chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Extreme pain in upper L arm two hours after injection. Unable to get out of bed without help the next morning due to pain, lightheadedness, weakness, and fatigue. Headache and shivering followed. Side effects gradually diminished the first 24 hours. The second day only fatigue and moderate pain in the L arm persisted. I would have appreciated the person giving me the injection alerting me to possible side effects. I called pharmacy for help but hung up after over 20 minutes on hold. I didn't report this to Dr. as I read the information online about side effects. I've never had an adverse reaction to a vaccination before, so waited it out.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Extreme pain in upper L arm two hours after injection. Unable to get out of bed without help the next morning due to pain, lightheadedness, weakness, and fatigue. Headache and shivering followed. Side effects gradually diminished the first 24 hours. The second day only fatigue and moderate pain in the L arm persisted. I would have appreciated the person giving me the injection alerting me to possible side effects. I called pharmacy for help but hung up after over 20 minutes on hold. I didn't report this to Dr. as I read the information online about side effects. I've never had an adverse reaction to a vaccination before, so waited it out.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash, Swelling
Clinical narrative: Verbal communication, patient reported approx. 3 days after injection, swelling and rash appeared in arms, legs, and back. Pt. saw doctor who gave prednisone to control. No further progression.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, Culture urine negative, Emotional distress
Clinical narrative: Pt started to get fussy two hours after vaccinations were administered and became inconsolable. within 5 hours she started to get a fever, she did have a small amount of tylenol but it did not help, by 6 hours she had a fever of 100.4 so we took her to the hospital and when they took a rectal temperature she was at 101.4 the nurse administered tylenol to her. Once admitted they ran blood, urine, spinal tap tests on her to make sure no bacteria was present, because of her age she had to stay in the hospital for three days to be monitored and make sure no bacteria was growing in her cultures. They did give me paperwork stating that this was a reaction to her vaccines.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia, Vaccination complication
Clinical narrative: Pt started to get fussy two hours after vaccinations were administered and became inconsolable. within 5 hours she started to get a fever, she did have a small amount of tylenol but it did not help, by 6 hours she had a fever of 100.4 so we took her to the hospital and when they took a rectal temperature she was at 101.4 the nurse administered tylenol to her. Once admitted they ran blood, urine, spinal tap tests on her to make sure no bacteria was present, because of her age she had to stay in the hospital for three days to be monitored and make sure no bacteria was growing in her cultures. They did give me paperwork stating that this was a reaction to her vaccines.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed severe pain in right deltoid a few hours following vaccine. On exam in office on 12/11/18 (following day), right deltoid area with moderate swelling, exquisite tenderness, fever to 101.6. Placed on antibiotics for cellulitis. Received flu vaccine on the same day on same arm. Received HepA and HPV vaccines on the same day on opposite (left) arm.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Drooling, Facial paralysis, Hypogeusia
Clinical narrative: Started noticing slobbering while brushing teeth then three days later during drinking from soda bottle and noticed loss of sweet taste.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: 102 fever and mild rash on her chest.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: ARM TURNED RED AT THE INJECTION SITE. REDNESS GOT BIGGER AS THE DAY WENT ON.  PATIENT WENT TO ER. DOCTOR TOLD HER IT WAS CELLULITIS. PATIENT WAS GIVEN AN ANTIBIOTIC. GENERIC BACTRIM DS.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria, Vaccination complication
Clinical narrative: Reports a reaction after the 1st shot. States she had itching, rash, and hives.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Localised oedema
Clinical narrative: Patient experience local erythema and edema which resolved in "a few days" without medical treatment per patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue, fever, chills, muscle aches headache.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient reported severe pain at injection site and shoulder following administration of BEXSERO for prophylaxis. Previously administered dose of BEXSERO given at pediatricians office on 09/06/18 produced a similar response. Patient described pain after second dose as more severe with significant impairment to range of motion and difficulty completing activities of daily ling X 1 day. States pain occurs only with movement. Pain was described as "burning" with a sensation of being "punched". Site was free of redness, swelling. Area was NOT tender to touch. Patient reported significant improvement to symptoms with use of OTC ADVIL and complete resolution to symptoms occurring with 48/hours.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: Body wide rash.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experience redness, swelling and skin hot to the touch below injection site and on the back side of the arm. Symptoms were the worst 2 days post injection and seemed to be subsiding 3 days post injection.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported a numb arm less than 5 minutes after receiving vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: A family member called the pahrmacy to report the event. She said patient started having severe pain in her shoulder and down her arm the same day after getting  the vaccination. The pain was so severe she had to go to the emergency room. She ended up being admitted to the hospital.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Rash
Clinical narrative: Rash for 3 days, but does not hurt. A little hard. Told patient to put a cold pack for now, possibly contact doctor if rash worsens.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient presented reporting continued achy arm following vaccination. Referred to a doctor and at home pain relief remedies ie. cold compress, normal pain relievers.
Age: 51.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Blood test, Erythema, Induration, Inflammation, Pain
Clinical narrative: Patient stated that he did feel some soreness after injection (on a Sunday), but didn't see any real symptoms until the following (Wednesday). He said he felt a fever and his arm get sore and red and hard to the touch. The inflammation was substantial in his opinion, but only on his left arm.  He said the left arm also got a little red, but not as bad as the left arm in his opinion. He went to the pharmacy and spoke to the pharmacist on duty (the following  Saturday), at which point he was referred to a doctor for further evaluation. He then came back on the following Sunday, and presented with an rx for an antibiotic. In a follow up conversation with the patient by the vaccinating pharmacist, he stated his arm is looking much better, and the redness and swelling have gone down. He stated he no longer felt a fever or pain, but stil felt sore.
Age: 51.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, X-ray
Clinical narrative: Patient stated that he did feel some soreness after injection (on a Sunday), but didn't see any real symptoms until the following (Wednesday). He said he felt a fever and his arm get sore and red and hard to the touch. The inflammation was substantial in his opinion, but only on his left arm.  He said the left arm also got a little red, but not as bad as the left arm in his opinion. He went to the pharmacy and spoke to the pharmacist on duty (the following  Saturday), at which point he was referred to a doctor for further evaluation. He then came back on the following Sunday, and presented with an rx for an antibiotic. In a follow up conversation with the patient by the vaccinating pharmacist, he stated his arm is looking much better, and the redness and swelling have gone down. He stated he no longer felt a fever or pain, but stil felt sore.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site no pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: While driving home after receiving the vaccine, she started seeing colorful dots out of the eye where she'd had a cataracts surgery and implant. At the time of the call (20 minutes after the administration), she reported via phone that symptoms were improving.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient had a seizure (with a fever of 100.5F) approximately 4 hours after receiving MMR and Varicella. I am unsure of the site of injection or the brand of the vaccination I just saw him in the emergency department.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Had Flu like symptoms with fever and aches for 3 days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Bad headache, Muscle aches, Fever, Chills.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Constipation, Diarrhoea, Emotional distress, Insomnia, Middle insomnia
Clinical narrative: Twenty-four hours later... 101 degree fever, screamed inconsolably for three nights and could not be comforted or helped to sleep. Then developed very bad diarrhea. Still woke screaming every 2 hours but could be consoled to sleep. Now a week later, waking more frequently at night, less consolable, and constipated.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Screaming
Clinical narrative: Twenty-four hours later... 101 degree fever, screamed inconsolably for three nights and could not be comforted or helped to sleep. Then developed very bad diarrhea. Still woke screaming every 2 hours but could be consoled to sleep. Now a week later, waking more frequently at night, less consolable, and constipated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt called 12/12/18 around 11:30 am and reported since she got the vaccine, right the next day she experienced high fever, body ache, lasted a few days, the symptoms got better when she called pharmacy however, she reported that the night before (12/11/18), at the injection site, the area (about the size of the palm of hand) turned red and raised and blotchy. The area is hot to touch and she's got an achy arm. She has been taking Tylenol. Advised pt to see her md so she could be monitored.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Pt called 12/12/18 around 11:30 am and reported since she got the vaccine, right the next day she experienced high fever, body ache, lasted a few days, the symptoms got better when she called pharmacy however, she reported that the night before (12/11/18), at the injection site, the area (about the size of the palm of hand) turned red and raised and blotchy. The area is hot to touch and she's got an achy arm. She has been taking Tylenol. Advised pt to see her md so she could be monitored.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache
Clinical narrative: Pt states she got up the next morning and had upset stomach, headache and dizziness. These symptoms continued for 6 more days and she only felt able to get up on the 7th day. After discussion, pt agrees these are some of the listed side effects of the vaccine, not adverse events, but she feels side effects should not be so severe or long lasting and asks that we report to the CDC.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received vaccine at 2:00 PM on 12/12/18 - at 2:25 PM patient experienced erythema and warmth 4 cm around injection site.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Noted left deltoid site was red and warm to the touch. Starts at shoulder and comes down midway.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Vision blurred
Clinical narrative: 12 hours after Tdap given experienced severe blurred vision, migraine headache.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the Left thigh measuring approximately 6 in. in diameter.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Feeling abnormal, Headache, Joint swelling
Clinical narrative: On Sept 30th 2018, I woke up with a severe headache and a buzzing feeling. My ankles were swollen, and my knees felt weak and shaky. My legs were heavy. I had blood work 10/4/18 and regular check-up 10/11/18 with my PCP. Everything was good. I went back to Dr 12/4/18. He gave me a prescription for methylprednisolone tablets - 4 mg - for 6 days. I have taken all of the pills and feel a little better, but I still have the buzzing feeling, headache off and on and heaviness in my legs. Never had a problem before. Please advise next course of treatment. Keep in mind, it takes 2 months to get an appointment with my PCP at this time of the year.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Limb discomfort, Nervousness
Clinical narrative: On Sept 30th 2018, I woke up with a severe headache and a buzzing feeling. My ankles were swollen, and my knees felt weak and shaky. My legs were heavy. I had blood work 10/4/18 and regular check-up 10/11/18 with my PCP. Everything was good. I went back to Dr 12/4/18. He gave me a prescription for methylprednisolone tablets - 4 mg - for 6 days. I have taken all of the pills and feel a little better, but I still have the buzzing feeling, headache off and on and heaviness in my legs. Never had a problem before. Please advise next course of treatment. Keep in mind, it takes 2 months to get an appointment with my PCP at this time of the year.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Fall, Feeling abnormal, Headache
Clinical narrative: On Sept. 30 2018, my body felt like it was vibrating internally. I had a terrible headache. My feet were swollen (feet were normal the next day). My top teeth hurt. My legs were weak, esp. the left one. I fell 3 times. My memory was also affected but that is coming back. I saw my primary care doctor 10/11/18. Both my blood work and physical were great. About 2 weeks later, I felt so bad that I went to the ER. They did a CT scan and blood work, both were normal. Dr. asked if I was sick the day of the shot, I said "no". He referred me back to my PCP. I went back to Dr (PCP) and he gave me (6) days of methylprednisolone 4 mg tabs. I finished the Rx, but I still have the vibrating, headache, and weak legs. The symptoms aren't as bad, but they're still there. Where do I go from here! It takes 2 months to get an appointment with my PCP for a referral to a specialist and 6 months for an appointment if you're a new patient. Will this ever go away? I would appreciate any help you can provide me with. You'll also be getting a form from my husband who also had a reaction. "Thank you" in advance for any help you can provide.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Memory impairment, Muscular weakness, Peripheral swelling, Toothache
Clinical narrative: On Sept. 30 2018, my body felt like it was vibrating internally. I had a terrible headache. My feet were swollen (feet were normal the next day). My top teeth hurt. My legs were weak, esp. the left one. I fell 3 times. My memory was also affected but that is coming back. I saw my primary care doctor 10/11/18. Both my blood work and physical were great. About 2 weeks later, I felt so bad that I went to the ER. They did a CT scan and blood work, both were normal. Dr. asked if I was sick the day of the shot, I said "no". He referred me back to my PCP. I went back to Dr (PCP) and he gave me (6) days of methylprednisolone 4 mg tabs. I finished the Rx, but I still have the vibrating, headache, and weak legs. The symptoms aren't as bad, but they're still there. Where do I go from here! It takes 2 months to get an appointment with my PCP for a referral to a specialist and 6 months for an appointment if you're a new patient. Will this ever go away? I would appreciate any help you can provide me with. You'll also be getting a form from my husband who also had a reaction. "Thank you" in advance for any help you can provide.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eye movement disorder, Head injury, Joint injury, Syncope
Clinical narrative: While walking out of office, Pt fainted hit head, elbow on the wall near doorway, Eyes rolled back. Nurse sat her up. She got her balance and walked into a room, laid on table, drank juice - BP after incident was 132/56, then 10min later was 100/60. Dr. assessed Pt, 2 mins here with Pt. After approximately 20 min, Pt walked out office with mom.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, shaking, joint muscular ache, HA 5 PM - 2 AM following day.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Fever, chills, shaking, joint muscular ache, HA 5 PM - 2 AM following day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm hurts at injection site greater than 2 days after injection.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Patient reported shortness of breath, swelling at site of injection, slight fever, and lethargy.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Dysphagia, Endotracheal intubation, Gait inability, Lumbar puncture, Muscular weakness
Clinical narrative: Guillian Barre Syndrome, patient hospitalized.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Respiration abnormal, Respiratory failure, Speech disorder
Clinical narrative: Guillian Barre Syndrome, patient hospitalized.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre Syndrome, patient hospitalized.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Antinuclear antibody increased, Asthenia, Blood creatinine normal, Blood pressure increased, Blood test
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Catheterisation cardiac normal, Chest X-ray abnormal, Chest pain, Chills, Dyspnoea
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Feeling abnormal, Headache
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Malaise, Pleural effusion, Pyrexia, Red blood cell sedimentation rate increased, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Catheterisation cardiac normal, Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Malaise
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pleural effusion
Clinical narrative: This spontaneous report was received from a consumer referring to herself a female patient of unknown age. The patient had no pertinent medical history and drug reactions or allergies. Patient's concomitant medication included raloxifene. On approximately 26-OCT-2018 (reported as 3 weeks ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided), 0.5 milliliter, once, intramuscular for routine vaccination prophylaxis. Other suspect therapies included SHINGRIX (dose, strength, frequency, indication, lot number and expiration date were not provided). On the same date, the patient felt sick (malaise) and the following day she went to Hospital because she had also trouble breathing, but she was not admitted. The reporter stated that she had fluid in her lungs which was affecting her breathing (pleural effusion). The hospital staff did an X-ray and electrocardiogram (EKG) and ruled out a heart attack. The patient went to her cardiologist on a later date. The cardiologist did a EKG and catheterized the patient's heart in case there was a blockage, it was later determined that there was no blockage and the patient was put on PLAQUINIL and steroids to treat the adverse event. The patient stated that she was getting better but still had some difficulty breathing when she bends over. The outcome of pleural effusion and malaise was reported as recovering. The causality assessment between the suspect therapies and the adverse event was unknown at the time of the report.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Back pain, Blood folate normal
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: C-reactive protein normal, Electromyogram abnormal, HIV test negative, Hepatitis viral test negative, Hyporeflexia
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immunology test normal, Laboratory test normal, Lumbosacral plexopathy, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Treponema test negative
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vitamin B12 normal
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Back pain, Electromyogram abnormal, Lumbosacral plexopathy, Muscle atrophy
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abdominal normal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Blindness unilateral, Blood homocysteine normal, Borrelia test negative, Cardiolipin antibody negative
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Differential white blood cell count normal, Full blood count normal, Glycosylated haemoglobin increased, Guillain-Barre syndrome, Immunology test
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lipids abnormal, Metabolic function test normal, Muscular weakness, Optic ischaemic neuropathy, Pain in extremity
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Papilloedema, Platelet count normal, Red blood cell sedimentation rate, Treponema test negative, Visual impairment
Clinical narrative: Lumbar plexopathy: Acute onset of left side lower back and left leg pain with weakness of left hip flexion and adduction, as well as muscle atrophy.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Back pain, Blood folate normal
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: C-reactive protein normal, Electromyogram abnormal, HIV test negative, Hepatitis viral test negative, Hyporeflexia
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immunology test normal, Laboratory test normal, Lumbosacral plexopathy, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Treponema test negative
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vitamin B12 normal
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Back pain, Electromyogram abnormal, Lumbosacral plexopathy, Muscle atrophy
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abdominal normal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Blindness unilateral, Blood homocysteine normal, Borrelia test negative, Cardiolipin antibody negative
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Differential white blood cell count normal, Full blood count normal, Glycosylated haemoglobin increased, Guillain-Barre syndrome, Immunology test
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lipids abnormal, Metabolic function test normal, Muscular weakness, Optic ischaemic neuropathy, Pain in extremity
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Papilloedema, Platelet count normal, Red blood cell sedimentation rate, Treponema test negative, Visual impairment
Clinical narrative: On 9/19/2014, I awoke with a visual defect in right eye 20% in inferior nasal area; Seen within hours with a retinal near-ophthalmologist Dr. and diagnosed as NAION. The ophthalmologist could not determine why this happened as I had no predisposing factors. Her theory was that something caused a swelling of the optic nerve and the nerve became entrapped in the passage through the sclera and a venous and then arterial infarction of the nerve occurred. Over the next 3 months I was followed closely and eventually lost vision in that eye except for light awareness in 10% of outer upper quadrant. This persists to today 12/13/2018; My records were reviewed because (under temporary adverse event ID file 157488) one week after a flu shot, I developed pain and weakness of left leg now diagnosed as Guillain-Barre and adverse event was filed by me and by Dr. recently. In this review it was seen that the optic nerve swelled 2 days following the flu shot, but at the time no correlation was made. In fact the first case like this was only published late 2014. It was only yesterday (12/12/2018) that this was discovered. It is now thought that the flu shot caused this.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Oxygen saturation normal, Pyrexia, Rash generalised, Respiratory disorder
Clinical narrative: One week after vaccine my daughter came down with a low grade fever followed by a rash over her entire body. Two days later she had breathing issues and was gasping in her car seat.