chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Face oedema, Musculoskeletal chest pain, Night sweats, Pain, Pain in jaw
Clinical narrative: On October 16, 2018, I received the flu vaccine at Hospital as required by employer. That evening around 10:00pm I developed body aches. From October 17, 2018 to October 22, 2018, I developed severe body aches, rib pain, jaw pain, facial edema, shortness of breath, and night sweats. There was no irritation, swelling, or redness at the injection site. On October 19, 2018, I presented to Express Care Clinic and no definitive diagnosis was given. Symptoms worsened and on October 21, 2018, I presented to Express Care Clinic again. A chest XR was obtained and found to have innumerable pulmonary nodules scattered throughout all four lobes. I was sent to ER. While at ER, many labs were ordered along with chest CT and head CT. Chest CT confirmed innumerable pulmonary nodules indicating sarcoidosis, Wegener's granulmatosis, metastatic disease, or atypical bacterial/fungal infection. While in ER, I was seen by pulmonologist and recommended follow up with rheumatologist and pulmonologist. I followed up with rheumatologist on October 23, 2018, and was not found to have an autoimmune disorder. I followed up with the ER pulmonologist on October 24, 2018, and he ordered a bronchoscopy. On October 31, 2018, I had  bronchoscopy and per Dr., was found to have a influenza vaccine reaction.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pulmonary mass, Red blood cell sedimentation rate increased
Clinical narrative: On October 16, 2018, I received the flu vaccine at Hospital as required by employer. That evening around 10:00pm I developed body aches. From October 17, 2018 to October 22, 2018, I developed severe body aches, rib pain, jaw pain, facial edema, shortness of breath, and night sweats. There was no irritation, swelling, or redness at the injection site. On October 19, 2018, I presented to Express Care Clinic and no definitive diagnosis was given. Symptoms worsened and on October 21, 2018, I presented to Express Care Clinic again. A chest XR was obtained and found to have innumerable pulmonary nodules scattered throughout all four lobes. I was sent to ER. While at ER, many labs were ordered along with chest CT and head CT. Chest CT confirmed innumerable pulmonary nodules indicating sarcoidosis, Wegener's granulmatosis, metastatic disease, or atypical bacterial/fungal infection. While in ER, I was seen by pulmonologist and recommended follow up with rheumatologist and pulmonologist. I followed up with rheumatologist on October 23, 2018, and was not found to have an autoimmune disorder. I followed up with the ER pulmonologist on October 24, 2018, and he ordered a bronchoscopy. On October 31, 2018, I had  bronchoscopy and per Dr., was found to have a influenza vaccine reaction.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Onset of Left Shoulder pain immediately after Flu vaccination. Pain continues at site of injection. Continuation of pain reported to Employee Health Nurse on 11-9-2018. Denied need for Provider evaluation and he is doing Self stretches.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at site of injection.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: 15 Minutes after administration patient noticed redness on their chest, upon further exam redness extended over upper back and shoulder area, patient denied itching, SOB, or other symptoms only the red rash was present. Provider evaluated the patient 0.25 mg BENADRYL IM was administered patient observed for 15 minutes. Rash dissipated no further issues reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain on injected arm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM LASTING 4 DAYS; SWEATING, FEVERISH FOR ONE NIGHT.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave booster dose of flu vaccine before due, was due November 23rd.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: I just want to report that shortly after I received the flu shot I came down with the shingles. Just put my report on file and maybe if you get enough of the same complaint after a while you might start to believe in some sort of connection. What I'm suggesting is the flu shot weakened my immune system causing the shingles to activate.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Moderate redness, one large circle around injection site approx 4" across x7 days. No itching, pain, swelling.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ taken orally, lot # N022173 with expiration date 15-MAR-2019 (dose, strength and frequency) for prophylaxis. No adverse effect reported. The storage temperature of the vaccine was reported as 53.1 degrees Fahrenheit for a time frame of 15 minutes. There was no previous temperature excursion. No product complaint was involved. The call was due to a data logger. This is a non-valid case due to lack of patient identifiers. Follow-up information was received from the Medical assistant on 12-NOV-2018 concerning a 4 months old female patient. On 18-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st October 2018, 5 days after receiving SHINGRIX, the patient experienced red rash, itchy rash and blistery rash. On an unknown date, the outcome of the red rash, itchy rash and blistery rash were not recovered/not resolved. It was unknown if the reporter considered the red rash, itchy rash and blistery rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Around 21st October 2018, the patient experienced a rash that was red and itchy on top of her left ankle. The patient was starting to have blisters on the rash as well.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 60-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced blistery rash and spot-like rash. On an unknown date, the outcome of the blistery rash and spot-like rash were recovered/resolved. It was unknown if the reporter considered the blistery rash and spot-like rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case for the patient. The patient received SHINGRIX in the left deltoid. Within 1 week (reporter was not sure of exact time) the patient developed a rash on his body in a few spots and a rash on his leg that was in a straight line. The patient reported to the reporter that the rash was blister-like and the patient did report the event to his physician. The reporter was not sure if a visit to the physician was required or if the patient just called the physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received SHINGRIX. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that the patient went to the pharmacy but reported back to the physician's office that the vaccine looked dark in color and then after the injection was given, her arm hurt. The physician's office did not give SHINGRIX vaccines at their location and send patients to their retail pharmacy. The confirmation was received from QA team that there was no product quality issue.
Sex: M
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 29-year-old male patient who received DTPa (Reduced antigen) (dTpa vaccine) for an unknown indication. 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 vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the whooping cough was recovered/resolved. It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The whooping cough was resolved after 3 month. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for pertussis, vaccine schedule completion and exact time to onset were unknown.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number L349E, expiry date unknown) for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site hives and fever. On an unknown date, the outcome of the injection site erythema, injection site hives and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site hives and fever to be related to SHINGRIX. Additional details reported as follows: The patient received a dose of SHINGRIX on the left deltoid. Within 4 hours after vaccination, the patient experienced a raised red hives, forming approximately a 2 inch ring around the injection site and a low grade fever of 99.5 degree F. The reporter was given consent for follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Loss of consciousness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 71-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 5th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, 1 days after receiving SHINGRIX, the patient experienced dizziness. In November 2018, the patient experienced passed out (serious criteria GSK medically significant) and injection site pain. On an unknown date, the outcome of the passed out, injection site pain and dizziness were unknown. It was unknown if the reporter considered the passed out, injection site pain and dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The patient received her dose of SHINGRIX, about noon a day before date of reporting. The patient called the office to report that she woke up at about 5am, got out of bed and passed out. The patient also noted local soreness at the site of injection in her deltoid muscle and felt she was too dizzy to drive to the office. The physician directed her to stay home, stay hydrated and rest. The patient consented to be followed up.
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: I received the Senior Flu vaccination Nov. 3rd. Pain began before bed and intensified extremely. Pain may be muscular? All of left shoulder and like a band of pain around upper left arm, to the extreme of being unable to lift my arm from my side. It has eased 9 days following, but pain is still noticeably there.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Altered state of consciousness, Angioedema, Bone pain, Burning sensation, Diplegia
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Disability, Dyspnoea, Dysstasia, Electromyogram abnormal, Eye discharge
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Food allergy, Gluten sensitivity, Injected limb mobility decreased, Injection site granuloma
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Musculoskeletal disorder, Myofascial pain syndrome, Nerve conduction studies abnormal, Nerve degeneration
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Neuralgia, Neuralgic amyotrophy, Neuropathy peripheral, Nuclear magnetic resonance imaging, Pain
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Periorbital swelling, Phrenic nerve paralysis, Posture abnormal, Rash, Rash erythematous
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Reaction to food additive, Secretion discharge, Skin exfoliation, Sleep apnoea syndrome, Spinal pain
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Swelling face, Tetanus, Tinnitus
Clinical narrative: On 9/20/15 I woke up and couldn't lift my right arm. It continued to get worse every day. I got localized tetanus in right arm, brachial plexus neuritis, both my right and left arms were paralyzed with nerve degeneration, severe pain that continues today, chronic fatigue, paralysis of left phrenic nerve, antinuclear antibodies, suffer from severe food allergies now to gluten, MSG, suffer periorbital swelling and angioedema for months at a time - up to 4 months consecutively twice since the TD vaccine with red rash on face and peeling and oozing liquid of skin from face with a chemical burn feeling like face is on fire for months at a time. Constant ringing of ears, running of eyes. Massive severe pain - lost use of right and left arms - massive pain of phrenic nerve with trouble breathing, unable to sit upright or stand upright for longer than 5-10 minutes without coming close to blacking out and seeing stars. My days have been spent doing physical and occupational therapy and chiropractic care. My doctor refused to fill this out and I've been too sick until now to get this filled out. This is a tabled vaccine injury and a direct injury and disability caused from the TD vaccine. I live with paralysis, chronic severe pain, disability, severe food allergies, facial and periorbital swelling, chronic fatigue and sleep apnea. Right axillary neuropathy. Severe bone pain in both forearms and clavicle bones and spine. Have to wear double compression sleeves on both arms. Myofascial pain. Severe denervation on EMG! Large granuloma still at injection site 3 plus years later!
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Started vomiting at 2:30 AM and allowed sleep at 4:00 AM then 8:00 AM got loose stools then somewhat better and in evening had nausea again at bedtime relieved by PEPTO BISMOL.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Immobile, Pain in extremity
Clinical narrative: Immobility and pain of arm, chills and sweating.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Deafness, Ear infection, Eustachian tube disorder, Eustachian tube operation, Pain
Clinical narrative: Recurrent fever, body aches, Upper respiratory, ear, sinus infections, hearing loss and surgery for collapsed Eustachian tube. Required recurrent treatment of antibiotics.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Sinusitis, Upper respiratory tract infection
Clinical narrative: Recurrent fever, body aches, Upper respiratory, ear, sinus infections, hearing loss and surgery for collapsed Eustachian tube. Required recurrent treatment of antibiotics.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient requested pneumonia vaccine, but without verifying the paperwork she filled I gave her FLUARIX vaccine.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Patient experienced pain in the joints and muscles of the right arm the day after the FLUAD was administered.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Diagnostic procedure, Electrocardiogram normal, Fall, Head discomfort, Head injury
Clinical narrative: Shortly after receiving the flu shot while patient was in observation area, patient fell to floor. He was having tonic clonic movement while falling prone and hit head during the fall. EMT's were called. He was placed on his side. Approx 3 seconds he returned to consciousness. BP 100/60, P 60, T 98.9. Redness noted to forehead and c/o discomfort, ice was applied. Patient was aware of place, name and receiving the vaccine. Approx 6:15pm EMT arrived to assess, BP 112/64, P 88, PO2 99%. EMT's stayed with patient until 6:45 and parents took him to Hospital. Hospital stated patient was negative for concussion, they did orthostatic VS, EKG and neuro checks, all normal. He was sent home with parents.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Neurological examination normal, Tonic clonic movements
Clinical narrative: Shortly after receiving the flu shot while patient was in observation area, patient fell to floor. He was having tonic clonic movement while falling prone and hit head during the fall. EMT's were called. He was placed on his side. Approx 3 seconds he returned to consciousness. BP 100/60, P 60, T 98.9. Redness noted to forehead and c/o discomfort, ice was applied. Patient was aware of place, name and receiving the vaccine. Approx 6:15pm EMT arrived to assess, BP 112/64, P 88, PO2 99%. EMT's stayed with patient until 6:45 and parents took him to Hospital. Hospital stated patient was negative for concussion, they did orthostatic VS, EKG and neuro checks, all normal. He was sent home with parents.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram normal, Computerised tomogram head normal, Drug screen negative, Echocardiogram normal, Feeling abnormal
Clinical narrative: 11/7/18 after SHINGRIX #2 she had sore arm and "just didn't feel good" for 1-2 days after which she attributed to the vaccine but was not concerned about. (Patient reported she did not have arm pain or similar feeling of not feeling well after her SHINGRIX #1 vaccination which was given 5/16/18.)  On 11/10/18 patient had apparent (by history & clinical findings) new onset seizure. She was evaluated at  Emergency Room and admitted for evaluation observation 11/10/18-11/11/18. She appeared to have recovered completely without any ongoing symptoms at the time of discharge. Was seen in clinic for follow-up by myself 11/12/18. Patient is aware not able to tell if her seizure is related to the SHINGRIX vaccination for certain but that was the only change she was able to identify prior to the apparent seizure episode.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test increased, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Seizure, Shift to the left
Clinical narrative: 11/7/18 after SHINGRIX #2 she had sore arm and "just didn't feel good" for 1-2 days after which she attributed to the vaccine but was not concerned about. (Patient reported she did not have arm pain or similar feeling of not feeling well after her SHINGRIX #1 vaccination which was given 5/16/18.)  On 11/10/18 patient had apparent (by history & clinical findings) new onset seizure. She was evaluated at  Emergency Room and admitted for evaluation observation 11/10/18-11/11/18. She appeared to have recovered completely without any ongoing symptoms at the time of discharge. Was seen in clinic for follow-up by myself 11/12/18. Patient is aware not able to tell if her seizure is related to the SHINGRIX vaccination for certain but that was the only change she was able to identify prior to the apparent seizure episode.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Troponin increased, White blood cell count increased
Clinical narrative: 11/7/18 after SHINGRIX #2 she had sore arm and "just didn't feel good" for 1-2 days after which she attributed to the vaccine but was not concerned about. (Patient reported she did not have arm pain or similar feeling of not feeling well after her SHINGRIX #1 vaccination which was given 5/16/18.)  On 11/10/18 patient had apparent (by history & clinical findings) new onset seizure. She was evaluated at  Emergency Room and admitted for evaluation observation 11/10/18-11/11/18. She appeared to have recovered completely without any ongoing symptoms at the time of discharge. Was seen in clinic for follow-up by myself 11/12/18. Patient is aware not able to tell if her seizure is related to the SHINGRIX vaccination for certain but that was the only change she was able to identify prior to the apparent seizure episode.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Shortly after vaccination, patient became itchy on arms, neck, back and legs. No hives or swelling noted. No difficulty breathing. 5:45 pm 50 mg BENADRYL given with good effect. 5:48 pm BP 142/96, P 84. 6:02 p, BP 142/80, P 82. after approx 30 mins, patient was feeling better and left for home with daughter at 6:15pm.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Pulse absent, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Several hours after vaccine was administered, Mother found child unresponsive, not breathing and without pulse. Child taken to medical center via EMT. Other circumstances, Child was sleeping and mother stated found child blue with a teddy bear.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Lip swelling
Clinical narrative: Red face, swollen lips.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered FLUCELVAX and it's for patients 4 years old and up. Patient was 2 years old and 10 months at time of administration. No adverse event. Patient has no complaints.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Took first VIVOTIF on Monday morning 11/5/18. Took at 7 AM on empty stomach with cold water and didn't eat for over an hour. Began experiencing nausea at 1 PM. Vomited 1 time and diarrhea 2 times between 3 and 5 pm. No side effects next day. Nausea only on Wednesday after 2nd pill, consumed very little food. Thursday no side effects. Friday took 3rd pill - nausea began around noon and worsened throughout afternoon. Diarrhea 2 times early evening. Saturday (no pill) experienced diarrhea 6 plus times late morning to early afternoon. Sunday took last pill - no side effects. On days with side effects ate only CHEERIOS, noodle soup, saltines, bananas, and ginger ale.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: I had my second SHINGRIX injection at lunchtime on 11-9-18 (had first one on 8-14-18). The injection itself was quite painful and felt as though it even went in so deep it hit my bone! I have redness and pain at the injection site that started on 11-10-18. About 2:00 AM on the 10th I awoke feeling ill, with a fever of 101, chills, headache, severe body muscle aches, nausea and generally feeling poorly. The fever and chills and nausea lasted for 24 hours but the headache and body aches for 48 hours, and then I developed diarrhea on 11-11-18 which only lasted a few hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: I had my second SHINGRIX injection at lunchtime on 11-9-18 (had first one on 8-14-18). The injection itself was quite painful and felt as though it even went in so deep it hit my bone! I have redness and pain at the injection site that started on 11-10-18. About 2:00 AM on the 10th I awoke feeling ill, with a fever of 101, chills, headache, severe body muscle aches, nausea and generally feeling poorly. The fever and chills and nausea lasted for 24 hours but the headache and body aches for 48 hours, and then I developed diarrhea on 11-11-18 which only lasted a few hours.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pyrexia, Rash macular
Clinical narrative: Pt. received FLUZONE HD on 11/06/2018. The following day the patient experienced typical injection site reaction in addition to fever. She then developed a blotchy rash on her back and legs.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Nausea, Visual acuity tests abnormal, Visual impairment
Clinical narrative: My son is fully vaccinated and has never had an adverse reaction to vaccines before. After having the GARDASIL vaccine, he reported feelings of dizziness, foggy brain, nausea, and vision problems. We had the family vision tested prior to this vaccine and he tested 20/20 in August. We had his vision retested after his complaints and he now tests at 20/80, 2 months later after receiving GARDASIL vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Diffuse itchy rash - torso, arms, legs.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced fever, muscle pain, feeling cold and headache. On an unknown date, the outcome of the fever, muscle pain, feeling cold and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, feeling cold and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows. The reporter was the son of the patient. He did not know for sure if his dad (patient) had the a dose of SHINGRIX 2 or 3 days before the time of reporting. The patient started experiencing symptoms and had not recovered till the time of reporting. The patient did not know when the symptoms started. The patient also received the flu vaccine on the same day as having the dose of SHINGRIX. The reporter did not know the brand of the flu vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of herpes zoster 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, 21 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Approximately 3 weeks after receiving SHINGRIX, the patient experienced herpes zoster on chin. The patient's initials and date of birth was unknown. The nurse agreed to receive follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. On an unknown date, the outcome of the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset were unknown. It was unknown if the reporter considered the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Within an hour after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. The physician agreed to receive follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. On an unknown date, the outcome of the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset were unknown. It was unknown if the reporter considered the myalgia, fatigue, headache, shivering, fever and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Within an hour after receiving SHINGRIX, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal upset. The physician agreed to receive follow up from GSK.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of 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 recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for his staff member. The age at vaccination was not reported. The patient experienced flu like symptoms which impacted him for a few days. The patient stated that he would be receiving the second dose of SHINGRIX. The reporter did not agree to be followed up. This is 1 of the 6 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of 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 recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for his staff member. The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient experienced flu like symptoms which impacted the patient for a few days. The reporter did not agree to be followed up. This is 1 of the 6 cases reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Herpes zoster, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 26th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills. On an unknown date, the outcome of the pain in arm, erythema, shingles, fever, pruritus, tingling and chills were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced tingling in lower hip. The reporter did not consent to follow-up. The reporter did not give permission to contact physician.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 26th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills. On an unknown date, the outcome of the pain in arm, erythema, shingles, fever, pruritus, tingling and chills were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced tingling in lower hip. The reporter did not consent to follow-up. The reporter did not give permission to contact physician.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and induration. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the induration was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and induration to be related to SHINGRIX. Additional details were reported as follows: The patient experienced sore around the injection site, big red patch, warm to touch even after 10 days. On the reporting date the physician had been contacted again and reported that the patient experienced induration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and feeling unwell. On an unknown date, the outcome of the chills and feeling unwell were unknown. It was unknown if the reporter considered the chills and feeling unwell to be related to SHINGRIX. Additional details reported as follows: The patient experienced chills and had not feeling well, that began from the night of the vaccination. At the time of reporting, the patient could not locate the 2nd dose of SHINGRIX. The patient asked about that, need to get a 2nd dose. The reporter referred to her physician. The call center representative not asked about health care provider. The reporter requested to end this call, she had to go.