chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram head normal, Dysarthria, Dysgeusia
Clinical narrative: She didn't feel well when driving from Pharmacy (where she received the vaccines) to coffee shop. When she got home she felt "really ill." She states she was unable to take her dog out and never drank her coffee. She went to the den to lie down and husband found her at 530pm "wiped out." She had a metallic taste in her mouth and was "freezing." She went to bed at 7pm and had chills. Saturday she continued to have chills and the metallic taste and no energy. Sunday was the same. She was unable to go to church. She went back to bed at 1:30 pm and got up at 3:30 pm. Her husband said her face was drawn and she was slurring her speech. He took her to the ER. CT Head and CTA Head and Neck were unremarkable. An MRI 9/2/18 showed a small acute ischemic infarct in the left insular cortex and tiny focal acute ischemic infarct in the left cerebellum. She was transferred to Medical Center for further care. Overnight on 9/3/18 she had episodes of atrial fibrillation and was started on ELIQUIS. Metoprolol was started as well for elevated heart rate. Echocardiogram and EKG were normal. She was discharged 9/4/18. She is doing well except some difficulty with words if she is tired. She also tires more easily. 10/16/2018 The patient is a 73 year old female who presents for a follow up visit. The patient's last visit was 1 month ago. The patient's chronic conditions included Dysthymia and hyperlipidemia. The patient feels well with minor complaints. The patient was here in September for a hospital follow up for CVA. The patient reports she is not experiencing any side effects on her new medications: ELIQUIS, Metoprolol, Fish Oil, and LIPITOR. She was experiencing a lot of fatigue with the Metoprolol 1/2 BID so Dr. changed it to 1 tab QHS and that has helped. The patient would like to know when she will be cleared to drive. She was referred to Dr. at her last visit, but has not been seen yet. The patient also states there are times she feels like she can't take a deep breath. The patient is declining the flu vaccine and further vaccinations because she the SHINGRIX made her "deathly ill." 11/19/2018 It has been 6 weeks since her stroke and she is doing very well. I have told her today that she can drive.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Facial paralysis, Fatigue
Clinical narrative: She didn't feel well when driving from Pharmacy (where she received the vaccines) to coffee shop. When she got home she felt "really ill." She states she was unable to take her dog out and never drank her coffee. She went to the den to lie down and husband found her at 530pm "wiped out." She had a metallic taste in her mouth and was "freezing." She went to bed at 7pm and had chills. Saturday she continued to have chills and the metallic taste and no energy. Sunday was the same. She was unable to go to church. She went back to bed at 1:30 pm and got up at 3:30 pm. Her husband said her face was drawn and she was slurring her speech. He took her to the ER. CT Head and CTA Head and Neck were unremarkable. An MRI 9/2/18 showed a small acute ischemic infarct in the left insular cortex and tiny focal acute ischemic infarct in the left cerebellum. She was transferred to Medical Center for further care. Overnight on 9/3/18 she had episodes of atrial fibrillation and was started on ELIQUIS. Metoprolol was started as well for elevated heart rate. Echocardiogram and EKG were normal. She was discharged 9/4/18. She is doing well except some difficulty with words if she is tired. She also tires more easily. 10/16/2018 The patient is a 73 year old female who presents for a follow up visit. The patient's last visit was 1 month ago. The patient's chronic conditions included Dysthymia and hyperlipidemia. The patient feels well with minor complaints. The patient was here in September for a hospital follow up for CVA. The patient reports she is not experiencing any side effects on her new medications: ELIQUIS, Metoprolol, Fish Oil, and LIPITOR. She was experiencing a lot of fatigue with the Metoprolol 1/2 BID so Dr. changed it to 1 tab QHS and that has helped. The patient would like to know when she will be cleared to drive. She was referred to Dr. at her last visit, but has not been seen yet. The patient also states there are times she feels like she can't take a deep breath. The patient is declining the flu vaccine and further vaccinations because she the SHINGRIX made her "deathly ill." 11/19/2018 It has been 6 weeks since her stroke and she is doing very well. I have told her today that she can drive.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Heart rate increased, Impaired driving ability, Ischaemic cerebral infarction, Loss of personal independence in daily activities
Clinical narrative: She didn't feel well when driving from Pharmacy (where she received the vaccines) to coffee shop. When she got home she felt "really ill." She states she was unable to take her dog out and never drank her coffee. She went to the den to lie down and husband found her at 530pm "wiped out." She had a metallic taste in her mouth and was "freezing." She went to bed at 7pm and had chills. Saturday she continued to have chills and the metallic taste and no energy. Sunday was the same. She was unable to go to church. She went back to bed at 1:30 pm and got up at 3:30 pm. Her husband said her face was drawn and she was slurring her speech. He took her to the ER. CT Head and CTA Head and Neck were unremarkable. An MRI 9/2/18 showed a small acute ischemic infarct in the left insular cortex and tiny focal acute ischemic infarct in the left cerebellum. She was transferred to Medical Center for further care. Overnight on 9/3/18 she had episodes of atrial fibrillation and was started on ELIQUIS. Metoprolol was started as well for elevated heart rate. Echocardiogram and EKG were normal. She was discharged 9/4/18. She is doing well except some difficulty with words if she is tired. She also tires more easily. 10/16/2018 The patient is a 73 year old female who presents for a follow up visit. The patient's last visit was 1 month ago. The patient's chronic conditions included Dysthymia and hyperlipidemia. The patient feels well with minor complaints. The patient was here in September for a hospital follow up for CVA. The patient reports she is not experiencing any side effects on her new medications: ELIQUIS, Metoprolol, Fish Oil, and LIPITOR. She was experiencing a lot of fatigue with the Metoprolol 1/2 BID so Dr. changed it to 1 tab QHS and that has helped. The patient would like to know when she will be cleared to drive. She was referred to Dr. at her last visit, but has not been seen yet. The patient also states there are times she feels like she can't take a deep breath. The patient is declining the flu vaccine and further vaccinations because she the SHINGRIX made her "deathly ill." 11/19/2018 It has been 6 weeks since her stroke and she is doing very well. I have told her today that she can drive.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: She didn't feel well when driving from Pharmacy (where she received the vaccines) to coffee shop. When she got home she felt "really ill." She states she was unable to take her dog out and never drank her coffee. She went to the den to lie down and husband found her at 530pm "wiped out." She had a metallic taste in her mouth and was "freezing." She went to bed at 7pm and had chills. Saturday she continued to have chills and the metallic taste and no energy. Sunday was the same. She was unable to go to church. She went back to bed at 1:30 pm and got up at 3:30 pm. Her husband said her face was drawn and she was slurring her speech. He took her to the ER. CT Head and CTA Head and Neck were unremarkable. An MRI 9/2/18 showed a small acute ischemic infarct in the left insular cortex and tiny focal acute ischemic infarct in the left cerebellum. She was transferred to Medical Center for further care. Overnight on 9/3/18 she had episodes of atrial fibrillation and was started on ELIQUIS. Metoprolol was started as well for elevated heart rate. Echocardiogram and EKG were normal. She was discharged 9/4/18. She is doing well except some difficulty with words if she is tired. She also tires more easily. 10/16/2018 The patient is a 73 year old female who presents for a follow up visit. The patient's last visit was 1 month ago. The patient's chronic conditions included Dysthymia and hyperlipidemia. The patient feels well with minor complaints. The patient was here in September for a hospital follow up for CVA. The patient reports she is not experiencing any side effects on her new medications: ELIQUIS, Metoprolol, Fish Oil, and LIPITOR. She was experiencing a lot of fatigue with the Metoprolol 1/2 BID so Dr. changed it to 1 tab QHS and that has helped. The patient would like to know when she will be cleared to drive. She was referred to Dr. at her last visit, but has not been seen yet. The patient also states there are times she feels like she can't take a deep breath. The patient is declining the flu vaccine and further vaccinations because she the SHINGRIX made her "deathly ill." 11/19/2018 It has been 6 weeks since her stroke and she is doing very well. I have told her today that she can drive.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: After injection client states that pain and pressure started immediately. Client reports soreness at the injection site and shoulder with limited ROM. Reports sharp pain with movement only. 10/26/18 continues to report sharp pain with movement and aches at night when trying to sleep. Client scheduled US for 10/31/2018. Will continue to follow up.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Ultrasound scan
Clinical narrative: After injection client states that pain and pressure started immediately. Client reports soreness at the injection site and shoulder with limited ROM. Reports sharp pain with movement only. 10/26/18 continues to report sharp pain with movement and aches at night when trying to sleep. Client scheduled US for 10/31/2018. Will continue to follow up.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Injection site pain, Myalgia, Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Left shoulder pain starting 2-3 days after injection. Pain has persisted and worsening. Intermittent radiation up into trapezius and halfway down upper arm. Subjective weakness. No numbness/tingling. Started PT. Taking naproxen.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUZONE HIGH DOSE vaccine administered by mistake instead of administering the FLUARIX regular dose. Patient experienced no adverse reaction at the time of vaccination and no reported complains or reaction in the days to weeks following the vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient had unbelievable pain, which we explained could happen for a week or so. The patient still has the pain and it has been almost a month now. I called the doctor who prescribed the vaccine for the patient and they were going to call her and discuss it. Her arm was not red or have heat coming from it, so I ruled out infection I believe.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: I had severe-shivering, joint and muscle pain throughout the night. I also had a headache and a nausea tword morning. By about 2:00pm I was feeling mostly better. The injection site redness, swelling and pain went on for over 3 days. I couldn't sleep on that arm because of the pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Myalgia, Nausea
Clinical narrative: I had severe-shivering, joint and muscle pain throughout the night. I also had a headache and a nausea tword morning. By about 2:00pm I was feeling mostly better. The injection site redness, swelling and pain went on for over 3 days. I couldn't sleep on that arm because of the pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Lethargy, Malaise
Clinical narrative: Pain at injection site lasting 3+ days; redness starting day 2 lasting 3+ days; lethargy, headache, general malaise day 2 only.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of consciousness, Myoclonus, Seizure, Syncope
Clinical narrative: Patient reports brief syncopal episodes within minutes after receipt of anthrax vaccine (most recent episode after anthrax vaccine #6 on 9 Jul 2011, but had 3 other episodes following 3 previous doses of anthrax vaccine). Patient describes as "blacking out within a minute of getting vaccine".  All episodes witnessed and patient experienced "convulsions" or what he was told were "seizures".  (No documentation) Per evaluating Allergist, Nov 2018, seizures likely to be myoclonic jerks associated with syncope. Denies syncopal episodes with receipt of other vaccines. No injuries associated with syncopal episodes. Due to reproducibility of episodes, medically exempted from future anthrax vaccines in pre-event setting.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Extreme interior arm pain, redness below injection site that spread over a 48 hour period. Patient ended up going to urgent care and was given an antibiotic, prescriber was unsure why the pain and redness but gave her an antibiotic in case it was possible cellulitis. Patient has been improving to date. Patient was given flu shot at the same time as the PNEUMOVAX.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Feeling abnormal, Sepsis
Clinical narrative: Patient stated the morning after vaccination he was feeding his cat and just felt faint and "off", he called 911 and the came and brought him to the hospital up where he stayed 5 days and was treated for sepsis.
Age: 67.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized topical injection site reaction including redness, swelling, and soreness. Circular shape.  Contained to above the elbow. Treatment of cold compress, diphenhydramine and acetaminophen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Injection site erythema, Musculoskeletal stiffness, Nausea
Clinical narrative: Stiff neck, elbow/neck pain, red splotches around vaccination site, some diarrhea, aches, nausea, low grade fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Stiff neck, elbow/neck pain, red splotches around vaccination site, some diarrhea, aches, nausea, low grade fever.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Chills, Condition aggravated, Dizziness, Fatigue
Clinical narrative: Pain at injection site, 103 degree fever, tiredness, headache, shivering, body ache, dizzy, nauseous, elevated blood sugar Range of (275 to 375) when my normal weeks prior was average of 176.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Pain at injection site, 103 degree fever, tiredness, headache, shivering, body ache, dizzy, nauseous, elevated blood sugar Range of (275 to 375) when my normal weeks prior was average of 176.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: ARM PAIN, DIFFICULT TO RAISE ARM, PAIN RADIATING UP NECK AND DOWN ARM TO FINGERS, SHOULDER PAIN.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report, was received from a nurse practitioner, and refers to a female patient of unknown age. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not provided. On an unknown date, the patient became pregnant, however, the last menstrual period (LMP) and estimated delivery date (EDD) were not known. Moreover, on an unknown date, the patient was vaccinated with a dose of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. At the time of reporting, the pregnancy outcome was pending.
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. 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 26-MAY-2010, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 16-OCT-2012, the patient was treated by a healthcare provider 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. 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 23-MAY-2007, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: The initial case was missing the following minimum criteria: unspecified suspect drug. Upon receipt of follow-up information on 06Nov2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported for a female patient in her 70's received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen at injection and inflamed a couple of days, no restriction of movement with outcome of unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer RxPathways, received from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in the left arm on 06Nov2018 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Nov2018, the patient reported redness, swelling, and pain at the site of injection. The patient reported pain in left arm when something touches it, when she turns on her side or touch it against anything and that her arm was red and swollen, probably 3 inches all around where she got it. The patient would like to know how long the redness and swelling would last and wonders if it was a couple days, 5 days or should it be something she should be concerned about. The outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician Pfizer via a sales representative. A patient of unspecified age and gender received first dose of PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on 17Oct2018 at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient came back 2 days (unspecified date in 2018) later with reaction- redness, swelling below injection site. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness and nausea, vomiting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Crying, Headache, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: My arm became sore immediately. By early evening, I was unable to use my arm at all; unable to even move it. I had pain going into my jaw, into my shoulder and shoulder blade area, and pain down my arm, going into my hand. I also had headaches, which I seldom get. I was in so much pain that I was crying that night. I could not sleep or get comfortable to sleep. The next day, pretty much everything the same, the pain had gone from screaming 10, to probably an 8. My husband had to help me get dressed and undressed for all of three days; it was that bad! Saturday I was starting to be able to do a few things on my own, like get dressed. Still, my arm was very painful with pain still reaching out. Each day gets better. Today, I have very little pain, and it is primarily in the upper muscle of my arm. I am still having difficulty with sleeping in bed, even with a prop. My husband and I both received the shot that day. He had headaches, with just a small amount of arm pain. The number I indicated on previous page is his number, mine was thrown out. I should mention, that on that Thursday night, the area of my heart, between my chest and my back, was feeling strange. That was late in the evening.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity, Pain in jaw
Clinical narrative: My arm became sore immediately. By early evening, I was unable to use my arm at all; unable to even move it. I had pain going into my jaw, into my shoulder and shoulder blade area, and pain down my arm, going into my hand. I also had headaches, which I seldom get. I was in so much pain that I was crying that night. I could not sleep or get comfortable to sleep. The next day, pretty much everything the same, the pain had gone from screaming 10, to probably an 8. My husband had to help me get dressed and undressed for all of three days; it was that bad! Saturday I was starting to be able to do a few things on my own, like get dressed. Still, my arm was very painful with pain still reaching out. Each day gets better. Today, I have very little pain, and it is primarily in the upper muscle of my arm. I am still having difficulty with sleeping in bed, even with a prop. My husband and I both received the shot that day. He had headaches, with just a small amount of arm pain. The number I indicated on previous page is his number, mine was thrown out. I should mention, that on that Thursday night, the area of my heart, between my chest and my back, was feeling strange. That was late in the evening.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: I developed a headache about 4 hours after receiving the injection. I have had a headache the following two days after the injection (up to time of this report). On the second morning after the injection, I woke up feeling nauseous, and vomited.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: PARENT REPORTED TO SCHOOL NURSE LEADER THAT LATER THAT DAY CHILD DEVELOPED "HIVE LIKE" RASH AROUND INJECTION SITE [MOM DESCRIBED LOOKING LIKE MOSQUITO BITES]. NO HIVES ELSEWHERE, NO BREATHING DIFFICULTIES, FLUSHING, PROJECTILE VOMITING, LARYNGOEDEMA. 'HIVES' AROUND INJECTION SITE RESOLVED SPONTANEOUSLY.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Nodule, Pharyngeal oedema, Wheezing
Clinical narrative: Large knot on arm that lasted greater than 2 weeks, throat swelling and wheezing- patient administered BENADRYL and EPIPEN. Symptoms were resolved after doing this.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Lip blister, Pharyngeal hypoaesthesia
Clinical narrative: Numbness in throat, blisters on lips.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms; muscle/joint aches, fever, chills, sweats for 2 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms; muscle/joint aches, fever, chills, sweats for 2 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Malaise, Pain, Pain in extremity
Clinical narrative: Received vaccine Friday late morning. Arm was sore by Friday evening. Saturday morning awoke with slight fever, malaise, and extremely sore arm. Both sore to the touch and painful to move. Sunday morning awoke with arm swelling and redness. Swollen area feels hard and warm to the touch. About the size of the palm of an adult hand. While not centered on the location of injection, there is overlap. Report is filed Monday - arm is still red, swollen, warm to the touch, and painful to touch. It is now only slightly painful to move the arm. Note: patient does not recall having any visible reaction to a vaccine prior to this one. This was the second shot; the first only made the arm sore, much like a flu vaccine might do.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Received vaccine Friday late morning. Arm was sore by Friday evening. Saturday morning awoke with slight fever, malaise, and extremely sore arm. Both sore to the touch and painful to move. Sunday morning awoke with arm swelling and redness. Swollen area feels hard and warm to the touch. About the size of the palm of an adult hand. While not centered on the location of injection, there is overlap. Report is filed Monday - arm is still red, swollen, warm to the touch, and painful to touch. It is now only slightly painful to move the arm. Note: patient does not recall having any visible reaction to a vaccine prior to this one. This was the second shot; the first only made the arm sore, much like a flu vaccine might do.
Age: 11.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Blood glucose, Consciousness fluctuating, Loss of consciousness
Clinical narrative: Patient passed out after administering the BOOSTRIX. She came to and then was in and out of consciousness multiple times. I used smelling salts to help wake her up and called 911. EMT came in and ended up taking her to the hospital due to not being able to get her fully stabilized after.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site nodule, Musculoskeletal pain
Clinical narrative: Pt came in store 11-17-18 indicated that he received a flu shot and his shoulder in now hurting. He indicated initally he had a knot as site of injection and now his shoulder is hurting. Pt indicated he is going to see his pcp as a follow up.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash in area where he had PNEUMOVAX 23 vaccine. Reported the day after receiving the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Laboratory test, Malaise
Clinical narrative: Muscle pain, weak tired, headaches, fever, neck pain, body hurting all over, had to go to bed very weak. Went 2 ER on 9-12-2018 - still sick. Doc put me in Hospital stayed 4 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: Muscle pain, weak tired, headaches, fever, neck pain, body hurting all over, had to go to bed very weak. Went 2 ER on 9-12-2018 - still sick. Doc put me in Hospital stayed 4 days.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Left side facial paralysis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Loss of consciousness, Nausea
Clinical narrative: Received second dose of shingles (SHINGRIX) about 3pm on Monday 11/12/18 at doctor's office. Awoke early in the morning on 11/13/18 about 2am to use the restroom. Upon attempting to return to bed had severe dizziness, nausea, fading vision and eventually lost consciousness and fell. Awoke about 5 minutes later (per partner) still dizzy, nauseated, cold and clammy. Was able to get up (on own) and back in bed in about 20 minutes or so. Remained shaky, dizzy and nauseous until Tuesday afternoon when those symptoms resolved, approximately 24 hours after the vaccine was administered. Remained sore due to fall but was able to go to work on Wednesday with no lingering dizziness and no other lack of consciousness. No other symptoms such as vomiting and diarrhea were experienced at any time. Unable to identify any other cause for reaction. No issues with 1st dose of SHINGRIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Visual impairment
Clinical narrative: Received second dose of shingles (SHINGRIX) about 3pm on Monday 11/12/18 at doctor's office. Awoke early in the morning on 11/13/18 about 2am to use the restroom. Upon attempting to return to bed had severe dizziness, nausea, fading vision and eventually lost consciousness and fell. Awoke about 5 minutes later (per partner) still dizzy, nauseated, cold and clammy. Was able to get up (on own) and back in bed in about 20 minutes or so. Remained shaky, dizzy and nauseous until Tuesday afternoon when those symptoms resolved, approximately 24 hours after the vaccine was administered. Remained sore due to fall but was able to go to work on Wednesday with no lingering dizziness and no other lack of consciousness. No other symptoms such as vomiting and diarrhea were experienced at any time. Unable to identify any other cause for reaction. No issues with 1st dose of SHINGRIX.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Deep vein thrombosis, Erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: After receiving PREVNAR 23 injection, I noticed soreness and swelling at injection site. Later in the day I had pain in my arm and it continued to get worse. That night the pain was severe; the next morning, my arm was red and swollen and I could barely move it. The swelling and redness had spread to my wrist and it was warm to touch. Went to E.R. and ultrasound of my left arm revealed a DVT. I was given XARELTO for 3 months and later received VOLTAREN Gel and Lidocaine patches for pain. However, I am still experiencing pain and weakness in my left arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Skin warm, Ultrasound scan abnormal
Clinical narrative: After receiving PREVNAR 23 injection, I noticed soreness and swelling at injection site. Later in the day I had pain in my arm and it continued to get worse. That night the pain was severe; the next morning, my arm was red and swollen and I could barely move it. The swelling and redness had spread to my wrist and it was warm to touch. Went to E.R. and ultrasound of my left arm revealed a DVT. I was given XARELTO for 3 months and later received VOLTAREN Gel and Lidocaine patches for pain. However, I am still experiencing pain and weakness in my left arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Patient reports flu-like symptoms after injection of SHINGRIX, declines to obtain second dose.
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. In 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot# and route unknown) 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 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. 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. The outcome of the events were considered not resolved. Causality assessment was related. 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 2014, the physician 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. In 2016, the patient was treated by the 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 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.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration in the upper arm on 07Nov2018 03:30 p.m., at a single dose  for protective from getting pneumonia, preventive shot. Medical history included 'mitral' valve that was just put in patient's heart four months from the time of the report (Jul2018) and allergy with penicillin. Concomitant medication included ongoing warfarin, oral for 'mitral' valve that was just put in patient's heart. On 08Nov2018 03:00 a.m., the patient reported having so much pain in her shoulder, elbow and arm that she cannot use it. The reported that she can use her fingers but cannot use her arm and having such a hard time with it. The patient reported being in the urgent care in the morning of the report. The outcome of the events was not recovered. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer. A child patient of an unspecified gender received PREVNAR 13 (lot: R75851), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Constipation, Inappropriate schedule of product administration, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 6-month-old male patient received PREVNAR 13, via intramuscular in the Vastus Lateralis Left, first dose (Lot number: X13847, expiration date: 01Jul2020) on 23Oct2018 at 1:23 p.m. and second dose (Lot number: X34315, expiration date: 30Sep2020) on 02Nov2018, both for immunisation. The patient's medical history and family medical history relevant to AEs were reported as none. Concomitant products included PENTACEL vaccine and Rotavirus vaccine in error on 23Oct2018 plus the flu vaccine as part of the patient's 6 month wellness visit. She declined to provide any additional information for these products including Lot, Expiry, NDC, and manufacture explaining it has already been reported to those companies. The nurse reported that pneumococcal 13-val conj vac (dipht crm197 protein) was given too soon to a patient. One week after the first administration, another was given. The first one was received on 23Oct2018, the second was given on 02Nov2018. It was marked in the patient's chart that the visit was 6 month well check and that was not accurate. The nurse explained later in the call that the patient returned to the office yesterday, on 08Nov2018, with fever, vomiting, and constipation. She was not sure if there is a correlation. The only treatment was prune juice. The nurse did not think there has been any harm to the patient as a result of the events. The outcome of the event "given too soon" was recovered on 02Nov2018, the outcome of the other events was not recovered. The event "given too soon" was assessed as serious (medically significant) and unrelated to pneumococcal 13-val conj vac (dipht crm197 protein) by the reporter.
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date (reported a year and a half ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced terrible body aches that lasted a few days. The outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A female patient (Age: 66; unit was not reported) received PREVNAR 13 (Lot number and expiration date were not reported), with route of administration unspecified on 06Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06Nov2018, six hours after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), the patient had fever and chills. The patient had received BENARDYL as treatment for the fever. The outcome of the events was recovering for fever; and was unknown for chills.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site red and sore about 3 wk, itchy and sore about 1 mo. Slightly itchy about 2 mo.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: R arm at site of injection is swollen, red and inflamed. Patient states it is very tender. Patient advised to apply heat and rub arm. Also told to call if not gone down in 7 days.
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 2012, the patient's healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 18-DEC-2016, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the Zoster Vaccine Live (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.