chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Urticaria
Clinical narrative: 11/1/18 AM TC from client who states that approx at 2 PM on 10/31/18 client experienced fatigue and an itchy sensation all over her body eps. the arms and back that lasted into the evening. Client states both arms where she received the vaccinations felt heavy and achey and didn't notice any redness or swelling. Client states approx 9:30 AM on 11/1/18 she developed a hive on her face. Client states her husband gave her some CALADRYL cream to put on her face. Client states she has a developed an additional hive behind her ear. Client reports no respiratory Sx or fever. Instructed client to contact her health care provider ASAP for an evaluation and PHN will call client this afternoon to assess her status. 11/1/18 PM TC from client. Client states she saw her PCP and was given Famotidine (antihistamine), hydroxyzine for itching and ice packs for hives. Client states her PCP does not know what caused the reaction. PHN to contact client next week to see if Sx have resolved. 11/8/18 TC to client. Client states that she is better but still experiencing some episodic itchiness and minor rashes in her hairline, on her cheek and on her left shoulder. Client denies having a latex allergy. Advised client that it would be recommended she be evaluated by an allergist and to have her next Hep A and Hep B vaccination done thru an allergist. Client agreed to do this. PHN contacted allergist Dr.'s office and spoke with her nurse. Dr.'s nurse arranged with client two appointments on 12/3/18 and 12/12/18 for client to be evaluated, allergy tested and to have single antigen Hep A and Hep B vaccinations administered. 11/28/18 TC to client. Client states that her symptoms resolved.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Tremor
Clinical narrative: Patient reports that following SHINGRIX vaccination, besides the initial soreness, between midnight and 1 AM following the vaccination, he experienced shivers and shaking. He reported taking a shower to warm up, and thereafter symptoms resolved. He denies any fever.
Age: 61.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Fall, Seizure
Clinical narrative: Flu shot given in R arm no problem. PREVNAR 13 in left arm, patient fell ground and had partial seizure for 30 seconds then woke up. Gave orange juice made patient sit for half hour, and patient wife drive home.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Injection site swelling
Clinical narrative: Swollen, sore at injection site and upper back.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient received Hepatitis B vaccine on 11/20/2018: Left Deltoid IM. States she broke to in Rash present on Chest/Forehead, woke up to itchy Chest w/ rash on 11/25/2018, when she first noticed Rash. No other Sx. Patient came back to office on 11/26/2018 for MMRR#1, patient didn't disclosed that she was having a rash break out at time of visit. MMR#1 was administered, with no complications or new symptoms. Patient states she has very sensitive skin, not sure if food, dairy, or contact.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness 13cm x 14cm at site of injection.
Age: 81.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: His (R) arm became swollen and painful and red. Also developed a fever. It was a few hours after the symptoms began.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Tremor
Clinical narrative: Approx 15 minutes after getting vaccines, the patient kicked the MA to get her attention. He kicked twice - when she looked his legs were shaking. Then his arms shook. He closed his eyes for 1 second. Then he returned to normal.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient has struggled with infertility for 2 plus years. She reported on the day of the vaccination that she was 3 months pregnant with twins. Patient stated that on the day following the vaccination, she was on an international flight when she miscarried the twins.
Age: 67.0
Sex: M
Vaccine: VARZOS, FLU4
Symptoms: Feeling hot, Injection site pain, Night sweats
Clinical narrative: Shoulder joint very sore. Muscle soreness for a few days but shoulder ache and soreness continued and is not getting better. Have not been able to sleep on left side since receiving the shot. Hurts on its on and hurts to move it. The joint itself hurts. No pain in the right side and I don't have arthritis anywhere else. If I roll over in my sleep to my left side the pain will wake me up and I have to roll back over.
Age: 67.0
Sex: M
Vaccine: VARZOS, FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia
Clinical narrative: Shoulder joint very sore. Muscle soreness for a few days but shoulder ache and soreness continued and is not getting better. Have not been able to sleep on left side since receiving the shot. Hurts on its on and hurts to move it. The joint itself hurts. No pain in the right side and I don't have arthritis anywhere else. If I roll over in my sleep to my left side the pain will wake me up and I have to roll back over.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Bacterial test negative, Guillain-Barre syndrome, Neurological examination abnormal, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Patient was admitted with bilateral weakness in her arms and legs which progressed to paralysis. She was diagnosed with Guillain Barre syndrome and was in the medical intensive care unit for 29 days (10/19/18-11/17/18) where she went into respiratory failure secondary to muscle paralysis and required intubation. She has been in inpatient rehab since 11/17/18 and now has a tracheostomy and voice box and is slowly regaining motor function back but is unable to walk at this time.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Viral test negative
Clinical narrative: Patient was admitted with bilateral weakness in her arms and legs which progressed to paralysis. She was diagnosed with Guillain Barre syndrome and was in the medical intensive care unit for 29 days (10/19/18-11/17/18) where she went into respiratory failure secondary to muscle paralysis and required intubation. She has been in inpatient rehab since 11/17/18 and now has a tracheostomy and voice box and is slowly regaining motor function back but is unable to walk at this time.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Intensive care, Medical device implantation
Clinical narrative: Patient was admitted with bilateral weakness in her arms and legs which progressed to paralysis. She was diagnosed with Guillain Barre syndrome and was in the medical intensive care unit for 29 days (10/19/18-11/17/18) where she went into respiratory failure secondary to muscle paralysis and required intubation. She has been in inpatient rehab since 11/17/18 and now has a tracheostomy and voice box and is slowly regaining motor function back but is unable to walk at this time.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUR4
Symptoms: Motor dysfunction, Muscular weakness, Paralysis, Respiratory failure, Tracheostomy
Clinical narrative: Patient was admitted with bilateral weakness in her arms and legs which progressed to paralysis. She was diagnosed with Guillain Barre syndrome and was in the medical intensive care unit for 29 days (10/19/18-11/17/18) where she went into respiratory failure secondary to muscle paralysis and required intubation. She has been in inpatient rehab since 11/17/18 and now has a tracheostomy and voice box and is slowly regaining motor function back but is unable to walk at this time.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Biopsy skin, Musculoskeletal pain, Rash generalised, Wheezing
Clinical narrative: Systemic reaction. Rash to arms, legs, arms, back and trunk. Breathing difficulty. Multiple trips to urgent care. Received prednisone, benedryl, hydrozyzine.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised
Clinical narrative: Systemic reaction. Rash to arms, legs, arms, back and trunk. Breathing difficulty. Multiple trips to urgent care. Received prednisone, benedryl, hydrozyzine.
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, injection site erythema and injection site pain. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the fever, injection site erythema and injection site pain were recovered/resolved. The reporter considered the fever, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient developed a 102.9 degree F fever and redness and pain at the injection site in her right upper arm. This case was not associated with product quality complaint.
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, injection site erythema and injection site pain. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the fever, injection site erythema and injection site pain were recovered/resolved. The reporter considered the fever, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient developed a 102.9 degree F fever and redness and pain at the injection site in her right upper arm. This case was not associated with product quality complaint.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Feeding disorder, Hyperhidrosis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 10th November 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced abdominal cramp, explosive diarrhea, appetite absent and fluid loss. In November 2018, the patient experienced chills, blood pressure decreased, injection site swelling, injection site erythema, injection site warmth, injection site tenderness and sweating. In November 2018, the outcome of the abdominal cramp and explosive diarrhea were recovered/resolved. On an unknown date, the outcome of the chills, appetite absent, injection site swelling, injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved and the outcome of the blood pressure decreased, fluid loss and sweating were unknown. The reporter considered the chills, abdominal cramp, explosive diarrhea, blood pressure decreased, appetite absent, injection site swelling, injection site erythema, injection site warmth, injection site tenderness, fluid loss and sweating to be related to SHINGRIX. Additional details were received as follows: At 12 noon, the patient received SHINGRIX vaccine right deltoid in pharmacy and in initial 12 hours the patient was fine and then he experienced severe chills and sweating. For 36 hours he had severe abdominal cramping with severe projectile diarrhea for hours. The cramping lasted for the next two days. The day before reporting, the patient left his dental practice and went to his physician his physician believes that his symptoms are related to the vaccination. He reported that his blood pressure went down to 100/60 because of a loss of fluids and his chills are still occurring on and off as well as his cramps. The patient had no appetite and no interest in eating. The patient was presented with the injection site was raised 3 inches around the injection site and was red in color and it is warm to the touch. The reporter did not have batch number and could be follow up with pharmacy for details. The physician had not eaten in two days due to the ill effects he had been experiencing. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 10th November 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced abdominal cramp, explosive diarrhea, appetite absent and fluid loss. In November 2018, the patient experienced chills, blood pressure decreased, injection site swelling, injection site erythema, injection site warmth, injection site tenderness and sweating. In November 2018, the outcome of the abdominal cramp and explosive diarrhea were recovered/resolved. On an unknown date, the outcome of the chills, appetite absent, injection site swelling, injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved and the outcome of the blood pressure decreased, fluid loss and sweating were unknown. The reporter considered the chills, abdominal cramp, explosive diarrhea, blood pressure decreased, appetite absent, injection site swelling, injection site erythema, injection site warmth, injection site tenderness, fluid loss and sweating to be related to SHINGRIX. Additional details were received as follows: At 12 noon, the patient received SHINGRIX vaccine right deltoid in pharmacy and in initial 12 hours the patient was fine and then he experienced severe chills and sweating. For 36 hours he had severe abdominal cramping with severe projectile diarrhea for hours. The cramping lasted for the next two days. The day before reporting, the patient left his dental practice and went to his physician his physician believes that his symptoms are related to the vaccination. He reported that his blood pressure went down to 100/60 because of a loss of fluids and his chills are still occurring on and off as well as his cramps. The patient had no appetite and no interest in eating. The patient was presented with the injection site was raised 3 inches around the injection site and was red in color and it is warm to the touch. The reporter did not have batch number and could be follow up with pharmacy for details. The physician had not eaten in two days due to the ill effects he had been experiencing. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Blood pressure decreased, Chills, Decreased appetite, Dehydration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 10th November 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced abdominal cramp, explosive diarrhea, appetite absent and fluid loss. In November 2018, the patient experienced chills, blood pressure decreased, injection site swelling, injection site erythema, injection site warmth, injection site tenderness and sweating. In November 2018, the outcome of the abdominal cramp and explosive diarrhea were recovered/resolved. On an unknown date, the outcome of the chills, appetite absent, injection site swelling, injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved and the outcome of the blood pressure decreased, fluid loss and sweating were unknown. The reporter considered the chills, abdominal cramp, explosive diarrhea, blood pressure decreased, appetite absent, injection site swelling, injection site erythema, injection site warmth, injection site tenderness, fluid loss and sweating to be related to SHINGRIX. Additional details were received as follows: At 12 noon, the patient received SHINGRIX vaccine right deltoid in pharmacy and in initial 12 hours the patient was fine and then he experienced severe chills and sweating. For 36 hours he had severe abdominal cramping with severe projectile diarrhea for hours. The cramping lasted for the next two days. The day before reporting, the patient left his dental practice and went to his physician his physician believes that his symptoms are related to the vaccination. He reported that his blood pressure went down to 100/60 because of a loss of fluids and his chills are still occurring on and off as well as his cramps. The patient had no appetite and no interest in eating. The patient was presented with the injection site was raised 3 inches around the injection site and was red in color and it is warm to the touch. The reporter did not have batch number and could be follow up with pharmacy for details. The physician had not eaten in two days due to the ill effects he had been experiencing. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 10th November 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced abdominal cramp, explosive diarrhea, appetite absent and fluid loss. In November 2018, the patient experienced chills, blood pressure decreased, injection site swelling, injection site erythema, injection site warmth, injection site tenderness and sweating. In November 2018, the outcome of the abdominal cramp and explosive diarrhea were recovered/resolved. On an unknown date, the outcome of the chills, appetite absent, injection site swelling, injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved and the outcome of the blood pressure decreased, fluid loss and sweating were unknown. The reporter considered the chills, abdominal cramp, explosive diarrhea, blood pressure decreased, appetite absent, injection site swelling, injection site erythema, injection site warmth, injection site tenderness, fluid loss and sweating to be related to SHINGRIX. Additional details were received as follows: At 12 noon, the patient received SHINGRIX vaccine right deltoid in pharmacy and in initial 12 hours the patient was fine and then he experienced severe chills and sweating. For 36 hours he had severe abdominal cramping with severe projectile diarrhea for hours. The cramping lasted for the next two days. The day before reporting, the patient left his dental practice and went to his physician his physician believes that his symptoms are related to the vaccination. He reported that his blood pressure went down to 100/60 because of a loss of fluids and his chills are still occurring on and off as well as his cramps. The patient had no appetite and no interest in eating. The patient was presented with the injection site was raised 3 inches around the injection site and was red in color and it is warm to the touch. The reporter did not have batch number and could be follow up with pharmacy for details. The physician had not eaten in two days due to the ill effects he had been experiencing. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 10th November 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced abdominal cramp, explosive diarrhea, appetite absent and fluid loss. In November 2018, the patient experienced chills, blood pressure decreased, injection site swelling, injection site erythema, injection site warmth, injection site tenderness and sweating. In November 2018, the outcome of the abdominal cramp and explosive diarrhea were recovered/resolved. On an unknown date, the outcome of the chills, appetite absent, injection site swelling, injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved and the outcome of the blood pressure decreased, fluid loss and sweating were unknown. The reporter considered the chills, abdominal cramp, explosive diarrhea, blood pressure decreased, appetite absent, injection site swelling, injection site erythema, injection site warmth, injection site tenderness, fluid loss and sweating to be related to SHINGRIX. Additional details were received as follows: At 12 noon, the patient received SHINGRIX vaccine right deltoid in pharmacy and in initial 12 hours the patient was fine and then he experienced severe chills and sweating. For 36 hours he had severe abdominal cramping with severe projectile diarrhea for hours. The cramping lasted for the next two days. The day before reporting, the patient left his dental practice and went to his physician his physician believes that his symptoms are related to the vaccination. He reported that his blood pressure went down to 100/60 because of a loss of fluids and his chills are still occurring on and off as well as his cramps. The patient had no appetite and no interest in eating. The patient was presented with the injection site was raised 3 inches around the injection site and was red in color and it is warm to the touch. The reporter did not have batch number and could be follow up with pharmacy for details. The physician had not eaten in two days due to the ill effects he had been experiencing. The contact details of the physician was provided.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced localized erythema, weakness, sweating, influenza-like symptoms and fever. In August 2018, the outcome of the localized erythema, weakness, sweating and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the localized erythema, weakness, sweating, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was reported as follows: On 12th or 13th August 2018, the patient received a dose of SHINGRIX. Twenty-four hours after receiving SHINGRIX, the patient experienced red dots on her chest and shoulder, felt weak, had fever, loss of energy, sweating and also experienced flu like symptoms. All the events experienced by the patient lasted for a period of two weeks, except fever, the patient did not remember for long fever had lasted. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced localized erythema, weakness, sweating, influenza-like symptoms and fever. In August 2018, the outcome of the localized erythema, weakness, sweating and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the localized erythema, weakness, sweating, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was reported as follows: On 12th or 13th August 2018, the patient received a dose of SHINGRIX. Twenty-four hours after receiving SHINGRIX, the patient experienced red dots on her chest and shoulder, felt weak, had fever, loss of energy, sweating and also experienced flu like symptoms. All the events experienced by the patient lasted for a period of two weeks, except fever, the patient did not remember for long fever had lasted. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced localized erythema, weakness, sweating, influenza-like symptoms and fever. In August 2018, the outcome of the localized erythema, weakness, sweating and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the localized erythema, weakness, sweating, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was reported as follows: On 12th or 13th August 2018, the patient received a dose of SHINGRIX. Twenty-four hours after receiving SHINGRIX, the patient experienced red dots on her chest and shoulder, felt weak, had fever, loss of energy, sweating and also experienced flu like symptoms. All the events experienced by the patient lasted for a period of two weeks, except fever, the patient did not remember for long fever had lasted. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced localized erythema, weakness, sweating, influenza-like symptoms and fever. In August 2018, the outcome of the localized erythema, weakness, sweating and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the localized erythema, weakness, sweating, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was reported as follows: On 12th or 13th August 2018, the patient received a dose of SHINGRIX. Twenty-four hours after receiving SHINGRIX, the patient experienced red dots on her chest and shoulder, felt weak, had fever, loss of energy, sweating and also experienced flu like symptoms. All the events experienced by the patient lasted for a period of two weeks, except fever, the patient did not remember for long fever had lasted. The reporter gave consent to follow up.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Effusion, Inflammation, Joint range of motion decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 46 years old female patient who experienced intense pain, left shoulder pain, mobility problem, can't lift or grab above my head and has limited use of left arm and cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient never had previous orthopedic issues in that arm or shoulder and has been a vision of health up till now. Patient was on oral contraceptive for migraines but not pregnant. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ034AD via unknown route in the left arm. On an unknown date, patient developed a non-serious intense pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious left shoulder pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious mobility problem, can't lift or grab above my head and has limited use of left arm following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She visited orthopedic surgeon. (Other relevant tests included NO lab test.) Final diagnosis was cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, mobility problem, can't lift or grab above my head and has limited use of left arm, left shoulder pain and intense pain. Patient took Ibuprofen as corrective treatment. The patient outcome is reported as Unknown for intense pain, as Unknown for left shoulder pain, as Unknown for mobility problem, can't lift or grab above my head and has limited use of left arm and as Unknown for cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 46 years old female patient who experienced intense pain, left shoulder pain, mobility problem, can't lift or grab above my head and has limited use of left arm and cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient never had previous orthopedic issues in that arm or shoulder and has been a vision of health up till now. Patient was on oral contraceptive for migraines but not pregnant. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ034AD via unknown route in the left arm. On an unknown date, patient developed a non-serious intense pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious left shoulder pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious mobility problem, can't lift or grab above my head and has limited use of left arm following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She visited orthopedic surgeon. (Other relevant tests included NO lab test.) Final diagnosis was cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, mobility problem, can't lift or grab above my head and has limited use of left arm, left shoulder pain and intense pain. Patient took Ibuprofen as corrective treatment. The patient outcome is reported as Unknown for intense pain, as Unknown for left shoulder pain, as Unknown for mobility problem, can't lift or grab above my head and has limited use of left arm and as Unknown for cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 46 years old female patient who experienced intense pain, left shoulder pain, mobility problem, can't lift or grab above my head and has limited use of left arm and cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient never had previous orthopedic issues in that arm or shoulder and has been a vision of health up till now. Patient was on oral contraceptive for migraines but not pregnant. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ034AD via unknown route in the left arm. On an unknown date, patient developed a non-serious intense pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious left shoulder pain following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious mobility problem, can't lift or grab above my head and has limited use of left arm following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date patient developed a non-serious cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up following the administration of INFLUENZA QUADRIVAL A-B VACCINE. She visited orthopedic surgeon. (Other relevant tests included NO lab test.) Final diagnosis was cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up, mobility problem, can't lift or grab above my head and has limited use of left arm, left shoulder pain and intense pain. Patient took Ibuprofen as corrective treatment. The patient outcome is reported as Unknown for intense pain, as Unknown for left shoulder pain, as Unknown for mobility problem, can't lift or grab above my head and has limited use of left arm and as Unknown for cannot sleep on affected side, waking up at 5-6am every morning due to pain that wakes her up.
Age: 15.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Breath sounds abnormal, Electroencephalogram normal, Fall, Feeling abnormal, Laboratory test normal
Clinical narrative: On Wednesday, Nov, 7, 2018 at approximately 5pm my daughter received her Flu shot. The following day she was not feeling herself so she stayed home from school. On Friday Nov, 9, 2018 at approximately 1pm she had a seizure at school. As described by the teacher, it lasted approximately a min and a half, then followed by a period of deep sleep and snoring. She was then taken to Hospital for observation. Blood test were taken, and she was referred to an Neurologist for further testing. On Tuesday, Nov, 13, 2018 she had her first appointment at the Neurologist center where they did an EEG and scheduled her for an MRI, on the following day, Nov, 14th. All test have come back negative. She has never had any problems with epileptic Seizure nor has she had any major health problems.
Age: 15.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: On Wednesday, Nov, 7, 2018 at approximately 5pm my daughter received her Flu shot. The following day she was not feeling herself so she stayed home from school. On Friday Nov, 9, 2018 at approximately 1pm she had a seizure at school. As described by the teacher, it lasted approximately a min and a half, then followed by a period of deep sleep and snoring. She was then taken to Hospital for observation. Blood test were taken, and she was referred to an Neurologist for further testing. On Tuesday, Nov, 13, 2018 she had her first appointment at the Neurologist center where they did an EEG and scheduled her for an MRI, on the following day, Nov, 14th. All test have come back negative. She has never had any problems with epileptic Seizure nor has she had any major health problems.
Age: 15.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Blood test normal, Electroencephalogram normal, Feeling abnormal, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging normal
Clinical narrative: On Wednesday, Nov, 7, 2018 at approximately 5pm my daughter received her Flu shot. The following day she was not feeling herself so she stayed home from school. On Friday Nov, 9, 2018 at approximately 1pm she had a seizure at school. As described by the teacher, it lasted approximately a min and a half, then followed by a period of deep sleep and snoring. She was then taken to Hospital for observation. Blood test were taken, and she was referred to an Neurologist for further testing. On Tuesday, Nov, 13, 2018 she had her first appointment at the Neurologist center where they did an EEG and scheduled her for an MRI, on the following day, Nov, 14th. All test have come back negative. She has never had any problems with epileptic Seizure nor has she had any major health problems.
Age: 15.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Seizure, Snoring
Clinical narrative: On Wednesday, Nov, 7, 2018 at approximately 5pm my daughter received her Flu shot. The following day she was not feeling herself so she stayed home from school. On Friday Nov, 9, 2018 at approximately 1pm she had a seizure at school. As described by the teacher, it lasted approximately a min and a half, then followed by a period of deep sleep and snoring. She was then taken to Hospital for observation. Blood test were taken, and she was referred to an Neurologist for further testing. On Tuesday, Nov, 13, 2018 she had her first appointment at the Neurologist center where they did an EEG and scheduled her for an MRI, on the following day, Nov, 14th. All test have come back negative. She has never had any problems with epileptic Seizure nor has she had any major health problems.
Age: 15.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Seizure
Clinical narrative: On Wednesday, Nov, 7, 2018 at approximately 5pm my daughter received her Flu shot. The following day she was not feeling herself so she stayed home from school. On Friday Nov, 9, 2018 at approximately 1pm she had a seizure at school. As described by the teacher, it lasted approximately a min and a half, then followed by a period of deep sleep and snoring. She was then taken to Hospital for observation. Blood test were taken, and she was referred to an Neurologist for further testing. On Tuesday, Nov, 13, 2018 she had her first appointment at the Neurologist center where they did an EEG and scheduled her for an MRI, on the following day, Nov, 14th. All test have come back negative. She has never had any problems with epileptic Seizure nor has she had any major health problems.
Age: 57.0
Sex: M
Vaccine: MMRV, VARZOS
Symptoms: Dizziness, Euphoric mood, Feeling drunk, Impaired work ability, Somnolence
Clinical narrative: Was lightheaded, felt like I was drunk or high for 3 days, should not have been driving to and from work. Felt like sleeping all day. Could not go to work for a day and a half.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Supraventricular tachycardia
Clinical narrative: Tdap vaccine while pregnant, due date Jan 25th 2019. Developed SVT, heart rate of 200 several hours after the vaccine. Went to ER, where I got medication to bring my heart rate back to normal. No history of anything like this before.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain, Pyrexia, Tremor
Clinical narrative: 13 hours later i began to shake uncontrollably for about 15-20 minutes. Shivering, very cold, seemed like a fever. 7 hours after that my whole body aches, but no shivering.
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: This spontaneous case was received from a consumer regarding her daughter, a non-pregnant female patient of unknown age. The patient's concurrent conditions historical conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with GARDASIL (strength, dosage, route, lot number and expiration date were not reported) for prophylaxis. On unknown date, after the vaccination, the patient started experiencing infertility. The outcome of the event was reported as not resolved. Although the reporter stated that she read online that GARDASIL caused infertility. The causality assessment between the suspect therapy and the event was not reported. This is one of two cases received from the same reporter captured in (MARRS # 1811USA011585). Sender's Comments: US-009507513-1811USA011585.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLUX, MMR, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a physician via a company employee referring to a 4 year old female patient. The patient's pertinent medical history and drug reactions/allergies were unknown by reporter. Concomitant therapies included a dose of poliovirus vaccine inactivated (unspecified), a dose of hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis vaccine (unspecified), a dose of tetanus toxoid and influenza virus vaccine (unspecified) on 19-OCT-2018. On 19-OCT-2018, the patient was vaccinated with a dose of VARIVAX (route, strength, batch/lot # and expiration date were not reported) and a dose of M-M-R II (route, strength, batch/lot # and expiration date were not reported) for prophylaxis. The physician reported that the patient's mother called the office on 02-NOV-2018 and reported that the patient "had a varicella like rash" and "sent a picture". The physician reported that "he diagnosed it as varicella and prescribed BENADRYL elixir 5ml 2 to 3 times a day". The outcome of varicella was unknown. The causality was not reported.
Sex: F
Vaccine: PPV
Symptoms: Headache, Immediate post-injection reaction, Injection site haemorrhage, Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist, referring to a 55 year old female patient with diabetes. Information about medical history and concomitant therapy was unknown. On 11-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (0.5ml, lot # R011632, expiration date 02-FEB-2020; strength and frequency were unknown) intramuscular (reported as in the vasculature) for prophylaxis (reported as inoculate against pneumococcal). On the same day, immediately after withdrawing the needle, the patient bled 1-5 milliliters of blood for 30 seconds before clotting. The pharmacist reported concern whether inadvertently piercing a vessel (it was also reported as the patient experienced bleeding more than what the pharmacist would normally expect so she thought the vaccine might have been inadvertently administered into the vasculature) (vascular injury and incorrect route of product administration). On 12-NOV-2018, the patient experienced fever, headache and vomiting. The vaccine was administered per pharmacy standing order and not at the specific recommendation of the patient's physician. The outcome of bleeding, vomiting, headache, fever and vascular injury was unknown. The causality assessment was not provided by the reporter.
Age: 2.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Choking, Cyanosis, Electrocardiogram, Lethargy, Pallor
Clinical narrative: This spontaneous report was received by a physician referring to a 2 years old female patient. The patient's concurrent conditions included asthma, allergies and low blood immunoglobulin A (IGA). The patient's concomitant medications included an unspecified inhaler. The patient did not have any known drug reactions/allergies. In October 2015, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not reported) for low pneumococcal titers as prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The patient received concomitantly an unspecified flu vaccine with the administration of PNEUMOVAX 23. Immediately after administration of PNEUMOVAX 23 the patient seemed pale, became lethargic and then vomited. The patient was taken to the emergency room where she subsequently choked on a fruit snack which resulted in her lips turning blue until the fruit snack was able to be dislodged. It was reported the patient received treatment for the above mentioned adverse events. Also an X-Ray and an electrocardiogram were performed (results not available). At the reporting time, the patient had recovered from the above mentioned events. The causality assessment between the suspect vaccines and the above mentioned events was not reported.
Age: 2.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vomiting, X-ray
Clinical narrative: This spontaneous report was received by a physician referring to a 2 years old female patient. The patient's concurrent conditions included asthma, allergies and low blood immunoglobulin A (IGA). The patient's concomitant medications included an unspecified inhaler. The patient did not have any known drug reactions/allergies. In October 2015, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not reported) for low pneumococcal titers as prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The patient received concomitantly an unspecified flu vaccine with the administration of PNEUMOVAX 23. Immediately after administration of PNEUMOVAX 23 the patient seemed pale, became lethargic and then vomited. The patient was taken to the emergency room where she subsequently choked on a fruit snack which resulted in her lips turning blue until the fruit snack was able to be dislodged. It was reported the patient received treatment for the above mentioned adverse events. Also an X-Ray and an electrocardiogram were performed (results not available). At the reporting time, the patient had recovered from the above mentioned events. The causality assessment between the suspect vaccines and the above mentioned events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated improperly stored dose of PROQUAD (therapy type rHA) (lot # R015742 with expiry date of 02-DEC-2019) subcutaneously for prophylaxis. It was reported that, data logger was in use but it did not alarm and excursion was discovered later. No adverse effects were reported. The vaccine was stored at the temperature of 6 Fahrenheit to 14 Fahrenheit (5.9 Fahrenheit) for 20 minutes. No previous temperature excursion was reported. The call was due to data logger. No product quality complaint was filed.