chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Chest X-ray normal, Crying, Decreased appetite, Decreased eye contact
Clinical narrative: Running a fever on Wednesday night (4/11/18) treated with TYLENOL/ibuprofen. Continued to run a fever Thursday (4/12/18) and very lethargic and sleepy all day continued to treat with TYLENOL/ibuprofen. Friday (4/13/18) she started to not seem herself at all, no smiling, not babbling, very sleepy still high fever and breathing very heavy and woke up with really crusty pink and gooey eyes. On Satruday (4/14/18) she was only getting worse running a high fever of 103.0 and screaming, crying, not sleeping, rapid breathing. Around 6:00pm we noticed she was not herself almost like having spasms or seizures. She would scream then stiffen up. Her hands and feet were turning purple so we rushed her to hospital that evening. They did a chest x-ray and urinalysis and sucked her nose out. They told us it was an upper respiratory tract infection. We went home around midnight on Saturday. She was not any better still fussy screaming not herself. Sunday (4/15/18) she would hardly eat anything and wanted to sleep all day. She was still running a fever on the TYLENOL of 101.8 and was not smiling or making eye contact with us. Monday (4/16/18) she was still acting the same so I took her back into the pediatrics office and they looked at her and said she had an ear infection. We started the antibiotics right away but she still did not laugh, smile, or act herself.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Dyspnoea, Ear infection, Eye discharge, Eyelid margin crusting, Insomnia
Clinical narrative: Running a fever on Wednesday night (4/11/18) treated with TYLENOL/ibuprofen. Continued to run a fever Thursday (4/12/18) and very lethargic and sleepy all day continued to treat with TYLENOL/ibuprofen. Friday (4/13/18) she started to not seem herself at all, no smiling, not babbling, very sleepy still high fever and breathing very heavy and woke up with really crusty pink and gooey eyes. On Satruday (4/14/18) she was only getting worse running a high fever of 103.0 and screaming, crying, not sleeping, rapid breathing. Around 6:00pm we noticed she was not herself almost like having spasms or seizures. She would scream then stiffen up. Her hands and feet were turning purple so we rushed her to hospital that evening. They did a chest x-ray and urinalysis and sucked her nose out. They told us it was an upper respiratory tract infection. We went home around midnight on Saturday. She was not any better still fussy screaming not herself. Sunday (4/15/18) she would hardly eat anything and wanted to sleep all day. She was still running a fever on the TYLENOL of 101.8 and was not smiling or making eye contact with us. Monday (4/16/18) she was still acting the same so I took her back into the pediatrics office and they looked at her and said she had an ear infection. We started the antibiotics right away but she still did not laugh, smile, or act herself.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Lethargy, Musculoskeletal stiffness, Pyrexia, Respiratory rate increased
Clinical narrative: Running a fever on Wednesday night (4/11/18) treated with TYLENOL/ibuprofen. Continued to run a fever Thursday (4/12/18) and very lethargic and sleepy all day continued to treat with TYLENOL/ibuprofen. Friday (4/13/18) she started to not seem herself at all, no smiling, not babbling, very sleepy still high fever and breathing very heavy and woke up with really crusty pink and gooey eyes. On Satruday (4/14/18) she was only getting worse running a high fever of 103.0 and screaming, crying, not sleeping, rapid breathing. Around 6:00pm we noticed she was not herself almost like having spasms or seizures. She would scream then stiffen up. Her hands and feet were turning purple so we rushed her to hospital that evening. They did a chest x-ray and urinalysis and sucked her nose out. They told us it was an upper respiratory tract infection. We went home around midnight on Saturday. She was not any better still fussy screaming not herself. Sunday (4/15/18) she would hardly eat anything and wanted to sleep all day. She was still running a fever on the TYLENOL of 101.8 and was not smiling or making eye contact with us. Monday (4/16/18) she was still acting the same so I took her back into the pediatrics office and they looked at her and said she had an ear infection. We started the antibiotics right away but she still did not laugh, smile, or act herself.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Screaming, Skin discolouration, Somnolence, Upper respiratory tract infection, Urine analysis normal
Clinical narrative: Running a fever on Wednesday night (4/11/18) treated with TYLENOL/ibuprofen. Continued to run a fever Thursday (4/12/18) and very lethargic and sleepy all day continued to treat with TYLENOL/ibuprofen. Friday (4/13/18) she started to not seem herself at all, no smiling, not babbling, very sleepy still high fever and breathing very heavy and woke up with really crusty pink and gooey eyes. On Satruday (4/14/18) she was only getting worse running a high fever of 103.0 and screaming, crying, not sleeping, rapid breathing. Around 6:00pm we noticed she was not herself almost like having spasms or seizures. She would scream then stiffen up. Her hands and feet were turning purple so we rushed her to hospital that evening. They did a chest x-ray and urinalysis and sucked her nose out. They told us it was an upper respiratory tract infection. We went home around midnight on Saturday. She was not any better still fussy screaming not herself. Sunday (4/15/18) she would hardly eat anything and wanted to sleep all day. She was still running a fever on the TYLENOL of 101.8 and was not smiling or making eye contact with us. Monday (4/16/18) she was still acting the same so I took her back into the pediatrics office and they looked at her and said she had an ear infection. We started the antibiotics right away but she still did not laugh, smile, or act herself.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Deep vein thrombosis
Clinical narrative: DVT. 4/29 - pt went to ER in afternoon.
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Parent brings child to ED with itchy red rash on left deltoid. Child administered immunization in pediatrician office 24 hours earlier.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Extra dose administered, Incorrect route of drug administration
Clinical narrative: In order to decrease his anxiety, his mother consented to receive vaccine (MMR and QUADRICEL) at the same time. He received the subcutaneous MMR and the person injecting the IM vaccine thought she had the QUADRICEL in her hand and instead had another dose of MMR (despite the labeling on the syringe) and he received a sub-cutaneous dose and an intramuscular dose of MMR at the same time. So he received two doses of MMR; one was Sub-Q and the other IM. Despite offering to delay to another date/meet Mom and child based on her work schedule, his Mom asked to proceed with giving the QUADRICEL. He is a twin hence having two of each vaccine prepared for administration.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Relieved by taking OTC ADVIL and sleeping. Headache, Fever and Flu-like symptoms. Ibuprofen.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient developed redness, warmth, and pain at the injection site on the same day it was administered. She was seen by her PCP two days later and given BENADRYL and Cephalexin. Was instructed to start Cephalexin if redness spreads. As of 4-27, the redness has migrated further down the arm, and Cephalexin was started.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache that has persisted since vaccine administration. Also fatigue and tiredness.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Eye pain, Eye swelling, Facial pain, Headache
Clinical narrative: Headache that has persisted since vaccine administration. Also fatigue and tiredness.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Ophthalmic herpes zoster, Rash, Scab
Clinical narrative: Headache that has persisted since vaccine administration. Also fatigue and tiredness.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Decreased appetite, Headache, Herpes zoster, Ophthalmic herpes zoster, Somnolence
Clinical narrative: Headache that has persisted since vaccine administration. Also fatigue and tiredness.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Myalgia
Clinical narrative: Fatigue, joint pains, muscle aches, shivering, redness at injection site.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Got Hep A # 2 in R thigh, and developed warm red area radiating outward from the site. No fever.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 102F fever for 48 hours, unresponsive to TYLENOL.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of stiff neck in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced stiff neck and tiredness. On an unknown date, the outcome of the stiff neck and tiredness were unknown. It was unknown if the reporter considered the stiff neck and tiredness to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not reported. The reporter stated that the patient told that he was tired and also complained about a stiff neck.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Depressed mood, Depression
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of depression in a 17-year-old female patient who received BEXSERO. In April 2018, the patient received BEXSERO. In April 2018, less than a day after receiving BEXSERO, the patient experienced depression, feeling sad and crying. On an unknown date, the outcome of the depression, feeling sad and crying were unknown. It was unknown if the reporter considered the depression, feeling sad and crying to be related to BEXSERO. Additional details were provided as follows: The patient had no history of depression. The patient experienced sadness, depression, crying. At the time of reporting, the patient was still experiencing depression and sadness. This was the 1 of 3 cases, reported by same reporter.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fatigue in a 16-year-old male patient who received BEXSERO. In April 2018, the patient received BEXSERO. In April 2018, less than a day after receiving BEXSERO, the patient experienced fatigue, stiff neck and neck pain. On an unknown date, the outcome of the fatigue, stiff neck and neck pain were recovering/resolving. It was unknown if the reporter considered the fatigue, stiff neck and neck pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced fatigue with stiff achy neck. At the time of the report earlier this afternoon, the physician reported that the patient was better. This is the 2 of 2 cases reported by same reporter.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Flu trivalent vaccine. Additional details were provided as follows: The pharmacist did not provide any patient information. The age at vaccination was not reported. In 2011, the patient developed Guillain Barre after a flu shot. The pharmacist did not know which flu vaccine caused this reaction.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: As per reporter, she was seeing more pain, redness at the injection than any other vaccine. This case has been linked with cases US2018GSK075115 and US2018GSK070534, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt received SHINGRIX vaccine subq left arm on 4/26/18. Came to pharmacy 4/30/18 with large rash and swelling on left arm triceps injection site area. Per pt rash started 4/27/18, was red, painful and swollen, has improved but still swollen and painful.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Pt received the first dose on 1/21/18 and came in today 4/17/18 to receive her second dose, she said was given at the back of her arm and not in the deltoid muscle (the first dose).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Flushing, Lethargy, Pharyngeal oedema, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a adult male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy. On an unknown date, the outcome of the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy were recovered/resolved. The reporter considered the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two to three hours following the SHINGRIX dose, the patient reported swelling of the tongue and throat, as well as lethargy, and pain at the injection site. The patient was not feeling too well that night but all of the symptoms resolved the following morning without the patient seeking medical attention or treating with over the counter medication. The health care professional reported that incident to VAERS as well as her corporate office and was uncertain if the corporate office subsequently reported the incident to GlaxoSmithKline. So uncertain if this was an initial or follow up report.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a adult male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy. On an unknown date, the outcome of the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy were recovered/resolved. The reporter considered the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two to three hours following the SHINGRIX dose, the patient reported swelling of the tongue and throat, as well as lethargy, and pain at the injection site. The patient was not feeling too well that night but all of the symptoms resolved the following morning without the patient seeking medical attention or treating with over the counter medication. The health care professional reported that incident to VAERS as well as her corporate office and was uncertain if the corporate office subsequently reported the incident to GlaxoSmithKline. So uncertain if this was an initial or follow up report.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lethargy, Malaise, Pharyngeal oedema, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a adult male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy. On an unknown date, the outcome of the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy were recovered/resolved. The reporter considered the throat swelling, feeling unwell, injection site pain, swollen tongue and lethargy to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two to three hours following the SHINGRIX dose, the patient reported swelling of the tongue and throat, as well as lethargy, and pain at the injection site. The patient was not feeling too well that night but all of the symptoms resolved the following morning without the patient seeking medical attention or treating with over the counter medication. The health care professional reported that incident to VAERS as well as her corporate office and was uncertain if the corporate office subsequently reported the incident to GlaxoSmithKline. So uncertain if this was an initial or follow up report.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a elderly male patient who received SHINGRIX (batch number XC534, expiry date 31st January 2019). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, tremor and vomiting. On an unknown date, the outcome of the fever, tremor and vomiting were recovered/resolved. The reporter considered the fever to be possibly related to SHINGRIX. It was unknown if the reporter considered the tremor and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 67 or 68. The patient received a dose of SHINGRIX in left arm. It was reported that the patient experienced vomiting 3 times, shaking and a fever (body temperature of 102). These events occurred during 2 days after SHINGRIX administration. The reporter stated that she had already submitted this report via the online VAERS system.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 60-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 13th April 2020). Concomitant products included Calcium, Diltiazem, Magnesium, simvastatin and lisinopril. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, several hours after receiving SHINGRIX, the patient experienced swelling, fever, pruritus and erythema. On 14th April 2018, the patient experienced welts. The patient was treated with ADVIL. On an unknown date, the outcome of the swelling and pruritus were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the welts and erythema were unknown. It was unknown if the reporter considered the swelling, fever, pruritus, welts and erythema to be related to SHINGRIX. Additional details were provided as follows: At 9:42, the patient received SHINGRIX in right deltoid. The patient experienced an area of swelling that was red and itchy approximately 2 inches below the injection site. It was 2.5 inches in depth and 2 inches in width. The swelling presented the evening after receiving the vaccine and by morning there was a welt that was red and itchy. She also reported feeling feverish that evening and took some ADVIL.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 60-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 13th April 2020). Concomitant products included Calcium, Diltiazem, Magnesium, simvastatin and lisinopril. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, several hours after receiving SHINGRIX, the patient experienced swelling, fever, pruritus and erythema. On 14th April 2018, the patient experienced welts. The patient was treated with ADVIL. On an unknown date, the outcome of the swelling and pruritus were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the welts and erythema were unknown. It was unknown if the reporter considered the swelling, fever, pruritus, welts and erythema to be related to SHINGRIX. Additional details were provided as follows: At 9:42, the patient received SHINGRIX in right deltoid. The patient experienced an area of swelling that was red and itchy approximately 2 inches below the injection site. It was 2.5 inches in depth and 2 inches in width. The swelling presented the evening after receiving the vaccine and by morning there was a welt that was red and itchy. She also reported feeling feverish that evening and took some ADVIL.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 60-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 13th April 2020). Concomitant products included Calcium, Diltiazem, Magnesium, simvastatin and lisinopril. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 13th April 2018, several hours after receiving SHINGRIX, the patient experienced swelling, fever, pruritus and erythema. On 14th April 2018, the patient experienced welts. The patient was treated with ADVIL. On an unknown date, the outcome of the swelling and pruritus were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the welts and erythema were unknown. It was unknown if the reporter considered the swelling, fever, pruritus, welts and erythema to be related to SHINGRIX. Additional details were provided as follows: At 9:42, the patient received SHINGRIX in right deltoid. The patient experienced an area of swelling that was red and itchy approximately 2 inches below the injection site. It was 2.5 inches in depth and 2 inches in width. The swelling presented the evening after receiving the vaccine and by morning there was a welt that was red and itchy. She also reported feeling feverish that evening and took some ADVIL.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 83-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included Atorvastatin, Levothyroxine, Losartan, Dicyclomine and temazepam. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced hives, injection site warmth and injection site erythema. On an unknown date, the outcome of the hives was unknown and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved. The reporter considered the hives to be possibly related to SHINGRIX. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received hyothiamine as concomitant medication. At 16:00, the patient received SHINGRIX on right arm. The hives were on the patient's left arm and buttocks. There were no hives on the right arm of the patient where she received SHINGRIX. There was some redness that was warm to the touch at the site of the injection.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 83-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included Atorvastatin, Levothyroxine, Losartan, Dicyclomine and temazepam. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced hives, injection site warmth and injection site erythema. On an unknown date, the outcome of the hives was unknown and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved. The reporter considered the hives to be possibly related to SHINGRIX. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received hyothiamine as concomitant medication. At 16:00, the patient received SHINGRIX on right arm. The hives were on the patient's left arm and buttocks. There were no hives on the right arm of the patient where she received SHINGRIX. There was some redness that was warm to the touch at the site of the injection.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site rash, Pruritus, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 11th April 2018 17:00, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient developed rash that looks like shingles rash. The reporter gave permission to contact physician. All questions were asked.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 11th April 2018 17:00, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient developed rash that looks like shingles rash. The reporter gave permission to contact physician. All questions were asked.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: My husband and took patient into her first month check-up on 4/30/18 and was going to get the second shot for Hepatitis B, the first dose was administered at the hospital at the time of her birth. During the appointment we discussed several different times that she was supposed to be getting the second shot in the series for Hepatitis B. When the nurse brought the shot in the room there was another nurse with her, whom she announced was being trained. After nurse gave her the shot we were told we could get her dressed and go. However, once we got ready to leave Dr. asked us to come back into the room where they told us that she was given Hepatitis A vaccine HAVRIX 720 ECU/0.5 mL. We are very concerned that this vaccine for Hep A was administered negligently and what possible harmful effects it may have on our daughter as it is recommended at 12 months but she was given it at one month. Upon apologizing for the error, we left feeling not very reassured that our daughter's safety was the main focus but rather the mistake was downplayed. It is impossible to find information on this scenario because it seems it has not occurred to anyone else. We called the CDC and the State Health Department and did not get satisfactory assurance that the critical error was safe. We are frustrated and would like to report this mistake as legal action may be taken if necessary. At this time, twelve hours later, there seem to be no adverse side effects but we are closely monitoring her. The frustration is that we did not agree to or give permission for the Hepatitis A vaccine nor were we asked if we wished to proceed with this nor were we given materials on the manufacturer who makes the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: Headache, shivering, pain at vaccination site.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Malaise, Syncope
Clinical narrative: Patient was standing at the checkout counter and stated "I don't feel well" and fainted. Front desk called for help, of which Dr  and the office manager were the first to get to patient and her mother followed by myself. Patient came to and asked what happen. We informed her that she fainted. We allowed for her to lay there for a minute before taking her to an exam room where she was watched for the next 10-15 minutes to make sure she would be ok. Pt was provided juice and a snack, we also monitored her blood pressure and pulse until she felt ok to sit up by herself. After pt stated she was ok, we checked her blood pressure again and allowed for her to walk around the room a little before allowing her to leave the building.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to a 2 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unspecified date, the patient received GARDASIL 9 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). No adverse effect was reported.
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Drug administered to patient of inappropriate age, Syncope
Clinical narrative: This spontaneous report was received from a nurse via a field representative, regarding a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in January 2018, reported as "about 3 months ago", the patient was vaccinated with GARDASIL 9 (dose, frequency, strength, lot # and expiration date were not reported) as part of the "adolescent shots" (prophylaxis). On the same date, the patient also received BEXSERO and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (dose, frequency, strength, indication lot # and expiration date were not reported for both of the vaccines). At that time, the patient experienced syncope after leaving the practice. At the time of reporting, the patient recovered from the syncope. The causality assessment was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Dyspnoea, Enuresis
Clinical narrative: This spontaneous report was received on 27-APR-2018 from a consumer concerning his 11 year old daughter. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date in April 2018 (also reported as last week), the patient was vaccinated with GARDASIL 9, (lot number, dosage, and route of administration not provided). The reporter stated that "one day later, the patient started acting differently, had problems breathing and wet the bed" (no further information was provided). The outcome of acting differently, problems breathing and wet the bed was reported as not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Lip disorder
Clinical narrative: Pt felt tightness in lips and numbness in feet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, fatigue, headache, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Parotitis
Clinical narrative: Right parotitis- felt to be secondary to MMR vaccine but treated with cefdinir in case of bacterial infection.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Product quality issue, Seizure
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure in a 20-year-old female patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). This case was associated with a product complaint. In March 2018, the patient received the 1st dose of HAVRIX .5 ml. In March 2018, immediately after receiving HAVRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. The reporter considered the seizure to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that she administered the HAVRIX vaccine in the afternoon to the patient (in right deltoid). No additional details were available. Follow up information was received from nurse via call center representative on 24th April 2018: This case was associated with product complaint. The health care professional called back later relating previously reported adverse event to two new adverse event with a quality complaint. In addition, the nurse reported that she previously reported seizure but she used the term convulsion when she called back. The dosage of the vaccine administered was corrected to 1 ml.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash pruritic
Clinical narrative: With 24 hours Patient developed soreness and a rash that was very itchy. Soreness is gone; but rash still itchy. Tx topical cortisone and oral antihistamine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Two days after receiving vaccination, patient returned to primary care. Right arm was red, warm, and swollen at injection site. No pain in area.
Age: 0.58
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Fussy-red area on anterior aspect right thigh, no fever local reaction to vaccine. Observe-TYLENOL as needed for discomfort.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Nausea that begins around 11am and lasts up to 6 hours; headache that goes away with TYLENOL.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENVEO or MENACTRA. No adverse reaction reported to this facility.
Age: 13.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was administered in place of MENVEO or MENACTRA. No adverse reaction reported to this facility.
Age: 15.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENVEO or MENACTRA. No adverse reactions reported to this facility.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Pruritus generalised, Urticaria
Clinical narrative: Severe itching in hands (tops and palms) that spread to upper back and moved from area to area in the body. The itching lasted 5-6 days before red welts (hives? ? I've never had them, so unsure) appeared with the severe itching.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Age: 11.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: TRUMENBA was administered as an alternative to MENVEO or MENACTRA. No adverse reactions reported to this facility.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Sjogren's syndrome
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date in 2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date in 2018 (reported as "subsequently"), the patient developed Sjogren's syndrome. The patient sought medical attention, however, she did not receive any treatment. It was unknown if diagnostic laboratories were performed. At the time of reporting, the outcome of Sjogren's syndrome was unknown. Additionally, the causality assessment between Sjogren's syndrome and GARDASIL 9 was not provided. Upon internal review, Sjogren's syndrome was determined to be a medically significant event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 104, chills, aches, mild nausea over night, low fever next day.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Bacterial test, Clostridium test, Dermatitis diaper, Diarrhoea, Giardia test
Clinical narrative: 10 days of diarrhea following vaccine, developed diaper rash from diarrhea.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Parasite stool test, Rotavirus test
Clinical narrative: 10 days of diarrhea following vaccine, developed diaper rash from diarrhea.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Alveolitis allergic, Asthma, Blood test normal, Computerised tomogram thorax abnormal, Fatigue
Clinical narrative: First day.....sore arm, feverish. Second day......achy, feverish, tired. Third day....felt better. Fourth day.....while skiing uphill had what we think was an asthma attack. Never had asthma. I'm in good physical shape. The following week I was lethargic and got worse as the week progressed. Actually ended up admitted to the hospital on 3/19 and given intravenous steroids. Was very sick, nauseous and unable to even sit up on exam table. Prior winter was diagnosed with cryptogenic organizing pneumonia as I'm convinced the pneumonia booster shot reactivated whatever was dormant in my lungs. They are not sure what I have but their best guess is hypersensitive pneumonitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: First day.....sore arm, feverish. Second day......achy, feverish, tired. Third day....felt better. Fourth day.....while skiing uphill had what we think was an asthma attack. Never had asthma. I'm in good physical shape. The following week I was lethargic and got worse as the week progressed. Actually ended up admitted to the hospital on 3/19 and given intravenous steroids. Was very sick, nauseous and unable to even sit up on exam table. Prior winter was diagnosed with cryptogenic organizing pneumonia as I'm convinced the pneumonia booster shot reactivated whatever was dormant in my lungs. They are not sure what I have but their best guess is hypersensitive pneumonitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pulmonary fibrosis, Pulmonary function test normal, Pyrexia
Clinical narrative: First day.....sore arm, feverish. Second day......achy, feverish, tired. Third day....felt better. Fourth day.....while skiing uphill had what we think was an asthma attack. Never had asthma. I'm in good physical shape. The following week I was lethargic and got worse as the week progressed. Actually ended up admitted to the hospital on 3/19 and given intravenous steroids. Was very sick, nauseous and unable to even sit up on exam table. Prior winter was diagnosed with cryptogenic organizing pneumonia as I'm convinced the pneumonia booster shot reactivated whatever was dormant in my lungs. They are not sure what I have but their best guess is hypersensitive pneumonitis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash
Clinical narrative: Within first 24 hours diffuse rash around neck and shoulders, red, hard and warm induration at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Patient reported severe reaction. Patient unable to move his arm, and reported no strength. Patient stated that he "dropped a plate of food at dinner b/c of the weakness in that injected arm." He presented himself to a primary care provider which recommended him to see a neurologist.  Appointment pending in 3 weeks.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient reported severe reaction. Patient unable to move his arm, and reported no strength. Patient stated that he "dropped a plate of food at dinner b/c of the weakness in that injected arm." He presented himself to a primary care provider which recommended him to see a neurologist.  Appointment pending in 3 weeks.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Nausea, Syncope, Urinary incontinence
Clinical narrative: Nausea, Dizziness , Fainting, lost control of bladder and Jerky movements of upper body.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: PATIENT REPORTED PAIN, FEVER, AND MUSCLE SPASM. MUSCLE SPASM DEVELOPED THE DAY AFTER INJECTION AND PAIN NOT RESOLVED WITH OVER THE COUNTER PAIN MEDS (IBUPROFEN).
Age: 70.0
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a elderly patient who received Hepatitis A vaccine. The patient's past medical history included breast cancer. In February 2018 the patient received the 1st dose of Hepatitis A vaccine. On an unknown date, less than a year after receiving Hepatitis A vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had a Hepatitis A vaccine (unknown name) two months before the date of reporting, on Feb 2018, the first injection of two, and experienced right arm pain at the injection site. The patient was also a retired physician. The patient had denied permission to contact their physician. This case has been linked with US2018068933, reported by the same reporter for the same patient.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Psychogenic seizure, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anal incontinence, Blood electrolytes normal, Loss of consciousness, Psychogenic seizure, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination.
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Urinary incontinence
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fainting in a adult male patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On an unknown date, the patient received HAVRIX 1440 adult (intramuscular) 1 ml. On an unknown date, 1 min after receiving HAVRIX 1440 adult, the patient experienced fainting and pseudoseizure. On an unknown date, the outcome of the fainting and pseudoseizure were recovered/resolved. The reporter considered the fainting and pseudoseizure to be unrelated to HAVRIX 1440 adult. Additional details were provided as follows: The age at the vaccination was not reported. The patient received HAVRIX 1440 adult in the left deltoid. The patient fainted 1 minute after getting the vaccination and fainted again 6 hours later. The patient was taken to the emergency room where it was determined that it was not related to the vaccination.