chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2018SA312352 (Same reporter). This case involves a 16 years old female patient who received 0.5ml of vaccine FLUZONE QUADRIVALENT (batch number: UT6258MA, expiry date: 30-Jun-2019) (dose in series and site of administration were not reported) via intramuscular route on 05-Nov-2018 which was frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as No other medication or vaccines were given. It was a case of potential medication error due to incorrect product storage. It was reported as, on 11/5/2018, staff person attempted to give a 0.5 ml dose of FLUZONE QUAD IM to patient, but the plunger wouldn't depress because the "vaccine was frozen". No other medication or vaccines were given except a second, unfrozen 0.5ml IM injection of FLUZONE QUAD, in the right arm. The frozen syringe was thrown away. It was not reported that if any adverse reaction was experienced or not. 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.
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date were not reported) which was frozen then thawed. The patient medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. There were no side effects or treatment. 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.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. The case was linked with 2018SA312242 (same reporter). This case involves a 30 years old patient (gender not reported) who was vaccinated with an expired dose of TYPHIM VI (batch number, expiration date, dose, route and site of administration was not reported) on 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The vaccine was used 14 days post expiration date. No side effects 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: 50.0
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. The case was linked with 2018SA312227 (same reporter). This case involves an about 50 years old patient (gender not reported) who received an expired dose of TYPHIM VI (batch number, expiration date, dose, route and site of administration was not reported) on 07-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was reported that the patient had no 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 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.
Sex: U
Vaccine: FLU4, HPV4, MNQ, TYP
Symptoms: Product dose omission, Syringe issue
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old patient (gender not reported) who suppose to received TYPHIM VI (lot N1K801M, expiry date 15 Oct 2019) on an unknown. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication involved Patient also received FLULAVAL 0.5 ml, MENACTRA 0.5 ml and GARDASIL 0.5 ml. It was a case of potential medication error due to Missed dose and Syringe leak as Pharmacist states when she showed him the syringe after the incident the needle was attached to the luer lock but the syringe was not attached and nothing looked broken. Pharmacist states patient, missed their dose because they only had the one dose. 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA308949 (same reporter). This case involves Adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (Lot number: UT6258MA and expiry date: 30-Jun-2019) (dose in series, route and site of administration were not reported) on 05-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage because the vaccine thawed out in the refrigerator door and kept their freeze at 31.0F-32.0F. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender not reported) who was inadvertently vaccinated with an expired dose of suspect vaccine 0.25 mL FLUZONE QUADRIVALENT lot UT5949JA via unknown route in the thigh on an unspecified date (reported as Monday). The patient's medical history and concomitant medications were not reported. No other vaccines were administered. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. 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: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 47 years old female patient who experienced shoulder pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Bursitis in left shoulder. The patient did not receive any concomitant medication. Notes- The patient has a MIRENA IUD in place so does not get regular periods. On 05-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI996AB, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious shoulder pain with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of an actual medication error due to Vaccine administered at inappropriate site as FLUZONE QUAD was given in the deltoid or was perhaps not entirely in deltoid, given too high on a patient's arm, unsure if it was injected in right place. Lab data was not provided. Final diagnosis was shoulder pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for shoulder pain. 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: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, VARCEL
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a one-years old female patient who received fourth dose 0.5 mL vaccine PENTACEL lot C5530AA via unknown route in the thigh on 07-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. It was actual medication error due to inappropriate reconstitution technique. It was reported that the patient received the liquid part and not the powder of PENTACEL. It was unknown if any adverse event was 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 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. Follow-up information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. The report contains no new information. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 61 years old male patient received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 07-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ047AA, expiry date 28-May-2019 via unknown route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that MA gave FLUZONE HD to a male 61-year-old, thinking that he was 65 years of age. 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.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 13 months and 27 days old patient who received second dose of 0.25 ml of FLUZONE QUADRIVALENT one week early. The patient's past medical history, medical treatment(s), and family history were not provided. No other vaccines were given. On 17-Oct-2018, the patient received first dose of 0.25 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6262NA and expiry date: 30-Jun-2020) via unknown route in the right thigh and on 07-Nov-2018, received second dose of the same vaccine. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown if the patient had any adverse event. 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA312656 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date was not reported) that was stored in a low temperature for 12 hours on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if any adverse event occurred or not. 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. Documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA312306. This case involves a nine years old male patient who received only 4 of the necessary 5 doses of DAPTACEL. The patient's medical history and concomitant medications were not reported. The patient received historical vaccine with DAPTACEL. It was an actual medication error due to incomplete course of vaccination. It was also reported that the patient received last dose DAPTACEL vaccine when he was < 4years old. It was unknown whether the patient had any adverse event. 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.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient had COPD (Chronic obstructive pulmonary disease). Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose as High Dose was given to a 60 year old with COPD. It was not reported that if any adverse reaction 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. Documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Chills, Decreased activity, Feeding disorder, Pyrexia
Clinical narrative: By the evening time patient began developing a fever of 102, he would also not eat. We knew he had his shot that morning so didn't think too much of this. Wednesday patient was less than his normal energetic self and continued to run the 102 fever, my husband called the doctor to alert them of this. They said they would follow up again on Thursday. Wednesday evening patient's fever was still hovering around 102, we were giving him TYLENOL. We gave him the normal shower he gets every evening and he was acting very weird in the warm shower, kept shivering, and shaking his head. When I took him out of his shower he's usually very excited to dry off and get his pajamas on, but he kept shivering and laid his head on my shoulder and closed his eyes. I took him to my bed like I normally do to get him dressed and he immediately went to sleep (undressed, etc.), This is EXTREMELY not normal for him, he usually gets dressed, runs across the bed to kiss his daddy and hops in my arms to go in his room. I was so worried I started crying, my husband came over, picked him up, tried to stand him up and he kept acting like he was completely in a deep sleep. That's when I decided he was going to lay with me for a while. We tried to give him his warm milk that he drinks every night and we couldn't get him to take it. I ended up having him lay on my chest for a while, but he was completely out of it. I laid him in his bed about an hour later because he has a breathing monitor so I knew it would monitor him while he slept. Today, Thursday November 15, he woke up again with a 102 fever. My husband called the doctor and they said it had not been a full 48 hours yet, to let that occur (even though it has been since the shot). We are continuing to monitor him. This is NOT normal for my son at all.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Tremor
Clinical narrative: By the evening time patient began developing a fever of 102, he would also not eat. We knew he had his shot that morning so didn't think too much of this. Wednesday patient was less than his normal energetic self and continued to run the 102 fever, my husband called the doctor to alert them of this. They said they would follow up again on Thursday. Wednesday evening patient's fever was still hovering around 102, we were giving him TYLENOL. We gave him the normal shower he gets every evening and he was acting very weird in the warm shower, kept shivering, and shaking his head. When I took him out of his shower he's usually very excited to dry off and get his pajamas on, but he kept shivering and laid his head on my shoulder and closed his eyes. I took him to my bed like I normally do to get him dressed and he immediately went to sleep (undressed, etc.), This is EXTREMELY not normal for him, he usually gets dressed, runs across the bed to kiss his daddy and hops in my arms to go in his room. I was so worried I started crying, my husband came over, picked him up, tried to stand him up and he kept acting like he was completely in a deep sleep. That's when I decided he was going to lay with me for a while. We tried to give him his warm milk that he drinks every night and we couldn't get him to take it. I ended up having him lay on my chest for a while, but he was completely out of it. I laid him in his bed about an hour later because he has a breathing monitor so I knew it would monitor him while he slept. Today, Thursday November 15, he woke up again with a 102 fever. My husband called the doctor and they said it had not been a full 48 hours yet, to let that occur (even though it has been since the shot). We are continuing to monitor him. This is NOT normal for my son at all.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: Patient developed a bruise the size of a quarter that has not gone away yet (it's been 12 days).
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Patient had a 1/2-3/4 inch lump with 2 inch circumference at the injection site. The area was raised. It was not red. The lump lasted approximately 48 hours. We were notified by family 11/14/18.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Cartilage injury, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff repair
Clinical narrative: Nine weeks of pain, sent to Orthopedic Doctor followed by cortisone shot and steroids medicine. Physical therapy next as pain and limitations continue.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Cough, Dyspnoea, Malaise, Nausea
Clinical narrative: Developed a cough and difficulty breathing. Began to feel ill with mild joint ache and nausea. Condition started about 3 hours after the injection. Breathing returned to normal but the ill feeling and nausea continue now 20 hours later.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Livedo reticularis, Paraesthesia, Skin burning sensation
Clinical narrative: Patient got IIV 4 in the morning 10/28/18 she started feeling an allergic reaction that evening (about 5 hours later) tingling and burning and mottling of skin. She went to ED on 11/2 and was given prednisone. The reaction was under control while on prednisone but returned every time she tried to taper off. She was seen by her primary care. She went to ED 2 weeks after shot. The reaction continues to increase. She is seeing a neurologist today (11/15).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Dysgeusia, Dyspepsia, Immediate post-injection reaction
Clinical narrative: I received my annual flu shot on the above date. After receiving the flu shot, I immediately felt the medication go all over my body, I could taste it in my mouth, and also felt like my stomach was on fire. I felt an intense burning in my stomach that last several minutes. Out of fear of what was happening, I jumped to my feet, where I immediately started seeing stars and felt like I was going to pass out. Several hours later, I became nauseous and felt like my body was shaking. Within about 30 minutes of this, I started with chills. Within another 30 minutes, I began to run fever of 101.2. This continued for two days. I did go to my physician for a follow up to the incident on Thursday, November 1, and will notify her of our conversation and ask her for documentation.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: I received my annual flu shot on the above date. After receiving the flu shot, I immediately felt the medication go all over my body, I could taste it in my mouth, and also felt like my stomach was on fire. I felt an intense burning in my stomach that last several minutes. Out of fear of what was happening, I jumped to my feet, where I immediately started seeing stars and felt like I was going to pass out. Several hours later, I became nauseous and felt like my body was shaking. Within about 30 minutes of this, I started with chills. Within another 30 minutes, I began to run fever of 101.2. This continued for two days. I did go to my physician for a follow up to the incident on Thursday, November 1, and will notify her of our conversation and ask her for documentation.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: According to Historical Immunization records, this 78 yo F received Varicella zoster (SHINGRIX; Lot #957J3) on 08/07/18 and influenza vaccine (no lot documented; date unclear as there is "given" documented on both 08/10/18 and 08/12/18. Neither injection documented a site. On 08/31/18, pt presented to clinic and reported that these injections were given in same arm (again arm not identified) and resulted in redness and swelling at the injection site and redness extending across anterior chest, arm soreness, headaches, body aches and fever. Pt reported that these symptoms persisted until 08/30. Pt self-medicated with aspirin, cetirizine and naproxyn. MD recommended that pt "continue ALEVE [naproxyn] BID PRN until symptoms resolve.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: According to Historical Immunization records, this 78 yo F received Varicella zoster (SHINGRIX; Lot #957J3) on 08/07/18 and influenza vaccine (no lot documented; date unclear as there is "given" documented on both 08/10/18 and 08/12/18. Neither injection documented a site. On 08/31/18, pt presented to clinic and reported that these injections were given in same arm (again arm not identified) and resulted in redness and swelling at the injection site and redness extending across anterior chest, arm soreness, headaches, body aches and fever. Pt reported that these symptoms persisted until 08/30. Pt self-medicated with aspirin, cetirizine and naproxyn. MD recommended that pt "continue ALEVE [naproxyn] BID PRN until symptoms resolve.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: According to Historical Immunization records, this 78 yo F received Varicella zoster (SHINGRIX; Lot #957J3) on 08/07/18 and influenza vaccine (no lot documented; date unclear as there is "given" documented on both 08/10/18 and 08/12/18. Neither injection documented a site. On 08/31/18, pt presented to clinic and reported that these injections were given in same arm (again arm not identified) and resulted in redness and swelling at the injection site and redness extending across anterior chest, arm soreness, headaches, body aches and fever. Pt reported that these symptoms persisted until 08/30. Pt self-medicated with aspirin, cetirizine and naproxyn. MD recommended that pt "continue ALEVE [naproxyn] BID PRN until symptoms resolve.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: According to Historical Immunization records, this 78 yo F received Varicella zoster (SHINGRIX; Lot #957J3) on 08/07/18 and influenza vaccine (no lot documented; date unclear as there is "given" documented on both 08/10/18 and 08/12/18. Neither injection documented a site. On 08/31/18, pt presented to clinic and reported that these injections were given in same arm (again arm not identified) and resulted in redness and swelling at the injection site and redness extending across anterior chest, arm soreness, headaches, body aches and fever. Pt reported that these symptoms persisted until 08/30. Pt self-medicated with aspirin, cetirizine and naproxyn. MD recommended that pt "continue ALEVE [naproxyn] BID PRN until symptoms resolve.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had redness and warm to touch on site.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Antinuclear antibody, Biopsy skin, Blood thyroid stimulating hormone, Borrelia test, C-reactive protein
Clinical narrative: Extreme rash starting on legs and moving up through face - duration of 3 weeks.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Differential white blood cell count, Full blood count, Immunology test, Metabolic function test, Rash generalised
Clinical narrative: Extreme rash starting on legs and moving up through face - duration of 3 weeks.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Thyroid function test, Thyroxine free
Clinical narrative: Extreme rash starting on legs and moving up through face - duration of 3 weeks.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Shingles vaccine for prophylaxis. The patient's past medical history included shingles (in 1972). In October 2018, the patient received the 1st dose of Shingles vaccine. In October 2018, less than a month after receiving Shingles vaccine, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine. Additional details were reported as follows: The patient received a shingles vaccine a week before the date of reporting at her physician's office. The patient was unsure about it being a first dose of two because she was not told to return for 2nd dose. The patient noted it was the first shingles vaccine she had received. The patient received the shot in her left hip area of her upper buttocks area, which led to inappropriate site of vaccination. The patient noted it hurt, like she had hit something but there was no bruise. No other events were noted.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Asthma, Chest discomfort, Condition aggravated, Cough, Crying
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of crying in a 2-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis. The patient had a Family History of allergy (seasonal), asthma, hypertension, cancer and seizure. On 12th January 2000, the patient received DTaP vaccine. On an unknown date, less than a year after receiving DTaP vaccine, the patient experienced crying and screaming. On an unknown date, the outcome of the crying and screaming were unknown. It was unknown if the reporter considered the crying and screaming to be related to DTaP vaccine. Additional details were deceived as follows: In 2013, mild persistent asthma. Recently the patient received the TRUMENBA. The patient presented with body aches, pain up to her shoulder. The patient also received some drugs on 11th September 18, the patient had Flovent 44 mcg inhaler for asthma 2 puffs BID, 2 puffs q 4 prn cough, wheeze , chest tightness, Albuterol MDI  and Ibuprofen oral.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal pain, Pain, Screaming, Wheezing
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of crying in a 2-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis. The patient had a Family History of allergy (seasonal), asthma, hypertension, cancer and seizure. On 12th January 2000, the patient received DTaP vaccine. On an unknown date, less than a year after receiving DTaP vaccine, the patient experienced crying and screaming. On an unknown date, the outcome of the crying and screaming were unknown. It was unknown if the reporter considered the crying and screaming to be related to DTaP vaccine. Additional details were deceived as follows: In 2013, mild persistent asthma. Recently the patient received the TRUMENBA. The patient presented with body aches, pain up to her shoulder. The patient also received some drugs on 11th September 18, the patient had Flovent 44 mcg inhaler for asthma 2 puffs BID, 2 puffs q 4 prn cough, wheeze , chest tightness, Albuterol MDI  and Ibuprofen oral.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer and described the occurrence of erythematous rash in a adult patient who received SHINGRIX for prophylaxis. On 10th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced erythematous rash, painful rash and pain burning. On an unknown date, the outcome of the erythematous rash, painful rash and pain burning were unknown. It was unknown if the reporter considered the erythematous rash, painful rash and pain burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine the week before the reporting date and developed a rash under both the arms, it was red, burning, stinging and somewhat painful. The patient was wondering if this could be a side effect of the vaccine or something else and requested to advise if this was something that's needed to be shown to doctor or will it go on its own.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a female 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 swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced swelling which lasted for 14 days. The patient asked if this was a normal reaction and mentioned that she was afraid to get the second shot.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Blindness unilateral, Headache, Visual impairment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of unilateral blindness in a 17-year-old male patient who received Meningococcal B vaccine for prophylaxis. Previously administered products included HPV vaccine with an associated reaction of headache (see case: US2018GSK207759). On 5th November 2018, the patient received 1st dose of Meningococcal B vaccine. On 6th November 2018, 1 days after receiving Meningococcal B vaccine, the patient experienced unilateral blindness (serious criteria GSK medically significant), headache and spots before eyes. On an unknown date, the outcome of the unilateral blindness, headache and spots before eyes were unknown. It was unknown if the reporter considered the unilateral blindness, headache and spots before eyes to be related to Meningococcal B vaccine. Additional details were reported as follows: This case was reported by the patient's mother who herself was a nurse. The patient's historical vaccine included HPV vaccine and experienced recurring headaches after it. On Monday from the reporting date the patient received Meningococcal Group B Vaccine. The patient experienced left sided blinding headache and went to the nurse with spotty vision. The reporter had provided her contact details. On the reporting date, the reporter called the pediatrician. The patient had left sighted blindness and severe headache, went to the nurse and had to come home. The patient had black spots in front of him too. The representative stated to the reporter that, this was the type of information that safety department like to capture in an effort to monitor the ongoing safety of our medications and asked for the patient consent. The reporter asked whether the patient could receive the 2nd dose of BEXSERO in the next month. The reporter was trying to find out if a meningococcal group B Vaccine was a live vaccine or not. The reporter was referred to a medical specialist for meningococcal group B Vaccine. The reporter was a nurse hence she had a concerned about getting 2nd dose of Meningococcal Group B Vaccine. The reporter was not sure if the patient received BEXSERO or not. The medical specialist stated that he need to escalate this chat within his department because all of the information that representative was having at GSK was for the BEXSERO, and advised to the reporter that if she find out later her son's men b vaccine was a different manufacturer, she need to contact the that particular manufacturer.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On 15th August 2018, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and pain in joint involving shoulder region. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth were recovered/resolved and the outcome of the pain in joint involving shoulder region was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and pain in joint involving shoulder region to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient could not remember if that same day of vaccination or the day after she started having pain at the site of the injection. It was pain, redness, heat and swelling at the injection site. The patient described it as having a greater around her arm at the site of injection that spread five inches wide around her arm radiating heat, swelling and redness. The patient said that less than a year after receiving SHINGRIX, she was still experiencing pain in her upper arm, where the shoulder joins the body (not the injection site). The patient had that pain any time she moves her arm around.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On 15th August 2018, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and pain in joint involving shoulder region. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth were recovered/resolved and the outcome of the pain in joint involving shoulder region was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and pain in joint involving shoulder region to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient could not remember if that same day of vaccination or the day after she started having pain at the site of the injection. It was pain, redness, heat and swelling at the injection site. The patient described it as having a greater around her arm at the site of injection that spread five inches wide around her arm radiating heat, swelling and redness. The patient said that less than a year after receiving SHINGRIX, she was still experiencing pain in her upper arm, where the shoulder joins the body (not the injection site). The patient had that pain any time she moves her arm around.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intravenous). In September 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm and pain in arm were recovering/resolving and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that in the beginning of September 2018, she received SHINGRIX vaccine on left arm in the vein where you bend the arm, which led to vaccine administered at inappropriate site and inappropriate route of vaccination. Less than a year after receiving SHINGRIX, the patient experienced swollen and painful arm. The pain was on and off the day. The swelling and pain has decreased from before. The patient had to take two Tylenol at night for the pain. The patient visited her doctor once, and she had another visit scheduled next week from the reporting date. The reporter did not consent to follow up. The referred patient to health care provider. No further details were provided. This case was an accidental medication error associated with an adverse event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of contusion in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced contusion. On an unknown date, the outcome of the contusion was not recovered/not resolved. It was unknown if the reporter considered the contusion to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced permanent bruise. She had fear that the bruise would not go away.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. On 5th November 2018, 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 were provided as follows: The age at vaccination was not reported. On 1st September 2018, the patient received 2nd dose of INFANRIX HEXA. In November 2018, a 3rd dose was administered, which led to shortening of the vaccination schedule. According to MA of INFANRIX HEXA, the 3rd dose should be given at least 6 months after the 2nd dose. During the administration, leakage was occurred (no details available regarding the level of the leakage). The physician gave a 1 by 4 of a replacement dose, which led to wrong technique in drug usage process. Sample would be available.