chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281687, 2018SA281692 (Same reporter). This case involves a 15-months old female patient who received a 0.5 mL dose of PENTACEL (lot number: C5507AA and expiry date: 05-Sep-2019) (dose in series and route was not reported) in the left thigh on 12-Sep-2018 which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. 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 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. List of documents held by sender: none.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281636, 2018SA281637, 2018SA281635, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a 16 months old female patient who was vaccinated with a dose of PENTACEL (Batch number: C5507AA, expiration date: 05-Sep-2019, site of administration: left thigh, dose and route was not reported) on 11-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. 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. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a four-months old female patient who was vaccinated with a 0.5 mL dose of PENTACEL (Batch number, expiration date, route and site of administration was not reported) on 12-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. 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. List of documents held by sender: none.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687, 2018SA281692 (Same reporter). This case involves a three months-old (also reported as 4 months old) female patient who received a dose of PENTACEL, lot C5507AA, expiry date- 05-Sep-2019 via unknown route in the left thigh on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of actual medication error due to incorrect product storage. It was reported that the vaccine was given after temperature was at 30 F for 4 hours: below freezing. No adverse event was experienced. 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 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. List of documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA281638, 2018SA279966, 2018SA281635, 2018SA279965, 2018SA279973, 2018SA281633, 2018SA279967, 2018SA281636, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692. This case involves a 6 months old male patient who received vaccine PENTACEL. The patient's past medical history, concomitant medication and family history were not provided. On 11-Sep-2018, the patient received injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5507AA, expiry date 05-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Two hours after receiving vaccine presented with body aches, chills, sweating and fatigue.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Fatigue, Feeling hot, Hyperhidrosis, Joint contracture
Clinical narrative: Patient states she was watching a play with her husband and daughter when she started to feel "hot and sweaty". Per daughter, the patient then "slumped over" onto her husband's shoulder, was not shaking, but did seem to have her hands curled up in a ball on both sides. Daughter reports she then came to in less than a minute, was a little confused, but was back to her normal self by the time they got her to the ambulance outside the theater. The patient adds she realized she had urinated on herself once she got to the ambulance and that she felt very tired after the episode, but denied any chest pain, shortness of breath, slurred speech, facial droop, or unilateral weakness. The only thing out of the ordinary was that she got a flu shot today.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal, Urinary incontinence
Clinical narrative: Patient states she was watching a play with her husband and daughter when she started to feel "hot and sweaty". Per daughter, the patient then "slumped over" onto her husband's shoulder, was not shaking, but did seem to have her hands curled up in a ball on both sides. Daughter reports she then came to in less than a minute, was a little confused, but was back to her normal self by the time they got her to the ambulance outside the theater. The patient adds she realized she had urinated on herself once she got to the ambulance and that she felt very tired after the episode, but denied any chest pain, shortness of breath, slurred speech, facial droop, or unilateral weakness. The only thing out of the ordinary was that she got a flu shot today.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported red, swollen, and warm to the touch right bicep approximately 2 hours after vaccination. Also had chills and pain radiating to chest. Also reported when he blinked his eyes objects were vibrating but that went away. He reported this to me the following morning around 9:45am. Symptoms improved slightly. I advised that he may need to see primary physician to get checked out. He said he'd wait and see if cleared up and would go to his doctor if not better.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Visual impairment
Clinical narrative: Patient reported red, swollen, and warm to the touch right bicep approximately 2 hours after vaccination. Also had chills and pain radiating to chest. Also reported when he blinked his eyes objects were vibrating but that went away. He reported this to me the following morning around 9:45am. Symptoms improved slightly. I advised that he may need to see primary physician to get checked out. He said he'd wait and see if cleared up and would go to his doctor if not better.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: Patient reported red, swollen, and warm to the touch right bicep approximately 2 hours after vaccination. Also had chills and pain radiating to chest. Also reported when he blinked his eyes objects were vibrating but that went away. He reported this to me the following morning around 9:45am. Symptoms improved slightly. I advised that he may need to see primary physician to get checked out. He said he'd wait and see if cleared up and would go to his doctor if not better.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin warm, Visual impairment
Clinical narrative: Patient reported red, swollen, and warm to the touch right bicep approximately 2 hours after vaccination. Also had chills and pain radiating to chest. Also reported when he blinked his eyes objects were vibrating but that went away. He reported this to me the following morning around 9:45am. Symptoms improved slightly. I advised that he may need to see primary physician to get checked out. He said he'd wait and see if cleared up and would go to his doctor if not better.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient said starting Wednesday 10/3/2018 (evening hours) had swelling and extreme pain through the night. She also said arm felt hot. On Saturday 10/6/2018 patient went to a walk in medical facility to have arm checked. Patient called pharmacy on Monday 10/8/2018 to report incident. Said during the past week she could hardly lift her arm and had pain. She had been putting ice on ram and taking Tylenol. On Wednesday 10/10/2018 patient felt much better and was able to lift arm. Spoke with patient again on Thursday 10/11/2018 and was told she is feeling much better but still has slight pain in arm. Patient had said she wanted incident reported. Verified patient's address, DOB, phone number and asked if her personal information could be reported to Vaers site.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Dysphagia, Induration, Limb mass, Pain, Pain in extremity
Clinical narrative: CLIENT CALLED 10/12 TO SAY SHE WENT TO THE EMERGENCY ROOM ON 10/11 AFTER RECIEVING VACCINES ON 10/10. HER RIGHT ARM WAS VERY SORE AND SHE STATED SHE HAD A HARD LUMP UNDER THE SKIN. THE PAIN RADIATED UP TO HER NECK. PT STATES HER THROAT SWELLED AND SHE HAD A HARD TIME SWALLOWING. CLIENT RECIEVED ATIVAN, BENYDRAL, AND POTAISUM ACCORDING TO THE CLIENT. CLIENT STATED THAT SHE FELT FINE TODAY.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pharyngeal oedema
Clinical narrative: CLIENT CALLED 10/12 TO SAY SHE WENT TO THE EMERGENCY ROOM ON 10/11 AFTER RECIEVING VACCINES ON 10/10. HER RIGHT ARM WAS VERY SORE AND SHE STATED SHE HAD A HARD LUMP UNDER THE SKIN. THE PAIN RADIATED UP TO HER NECK. PT STATES HER THROAT SWELLED AND SHE HAD A HARD TIME SWALLOWING. CLIENT RECIEVED ATIVAN, BENYDRAL, AND POTAISUM ACCORDING TO THE CLIENT. CLIENT STATED THAT SHE FELT FINE TODAY.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: EMPLOYEE REPORTED LEG, ARM, BACK ITCHING 40 MINUTES AFTER RECEIVING THE INFLUENZA VACCINATION AND CAME TO OH TO BE SEEN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Patient claimed that she had a reaction with a red circle/rash on arm that kept getting bigger. It started after she got the shot on 10/5/18 within an hour. She said it was bright red on her whole upper arm. She contacted a nurse and her doctors office. They told her to take BENADRYL or use hydrocortisone cream and call the pharmacy. The patient did not contact the pharmacy where she got the shot until 10/11/18. At that point the rash was already clear.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site warmth
Clinical narrative: Bruise almost near the elbow, significantly lower than where injection occurred. Hot to touch but not red. No movement issue or pain in shoulder.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Sat the patient down for their vaccine, after administration patient stood to wait while mother and sister received their vaccines. While waiting patient was leaning on wall when she passed out and slid down, that's when I ran over to catch the patient and help her into a chair. Gave her water, orange juice and a granola bar. After patient felt better I checked her blood pressure and it was within normal limits.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient claims pain in her left arm following the immunization. She has limited range of motion in the left arm and is unable to lift the left arm. Patient has visited her family doctor on 10/12/18 and is currently on a muscle relaxant to treat the pain and stiffness.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Pain at point of injection, slight fever, general malaise.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: On 10-9 patient received her flu vaccine. The evening of 10-10 patient took 25 mg of Benadryl po for c/o localized pain, swelling and redness to her left arm. No c/o Sob. On the morning of 10-11 the patient noted that she had increased localized  pain, swelling and redness  to her left arm. No c/o Sob.  During the day she took additional two Benadryl. On  10-12 patient reported to Dr. that her arm has much improved with little redness, swelling  and not much pain.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-SEP-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the 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 condition of herpes zoster. On or about 29-SEP-2016, the patient was treated at a medical university (did not specified whether admitted therefore considered an Emergency Room (ER) visit until follow-up is received) for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered 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: Blister, Herpes zoster, Pain, 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 03-OCT-2012, the patient was inoculated with ZOSTAVAX at physician's office as recommended for routine adult health maintenance for the 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 condition of herpes zoster. On or about 02-JUN-2013, the patient was treated at the same physician's office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was prescribed VALTREX and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered 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: Blister, 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. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the 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 condition of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered 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.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Skeletal injury, Syringe issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Bone injury in a 79-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown. Additional details reported as follows: The healthcare professional stated that another pharmacist was giving a patient second dose and for some reason the needle and plunger would not work and patient only got 0.2 mL instead of 0.5 mL, which led to accidental underdose. The reporter's contact details were updated. In Aug 2018, the patient received SHINGRIX intramuscularly. The patient experienced bone injury after 1st dose. The pharmacist, who gave the vaccine, gave it only 0.2 ml. He does not know if he hit the bone or if the syringe was defective. The patient come back in the following week on 15th August 2018, and received the corrective dose (0.5 ml), without adverse effects. The VAERS details were updated.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 74-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced vesicular rash and pain. On an unknown date, the outcome of the vesicular rash and pain were recovered/resolved. It was unknown if the reporter considered the vesicular rash and pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported via click to chat. The age at vaccination was not reported however, it could be 73 or 74 years. The patient came in after receiving SHINGRIX in the previous week from the date of reporting with unusual rash which was painful and almost reminiscent of shingles but came and gone which was bilateral. The physician did not have lot number, and stated the vaccine was given at a pharmacy.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Feeling abnormal, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included shoulder replacement (In February 2018) and multiple allergies. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season and the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX, the patient experienced vomiting. On 29th September 2018, the patient experienced swelling arm, chills, fever and feeling bad. On an unknown date, the outcome of the swelling arm, chills, fever and feeling bad were recovering/resolving and the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the chills, vomiting, fever and feeling bad to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she received SHINGRIX (right arm) and a flu vaccine (left arm) on either on 27th September 2018 or on 28th September 2018. On 29th September 2018 (1 or 2 days after vaccination), around evening she started feeling bad. Her right arm, where she received SHINGRIX, swelled up and she also had fever and chills. The patient had some vomiting, but she said she had that periodically due to her bad allergies. The patient had started feeling a little better on the day of reporting. The patient had denied permission to contact their physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 14 days after receiving SHINGRIX, the patient experienced burning sensation skin. In October 2018, the outcome of the burning sensation skin was recovered/resolved. It was unknown if the reporter considered the burning sensation skin to be related to SHINGRIX. Additional details were received as follows: The patient stated that he had no irritation at the injection site. About 2 weeks after the vaccination with SHINGRIX, the patient started getting a burning sensation around the waist and the right side of his navel that moved around to the right side of his back and half way up the side of his spine. There had not been any break outs or rash and he states that it feels like a really bad sunburn. The burning has resolved some but if it is touched, it is more noticeable, especially in the back. He has reported his symptoms to his doctor. Obtained permission to contact physician.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of itching both hands in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, 1 day after receiving SHINGRIX, the patient experienced itching both hands and allergic reaction. On an unknown date, the outcome of the itching both hands was recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the itching both hands and allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient receive SHINGRIX vaccine in right arm. The reporter who himself a patient reported that, approximately three weeks ago next day after receiving SHINGRIX vaccination, he began to experience itching on the top and bottom of both hands. The itching was resolving slowly. Till the time of reporting, the patient was getting it less frequently. This case was previously reported to the physician. The patient called to report an allergic reaction to a medication. The patient was not looking for a resolution to the issue, so the patient did not hold it against my representative for not solving my problem that could not be solved, but it was just my reporting an issue that I was having after receiving a SHINGRIX shot. The reporter gave permission for his physician to be contacted. This case was link with case US2018GSK184601, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (administered 3 to 4 years ago). In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 1 day after receiving SHINGRIX, the patient experienced runny nose and injection site pain. On an unknown date, the outcome of the runny nose and injection site pain were recovered/resolved. It was unknown if the reporter considered the runny nose and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. In September 2018, approximately 2 weeks before the date of reporting, the patient was vaccinated with SHINGRIX. On the next morning of vaccination with SHINGRIX, the patient experienced runny nose. The injection site soreness and runny nose lasted for a period of 5 days. The patient stated that she already had a standing appointment with her doctor that was scheduled prior to the vaccination of SHINGRIX and so the patient went for her appointment and mentioned that the adverse events experienced by her to the doctor. The patient requested that she should not receive any additional correspondence that was any calls or letters regarding the events experienced by her as she was busy in taking care of her husband at the time of reporting. This case was linked to case US2018179127 reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Apathy, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, headache and lack of motivation. On an unknown date, the outcome of the fatigue, headache and lack of motivation were unknown. It was unknown if the reporter considered the fatigue, headache and lack of motivation to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX sometime in August 2018. The patient received SHINGRIX on the left arm. The patient reported that during the past 2 weeks before from the reporting date, he had experienced fatigue, no motivation and slight headaches. The patient stated that he was a widower and had not been eating well either and recently added Ensure and Boost to his diet.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter stated that her doctor had heard of a lots of patients who experienced a sore arm after vaccination with SHINGRIX. The reporter did not have any additional details regarding this event. This case was linked with case US2018179125, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ibuprofen. In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fatigue, upset stomach and activities of daily living impaired. On an unknown date, the outcome of the fatigue, upset stomach and activities of daily living impaired were unknown. It was unknown if the reporter considered the fatigue, upset stomach and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included cholesterol medication. The age at vaccination was not reported. The patient received dose of SHINGRIX about 2 to 3 weeks ago in the left arm. The patient reported that recently she had experienced fatigue and that it was getting worse. The patient was so fatigued she was almost unable to do her housework and was experiencing upset stomach. The patient had provided contact details of the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a adult 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 influenza and headache. On an unknown date, the outcome of the influenza and headache were unknown. It was unknown if the reporter considered the influenza and headache to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The patient did not want to provide any details on herself or the vaccines. She called because she was concerned about getting the SHINGRIX vaccine. The patient had talked to the people that have had the flu and headache with SHINGRIX vaccine. This has been linked to the case US2018179209, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that she always reponded to the shots by experiencing a sore arm within 24 to 48 hours after vaccination. The sore arm experienced by the patient lasted for 3 to 4 days for SHINGRIX, it was about a week. This case was linked with US2018GSK182226 case reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a 67-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was the physician stated that one of her friends (patient) received the SHINGRIX vaccine and reported a rash at a remote location that was still cropping up at the time of reporting.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, headache, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site erythema, injection site warmth, headache, influenza-like symptoms and fever were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was the son of the patient. The patient had injection site redness and the site was hot for 2 to 3 days. The reporter stated that his mother had a fever, headaches and flu like symptoms for a day after receiving the injection. The reporter was unable to report the lot number or injection site. The reporter failed to obtain physician information.
Sex: U
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Malaise, Pyrexia
Clinical narrative: This case was reported by a dentist via call center representative and described the occurrence of malaise in a unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced malaise, gastrointestinal symptom nos and fever. On an unknown date, the outcome of the malaise, gastrointestinal symptom nos and fever were unknown. It was unknown if the reporter considered the malaise, gastrointestinal symptom nos and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter said he recommended to his patients to get vaccinated with SHINGRIX. The health care professional said a lot of his patients had complained of having malaise, fever and gastrointestinal symptoms after the 1st dose of SHINGRIX. The health care professional was calling to ask if patients would have the same or worse reaction after the 2nd dose to SHINGRIX so he could continue to recommend to his patients to receive the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 1st October 2018, the patient received SHINGRIX. On 3rd October 2018, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The case was came in via chat. The age at vaccination was not reported. At 2:00 pm, the patient received the SHINGRIX. Her arm was red.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 1st October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site wheal. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site wheal were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site wheal to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX was EH927, which was changed to EH9Z7, as per sales data sheet. After receiving SHINGRIX, the patient experienced two large red welts near the injection site along with pain. The reporter asked does GSK have recommendations on what to do. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Impaired work ability, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a adult 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 fever, adverse reaction and impaired work ability. On an unknown date, the outcome of the fever, adverse reaction and impaired work ability were unknown. It was unknown if the reporter considered the fever, adverse reaction and impaired work ability to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter mentioned that after receiving SHINGRIX, many of his patients had complained to him about the unpleasant reactions. They complained of fevers and being out of commission for 24 hours. The reporter did not have any specific patients to mention, was just relaying information that he has heard from his patients.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional requested Safety Department reach out to her to obtain details about the patient and their experience. The health care professional did not have time to stay on call. This case has been linked with case US2018GSK184102, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 71-year-old female patient who received SHINGRIX (batch number 954K9, expiry date 24th February 2021) (GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On 10th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th August 2018, immediately after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional information received as follows: The healthcare professional reported that the patient did well after the first dose. The healthcare professional reported that the patient experienced the shingles-like rash right after receiving the dose of SHINGRIX. The patient had the rash on her trunk and legs. The healthcare professional reported that the patient did well after the first dose. The patient had been in touch with her physician. She informed to the healthcare professional about the reaction on the reporting day.
Sex: F
Vaccine: VARZOS
Symptoms: Complex regional pain syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of reflex sympathetic dystrophy in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included reflex sympathetic dystrophy. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced reflex sympathetic dystrophy. On an unknown date, the outcome of the reflex sympathetic dystrophy was not recovered/not resolved. It was unknown if the reporter considered the reflex sympathetic dystrophy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician reported that the patient's preexistent condition of reflex sympathetic dystrophy was greatly exaggerated on the day of the vaccination. Till the time of reporting, the patient still not back to baseline. The information was provided to the MSO (healthcare management service organization) by text message from the physician. No additional details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced bad flu type reaction, Fever (101), aches, general tiredness as well as pain and redness at injection site after receiveing first shot of SHINGRIX. It lasted for a week. Lab Comments: On an unknown date, the patient's body temperature test was performed.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced bad flu type reaction, Fever (101), aches, general tiredness as well as pain and redness at injection site after receiveing first shot of SHINGRIX. It lasted for a week. Lab Comments: On an unknown date, the patient's body temperature test was performed.