chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Patient reports onset of general weakness 4 days after administration of vaccine. Weakness gradually progressed to the point of inability to walk and, eventually, stand. Weakness became associated with limb rigidity. Amid these events, patient became febrile and this prompted presentation to the hospital where he was admitted with acute illness presumed to be secondary to pneumonia.
Age: 12.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Student presented to the clinic with c/o right upper arm itching "where shots were given". Onset reported 11/14/18 at round 9:00pm. States arm began itching and mother gave him Tylenol. Presented to the School base clinic on 11/16/18  with redness (school base nurse describe redness area the size of a baseball) to right upper deltoid, reports itching and he reported "has been scratching site a little".  School base placed Ice pack to area. No respiratory distress, denies headache or pain. Mother was instructed by school base to follow up with PCP and to continue with ice packs and cortisone crème as needed. BP 120/77, P 118, R 20, T 98.3 oral.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Syncope
Clinical narrative: Patient fainted upon standing after getting vaccine. She hit her head on the counter. Patient's parent was there and is a physician. Observed her and said she will be fine.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Blood test, Nausea, Pyrexia
Clinical narrative: High fever, nausea, weakness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hypertension, Hypotension, Laboratory test
Clinical narrative: Patient states pharmacist told her to stay in store for 20 minutes. She works at local hospital so she went to work. Felt "funny" and BP was high, started IV steroids in clinic b/c of rash. She passed out and went to ED. Given meds to lower BP and released. Next day had terrible headache. Back to Dr. and diagnosed with meningitis. Sick for 6 weeks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Meningitis, Rash
Clinical narrative: Patient states pharmacist told her to stay in store for 20 minutes. She works at local hospital so she went to work. Felt "funny" and BP was high, started IV steroids in clinic b/c of rash. She passed out and went to ED. Given meds to lower BP and released. Next day had terrible headache. Back to Dr. and diagnosed with meningitis. Sick for 6 weeks.
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. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, subcutaneous, lot # M045101, expiration date on: 10-NOV-2018 (anatomical location was not provided) for prophylaxis. Concomitant therapies included sterile diluent(manufacturer unknown), however no adverse events reported.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Insomnia
Clinical narrative: Pain immediately after, joint aching/pain from time of injection to present, unable to lift up all the way, unable to sleep on (L) side or hold my 2 year old with (L) arm, pain is at worst with lifting arm/turning to look at watch. I was in standing position when vaccine was given. When medication was pushed, burning sensation was much more than when I have had previous flu shots in past years. I have had pain in joint same day of administration and have noticed limited ability to raise my left arm. Pain worse when I sleep on (L) side or raise my arm and turn wrist as in when I look at my watch.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain immediately after, joint aching/pain from time of injection to present, unable to lift up all the way, unable to sleep on (L) side or hold my 2 year old with (L) arm, pain is at worst with lifting arm/turning to look at watch. I was in standing position when vaccine was given. When medication was pushed, burning sensation was much more than when I have had previous flu shots in past years. I have had pain in joint same day of administration and have noticed limited ability to raise my left arm. Pain worse when I sleep on (L) side or raise my arm and turn wrist as in when I look at my watch.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dyspnoea, Hyperhidrosis, Muscle spasms, Muscle tightness, Pallor
Clinical narrative: Syncope labored breathing, sweating, pallor, Patient complaints of all muscles in body tightening and cramping.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Syncope labored breathing, sweating, pallor, Patient complaints of all muscles in body tightening and cramping.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Blepharitis, Eyelids pruritus, Oesophageal disorder, Pruritus, Urticaria
Clinical narrative: Patient states: "received my flu vaccine on Thurs 15th and approximately 36 hours later I developed severe itching, hives, swelling in eyelids and unusual knotted feeling from my esophagus. I am itching from both of my inner forearms, face, neck, torso and thighs. notified my physician of the symptoms."  Patient states she took BENADRYL in the night of 11/18/2018 and the hives resolved. She was later contacted by her MD and directed: "that she could take BENADRYL and ZANTAC if needed.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness neurosensory, Deafness unilateral, Laboratory test, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: Within 48 hours after receiving the influenza vaccine, patient experienced a sudden loss of hearing in his right ear. He was taking a hike and listening to music with headphones in both ears. As he was driving home, he noticed the loss of hearing accompanied by tinnitus. On 10/26/18, he went to the clinic and saw a nurse practitioner who confirmed no build up of wax or fluid in the ear. She suggested the patient try Sudofed and a nasal spray, neither of which worked. On 10/30/18, patient was seen by Dr. and an audiologist and was diagnosed with sudden sensorineural hearing loss (SSHL). He was given oral prednisone for 1 week until he received a steroid injection into the ear on 11/6/18. Neither of these therapies improved his hearing. On 11/13 lab work was done and a MRI was scheduled for 11/19/18. The MRI was done on 11/19/18 and confirmed no tumors or other explanation for the hearing loss. Between the time of the vaccination and the hearing loss, the patient reports no changes in prescriptions or health. He continues to have hearing loss and constant tinnitus that varies in intensity and characteristic. Dr.has recommended a bicross hearing aid to assist.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Within 48 hours after receiving the influenza vaccine, patient experienced a sudden loss of hearing in his right ear. He was taking a hike and listening to music with headphones in both ears. As he was driving home, he noticed the loss of hearing accompanied by tinnitus. On 10/26/18, he went to the clinic and saw a nurse practitioner who confirmed no build up of wax or fluid in the ear. She suggested the patient try Sudofed and a nasal spray, neither of which worked. On 10/30/18, patient was seen by Dr. and an audiologist and was diagnosed with sudden sensorineural hearing loss (SSHL). He was given oral prednisone for 1 week until he received a steroid injection into the ear on 11/6/18. Neither of these therapies improved his hearing. On 11/13 lab work was done and a MRI was scheduled for 11/19/18. The MRI was done on 11/19/18 and confirmed no tumors or other explanation for the hearing loss. Between the time of the vaccination and the hearing loss, the patient reports no changes in prescriptions or health. He continues to have hearing loss and constant tinnitus that varies in intensity and characteristic. Dr.has recommended a bicross hearing aid to assist.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was administered with a 5/8 inch needle instead of a 1 inch needle. Per CDC guidelines re-vaccination is recommended in this situation. Patient received their re-vaccination same day in right arm at 2:22PM.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Crying, Decreased activity, Erythema, Eye movement disorder, Pallor
Clinical narrative: This is 39 weeks +2 gestation baby boy, S/P NSVD, came to check up and received the 2nd dose of hepatitis B vaccine 3 days ago. Right after injection grandma brought baby back to Dr. PCP and complaint baby's face turned pale with less active. Dr. checked the patient's heart rate that was regular. Dr. examined the patient and then the patient cried and face turned to red. It was about 5 minutes. Dr. asked mother to feed baby with bottle formula. The patient's suction was strong. After feeding (2 OZs) baby fell sleep and face color maintained normal. Dr. discharged the baby home afterwards. Dr. made a follow-up call 2-3 hours later. Mother said baby is OK, just quiet than before. The following night mother saw patient rolling his eye and went to Hospital - ER. ER attending discharged him home the same day. Last night patient had eye rolling episodes again. No fever, respiratory distress, no seizure noticed. Bottle feeding 2 OZs every 2 hours. Stool once a day. Mother complained that patient's extremities feel cold and look pale than before. I checked patient big toe O2 sat: 100% on room air. Pals: 150-160. Mother said patient did not sleep well last night and sleep day time now.The following night mother saw patient rolling his eye and went to ER. ER attending discharged him home the same day. Last night patient had eye rolling episodes again. No fever, respiratory distress, no seizure noticed. Bottle feeding 2 OZs every 2 hours. Stool once a day. Mother complained that patient's extremities feel cold and look pale than before. Dr. checked patient big toe O2 sat: 100% on room air. Pals: 150-160. Mother said patient did not sleep well last night and sleep day time now.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Peripheral coldness, Poor quality sleep, Somnolence
Clinical narrative: This is 39 weeks +2 gestation baby boy, S/P NSVD, came to check up and received the 2nd dose of hepatitis B vaccine 3 days ago. Right after injection grandma brought baby back to Dr. PCP and complaint baby's face turned pale with less active. Dr. checked the patient's heart rate that was regular. Dr. examined the patient and then the patient cried and face turned to red. It was about 5 minutes. Dr. asked mother to feed baby with bottle formula. The patient's suction was strong. After feeding (2 OZs) baby fell sleep and face color maintained normal. Dr. discharged the baby home afterwards. Dr. made a follow-up call 2-3 hours later. Mother said baby is OK, just quiet than before. The following night mother saw patient rolling his eye and went to Hospital - ER. ER attending discharged him home the same day. Last night patient had eye rolling episodes again. No fever, respiratory distress, no seizure noticed. Bottle feeding 2 OZs every 2 hours. Stool once a day. Mother complained that patient's extremities feel cold and look pale than before. I checked patient big toe O2 sat: 100% on room air. Pals: 150-160. Mother said patient did not sleep well last night and sleep day time now.The following night mother saw patient rolling his eye and went to ER. ER attending discharged him home the same day. Last night patient had eye rolling episodes again. No fever, respiratory distress, no seizure noticed. Bottle feeding 2 OZs every 2 hours. Stool once a day. Mother complained that patient's extremities feel cold and look pale than before. Dr. checked patient big toe O2 sat: 100% on room air. Pals: 150-160. Mother said patient did not sleep well last night and sleep day time now.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given peds hep A, not adult. Will be given adult in 6 mos.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: CSF test abnormal, Meningitis viral, Polymerase chain reaction positive, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: Developed VZV meningitis- CSF pos for VZV by PCR<, strain tested at CDC was vaccine strain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given high dose flu shot.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Oedema, Tendon rupture
Clinical narrative: Shoulder pain, tear in tendon, and edema.
Age: 82.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine #3 in series provided too soon. No S/S. Patient contacted and informed next dosage should be on or after January 1st.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient given DTaP, not Tdap.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient given Tdap, not DTaP.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient had swelling on arm that extend down to upper forearm after morning of the 3rd day (received shot on Saturday; swelling at upper foreman did not occur until Tuesday AM per patient. No other noted issues.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Paraesthesia, Pyrexia
Clinical narrative: Wife stated patient was febrile, tingling in arms, and difficulty breathing. Patient is currently in emergency room.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Emotional distress, Headache
Clinical narrative: Had the injection on Friday morning. I had no problems Friday or Saturday. Woke up Sunday morning and was lightheaded and disoriented when standing up to get out of bed. Was not really dizzy and was not nauseated. Laying down or sitting down reclined I felt OK, but was distressed if I sat upright and particularly if I stood up. I was like this all day Sunday and all day Monday. Today, on Tuesday the symptoms have decreased but I still feel a little disoriented with a mild headache. During this whole time I was able to eat and drink pretty normally, but in small quantities. Hopefully will feel better on Wednesday.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Impaired work ability, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Within a few hours, soreness at injection site which was expected, that was the only reaction I had with the first dose, a couple months ago. A few hours after that, my arm felt sore. About 16 hours later, slight malaise, just didn't feel great. 28 hours after injection, intense malaise; 30 hours after, intense, uncontrolled shaking and severe malaise. Had to miss work the next day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Within a few hours, soreness at injection site which was expected, that was the only reaction I had with the first dose, a couple months ago. A few hours after that, my arm felt sore. About 16 hours later, slight malaise, just didn't feel great. 28 hours after injection, intense malaise; 30 hours after, intense, uncontrolled shaking and severe malaise. Had to miss work the next day.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm very painful, red and swollen.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Complaints of feet going numb and traveling upwards towards midsection. Neurologist contacted and prescribed IV steroids for 3 days and oral medications for a week.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was already vaccinated for Influenza on 9/26/18, second one was given in error. Patient had no adverse reaction to first or second vaccine.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of 3 years and 9 months and unknown gender. There was no information about the patient's concurrent conditions, medical history, allergies or concomitant medications. On an unknown date, reported as "recent", the patient was vaccinated with M-M-R II dose 2, for prophylaxis, lot # N004433 (expiration date 07-FEB-2019) (frequency, anatomical location and route of administration were not provided). According to the report, the patient received the second dose of the vaccine at age 3 years and 9 months (administered early). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 05-NOV-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N025428 with expiration date on 19-JUN-2020 (strength, anatomical location or route of administration were not provided), for prophylaxis. The storage temperature of the vaccine was reported as 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36 to 46°F for 10 hours and 25 minutes; and 32 up to 35 °F for 3 hours and 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2012, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient. In 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-MAY-2014, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-FEB-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 16-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. All available medical records will be provided upon request.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-APR-2012, a physician at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 09-OCT-2016, the patient was treated by a nurse practitioner at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited non-valid non-serious case received from a nurse via phone. This case involves a 66 years old female patient who received a 0.5ml first and second dose of FLUZONE QUADRIVALENT, lot UT6290KA via intramuscular route in the left deltoid on 04-Oct-2018 and 02-Nov-2018 respectively. Concomitant medications included was Pneumococcal Vaccine for Immunisation. The patient's medical history were not reported. It was an actual medication case error due to extra dose administered. The patient received two FLUZONE QUADRIVALENT 0.5ml, intramuscular injections in her left deltoid one month apart. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 10 years old male patient who experienced tingling and numbness from his elbow down to fingers, the 5th, 4th and 3rd fingers were particularly affected and pain, redness and swelling at the injection site, while he received vaccines FLUZONE QUADRIVALENT and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 15-Nov-2018, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (lot C5519AA and expiration date 12-Sep-2020) via intramuscular route in unknown administration site. On the same day, the patient also received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine (lot number not reported) via intramuscular route in unknown administration site. On 15-Nov-2018, the patient developed a non-serious tingling (paraesthesia) and numbness from his elbow down to fingers, the 5th, 4th and 3rd fingers were particularly affected (hypoaesthesia) within 20 minutes following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine and Influenza Quadrival A-B Vaccine. Till 16-Nov-2018, the symptoms continued and he was evaluated by the physician. Physician reported that his strength was good and was able to squeeze hands equally. ROM fair. On an unknown date, the patient developed a non-serious pain, redness and swelling at the injection site (vaccination site inflammation) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine and following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included No lab data.) Final diagnosis was pain, redness and swelling at the injection site, numbness from his elbow down to fingers, the 5th, 4th and 3rd fingers were particularly affected and tingling. It was not reported if the patient received a corrective treatment. Physician recommended ibuprofen and cool compress. The patient outcome is reported as Unknown for tingling, numbness from his elbow down to fingers, the 5th, 4th and 3rd fingers were particularly affected and pain, redness and swelling at the injection site. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Local reaction, Mass, Pain, Swelling
Clinical narrative: I had to present to Urgent Care on 11/16/18 (per Pharmacist) for local reaction. Redness, swelling, soreness, large baseball sized lump. Took TYLENOL for pain and am now on Prednisone for 5 days (20 mg tabs - 2 x day). $40 co-pay.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Dyspnoea, Lacrimation increased
Clinical narrative: Severely red eyes, eyes watering, lips swollen, slight fever and chills, slight problem breathing, a bit of a cough, runny nose, congestion in sinuses, achy joints in certain limbs.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Ocular hyperaemia, Pyrexia, Rhinorrhoea, Sinus congestion
Clinical narrative: Severely red eyes, eyes watering, lips swollen, slight fever and chills, slight problem breathing, a bit of a cough, runny nose, congestion in sinuses, achy joints in certain limbs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site reaction, Insomnia, Pain in extremity
Clinical narrative: 1 day after: Extremely sore arm with redness and swelling - enough to cause sleeplessness; 3 days after: Shingles rash at site of previous shingles outbreak (2013) - treated with lidocaine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 1 day after: Extremely sore arm with redness and swelling - enough to cause sleeplessness; 3 days after: Shingles rash at site of previous shingles outbreak (2013) - treated with lidocaine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Neurological examination, Pain, Pain in extremity
Clinical narrative: RECEIVED A INFLUENZA VACCINE AT 1:30PM, 10 HOURS LATER, 11:30PM STARTED FEELING MUSCULAR SEVERE PAIN IN BOTH LEGS. ON A SCALE OF 1-10, PAIN FELT LIKE 7-8. A BURNING PAIN  LASTED 2-DAYS, BOTH LEGS LOST STRENGTH. WAS UNABLE TO LIFT MYSELF OF THE TOILET SEAT, WAS IN BED FOR TWO DAYS. PAIN RESOLVED ON ITS OWN AFTER SECOND DAY ARRIVED AT CLINIC TO SEEK MEDICAL ASSISTANCE PAIN WAS THEN AT A 1-2 LEVEL.  MY PCP'S  PARTNER REFERRED ME TO A NEUROLOGIST, UNDER WENT NEUROLOGICAL TESTING.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Patient experienced tingling in her index, middle, and ring finger of the injected arm. Patient also experienced slight swelling at the injection site as well as some tingling in her bicep area. The shot was administered in her deltoid. Our recommended tx was IBU and cold compresses. Outcome unknown yet, but we've instructed her to follow up with us if the symptoms change and each day.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: .25ml dose given to the 3 year old, instead of indicated .5ml.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye swelling
Clinical narrative: Took the flu shot around 2pm and went for a nap two hours later and left eye is swollen.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Stiff, sore left shoulder. Unable to raise arm or lift objects. No apparent nerve damage. Painful as the fluid was going in and was immediately sore. After shot, she realized the shot was given too high. (She is an RN). Arm became more and more stiff. Within 2 hours after administration she was unable to lift her left arm or cross over her body. Pain down the back of her left arm and in her left shoulder. Went to urgent care 10/20/18. Oral steroids did not give lasting relief after finished. Posterolateral left shoulder injections with KENALOG, bupivacaine and lidocaine resolved pain.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: Stiff, sore left shoulder. Unable to raise arm or lift objects. No apparent nerve damage. Painful as the fluid was going in and was immediately sore. After shot, she realized the shot was given too high. (She is an RN). Arm became more and more stiff. Within 2 hours after administration she was unable to lift her left arm or cross over her body. Pain down the back of her left arm and in her left shoulder. Went to urgent care 10/20/18. Oral steroids did not give lasting relief after finished. Posterolateral left shoulder injections with KENALOG, bupivacaine and lidocaine resolved pain.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient experienced redness, inflammation, soreness, warm to touch and itching at the vaccination site. Patient was recommended to take ibuprofen, apply BENADRYL cream and ice packing. We called the patient 2 days later and she said everything is fine and no symptoms.
Age: 0.92
Sex: F
Vaccine: PNC13
Symptoms: Diet refusal, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Thigh become red, swollen and warm to touch. That evening she developed a 103 fever, was lethargic and refusing all food. She ended up being sick for an entire week after this. She was completely fine prior to the vaccine.
Age: 0.92
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pyrexia
Clinical narrative: Thigh become red, swollen and warm to touch. That evening she developed a 103 fever, was lethargic and refusing all food. She ended up being sick for an entire week after this. She was completely fine prior to the vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: Patient developed fever (100 F) at 9 pm that lasted about 4  hours. Patient felt ill (very lethargic ) for next FIVE days.
Age: 20.0
Sex: F
Vaccine: FLUC4, MENB
Symptoms: Dizziness, Paraesthesia, Tinnitus, Vision blurred
Clinical narrative: Light headed, ringing in the ears, blurred vision, tingling in the arms.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Musculoskeletal stiffness, Pallor, Seizure
Clinical narrative: Patient was standing by the counter after receiving her vaccine. While Mom was holding her brother, the patient slumped to the floor and Mom shouted "She's having a seizure". Both of us immediately picked the child up and mom held her. The patient was not shaking; she was stiff and very pale. She came to and said "I had a seizure".  Mom then reported that patient has a history of pain-induced seizures. No injuries were reported. Patient was given a bottle of water and Mom held her for about 10 minutes in the clinic room. Patient walked out with Mom about 10-15 minutes after the incident.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore Throat, Sneezing violently, Stuffiness, Runny Nose, Severe Weakness, Fatigue, Headache, General Aches all over body. Has been going on since about 10/11/2018.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rhinorrhoea, Sneezing
Clinical narrative: Sore Throat, Sneezing violently, Stuffiness, Runny Nose, Severe Weakness, Fatigue, Headache, General Aches all over body. Has been going on since about 10/11/2018.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A KINRIX was administered to 6 month old patient, KINRIX is indicated for 4 year old to 6 year old. Patient was suppose to receive PEDIARIX instead which recommended for patients age.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient states that she has suffered a shoulder injury from the administration technique. Patient is receiving treatment by her physician.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site macule, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, macular, warm, and swollen "to the size of a baseball."
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: 7 hours after receiving the influenza, quadrivalent (P-free) vaccine I started to get intense body aches, nausea, light headedness, and a fever (101). The fever and body aches lasted for approximately 10 hours (from 4 pm - ~2 am?). When I woke up at 6 am the fever was gone and I felt back to normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Asthenia, Hypotonia, Muscular weakness, Pyrexia, Skin warm
Clinical narrative: Mom called on 11/20/18 and reported that MGM initially noticed pt to be "staring" about 6-7 hours after vaccination. He also had fever, up til 103 F at 6 pm. (Vague about exact time). Pt seen with mom. Some hx obtained from Grandma on phone. Grandma reports around 6pm, on the evening of immunizations, she noticed him in the crib with eyes open, "staring up". Picked him up and felt warm. She checked the temperature and it was 103F per MGM. MGM reports she gave him TYLENOL and watched him. Reports he had "no energy" /"limp", "weak" was not holding his neck, like he usually does, per MGM. Was moving his tongue. Denies any tonic-clonic convulsions with the episode. Acting like "zombie". Denies his tongue swelling/wheezing/resp. distress. Reports didn't call 911/doctor as thought it may be "normal reaction" to the shot. MGM reports she had watched a TV commercial about side effects of Dtap, few days prior and it seemed like that. She reports that she doesn't want to give him Dtap, next time. MGM reports she fed him, though and he took 1/4 of bottle and then slept for 3 hours or so. Mom reports she had work shift from 6-10pm that night. When, mom came back from work same night, she reports she checked temp. and it was still 103. (Axillary) (MGM reported that after about 1 hour of TYLENOL, temp. dropped to 99F). Mom wonders if fever came back again. Mom reports, for her, he had less energy. "He was here but not here". Mom reports she thinks his mind was somewhere else. Mom reports she waved her hand in front of him, waved his toy, but didn't seem as interactive. Mom reports he slept soon afterwards and slept through rest of the night. She reports Sx of less than normal energy level lasted less than 24 hours, and then he started getting back his energy. She reports that is why she didn't call doctor/take him for evaluation. On her way out, at check out desk mom mentioned that on Sunday, while she held him, felt like his legs were shaking. She reports she is not sure whether with her hand movement, it stopped. It lasted, maybe for 30-45 seconds. There was one more episode like that of similar nature few hours later, on Sunday as well (details not-specific and vague) and then it never happened. Mom reports she was scared, however, she told her mom about it but didn't call doctor /seeked care as it was very brief and he has been acting like himself right afterwards and since then. Mom reports it didn't look like a seizure. (Mom had a list of reported symptoms from MGM on her phone). We got MGM on speaker and got hx from her directly as well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Staring, Tremor
Clinical narrative: Mom called on 11/20/18 and reported that MGM initially noticed pt to be "staring" about 6-7 hours after vaccination. He also had fever, up til 103 F at 6 pm. (Vague about exact time). Pt seen with mom. Some hx obtained from Grandma on phone. Grandma reports around 6pm, on the evening of immunizations, she noticed him in the crib with eyes open, "staring up". Picked him up and felt warm. She checked the temperature and it was 103F per MGM. MGM reports she gave him TYLENOL and watched him. Reports he had "no energy" /"limp", "weak" was not holding his neck, like he usually does, per MGM. Was moving his tongue. Denies any tonic-clonic convulsions with the episode. Acting like "zombie". Denies his tongue swelling/wheezing/resp. distress. Reports didn't call 911/doctor as thought it may be "normal reaction" to the shot. MGM reports she had watched a TV commercial about side effects of Dtap, few days prior and it seemed like that. She reports that she doesn't want to give him Dtap, next time. MGM reports she fed him, though and he took 1/4 of bottle and then slept for 3 hours or so. Mom reports she had work shift from 6-10pm that night. When, mom came back from work same night, she reports she checked temp. and it was still 103. (Axillary) (MGM reported that after about 1 hour of TYLENOL, temp. dropped to 99F). Mom wonders if fever came back again. Mom reports, for her, he had less energy. "He was here but not here". Mom reports she thinks his mind was somewhere else. Mom reports she waved her hand in front of him, waved his toy, but didn't seem as interactive. Mom reports he slept soon afterwards and slept through rest of the night. She reports Sx of less than normal energy level lasted less than 24 hours, and then he started getting back his energy. She reports that is why she didn't call doctor/take him for evaluation. On her way out, at check out desk mom mentioned that on Sunday, while she held him, felt like his legs were shaking. She reports she is not sure whether with her hand movement, it stopped. It lasted, maybe for 30-45 seconds. There was one more episode like that of similar nature few hours later, on Sunday as well (details not-specific and vague) and then it never happened. Mom reports she was scared, however, she told her mom about it but didn't call doctor /seeked care as it was very brief and he has been acting like himself right afterwards and since then. Mom reports it didn't look like a seizure. (Mom had a list of reported symptoms from MGM on her phone). We got MGM on speaker and got hx from her directly as well.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Torticollis
Clinical narrative: Cervical dystonia starting at 1am 11/8/18 clonazepam increased in frequency and not control by initial dose of clonazepam.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Lumbar puncture, Multiple sclerosis, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Paresthesias of right leg started on 12/26 and over the next month progressed to bilateral legs and bilateral arms paresthesias with associated nerve pain. Also developed bilateral hand stiffness. Diagnosed with Multiple Sclerosis Feb 2017.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Paresthesias of right leg started on 12/26 and over the next month progressed to bilateral legs and bilateral arms paresthesias with associated nerve pain. Also developed bilateral hand stiffness. Diagnosed with Multiple Sclerosis Feb 2017.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: Patient felt flu like symptoms along with a headache for approximately 5 days after receiving the vaccination. She never developed a fever during those days, only body aches, like the flu and headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was administered a dose of SHINGRIX on 11/14/2018. Patient started experiencing signs/symptoms of shingles on 11/17/2018. Patient was seen by Dr. on 11/20/2018 who diagnosed patient with shingles. Dr. called the pharmacy to inform of diagnosis.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Headache, fever, toothache, skin hurt, nausea, dizzy, extreme fatigue, aches joints, stomach ache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin, Pyrexia, Toothache
Clinical narrative: Headache, fever, toothache, skin hurt, nausea, dizzy, extreme fatigue, aches joints, stomach ache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Malaise, Pain of skin
Clinical narrative: Patient reported 2 areas that were red and sore 24-48 hours after the immunization. The 1st area was at injection site and was about 1.5"x 1.5" and the 2nd area was on the bicep area of same arm near the elbow which the painful rash was about 3" x 5" in size. Patient also reported that her skin on the back of her neck and shoulder was sore to touch and hot. Patient reported a fever about 24 hours after immunization and malaise for 48 hours. Patient stated she felt like she was getting shingles. Patient stated that after 5 days she started feeling better.