chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies or were reported. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II (which had a lot # of N027780 and an expiration date of 08-AUG-2019; however, dosage number and route of administration were not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees for 20 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA011769: US-009507513-1808USA011662.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 22-AUG-2018, the patient was vaccinated with two doses of the pediatric formulation of VAQTA 25/0.5, with lot# R002086 with expiration date on 22-APR-2019 for prophylaxis (dose and route of administration). No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 27-AUG-2018, the patient received one dose of VAQTA 25U/0.5ml, per intramuscular route, lot # R013859 and expiration date on 14-JUN-2019, for prophylaxis. The vaccine was administered following a possible temperature excursion. The temperatures and time frames of the possible temperature excursion were unknown and were not recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Headache
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient's mother). A 16 year old female patient received, on 24Aug2018 (in the morning), the second dose of TRUMENBA at single dose, for immunization. Relevant medical history and concomitant medications were none. On 24Aug2018, around 9:40 AM, the patient developed headache, chills and was feeling bad. The events were described as following: "very bad headache and cold chills, and she was feeling horrible". The patient took ibuprofen for the headache. The mother confirmed that her daughter did not have these symptoms before the vaccination. The patient did not recover from the events at time of this report.  The information on the lot number has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Oral mucosal blistering, Pyrexia, Vomiting
Clinical narrative: Fever, blisters in mouth, vomiting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: PATIENT STATED FEVER ACHES AND PAINS.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A adult vaccine for Hepatitis A was given to a pediatric pt. No reaction occurred.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Localized swelling, redness, and warmth.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Patient broke out in hives as well as experiencing pain and soreness all over body.
Age: 22.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site pain, Pharyngeal oedema
Clinical narrative: THE PATIENT CALLED THE PHARMACY ON 8/29/2018 AND STATED THAT HER RIGHT ARM HURT AT THE INJECTION SITE OF THE MENACTRA AND THAT HER THROAT FELT SWOLLEN . A SWOLLEN THROAT WAS LISTED AS A RARE SIDE EFFECT & REFERRAL TO PHYSICIAN WAS RECOMMENDED IN THE LITERATURE. THE PHARMACY RECOMMENDED SHE CONTACT HER PHYSICIAN ASAP. THE PHARMACY ALSO RECOMMENDED SHE TAKE 25 MG OF BENADRYL IF SHE FELT HER THROAT WAS STARTING TO CLOSE AND SHE WOULD NOT BE ABLE TO BREATHE ADEQUATELY. THE PATIENT ASKED IF SHE COULD USE A COLD PACK ON HER THROAT. THE PHARMACY SAID YES BUT IF SHE WAS STRUGGLING TO BREATHE SHE SHOULD TAKE THE BENADRYL AND DIAL 9-1-1. SHE STATED THAT SHE DID NOT FEEL HER LIFE WAS IN PERIL AT THIS TIME.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Injection site painful and warm. When seen in office on 8/27/18, (L) arm injection site slightly warm to touch at triceps injection site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician reffering to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously lot# R006753, expiration date 06-MAR-2020 or dose of VARIVAX subcutaneously lot # N026999, expiration date 28-SEP-2019 (also reported as 20-SEP-2019),  for prophylaxis. It was unspecified which lots of VARIVAX was given to the patient. The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered doses of vaccine were exposed to the temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13.7 degrees Celsius) for 2 hours 6 minutes. Data logger was involved. There were no previous temperature excursions. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1808USA004633: US-009507513-1808USA004634:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician reffering to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously lot# R006753, expiration date 06-MAR-2020 or with dose of VARIVAX subcutaneously lot # N026999, expiration date 28-SEP-2019 (also reported as 20-SEP-2019), for prophylaxis. It was unspecified which lots of VARIVAX was given to the patient. The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered doses of vaccine were exposed to the temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13.7 degrees Celsius) for 2 hours 6 minutes. Data logger was involved. There were no previous excursions. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004533: US-009507513-1808USA004634:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician reffering to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously lot# R006753, expiration date 06-MAR-2020 or dose of VARIVAX subcutaneously lot # N026999, expiration date 28-SEP-2019  (also reported as 20-SEP-2019), for prophylaxis. It was unspecified which lots of VARIVAX was given to the patient. The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered doses of vaccine were exposed to the temperature excursion of -14 degrees Celsius to -10 degrees (-13.7 degrees Celsius) Celsius for 2 hours 6 minutes. Data logger was involved. There were no previous temperature excursions. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004533: US-009507513-1808USA004633.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-SEP-2014, the patient received the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his (Conflicting information, as patient was a female, with a female first name) body. The patient did not have a Shingles outbreak until 20-DEC-2016 and a return outbreak on 02-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his (conflicting information) condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the event was unknown. The reporter considered the events to be related to ZOSTAVAX. The event of shingles outbreak and Return outbreak of Shingles were considered disabling. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who received a liquid portion without the ACTHIB component, while he received vaccine PENTACEL (lot number: C5550AA, expiry date: 10-Oct-2019) in right leg. The patient's past vaccination(s) included first dose of PENTACEL. he patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that initial dose given was liquid portion only without ACTHIB component, in right leg. Second dose was given with full PENTACEL dose with both components mixed and also given in right leg. Liquid component: Lot: C5409AA, Exp: 10-Oct-2019, ACTHIB component: Lot: C5550AA, Exp 10-Oct-2019. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 10 weeks old female patient who had received liquid component of the first dose of PENTACEL (lot number: C5439A, expiry date: 29-Oct-2018) via intramuscular route in right thigh on 20-Aug-2018. It was a case of actual medication error due to inappropriate reconstitution technique. 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.
Age: 0.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two-years old male patient who was given ADACEL instead of DAPTACEL. This was actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (2-year-old patient had been given ADACEL instead of DAPTACEL). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 20-Apr-2016, the patient received a fourth dose of 0.5 ml of suspect ADACEL lot U5798AB, exp date: 15-November-2019, via unknown route in unknown administration site, instead of DAPTACEL. The patient had been kept at the office for 20 minutes afterwards for observation. It was not reported if the patient experienced any adverse event. Lab test and corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity
Clinical narrative: 2 days ago rec'd Men B vaccine in Rt. arm. Presents today with pain, redness over most of upper arm. Treating today with antibiotic, orally.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Affective disorder, Injection site swelling, Personality disorder, Tic
Clinical narrative: Extreme injection site swelling for over a week, severe facial tics began within a few days of vaccine and still continue from time to time. Rapid decline in mood and personality.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Cyanosis, Eye movement disorder, Fatigue
Clinical narrative: Pt fine after vaccinations. Approx. 11 hours after, pt became "tired" and fussy. No fever. MOC gave TYLENOL. Was laying in bed approx. one hour later and pt rolled over with face in pillow and became stiff. MOC rolled her over. Pt was "extremely hot", eyes rolled back in head, and cyanotic.  Pt vomited and was breathing on own, but still cyanotic for another 5-10 min until EMS arrived.  Normal ER evaluation and has been fine since.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Full blood count normal, Irritability, Musculoskeletal stiffness, Urine analysis normal, Vomiting
Clinical narrative: Pt fine after vaccinations. Approx. 11 hours after, pt became "tired" and fussy. No fever. MOC gave TYLENOL. Was laying in bed approx. one hour later and pt rolled over with face in pillow and became stiff. MOC rolled her over. Pt was "extremely hot", eyes rolled back in head, and cyanotic.  Pt vomited and was breathing on own, but still cyanotic for another 5-10 min until EMS arrived.  Normal ER evaluation and has been fine since.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Pruritus, Rash erythematous
Clinical narrative: Red, scattered Rash on the morning after injection. Mother reports on the left back/torso area. At the end of the day, mother noted rash had spread to the Left leg and foot. Itching. On 8/30/18, after OTC BENADRYL, rash had not improved and was beginning to spread to right side of body and child c/o sore throat.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Loss of consciousness, Staring
Clinical narrative: Morning after vaccine administration- approximately 6:00am pt stared off and husband could not communicate with her for a few minutes. Then a few minutes later she passed out at the breakfast table and hit her head on the table. She awoke when her head hit the table and her husband helped her to the couch, obtained her BP 113/72. No further adverse events. Pt scheduled to go to general practitioner on this date 8/30/18.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Varicella post vaccine
Clinical narrative: Noticed small red "bumps" on patient's stomach spread to arms. Taken to ER - MD suspect for chicken pox - script for Acyclovir given, discontinue if "rash" does not further develop and seek PCP opinion.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Severe arm pain, sick to stomach, chills, could not sleep first night do to pain. I had limited ability to raise my arm for three days after receiving,
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Arm swelling, redness morning after immunization. Pt applied ice. Evaluated in clinic for subsequent cellulitis.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: She had a fever and rash all over her body.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: MMRV was given by medical assistant in place of MMR. Patient also received a dose of Varicella vaccine. No adverse effect occurred.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: Shortness of breath, chest pain, which got progressively worse, fatigue, pericardial swelling (diagnosed during inpatient admission following), treated with pain management, bronchodilators, NSAIDs.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pericardial disease, Pulmonary function test
Clinical narrative: Shortness of breath, chest pain, which got progressively worse, fatigue, pericardial swelling (diagnosed during inpatient admission following), treated with pain management, bronchodilators, NSAIDs.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: SKIN left deltoid region with oval shaped non raised rash, pen mark drawn yesterday reportedly by a nurse in the family continues to encircle the rash. It's warm to touch, no discharge, slightly itchy. BENADRYL Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Differential white blood cell count, Epstein-Barr virus antibody, Eye swelling, Eyelid oedema, Full blood count
Clinical narrative: Hives over body within 2 hours of vaccine. Next morning eyes and face puffy, vomited once. F/U phone call day #4 lips and eyes swollen. Refer to allergist. 12/1/17 Sore throat x 3 weeks, seen by Dr. 3 weeks ago. TC neg at that time. Rx OMNICEF. Without fever, without improvement. PE: exudate on cryptic tonsils, erythematous, TM's clear. Lungs clear. T 98.6.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mononucleosis heterophile test, Oropharyngeal pain, Red blood cell sedimentation rate, Swelling face, Tonsillar erythema
Clinical narrative: Hives over body within 2 hours of vaccine. Next morning eyes and face puffy, vomited once. F/U phone call day #4 lips and eyes swollen. Refer to allergist. 12/1/17 Sore throat x 3 weeks, seen by Dr. 3 weeks ago. TC neg at that time. Rx OMNICEF. Without fever, without improvement. PE: exudate on cryptic tonsils, erythematous, TM's clear. Lungs clear. T 98.6.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tonsillar exudate, Urticaria, Vomiting
Clinical narrative: Hives over body within 2 hours of vaccine. Next morning eyes and face puffy, vomited once. F/U phone call day #4 lips and eyes swollen. Refer to allergist. 12/1/17 Sore throat x 3 weeks, seen by Dr. 3 weeks ago. TC neg at that time. Rx OMNICEF. Without fever, without improvement. PE: exudate on cryptic tonsils, erythematous, TM's clear. Lungs clear. T 98.6.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Eyelid oedema, Lip swelling, Urticaria, Vomiting
Clinical narrative: Hives over body within 2 hours of vaccine. Next morning eyes and face puffy, vomited once. F/U phone call day #4 lips and eyes swollen. Refer to allergist. 12/1/17 Sore throat x 3 weeks, seen by Dr. 3 weeks ago. TC neg at that time. Rx OMNICEF. Without fever, without improvement. PE: exudate on cryptic tonsils, erythematous, TM's clear. Lungs clear. T 98.6.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8/29/18 Initial reaction within 24 hrs, redness, swelling, pain at injection site. Employee reports about an 3 in area. Called Employee Health/server-directed to use BENADRYL 25g and ice pack. 8/30/18 Evaluated in clinic office, no swelling, no redness, mild pain and tenderness, denies N/V, fever. Adverse reaction resolved at 48 hrs post vaccine.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-JUL-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot# N022979, expiration date: 23-AUG-2019 (dose, frequency and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MRK INJ). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. Upon receipt of follow-up information, it was determined that this case is now valid because (patient identifier was received). Follow-up information was received from the nurse on 24-AUG-2018. The patient demographics were received (Initials and date of birth). The reporter reported that there were no issues to the patient after receiving the VARIVAX.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a currently 18 year old female consumer referring to herself. The patient's concurrent conditions and medical history was not reported. On 14-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (Lot #, expiration date and frequency unknown), 0.05 ml via intramuscular route for prophylaxis. Concomitant medications included prenatal vitamins. On 21-AUG-2018, the patient underwent pregnancy test and found to be 5 weeks pregnant (Exposure during pregnancy). The patient's Last menstrual period (LMP) was on 17-JUL-2018 and Estimated date of delivery (EDD) would be 23-APR-2019. No adverse reactions reported.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Malaise, Skin irritation
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on behalf of her daughter, received via a sales representative. A female patient of unspecified age (reported only as 19) received TRUMENBA on an unknown date, at single dose, for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness, irritation and she did not feel good and said it was the ''worse shot she ever received''. Events outcome was unknown.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid oedema, Swelling face
Clinical narrative: Patient received her 2nd SHINGRIX shot on 8/26 at 4:08 pm. On 8/27 she woke to swollen face with redness on cheeks. By 8/29 she had a swollen puffy right eye. She went in to see MD on 8/29. Patient cannot relate this incident to any new food/insect bite/other med and so suspects SHINGRIX could have caused the reaction.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, raised, itchy, hot.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin, rash. Prednisone 20 mg every day, loratadine 10 mg every day.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Livedo reticularis, Rash, Urticaria
Clinical narrative: Symptoms started within a couple hours of receiving vaccine. Hives started on legs during the day and by evening on first day, legs were covered in bumps and slightly less on the arms, neck and face. By 8am the next day, the hives turned red and puffier, chest and stomach were mottled with spots. No fever. Returned to Dr at 4:30pm on the day after the vax and was instructed to give BENADRYL. Gave him one dose at 6:30pm with no real improvement. Morning of 2nd day after the vax and hives are slightly less red on thighs and still the same on lower legs.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Concussion, Fall, Head injury, Loss of consciousness
Clinical narrative: I got out of bed at 1am because I felt sick to me stomach and I walked about 5 steps to cupboard. Once I found PEPTO BISMAL I tried to remove the cap. I very suddenly lost consciousness and struck the floor. Alerted to the noise my wife came to my aid. I have no memory for approximately the next hour or so. My wife called 911 and I was transported to Hospital. I was released about 13 hours later with a concussion as the back of my head struck the floor.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment
Clinical narrative: I got out of bed at 1am because I felt sick to me stomach and I walked about 5 steps to cupboard. Once I found PEPTO BISMAL I tried to remove the cap. I very suddenly lost consciousness and struck the floor. Alerted to the noise my wife came to my aid. I have no memory for approximately the next hour or so. My wife called 911 and I was transported to Hospital. I was released about 13 hours later with a concussion as the back of my head struck the floor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chiropractic, Injected limb mobility decreased, Injection site bruising, Pain in extremity, Peripheral swelling
Clinical narrative: Patient said that right arm became very sore, tender, and swollen to a point where she was not able to lift her arm upon the 2nd day and has lasted for over a week. Noticed a bruise at the site of injection. Started taking naproxen to alleviate the pain and went to see chiropractic Dr. on 8/27 & 8/28 and was diagnosed with tendonitis. As of today, patient is able to lift arm, but cannot reach behind her back.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rotator cuff syndrome, Tenderness
Clinical narrative: Patient said that right arm became very sore, tender, and swollen to a point where she was not able to lift her arm upon the 2nd day and has lasted for over a week. Noticed a bruise at the site of injection. Started taking naproxen to alleviate the pain and went to see chiropractic Dr. on 8/27 & 8/28 and was diagnosed with tendonitis. As of today, patient is able to lift arm, but cannot reach behind her back.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: "Per MD: no fever (Skin on the L upper arm is erythematous and edematous. Warm and tender). The pain is mild (With movement of the L arm.). Pertinent negatives include no chills, coughing or shortness of breath. The history is provided by the patient."
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: "Per MD: no fever (Skin on the L upper arm is erythematous and edematous. Warm and tender). The pain is mild (With movement of the L arm.). Pertinent negatives include no chills, coughing or shortness of breath. The history is provided by the patient."
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: After experiencing the usual redness, swelling and itching for three days, all was well. Woke up this morning with a bright red dot at the injection site, minor swelling and itching.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, PNC13, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given a PCV13 vaccine which was not due. Local Health department informed and parent and provider informed.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Eye irritation, Limb discomfort, Pain
Clinical narrative: Pt states he had a sore arm, achy body, overnight had chills and felt body was on fire, eyes burning.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Noted yesterday afternoon to have erythema and firmness at the injection site. Local reaction more likely, plan is to check status tomorrow. VAERS report.
Age: 17.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dyspnoea, Erythema, Pruritus, Skin warm
Clinical narrative: Patient's arm became red and hot, and started itching. The itching spread to her legs and she said she was having difficulty breathing. It happened within 30 mins after giving the shot.
Age: 17.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient's arm became red and hot, and started itching. The itching spread to her legs and she said she was having difficulty breathing. It happened within 30 mins after giving the shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: On 8/23/18, PM: arm swollen below the injection site. On 8/24/18: upper arm swollen to softball size, very warm tender, painful and red spot or "rash" noted below injection site and grew to 3 inches by 3 inches. On 8/25/18: ill with fever, chills, more painful arm and headache. Called her doctor 8/27/18, but did not receive a call back. As of today 8/30/18, she is mostly back to normal but is not planning to receive the second dose of SHINGRIX.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: On 8/23/18, PM: arm swollen below the injection site. On 8/24/18: upper arm swollen to softball size, very warm tender, painful and red spot or "rash" noted below injection site and grew to 3 inches by 3 inches. On 8/25/18: ill with fever, chills, more painful arm and headache. Called her doctor 8/27/18, but did not receive a call back. As of today 8/30/18, she is mostly back to normal but is not planning to receive the second dose of SHINGRIX.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Drooling, Generalised tonic-clonic seizure, Postictal state, Pyrexia
Clinical narrative: PER MOTHER PT HAD TONIC CLONIC SEIZURE LASTING LESS THAN 30 SECONDS. PT WAS DROOLING. HAD POST-ICTAL STATE AFTERWARDS. ONE HOUR LATER HE DEVELOPED FEVER OF 101 F. PT DOES HAVE H/O HAVING SEIZURES IN THE PAST. MOTHER DID NOT TAKE HIM TO ER. HE IS DOING WELL NOW. HE HAS BEEN REFERRED TO NEUROLOGIST SINCE HE HAS NOT FOLLOWED UP IN ALMOST 1 YEAR. THIS WAS OUR FIRST TIME SEEING PT AT OUR OFFICE.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Pale and dizzy after immunizations. Did not faint. Had pt lie down, juice to drink, ice pack to back of neck. BP WNL and pt reported feeling better after approx. 20min. D/c from clinic home with parents.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose 3 of Hepatitis B vaccine administered to patient on August 27, 2018 was one day past expiration date. Expiration date of vaccine was August 26, 2018. Patient with no adverse reactions at this time per mother.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Pale and dizzy after immunizations. Did not faint. Had pt lie down, ice pack to back of neck. BP WNL and pt reported feeling better after approx. 20min. D/c from clinic home with parents.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Pt received diluent without active component.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies, concomitant and historical drugs was not provided. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025719, expiration date 17-MAR-2019, subcutaneouslly (dose was not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of -14°C to -10°C for 15 hours and 57 minutes, and in the range of -9°C to 8°C for 27 hours and 48 minutes. There was not previous temperature excursion. It was reported that data logger was involved. No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac arrest, Gait disturbance, Intensive care, Movement disorder, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cardiac arrest in a male patient who received SHINGRIX for prophylaxis. On 29th July 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced cardiac arrest (serious criteria hospitalization and GSK medically significant), swelling arm, fever, movement disorder and walking difficulty. On an unknown date, the outcome of the cardiac arrest, swelling arm, fever, movement disorder and walking difficulty were unknown. It was unknown if the reporter considered the cardiac arrest, swelling arm, fever, movement disorder and walking difficulty to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced a severe reaction after vaccination with SHINGRIX. The patient was hospitalized at the time of reporting. The reporter spoke to the patient's wife on the day of reporting in the morning, where the reporter was provided with the patient's current condition status. The patient started with arm and hand swelling, fever and progressed to difficulty in moving his left side and also difficulty in walking, the patient was taken to a local hospital by ambulance at this point. The patient was treated and sent home. The patient, soon after sending home went into a cardiac arrest. The emergency number was contacted. The patient was resuscitated; also the patient was kept in the Intensive care unit (ICU), where the patient remained there one day before the date of reporting. The patient was still hospitalized at the date of reporting. Follow up information received from pharmacist (pharmacy contact) via sales representative on 24th August 2018. The adverse event was reported to VAERS. The reporter's details were updated. The patient was still hospitalized at the time of reporting, but his condition was improving. The patient was moved from intensive care unit (ICU), into a regular room on Sunday earlier to the date of reporting. The patient's wife did not provide additional information on who the patient's care team was and the patient did not have a primary care physician. The local pharmacy was waiting for the patient to be discharged before they seek out more information, but the reporter would be kept in the loop as they had learned more. The reporter would continue to provide follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Resuscitation, Vaccination complication
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cardiac arrest in a male patient who received SHINGRIX for prophylaxis. On 29th July 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced cardiac arrest (serious criteria hospitalization and GSK medically significant), swelling arm, fever, movement disorder and walking difficulty. On an unknown date, the outcome of the cardiac arrest, swelling arm, fever, movement disorder and walking difficulty were unknown. It was unknown if the reporter considered the cardiac arrest, swelling arm, fever, movement disorder and walking difficulty to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced a severe reaction after vaccination with SHINGRIX. The patient was hospitalized at the time of reporting. The reporter spoke to the patient's wife on the day of reporting in the morning, where the reporter was provided with the patient's current condition status. The patient started with arm and hand swelling, fever and progressed to difficulty in moving his left side and also difficulty in walking, the patient was taken to a local hospital by ambulance at this point. The patient was treated and sent home. The patient, soon after sending home went into a cardiac arrest. The emergency number was contacted. The patient was resuscitated; also the patient was kept in the Intensive care unit (ICU), where the patient remained there one day before the date of reporting. The patient was still hospitalized at the date of reporting. Follow up information received from pharmacist (pharmacy contact) via sales representative on 24th August 2018. The adverse event was reported to VAERS. The reporter's details were updated. The patient was still hospitalized at the time of reporting, but his condition was improving. The patient was moved from intensive care unit (ICU), into a regular room on Sunday earlier to the date of reporting. The patient's wife did not provide additional information on who the patient's care team was and the patient did not have a primary care physician. The local pharmacy was waiting for the patient to be discharged before they seek out more information, but the reporter would be kept in the loop as they had learned more. The reporter would continue to provide follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On 13th June 2018, 36 days after receiving SHINGRIX, the patient experienced shingles and vesicular rash. On 9th July 2018, the patient experienced headache. On an unknown date, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles and vesicular rash were recovering/resolving and the outcome of the headache was unknown and the outcome of the feeling unwell was recovered/resolved.  It was unknown if the reporter considered the shingles, vesicular rash, headache and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The physician reported that the patient developed a vesicular shingles rash on their right lower abdomen. On 14th July 2018, the patient was started valacyclovir. As per the physician the patient's usual experience was she developed a headache and felt sick and then developed shingles rash. A day before the time of reporting (13th August 2018), she presented with a shingles spot on her left thigh and again, she started valacyclovir.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and blister. On an unknown date, the outcome of the erythema of extremities and blister were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and blister to be related to SHINGRIX. Additional information was received as follows: This case was reported by the pharmacy technician. The patient received SHINGRIX on the left arm. The patient presented with redness on the entire left arm, along with blisters right above her elbow on the left arm. This lasted for about a total of one week. No further details were provided by the pharmacy technician.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in an unspecified number of adult patients 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 malaise, nausea, chills and headache. On an unknown date, the outcome of the malaise, nausea, chills and headache were unknown. It was unknown if the reporter considered the malaise, nausea, chills and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist called to report that almost all of the patients he vaccinated with SHINGRIX reported malaise, headache, nausea, chills lasting for 3 to 4 hours after administration. The pharmacist did not want to report a particular case. He called questioning the contents of the adjuvant.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Eyelid rash, Glossodynia, Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles 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, 61 days after receiving SHINGRIX, the patient experienced shingles, rash, jaw pain, tongue pain, blister and ear pain. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, rash, jaw pain, tongue pain, blister and ear pain were unknown. It was unknown if the reporter considered the shingles, rash, jaw pain, tongue pain, blister and ear pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The healthcare professional reported that, the patient developed shingles about 2 months after receiving the SHINGRIX vaccine. The patient developed rash on eyes, blisters, pain in the ear canal, jaw, and the lateral side of the tongue.  The patient was seen in the emergency room (ER) and was diagnosed with a mild case of shingles. The patient was prescribed with antiviral.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles 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, 61 days after receiving SHINGRIX, the patient experienced shingles, rash, jaw pain, tongue pain, blister and ear pain. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, rash, jaw pain, tongue pain, blister and ear pain were unknown. It was unknown if the reporter considered the shingles, rash, jaw pain, tongue pain, blister and ear pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The healthcare professional reported that, the patient developed shingles about 2 months after receiving the SHINGRIX vaccine. The patient developed rash on eyes, blisters, pain in the ear canal, jaw, and the lateral side of the tongue.  The patient was seen in the emergency room (ER) and was diagnosed with a mild case of shingles. The patient was prescribed with antiviral.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Injection site pain, Insomnia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythropapular rash in a 73-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (7 years ago had the live shingles). On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced erythropapular rash, erythromacular rash and pruritus. On an unknown date, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). SHINGRIX was discontinued. On an unknown date, the outcome of the erythropapular rash and injection site pain were recovered/resolved and the outcome of the erythromacular rash, pruritus and exhaustion were unknown and the outcome of the sleep decreased and discomfort were not recovered/not resolved. The reporter considered the erythropapular rash, erythromacular rash, pruritus, sleep decreased, discomfort, exhaustion and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient described the symptoms as red, itchy bumps everywhere on the body, red splotches on the back and both sides and the newest symptom includes red splotches under the lips. On same day on initial reporting, the reporter provider more details of the events. The reporter stated that the red itch spots were almost every part of her body except from the nose up. She stated that she had been visited to 3 doctors for treatment of events. She was given prednisone and a cream that did not help. Then she went to an allergist and he changed the cream to and told her to take Zyrtec and then last weekend the red spots were bad again so she went to a clinic. She said the ointment helps but it wears off. She said that the redness and itchiness started around her waist, stomach, back and shoulder. She said it was not painful just red and itchy. She said her symptoms were getting worse and that hardly anywhere on her body where she did not have the redness or itchy bumps. She wants to know what could be done to stop this reaction. She said she had not changed detergents, soaps or eaten any different foods. She said that one doctor and one pharmacist had advised her not to get the second shot in the SHINGRIX series. On an unknown date, less tha year after vaccination, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient stated that, she had only been able to get 3 to 4 hours of sleep per night because she was not comfortable and her legs itch. The patient was wearing herself out (due to lack of sleep). The patient said, she had not much pain or no pain at the injection site and no redness at the injection site.