chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient came with her right arm in the deltoid area being red, sore to the touch, and tender about 3/4th of the circumference of the arm. Advised patient to talk to her physician about the reaction so they can document and possibly treat.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: After receiving the Tdap vaccination, I had arm swelling, dizziness, nausea, fever after receiving the TDAP vaccination starting on the day I was injected (Thursday, September 13th, 2018). The side effects carried on September 13th 2018 through September 18th 2018. Today (September 19th 2018), I still have arm soreness from the injection but the nausea, dizziness and fever have gone away.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: Patient complained of stomach ache, muscle ache, malaise, runny nose and headache. She got vaccine Saturday near 6 PM and starting feeling bad that night around 2 or 3 AM. She called pharmacy Tuesday night, said Monday and Tuesday were less severe, but still not feeling back to normal. Sunday was the worst of the symptoms, which started to subside around 8:30 PM or 9 PM. Symptoms lingered Monday and Tuesday. She did not require emergency medical attention.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Patient complained of stomach ache, muscle ache, malaise, runny nose and headache. She got vaccine Saturday near 6 PM and starting feeling bad that night around 2 or 3 AM. She called pharmacy Tuesday night, said Monday and Tuesday were less severe, but still not feeling back to normal. Sunday was the worst of the symptoms, which started to subside around 8:30 PM or 9 PM. Symptoms lingered Monday and Tuesday. She did not require emergency medical attention.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Vomiting
Clinical narrative: Vomiting started about 7 hours after vaccine and has continued. He has not been able to hold down solid food. He has joint pain also. No fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever, malaise, headache, body aches. TYLENOL, rest.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Peripheral swelling
Clinical narrative: (09/11/2018, morning) Red, itchy, pain left arm bicep (front part upper arm). Symptoms traveled down bicep until reaching bottom of bicep (09/11/2018, afternoon). As symptoms traveled down arm, upper arm cleared. Also associated with these symptoms was swelling of inner arm. When symptoms reached bottom of bicep swelling was quite pronounced (inner part bulging out at elbow). The symptoms started clearing on 09/13/2018 and as of today, 09/18/2018, the arm looks normal. The afternoon of 09/11/2018, I went back to the pharmacy that administered the vaccine and showed another pharmacist my arm. He said he had never seen that symptom before but he talked to another pharmacist their and she said it would go away.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Basophil count decreased, Chills, Differential white blood cell count, Eosinophil count decreased, Eosinophil percentage
Clinical narrative: Redness, swelling, soreness, chills, night sweats, fever. Started 9/15 in right arm, 9/16 in left arm, worsened on 9/17 in left arm and 9/18 getting better in right arm. Left arm is very badly swollen, red, hot, sore unable to lift. Lab tests done today.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Full blood count, Injected limb mobility decreased, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: Redness, swelling, soreness, chills, night sweats, fever. Started 9/15 in right arm, 9/16 in left arm, worsened on 9/17 in left arm and 9/18 getting better in right arm. Left arm is very badly swollen, red, hot, sore unable to lift. Lab tests done today.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Monocyte count normal, Monocyte percentage increased, Neutrophil count increased, Neutrophil percentage increased, Night sweats
Clinical narrative: Redness, swelling, soreness, chills, night sweats, fever. Started 9/15 in right arm, 9/16 in left arm, worsened on 9/17 in left arm and 9/18 getting better in right arm. Left arm is very badly swollen, red, hot, sore unable to lift. Lab tests done today.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: Redness, swelling, soreness, chills, night sweats, fever. Started 9/15 in right arm, 9/16 in left arm, worsened on 9/17 in left arm and 9/18 getting better in right arm. Left arm is very badly swollen, red, hot, sore unable to lift. Lab tests done today.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Received DTAP on Thursday morning and daughter experienced sore throat the following day with 4 days of fever, sore throat and runny nose. Also very lethargic - napping for 2 hrs a day for 3 days straight even though she hadn't napped for over a year. Today is Tuesday, she still has a slight runny nose but seems to be doing better.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased
Clinical narrative: Patient claims she cannot move her arm at all. She thinks the needle may have gone into the bursa.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: L arm pain, redness and swelling shortly after receiving vaccine.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Cold sweat, Discomfort, Dizziness, Dry mouth
Clinical narrative: Patient had received her #2 Hepatitis B vaccine at 11:15 AM. Patient had slight discomfort with injection. Patient went to work and at approx 3:10 patient had nausea and vomiting with minimal emesis. Patient then return to work at approx 3:30 PM patient had dizziness, dry mouth, was light headed, clammy, weak, and complained of a headache. Vital signs at 3:35 PM were 102/64 and pulse 82 bpm. Patient was sat down and given POWERADE. Patient symptoms resolved quickly except for slight headache. Vitals at 3:42 PM were 96/60 and pulse of 60 bpm. Last set of vitals taken at 3:45 PM were 92/70 Pulse 84 bpm. Patient was able to return to work after symptoms resolved.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient had received her #2 Hepatitis B vaccine at 11:15 AM. Patient had slight discomfort with injection. Patient went to work and at approx 3:10 patient had nausea and vomiting with minimal emesis. Patient then return to work at approx 3:30 PM patient had dizziness, dry mouth, was light headed, clammy, weak, and complained of a headache. Vital signs at 3:35 PM were 102/64 and pulse 82 bpm. Patient was sat down and given POWERADE. Patient symptoms resolved quickly except for slight headache. Vitals at 3:42 PM were 96/60 and pulse of 60 bpm. Last set of vitals taken at 3:45 PM were 92/70 Pulse 84 bpm. Patient was able to return to work after symptoms resolved.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PT HAD A RXN TO THE FLU SHOT; RED, SWELLING, ITCH, AND WARM TO TOUCH. WENT DOWN HER ARM PAST THE ELBOW.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt was given flu shot - stated that he was fine - got up and went and sat down on the pharmacy bench in the waiting area - then about 3 minutes later started to pass out and patient's mom caught him before he fell off of the bench after passing out and slumping over. 911 was contacted and paramedics took him on to the hospital. Pt was awake and alert when he left to go to the hospital and said he was feeling better.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Joint swelling, Pain, Skin warm
Clinical narrative: Swelling at the elbow joint, erythema, hot to touch, mild pain (cellulitis like in appearance). Pain with 7 hours of receiving shot.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient called about 2 pm and stated that she had hives on her arms hours of getting the flu vaccine. I told her to take BENADRYL which she did. The following day I called and she said the hive a getting better and she is feeling better.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had swelling and redness after injection. She has pain in her arm and arm weakness. It hurts to hold a coffee cup, fold cloths, and drive. She has an appointment with her physician 9/21/18.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Patient states after the vaccine she felt fine all evening of Sept 17, 2018  with exception of what you would expect from an IM vaccine such as arm soreness. However when she woke up Tues, Sept 18, 2018 pt states through out the date she began to experience extreme fatigue, dizziness, nausea/belly pain, mild headache and rapid heart rate by her definition at 100bpm. I asked how she was doing at the time she called me and advised she should seek medical care if she is concerned about the reaction she is feeling. Pt stated she beginning to feel better but felt she was having an extreme reaction to the SHINGRIX vaccine and wanted to let me know to fill out a vaers form. I think the patient also went online and filled out one herself so this may be a duplicate.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient states after the vaccine she felt fine all evening of Sept 17, 2018  with exception of what you would expect from an IM vaccine such as arm soreness. However when she woke up Tues, Sept 18, 2018 pt states through out the date she began to experience extreme fatigue, dizziness, nausea/belly pain, mild headache and rapid heart rate by her definition at 100bpm. I asked how she was doing at the time she called me and advised she should seek medical care if she is concerned about the reaction she is feeling. Pt stated she beginning to feel better but felt she was having an extreme reaction to the SHINGRIX vaccine and wanted to let me know to fill out a vaers form. I think the patient also went online and filled out one herself so this may be a duplicate.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Neck pain
Clinical narrative: Severe headache, shooting pains neck.
Age: 77.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Back pain, Blood pressure increased, Erythema, Malaise, Mobility decreased
Clinical narrative: Minutes after patient had walked away after receiving vaccines, patient came back skin and eyes very red, he stated he did not feel well, sat on a bench and then stated his low back hurt to the point he could not move. EMS/911 was contacted, paramedics arrived; at that point the patient stated he felt that the pain had moved down from his back to his legs but was well enough to not go in the ambulance.
Age: 77.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Ocular hyperaemia, Pain in extremity
Clinical narrative: Minutes after patient had walked away after receiving vaccines, patient came back skin and eyes very red, he stated he did not feel well, sat on a bench and then stated his low back hurt to the point he could not move. EMS/911 was contacted, paramedics arrived; at that point the patient stated he felt that the pain had moved down from his back to his legs but was well enough to not go in the ambulance.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: AT SITE OF INJECTION SLIGHT PINK/RED COLOR 3INX4IN AREA, SWELLING, WARM TO THE TOUCH.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Injection site pain
Clinical narrative: Patient reported extreme muscle pain at site of injection; bursitis.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Patient complained tingling on the vaccinated arm on and off.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Cough, Dyspnoea, Rash
Clinical narrative: PATIENT BEGAN SEVERELY COUGH AND BROKE OUT IN RASH 5 MINUTES AFTER RECEIVING SHOT, PATIENT STARTED USING HER INHALER AND WE GAVE HER BENADRYL. PATIENT CONTINUED TO HAVE INCREASED LABORED BREATHING, SEVERE COUGHING AND GASPING FOR AIR. PHARMACISTS CALLED 911 AND GAVE PATIENT EPIPEN. PATIENT WAS TAKEN TO HOSPITAL WHERE SHE WAS GIVEN BREATHING TREATMENT AND SOLUMEDROL INJECTION. SHE WAS LATER RELEASED TO HOME WITHIN A FEW HOURS.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased, Pain in extremity, Rash erythematous
Clinical narrative: 4 days later it was his lower back that hurt, 12 days later pt said his arm started having some pain and red spots. Pt had acyclovir topical from a different country prior to the shot and applied that on the arm and the redness went away. He still reports of arm pain and not being able to lift the arm above the shoulders.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient is currently unable to rotate arm. She claims that it hurts when she drives and in general has a lot of pain associated with injury. Patient is currently doing cold compresses and starting ALEVE to help ease pain. Will follow up with pharmacy in 5-7 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient called pharmacy 9/18/18 and complained of Chills, fever, and sweating along with a swollen and painful left arm. He stated that the chills and fever started the evening of 9/17/18.
Age: 16.0
Sex: M
Vaccine: JEV1
Symptoms: Injection site discolouration, Injection site granuloma
Clinical narrative: Needle puncture site remained purple - no associated edema, no erythema, no pain. On 9/17/2018, solid white substance was expressed from the injection site. Area around the puncture site remains purple. Injection site appears to have formed a granuloma.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Superficial vein prominence
Clinical narrative: I had my first pneumonia shot at about 5 p.m. At 9 p.m. while I was watching TV in my recliner, I started getting muscle cramps in the top of my foot. As the evening progressed, the cramps increased in intensity and frequency. The veins in the top of my right foot were extremely prominent. I tried a muscle cramping pill, drinking vinegar, quinine, a TYLENOL and a Ibuprofen, but nothing helped for a few hours. I thought I would have to go to ER, but took a XANAX which helped me to calm down.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient was given SHINGRIX inj. at Pharmacy in the left deltoid on 9/4/18. Patient was seen by primary physician 9/7/18 due to the adverse reaction of redness, warmth and tenderness of the injection site. Denies fever, nausea, vomiting, diarrhea or any other concerns.
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Fever, golf-ball sized knot on the back of the upper Lt arm. It was swollen and red. Mother advised to give BENADRYL q4-6 hrs PRN.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Feeling abnormal, Headache, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: I received a ZOSTAVAX Shingles Vaccine from my local pharmacy. Within 1/2 hour I had numbness in my left arm and extreme pain in my left shoulder and shooting up into my head. It lasted about a week and then calmed down. But it reoccurs frequently (not numbness, but pain) and has made my life miserable. It even hurts to wear my glasses over my left ear. I refused to have the second shot for fear of an even worse reaction. The date I listed was a guess, but I know I had it in February.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Leukocytosis, Localised oedema
Clinical narrative: Localized edema and leukocytosis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm red, hot to touch, swollen induration, neck and arm pain going to prescribe pt Prednisone 40 mg for 5 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: (L) arm red, hot to touch, swollen induration, neck and arm pain going to prescribe pt Prednisone 40 mg for 5 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pyrexia
Clinical narrative: Patient said she got the flu from the flu shot she had yesterday. She still had fever at time of call and might go see physician at urgent care.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fever.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling - no fever.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itches, red, swollen. Warm to touch.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: 12 hrs after taking injection I started being cold to the point that I was shivering and shaking. Lasted around 12 hrs.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope with lightheadedness. Patient never lost consciousness. Patient placed on floor and feet elevated.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-AUG-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-AUG-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Food allergy, Hyperhidrosis, Insomnia
Clinical narrative: Patient reportedly had rash with fever, nausea, and difficulty breathing that started the day of the injection. Patient reported calling Dr.'s office who isntructed patient to use her albuterol inhaler to help with the difficulty breathing. Dr. has notes of the adverse event being documented in her charts on 6/13. Patient reports that symptoms resolved and that Dr. instructed the patient not to receive the follow up vaccination.  =The administering pharmacy was not made aware of this until 9/10. Pharmacy waited to report until gathering more information from Dr.'s office to confirm the nature of the adverse event and sequence of events that occurred.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Irritability, Pyrexia, Rash, Swelling
Clinical narrative: Patient reportedly had rash with fever, nausea, and difficulty breathing that started the day of the injection. Patient reported calling Dr.'s office who isntructed patient to use her albuterol inhaler to help with the difficulty breathing. Dr. has notes of the adverse event being documented in her charts on 6/13. Patient reports that symptoms resolved and that Dr. instructed the patient not to receive the follow up vaccination.  =The administering pharmacy was not made aware of this until 9/10. Pharmacy waited to report until gathering more information from Dr.'s office to confirm the nature of the adverse event and sequence of events that occurred.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Nausea, Pyrexia, Rash
Clinical narrative: Patient reportedly had rash with fever, nausea, and difficulty breathing that started the day of the injection. Patient reported calling Dr.'s office who isntructed patient to use her albuterol inhaler to help with the difficulty breathing. Dr. has notes of the adverse event being documented in her charts on 6/13. Patient reports that symptoms resolved and that Dr. instructed the patient not to receive the follow up vaccination.  =The administering pharmacy was not made aware of this until 9/10. Pharmacy waited to report until gathering more information from Dr.'s office to confirm the nature of the adverse event and sequence of events that occurred.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Peripheral swelling, Pyrexia, Skin warm, Thrombosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cancer. On 9th July 2018, the patient received SHINGRIX (intramuscular). On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and skin warm. In July 2018, the patient experienced pulmonary embolism (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the pulmonary embolism and clot blood were recovering/resolving and the outcome of the pain in arm, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pulmonary embolism, clot blood, pain in arm, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness with swelling and hot to touch starting the day of the vaccine and lasting 3 to 4 days. Few days following the vaccine, her right leg was hot and swollen. She had a scan completed and it showed a blood clot in her right leg and right lung.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary embolism, Scan abnormal, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cancer. On 9th July 2018, the patient received SHINGRIX (intramuscular). On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and skin warm. In July 2018, the patient experienced pulmonary embolism (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the pulmonary embolism and clot blood were recovering/resolving and the outcome of the pain in arm, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pulmonary embolism, clot blood, pain in arm, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness with swelling and hot to touch starting the day of the vaccine and lasting 3 to 4 days. Few days following the vaccine, her right leg was hot and swollen. She had a scan completed and it showed a blood clot in her right leg and right lung.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thrombosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cancer. On 9th July 2018, the patient received SHINGRIX (intramuscular). On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and skin warm. In July 2018, the patient experienced pulmonary embolism (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the pulmonary embolism and clot blood were recovering/resolving and the outcome of the pain in arm, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pulmonary embolism, clot blood, pain in arm, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness with swelling and hot to touch starting the day of the vaccine and lasting 3 to 4 days. Few days following the vaccine, her right leg was hot and swollen. She had a scan completed and it showed a blood clot in her right leg and right lung.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Shivering, fevere, fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Shivering, fevere, fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Shivering, fevere, fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Shivering, fevere, fatigue.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Diarrhoea, Hyperhidrosis, Injection site bruising, Injection site swelling, Injection site vesicles
Clinical narrative: I received the pneumococcal 23 vaccine in the evening on 9/7 at pharmacy by the mid morning of 9/8 I started to have flu like symptoms which included headache, fatigue, fever, chills, aches and sweats. As the day progressed the injection site began to swell extensively, it was hot, red and started to blister. By the evening I was running a 102.5 fever, I was experiencing vomiting, diarrhea, awful fatigue and excessive sweating. The symptoms were so bad I fainted a few times. I have never had this vaccination before and I will never have it again. I saw my primary care doctor on 9/10 and she gave me ZOFRAN and an IV for dehydration. Today is 9/11/18 and I am still experiencing side effects. I have taken pictures of the injection site to show the severity and my doctor has records. I want to report this so other patients know the severe side effects of this vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site warmth, Nausea, Pyrexia, Syncope, Vomiting
Clinical narrative: I received the pneumococcal 23 vaccine in the evening on 9/7 at pharmacy by the mid morning of 9/8 I started to have flu like symptoms which included headache, fatigue, fever, chills, aches and sweats. As the day progressed the injection site began to swell extensively, it was hot, red and started to blister. By the evening I was running a 102.5 fever, I was experiencing vomiting, diarrhea, awful fatigue and excessive sweating. The symptoms were so bad I fainted a few times. I have never had this vaccination before and I will never have it again. I saw my primary care doctor on 9/10 and she gave me ZOFRAN and an IV for dehydration. Today is 9/11/18 and I am still experiencing side effects. I have taken pictures of the injection site to show the severity and my doctor has records. I want to report this so other patients know the severe side effects of this vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Chills, Dehydration, Diarrhoea, Fatigue, Headache
Clinical narrative: I received the pneumococcal 23 vaccine in the evening on 9/7 at pharmacy by the mid morning of 9/8 I started to have flu like symptoms which included headache, fatigue, fever, chills, aches and sweats. As the day progressed the injection site began to swell extensively, it was hot, red and started to blister. By the evening I was running a 102.5 fever, I was experiencing vomiting, diarrhea, awful fatigue and excessive sweating. The symptoms were so bad I fainted a few times. I have never had this vaccination before and I will never have it again. I saw my primary care doctor on 9/10 and she gave me ZOFRAN and an IV for dehydration. Today is 9/11/18 and I am still experiencing side effects. I have taken pictures of the injection site to show the severity and my doctor has records. I want to report this so other patients know the severe side effects of this vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Hyperhidrosis, Injection site swelling, Injection site vesicles, Injection site warmth, Pain
Clinical narrative: I received the pneumococcal 23 vaccine in the evening on 9/7 at pharmacy by the mid morning of 9/8 I started to have flu like symptoms which included headache, fatigue, fever, chills, aches and sweats. As the day progressed the injection site began to swell extensively, it was hot, red and started to blister. By the evening I was running a 102.5 fever, I was experiencing vomiting, diarrhea, awful fatigue and excessive sweating. The symptoms were so bad I fainted a few times. I have never had this vaccination before and I will never have it again. I saw my primary care doctor on 9/10 and she gave me ZOFRAN and an IV for dehydration. Today is 9/11/18 and I am still experiencing side effects. I have taken pictures of the injection site to show the severity and my doctor has records. I want to report this so other patients know the severe side effects of this vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: I received the pneumococcal 23 vaccine in the evening on 9/7 at pharmacy by the mid morning of 9/8 I started to have flu like symptoms which included headache, fatigue, fever, chills, aches and sweats. As the day progressed the injection site began to swell extensively, it was hot, red and started to blister. By the evening I was running a 102.5 fever, I was experiencing vomiting, diarrhea, awful fatigue and excessive sweating. The symptoms were so bad I fainted a few times. I have never had this vaccination before and I will never have it again. I saw my primary care doctor on 9/10 and she gave me ZOFRAN and an IV for dehydration. Today is 9/11/18 and I am still experiencing side effects. I have taken pictures of the injection site to show the severity and my doctor has records. I want to report this so other patients know the severe side effects of this vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: 3x3 cm redness/ warmth/ induration at vaccination site within 20 minutes relieved with ice pack and 10mg Zyrtec.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Nausea, Nightmare
Clinical narrative: At first just nausea. Then I woke up in the middle of the night with shivers and could not get warm enough. Terrible headache. I kept dreaming that I had boils on my arms. Woke up and the shivers are gone but the headache remains. Of course I have a sore arm too. The first dose only gave me a sore arm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: At first just nausea. Then I woke up in the middle of the night with shivers and could not get warm enough. Terrible headache. I kept dreaming that I had boils on my arms. Woke up and the shivers are gone but the headache remains. Of course I have a sore arm too. The first dose only gave me a sore arm.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, Herpangina, Pyrexia
Clinical narrative: Patient received duplicate varicella vaccine 1 week after receiving original vaccine. On the evening of duplicate vaccine he began having fever. Later encounter in office on 9/17/18 showed he had herpangina. This was not thought to be related to vaccine.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Appetite disorder, Asthenia, Headache, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: PANS; strep throat twice. Unexplained upper respitory infection. Night terrors. Sleep walking. Personality change. Urinary issues. Attachment issues. Appetite change. Headaches. Body weekness. Aggression.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Personality change, Pharyngitis streptococcal, Reactive attachment disorder of infancy or early childhood, Sleep terror, Somnambulism
Clinical narrative: PANS; strep throat twice. Unexplained upper respitory infection. Night terrors. Sleep walking. Personality change. Urinary issues. Attachment issues. Appetite change. Headaches. Body weekness. Aggression.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Urinary tract disorder
Clinical narrative: PANS; strep throat twice. Unexplained upper respitory infection. Night terrors. Sleep walking. Personality change. Urinary issues. Attachment issues. Appetite change. Headaches. Body weekness. Aggression.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Headache, Injection site induration
Clinical narrative: Swollen arm where injection was given - two inch round diameter hard and raised injection site.  Diarrhea- stomach pain and loss of appitite.  Headache- Fever- lethargic - Rash Headache - 9/17 11:00am Fever 9/17 12:00 Muscle pain in arm  9/17 2:00 Redness and swelling on site 9/17 2:00 Raised and hard injection site 9/18 9am Loss of Appitite 9/18 1:00 pm Continued pain in arm and swelling 3pm Fever and lethargic 4pm Stomachs ache 6pm.   Diarrhea 9/19   7am Rash on chest and back of left arm. 830am     diarrhea- muscle pain-
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Lethargy, Myalgia, Pyrexia, Rash
Clinical narrative: Swollen arm where injection was given - two inch round diameter hard and raised injection site.  Diarrhea- stomach pain and loss of appitite.  Headache- Fever- lethargic - Rash Headache - 9/17 11:00am Fever 9/17 12:00 Muscle pain in arm  9/17 2:00 Redness and swelling on site 9/17 2:00 Raised and hard injection site 9/18 9am Loss of Appitite 9/18 1:00 pm Continued pain in arm and swelling 3pm Fever and lethargic 4pm Stomachs ache 6pm.   Diarrhea 9/19   7am Rash on chest and back of left arm. 830am     diarrhea- muscle pain-
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 15 weeks and 2 days old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 20-AUG-2018, the patient was inadvertently administered her first dose of ROTATEQ (dose and frequency were not provided, lot # N030175, expiration date 16-JUN-2019) orally for prophylaxis at age 15 weeks and 2 days (drug administered to patient of inappropriate age). No adverse effects were reported.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Nasopharyngitis, Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 13 month old male patient. The patient had none pertinent medical history, concomitant medication and drug reactions or allergies. On 21-AUG-2018, the patient was vaccinated with first dose of M-M-R II injection, therapy type: rHA, lot # N025894 (expiry date: 19-SEP-2019), subcutaneously for prophylaxis (dose not provided), at physician's office. Approximately on 24-AUG-2018 (reported as "3 to 4 days afterwards"), the patient experienced hives, fever and cold symptoms. The patient made an unscheduled visit to the emergency room. The patient was treated with diphenhydramine (BENADRYL) liquid, (Lot number and expiration date unspecified) at a dosage of 3/4 teaspoon every 6 to 8 hours as needed. None lab diagnostics/studies were performed. On 29-AUG2018, the patient returned to physician's office for a follow-up examination and the patient was recovering. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUN-2015, the patient was treated by a physician for a vesicular outbreak, for the diagnosed of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed LIDODERM for management for his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2011, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Dyspnoea, Eating disorder, Gait disturbance, Muscular weakness
Clinical narrative: This spontaneous report was received from the patient's aunt and the patient's mother and refers to a 11 year old female patient. The patient had no pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions or allergies. On 28-JUN-2018, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular, schedule reported as:0, 2 and 6 months (lot # and expiration date were not provided) for prevention of human papillomavirus (HPV). On 04-JUL-2018, the patient started experience muscular weakness and a lot of pain, which started in the patient's legs and spread later to the her arms (pain in extremity). It was also reported that, the patient could not walk without using a walker. Since on unknown dates in 2018, the patient had not been eating (eating disorder) and was experiencing shortness of breath (dyspnoea). Since then, the patient had been seeing multiple doctors and no one could find anything wrong. It was reported that the patient was given unspecified treatment for the adverse events. Additionally, the patient was admitted to the hospital in an unspecified date in July 2018 and stayed 2 days there. Subsequently, on 22-AUG-2018, the patient was again admitted to the hospital, and was there for a week. The cause of the hospitalization was not reported. On unknown dates, diagnostic test such as brain scans, magnetic resonance imaging (MRI) and unspecified blood work were performed, however results were not provided. The outcome of pain in extremity, muscular weakness, dyspnoea and eating disorder was reported as not recovered/not resolved. The outcome of the adverse event that lead the patient's hospitalization was not reported. The causality between the events and GARDASIL 9 was not reported. Upon internal review the event pain of extremities was considered to be serious as the patient could not walk without using a walker (disability).
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Scan brain, Walking aid user
Clinical narrative: This spontaneous report was received from the patient's aunt and the patient's mother and refers to a 11 year old female patient. The patient had no pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions or allergies. On 28-JUN-2018, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular, schedule reported as:0, 2 and 6 months (lot # and expiration date were not provided) for prevention of human papillomavirus (HPV). On 04-JUL-2018, the patient started experience muscular weakness and a lot of pain, which started in the patient's legs and spread later to the her arms (pain in extremity). It was also reported that, the patient could not walk without using a walker. Since on unknown dates in 2018, the patient had not been eating (eating disorder) and was experiencing shortness of breath (dyspnoea). Since then, the patient had been seeing multiple doctors and no one could find anything wrong. It was reported that the patient was given unspecified treatment for the adverse events. Additionally, the patient was admitted to the hospital in an unspecified date in July 2018 and stayed 2 days there. Subsequently, on 22-AUG-2018, the patient was again admitted to the hospital, and was there for a week. The cause of the hospitalization was not reported. On unknown dates, diagnostic test such as brain scans, magnetic resonance imaging (MRI) and unspecified blood work were performed, however results were not provided. The outcome of pain in extremity, muscular weakness, dyspnoea and eating disorder was reported as not recovered/not resolved. The outcome of the adverse event that lead the patient's hospitalization was not reported. The causality between the events and GARDASIL 9 was not reported. Upon internal review the event pain of extremities was considered to be serious as the patient could not walk without using a walker (disability).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 09-SEP-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2013, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with 4th dose of GARDASIL 9 (lot # N023828) (expiry date: 25-JUN-2020) for prophylaxis (extra dose administered). No adverse event was reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.