chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site erythema, Injection site inflammation
Clinical narrative: Injection site inflamed; right arm was red; spots four inches wide by two inches high on his arm at the injection site; tiredness; achiness; feel crappy; headache; fever; stuffy nose; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness. On an unknown date, the outcome of the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness to be related to Shingrix.  Additional details were provided as follows: The patient received the injection on his right arm just below the deltoid muscle. The patient received Shingrix and within 36 hours he started to feel crappy and his right arm was red and inflamed and he has spots four inches wide by two inches high on his arm at the injection site. He was tired, achy, has a headache, fever, and a stuffy nose. He claims that he has all the side effects listed on our website for Shingrix. He reported that he started to get a little better and all his symptoms are back. He claims that he received the injection on his right arm just below the deltoid muscle. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Nasal congestion, Pain, Pyrexia
Clinical narrative: Injection site inflamed; right arm was red; spots four inches wide by two inches high on his arm at the injection site; tiredness; achiness; feel crappy; headache; fever; stuffy nose; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness. On an unknown date, the outcome of the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site inflammation, injection site rash, tiredness, pain, feeling bad, headache, fever and nasal stuffiness to be related to Shingrix.  Additional details were provided as follows: The patient received the injection on his right arm just below the deltoid muscle. The patient received Shingrix and within 36 hours he started to feel crappy and his right arm was red and inflamed and he has spots four inches wide by two inches high on his arm at the injection site. He was tired, achy, has a headache, fever, and a stuffy nose. He claims that he has all the side effects listed on our website for Shingrix. He reported that he started to get a little better and all his symptoms are back. He claims that he received the injection on his right arm just below the deltoid muscle. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site; swelling at injection site; fatigue; This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site swelling and fatigue. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown and the outcome of the fatigue was resolved with sequelae.   It was unknown if the reporter considered the injection site pain, injection site swelling and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient after receiving the vaccine, developed severe pain and swelling at the injection site. The patient also developed fatigue that lasted for a few days. The reporter did not have healthcare professional name or contact information at the time of the reporting. The reporter stated that he will get the information and more details and call back to Agency.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Skin lesion
Clinical narrative: Vaccination Failure; Herpes zoster with vesicles and lesions which were painful and itchy; Lesions; Painful lesion; Itchy; Vesicles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, skin lesion, pain, pruritus and vesicles. The patient was treated with capsaicin (Capsaicin Cream). On an unknown date, the outcome of the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received the two doses of the Shingrix vaccine about two years ago and about two weeks ago, the patient developed herpes zoster with vesicles and lesions which were painful and itchy. The patient was not prescribed any antiviral therapy. The patient only applied topical Capsaicin Cream.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Vaccination Failure; Herpes zoster with vesicles and lesions which were painful and itchy; Lesions; Painful lesion; Itchy; Vesicles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, skin lesion, pain, pruritus and vesicles. The patient was treated with capsaicin (Capsaicin Cream). On an unknown date, the outcome of the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, skin lesion, pain, pruritus and vesicles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received the two doses of the Shingrix vaccine about two years ago and about two weeks ago, the patient developed herpes zoster with vesicles and lesions which were painful and itchy. The patient was not prescribed any antiviral therapy. The patient only applied topical Capsaicin Cream.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal pain, Pain in extremity, Skin lesion, Streptococcus test negative
Clinical narrative: toothache / tooth throbbing; lessions on chest and back; blisters in throat; sore throat; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included root canal procedure.   On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th May 2019, the patient experienced throat blister (serious criteria GSK medically significant) and sore throat. On 7th July 2019, the patient experienced skin lesion. On an unknown date, the patient experienced toothache. The patient was treated with Antibiotic (Details Unknown) and antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the throat blister, sore throat and toothache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the throat blister, pain in arm, sore throat, toothache and skin lesion to be related to Shingrix.  Additional information was reported as follows: The patient experienced a sore arm after the injection. The day after the injection, the patient started having a sore throat. By the end of the week, her throat was still sore, so the patient looked at it and saw blisters in her throat. Around 16th June 2019, after 3 weeks the blisters and sore throat were resolved. The patient did not seen her physician, she thought did place a call towards the end and an antiviral was prescribed which she never took because the symptoms resolved. On 7th July 2019, the sore throat and blisters were returned, along with lesions on her chest and back and lasted another 2 to 3 weeks. This time the patient had visited her physician and she was prescribed an antibiotic and antiviral. A culture of the throat was also taken, which was negative for strep. The symptoms were resolved about 4 days after starting the medications. Less than two months after vaccination, during this 2nd outbreak the patient also started having a toothache in a tooth that previously had a root canal. The patient had a regular dental visit scheduled on 19th July 2019, which happened to occur shortly after the resolution of the second outbreak of blisters. The patient's physician referred her to another provider, who advised that she would need to get an implant.  On 24th September 2019, the patient started having another outbreak of blisters in her throat that was still ongoing. The patient also noted that, her tooth was not aching and throbbing as much as it was, but she can still feel it when using her water pick. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: toothache / tooth throbbing; lessions on chest and back; blisters in throat; sore throat; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included root canal procedure.   On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th May 2019, the patient experienced throat blister (serious criteria GSK medically significant) and sore throat. On 7th July 2019, the patient experienced skin lesion. On an unknown date, the patient experienced toothache. The patient was treated with Antibiotic (Details Unknown) and antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the throat blister, sore throat and toothache were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the throat blister, pain in arm, sore throat, toothache and skin lesion to be related to Shingrix.  Additional information was reported as follows: The patient experienced a sore arm after the injection. The day after the injection, the patient started having a sore throat. By the end of the week, her throat was still sore, so the patient looked at it and saw blisters in her throat. Around 16th June 2019, after 3 weeks the blisters and sore throat were resolved. The patient did not seen her physician, she thought did place a call towards the end and an antiviral was prescribed which she never took because the symptoms resolved. On 7th July 2019, the sore throat and blisters were returned, along with lesions on her chest and back and lasted another 2 to 3 weeks. This time the patient had visited her physician and she was prescribed an antibiotic and antiviral. A culture of the throat was also taken, which was negative for strep. The symptoms were resolved about 4 days after starting the medications. Less than two months after vaccination, during this 2nd outbreak the patient also started having a toothache in a tooth that previously had a root canal. The patient had a regular dental visit scheduled on 19th July 2019, which happened to occur shortly after the resolution of the second outbreak of blisters. The patient's physician referred her to another provider, who advised that she would need to get an implant.  On 24th September 2019, the patient started having another outbreak of blisters in her throat that was still ongoing. The patient also noted that, her tooth was not aching and throbbing as much as it was, but she can still feel it when using her water pick. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Feeling abnormal, Heart rate increased, Insomnia
Clinical narrative: fever, especially first day, over 102 Chills Muscle and joint pain high heart rate.  it was steady between 90 and 100 (normal in the 60's) insomnia Felt terrible
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever, especially first day, over 102 Chills Muscle and joint pain high heart rate.  it was steady between 90 and 100 (normal in the 60's) insomnia Felt terrible
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, fever, chills, body aches
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: Warm and red to touch
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Limb discomfort, Pain
Clinical narrative: 15 hours post Shingrix vaccine.  Developed fever 101-103 F..., chills, body aches, resting heart rate 108-113, headache, legs felt heavy when attempting to walk. Symptoms mimic the flu that lasted for 12 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 15 hours post Shingrix vaccine.  Developed fever 101-103 F..., chills, body aches, resting heart rate 108-113, headache, legs felt heavy when attempting to walk. Symptoms mimic the flu that lasted for 12 hours.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red and extremely sore at injection site beginning night of administration. Over next two days, redness moved to inside of upper arm, became itchy but pain subsided. Advised patient to monitor for 2 to 3 more days and seek medical attention in the meantime if it gets worse instead of better.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Patient reported redness, welts, warmth and itching at the site of the Prevnar  injection
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Body rash
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Peripheral swelling, Rash
Clinical narrative: Patient's left arm is inflamed, rash, red and swollen.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 17yr old female complained about pain, redness , some swelling and warmness to right arm, she received MCV4 vaccine on Tuesday.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia, Rash erythematous, Swelling
Clinical narrative: Patient received both vaccinations in left arm at 2pm. Patient reported getting red spots at first then throughout the day gradually got puffy and red. She put an ice pack and took advil. She had very similar reaction to the prevnar 13 which was never reported. She had chills and feverish but never took a temperature.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain
Clinical narrative: Patient states that her arm started to become stiff and hot at the injection site and complained of inability to pick up anything without severe pain. Patient presented to the pharmacy with symptoms 2 days after receiving the injection.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain
Clinical narrative: Patients wife stated that they had pain in upper chest area however it was on the left side of chest not the right side and vaccine was given in right deltoid
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dysphagia, Nausea, Pain
Clinical narrative: Feeling of tightness in chest as if there were an air bubble,  then tightening of throat with some difficulty of swallowing,  then several hours of  nausea, fever and body aches  over a period of 6 hours.   Took an antihistamine for the chest and throat reaction   and then in a couple of hours took ibuprophen for the fever and aches. After about 6 hours I began to feel  better but still weakness through the next day.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Feeling of tightness in chest as if there were an air bubble,  then tightening of throat with some difficulty of swallowing,  then several hours of  nausea, fever and body aches  over a period of 6 hours.   Took an antihistamine for the chest and throat reaction   and then in a couple of hours took ibuprophen for the fever and aches. After about 6 hours I began to feel  better but still weakness through the next day.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain
Clinical narrative: Patient described pain on left side of upper side of chest however flu shot was given in right arm
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Patient had received the flu vaccine and had gone to waiting room to wait 15 before leaving. Patient had not been sitting one minute when she reported to her friend she was dizzy and had a syncopal event. She fell to the left hitting her head on the wall. Patient was unconscious for approximately one minute. Vitals were stable. Patient remained pale and lightheaded for approximately 20 + minutes until EMS took her in for further evaluation.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient had received the flu vaccine and had gone to waiting room to wait 15 before leaving. Patient had not been sitting one minute when she reported to her friend she was dizzy and had a syncopal event. She fell to the left hitting her head on the wall. Patient was unconscious for approximately one minute. Vitals were stable. Patient remained pale and lightheaded for approximately 20 + minutes until EMS took her in for further evaluation.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Hypersensitivity, Injection site erythema, Pain in extremity, Wrong product administered
Clinical narrative: patients  doctor called saying patient had an allergic reaction to the shot, since the pneumovax 23 was given in error (patient was supposed to get prevnar 13, as they had pneumovax23 back in 2011.) Md said the allergic reaction was due to getting the same shot twice , and the reaction involved a sore arm, with redness at the injection site
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Pt described his left upper arm and leg being numb the day after flu vaccination and it was resolved the following day.   He did not report the symptoms (until today 10/4/19) or require/request treatment.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Gave patient extra dose of HIB, patient has to catch up on hep b vaccine.
Age: 10.0
Sex: M
Vaccine: FLU4, HEP, IPV, MMRV, TD
Symptoms: Fall, Generalised tonic-clonic seizure, Head injury, Neurological symptom
Clinical narrative: Patient was vaccinated in exam room and after 5 minutes patient was instructed to walk to the lab for additional testing.  The lab assistant  heard a knock on the wall and looked out into the hallway when she witnessed patient falling to floor.  She grabbed patient in time before he hit the floor.  The patient was quickly examined by physician who reports he had a tonic clonic seizure for 5-10 seconds.  The patient awoke after seizure and vital done (wnl) and juice was given.  The patient was brought back to room and assessed.  He was sent to ER for evaluation given neurologic sx after head injury.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported he started having redness and swelling at the injection site within 2 hours.  Redness, swelling & pain progressed through the evening.  He reported to the office the following day with redness and pain extending through (L)Deltoid around the injection site.  Pt was seen here at the office by Dr. and advised pt to use hot/cold compress and Tylenol as needed to help with symptoms.  Pt was also advised to go to ER if he experiences any numbness, tingling or weakness in (L)UE.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Mom stated this AM pt woke up site was about a dollar size in redness and itched. Mom then gave Benadryl and redness and itching went away.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: developed hives 24 hours later, itchy, treated with benadryl seen in Dr's office 48 hours later, still with hives, treat with benadryl, referred to allergist
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Neck pain
Clinical narrative: I started with a severe headache and neck pain around 10PM the night of my getting the vaccine.  I woke up in a soaked bed from sweat and had chills around 7AM.  I had muscle aches, was feverish and my throat was bothering me.  I took some cough medicine to help my throat, which is soothed it for awhile.  All that day I slept a lot and when awoke felt very warm inside but chills outside of my body.  The following night while I was asleep, I woke again in a soaked bed and felt warm inside with chills outside.  This subsided as the day went on.  I do not know for sure this was from the vaccine but thought I should complete this form.  I want you to know that I lost my husband 6 months ago and have been having a hard time coping with being alone.  I have been getting flu vaccines for decades and have never had a reaction.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence, Throat irritation
Clinical narrative: I started with a severe headache and neck pain around 10PM the night of my getting the vaccine.  I woke up in a soaked bed from sweat and had chills around 7AM.  I had muscle aches, was feverish and my throat was bothering me.  I took some cough medicine to help my throat, which is soothed it for awhile.  All that day I slept a lot and when awoke felt very warm inside but chills outside of my body.  The following night while I was asleep, I woke again in a soaked bed and felt warm inside with chills outside.  This subsided as the day went on.  I do not know for sure this was from the vaccine but thought I should complete this form.  I want you to know that I lost my husband 6 months ago and have been having a hard time coping with being alone.  I have been getting flu vaccines for decades and have never had a reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Dizziness postural, Flushing, Hypertension, Palmar erythema
Clinical narrative: Within 5 minutes of receiving  vaccine, she experienced itching all over and flushing, but no rash. She was given Benadryl 25mg po with minimal relief. She was kept in the clinic for observation. Within 30 minutes, she reporting shaking and dizziness on standing. Blood pressure was checked and was 195/98 (136 systolic on arrival to clinic). She continued to be significantly hypertensive and was sent to the Emergency Department for further treatment. She was eventually hospitalized.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin warm, Tremor
Clinical narrative: Within 5 minutes of receiving  vaccine, she experienced itching all over and flushing, but no rash. She was given Benadryl 25mg po with minimal relief. She was kept in the clinic for observation. Within 30 minutes, she reporting shaking and dizziness on standing. Blood pressure was checked and was 195/98 (136 systolic on arrival to clinic). She continued to be significantly hypertensive and was sent to the Emergency Department for further treatment. She was eventually hospitalized.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: A few hours after receiving vaccine, she noted a firm red "bump" around the injection site.  Bump was slightly tender to palpation.  Felt itchy by the center.  A few days later indurated area is wider but not as firm or red.  Arm also felt "heavy."  Still had full mobility and strength to arm and shoulder.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort
Clinical narrative: A few hours after receiving vaccine, she noted a firm red "bump" around the injection site.  Bump was slightly tender to palpation.  Felt itchy by the center.  A few days later indurated area is wider but not as firm or red.  Arm also felt "heavy."  Still had full mobility and strength to arm and shoulder.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: 10/2/2019; 4pm; diarrhea ( no food since 12 noon) 10/3/2019;4 am; abdominal cramps, diarrhea ( no food since 7 pm, 10/2, light meal)                           8 am- 12 midnight; low grade fever, photophobia, malaise, headache, body aches, and continuing abdominal cramps( no food intake, water and coca cola only) 10/4/2019 ; 10 am, diarrhea 30 min following intake of chicken broth with boiled egg; today the other symptoms are gone, but the diarrhea persisted with food intake.  Missed two days of work as RN due to diarrhea and other symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Photophobia, Pyrexia
Clinical narrative: 10/2/2019; 4pm; diarrhea ( no food since 12 noon) 10/3/2019;4 am; abdominal cramps, diarrhea ( no food since 7 pm, 10/2, light meal)                           8 am- 12 midnight; low grade fever, photophobia, malaise, headache, body aches, and continuing abdominal cramps( no food intake, water and coca cola only) 10/4/2019 ; 10 am, diarrhea 30 min following intake of chicken broth with boiled egg; today the other symptoms are gone, but the diarrhea persisted with food intake.  Missed two days of work as RN due to diarrhea and other symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash surrounding injection site (approximately 3 inches in diameter)
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Parent states child's right arm became red, swollen, and painful at the injection site after one hour of receiving the injection. Parent states she has adminstered benadryl and ibuprofen to the child Parent states she applied an ice pack to child's right arm. Since the time of injection, parent states the redness and swelling have increased over the child's arm and skin is warm to touch.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Child inadvertently received 2 doses of flu mist within minutes of each other. The order for administration of flumist was sent electronically to both the medical assistant and the RN (me) working in the sick clinic. After I received the order for the flumist, I entered the patient's room and advised mother that the child was receiving flumist. I verified child's name and date of birth and reviewed the screening questions with the mother of the child. All answers were negative for contraindications, mother signed the screening form. Flumist was administered to the child and the mother then requested a school note. Upon returning to the room with the school note, Dr was in the room. At that time it was discovered that the child had received the flumist minutes before, administered by the medical assistant. Mother did not inform me that the child had already received the flumist. The mother had completed the screening questionaire prior to the first dose of flumist also. Child received 2 doses of flumist within minutes of each other. Mother was counseled to return to office or seek medical attention for any adverse effects. No medical treatment was provided. Dr spoke with mother on 10/04/19. Mother stated child was in her usual state of health.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Within minutes of receiving vaccine pain began in my left shoulder.  The pain continued to increase until it was SEVERE.  I treated it with Ibuprofen which offered some relief.  However, 3 weeks s/p the shot, though improved somewhat, the pain continues and some ranges of motion are almost impossible.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects reported; A patient 14 months old was administered GRDASIL 9; This spontaneous report was received from a medical assistant, concerning a 14-months-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 23-SEP-2019, the 14-months-old patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) 0.5 milliliter (ml), for prophylaxis, lot number 1614897, with an expiration date on 20-SEP-2021 (frequency, route of administration and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified patient or multiple unspecified patients may have received improperly stored doses of vaccine on unspecified date or multiple unspecified dates; No adverse effects reported; This spontaneous report was received from a health care professional referring to an unspecified patient or multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concomitant medications, or drug reactions and allergies was not provided.  On an unknown date, the patient or multiple patients may have been vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported), for prophylaxis. Sterile diluent was properly stored (lot " and expiration date not reported). The dose of the vaccine was exposed to a temperature excursion of 19 Centigrade (C), total time and highest temperature above 47° Fahrenheit (F)/9°C, during a timeframe of 2 hours 30 minutes, which was detected by a data logger. There were no previous temperature excursions. No adverse effects reported.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: swelling and hard lump at the injection site, redness, and heat; swelling and hard lump at the injection site; at the injection site redness; at the injection site heat; hard lump at the injection site; hard lump at the injection site; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (reported as 4) who experienced swelling and hard lump at the injection site, redness, and heat (vaccination site inflammation, vaccination site mass, vaccination site induration, vaccination site swelling, vaccination site erythema and vaccination site warmth), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-SEP-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route and unknown site.  On an unknown date, the patient had swelling and hard lump at the injection site, redness, and heat (vaccination site inflammation, vaccination site mass, vaccination site induration, vaccination site swelling, vaccination site erythema and vaccination site warmth) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site inflammation, vaccination site mass, vaccination site induration, vaccination site swelling, vaccination site erythema and vaccination site warmth.   Patient was recommended with ice the injection site, take Motrin and Benadryl  The patient outcome was reported as unknown for vaccination site inflammation, vaccination site mass, vaccination site induration, vaccination site swelling, vaccination site erythema and vaccination site warmth.  Information on the batch number is requested.  List of document held by sender: none.
Age: 16.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: nurse reports that an MA gave16 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; nurse reports that an MA gave16 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via Office Staff.  This case is linked with 2019SA267180, 2019SA267187, 2019SA267188 (same reporter)  This case involves a 16 years old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE , Frequency: once, lot QFAA1903 , exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Nodule, Peripheral swelling
Clinical narrative: hard nodule in the arm then the next day this turned into a knot; swelling and redness then diffused over the arm; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves two patients (demographics unknown) who experienced hard nodule in the arm then the next day this turned into a knot (nodule), swelling and redness then diffused over the arm (inflammation), when they received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringe lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious hard nodule in the arm then the next day this turned into a knot (nodule), swelling and redness then diffused over the arm (inflammation) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was swelling and redness then diffused over the arm and hard nodule in the arm then the next day this turned into a knot.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.   Information on the batch number was requested.  List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Ephelides, Rash, Rash erythematous, Thrombocytopenia, Transfusion
Clinical narrative: thrombocytopenia; red dots on her body, like freckles, throughout the body, was diagnosed with thrombocytopenia; Initial information received on 26-Sep-2019 regarding an unsolicited valid serious case received from a pharmacist in the.   This case involves a 32 years old female patient who experienced thrombocytopenia (thrombocytopenia) and red dots on her body, like freckles, throughout the body (Ephelides), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Bacterial infection (patient had been fighting a bacterial or viral bug for the last month, and she thought it was could have been pneumonia) and Malaise (had been sick for a month on and off).  The patient's past vaccination(s) included flu vaccines. The patient's past medical treatment(s) and family history were not provided.  On 24-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ209AB, Exp. Date 30-Jun-2020 via intramuscular route in the left arm.  On 25-Sep-2019, the patient developed a serious thrombocytopenia (thrombocytopenia) and red dots on her body, like freckles, throughout the body (Ephelides) one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This events were assessed as medically significant. The patient was hospitalized for these events.  Other relevant tests not reported. It was reported hematologists were conducting more tests  Final diagnosis was thrombocytopenia.  An unknown corrective treatment was received. Patient received a blood transfusion  The outcome was unknown for thrombocytopenia and Ephelides.  List of documents held by sender: none.; Sender's Comments: This case involves a 32 years old female patient who developed thrombocytopenia one day after vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible. The patient's past medical history included Bacterial infection (patient had been fighting a bacterial or viral bug for the last month, and she thought it was could have been pneumonia) and Malaise (had been sick for a month on and off) and weaken immune system due to infection is common cause of thrombocytopenia. Therefore, additional information including patient's medical condition at the time of vaccination, lab test excluding other etiologies are needed for further assessment of the case. Based on the available information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: 13 year old patient was administered a dose of Adacel and Menactra vaccine which had a temperature excursion due to the malfunction with data logger at 52 F for about 31 hours and 31.2 F for 30 minutes/No AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA273650 (same reporter).  This case involves a 13 years old patient who was administered a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6521AA and expiry date: 26-Jan-2021) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6128AA and expiry date: 20-Nov-2020) vaccine which had a temperature excursion due to the malfunction with data logger at 52 f for about 31 hours and 31.2 f for 30 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Discomfort, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: pain as like it is broken, can barely lift it; cannot sleep well from the discomfort; sweats and has clammy skin; Bad injection site pain in the left arm; patient received a dosde of Adacel at Gestation age: 30 weeks; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 32 years old female patient who experienced pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at Gestation age: 30 weeks on an unknown date.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The events occurred at 30 Weeks of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Epilepsy and was taking KEPPRA. The patient previous pregnancy/ies details not reported.   No concomitants reported.  On an unknown date (over 9 days ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date: 26-Apr-2021, via unknown route in the left arm.  On an unknown date, the patient developed a non-serious pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was injected limb mobility decreased, poor quality sleep, cold sweat and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from the events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Poor quality sleep
Clinical narrative: pain as like it is broken, can barely lift it; cannot sleep well from the discomfort; sweats and has clammy skin; Bad injection site pain in the left arm; patient received a dosde of Adacel at Gestation age: 30 weeks; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 32 years old female patient who experienced pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at Gestation age: 30 weeks on an unknown date.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The events occurred at 30 Weeks of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Epilepsy and was taking KEPPRA. The patient previous pregnancy/ies details not reported.   No concomitants reported.  On an unknown date (over 9 days ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date: 26-Apr-2021, via unknown route in the left arm.  On an unknown date, the patient developed a non-serious pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was injected limb mobility decreased, poor quality sleep, cold sweat and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from the events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.