chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Decreased appetite, Pyrexia
Clinical narrative: Decreased appetite, possibly dehydrated, cough, fever. Ibuprofen and Acetaminophen. Shot administered on 7/21 and symptoms started to appear on 7/22.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Dizziness
Clinical narrative: Dizzy, faint, joint pain and stiffness, nausea, weakness, fatigue, chills, fever, confusion, headache.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Joint stiffness, Nausea, Pyrexia
Clinical narrative: Dizzy, faint, joint pain and stiffness, nausea, weakness, fatigue, chills, fever, confusion, headache.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Dizzy, faint, joint pain and stiffness, nausea, weakness, fatigue, chills, fever, confusion, headache.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: General fatigue, soreness at injection site.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Bacterial test negative, Chest X-ray normal, Chills, Electrocardiogram normal
Clinical narrative: Chills, fatigue, body aches, high grade fever (103.7), swollen lymph node in left armpit (3 inches in length), night sweats, lower back pain, headache.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Full blood count normal, Headache, Lymphadenopathy, Night sweats
Clinical narrative: Chills, fatigue, body aches, high grade fever (103.7), swollen lymph node in left armpit (3 inches in length), night sweats, lower back pain, headache.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Viral test negative
Clinical narrative: Chills, fatigue, body aches, high grade fever (103.7), swollen lymph node in left armpit (3 inches in length), night sweats, lower back pain, headache.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Limb mass, Pain in extremity, Pallor
Clinical narrative: Fever, stomach pain, diarrhea, pale, sore arm, lump in arm. This evidently happened with 1st, but never reported by Mom.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Fever, stomach pain, diarrhea, pale, sore arm, lump in arm. This evidently happened with 1st, but never reported by Mom.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received an adult dose of vaccine and should have received an adolescent dose.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: B/P 100/50. C/O "head feels funny", like a headache after HPV given. C/O dizziness, pale after vaccines "I feel tired and weak". About 4p-4:30pm symptoms lessened then was sent home encouraged meal and increased fluids and rest, mother to observe closely.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: B/P 100/50. C/O "head feels funny", like a headache after HPV given. C/O dizziness, pale after vaccines "I feel tired and weak". About 4p-4:30pm symptoms lessened then was sent home encouraged meal and increased fluids and rest, mother to observe closely.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient received the above vaccines, because she was entering kindergarten. However, after giving the vaccines I looked at her immunization record and she had rec'd the above vaccines at age 4. This was an extra dose of the Dtap/IPV, MMR and VARIVAX.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Myalgia
Clinical narrative: One to two days after receiving SHINGRIX vaccination, patient experienced upset stomach, chills, and muscle/joint aches w/o fever. Symptoms have since lessened with time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Pt. mother reports fever 7/25/18 around midnight of 103.5F. Fever resolved 7/25/18. Mother states red patch noted around site of injection 7/26/18.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Two areas of (L) deltoid red, swollen, indurated after receiving vaccines in (L) arm. Pt. treated with ZYRTEC and KEFLEX.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site movement impairment, Injection site pain, Mobility decreased, Nerve injury
Clinical narrative: Apparent permanent nerve or other problem from PREVNAR 13 injection. Limited mobility in left shoulder. Well documented with several doctors soon after. Has not gone away in 16 months. Not severe but constant pain and discomfort from the area. Definitely related to the injection.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Apparent permanent nerve or other problem from PREVNAR 13 injection. Limited mobility in left shoulder. Well documented with several doctors soon after. Has not gone away in 16 months. Not severe but constant pain and discomfort from the area. Definitely related to the injection.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Asthenia, Hypotonia, Myelitis transverse
Clinical narrative: Hypotonia & transverse myelitis;  New onset of weakness began about 24 hours after vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cough, Dyspnoea, Nausea, Pruritus, Wheezing
Clinical narrative: Difficulty breathing, audible wheezing, coughing, nauseated, itching; Pt sent via ambulance to ED.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 52-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, headache, joint pain, fatigue, eye pain, swelling and shivering. On 8th April 2018, the outcome of the headache was recovered/resolved. On 16th April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the joint pain, eye pain and shivering were recovered/resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the erythema, headache, joint pain, fatigue, eye pain, swelling and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient planned to continue follow up with her physician on an unknown date.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 52-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, headache, joint pain, fatigue, eye pain, swelling and shivering. On 8th April 2018, the outcome of the headache was recovered/resolved. On 16th April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the joint pain, eye pain and shivering were recovered/resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the erythema, headache, joint pain, fatigue, eye pain, swelling and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient planned to continue follow up with her physician on an unknown date.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Erythema, Eye pain, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 52-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, headache, joint pain, fatigue, eye pain, swelling and shivering. On 8th April 2018, the outcome of the headache was recovered/resolved. On 16th April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the joint pain, eye pain and shivering were recovered/resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the erythema, headache, joint pain, fatigue, eye pain, swelling and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient planned to continue follow up with her physician on an unknown date.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 52-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, headache, joint pain, fatigue, eye pain, swelling and shivering. On 8th April 2018, the outcome of the headache was recovered/resolved. On 16th April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the joint pain, eye pain and shivering were recovered/resolved and the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the erythema, headache, joint pain, fatigue, eye pain, swelling and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient planned to continue follow up with her physician on an unknown date.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Myocarditis; note pt had elevated Parvo B19 IgM one month post myocarditis that fell to lower levels 30 days later. Also Coxsackie A IgM elevated and much lower 30 days later. Adjudication by Agency results by WHO Causality assessment: Indeterminate B2, Inconsistency of evidence.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Pericarditis, Troponin
Clinical narrative: Myocarditis; note pt had elevated Parvo B19 IgM one month post myocarditis that fell to lower levels 30 days later. Also Coxsackie A IgM elevated and much lower 30 days later. Adjudication by Agency results by WHO Causality assessment: Indeterminate B2, Inconsistency of evidence.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram change, Myocarditis, Troponin increased
Clinical narrative: Myocarditis; note pt had elevated Parvo B19 IgM one month post myocarditis that fell to lower levels 30 days later. Also Coxsackie A IgM elevated and much lower 30 days later. Adjudication by Agency results by WHO Causality assessment: Indeterminate B2, Inconsistency of evidence.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Coxsackie virus test positive, Electrocardiogram change, Myocarditis, Parvovirus B19 test positive
Clinical narrative: Myocarditis; note pt had elevated Parvo B19 IgM one month post myocarditis that fell to lower levels 30 days later. Also Coxsackie A IgM elevated and much lower 30 days later. Adjudication by Agency results by WHO Causality assessment: Indeterminate B2, Inconsistency of evidence.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: Myocarditis; note pt had elevated Parvo B19 IgM one month post myocarditis that fell to lower levels 30 days later. Also Coxsackie A IgM elevated and much lower 30 days later. Adjudication by Agency results by WHO Causality assessment: Indeterminate B2, Inconsistency of evidence.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Blood test normal, Chest X-ray normal, Chest discomfort, Computerised tomogram normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced heart racing, breathlessness, fatigue, nausea, dizziness and headache. On 15th June 2018, the outcome of the nausea, dizziness and headache were recovered/resolved. On an unknown date, the outcome of the heart racing and breathlessness were not recovered/not resolved and the outcome of the fatigue was recovered/resolved. The reporter considered the heart racing, breathlessness, fatigue, nausea, dizziness and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no history of cardio issues and does not have high cholesterol or high blood pressure. The patient received the SHINGRIX vaccine around noon in the left arm and reported that after waking up the next morning at 5:00 AM, she experienced her heart racing, shortness of breath which had persisted and was continuing now. The patient felt like an elephant was sitting on her chest. If the patient walked up a flight of stairs, she was winded. The patient also experienced a headache, nausea and dizziness which resolved after the first week and were gone by 15th June 2018. The patient did indicate that the headache persisted to the following week and then resolved and never reoccurred. The patient visited the emergency room on 15th June 2018 and was referred to cardiology. They completed a chest x-ray and ultrasound and both tests came back negative. The stress test they completed also came back fine. The patient cardiologist believed that her side effects were possibly vaccine related.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Headache, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced heart racing, breathlessness, fatigue, nausea, dizziness and headache. On 15th June 2018, the outcome of the nausea, dizziness and headache were recovered/resolved. On an unknown date, the outcome of the heart racing and breathlessness were not recovered/not resolved and the outcome of the fatigue was recovered/resolved. The reporter considered the heart racing, breathlessness, fatigue, nausea, dizziness and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no history of cardio issues and does not have high cholesterol or high blood pressure. The patient received the SHINGRIX vaccine around noon in the left arm and reported that after waking up the next morning at 5:00 AM, she experienced her heart racing, shortness of breath which had persisted and was continuing now. The patient felt like an elephant was sitting on her chest. If the patient walked up a flight of stairs, she was winded. The patient also experienced a headache, nausea and dizziness which resolved after the first week and were gone by 15th June 2018. The patient did indicate that the headache persisted to the following week and then resolved and never reoccurred. The patient visited the emergency room on 15th June 2018 and was referred to cardiology. They completed a chest x-ray and ultrasound and both tests came back negative. The stress test they completed also came back fine. The patient cardiologist believed that her side effects were possibly vaccine related.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Scan with contrast normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced heart racing, breathlessness, fatigue, nausea, dizziness and headache. On 15th June 2018, the outcome of the nausea, dizziness and headache were recovered/resolved. On an unknown date, the outcome of the heart racing and breathlessness were not recovered/not resolved and the outcome of the fatigue was recovered/resolved. The reporter considered the heart racing, breathlessness, fatigue, nausea, dizziness and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no history of cardio issues and does not have high cholesterol or high blood pressure. The patient received the SHINGRIX vaccine around noon in the left arm and reported that after waking up the next morning at 5:00 AM, she experienced her heart racing, shortness of breath which had persisted and was continuing now. The patient felt like an elephant was sitting on her chest. If the patient walked up a flight of stairs, she was winded. The patient also experienced a headache, nausea and dizziness which resolved after the first week and were gone by 15th June 2018. The patient did indicate that the headache persisted to the following week and then resolved and never reoccurred. The patient visited the emergency room on 15th June 2018 and was referred to cardiology. They completed a chest x-ray and ultrasound and both tests came back negative. The stress test they completed also came back fine. The patient cardiologist believed that her side effects were possibly vaccine related.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac stress test normal, Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced heart racing, breathlessness, fatigue, nausea, dizziness and headache. On 15th June 2018, the outcome of the nausea, dizziness and headache were recovered/resolved. On an unknown date, the outcome of the heart racing and breathlessness were not recovered/not resolved and the outcome of the fatigue was recovered/resolved. The reporter considered the heart racing, breathlessness, fatigue, nausea, dizziness and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no history of cardio issues and does not have high cholesterol or high blood pressure. The patient received the SHINGRIX vaccine around noon in the left arm and reported that after waking up the next morning at 5:00 AM, she experienced her heart racing, shortness of breath which had persisted and was continuing now. The patient felt like an elephant was sitting on her chest. If the patient walked up a flight of stairs, she was winded. The patient also experienced a headache, nausea and dizziness which resolved after the first week and were gone by 15th June 2018. The patient did indicate that the headache persisted to the following week and then resolved and never reoccurred. The patient visited the emergency room on 15th June 2018 and was referred to cardiology. They completed a chest x-ray and ultrasound and both tests came back negative. The stress test they completed also came back fine. The patient cardiologist believed that her side effects were possibly vaccine related.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea, Palpitations, Ultrasound scan normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart racing in a adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced heart racing, breathlessness, fatigue, nausea, dizziness and headache. On 15th June 2018, the outcome of the nausea, dizziness and headache were recovered/resolved. On an unknown date, the outcome of the heart racing and breathlessness were not recovered/not resolved and the outcome of the fatigue was recovered/resolved. The reporter considered the heart racing, breathlessness, fatigue, nausea, dizziness and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had no history of cardio issues and does not have high cholesterol or high blood pressure. The patient received the SHINGRIX vaccine around noon in the left arm and reported that after waking up the next morning at 5:00 AM, she experienced her heart racing, shortness of breath which had persisted and was continuing now. The patient felt like an elephant was sitting on her chest. If the patient walked up a flight of stairs, she was winded. The patient also experienced a headache, nausea and dizziness which resolved after the first week and were gone by 15th June 2018. The patient did indicate that the headache persisted to the following week and then resolved and never reoccurred. The patient visited the emergency room on 15th June 2018 and was referred to cardiology. They completed a chest x-ray and ultrasound and both tests came back negative. The stress test they completed also came back fine. The patient cardiologist believed that her side effects were possibly vaccine related.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysstasia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced swelling of feet, pain in extremity, knee pain and walking difficulty. On an unknown date, the outcome of the swelling of feet, knee pain and walking difficulty were recovering/resolving and the outcome of the pain in extremity was not recovered/not resolved. It was unknown if the reporter considered the swelling of feet, pain in extremity, knee pain and walking difficulty to be related to SHINGRIX. Additional information was reported as follows: The reporter herself was the patient. The reporter stated that a couple of days after the vaccination, she experienced a painful and swollen patch on her left foot, pain on insides of knees, top of thighs such that she had difficulty walking, and pain on upper arms and hands. The patient also stated that the events went on for a month after the event onset and then gradually improved starting with her feet and moving up as well as from right to left. The reporter also stated that at the time of reporting, she had much improvement for issues with knees and legs. Whereas, till the time of reporting, the patient's arms and hands still had pain. The reporter became upset at answering questions for the report and hung up. The reporter was unable to ask for prescriber information or permission to contact. Patient stated that she was suspicious of GlaxoSmithKline due to the bad reaction she had. The reporter stated that her pharmacist already reported events, but the caller did not get a copy of the report and she wanted to ensure her experience was reported.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced swelling of feet, pain in extremity, knee pain and walking difficulty. On an unknown date, the outcome of the swelling of feet, knee pain and walking difficulty were recovering/resolving and the outcome of the pain in extremity was not recovered/not resolved. It was unknown if the reporter considered the swelling of feet, pain in extremity, knee pain and walking difficulty to be related to SHINGRIX. Additional information was reported as follows: The reporter herself was the patient. The reporter stated that a couple of days after the vaccination, she experienced a painful and swollen patch on her left foot, pain on insides of knees, top of thighs such that she had difficulty walking, and pain on upper arms and hands. The patient also stated that the events went on for a month after the event onset and then gradually improved starting with her feet and moving up as well as from right to left. The reporter also stated that at the time of reporting, she had much improvement for issues with knees and legs. Whereas, till the time of reporting, the patient's arms and hands still had pain. The reporter became upset at answering questions for the report and hung up. The reporter was unable to ask for prescriber information or permission to contact. Patient stated that she was suspicious of GlaxoSmithKline due to the bad reaction she had. The reporter stated that her pharmacist already reported events, but the caller did not get a copy of the report and she wanted to ensure her experience was reported.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced swelling of feet, pain in extremity, knee pain and walking difficulty. On an unknown date, the outcome of the swelling of feet, knee pain and walking difficulty were recovering/resolving and the outcome of the pain in extremity was not recovered/not resolved. It was unknown if the reporter considered the swelling of feet, pain in extremity, knee pain and walking difficulty to be related to SHINGRIX. Additional information was reported as follows: The reporter herself was the patient. The reporter stated that a couple of days after the vaccination, she experienced a painful and swollen patch on her left foot, pain on insides of knees, top of thighs such that she had difficulty walking, and pain on upper arms and hands. The patient also stated that the events went on for a month after the event onset and then gradually improved starting with her feet and moving up as well as from right to left. The reporter also stated that at the time of reporting, she had much improvement for issues with knees and legs. Whereas, till the time of reporting, the patient's arms and hands still had pain. The reporter became upset at answering questions for the report and hung up. The reporter was unable to ask for prescriber information or permission to contact. Patient stated that she was suspicious of GlaxoSmithKline due to the bad reaction she had. The reporter stated that her pharmacist already reported events, but the caller did not get a copy of the report and she wanted to ensure her experience was reported.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Neuropathy peripheral, Pain in extremity, Trigeminal neuralgia
Clinical narrative: As a kid, lived and worked internationally with many, many vaccinations, never a problem, or reactions. This time from Day One arm from elbow to shoulder extremely sore and hot and red,  swollen large area around injection site. Day four and five, transient incidents lasting about 10 minutes each extreme facial pain [trigeminal neuralgia] mostly mandibular nerve. Day 10 left for trip. Day 13 - 17 spent entire day in bed curled up in fetal position. Extremely serious facial pain continuously. Unable to eat or barely move. Eating pain meds [NORCO] and gabapentin every 2 hours just to cope. Later days transient episodes.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Feeding disorder, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: As a kid, lived and worked internationally with many, many vaccinations, never a problem, or reactions. This time from Day One arm from elbow to shoulder extremely sore and hot and red,  swollen large area around injection site. Day four and five, transient incidents lasting about 10 minutes each extreme facial pain [trigeminal neuralgia] mostly mandibular nerve. Day 10 left for trip. Day 13 - 17 spent entire day in bed curled up in fetal position. Extremely serious facial pain continuously. Unable to eat or barely move. Eating pain meds [NORCO] and gabapentin every 2 hours just to cope. Later days transient episodes.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Trigeminal neuralgia
Clinical narrative: As a kid, lived and worked internationally with many, many vaccinations, never a problem, or reactions. This time from Day One arm from elbow to shoulder extremely sore and hot and red,  swollen large area around injection site. Day four and five, transient incidents lasting about 10 minutes each extreme facial pain [trigeminal neuralgia] mostly mandibular nerve. Day 10 left for trip. Day 13 - 17 spent entire day in bed curled up in fetal position. Extremely serious facial pain continuously. Unable to eat or barely move. Eating pain meds [NORCO] and gabapentin every 2 hours just to cope. Later days transient episodes.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: Had very mild Flu-like symptoms post 1st injection 3 months ago. General malaise, diffuse myalgia, anorexia w/o V/D. Mild nausea, & slight HA. SAME symptoms, but much more intense so much that I did not even want to walk outside.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Had very mild Flu-like symptoms post 1st injection 3 months ago. General malaise, diffuse myalgia, anorexia w/o V/D. Mild nausea, & slight HA. SAME symptoms, but much more intense so much that I did not even want to walk outside.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Around 7 hours after the vaccine, internal pain started in the arm where the injection was made. After 24 hours had passed, the pain was stronger than any pain I have felt before. 6 days later, it is still interfering with daily activities as well as with sleep quality. No redness or swelling is visible, and pain is more pronounced when I make movements where I have to push my hand out. Only things that have helped are NSAIDs (I specifically used CELEBREX as I get adverse reactions with other NSAIDs, but while things improved over several days, my grabbing a tree leaf in my backyard and throwing it away (the movement made in throwing something quickly) brought me back to the pain I had 24 hours after the injection. I believe the pain/internal inflammation will dissipate on its own, but wanted to report this for statistical purposes. The Tdap vaccine I had 10 years ago did not cause me any discomfort beyond 36 hours after injection. Only thing I recall being different in my medical situation is I was on fexofenadine instead of ZYRTEC, and the age difference.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Computerised tomogram, Lung consolidation, Pneumonia, Pyrexia
Clinical narrative: I got fever of over 104F on July 3 and was sent to emergency room on July 3 and 4. After CT scan doctor found consolidation on right lower lung lobe and diagnosed I was having pneumonia although I received PPSV23 injection just over one month ago.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis
Clinical narrative: I got fever of over 104F on July 3 and was sent to emergency room on July 3 and 4. After CT scan doctor found consolidation on right lower lung lobe and diagnosed I was having pneumonia although I received PPSV23 injection just over one month ago.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Large amount of swelling around area and severe pain lasting 7-8 days. Still experiencing soreness around the injection site.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Nausea
Clinical narrative: Daughter felt like she was going to vomit and almost passed out. Very sick to her stomach.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Major swelling; redness; pain (injection site and entire arm); fever; immobility of arm - 1 week; upset stomach (day of injection); continued pain since vaccination date that worsens with activity; visible inflammation. Initial treatment: taradol shot (anti-inflammatory), 10 days antibiotics; over the counter anti-inflammatories; heat and ice; 1 year later - prescribed Z-PACK and prednisone (10 days) for localized inflammation at injection site.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Major swelling; redness; pain (injection site and entire arm); fever; immobility of arm - 1 week; upset stomach (day of injection); continued pain since vaccination date that worsens with activity; visible inflammation. Initial treatment: taradol shot (anti-inflammatory), 10 days antibiotics; over the counter anti-inflammatories; heat and ice; 1 year later - prescribed Z-PACK and prednisone (10 days) for localized inflammation at injection site.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Major swelling; redness; pain (injection site and entire arm); fever; immobility of arm - 1 week; upset stomach (day of injection); continued pain since vaccination date that worsens with activity; visible inflammation. Initial treatment: taradol shot (anti-inflammatory), 10 days antibiotics; over the counter anti-inflammatories; heat and ice; 1 year later - prescribed Z-PACK and prednisone (10 days) for localized inflammation at injection site.
Age: 1.25
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and was referring to a 15 month old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies were reported. On 21-JUN-2018, the patient was vaccinated with an expired dose of VAQTA, 25/0.5 DF, lot # N005274, expiration date 03-APR-2018), by intramuscular ropute, (dose, and dose number were not reported), for prophylaxis. No other suspect or concomitant therapies were reported. No adverse effects were reported.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Fatigue, Headache
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 58-year-old female patient. The patient's pertinent medical history included seasonal allergies and chronic insomnia. The patient's drug reactions or allergies included phenylephrine, nystatin and pseudoephedrine hypersensitivity. On 21-JUN-2018, the patient was vaccinated with PNEUMOVAX 23, 1 dose, 0.5 ml, intramuscularly (lot # N034512, expiration date: 13-SEP-2019) for prophylaxis. Concomitant therapies included levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR) and trazodone hydrochloride. On 22-JUN-2018, the patient experienced bruising all over her body, headaches and feeling tired. The patient sought medical attention and on the same date, she was seen by the physician. An unspecified treatment for the events was administered. On 26-JUN-2018, the patient went to the physician for a follow-up visit and the bruising was reported as resolved. The outcome of headaches and feeling tired was reported as recovered on an unknown date in 2018. Relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 11-JUL-2018, the patient was vaccinated with and expired dose of M-M-R II lot # M027637, expiry date: 02-JUN-2018, therapy type rHA, for prophylaxis. Concomitant therapies included sterile diluent. The patient experienced no adverse event.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an 18 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unknown date, the patient inadvertently received an unspecified first dose of adult formulation of VAQTA (Unknown Lot#/ Exp date), instead of a pediatric dose. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender who refers to him/herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2014, reported as four years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient received a first dose of SHINGRIX in approximately May 2018, reported as six weeks ago, for the prevention of shingles. No adverse effects were reported. According to the current prescribing information for ZOSTAVAX, the need for revaccination had not been defined. The outcome of the event and causality assessment were not provided.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions drug reactions, allergies and concomitant medications were not reported. On 07-AUG-2012, the patient received a dose of PNEUMOVAX 23 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 17-JUL-2018, the patient inadvertently received a dose of PNEUMOVAX 23 for prophylaxis, intramuscularly on the left deltoid, lot #N024717 and expiration date 06-APR-2019. No adverse effects were reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that the patient received his first pediatric dose of VAQTA 25/0.5, on 16-NOV-2016 at age 17 years (route, frequency, lot/batch # and expiration date were not reported) and received the second pediatric dose of VAQTA lot# N023953 with expiration date of 05-NOV-2018 (route and frequency were not reported) on 12-JUL-2018 at the age 19 years old. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to currently 13 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excusions and the aformentioned one were not identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Renal injury, Vasculitis
Clinical narrative: Information has been received from a consumer referring to his/her daughter, a 5 year old female patient. The patient's concurrent condition, medical history and concomitant medication were unknown. In July 1993 (reported as 25 years ago), the patient received VARIVAX (dose, route, lot number and expiration date unknown) for prophylaxis. Then on an unknown date in July 1993 (reported as 25 years ago), the patient had vasculitis of blood which caused kidney damage. The outcome of the events was unknown. The causality assessment was not provided by reporter. Upon internal review, vasculitis of blood and kidney damage were determined to be medically significant.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin, Skin disorder
Clinical narrative: This spontaneous report was received from a pharmacist concerning a non pregnant female patient of currently 57 years old. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On an unspecified date in March 2018, the patient was vaccinated with VARIVAX injection, for prophylaxis (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided); also, on the same month, the patient started therapy prednisone (manufacturer unknown) tablet, orally, for an unspecified reason (strength, dose, frequency, lot # and expiry date were not reported). Subsequently, on an unspecified date in 2018, the patient was diagnosed with an unspecified dermatological disease. Also a biopsy was performed, however no details were known. Therefore, she had been treated with unspecified high doses of methotrexate until the time of reporting. The pharmacist stated that it was not known exactly why the patient needed VARIVAX but it was believed to be proof of vaccination. It was unknown by the reporter if the patient sought medical attention. At the reporting time, the patient had not recovered from the event. The action taken with prednisone (manufacturer unknown) and the reporter's causality assessment between prednisone (manufacturer unknown) and VARIVAX with skin disorder were not reported. Upon internal review, unspecified dermatological disease treated with methotrexate was considered to be medically significant.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age with hypertension, hypothyroidism and allergy to sulfa and MEDROL. The patient had no concomitant medications. On 19-JUL-2018 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N029303 with an expiration date in 21-APR-2019), intramuscular, to prevent pneumococcal disease (prophylaxis), (dose, frequency and strength were not provided). On an unspecified date in July 2018, the patient developed redness and warmth at the site of PNEUMOVAX 23. It was also reported that the patient sought medical attention with the pharmacist and an unspecified treatment was prescribed for the aforementioned events. At the time of reporting, the outcome of injection site erythema and injection site warmth was reported as not resolved. The causal relationship between PNEUMOVAX 23 and the reported events was not provided.
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 5 month old patient of unknown gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9, for prophylaxis (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). The physician specified that, no adverse effects were reported
Sex: U
Vaccine: HEP, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, concerning unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were inadvertently vaccinated improperly stored doses with ROTATEQ orally, lot # N029868 and expiration date 12-MARCH-2019.  Furthermore, on an unknown dates, the patients were vaccinates with RECOMBIVAX HB lot # R006746 and expiration date 09-NOV-2020 and, LIQUID PEDVAXHIB lot # N013293 and expiration date 29-FEB-2020 (doses, frequencies and routes were not provided) for prophylaxis. No adverse effects reported. The vaccines were stored at a temperature of 0 degree Centigrade to 1 degree Centigrade, time frame of 30 minutes with no previous temperature excursion of (0 degree Centigrade for 13 hours 30 minutes). Digital Data logger was involved.
Sex: F
Vaccine: HPVX
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a registered nurse (who is also 31 year old female patient) referring to herself. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 or GARDASIL unidentified Merck hpv vaccine (name and lot number not provided) (strength, dose, route of administration and expiry date were not reported) for prophylaxis (reported as "vaccine"). On an unknown date, the patient reported that "GARDASIL hurts" (pain). The reporter did not clarify what "GARDASIL hurts" meant. The outcome of pain was unknown. The causality was not reported. There was no product quality complaint (PQC) reported.