chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Hypoaesthesia oral, Injection site erythema, Injection site pain
Clinical narrative: Patient reported extreme fatigue the night she receive the vaccination. 3 days after vaccination pt reports Unusual tingling in leg and sudden numbness in hand. Then her gums felt numb. All of this came and went quickly, within a 20 minute period. There was pain and redness at the injection site reported this day too. 6 days after injection pt reports some redness and soreness at injection site still.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient reported extreme fatigue the night she receive the vaccination. 3 days after vaccination pt reports Unusual tingling in leg and sudden numbness in hand. Then her gums felt numb. All of this came and went quickly, within a 20 minute period. There was pain and redness at the injection site reported this day too. 6 days after injection pt reports some redness and soreness at injection site still.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: LOSS OF VISION THE DAY OF VACCINATION-DID NOT NOTIFY PHARMACY, BUT WENT TO DOCTOR AFTER 2 WEEKS. NOT CLEAR IF VISION GOT BETTER THEN WORSE DURING THAT TIME. THE DOCTOR CONCLUDED THAT THE PROBLEM WAS DUE TO THE VACCINE AND IS TREATING WITH STEROID DROPS. OUTCOME UNKNOWN AT THIS TIME.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Sore arm where shot was given, very tired, fever, chills, achy all over. Symptoms lasted 24 hours.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Feeling cold, Pyrexia, Vomiting
Clinical narrative: Client received vaccines on 1/30/2019 at approx 08:50 am. Client's mom called on 1/31/2019 around 2:15 pm reporting client started with fever on 1/30/2019 and that he has been cold. She reports that today he vomited.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Loss of personal independence in daily activities, Malaise
Clinical narrative: Severe shaking and chills began around 9 hours after injection. I was unable to sleep the entire night. Shaking subsided after approximately 12 hours after it began (around 7 AM on 8/25/2018).  I felt generally ill and headache for approximately 2 days. There was soreness in the arm, but that was manageable. I was "out of action" for two days, and the symptoms were, by far, the worst I ever experienced. I debated about having the second dose, but went ahead with it earlier today (5 months and 1 week after the first dose.)  This time I know what to expect.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tremor
Clinical narrative: Severe shaking and chills began around 9 hours after injection. I was unable to sleep the entire night. Shaking subsided after approximately 12 hours after it began (around 7 AM on 8/25/2018).  I felt generally ill and headache for approximately 2 days. There was soreness in the arm, but that was manageable. I was "out of action" for two days, and the symptoms were, by far, the worst I ever experienced. I debated about having the second dose, but went ahead with it earlier today (5 months and 1 week after the first dose.)  This time I know what to expect.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Crying, Muscular weakness, Pyrexia
Clinical narrative: Provider stated that the mother told him that he had a fever of 103 piercing cry and weakness in his legs.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pain in extremity, Pyrexia
Clinical narrative: 1/26/19-sore arm; 1/27/19-pt stated she "didn't feel well"; 1/28/19-fever 100.1 F, injection site and surrounding areas warm to touch; 1/29-1/30-area around injection site more warm and increased in size to 2x2 inches per pt; 1/31-pt saw Dr and was prescribed 10 days oral antibiotic and steroid cream.
Age: 47.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Headache, Musculoskeletal discomfort, Oral herpes, Pyrexia, Spinal pain
Clinical narrative: Patient reporting that in the morning after the injection she experienced fever, cold sores in mouth, joint discomfort, emesis for 3 days and a headache in the back of her head/spine area.
Age: 47.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient reporting that in the morning after the injection she experienced fever, cold sores in mouth, joint discomfort, emesis for 3 days and a headache in the back of her head/spine area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Eczema, Erythema, Pain of skin
Clinical narrative: After receiving the 2nd shot in the SHINGRIX, I developed a full body rash with huge red spots that hurt and and the skin broke open and peeled and drained fluid. I saw my dermatologist 4 times and was treated with creams. She did a skin biopsy and it showed Eczema. It has lasted for more than 2 -3 months. She gave me a Hydrocortisone injection. The spots hurt and are drying up but itch a lot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Secretion discharge, Skin exfoliation
Clinical narrative: After receiving the 2nd shot in the SHINGRIX, I developed a full body rash with huge red spots that hurt and and the skin broke open and peeled and drained fluid. I saw my dermatologist 4 times and was treated with creams. She did a skin biopsy and it showed Eczema. It has lasted for more than 2 -3 months. She gave me a Hydrocortisone injection. The spots hurt and are drying up but itch a lot.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Abdominal pain, Diarrhoea, Enema administration, Intussusception, Irritability
Clinical narrative: Vomiting and loose stools started on 1/16/19. Seen in office on 1/17/19 trial of zofran for vomiting. Seen in ER on 1/18/19 due to persistent vomiting even after zofran and colicky fussiness episodes. Ultrasound showed intussusception and was reduced. Symptoms resolved. Patient was discharged home on 1/19/19. Follow up done by phone on 1/24/19, mom reported patient back to her normal self. Eating normally.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray
Clinical narrative: Vomiting and loose stools started on 1/16/19. Seen in office on 1/17/19 trial of zofran for vomiting. Seen in ER on 1/18/19 due to persistent vomiting even after zofran and colicky fussiness episodes. Ultrasound showed intussusception and was reduced. Symptoms resolved. Patient was discharged home on 1/19/19. Follow up done by phone on 1/24/19, mom reported patient back to her normal self. Eating normally.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Rash
Clinical narrative: Rash on right arm and increased heart rate.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: The patient stated that his arm continues to be sore even months after the immunization. He states the pain is not severe, and dose not interfere with his activities, however it has not "gone away." He stated that he spoke with his doctor about it, and was told "this happens sometimes with the PREVNAR shot."
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Sore arm immediately after injection. Started getting very achy during the night. Could barely move by the next morning. Severe aches, headache and chills. Have been flat on my back in bed for the last day and a half. Have taken ADVIL only.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm immediately after injection. Started getting very achy during the night. Could barely move by the next morning. Severe aches, headache and chills. Have been flat on my back in bed for the last day and a half. Have taken ADVIL only.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Fatigue, Pyrexia
Clinical narrative: 104.3 fever. Very tired.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nodule, Peripheral swelling, Skin warm
Clinical narrative: Patient stated her arm was feverish, swollen and had a knot that was moving up into her armpit. She also stated she could not move her arm. I advised her to see her Doctor and she stated if it wasn't better tomorrow, she would be seen.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema, Pain, Skin discolouration, Skin warm, Urticaria
Clinical narrative: Pain when resting & walking, hot to touch, raised welts, redness, spread on 4th day over 5inches, began to turn purple.
Age: 21.0
Sex: F
Vaccine: ANTH, HPV9
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling, bruising spreading throughout the arm. No cellulitis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Arm very sore, but to be expected. Otherwise, made me feel like I have the flu - body aches, cold and tired. Didn't happen the first shot. Not that horrible, but wanted to report it for data keeping purposes. In other words, minor side effect in the grander scheme of things.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Full blood count, Metabolic function test, Respiratory syncytial virus infection
Clinical narrative: Simple febrile seizure for less then 5 min, onset 1/30/19 at 6:02AM.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Respiratory viral panel, Urine analysis
Clinical narrative: Simple febrile seizure for less then 5 min, onset 1/30/19 at 6:02AM.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Fever, myalgias, headache started about 14 hours after vaccine. Fever as high as 102.8. Subsided after 36 hours. Unable to go to work the day after the vaccine due to high fever.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: I'm not sure which TDaP shot I was given, but for more than 5 days I couldn't move my arm more than an inch and it was extremely painful even when I wasn't trying to move it. The pain was so bad it would wake me at night (and no, I wasn't sleeping on that side). It continued to hurt and have limited mobility for an additional 7 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, uncontrolled shivering, muscle aches on night of injection. Lasted 12 hours. Was brutal and exhausting. Two weeks later developed shingles like rash on back and legs.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Headache, fever, uncontrolled shivering, muscle aches on night of injection. Lasted 12 hours. Was brutal and exhausting. Two weeks later developed shingles like rash on back and legs.
Age: 45.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Several minutes after receiving the vaccinations the patient felt very nauseous and faint. Sat down then laid down on the ground with legs bent at the knee. Reported feeling tingling sensation throughout arms and hands. Tingling feeling went away after 5-10 minutes. I sat with the patient for approximately 10 minutes, monitored his respiration rate, checked his pulse and O2 sat, and blood pressure. All values were within normal range for the patient. Patient remained alert aware and oriented the entire time, never lost conscious.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Regressive behaviour
Clinical narrative: Regression. Autism.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 1/31/2019 C/O redness/swelling/induration 4 days post vaccination (R) arm PNEUMOVAX 23. 2nd revaccination approximately 75 years. 9 x 7 cm erythema 2 inches below injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came in to get an antibiotic and said she had gone to her doctor because her injection site was hot and red. It had started last night and got worse today. She said she got a steroid shot, doctor gave her KEFLEX and she bought BENADRYL to take.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Lip swelling, Rash
Clinical narrative: Pt received TDAP vaccine on 1-22-19 she then had swelling of her bottom lip and a rash on her abdomen on 1-23-19. She also had some joint pain. Symptoms started to clear up on their own she did not need BENADRYL or a steroid.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Muscle twitching, Tremor
Clinical narrative: Has involuntary twitch on hands - tremors. Admitted to hospital.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Flatulence, Injection site pain, Pyrexia, Vomiting
Clinical narrative: 1/30/19 vaccine were given at 12:00 PM. When patient got home started complaining of (R) arm pain. Vomited 6 times from 4pm to 3:00 AM. 1/31/19 - mild stomach pain, Fever of 102 at 2:00 PM, Passing a lot of gas. 1/24/19 - went to see doctor for consult.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives, starting on arm and progressing to total body.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pruritus, Pyrexia, Rash macular
Clinical narrative: Patient got the shot on Thursday evening of Jan. 24,2019. Friday, soreness around injection site with mild fever. Saturday and Sunday, there were red blotches on upper arm and pain going down to the fingers. Monday, it was itching. Tuesday, patient said it's lobster looking. Patient took some BENADRYL and she contacted her doctor but did not go in to the office.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Child was given DTAP, IPV, Hep B in (R) leg had induration and erythema. Doctor examined and determined normal reaction.
Age: 94.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus generalised, Vision blurred
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724362), concerns a 94-year-old, elderly female patient. The patient's historical conditions included, atrial fibrillation (A-fib), coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD). The patient's current condition included egg allergy, canine allergy and an unspecified disease (reported as, none except chronic). On 15-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: injection (reported as SYR) anatomical location: right arm, batch number: 195221, expiry date: not reported]. On the same day, after vaccination, the patient experienced wide spread itching, redness and blurry vision. Since it was known that the patient was allergic to egg, she was administered a cell cultured derived vaccine. It was reported that after the vaccination, it was realized that the patient had canine allergy (dander contact allergy). The patient was prescribed with Prednisone for 3 days. It was reported that, the patient visited emergency room or office visit. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Paraesthesia oral, Sensation of foreign body
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724373), concerns a 32-year-old adult female patient. The patient's historical procedure included sinus surgery. The patient's historical condition included asthma and migraines. On an unknown date in 2016, the patient had received an unspecified vaccine and developed rash and nerve pain. The patient had no current illness. The patient had seasonal allergies. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 2), route of administration: intramuscular, anatomical location: unknown, batch number: 195232 and expiry date: not reported]. On the same day, one hour after vaccination, the patient complained of lip tingling, lump in throat and chills. The patient was advised to take BENADRYL and suggested not to receive vaccination in future. At the time of this report, the outcome of the events (chills, paraesthesia oral and sensation of foreign body) was unknown. The reporter assessed this case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea
Clinical narrative: This is spontaneous case, reported by other Health Professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724381), concerns a 64-year old, adult female patient. The patient's current condition included kidney disease [reported as medical history]. The patient had known no allergies. The patient's concomitant medications included lisinopril, tamoxifen and paricalcitol. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc [dose; 0.5 ml (frequency 1 as reported), route of administration: intramuscular, anatomical location: unknown, batch number: 195214 and expiry date not reported]. On 11-Oct-2017, 1 day after vaccination, the patient experienced shortness of breath for about 8 hours. At the time of this report the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728788), concerns a 31-year-old, adult female patient. The patient's historical condition and current illness were unknown. The patient had no known allergy. The patient's concomitant medications were unknown. On 27-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5ml (frequency reported as 1), route of administration: intramuscular, anatomical site: right arm, batch number: 195234 and expiry date: not reported]. On 28-Nov-2017, one day after vaccination, the patient experienced pain, swelling and pressure on the right side of the body. The patient described the pain as minor to moderate and had trouble in doing some usual jog. The reporter told the patient to monitor the symptoms in case of improvement and to seek medical attention if the symptoms get worse the next day. It was reported that, the reporter could not reach the patient for follow up. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The LLT for the event (loss of personal independence in daily activities) was changed from 'activities of daily living impaired' to 'loss of personal independence in daily activities'. The verbatim (loss of personal independence in daily activities) was added for the event (loss of personal independence in daily activities). No changes were done in the narrative.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Glossodynia, Throat tightness
Clinical narrative: Tongue pain, throat tightness, subjective dyspnea starting 1hr after vaccine administration. No urticaria, pruritus, objective tongue/lip/throat swelling, wheezing, hypoxia, hypotension. Given BENADRYL, ZANTAC, prednisone PO. No change in tongue pain but throat tightness and dyspnea resolved over 1-2hrs.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Influenza virus test, Pyrexia, Streptococcus test
Clinical narrative: HIGH FEVER OF OVER 103-104.7 FOR 3 DAYS SO FAR. STARTED 4 DAYS AFTER THE SHOT. FEVER IS STILL ONGOING.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Fatigue, Headache, Neuralgia, Pain
Clinical narrative: Headache, top arm ache fatigue next day under armpit pain level 7 got worse and into lymph arm pit pain radatiating down nerves into left hand extreme pain throbbing for 3 days almost saw a Dr. Tuesday had appointment Wednesday already set so it was just declining 7 days later no mild armpit tenderness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Headache, top arm ache fatigue next day under armpit pain level 7 got worse and into lymph arm pit pain radatiating down nerves into left hand extreme pain throbbing for 3 days almost saw a Dr. Tuesday had appointment Wednesday already set so it was just declining 7 days later no mild armpit tenderness.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Nurse referring to unspecified number of patients with unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The Nurse reported that, on 21-SEP-2018 and 29-SEP-2018 multiple unspecified patients administered with improperly stored ROTATEQ lot#N013886, expiry date: 09-DEC-2018. Temperature excursion was in between 9 degrees C to 25 degrees C for 16 minutes. Digital data logger was involved and no previous temperature excursion was reported. No adverse events reported. As of 30-JAN-2019, all telephone attempts to obtain followup information have been unsuccessful.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included sterile diluent (lot numbers and expiration dates were not known). On 17-JAN-2019, the patient received PROQUAD (therapy type: recombinant Human albumin (rHA), injection, lot number: R020815, expiration date: 16-JAN-2020, dose/frequency: 0.5 ml/once, route: subcutaneous) and varicella VARIVAX, (lot#: R009410, expiration date: 29-MAR-2020; dose, frequency, route and strength were not reported) for prophylaxis (Inappropriate schedule of vaccine administered and overdose). Medical assistant reported the patient was to receive VARIVAX and M-M-R II, and not the PROQUAD (Wrong vaccine administered). No adverse reactions were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 21-JAN-2019, the patient inadvertently received an expired dose of PNEUMOVAX 23 lot # N011305, expiration date 20-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The patient did not experienced any adverse effects.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Shingles vaccine for prophylaxis. On 23rd January 2019, the patient received the 2nd dose of Shingles vaccine. In January 2019, less than a day after receiving Shingles vaccine, the patient experienced chills, fever, headache, diarrhea and nausea. On an unknown date, the outcome of the chills, fever, headache, diarrhea and nausea were unknown. It was unknown if the reporter considered the chills, fever, headache, diarrhea and nausea to be related to Shingles vaccine. Additional details were reported as follows: The patient had all the adverse reactions from the Shingles shot that she got the day before reporting in the afternoon. The patient asked how long would these symptoms last.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and 91 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the sickness and sickness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After both the vaccination in 2018, the patient experienced very sick for 2 days but the patient was recovered. In 2018, three months later, the patient experienced a mild shingles outbreak on the nose. The pharmacist told that, it was mild because the shringrix gave him some immunity.  Since then, the patient had gotten shingles 3 more times and at the time of reporting healing from the last episode, which began on 18th January 2019. This case was considered as suspect vaccination failure since the details regarding lab test confirming shingles was not unknown at the time of reporting. The GlaxoSmithKline claimed that, the vaccine was 90 percent effective so the patient guess that he was fallen under the radar into the 10 percent category that it did not work even though the patient suffered so with side effects. The patient was wondered if the 90 percent was accurate or if it was more like Merck's ZOSTAVAX 51 percent. The patient wanted to know, if any follow up testing indicate a lower success rate. The patient contacted to the CDC about his side effects but obviously they lost the information as they never followed up on the report he filed with them.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Influenza vaccine for prophylaxis. Previously administered products included flu shot. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned to do continue to make vaccines that only work 4 percent. Also stated that they all love the wonderful side effects they can get from flu shots like Paralysis. The patient had the flu shot twice and still got the flu with little bit more. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site hyperaesthesia, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had five previous outbreaks of the shingles over the last 15 years). On 21st January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and injection site warmth. On 23rd January 2019, the patient experienced injection site wheal, shingles, injection site erythema and injection site hyperesthesia. On an unknown date, the outcome of the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia were recovering/resolving. It was unknown if the reporter considered the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. At 1:00 pm, the patient received SHINGRIX in the left arm. Within a few hours of receiving the vaccine, the patient began to experience pain and heat at the injection site. Two days after receiving vaccination, the patient reported that she developed an outbreak of shingles in a 2 to 3 inch diameter around the injection site. The patient had raised whelps on either side of the injection site that were sensitive to touch and were painful. The patient reported that all symptoms were starting to resolve at the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had five previous outbreaks of the shingles over the last 15 years). On 21st January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and injection site warmth. On 23rd January 2019, the patient experienced injection site wheal, shingles, injection site erythema and injection site hyperesthesia. On an unknown date, the outcome of the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia were recovering/resolving. It was unknown if the reporter considered the injection site wheal, shingles, injection site erythema, injection site pain, injection site warmth and injection site hyperesthesia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. At 1:00 pm, the patient received SHINGRIX in the left arm. Within a few hours of receiving the vaccine, the patient began to experience pain and heat at the injection site. Two days after receiving vaccination, the patient reported that she developed an outbreak of shingles in a 2 to 3 inch diameter around the injection site. The patient had raised whelps on either side of the injection site that were sensitive to touch and were painful. The patient reported that all symptoms were starting to resolve at the day of reporting. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Chromaturia, Decreased appetite, Diarrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 57-year-old male patient who received ENGERIX B (batch number 7N5M5, expiry date 16th November 2020) for prophylaxis. This case was associated with a product complaint. On 14th January 2019, the patient received the 1st dose of ENGERIX B. On 17th January 2019, 3 days after receiving ENGERIX B, the patient experienced weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea, loose stools and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools to be related to ENGERIX B. Additional details were reported as follows: The patient was diagnosed with jaundice and had elevated liver enzymes. The patient would like to investigate the remaining 6 doses that were in the same box to see if there was something wrong with this batch of vaccines. The reporter would returned the remaining 6 doses of the vaccine to the GlaxoSmithKline. The reporter requested a credit for 6 doses of ENGERIX-B and results of the investigation. The patient required the emergency room visit.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Faeces discoloured, Hepatic enzyme increased, Jaundice, Nausea, Product complaint
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 57-year-old male patient who received ENGERIX B (batch number 7N5M5, expiry date 16th November 2020) for prophylaxis. This case was associated with a product complaint. On 14th January 2019, the patient received the 1st dose of ENGERIX B. On 17th January 2019, 3 days after receiving ENGERIX B, the patient experienced weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea, loose stools and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the weakness, jaundice, elevated liver enzymes, stomach cramps, stool discolored, urine coloring orange, appetite lost, nausea and loose stools to be related to ENGERIX B. Additional details were reported as follows: The patient was diagnosed with jaundice and had elevated liver enzymes. The patient would like to investigate the remaining 6 doses that were in the same box to see if there was something wrong with this batch of vaccines. The reporter would returned the remaining 6 doses of the vaccine to the GlaxoSmithKline. The reporter requested a credit for 6 doses of ENGERIX-B and results of the investigation. The patient required the emergency room visit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial pain in a 61-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th June 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced facial pain. On an unknown date, the patient experienced incomplete course of vaccination. On 28th April 2018, the outcome of the facial pain was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the facial pain to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated the patient experienced facial pain the day of when patient received SHINGRIX, which subsided after 1 day. The healthcare professional did not report but patient was also delayed for second dose. As patient still had not received the second dose, which led to incomplete course of vaccination.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX (batch number 3393R, expiry date 30th June 2019) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient planned to follow up with her physician on an unknown date. The reporter gave consent to follow up.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Blood culture negative, C-reactive protein normal, Computerised tomogram normal
Clinical narrative: When the patient reported to the Emergency Department on 01/27/2019 at 0030, she reported that about a week ago she received the flu vaccine in her left shoulder. However, over the previous week she developed erythema, tenderness, and swelling in her left shoulder. She denied fever, dizziness, nausea, vomiting, change in appetite, sore throat, runny nose, abdominal pain, constipation, diarrhea, other joint pain, or other rash. In the emergency department, she had WBC 7.2, creatinine 1.09, CK 242, myoglobin 61.9.  CRP 0.6. CT scan of the left shoulder did not show any signs of osteomyelitis or fluid collections or concerns for abscess. Blood cultures were collected and she was started on vancomycin and piperacillin/tazobactam. Patient was instructed to keep her arm elevated. The next day (01/28/2019) the erythema was spreading distally, but appeared better proximally.  Piperacillin/tazobactam was discontinued. Patient was discharged from the hospital on 1/30/2019 with prescriptions for doxycycline 100mg PO BID and Cephalexin 500 mg PO Q6H for 3 days. Total antibiotic course was 7 days. At the time of this report, blood cultures were no growth at 4 days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myoglobin blood, White blood cell count normal
Clinical narrative: When the patient reported to the Emergency Department on 01/27/2019 at 0030, she reported that about a week ago she received the flu vaccine in her left shoulder. However, over the previous week she developed erythema, tenderness, and swelling in her left shoulder. She denied fever, dizziness, nausea, vomiting, change in appetite, sore throat, runny nose, abdominal pain, constipation, diarrhea, other joint pain, or other rash. In the emergency department, she had WBC 7.2, creatinine 1.09, CK 242, myoglobin 61.9.  CRP 0.6. CT scan of the left shoulder did not show any signs of osteomyelitis or fluid collections or concerns for abscess. Blood cultures were collected and she was started on vancomycin and piperacillin/tazobactam. Patient was instructed to keep her arm elevated. The next day (01/28/2019) the erythema was spreading distally, but appeared better proximally.  Piperacillin/tazobactam was discontinued. Patient was discharged from the hospital on 1/30/2019 with prescriptions for doxycycline 100mg PO BID and Cephalexin 500 mg PO Q6H for 3 days. Total antibiotic course was 7 days. At the time of this report, blood cultures were no growth at 4 days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Thirst
Clinical narrative: Fever, chills, ache-all-over, thirst; flu-like symptoms.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Delivery, Diarrhoea, Exposure during pregnancy, Gastrointestinal disorder
Clinical narrative: Was 30 weeks pregnant. Had no prior issues, just normal pregnancy things. 36 hours after vaccine injected, swelling of legs started. 11:30pm blood pressure was checked and it was 190/82. Admitted to OB clinic in hospital with dehydration and strong contractions 4 minutes apart. Gave something to slow down contractions and ordered me to rest the next few days. 5 days after the injection a rash over my entire body formed (thinking it was a heat rash). Went to urgent care and they only gave me a low dose steroid cream that did nothing. Rash lasted for 13 days. Rash was raised red bumps, itchy and nothing helped soothe. 3 weeks after injection terrible gut issues started. Diarrhea multiple times a day. I watched my diet and nothing helped. Went to OB and they tried to do a stool sample and it came back normal. Continue having gut issues to this day. I was in the hospital 4 more times with contractions and swelling over the course of 7 1/2 weeks following injection. Baby's estimated due date was 9-3-2018 and baby was born early 6lbs 13oz.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Rash erythematous, Rash generalised, Rash pruritic, Stool analysis normal
Clinical narrative: Was 30 weeks pregnant. Had no prior issues, just normal pregnancy things. 36 hours after vaccine injected, swelling of legs started. 11:30pm blood pressure was checked and it was 190/82. Admitted to OB clinic in hospital with dehydration and strong contractions 4 minutes apart. Gave something to slow down contractions and ordered me to rest the next few days. 5 days after the injection a rash over my entire body formed (thinking it was a heat rash). Went to urgent care and they only gave me a low dose steroid cream that did nothing. Rash lasted for 13 days. Rash was raised red bumps, itchy and nothing helped soothe. 3 weeks after injection terrible gut issues started. Diarrhea multiple times a day. I watched my diet and nothing helped. Went to OB and they tried to do a stool sample and it came back normal. Continue having gut issues to this day. I was in the hospital 4 more times with contractions and swelling over the course of 7 1/2 weeks following injection. Baby's estimated due date was 9-3-2018 and baby was born early 6lbs 13oz.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Uterine contractions during pregnancy
Clinical narrative: Was 30 weeks pregnant. Had no prior issues, just normal pregnancy things. 36 hours after vaccine injected, swelling of legs started. 11:30pm blood pressure was checked and it was 190/82. Admitted to OB clinic in hospital with dehydration and strong contractions 4 minutes apart. Gave something to slow down contractions and ordered me to rest the next few days. 5 days after the injection a rash over my entire body formed (thinking it was a heat rash). Went to urgent care and they only gave me a low dose steroid cream that did nothing. Rash lasted for 13 days. Rash was raised red bumps, itchy and nothing helped soothe. 3 weeks after injection terrible gut issues started. Diarrhea multiple times a day. I watched my diet and nothing helped. Went to OB and they tried to do a stool sample and it came back normal. Continue having gut issues to this day. I was in the hospital 4 more times with contractions and swelling over the course of 7 1/2 weeks following injection. Baby's estimated due date was 9-3-2018 and baby was born early 6lbs 13oz.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: Uncontrollable chills, fever, headache, soreness on shoulder and near arm pit.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy
Clinical narrative: This is a spontaneous case initially received from other non-health professional on 21-Nov-2018, concerning a pregnant female patient of an unspecified age. On an unspecified date, a 11-week pregnant female patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] (explicitly coded as vaccine exposure during pregnancy). At the time of this report, the outcome was unknown.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were recovered/resolved. It was unknown if the reporter considered the fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient experienced feverishness and fatigue for a couple of days after receiving SHINGRIX. The patient got a 2nd dose of SHINGRIX in an afternoon of 22nd January 2019 at a pharmacy. The patient stated that the pharmacist said the patient would therefore likely experience those side effects with the 2nd dose of SHINGRIX. The patient said might be the 2nd dose of SHINGRIX would not affect them. The patient had been advised to contact their physician if the patient experienced any of these symptoms after 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Immediate post-injection reaction, Injection site swelling, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, headache and rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache and rash were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 71 or 72 years. The patient experienced headache, swelling at injection site size of a grapefruit and rash over torso and arms. The reporter agreed to receive follow up from GlaxoSmithKline.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Malaise, Nausea, Palpitations
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of heart pounding in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SOMATULINE for an unknown indication. On 7th December 2018, the patient received the 1st dose of SHINGRIX and SOMATULINE at an unknown dose and frequency. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced heart pounding, tiredness, nausea, feeling hot and feeling unwell. On an unknown date, the outcome of the heart pounding, tiredness and nausea were unknown and the outcome of the feeling hot and feeling unwell were recovered/resolved. It was unknown if the reporter considered the heart pounding, tiredness, nausea, feeling hot and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: On 7th December 2018, the patient received SOMATULINE DEPOT. After receiving SHINGRIX, the patient experienced that her heart was pounding out of her chest, she was tired, nauseous (but did not throw up) and she felt hot for 3 to 4 days. The patient stated she did not go anywhere and did not feel like doing anything for about 3 to 4 days. No further follow up was anticipated.