chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 18-year-old male patient received TRUMENBA on 13Jul2018 in the evening, at single dose for immunization in left deltoid. The patient medical history and concomitant medications were not reported. The patient experienced episode of passing out, high fever, chills, vomiting, headache, muscle pain, hot flashes on an unknown date in Jul2018. The day after, in the morning, the patient had to go to urgent care due to the events and in the afternoon he was better.All the events are serious as medically significant.The final outcome of the event was recovering.Causality between TRUMENBA and all the events was reported as related.Information on the batch number has been requested. Sender's Comments: Based on the information currently available, the known adverse event profile of the suspect vaccine and the pathophysiology of the events, the Company cannot completely exclude that the suspect drug contributed to the development of the reported events.
Sex: U
Vaccine: MENB
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable Nurse and physician. This Nurse reported similar events for 3 patients. This is the 1st of three reports. A patient of unspecified age and gender received Meningococcal Group B RLP2086, via an unspecified route of administration on 06Jun2018 at a single dose for immunization at the physician's office. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines with meningococcal group b rlp2086. The patient woke up with pain, chills, tired, nausea on 07Jun2018. The patient recovered from the events on an unspecified date in 2018. Pfizer is a Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities. Sender's Comments: Linked Report(s): US-PFIZER INC-2018288887; Same reporter/drugs/events different patients. US-PFIZER INC-2018288886 Same reporter/drugs/events different patients.
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 19-year-old female patient received TRUMENBA via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea, low grade fever, and body ache. It was reported that the patient was healthy. She had just gotten NORPLANT since her last visit. Outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: LEFT THIGH WHERE MENACTRA WAS GIVEN SHE WAS RED, WARM, HAD A KNOT-PT WAS TOLD TO USE BENADRYL CREAM AND ICE. IBU IF NEEDED. A PA went in and saw pt.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea, Peripheral coldness
Clinical narrative: Severe headache began approx 8 hours after the injection. In the middle of the night, I became bitterly cold given it was 76 degrees in the house. Sheet and blanket and my left (injection) arm and hand were ice cold and would not warm up. Began taking extra strength TYLENOL next morning, but headache continued and felt close to a migraine. Thursday night did not repeat the cold, but the headache persisted and just generally nauseous. Friday morning switched to naproxen sodium and the headache became bearable but remained. 48 hours later, still a headache, but feeling better. I had no problems after the first shot in March 2018.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Blood glucose normal, Blood pressure normal, Heart rate normal, Malaise
Clinical narrative: APPROX 3-4 MINUTES AFTER COMPLETION OF VACCINATION (ONLY HEP A AT THIS VISIT) PATIENT WAS SITTING IN DADS LAP AND LOOKED VERY PALE, HE SAID THAT HE DIDN'T FEEL WELL. I CALLED A CLERK FOR ASSISTANCE AND WENT TO GET THE EMERGENCY BOX. THE PATIENT WAS PALE AND APPEARED WEAK BUT WAS BREATHING NORMALLY AND WAS AWAKE. WHEN RETURNING TO THE ROOM APPROX 1 MINUTE OR LESS LATER THE PATIENT REMAINED SEATED WITH DAD, I ASKED FOR HIM TO LAY THE PATIENT ON THE EXAM TABLE. PATIENT WAS PLACED IN SUPINE POSITION AND HIS LEGS WERE ELEVATED 25 degrees. THE PATIENT'S FACE QUICKLY STARTED TO RETURN TO NORMAL COLOR AND HE SLOWLY STARTED TO RETURN TO HIS NORMAL SELF. HE WAS READY TO SIT UP AFTER APPROX, 4 MINUTES OF LAYING DOWN BUT I ASKED HIM TO REMAIN IN SUPINE POSITION FOR A LITTLE BIT LONGER. THE PATIENT STATED PRIOR TO BEING LAID DOWN THAT HIS THROAT WAS HURTING BUT HE DID NOT HAVE ANY DIFFICULTY WITH BREATHING. HIS RESPIRATIONS WERE NORMAL, HE DID NOT COMPLAIN OF ITCHING, HE WAS SUNBURNED BELOW HIS EYES - OTHER REDNESS WASN'T NOTED, NO HIVES AND NO COMPLAINTS OF ABDOMINAL PAIN.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Oropharyngeal pain, Pallor
Clinical narrative: APPROX 3-4 MINUTES AFTER COMPLETION OF VACCINATION (ONLY HEP A AT THIS VISIT) PATIENT WAS SITTING IN DADS LAP AND LOOKED VERY PALE, HE SAID THAT HE DIDN'T FEEL WELL. I CALLED A CLERK FOR ASSISTANCE AND WENT TO GET THE EMERGENCY BOX. THE PATIENT WAS PALE AND APPEARED WEAK BUT WAS BREATHING NORMALLY AND WAS AWAKE. WHEN RETURNING TO THE ROOM APPROX 1 MINUTE OR LESS LATER THE PATIENT REMAINED SEATED WITH DAD, I ASKED FOR HIM TO LAY THE PATIENT ON THE EXAM TABLE. PATIENT WAS PLACED IN SUPINE POSITION AND HIS LEGS WERE ELEVATED 25 degrees. THE PATIENT'S FACE QUICKLY STARTED TO RETURN TO NORMAL COLOR AND HE SLOWLY STARTED TO RETURN TO HIS NORMAL SELF. HE WAS READY TO SIT UP AFTER APPROX, 4 MINUTES OF LAYING DOWN BUT I ASKED HIM TO REMAIN IN SUPINE POSITION FOR A LITTLE BIT LONGER. THE PATIENT STATED PRIOR TO BEING LAID DOWN THAT HIS THROAT WAS HURTING BUT HE DID NOT HAVE ANY DIFFICULTY WITH BREATHING. HIS RESPIRATIONS WERE NORMAL, HE DID NOT COMPLAIN OF ITCHING, HE WAS SUNBURNED BELOW HIS EYES - OTHER REDNESS WASN'T NOTED, NO HIVES AND NO COMPLAINTS OF ABDOMINAL PAIN.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Pallor, Swelling face
Clinical narrative: Facial swelling to right cheek, blanching, erythema to right cheek with trace, localized swelling, onset approximately 2 hours after typhoid injection. Given acetaminophen 325mg TID x 3 days, diphenhydramine 25mg BID x 2 days, hydrocortisone 1%.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Retching
Clinical narrative: PT SAID BEGINNING YESTERDAY (7/19/2018) MORNING SHE FELT ILL SYMPTOMS INCLUDE MILD FEVER, NAUSEA, DRY HEAVES. SHE ALSO REPORTED A VERY SORE ARM.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: About 3 hours after injection patient reports having severe pain at injeciton site, nausea, fever, chills, body ache and headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 3 hours after injection patient reports having severe pain at injeciton site, nausea, fever, chills, body ache and headache.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Breath sounds abnormal, Erythema, Irritability, Peripheral swelling, Pyrexia
Clinical narrative: Per parent: Patient began having hand and feet swelling, which progressed to facial and full body redness and swelling, as well as raspy breathing. Noted to have an axillary fever of 102F. Went to ED, and swelling self-resolved within 2 hours. Fever treated with TYLENOL suppository. Patient remained fussy for a few days afterward, but no recurrence of fever or swelling.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Swelling
Clinical narrative: Per parent: Patient began having hand and feet swelling, which progressed to facial and full body redness and swelling, as well as raspy breathing. Noted to have an axillary fever of 102F. Went to ED, and swelling self-resolved within 2 hours. Fever treated with TYLENOL suppository. Patient remained fussy for a few days afterward, but no recurrence of fever or swelling.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: This spontaneous case was received from a physician via company representative regarding a 6 month old (also reported as 1 year and 9 month old) male patient. The patient did not have any pertinent medical history, drug reactions/allergies and was not taking any concomitant medications. On 02-DEC-2016, the patient received the first dose of ROTATEQ (dose, unit not reported) (lot# M029252, expiration date: 14-MAR-2018) orally, on 10-FEB-2017, the patient received second dose of ROTATEQ (dose, unit not reported) (lot# M031650, expiration date: unknown) orally for vaccination (immunization). On 05-APR-2017, the patient received the third dose of ROTATEQ (dose, unit not reported) (lot# M031650, expiration date: unknown) orally for vaccination (immunization) (Drug administered to patient of inappropriate age). On 22-NOV-2017, the patient went to an unspecified hospital and was diagnosed with intussusception. The patient sought medical attention.The patient was treated with an unspecified enema and air treatment. No lab diagnostics/studies were performed. The outcome of the event was reported as recovered. The causality assessment of the event to the therapy with ROTATEQ was not reported. The event intussusception was considered to be life threatening. No product quality complaint (PQC) was reported. Upon internal review, the event intussusception was determined to be medically significant. This is one of the two reports from the same source. Sender's Comments:  US-009507513-1807USA006275.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JUN-2007, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 02-APR-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 19-AUG-2012, the patient was treated by a physician at a physician's office 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 and/or despite receiving the 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Diarrhoea, Loss of personal independence in daily activities, Mental impairment, Mental status changes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 6th July 2018 12:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th July 2018, less than a day after receiving SHINGRIX, the patient experienced sleepiness. On 7th July 2018, the patient experienced difficulty thinking (serious criteria GSK medically significant), diarrhea, muscle pain, mental status changes and activities of daily living impaired. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the difficulty thinking, sleepiness, diarrhea, balance difficulty, muscle pain, mental status changes and activities of daily living impaired were unknown. The reporter considered the difficulty thinking, diarrhea, balance difficulty, mental status changes and activities of daily living impaired to be possibly related to SHINGRIX. The reporter considered the sleepiness and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The patient received SHINGRIX in left arm. The patient had substantial muscle aches throughout his body. On 7th July 2018, he patient did not feel safe to drive. He would be emailing his experience to Centers for Disease Control and Prevention (CDC), the pharmacy and to GlaxoSmithKline. This case was linked with the case US2018127820, reported for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 6th July 2018 12:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th July 2018, less than a day after receiving SHINGRIX, the patient experienced sleepiness. On 7th July 2018, the patient experienced difficulty thinking (serious criteria GSK medically significant), diarrhea, muscle pain, mental status changes and activities of daily living impaired. On an unknown date, the patient experienced balance difficulty. On an unknown date, the outcome of the difficulty thinking, sleepiness, diarrhea, balance difficulty, muscle pain, mental status changes and activities of daily living impaired were unknown. The reporter considered the difficulty thinking, diarrhea, balance difficulty, mental status changes and activities of daily living impaired to be possibly related to SHINGRIX. The reporter considered the sleepiness and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The patient received SHINGRIX in left arm. The patient had substantial muscle aches throughout his body. On 7th July 2018, he patient did not feel safe to drive. He would be emailing his experience to Centers for Disease Control and Prevention (CDC), the pharmacy and to GlaxoSmithKline. This case was linked with the case US2018127820, reported for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Hallucination, Panic attack, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of abnormal dreams in a 52-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abnormal dreams, fever, sleep disturbance, chills and panic attack. On an unknown date, the outcome of the abnormal dreams, fever, sleep disturbance, chills and panic attack were unknown. It was unknown if the reporter considered the abnormal dreams, fever, sleep disturbance, chills and panic attack to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that one of his family member experienced hallucinatory dreams, fever of 100.7, sleep was messed up and though they were having a panic attack. This case was linked with the case US2018GSK124669, reported by the same reporter. Lab Comments: On an unspecified date, body temperature was 100.7.
Sex: U
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of abnormal dreams in a 52-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abnormal dreams, fever, sleep disturbance, chills and panic attack. On an unknown date, the outcome of the abnormal dreams, fever, sleep disturbance, chills and panic attack were unknown. It was unknown if the reporter considered the abnormal dreams, fever, sleep disturbance, chills and panic attack to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that one of his family member experienced hallucinatory dreams, fever of 100.7, sleep was messed up and though they were having a panic attack. This case was linked with the case US2018GSK124669, reported by the same reporter. Lab Comments: On an unspecified date, body temperature was 100.7.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 57 years old female patient who experienced severe shoulder pain and shoulder immobility and frozen shoulder, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In June 2018, the patient received a 0.5 ml single injection dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5771AA via intramuscular route in the right deltoid. The patient developed a non-serious experiencing severe shoulder pain following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious shoulder immobility and frozen shoulder following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data). Final diagnosis was shoulder immobility and frozen shoulder and experiencing severe shoulder pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered/Not Resolved on an unknown date for experiencing severe shoulder pain and as Not Recovered/Not Resolved on an unknown date for shoulder immobility and frozen shoulder.
Age: 10.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from a nurse on 10-Jul-2018. This case involves a 10-year-old male patient who was vaccinated with a dose of 0.5 ml ADACEL (lot number: U5875AB, expiration date: 14-Feb-2020) via intramuscular in left arm on 18-Jun-2018. The patients past vaccination(s) included ADACEL on 06-OCT-2017, typhoid on 25-JUN-2014 and DAPTACEL with 5 DAPACEL doses. The patients past medical history, medical treatment(s) and family history were not provided. Concomitant medications included 0.5 ml TYPHIM VI intramuscular in right arm for Immunisation. It was an actual medication error due to extra dose administered. It was not reported that patient had any side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 38 years old female patient who experienced hives to both arms and entire back, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 16-Oct-2017, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 195212, expiry date 31 Mar 2017 via intramuscular route in the left deltoid. It was reported that Infection Control and Employee Health nurse called from a hospital to request FLUZONE QUADRIVALENT single-dose syringe ingredient list for allergen testing, on an unknown date patient experienced hives after immunization with that product 3 years in a row. Hives to both arms and entire back post-injection. The patient was not pregnant at the time of injection and had been eating eggs without any signs or symptoms of allergy. The patient requested the ingredient list for the FLUZONE for an allergist to test for potential allergies to those ingredients. Lab data was not provided. Final diagnosis was hives to both arms and entire back. Patient did not receive any treatment or physician visit or ED visit. The patient outcome is reported as Unknown for hives to both arms and entire back. List of documents held by sender- none.
Age: 26.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case 26 year old patient who received vaccination with 0.5 ml expired dose of ADACEL (frequency once, batch number U5316AA, expiry date 30 Apr 2018) via intramuscular route in the left deltoid on 12 July 2018. It was a case of actual medication error due expired vaccine used. Patient had no treatment. It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 13-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old patient who was vaccinated with expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation. On 12-Jul-2018, the patient received a dose 4 Primary dose of suspect HIB (PRP/T) VACCINE lot U1796AA in the left thigh. It was an actual medication error due to expired dose of ACTHIB. The patient outcome is reported as Not Applicable for nurse gave an expired dose of ACTHIB. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain
Clinical narrative: Patient informs us that first shot was given in the back of her arm subcutaneously instead of IM as a result causing more pain. Patient informed shot is still effective given route of administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Mobility decreased
Clinical narrative: Approx 12 hours after shot I felt chills and body aches. Symptoms worsened when I woke up the next morning and could hardly get out of bed... felt like I had the flu. By midday I could move around a bit but still felt crummy (nausea, headache, chills, aches). The next day I still felt off but was functional.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Approx 12 hours after shot I felt chills and body aches. Symptoms worsened when I woke up the next morning and could hardly get out of bed... felt like I had the flu. By midday I could move around a bit but still felt crummy (nausea, headache, chills, aches). The next day I still felt off but was functional.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Patient had her vaccination on Wednesday 7/18/18 at 1:30 in the afternoon, she called in today 7/20/18 at 1:30pm saying that this morning she started with redness, swelling, hardness and heat at the site of the injection. I told her to put a cool compress on the site and take some ibuprofen to help with the inflammation. I also told her to keep a watch on it and if any changes to call me back otherwise I will call and check in with her later today.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Heart rate increased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced redness, swelling and itching at the injection site which was 4 by 4 inches in diameter. This lasted for about total of 2 weeks. On the sixth day after getting the vaccine the patient woke up in the middle of night and had vomiting, diarrhea and fast heart beat which lasted for total of 3 hours. The patient called to ask if she should get the second shot since she experienced adverse reactions with the first shot. The patient had denied permission to contact their physician. No further details were provided by the patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, heartbeats increased, vomiting, diarrhea, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced redness, swelling and itching at the injection site which was 4 by 4 inches in diameter. This lasted for about total of 2 weeks. On the sixth day after getting the vaccine the patient woke up in the middle of night and had vomiting, diarrhea and fast heart beat which lasted for total of 3 hours. The patient called to ask if she should get the second shot since she experienced adverse reactions with the first shot. The patient had denied permission to contact their physician. No further details were provided by the patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza, Nausea, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer and mastectomy bilateral (both conditions experienced 2 years before reporting date). On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, nausea, influenza and tremor. On 14th June 2018, the outcome of the weakness, nausea, influenza and tremor were recovered/resolved. The reporter considered the weakness to be related to SHINGRIX. It was unknown if the reporter considered the nausea, influenza and tremor to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine on the right arm. The patient reported that she felt weak, shaky and nauseated. She said it felt like she had the flu. The reporter gave permission to contact his physician and provided contact details for the same.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling of jaw angle in a 60-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX. On 13th July 2018, 3 days after receiving SHINGRIX, the patient experienced swelling of jaw angle. On an unknown date, the outcome of the swelling of jaw angle was unknown. It was unknown if the reporter considered the swelling of jaw angle to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a swollen jaw on the same side as where the SHINGRIX injection was given in the left side. The date of 1st injection was not discussed.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site ecchymosis. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site ecchymosis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site ecchymosis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. Redness, swelling and ecchymosis at the site were resolved after 10 days. The patient reported the events to her pharmacist. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK129632.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site ecchymosis. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site ecchymosis were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site ecchymosis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. Redness, swelling and ecchymosis at the site were resolved after 10 days. The patient reported the events to her pharmacist. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK129632.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included injection site swelling (1st dose history) and injection site ecchymosis (1st dose history). Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose, refer case US2018125503). On 12th July 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th July 2018 16:00, 3 hrs after receiving SHINGRIX, the patient experienced injected limb mobility decreased and pain in arm. The patient was treated with TYLENOL, muscle relaxants and PERCOCET. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. The patient could not move her right arm due to the pain. The patient took 3 extra strength TYLENOL, a muscle relaxant, iced it and also took a PERCOCET but nothing touched the pain. On the day of reporting, the patient noted it was better but not resolved. The patient was encouraged to report the pain issues to her physician with the 2nd dose.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included injection site swelling (1st dose history) and injection site ecchymosis (1st dose history). Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose, refer case US2018125503). On 12th July 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th July 2018 16:00, 3 hrs after receiving SHINGRIX, the patient experienced injected limb mobility decreased and pain in arm. The patient was treated with TYLENOL, muscle relaxants and PERCOCET. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. The patient could not move her right arm due to the pain. The patient took 3 extra strength TYLENOL, a muscle relaxant, iced it and also took a PERCOCET but nothing touched the pain. On the day of reporting, the patient noted it was better but not resolved. The patient was encouraged to report the pain issues to her physician with the 2nd dose.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pustule, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67 year old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 9th July 2018, the patient received SHINGRIX .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site pustule, shingles, pain in arm, drowsiness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pustule, shingles, drowsiness and fever were unknown and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pustule, shingles, pain in arm, drowsiness and fever to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported the patient developed drowsiness, fever and arm pain same day of injection. The healthcare professional also reported patient developed redness, swelling and pustules around injection site two days after administration. The patient reportedly went to physician who diagnosed the patient as having shingles. No further information was reported regarding the event.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67 year old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 9th July 2018, the patient received SHINGRIX .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site pustule, shingles, pain in arm, drowsiness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pustule, shingles, drowsiness and fever were unknown and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pustule, shingles, pain in arm, drowsiness and fever to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported the patient developed drowsiness, fever and arm pain same day of injection. The healthcare professional also reported patient developed redness, swelling and pustules around injection site two days after administration. The patient reportedly went to physician who diagnosed the patient as having shingles. No further information was reported regarding the event.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 76-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 13th April 2018, the patient received SHINGRIX .5 ml. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced feels awful, pain in arm and exhaustion. On an unknown date, the outcome of the feels awful, pain in arm and exhaustion were recovered/resolved. It was unknown if the reporter considered the feels awful, pain in arm and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. After receiving SHINGRIX, the patient felt terrible, exhausted with an extremely sore arm which fully resolved after a few days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal pain, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 8th July 2018, the patient received the 1st dose of SHINGRIX. On 8th July 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, muscle pain and pain in arm. In July 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, shoulder pain and muscle pain were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, shoulder pain, muscle pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received the SHINGRIX vaccine shot 4 days ago. Less than a week after receiving vaccination, the patient had experienced some of the common side effects which included redness around the site. The patient had shoulder and muscle pain and a very sore arm that is even tender to light touch. The patient felt pretty achy for the first two days and her arm soreness was still quite painful even now. The patient was concerned about the second shot in 6 months and wanted to know do people have less of a reaction with the second shot. The patient really dread the thought of this painful arm again and  do not know yet how long this pain would last and wanted any information or suggestions that would be very helpful.
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 8th July 2018, the patient received the 1st dose of SHINGRIX. On 8th July 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, muscle pain and pain in arm. In July 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, shoulder pain and muscle pain were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, shoulder pain, muscle pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received the SHINGRIX vaccine shot 4 days ago. Less than a week after receiving vaccination, the patient had experienced some of the common side effects which included redness around the site. The patient had shoulder and muscle pain and a very sore arm that is even tender to light touch. The patient felt pretty achy for the first two days and her arm soreness was still quite painful even now. The patient was concerned about the second shot in 6 months and wanted to know do people have less of a reaction with the second shot. The patient really dread the thought of this painful arm again and  do not know yet how long this pain would last and wanted any information or suggestions that would be very helpful.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of SHINGRIX and experienced unspecified adverse effects. The patient declined to participate in filing this adverse event. No further specifics were captured. No further adverse event information was provided.
Sex: U
Vaccine: MENB
Symptoms: Hypoaesthesia, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of numbness of upper extremities in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced numbness of upper extremities and vaccine administered at inappropriate site. On an unknown date, the outcome of the numbness of upper extremities was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the numbness of upper extremities to be related to BEXSERO. Additional details were provided as follows. The patient's initials, gender and date of birth were unknown. The doctor said that his Medical assistant administered BEXSERO in the front part of the patient's arm, not in the deltoid muscle. This led to vaccine administered at inappropriate site. The patient's arm was numb for 6 to 7 days. The patient was fine at the reporting time. The reporter said he did not call GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site pain, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site pain and headache were recovered/resolved and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid area. By that same evening, the patient developed flu like symptoms, fever, chills, body aches, pain at injection site and headache. The patient reported these symptoms were lasted for 48 hours and then resolved. This is 1 of 2 cases, reported by the same reporter for same patient.