chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Nephrolithiasis
Clinical narrative: This is an observational study case, initially received from other health professional on 08-Nov-2018, concerning a 25-year-old adult female pregnant patient of body weight 131.4 lbs, height 63.3 inches and body mass index (BMI) 23.1, enrolled in a prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject's obstetrical history included two previous full-term live births and had no birth defects occurred in previous pregnancies. The subject's last menstrual period (LMP) date was 26-Feb-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included low platelets since 07-May-2018. On 25-Sep-2018, the subject received TDAP. The subject's concomitant medication included PNV for pregnancy. On 18-Jul-2018, anatomical scan was performed, and no major congenital malformation was noted. On 05-May-2018, haemoglobin electrophoresis was performed, and no major congenital malformation was noted. On 21-May-2018, Zika virus testing was performed, and no major congenital malformation was noted. On 23-Oct-2018, at gestation age of 34 weeks (third trimester), the subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported). On an unspecified date, after vaccination, the subject developed chronic kidney stones. At the time of this report, the subject had not recovered from the event chronic kidney stones. The estimated date of delivery was reported as 03-Dec-2018.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Joint swelling, Peripheral swelling, Urticaria
Clinical narrative: This spontaneous case, initially received from other non-healthcare professional on 08-Nov-2018, concerns a 19-year-old, adult, female patient. The patient's vaccination history included unspecified flu vaccines without any adverse events. The patient had no relevant medical history and concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported]. On 06-Nov-2018, the patient developed hives all over the body and swelling of the eyes, wrists, knees, and fingers. On an unspecified date in Nov-2018, the patient went to the emergency room (ER), where she was given BENADRYL and unspecified steroid shot and was sent to home. The reporter stated that the swelling and hives had not gone away. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. This case was considered as lost to follow up, as the reporter had not given the consent to follow up.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Pyrexia
Clinical narrative: Fever of 104 and feeling faint the evening after TRUMENBA. The next day, symptoms resolved.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Aspiration pleural cavity, Balance disorder, Blood culture negative, Blood lactic acid normal, Blood prolactin normal
Clinical narrative: Fever 104 degrees F, chills, loss of balance, profuse rhinitis.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray abnormal, Chills, Culture, Culture urine negative, Pleural effusion
Clinical narrative: Fever 104 degrees F, chills, loss of balance, profuse rhinitis.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rhinitis, Urine analysis normal
Clinical narrative: Fever 104 degrees F, chills, loss of balance, profuse rhinitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Maternal report welt/hive (R) arm; that by time of exam, had improved and became less noticeable.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient reported muscle pain that lasted for more than 3 weeks before finally subsiding. He reported no change in ability to move arm just soreness. Took aspirin 81 mg daily with no help.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Area about the size of a softball was red, not swollen, warm to the touch and painful.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Scratch, Skin abrasion
Clinical narrative: Vaccinated 11/20/18 (L) deltoid with swelling and redness itching on vaccine site yesterday evening. Medicated with BENADRYL 25 m x 3 yesterday evening. Scratched area now with 10 x 12 cm swollen area with small open excoriated area to skin in center of lesion. Hx of skin reactions to flu vaccine but mother says it has never been this bad.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Skin lesion, Swelling
Clinical narrative: Vaccinated 11/20/18 (L) deltoid with swelling and redness itching on vaccine site yesterday evening. Medicated with BENADRYL 25 m x 3 yesterday evening. Scratched area now with 10 x 12 cm swollen area with small open excoriated area to skin in center of lesion. Hx of skin reactions to flu vaccine but mother says it has never been this bad.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Injection site erythema, induration and discomfort within 12-18 hr. after PNEUMOVAX.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Dysphagia, Feeling hot, Pharyngeal oedema
Clinical narrative: Tongue was hot feeling. Throat felt swollen. Having difficulty swallowing. Reaction happened when patient got home about 30 minutes. Mother told to take to ER if worsens. Mom administered BENADRYL. Called mom, patient is doing better 2:11pm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count, Dizziness, Electrocardiogram, Full blood count, Loss of consciousness
Clinical narrative: Patient received vaccine around 330pm. Arm started to hurt around 5p with pain becoming unbearable by 7p. She took ibuprofen at 8p night before but it didn't seem to help. Overnight, she had continued pain with nausea, shakiness and dizziness. She passed out in the am so her husband brought her into an ER. Upon admit, she had a CBC with differential, basic metabolic panel, and ECG. She was given an IV dose of Ketorolac. Per patient report, nothing else was found. She is now home, no longer nauseous, moving arm often, and taking ibuprofen 600mg TID per discharge instructions from ER. She is feeling better and planning on decreasing ibuprofen dose tomorrow.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Nausea, Pain in extremity, Tremor
Clinical narrative: Patient received vaccine around 330pm. Arm started to hurt around 5p with pain becoming unbearable by 7p. She took ibuprofen at 8p night before but it didn't seem to help. Overnight, she had continued pain with nausea, shakiness and dizziness. She passed out in the am so her husband brought her into an ER. Upon admit, she had a CBC with differential, basic metabolic panel, and ECG. She was given an IV dose of Ketorolac. Per patient report, nothing else was found. She is now home, no longer nauseous, moving arm often, and taking ibuprofen 600mg TID per discharge instructions from ER. She is feeling better and planning on decreasing ibuprofen dose tomorrow.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Eczema
Clinical narrative: Severe eczema.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Became feverish with severe joint pain. Took ibuprofen and began to feel better after six hours.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain lower, Bone pain, Chills, Decreased appetite, Nausea
Clinical narrative: Fever, chills, low right abdominal pain (severe overnight), nausea, vomitting, loss of appetite, aches and pains in bones.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, chills, low right abdominal pain (severe overnight), nausea, vomitting, loss of appetite, aches and pains in bones.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient reported swelling of arm, redness, and pain for a week post vaccination and declined second vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Local reaction, Skin warm, Tenderness
Clinical narrative: 10.5 CM X 11.5 CM area of local reaction- redness with underlying in duration warmth to touch and tender to touch (No systemic associated fever- 98.1 F Tympanic- on evaluation 2 days post vaccination administration).
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced swelling, and redness at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient started to develop redness and warmth on the right arm around the site of the PNEUMOVAX injection approx. 7 hrs after injection. Condition eventually extended to just below the elbow, but did not go higher than injection site. Patient also reported swelling, itching and some bruising on the 2nd day. Cortisone cream was applied to affected areas the evening of the 2nd day. Pharmacy was notified on the afternoon of the 3rd day (11/21/18) at which time symptoms had already started improving.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Reported site swelling, pain, rash and itching at the site of ther shot.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported to the pharmacy due to a red strip, about six inches in width, that circled her upper left arm near the vaccination location. She stated it had occurred shortly after the vaccine but then never went away. It is not painful, but it is itchy and warm to the touch. She has been treating with hydrocortisone 1% cream as well as diphenhydramine 25mg tablets. She says that it has improved, but is still there so she wanted to let us know. We discussed seeing a doctor if it has not improved by Saturday.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site reaction, Myalgia, Pyrexia, Urticaria
Clinical narrative: Fever and muscle aches, from 12 hours to 48 hours after vaccine. 2 inch welt on left arm at site of injection, from 10 hours to 4 days after vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Middle insomnia, Pain in extremity
Clinical narrative: Very sore arm that kept me awake during the night. Headache, flu-like lethargy. 24 hours later, it's still hard to get out of bed.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Red, hot, extremely swollen and stiff muscle, the redness traveled down the arm throughout the muscle over the course of 3 days. Extremely painful and red lines traveling away from injection site towards chest.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Oral herpes
Clinical narrative: Flu-like symptoms: shivering, 101.7 fever, extreme fatigue, loss of appetite; then 24 hours after those symptoms, cold sores on mouth and face multiple locations.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms: shivering, 101.7 fever, extreme fatigue, loss of appetite; then 24 hours after those symptoms, cold sores on mouth and face multiple locations.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Serum sickness
Clinical narrative: Serum sickness per pt.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pruritus
Clinical narrative: Reports he had pneumonia shot on Tuesday. He reports the next morning he woke up with stiffness and itching to his upper body. Symptoms -becoming more progressive. Patient states symptoms feel worse while in the clinic.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Axillary mass, Chills, Eye swelling, Headache
Clinical narrative: This is a spontaneous case, initially received on 09-Nov-2018 from other non-health professional and concerns a 70-year-old, elderly, female patient. On 29-Oct-2018, at 11:00 am, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, batch number: 250794, expiry date, dose, trade name, manufacturer: not reported). On the same day, by 6 pm, after vaccination, the patient developed fever chills (reported as fiever chills) with body temperature of 100.7 (unit unspecified), aches and pain all over-her muscles and joints, lumps in her armpits, a lump 1-2 inches away from the injection site towards her back. The patient also experienced headache (reported as HA) every morning. The patient was unable to do anything without taking ibuprofen. The patient reported decreased urine output, even though she was drinking the same amount of water daily and just 1 cup of coffee. Ever since, the day of vaccination, the patient wakes up from middle of sleep, with an unbelievable amount of pain. On an unspecified date in 2018, after vaccination, the patient experienced vertigo (reported as some vertigo situations with her right eye). She developed vertigo, when she looked upward toward the right side, and she has a convoluted vision and can see lines. It was reported that, the patient had consulted her Primary Care Physician (PCP) and performed unspecified tests. The patient was treated with ibuprofen which provided relief for about 5 hours. The patient was unable to do anything without taking Ibuprofen. On an unspecified date in 2018 (reported as this morning) the patient's eyes were swollen. On an unspecified date (reported as this morning), the patient was going to get the results of the tests performed. At the time of the report, the patient had not recovered from the events. This reporter assessed the case as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site mass, Middle insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous case, initially received on 09-Nov-2018 from other non-health professional and concerns a 70-year-old, elderly, female patient. On 29-Oct-2018, at 11:00 am, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, batch number: 250794, expiry date, dose, trade name, manufacturer: not reported). On the same day, by 6 pm, after vaccination, the patient developed fever chills (reported as fiever chills) with body temperature of 100.7 (unit unspecified), aches and pain all over-her muscles and joints, lumps in her armpits, a lump 1-2 inches away from the injection site towards her back. The patient also experienced headache (reported as HA) every morning. The patient was unable to do anything without taking ibuprofen. The patient reported decreased urine output, even though she was drinking the same amount of water daily and just 1 cup of coffee. Ever since, the day of vaccination, the patient wakes up from middle of sleep, with an unbelievable amount of pain. On an unspecified date in 2018, after vaccination, the patient experienced vertigo (reported as some vertigo situations with her right eye). She developed vertigo, when she looked upward toward the right side, and she has a convoluted vision and can see lines. It was reported that, the patient had consulted her Primary Care Physician (PCP) and performed unspecified tests. The patient was treated with ibuprofen which provided relief for about 5 hours. The patient was unable to do anything without taking Ibuprofen. On an unspecified date in 2018 (reported as this morning) the patient's eyes were swollen. On an unspecified date (reported as this morning), the patient was going to get the results of the tests performed. At the time of the report, the patient had not recovered from the events. This reporter assessed the case as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Urine output decreased, Vertigo, Visual impairment
Clinical narrative: This is a spontaneous case, initially received on 09-Nov-2018 from other non-health professional and concerns a 70-year-old, elderly, female patient. On 29-Oct-2018, at 11:00 am, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, batch number: 250794, expiry date, dose, trade name, manufacturer: not reported). On the same day, by 6 pm, after vaccination, the patient developed fever chills (reported as fiever chills) with body temperature of 100.7 (unit unspecified), aches and pain all over-her muscles and joints, lumps in her armpits, a lump 1-2 inches away from the injection site towards her back. The patient also experienced headache (reported as HA) every morning. The patient was unable to do anything without taking ibuprofen. The patient reported decreased urine output, even though she was drinking the same amount of water daily and just 1 cup of coffee. Ever since, the day of vaccination, the patient wakes up from middle of sleep, with an unbelievable amount of pain. On an unspecified date in 2018, after vaccination, the patient experienced vertigo (reported as some vertigo situations with her right eye). She developed vertigo, when she looked upward toward the right side, and she has a convoluted vision and can see lines. It was reported that, the patient had consulted her Primary Care Physician (PCP) and performed unspecified tests. The patient was treated with ibuprofen which provided relief for about 5 hours. The patient was unable to do anything without taking Ibuprofen. On an unspecified date in 2018 (reported as this morning) the patient's eyes were swollen. On an unspecified date (reported as this morning), the patient was going to get the results of the tests performed. At the time of the report, the patient had not recovered from the events. This reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Foetal disorder, Gene mutation identification test negative, Prenatal screening test
Clinical narrative: This is an observation study case, initially received on 08-Nov-2018, concerns a 30-year-old, adult pregnant female, subject of body mass index: 20.2, weight: 121.2 lbs and height: 65 in, enrolled in a prospective observational safety study. The subject had an obstetrical history of ectopic pregnancy and spontaneous abortion. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject had not used tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included Herpes simplex virus infection (since an unspecified date). The concomitant medications included PNV, Valacyclovir HCL for herpes simplex infection. The subject's last menstrual period date was 19-Mar-2018 and the type of pregnancy was reported as singleton. On 18-May-2018, the subject underwent cystic fibrosis mutation analysis and no major congenital malformations were revealed. On 12-Jun-2018, the first trimester screening test was performed, and no major congenital malformation was noted. On 06-Jul-2018, maternal serum alpha-fetoprotein (MSAFP) serum markers analysis performed showed no major congenital malformation. On 13-Aug-2018, anatomic scan was performed, and no major congenital malformation was noted. On 01-Oct-2018, the patient (28 weeks of gestational age) was administered non-company suspect TDAP vaccine (dose, route of administration, batch number, expiry date and anatomical location: not reported). On 17-Oct-2018 (30 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF41708, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject underwent ultrasound which revealed echogenic cardiac foci which was not as bright as bone. At the time of this report, the outcome of the event was unknown. The subject's estimated date of delivery was reported as 24-Dec-2018.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: This is an observation study case, initially received on 08-Nov-2018, concerns a 30-year-old, adult pregnant female, subject of body mass index: 20.2, weight: 121.2 lbs and height: 65 in, enrolled in a prospective observational safety study. The subject had an obstetrical history of ectopic pregnancy and spontaneous abortion. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject had not used tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included Herpes simplex virus infection (since an unspecified date). The concomitant medications included PNV, Valacyclovir HCL for herpes simplex infection. The subject's last menstrual period date was 19-Mar-2018 and the type of pregnancy was reported as singleton. On 18-May-2018, the subject underwent cystic fibrosis mutation analysis and no major congenital malformations were revealed. On 12-Jun-2018, the first trimester screening test was performed, and no major congenital malformation was noted. On 06-Jul-2018, maternal serum alpha-fetoprotein (MSAFP) serum markers analysis performed showed no major congenital malformation. On 13-Aug-2018, anatomic scan was performed, and no major congenital malformation was noted. On 01-Oct-2018, the patient (28 weeks of gestational age) was administered non-company suspect TDAP vaccine (dose, route of administration, batch number, expiry date and anatomical location: not reported). On 17-Oct-2018 (30 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF41708, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject underwent ultrasound which revealed echogenic cardiac foci which was not as bright as bone. At the time of this report, the outcome of the event was unknown. The subject's estimated date of delivery was reported as 24-Dec-2018.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary mass, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site, swelling at injection site, warm to touch, lump under arm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash macular (refer case US2018093570). Concurrent medical conditions included Hashimoto's disease (autoimmune disorder). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever and hives. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and hives were unknown. It was unknown if the reporter considered the fever and hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. Five to six days, after receiving SHINGRIX, the patient developed hives that eventually covered about half body. This lasted for day. The patient also experienced the common side effect of fever the day after receiving the vaccine. This post-vaccine episode was the only time the patient ever experienced hives. She did also report this to the Government VAERS website.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urticaria, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash macular (refer case US2018093570). Concurrent medical conditions included Hashimoto's disease (autoimmune disorder). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever and hives. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and hives were unknown. It was unknown if the reporter considered the fever and hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. Five to six days, after receiving SHINGRIX, the patient developed hives that eventually covered about half body. This lasted for day. The patient also experienced the common side effect of fever the day after receiving the vaccine. This post-vaccine episode was the only time the patient ever experienced hives. She did also report this to the Government VAERS website.
Age: 64.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Fall, Humerus fracture, Injection site erythema, Injection site pain, Lower limb fracture
Clinical narrative: This spontaneous report was received from a 64 year old female patient (who is also a retired medical assistant) and refers to herself. The patient had no pertinent medical history and drug reactions or allergies. She did not receive any concomitant medications. On 24-AUG-2017, the patient received her first dose of PNEUMOVAX 23 in left arm (dose, route of administration, lot# and expiration date were not reported). On 25-OCT-2018, the patient was intramuscularly vaccinated with a second dose of PNEUMOVAX 23 in the right arm (dose, lot# and expiration date were not reported). On the same day, the patient received influenza virus vaccine (unspecified)in the left arm at an unspecified rehabilitation center. On 25-OCT-2018, within 12 hours after receiving the vaccine, the patient experienced redness at the injection site. The patient did not seek any medical attention and no treatment was given for the event. No lab diagnostic studies were performed. The outcome of redness at the injection site was reported as recovered on an unknown date in 2018. The relatedness between the event and PNEUMOVAX 23 was not reported.
Age: 64.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Ulna fracture
Clinical narrative: This spontaneous report was received from a 64 year old female patient (who is also a retired medical assistant) and refers to herself. The patient had no pertinent medical history and drug reactions or allergies. She did not receive any concomitant medications. On 24-AUG-2017, the patient received her first dose of PNEUMOVAX 23 in left arm (dose, route of administration, lot# and expiration date were not reported). On 25-OCT-2018, the patient was intramuscularly vaccinated with a second dose of PNEUMOVAX 23 in the right arm (dose, lot# and expiration date were not reported). On the same day, the patient received influenza virus vaccine (unspecified)in the left arm at an unspecified rehabilitation center. On 25-OCT-2018, within 12 hours after receiving the vaccine, the patient experienced redness at the injection site. The patient did not seek any medical attention and no treatment was given for the event. No lab diagnostic studies were performed. The outcome of redness at the injection site was reported as recovered on an unknown date in 2018. The relatedness between the event and PNEUMOVAX 23 was not reported.
Age: 64.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a 64 year old female patient (who is also a retired medical assistant) and refers to herself. The patient had no pertinent medical history and drug reactions or allergies. She did not receive any concomitant medications. On 24-AUG-2017, the patient received her first dose of PNEUMOVAX 23 in left arm (dose, route of administration, lot# and expiration date were not reported). On 25-OCT-2018, the patient was intramuscularly vaccinated with a second dose of PNEUMOVAX 23 in the right arm (dose, lot# and expiration date were not reported). On the same day, the patient received influenza virus vaccine (unspecified)in the left arm at an unspecified rehabilitation center. On 25-OCT-2018, within 12 hours after receiving the vaccine, the patient experienced redness at the injection site. The patient did not seek any medical attention and no treatment was given for the event. No lab diagnostic studies were performed. The outcome of redness at the injection site was reported as recovered on an unknown date in 2018. The relatedness between the event and PNEUMOVAX 23 was not reported.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74-year-old female patient. The patient's medical history and concomitant medication were unknown. Additionally the patient was reported with a sulfa allergy. On 12-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R017900 and expiration date 20-MAR-2020) (strength, dose, frequency, route of administration and anatomical location were not reported) as vaccine. On 13-NOV-2018, reported as "today", the patient experienced injection site soreness and swelling with warm to touch (injection site pain, injection site warmth and injection site swelling). The patient did not sought for medical attention and no treatment was provided for the events. At the time of this report, the patient had not recovered from the events and the causality assessment between pneumococcal PNEUMOVAX 23 and the aforementioned, events were not provided.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74-year-old female patient. The patient's medical history and concomitant medication were unknown. Additionally the patient was reported with a sulfa allergy. On 12-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R017900 and expiration date 20-MAR-2020) (strength, dose, frequency, route of administration and anatomical location were not reported) as vaccine. On 13-NOV-2018, reported as "today", the patient experienced injection site soreness and swelling with warm to touch (injection site pain, injection site warmth and injection site swelling). The patient did not sought for medical attention and no treatment was provided for the events. At the time of this report, the patient had not recovered from the events and the causality assessment between pneumococcal PNEUMOVAX 23 and the aforementioned, events were not provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dizziness, Fatigue, Head discomfort, Hyperarousal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced dizzy spells. The patient was treated with Meclizine. On an unknown date, the outcome of the dizzy spells was unknown. It was unknown if the reporter considered the dizzy spells to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced occasional episodes of dizziness. The patient had reported this adverse event to the vaccinating pharmacy and to his doctor too. The patient also added, according to GlaxoSmithKline webpage, the event experienced by the patient was a severe and rare side effect. The patient further enquired what he can do to mitigate this side effects and was there any antidote for the same.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Palpitations, Paraesthesia, Throat tightness, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced dizzy spells. The patient was treated with Meclizine. On an unknown date, the outcome of the dizzy spells was unknown. It was unknown if the reporter considered the dizzy spells to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced occasional episodes of dizziness. The patient had reported this adverse event to the vaccinating pharmacy and to his doctor too. The patient also added, according to GlaxoSmithKline webpage, the event experienced by the patient was a severe and rare side effect. The patient further enquired what he can do to mitigate this side effects and was there any antidote for the same.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced dizzy spells. The patient was treated with Meclizine. On an unknown date, the outcome of the dizzy spells was unknown. It was unknown if the reporter considered the dizzy spells to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced occasional episodes of dizziness. The patient had reported this adverse event to the vaccinating pharmacy and to his doctor too. The patient also added, according to GlaxoSmithKline webpage, the event experienced by the patient was a severe and rare side effect. The patient further enquired what he can do to mitigate this side effects and was there any antidote for the same.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced dizzy spells. The patient was treated with Meclizine. On an unknown date, the outcome of the dizzy spells was unknown. It was unknown if the reporter considered the dizzy spells to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced occasional episodes of dizziness. The patient had reported this adverse event to the vaccinating pharmacy and to his doctor too. The patient also added, according to GlaxoSmithKline webpage, the event experienced by the patient was a severe and rare side effect. The patient further enquired what he can do to mitigate this side effects and was there any antidote for the same.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Malaise, Pain
Clinical narrative: Just under 24 hours after receiving the vaccine, I developed a low grade temp that fluctuated to 99.8 for 3 days, body aches, felt somewhat unwell and  fatigued. That all remitted at about 4 full days after receiving the vaccine. I did have arm aching within hours as well.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Flank pain, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: The shot in my left arm initially hurt more than usual. Around 1pm my arm started to ache and also my shoulder. A couple hours later it spread down my arm. The next day it spread to my left leg and then the right side of my body as well. The left arm and shoulder hurt the worst and the pain continues and is constant in arm and shoulder and is varied through rest of body. Dr. prescribed gabapentin which helps but doesn't entirely alleviate pain. Believes it to be permanent nerve damage.
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report has been received from a registered nurse via a field representative referring to a 11 or 12 years old female patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. It was also unknown if the patient received any other concomitant vaccines. On 29-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose detail, route, batch/lot #, and expiration date were not reported). On the same day (reported as 6 hours after vaccination), the patient began to experience nausea and vomiting. On an unknown date, the patient had been taken to unspecified emergency room due to the adverse events. The patient had been seen back in a pediatric office and consulted with an unspecified gastroenterologist. The patient had tried unspecified anti-nausea medications. As it reported, the symptoms persisted until the time of this report (not recovered). The causality assessment was not provided.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperaesthesia, Rash erythematous, Skin warm, Urticaria
Clinical narrative: This spontaneous report has been received from a non-pregnant, 50-year-old female consumer patient, reporting on herself. The patient's concurrent conditions included allergy to unspecified antibiotics and to morphine. The patient had none medical history and was not taking concomitant medications. On 22-OCT-2018, the patient was vaccinated with one injection of VAQTA, (route reported as "injection" and dose was not provided), lot # R022983 with expiration date 09-AUG-2019, for hepatitis A prevention. On 22-OCT-2018, within an hour of getting the vaccine, the patient broke out in hives (urticaria papular). She experienced her skin feeling sensitive (sensitive skin) and hot (skin warm) with red bumps, for a duration of 15 hours. The patient did not sought medical attention and no treatment was given for the events. Laboratory diagnostics or studies were not performed. At the time of reporting, the patient had recovered. The reporter did not assess the relationship between the vaccination with VAQTA and the events.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unspecified date in January 2016, the patient was vaccinated with PNEUMOVAX 23 (indication: prophylaxis; strength, dose, route, lot # and expiration date were not reported). On an unspecified date in April 2016, the patient was vaccinated with PREVNAR 13 by her unspecified physician. No adverse effects.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via field representative regarding to a male patient of unknown age. The patient's concurrent conditions, historical conditions, past drug and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route and dose were unknown). On an unknown date the patient experienced pain and tenderness at the injection site and was feeling sick (malaise). The outcome of injection site pain and malaise was unknown. The causality of events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Adverse drug reaction, Deafness, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a consumer and refers to a female patient of unknown age, who was reporting on herself. The patient had no pertinent medical history or any known drug reaction or allergies. Concomitant therapy included thyroid medicine and a water pill. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX, 0.65 milliliter (ml) injection, (route of administration, lot # and expiration date were not reported) to prevent shingles. On an unknown date reported as ''over 2 years ago'', the patient began to occasionally break out in little red dots that last for 2 or 3 weeks and then go away. The spots hurt but they did not itch. The patient's doctor told these spots were not shingles. On unknown date in 2017 reported as ''a little more than a tear ago'', she began experiencing hearing loss and the patient's hearing loss was getting worse. The patient had 2 or 3 hearing tests this year and she would need a special high powered hearing aid. On unknown date, the patient had once taken an unspecified antibiotics that ''starts with E'' and that hurt (her) stomach. The outcome of hearing loss was reported as not recovered. The outcome of little red dots/spots hurt was not recovered also reported as ''the patient did not specify if she at the time of the report has any red dots appearing on her body''. The outcome of hurt stomach was unknown. The causality assessment between the ZOSTAVAX and the events was not provided. Upon internal review, the event of hearing loss was considered to be medially significant.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Anaphylactic shock, Dyspnoea, Swelling of eyelid
Clinical narrative: This spontaneous report has been received from a 58 year old female patient referring to herself. The patient had a previous case of shingles. The patient was allergic to gelatin, latex and any derivatives of codeine. The patient had no concomitant medication. In approximately May 2018 (reported as about 6 months ago), the patient was vaccinated with ZOSTAVAX, 1 dose, for prophylaxis (strength, anatomical location, route of administration, batch/lot # and expiration date were not reported). In approximately May 2018 (reported as within 10 minutes of leaving the physician's office), she started going into an anaphylactic shock. Medical attention had been sought for the patient. The patient's husband drove her right back to the physician's office because she couldn't breathe, and her eyes had shut due to the anaphylactic reaction she was experiencing. Treatment was given for the event. At the doctor's office she was given two shots of cortisone to counter-act the anaphylactic reaction. No lab diagnostics/studies were performed. The outcome of anaphylactic shock was reported as recovered within one day post vaccination. No causality assessment was provided. Upon internal review, anaphylactic shock was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Pneumonia
Clinical narrative: This spontaneous report has been received from a pharmacist via a field representative referring to a female patient of unknown age. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm for prophylaxis (strength, dose number, route of administration, batch/lot # and expiration date were not reported). On unknown dates, after receiving PNEUMOVAX 23, the patient had extreme redness and swelling at injection site, diarrhea, and developed pneumonia. At the time of the report, the outcome of the events was unknown. No causality assessment was provided. Upon internal review, pneumonia was considered to be medically significant.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Pulmonary congestion
Clinical narrative: This spontaneous report as received from a nurse via a company representative and refers to a 65 year old male patient. The pertinent medical history of the patient included hypertension, atrial fibrillation, type 2 diabetes mellitus, prostate cancer and obesity. No information on the patient's concomitant medications and drug reactions or allergies was reported. The patient was vaccinated with the first dose of PNEUMOVAX 23 on 17-OCT-2002 for prophylaxis (dose, route of adminsitration, lot # and expiration date were not reported) and experienced no adverse events at that time. On 31-OCT-2018, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # R012360, expiration date 15-JAN-2020) injection, 0.5 milliliter, once, intramuscularly in the left deltoid for prophylaxis to prevent pneumococcal disease. The patient had an appointment with cardiology on 01-NOV-2018, when it was noted that the patient had coughing and shortness of breath (it was not specified if the cardiology appointment was related to something that occurred after the PNEUMOVAX 23 was administration or not). The patient saw physician on 06-NOV-2018 and presented with shortness of breath, coughing and congested lungs. The patient was admitted to an unspecified hospital on 06-NOV-2018 and released on 08-NOV-2018. The outcome of the events was reported as recovered/resolved on unspecified date in November 2018. Causality relatedness was not reported. Upon internal review, the event of congested lungs was considered as medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an expired dose of with M-M-R II 0.5 mL vial, subcutaneously, with lot # M045101 and expiration date on 10-NOV-2018 for prophylaxis. The vaccines was diluted on sterile diluent. No adverse reactions were experienced by the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Angiopathy, Bronchitis, Erythema, Sudden hearing loss
Clinical narrative: Information has been received on 20-NOV-2018 regarding a case in litigation from a lawyer and a female patient of unknown age and her spouse. There was no information provided regarding the patient's concurrent conditions, past medical history or concomitant medications. In or around 06-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered acute bronchitis, sudden idiopathic hearing loss in the patient's left ear secondary to microvascular disease, and erythematous skin patches. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Acute bronchitis, sudden idiopathic hearing loss in the patient's left ear secondary to microvascular disease, sudden idiopathic hearing loss in the patient's left ear secondary to microvascular disease and erythematous skin patches were considered to be disabling. Additional information was requested.