. Complained of his arm feeling heavy and hard to move and bruising on his arm around his elbow (beginning about 3 days after the immunization). He said swelling around his elbow began about 4 days after the immunization. He sought treatment from the prescribing MD who evaluated the bruising, swelling, and pain. Prescribed him a pain reliever and MD was not concerned about the swelling or bruising. Patient takes warfarin so extra bruising is common. Patient is content that we would report this event and speak to his MD about it. All issues were resolved with patient and after speaking to MD all issues were resolved with them as well.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. In 2016, the patient was treated by a physician for the onset of a rash which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, 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 not recovered. Causality assessment was related. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Injection site pain, Local reaction
Clinical narrative: Nurse spoke to mother @10:00 AM on 08/14/2018: mother reports  pain at injection site with large local reaction; pain and sensation of pressure in sternum resulting in "trouble breathing".  Afebrile and no other signs of illness. Mother giving Acetaminophen. Dr.consulted and concerned about possible pneumothorax. Mother spoke with doctor to discuss option of ER and/or Chest X-ray and mutually decided for Chest X-ray.  Dr. also advised giving 600mg of ibuprofen. Pt received Chest X-ray at 11:30 with normal results. Dr. advised to continue with ibuprofen and follow up if symptoms worsen. Mother reported on 08-15-2018: pt continues having symptoms but with lessening severity.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given too early.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: Developed extremely pain in arm 3 hours after injection until the next day. Developed chills and weakness in the middle of the night. Extreme fatigue. Slept through most of the next day until 4pm and then went to sleep at 9 and slept through til next morning. Noticed red blotchy rash across my stomach and chest area. It was a little itchy too. The nurse also found the rash inside my elbow joints, my back, and the back of my neck.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Developed extremely pain in arm 3 hours after injection until the next day. Developed chills and weakness in the middle of the night. Extreme fatigue. Slept through most of the next day until 4pm and then went to sleep at 9 and slept through til next morning. Noticed red blotchy rash across my stomach and chest area. It was a little itchy too. The nurse also found the rash inside my elbow joints, my back, and the back of my neck.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pruritus, Rash erythematous
Clinical narrative: Developed extremely pain in arm 3 hours after injection until the next day. Developed chills and weakness in the middle of the night. Extreme fatigue. Slept through most of the next day until 4pm and then went to sleep at 9 and slept through til next morning. Noticed red blotchy rash across my stomach and chest area. It was a little itchy too. The nurse also found the rash inside my elbow joints, my back, and the back of my neck.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head abnormal, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: On June 16 had shingles vaccine and 30 min later had a reaction. Symptoms have been constant since then. She has pressure left frontal/temple/side of head or face, behind the left eye, also feels intense dizziness (lightheaded like not inhabiting her body completely, no spinning), nauseous, fatigued. Sensitive to light and sound but had this at baseline as well. Maybe less intense then the beginning. Symptoms come and go like spells. No time of day more prominent. Usually lasts 10-15 min at a time but would return. Sometimes will have numbness left side of nose. Episodes occur daily since injection. No change in vision. She does feel her memory is not as good as it was (retrieval of names is more difficult), feels more foggy since the vaccine. In the first two weeks (after had to take a 1.5 hr nap every day which was much different for her. Initially had numbness/tingling to the left around her mouth but has not felt that since last week. Never had drooling or dribbling out the side of her mouth. No trouble or pain with chewing. No rashes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperacusis, Hypoaesthesia, Hypoaesthesia oral, Memory impairment, Meningioma
Clinical narrative: On June 16 had shingles vaccine and 30 min later had a reaction. Symptoms have been constant since then. She has pressure left frontal/temple/side of head or face, behind the left eye, also feels intense dizziness (lightheaded like not inhabiting her body completely, no spinning), nauseous, fatigued. Sensitive to light and sound but had this at baseline as well. Maybe less intense then the beginning. Symptoms come and go like spells. No time of day more prominent. Usually lasts 10-15 min at a time but would return. Sometimes will have numbness left side of nose. Episodes occur daily since injection. No change in vision. She does feel her memory is not as good as it was (retrieval of names is more difficult), feels more foggy since the vaccine. In the first two weeks (after had to take a 1.5 hr nap every day which was much different for her. Initially had numbness/tingling to the left around her mouth but has not felt that since last week. Never had drooling or dribbling out the side of her mouth. No trouble or pain with chewing. No rashes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nuclear magnetic resonance imaging brain abnormal, Ocular discomfort, Paraesthesia oral, Photophobia
Clinical narrative: On June 16 had shingles vaccine and 30 min later had a reaction. Symptoms have been constant since then. She has pressure left frontal/temple/side of head or face, behind the left eye, also feels intense dizziness (lightheaded like not inhabiting her body completely, no spinning), nauseous, fatigued. Sensitive to light and sound but had this at baseline as well. Maybe less intense then the beginning. Symptoms come and go like spells. No time of day more prominent. Usually lasts 10-15 min at a time but would return. Sometimes will have numbness left side of nose. Episodes occur daily since injection. No change in vision. She does feel her memory is not as good as it was (retrieval of names is more difficult), feels more foggy since the vaccine. In the first two weeks (after had to take a 1.5 hr nap every day which was much different for her. Initially had numbness/tingling to the left around her mouth but has not felt that since last week. Never had drooling or dribbling out the side of her mouth. No trouble or pain with chewing. No rashes.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Starting the day after vaccination, pt experienced swelling of the vaccinated arm from the injection site to elbow. It was hot, itchy and caused pt severe pain. Pt did not experience any other adverse reaction. At the time of reporting, 8.16.2018 the rxn had not abated. Told pt's husband who reported that she should call dr. I also tried to call dr.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: After giving the vaccination, it was found that vaccine was expired. The vaccine expired 01/01/2018. I contacted RN and Immunization Nurse with Health Dept to report this. Pts mother was made aware of the above and verbalized understanding.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Discomfort, Dyskinesia, Eye movement disorder, Hypotonia
Clinical narrative: PT RECEIVED THE IM SHOT AND IMMEDIATELY SLUMPED AND WAS CLAMMY. EYES ROLLED BACK SOME WHAT AND HE WENT LIMP. PT JERKED A COUPLE OF TIMES. WITH IN 20 SECONDS HE WAS RESPONDING TO HIS GRANDPA. HE CAME TO AND SIPPED ON SPRITE AND WITH IN 5 MINUTES SAID HE WAS OK. HE STAYED FOR 20 MINUTES AND LEFT AS THE PARAMEDICS ARRIVED. THE PARAMEDIC AGREED THAT THE PATIENT WAS OK. PT HAD TALKED A LOT ABOUT HOW DISCOMFORTED HE HAD BEEN WHEN HE GOT THE TDAP SHOT AT HIS DAD'S WORK LAST WEEK.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Immediate post-injection reaction
Clinical narrative: PT RECEIVED THE IM SHOT AND IMMEDIATELY SLUMPED AND WAS CLAMMY. EYES ROLLED BACK SOME WHAT AND HE WENT LIMP. PT JERKED A COUPLE OF TIMES. WITH IN 20 SECONDS HE WAS RESPONDING TO HIS GRANDPA. HE CAME TO AND SIPPED ON SPRITE AND WITH IN 5 MINUTES SAID HE WAS OK. HE STAYED FOR 20 MINUTES AND LEFT AS THE PARAMEDICS ARRIVED. THE PARAMEDIC AGREED THAT THE PATIENT WAS OK. PT HAD TALKED A LOT ABOUT HOW DISCOMFORTED HE HAD BEEN WHEN HE GOT THE TDAP SHOT AT HIS DAD'S WORK LAST WEEK.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient got her second dose of SHINGRIX on 7/27/18 and on 8/10/18 was diagnosed with and sought treatment for Shingles. She said she had a rash.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Red Rash that is warm touch and some minor arm swelling lasting 48 hours so far. Pt is now using BENADRYL, APAP, and cold compresses to relieve symptoms.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Headache, Hiccups
Clinical narrative: No immediate arm pain. Woke up at 3:00 a.m. the next morning with a 101.2 fever, chills, muscle aches throughout entire body. Severe headache as well. I took Advil and Tylenol which helped but fever stayed all that day at 100.6. Slight cough, and I kept getting the hiccups. Now I'm on day two and feeling better, but still fatigued and achey.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: No immediate arm pain. Woke up at 3:00 a.m. the next morning with a 101.2 fever, chills, muscle aches throughout entire body. Severe headache as well. I took Advil and Tylenol which helped but fever stayed all that day at 100.6. Slight cough, and I kept getting the hiccups. Now I'm on day two and feeling better, but still fatigued and achey.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Localised infection, Nodule, Scar
Clinical narrative: Infection, scar tissue build up in arm (large knot).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site pain, Pain, Pruritus
Clinical narrative: Patient reported pain at time of injection. Later reported redness, swelling, hot to touch, stinging, itching, and hardness in places.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Patient reported pain at time of injection. Later reported redness, swelling, hot to touch, stinging, itching, and hardness in places.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pain
Clinical narrative: 'Flu like symptoms' of headache, body aches, nausea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Musculoskeletal pain, Swelling
Clinical narrative: Patient called the pharmacy about pain, swelling, redness, and limited mobility in her shoulder. I explained to the patient that this is probably related to how the immunization was administered. I also explained that my team would get back to her about what her next steps would be in regards to going to see her primary care physician to treat the symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: Next day:  headache and arm ache. 2nd day: large red patch around injection site; warm to touch. 4-12th days:  Beginning "hives" around neck.... gradually progressing to under arms .... then to groin area; a lot of itching; topical CALADRYL and BENADRYL tabs taken; temp relief only. 13th day: symptoms continue; have not sought medical TX yet, but thinking about it.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Next day:  headache and arm ache. 2nd day: large red patch around injection site; warm to touch. 4-12th days:  Beginning "hives" around neck.... gradually progressing to under arms .... then to groin area; a lot of itching; topical CALADRYL and BENADRYL tabs taken; temp relief only. 13th day: symptoms continue; have not sought medical TX yet, but thinking about it.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed redness/swelling/pain at site of injection day after injection. Sought medical attention at urgent care and received ABX. Has pending follow up with physician.
Age: 38.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Muscular weakness
Clinical narrative: Minutes after the patient received both vaccines. He started to feel weakness on his right arm, in which I had injected PNEUMOVAX 23. About 5-10 minutes later, he was able to regain his strength. I made a second call a few hours later to see if there was any continued weakness or reaction, he said he was doing better.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain, Faeces soft, Sleep disorder
Clinical narrative: Developed abdominal pain the following morning which increased in intensity at night, waking her from sleep. Also had 2 soft stools, one in the middle of the night and one in the morning. No vomiting or fever.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Insomnia, Myalgia, Oropharyngeal pain
Clinical narrative: High fever, chills, weakness, muscle aches, insomnia, sore throat for two days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever, chills, weakness, muscle aches, insomnia, sore throat for two days.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Cough, Fatigue, Full blood count normal, Malaise
Clinical narrative: He reports fever up to 40C, malaise, cough, R arm swelling that started 2 hours after receiving injection. Seen in Urgent Care on 8/12/18 with normal CBC, BMP. Arm pain/swelling  have improved over time but 6 days later he continued to have purulent cough and fatigue. CXR 8/16/18 showed RML pneumonia. Treated with doxycycline. I advised that pneumovax cannot cause pneumonia but promised him to report it.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test normal, Pain in extremity, Peripheral swelling, Pneumonia, Purulent discharge
Clinical narrative: He reports fever up to 40C, malaise, cough, R arm swelling that started 2 hours after receiving injection. Seen in Urgent Care on 8/12/18 with normal CBC, BMP. Arm pain/swelling  have improved over time but 6 days later he continued to have purulent cough and fatigue. CXR 8/16/18 showed RML pneumonia. Treated with doxycycline. I advised that pneumovax cannot cause pneumonia but promised him to report it.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: He reports fever up to 40C, malaise, cough, R arm swelling that started 2 hours after receiving injection. Seen in Urgent Care on 8/12/18 with normal CBC, BMP. Arm pain/swelling  have improved over time but 6 days later he continued to have purulent cough and fatigue. CXR 8/16/18 showed RML pneumonia. Treated with doxycycline. I advised that pneumovax cannot cause pneumonia but promised him to report it.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Impaired work ability, Nausea
Clinical narrative: About 30 hours after receiving the vaccine, I began to feel nauseous and weak. About 10 minutes after that, I was unable to sit at a table and had to lie flat on the floor. About 20 minutes after that, I developed shaking and chills (despite wearing a heavy sweater and being wrapped in a warm blanket on a warm day). This lasted for about two hours. I may have had a fever but did not check. After that, I felt exhausted and weak, but no longer had chills. I had to miss a day of work. By early evening I was feeling better, though still tired. The next morning I was much better. I think having a reaction so severe that I missed work, while not causing disability or death, is significant. These were not "mild" events.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: About 30 hours after receiving the vaccine, I began to feel nauseous and weak. About 10 minutes after that, I was unable to sit at a table and had to lie flat on the floor. About 20 minutes after that, I developed shaking and chills (despite wearing a heavy sweater and being wrapped in a warm blanket on a warm day). This lasted for about two hours. I may have had a fever but did not check. After that, I felt exhausted and weak, but no longer had chills. I had to miss a day of work. By early evening I was feeling better, though still tired. The next morning I was much better. I think having a reaction so severe that I missed work, while not causing disability or death, is significant. These were not "mild" events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal discomfort, Discomfort, Eye swelling, Injection site movement impairment, Injection site rash
Clinical narrative: Started complaining about her leg not being able to run. No fever at this point, site of injection not swollen, feverish or hard but just little dots. She didn't eat lunch, started slowing down and was telling me she just couldn't run. She appeared a bit pale and bags around her eyes. Sat on my lap not wanting to do anything and couldn't get comfy enough to nap, we got tylenol. First dose went ok, she ate dinner and laughed. Then the 2nd does didn't relieve the fever she gained and she kept complaining of an upset tummy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pallor, Pyrexia
Clinical narrative: Started complaining about her leg not being able to run. No fever at this point, site of injection not swollen, feverish or hard but just little dots. She didn't eat lunch, started slowing down and was telling me she just couldn't run. She appeared a bit pale and bags around her eyes. Sat on my lap not wanting to do anything and couldn't get comfy enough to nap, we got tylenol. First dose went ok, she ate dinner and laughed. Then the 2nd does didn't relieve the fever she gained and she kept complaining of an upset tummy.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Erythema, Headache, Pain, Pyrexia
Clinical narrative: 6:00pm 7/27/18-felt feverish with chills, headaches and body aches. Morning of 7/30/18-almost golf ball size swelling with redness. Started taking TYLENOL. (24 hours total). Morning of 7/31/18-symptoms and reactions gone.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Swelling
Clinical narrative: 6:00pm 7/27/18-felt feverish with chills, headaches and body aches. Morning of 7/30/18-almost golf ball size swelling with redness. Started taking TYLENOL. (24 hours total). Morning of 7/31/18-symptoms and reactions gone.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Patient complained of soreness and stiffness in left arm the day after vaccination. Two days after vaccination, she reported redness and swelling extending down to elbow and was referred to a walk-in clinic. Began using diclofenac 1% gel with little relief of symptoms. Reported to emergency department 8/15/18 due to continued pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Fall, Musculoskeletal stiffness, Seizure, Syncope
Clinical narrative: Patient fainted after Vaccs administration today, patient walked to nurse station and suddenly fell forward. Stiffness and convulsion were noted for about 7 seconds, patient was turned face up and ice pack was placed behind her head. Patient was responsive with the minute, we got her up and take her back to her room via WC. Dr was notified, and FNP also noted the situation. VSS 105/67, HR 83 O2Sat 100 percent. Parent stated that patient was fasting, peanut butter crackers and water were given after checking Blood sugar, BS: 88. Patient waited for 15 minutes and was released, no other symptoms noted. Patient was escorted to parent's vehicle per nursing staff. Patient will follow up with MD on Monday.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Eyelid oedema, Rash, Rash pruritic, Urticaria
Clinical narrative: Pt broke out with rash the evening of the same day of her HPV vaccine. It was welt like and itchy. Eyes were puffy. Rash on trunk, arms and legs. Seen 2d later, already resolving. Rx antihistamine, CORTAID CREAM.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Headache, Sensory loss, Syncope
Clinical narrative: 1.5 hours after receiving vaccines, had an episode of syncope at a store. EMS/911 transported him to hospital. Complaints of decreased sensation in legs, feeling weak, severe headache.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection. Tx cephalexin (L) thigh.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient's mother reports that in the evening her daughter started to complain about soreness in her left arm and has generalized arm pain since. Mother also notes that she has been nauseous as well. Reaction discussed with PCP Dr. He suggests ice and Ibuprofen.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to the clinic on 8/11/18 with left upper arm, red swollen over deltoid area. Recommended MOTRIN and cool compresses. Reassured pt, symptoms would hopefully resolve over the next few days.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous case was received from a 70 years old, female consumer concerning herself. The patient's concurrent conditions, historical conditions and concomitant medications were not provided. On 22-SEP-2017, at an unspecified Pharmacy, the patient received ZOSTAVAX indicated for preventive of herpes zoster, lot number M041087, expiration date 03-JAN-2018 (strength, dosage, route administration were not provided). In June, 2018, the patient reported she broke out in a red rash all over her body which was itchy. The patient reported she had used rubbing alcohol on her skin and over the counter unspecified BENADRYL, with unknown dosage and frequency to treat the rash. Patient further reported that she did see her physician on unknown date, but few weeks later rash was almost healed. The causality assessment between ZOSTAVAX and the event was not provided.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Pallor
Clinical narrative: This spontaneous report has been received via a company representative and from a registered nurse and refers to a 16 year old (at the time of the event) male patient.  The patient's concurrent conditions, medical history or concomitant medications were not reported. The patient had no Pre-existing physician-diagnosed allergies, birth defects, medical conditions. On 09-APR-2018, the patient was administered the first doses of GARDASIL 9 intramuscular (IM) injection (lot number N022728, expiration date 31-MAY-2020) and BEXSERO IM (lot number M1704, expiration date not reported) and the second dose of MENVEO IM (lot number 16D501), all vaccines administered under aseptic measures in the left arm and right upper external part as routine immunization (dose and frequency were not reported). On the same date approximately at 2:00 pm, 5 to 10 minutes after administering the vaccines according to the vaccination protocol for the patient's age, he experienced syncope. The patient leaved the facilities of the office and when he was in the hall in front of the institution he became dizzy, pale, weak, and he needed help to stand up, then the patient's mother held him so that he would not hit the ground, as she verbalized herself. But the patient was weak and slide to the floor but did not receive any blow as verbalized by the patient's mother. Alcohol gauze was placed in front of the patient's nostrils to try to animate him. The patient continued to feel bad, so he was placed on a chair with the help of the father and the patient started to vomit (syncope). The mother called emergencies but they told her that they would not arrive soon, so patient's parents took him in to the hospital.  The reporting nurse accompanied the patient to the hospital to verify that he had arrived well and received first aid. The patient was evaluated by a doctor and the nurses on duty. When measuring the vital signs of the patient, it was noticed that the blood pressure was low, so they proceeded to place intravenous therapy of 9 NSS 1000ml, lowering full drip and placed the patient in the lemberg train position to bring blood pressure to normal levels. The patient began to feel better as he referred and indicated not to be dizzy and began to recover the normal color of the skin. The patient's blood pressure reached an appropriate level, so the reporting nurse leaved the patient under his parent company and under medical care. At the time of the report, the patient was recovered from syncope. The causal relationship between the event syncope and GARDASIL 9 was not reported.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Asthenia, Dizziness, Dysstasia, Fall, Feeling abnormal
Clinical narrative: This spontaneous report has been received via a company representative and from a registered nurse and refers to a 16 year old (at the time of the event) male patient.  The patient's concurrent conditions, medical history or concomitant medications were not reported. The patient had no Pre-existing physician-diagnosed allergies, birth defects, medical conditions. On 09-APR-2018, the patient was administered the first doses of GARDASIL 9 intramuscular (IM) injection (lot number N022728, expiration date 31-MAY-2020) and BEXSERO IM (lot number M1704, expiration date not reported) and the second dose of MENVEO IM (lot number 16D501), all vaccines administered under aseptic measures in the left arm and right upper external part as routine immunization (dose and frequency were not reported). On the same date approximately at 2:00 pm, 5 to 10 minutes after administering the vaccines according to the vaccination protocol for the patient's age, he experienced syncope. The patient leaved the facilities of the office and when he was in the hall in front of the institution he became dizzy, pale, weak, and he needed help to stand up, then the patient's mother held him so that he would not hit the ground, as she verbalized herself. But the patient was weak and slide to the floor but did not receive any blow as verbalized by the patient's mother. Alcohol gauze was placed in front of the patient's nostrils to try to animate him. The patient continued to feel bad, so he was placed on a chair with the help of the father and the patient started to vomit (syncope). The mother called emergencies but they told her that they would not arrive soon, so patient's parents took him in to the hospital.  The reporting nurse accompanied the patient to the hospital to verify that he had arrived well and received first aid. The patient was evaluated by a doctor and the nurses on duty. When measuring the vital signs of the patient, it was noticed that the blood pressure was low, so they proceeded to place intravenous therapy of 9 NSS 1000ml, lowering full drip and placed the patient in the lemberg train position to bring blood pressure to normal levels. The patient began to feel better as he referred and indicated not to be dizzy and began to recover the normal color of the skin. The patient's blood pressure reached an appropriate level, so the reporting nurse leaved the patient under his parent company and under medical care. At the time of the report, the patient was recovered from syncope. The causal relationship between the event syncope and GARDASIL 9 was not reported.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Hypotension, Pallor, Syncope, Vomiting
Clinical narrative: This spontaneous report has been received via a company representative and from a registered nurse and refers to a 16 year old (at the time of the event) male patient.  The patient's concurrent conditions, medical history or concomitant medications were not reported. The patient had no Pre-existing physician-diagnosed allergies, birth defects, medical conditions. On 09-APR-2018, the patient was administered the first doses of GARDASIL 9 intramuscular (IM) injection (lot number N022728, expiration date 31-MAY-2020) and BEXSERO IM (lot number M1704, expiration date not reported) and the second dose of MENVEO IM (lot number 16D501), all vaccines administered under aseptic measures in the left arm and right upper external part as routine immunization (dose and frequency were not reported). On the same date approximately at 2:00 pm, 5 to 10 minutes after administering the vaccines according to the vaccination protocol for the patient's age, he experienced syncope. The patient leaved the facilities of the office and when he was in the hall in front of the institution he became dizzy, pale, weak, and he needed help to stand up, then the patient's mother held him so that he would not hit the ground, as she verbalized herself. But the patient was weak and slide to the floor but did not receive any blow as verbalized by the patient's mother. Alcohol gauze was placed in front of the patient's nostrils to try to animate him. The patient continued to feel bad, so he was placed on a chair with the help of the father and the patient started to vomit (syncope). The mother called emergencies but they told her that they would not arrive soon, so patient's parents took him in to the hospital.  The reporting nurse accompanied the patient to the hospital to verify that he had arrived well and received first aid. The patient was evaluated by a doctor and the nurses on duty. When measuring the vital signs of the patient, it was noticed that the blood pressure was low, so they proceeded to place intravenous therapy of 9 NSS 1000ml, lowering full drip and placed the patient in the lemberg train position to bring blood pressure to normal levels. The patient began to feel better as he referred and indicated not to be dizzy and began to recover the normal color of the skin. The patient's blood pressure reached an appropriate level, so the reporting nurse leaved the patient under his parent company and under medical care. At the time of the report, the patient was recovered from syncope. The causal relationship between the event syncope and GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries. Upon information and belief, the physician prescribed and or administered the ZOSTAVAX to the patient. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 15-SEP-2015, the patient was treated by (an unspecified physician or health care professional) at an otolaryngology medical group and was diagnosed with Ramsey Hunt Syndrome and hearing loss. As a direct and proximate result of the ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require 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. Upon internal review, Ramsay Hunt Syndrome and hearing loss was determined to be medical significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries. Upon information and belief, the physician prescribed and or administered the ZOSTAVAX to the patient. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 15-SEP-2015, the patient was treated by (an unspecified physician or health care professional) at an otolaryngology medical group and was diagnosed with Ramsey Hunt Syndrome and hearing loss. As a direct and proximate result of the ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require 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. Upon internal review, Ramsay Hunt Syndrome and hearing loss was determined to be medical significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Hypoaesthesia, Paraesthesia, Presyncope
Clinical narrative: Information has been received from a medical assistant referring to an 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 23-JUL-2018 the patient received one dose of GARDASIL 9 (lot # N028567, expiration date 17-MAY-2020), intramuscularly for prophylaxis. On 23-JUL-2018, within one minute after receiving GARDASIL 9, the patient had a syncopal episode, numbness and tingling in her extremities, abdominal pain, and experienced tachycardia. The patient visited physician to seek medical attention. No treatment was given. No lab test was performed. On the same day, the patient recovered within 30 minutes after GARDASIL 9 was administered. The causality assessment was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Hypoaesthesia, Paraesthesia, Syncope, Tachycardia
Clinical narrative: Information has been received from a medical assistant referring to an 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 23-JUL-2018 the patient received one dose of GARDASIL 9 (lot # N028567, expiration date 17-MAY-2020), intramuscularly for prophylaxis. On 23-JUL-2018, within one minute after receiving GARDASIL 9, the patient had a syncopal episode, numbness and tingling in her extremities, abdominal pain, and experienced tachycardia. The patient visited physician to seek medical attention. No treatment was given. No lab test was performed. On the same day, the patient recovered within 30 minutes after GARDASIL 9 was administered. The causality assessment was not provided.