chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Wrong technique in product usage process
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of contusion in a female patient who received FLUARIX QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced contusion and wrong technique in product usage process. On an unknown date, the outcome of the contusion and wrong technique in product usage process were unknown. It was unknown if the reporter considered the contusion to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a large bruise. The air was not expelled from the syringe prior to administration, which led to wrong technique in product usage process. The patient had denied permission to contact their physician. The reason for the call was to ask if the air needed to be expelled from the prefilled syringes prior to administration. The healthcare professional stated that their health system nurse was in providing vaccination and did not remove the air and one of the recipients did develop a bruise. The healthcare professional was not sure if it had anything to do with the air or not. The healthcare professional did not have any product or patient info, as it was not their stock given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 54 years old. In 2018, the patient received a 1st dose of SHINGRIX about 4 months before the time of reporting. On 18th October 2018, the symptoms of shingles was started. On 20th October 2018, the patient was diagnosed with shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dermatitis allergic, Headache, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced headache, chills, cutaneous hypersensitivity and fever. On an unknown date, the outcome of the headache, chills, cutaneous hypersensitivity and fever were recovered/resolved. It was unknown if the reporter considered the headache, chills, cutaneous hypersensitivity and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 62 or 63 years. On the evening of the patient received SHINGRIX, she had a splitting headache, fever, chills and skin hypersensitivity. All the adverse events had cleared up by the next day.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Eye irritation, Eye swelling, Ocular hyperaemia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema in a male patient who received SHINGRIX for prophylaxis. On 25th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation. On an unknown date, the outcome of the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation were unknown. It was unknown if the reporter considered the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received a dose of SHINGRIX on left arm. On the day of reporting (26th October 2018), the patient presented to the office with redness, burning and swelling on right side of his head, face, eye and cheeks. The physician was not able to discuss the events as she had the patient in the office. She was seeking information on this being possible side effect of vaccine as it was not noted in the prescribing information as burning feeling on head, face eye and cheeks. It was attempted to transfer to MIS (medical information system), but caller was not able to hold, so disconnected. MIS number was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema in a male patient who received SHINGRIX for prophylaxis. On 25th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation. On an unknown date, the outcome of the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation were unknown. It was unknown if the reporter considered the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received a dose of SHINGRIX on left arm. On the day of reporting (26th October 2018), the patient presented to the office with redness, burning and swelling on right side of his head, face, eye and cheeks. The physician was not able to discuss the events as she had the patient in the office. She was seeking information on this being possible side effect of vaccine as it was not noted in the prescribing information as burning feeling on head, face eye and cheeks. It was attempted to transfer to MIS (medical information system), but caller was not able to hold, so disconnected. MIS number was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician reported that he personally received a shot of SHINGRIX and it was very painful. The reporter did not provide any detail as it was short conversation. The reporter was not agreed to be contacted for follow up.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema urticarial in a 75-year-old patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 2nd dose of SHINGRIX. On 27th October 2018, 3 days after receiving SHINGRIX, the patient experienced erythema urticarial and pruritus. On 28th October 2018, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythema urticarial, pruritus and erythromacular rash were unknown. It was unknown if the reporter considered the erythema urticarial, pruritus and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The had large red welts on both sides of butt crack. They were large/raised and very red. The patient also had a couple of the same welts on the back of left leg. Both of the back of hands had red welts and were very itchy. Four days after receiving SHINGRIX, when patient got out of bed had red marks on both of sides under arms that were long and red, almost like scratches would look. The patient also had one spot in the same area that looked like the beginning of shingles. Lots of red spots in an area about the size of a baseball. The patient also has some red spots on face and head. This case has been linked to case US2018GSK196604.
Sex: F
Vaccine: TDAP
Symptoms: Apparent death, Feeling abnormal
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a adult female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced near death experience (serious criteria GSK medically significant) and feels awful. On an unknown date, the outcome of the near death experience and feels awful were unknown. It was unknown if the reporter considered the near death experience and feels awful to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that, Tdap vaccine surely did her and it was horrible. The patient was trying to protect her grand babies and stated Dtap vaccine almost killed her. The patient stated that she did not care what anyone said.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Generalised erythema, Rash, Stevens-Johnson syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of stevens johnson syndrome in a 80-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Humira. In October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced stevens johnson syndrome (serious criteria hospitalization and GSK medically significant), shortness of breath (serious criteria hospitalization), generalized erythema and rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the stevens johnson syndrome, shortness of breath, generalized erythema and rash were unknown.  The reporter considered the stevens johnson syndrome, shortness of breath, generalized erythema and rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no immunodeficiency that would have caused these extreme reaction. The initial reporter saw the patient in the morning and referred her to the pharmacy for SHINGRIX. The patient went to the pharmacy and got the first dose of SHINGRIX that day mid October2018 and came back to the HCP office, on the same day, after getting the vaccine, which was when she saw the follow-up reporter. The patient experienced breakout of rash before returning home from pharmacy and also experienced shortness of breath and was admitted to hospital and was diagnosed with mild Stevens-Johnson syndrome. The follow-up reporter stated that the patient was lobster red from head to toe and went downhill from there. The patient required steroids which resulted in hospitalization for 8 days total to help reverse the effects. The reaction was believed to absolutely be direct result of SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of the adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The health care professional stated about 10 percent of the patients have reported flu like symptoms following SHINGRIX administration. This is 1 of the 5 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of local reaction (1st dose received on an unknown date. For tolerance, refer case US2018GSK198473). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local reaction, which was much milder than the reaction experienced with the 1st dose of SHINGRIX. The reporter did not agree to be followed up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 80-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 26th October 2018, the patient received the 2nd dose of SHINGRIX. On 27th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever and injection site rash. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the fever and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated that one day after receiving SHINGRIX, the patient experienced fever and red rash at the injection site. The healthcare professional stated that the patient stated the red rash had not resolved and was getting worse. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient reported that 1st SHINGRIX shot was much more painful than other vaccines she has received. The pain began within a couple of hours after receiving SHINGRIX, the patient experienced pain which resolved after 2 days. The patient planned to receive the 2nd dose. The patient consented to follow up. The healthcare professional details were not asked.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis ulcerative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 68-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant). On an unknown date, the outcome of the ulcerative colitis was unknown. It was unknown if the reporter considered the ulcerative colitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving SHINGRIX the patient was diagnosed with ulcerative colitis. The patient was consented to follow up. The patient's full address was not obtained during call.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Reported by school nurse to Public Health Dept. that the injection site was reddened, hard and the size of a baseball. Patient had discomfort at injection site. School nurse had called grandma to pick her up from school. PHN did call her also but no answer. Message left and she did return call. Grandma was going to take her home but PHN requested that she go to doctors office to have it checked out. Grandma will take her to PED's at this time.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt presented with swollen, red, bruised, hot to touch upper arm. Pt saw primary care dr and was administered a steroid injection and prescribed KEFLEX.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased, Laboratory test, Muscle spasms, Pain in extremity
Clinical narrative: Patient awoke with extreme hand pain/spasms and increase HR.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Experienced chills and was shaky from about 9:30 PM until Midnight the day of the vaccination.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Crying, Vomiting
Clinical narrative: Vomiting: toddler was crying middle of the night and we discovered that she threw up her dinner. Dinner foods were familiar - no new foods introduced. We gave her PEDIALYTE to replenish fluids.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye pruritus, Headache, Nasal congestion, Pain
Clinical narrative: Swollen tongue and throat, fever, aches, cough, headache, stuffy nose, itchy eyes.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Pyrexia, Swollen tongue
Clinical narrative: Swollen tongue and throat, fever, aches, cough, headache, stuffy nose, itchy eyes.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Tingling in fingers, hospital visit, diagnosed as Guillain-Barre. This was reported by human resources for the employer.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Feeling abnormal, Impaired work ability, Vomiting
Clinical narrative: Patient called on 11/02/2018 stating that she was vomiting for 5 days since she got the 2 immunizations. She stated that she knows that immunizations had caused her to feel very sick in the past and she was hesitant to get it but then she did it because she thought it was the right thing to do. On the same day patient was told that she has trichomoniasis and one of our provider sent antibiotics treatment and ZOFRAN to help with symptoms. Today 11/8/2018 I called patient to follow up. She is feeling better but for 10 days she was not able to work due to her symptoms.
Age: 27.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, pain, itching - left deltoid only.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a significantly bad local reaction. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK202483. The reporter did not agree to be followed up.
Age: 0.33
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction positive
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pertussis in a patient who received DTaP vaccine for prophylaxis. Concomitant products included DTaP vaccine. On an unknown date, the patient received the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown. It was unknown if the reporter considered the pertussis to be related to DTaP vaccine. Additional details were provided as follows: The patient received DTap vaccine at 2 and 4 months old and came down with polymerase chain reaction (PCR) confirmed pertussis. Lab Comments: On an unknown date, the polymerase chain reaction (PCR) was performed and it confirmed Pertussis.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in an unspecified number of patients who received PEDIARIX for prophylaxis.  On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. No lot number, expiry date and patient details were available. The licensed practical nurse reported that the patient had experienced a red, raised, swollen area at the injection site following administration of PEDIARIX. The area felt hard to the touch. The reporter did not consent to follow up. The call was disconnected before any healthcare professional details could be obtained. The reporter indicated that more than one patient experienced these symptoms, but did not have an estimated number of patients affected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 78-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. On 27th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, 1 day after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced injection site redness and itchiness. The redness was the size of a half gallon of milk and a softball. The symptoms might have begun the day after injection, but it was not certain. It was stated that, the symptoms had not improved. No inflammation was noted by the reporter. The reported gave consent to follow up.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season. On 30th October 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, chills and nausea. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the chills and nausea were resolved with sequelae. It was unknown if the reporter considered the headache, chills and nausea to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: On Monday, the patient got a dose of SHINGRIX. He also got a flu vaccine right before the SHINGRIX vaccine. The next day the patient experienced headache, chills and nausea. The patient had been taking TYLENOL to treat the symptoms. At the time of reporting, the patient still had a bit of a headache, but the chills and nausea had resolved. The reporter gave consent to contact the safety physician and provided contact details for the same. The reporter refused to provide his own address, but he did grant permission to contact his healthcare professional.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Induration, Peripheral swelling, Skin discolouration
Clinical narrative: Swelling and redness of almost entire upper arm including part of elbow area. Not much pain. Arm was hot and hard to the touch. Doctor prescribed BENADRYL beginning on Nov. 5. Swelling and redness began to subside, but skin on part of arm was discolored and appeared to be bruised. Symptoms mostly gone by Nov. 8 but still some discoloration.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Swelling and redness of almost entire upper arm including part of elbow area. Not much pain. Arm was hot and hard to the touch. Doctor prescribed BENADRYL beginning on Nov. 5. Swelling and redness began to subside, but skin on part of arm was discolored and appeared to be bruised. Symptoms mostly gone by Nov. 8 but still some discoloration.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Inflammation, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Immediately after injection, severe pain in upper left arm, loss of range of motion, that continued on for 3 weeks. Called the Pharmacy where I received the shot, they suggested I go to my doctor.  I went to my Doctor yesterday....Wed  Nov 7,2018 and received two Rx's :  MEDROL pack, FLEXERIL 5mg and Slow Mag. Dr. said to return to his office in 2 wks if not better.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 101.0, chills and headache.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash, treated with topicals steroids and if not improved oral prednisone.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chest discomfort, Chest pain, Injection site pain, Pain
Clinical narrative: Pain at injection site, (L) axilla, chest wall, with chest tightness, pain with moving left arm.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Influenza like illness, Injection site pain
Clinical narrative: Patient experienced joint pain, upset stomach, diarrhea, pain and swelling at the injection site which has progressively gotten worse since the injection was given. Patient felt like he has the flu the day after the immunization was given and is feeling marginally better on day 2 after the injection was given.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient experienced joint pain, upset stomach, diarrhea, pain and swelling at the injection site which has progressively gotten worse since the injection was given. Patient felt like he has the flu the day after the immunization was given and is feeling marginally better on day 2 after the injection was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site cellulitis
Clinical narrative: Cellulitis at injection site which is getting bigger on the day after the injection. Patient is experiencing "flu like symptoms." She went home from work due to her symptoms the day after the injection was given.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Immediate post-injection reaction, Loss of personal independence in daily activities, Pain
Clinical narrative: Immediate pain-unlike all shots previous continued all day. 2nd day 1/2 pain but lasted all day-learned it was double dose-which I would not have agreed to. Everything ok until late November when I awoke it felt like the 2nd day of vaccination all day. March 2018-sharp pain when I reached to get water. Mid March-pain when I reached for towel. Next few days felt pain occasionally. Month of April-almost daily discomfort-not acute pain. Early May-sore-could not brush teeth for 3 minutes. Mid May-pain where I could not read newspaper. Pain persisting so called Dr to make appt-1st available date was in 90 days-this was May 24. May 30th felt so bad went to pharmacy to see if they could suggest relief. They referred me to Dept of Human Resources and asked that I notify them of adverse effect-delayed. Early June tried calling Dr several times but after about 12 minutes wait, phone could go dead. By noon had difficulty carrying groceries with rt arm. Mid June-started improving but still occasional pain and discomfort. Finally got to see my Dr on August 21. When I mentioned flu shot problem-he said no such thing-it only hurts for few days, after injection and if I'm having any kind of problems it is a rotator cuff problem and he would need an X-ray to determine course of treatment-since I was no longer having acute pain I declined.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm red, painful esp w/movement or lifting, was swollen. Has been icing - used some APAP.
Age: 74.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain
Clinical narrative: Right side, upper shoulder still painful.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, the patient's healthcare provider (an unspecified healthcare professional), administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by the healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site indentation
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 73 years old female patient who experienced indentation in arm below the injection site, tired and about an inch and half below the injection site got a bright red spot about the size of a penny form, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLU VACCINE in 2006. The patient's past medical history, medical treatment(s) and family history were not provided. On 27-Sep-2018, the patient received a dose of suspect FLUZONE HIGH DOSE lot number not reported (dose, expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious indentation in arm below the injection site, tired and about an inch and half below the injection site got a bright red spot about the size of a penny form (vaccination site inflammation) following the administration of FLUZONE HIGH DOSE. Other relevant tests included no lab data. Final diagnosis was about an inch and half below the injection site got a bright red spot about the size of a penny form, tired and indentation in arm below the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302872. This case involves a 28 months old female patient who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE (lot UJ009AA and Exp. Date 30-JUN-2019) via intramuscular route in the right thigh on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine overdose. It was not reported whether the patient experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLUC4, RAB, TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical Assistance). This case involves a 45 years old female patient who received vaccine IMOVAX RABIES. The patients past medical history and family history were not provided. Concomitant medications included TYPHIM VI for Immunisation; and FLUCELVAX for Immunisation on 01-Nov-2018. On 01-Nov-2018, the patient received a 0.5 ml dose of suspect RABIES (HDC) VACCINE lot M1492, expiry date 02-Oct-2018 via intramuscular route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was administered an expired dose (expiry date 02-Oct-2018) of IMOVAX on 01-Nov-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender none.
Age: 5.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 5 years old patient (gender not reported) who was vaccinated with vaccine FLUBLOK QUADRIVALENT on an unknown date (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history included egg allergy. The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the administration of the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown gender six months old patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259OA, expiration date: 30-Jun-2019, site of administration: left thigh and route was not reported) on an unknown date. Concomitant medications included was 0.5 ml dose of FLULAVAL QUADRIVALENT 2015/2016 lot number: B4J3H via unknown route on an unknown date. The patient's medical history were not reported. It was an actual medication error due to extra dose administered (two dose of FLUZONE QUADRIVALENT given too soon). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 25 patients (age and gender not reported) who was vaccinated with 0.5 ml expired dose of FLUBLOK QIV (Batch number: QFAA1703, expiration date: 26-MAR-2018 and site of administration was not reported) via intramuscular route on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA304934 same reporter. This case involves a 14 years old patient who received vaccine FLUBLOK QIV lot QSAA1803, expiry date: 31-May-2019 via intramuscular route in the left arm on 14-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate age at vaccine administration. It was reported that the patient under the age of 18 received the FLUBLOK QUADRIVALENT vaccine. 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.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA304921 same reporter. This case involves a 17-years old patient who received 0.5 ml dose FLUBLOK QIV lot no. QSAA1803, expiry date: 31-May-2019 via intramuscular route in the left arm on 14-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate age at vaccine administration. (It was reported that the patient received vaccine FLUBLOK QUADRIVALENT vaccine under the age of 18). 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical Assistant). This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304936, 2018SA304964 and 2018SA304964, same reporter. This case involves a 73 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 22-Oct-2018, the patient received a 0.5ml dose of suspect FLUZONE HIGH DOSE lot UI842AB, expiry date 04-Apr-2018 via intramuscular route in the left upper arm. It was an actual medication error due to expired vaccine used. It was reported that Patient was accidentally given an expired FLUZONE HIGH DOSE (expiry date 04-Apr-2018) on 22-Oct-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304964 and 2018SA304935. This case involves a 77 years old male patient and reported that accidentally gave an expired (4/4/2018) FLUZONE HIGH DOSE, while he received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 22-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI842AB and expiry date: 04-April-2018) via intramuscular route in left upper arm. It was a case of actual medication error due to expired product administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA304966, 2018SA304964, 2018SA304936 and 2018SA304935 (same reporter). This case involves an 88 years old male patient who accidentally received an expired dose of FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 26-Oct-2018, the patient received a dose of 0.5 ml suspect FLUZONE HD (lot number: UI842AB and expiry date: 04-Apr-2018) via intramuscular route in left upper arm. It was a case of actual medication error due to expired product administered. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.