chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four-months old female patient who was vaccinated with only a 0.5 ml of DTaP/IPV liquid portion from first dose of PENTACEL lot C5527AA (also vial Lot = C5527AA and ACTHIB powder = C5426AA); expiry date: 04-Oct-2019 via intramuscular route in the left thigh on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. Patient only received the DTaP/IPV liquid portion and not the ACTHIB Lyophilized powder portion of the vaccine. It was unknown whether the patient experienced any adverse reactions or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 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: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 4 years old male patient who had received vaccines liquid DTAP-IPV portion of PENTACEL instead of QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received a 0.5 ml dose of DTAP-IPV portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Lot C5595AA, exp date: 11/22/2019 unknown route in unknown administration site. It was a case of actual medication error due to inappropriate reconstitution technique and wrong vaccine administered because 0.5 ml DTAP-IPV given from PENTACEL without the ACTHIB portion and liquid portion of PENTACEL instead of QUADRACEL. It was not reported that if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who was vaccinated with a 0.5 ml fourth dose of QUADRACEL (formulation Suspension for injection) (Batch number: C5325BA, expiration date: 14-Nov-2019, site of administration: right thigh and route was not reported) on 15-Aug-2017. Concomitant medications included was ACT-HIB via right thigh and PREVNAR 13 via left thigh. The patient medical history medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. Nurse reports that female child 15 months received QUADRACEL injection for order for routine DTaP vaccination. 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.
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 4 months old male patient who received vaccine ACT-HIB. The patients past medical history, and family history were not provided. Concomitant medications included DAPTACEL on 28-Nov-2018. On 28-Nov-2018, the patient received a first dose of suspect HIB (PRP/T) VACCINE lot UI820AA, expiry date 18-Nov-2018 via unknown route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that 4-month old male received expired ACT-HIB vaccine. The patient did not experience any adverse reaction after the injection. 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.
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office staff manager). This case is linked to case 2018SA331474, same reporter. This case involves a 6 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 09-Nov-2018, the patient received a 0.25 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date 30-Mar-2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose. It was reported that patient who should have received 0.5 ml only received 0.25 ml of vaccine FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. 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.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA331473 (same reporter). This case involves a nine years old female patient who was vaccinated with a 0.25 ml dose instead of 0.5 ml dose FLUZONE QUADRIVALENT lot UT6259NA and Exp. Date 30-MAR-2019 via unknown route in the left deltoid on 09-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 57 years old female patient who experienced numbness in her left foot- it spread to both hands and feet and is worse in the morning/tingling, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Five or six years ago she had the Hypoaesthesia but it resolved in a week. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 15-Nov-2018, the patient received a 0.5 mL dose of suspect Influenza Quadrival A-B Vaccine, lot UJ070AA, expiry date: 30-Jun-2019 via unknown route in the left deltoid. On an unknown date, 12 hours later the patient developed a non-serious numbness in her left foot- it spread to both hands and feet and is worse in the morning/tingling (hypoaesthesia) following the administration of Influenza Quadrival A-B Vaccine. It was reported that the patient came back to see her doctor two days ago, her reflexes were good, no sensory defect with light touch. Her left arm was a little weaker but it could be because she was right handed. Other relevant tests included no lab data. Final diagnosis was numbness in her left foot- it spread to both hands and feet and is worse in the morning. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 59 years old female patient who experienced tingling in hands and feet, while she received vaccine INFLUENZA VACCINE. The patient's past vaccination(s) included flu vaccine received 6 years ago and resolved in a week. The patient's past medical history and concomitant medication were not provided. At the time of the event, the patient had ongoing Chronic fatigue syndrome. On 15-Nov-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, The patient experienced tingling in hands and feet (paraesthesia) following the administration of INFLUENZA VACCINE. Event had persisted. (Other relevant tests included no lab test.) Final diagnosis was tingling in hands and feet. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for tingling in hands and feet.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash erythematous, Scab
Clinical narrative: Pt describes rash as "pink/red bumps" on upper back. Rash started evening on day of vaccination. Rash lasted approximately 5 days, opened and scabbed over. Pt complained of intense pruritus, denied pain. Denied rash to L arm (location of vaccination). Pt used Calamine lotion and BENADRYL PO for itching. Pt reported event on 12/6/18 (close to 5 weeks after vaccination) when she returned for MMRV2. MMRV2 was not administered.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Diabetes mellitus inadequate control, Diabetic ketoacidosis, Laboratory test
Clinical narrative: 11/21/2018 at 10:30 at Urgent Care: Chills, cellulitis in left arm and painful urination which was an error - I just couldn't pee a sample. 11/22/2018 at 1900 at Emergency Room:  I triggered a code red. Diagnoses of diabetic ketoacidosis, blood sugar out of control, sepsis, white blood cell count 22,000, TIA (Transient  Ischemic Attack) and cellulitis. I was told at some point that I had liver damage but that it had repaired itself by the time I left the hospital around 1400 on 11/26/2018. Pneumonia was talked about constantly throughout the ER and hospital notes but not specifically diagnosed. My daughter was told I had fluid in my lungs at the ER. Dr. whose specialty is infectious disease, saw me.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Liver injury, Pulmonary oedema, Sepsis, Transient ischaemic attack, Urinary retention
Clinical narrative: 11/21/2018 at 10:30 at Urgent Care: Chills, cellulitis in left arm and painful urination which was an error - I just couldn't pee a sample. 11/22/2018 at 1900 at Emergency Room:  I triggered a code red. Diagnoses of diabetic ketoacidosis, blood sugar out of control, sepsis, white blood cell count 22,000, TIA (Transient  Ischemic Attack) and cellulitis. I was told at some point that I had liver damage but that it had repaired itself by the time I left the hospital around 1400 on 11/26/2018. Pneumonia was talked about constantly throughout the ER and hospital notes but not specifically diagnosed. My daughter was told I had fluid in my lungs at the ER. Dr. whose specialty is infectious disease, saw me.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: 11/21/2018 at 10:30 at Urgent Care: Chills, cellulitis in left arm and painful urination which was an error - I just couldn't pee a sample. 11/22/2018 at 1900 at Emergency Room:  I triggered a code red. Diagnoses of diabetic ketoacidosis, blood sugar out of control, sepsis, white blood cell count 22,000, TIA (Transient  Ischemic Attack) and cellulitis. I was told at some point that I had liver damage but that it had repaired itself by the time I left the hospital around 1400 on 11/26/2018. Pneumonia was talked about constantly throughout the ER and hospital notes but not specifically diagnosed. My daughter was told I had fluid in my lungs at the ER. Dr. whose specialty is infectious disease, saw me.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports soreness in arm, limited range of motion in shoulder when lifting arm, soreness in arm when sleeping at night x 1 week without improvement. Instructed pt to follow up with PCP for symptom treatment if it is very bothersome, continue to monitor and report if no improvement.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Mother called the health department at 1:30 p.m. on 12/6/18 stating that she had picked her child up from school due to pain in the right arm with child stating she could not use a pen. States no edema or erythema or other abnormal signs at injection site. Mom states that she complained of it being a little sore last night after the shot yesterday and mom told her this morning that if it started hurting her to call and she would come and pick her up from school. Child called this afternoon complaining that she could not use a pen to write without pain in her arm. I consulted with our medical director who advised TYLENOL or MOTRIN, cold compresses and to see her doctor if symptoms worsen.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives within 1 hour and the next day. No other symptoms. Via photos and telephone call: Advised cetirizine or oral BENADRYL.
Age: 3.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Computerised tomogram head, Electroencephalogram, Full blood count, Metabolic function test, Seizure
Clinical narrative: Patient had two seizures today, one at 4:30 AM and another at 11:30 AM. They did not require medications to stop them, but he is being admitted to the hospital for a neurologic workup.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Generalized erythematous urticarial rash with itching.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: R Bells palsy 2-3 days after getting the Flu vaccine.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site as patient's parent thinks it was administered incorrectly.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and soreness at injection site, which is to be expected but patient reported today (8 days later) that the redness flares up after showering, the exposure to warm water causes the redness to come back also had red marks that look like "capillaries are broken under the skin ".
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: The night of the injection, She began to get a few hives on her mid body. They still remain and are continuing to move upward on her body including in the armpit. Maybe 30 or 40 red spots total.  No other symptoms or problems at this time.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, and swelling at/around injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Headache, Injection site pain, Nausea
Clinical narrative: Nausea, stomach pain, head ache, joint pain, injection site pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Injection site erythema, Injection site swelling, Neck pain, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included zostavax with an associated reaction of herpes zoster (received in 2013). On 11th September 2018, the patient received SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 17th September 2018, the patient experienced nerve pain, ear pain, neck pain and jaw pain. The patient was treated with gabapentin. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the nerve pain was resolved with sequelae and the outcome of the ear pain, neck pain and jaw pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nerve pain, ear pain, neck pain and jaw pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient had experienced shingles 2 weeks following the ZOSTAVAX vaccine in 2013. The shingles presented on her left ear and down the left side of her neck. On the next day of SHINGRIX vaccination, the patient experienced a red, swollen area measuring 2 square inches at the injection site. The symptoms lasted 6 days. On 17th September 2018 (Monday morning), 6 days after receiving SHINGRIX vaccine, she woke up with ear, jaw and neck pain on the left side. She was examined by her dentist and he did not find any tooth issues. She was then examined by her physician who believed she experienced a flare up of nerve pain from the previous case of shingles. The pain comes and goes. The last time it presented was a couple of weeks ago. The patient took gabapentin to help control the pain. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included zostavax with an associated reaction of herpes zoster (received in 2013). On 11th September 2018, the patient received SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 17th September 2018, the patient experienced nerve pain, ear pain, neck pain and jaw pain. The patient was treated with gabapentin. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the nerve pain was resolved with sequelae and the outcome of the ear pain, neck pain and jaw pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nerve pain, ear pain, neck pain and jaw pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient had experienced shingles 2 weeks following the ZOSTAVAX vaccine in 2013. The shingles presented on her left ear and down the left side of her neck. On the next day of SHINGRIX vaccination, the patient experienced a red, swollen area measuring 2 square inches at the injection site. The symptoms lasted 6 days. On 17th September 2018 (Monday morning), 6 days after receiving SHINGRIX vaccine, she woke up with ear, jaw and neck pain on the left side. She was examined by her dentist and he did not find any tooth issues. She was then examined by her physician who believed she experienced a flare up of nerve pain from the previous case of shingles. The pain comes and goes. The last time it presented was a couple of weeks ago. The patient took gabapentin to help control the pain. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema
Clinical narrative: Patient reported on Monday pain in joints and redness on arm.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Grandmother reports that he had fever of 101 degrees F on 11/17, fever broke on 11/18 around 6 PM, on 11/19 broke out in light red non-raised scattered rash on head, face, back and trunk. On 11/21 Rash no longer visible. No treatment done.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood urine absent, Chromaturia, Full blood count, Urine analysis normal
Clinical narrative: Blood noted in diaper (orange coloration); Cath urine negative for blood or signs of infection.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Back pain, Blood culture, C-reactive protein, Diarrhoea
Clinical narrative: Muscular weakness, difficulty breathing, frequent diarrhea, abdominal and back pain, shortness of breath, worsening "twitching", and hives.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Full blood count, Metabolic function test, Muscle twitching, Muscular weakness
Clinical narrative: Muscular weakness, difficulty breathing, frequent diarrhea, abdominal and back pain, shortness of breath, worsening "twitching", and hives.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate, Respiratory viral panel, Urticaria
Clinical narrative: Muscular weakness, difficulty breathing, frequent diarrhea, abdominal and back pain, shortness of breath, worsening "twitching", and hives.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Asthenia, Back pain, Brown-Sequard syndrome, Computerised tomogram
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Dysstasia, Exaggerated startle response, Fatigue
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Guillain-Barre syndrome, Head discomfort, Headache, Hemiparesis
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperacusis, Hypokinesia, Insomnia, Laboratory test, Lacrimation increased
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of proprioception, Muscle spasticity, Neck pain, Nervous system disorder, Rhinorrhoea
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory loss, Sneezing, Syncope, Temperature regulation disorder, Yawning
Clinical narrative: 11/21/2011 approx.8:30 PM-Began to feel weak, dizzy, faint. Went to lay down, about 4 hours later woke to go to the bathroom, while in bathroom lost all movement and feeling in both arms from shoulders down, made it back to bed before losing all movement in both legs, then began to have trouble breathing. Approx 1:30 AM on 11/22/2011. arrived by ambulance at Hospital. Later that morning was transferred to another Hospital with "no voluntary movement". Was inpatient at hospital for 8 days then transferred to Rehabilitation for "Acute Inpatient Rehab." where I stayed from 11/29/2011 - 12/08/2011. There are copious medical records from all institutions. I have regained most movement but have many neurological deficits. In no particular order this is a list of some of my deficits. 1) Vasovagal Syncope, 2) Brown-Sequard Syndrome, 2a) Right sided weakness, spasticity & loss of proprioception, 2b) Left-sided loss of sensations - no feeling of pain or of temperature. 3) Chronic, constant headache with pressure & throbbing in head, neck & upper back. 4) Hyperacusis - both ears - Causes extreme startle response to normal noises, also difficulty separating multiple sounds sources. 5) Intermittent spastic autonomic functions - yawning, sneezing, runny eyes and nose. 6) Unable to regulate body temperature - am either extremely hot or cold. 7) Unable to sleep for more than 2 1/2 - 3 hours at a time. 8) Left arm & hand permanently feel frozen. 9) Unable to stand unsupported for more than a few minutes. 10) Tire quickly from minimum physical exertion. What I did not know in 2011 was that what happened to me and what I was experiencing, and continue to deal with to this day, is Guillian-Barre Syndrome.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt called pharmacy back the following day to report he wasn't told his arm would hurt after getting the vaccine. He reported his arm was very sore and he wasn't even able to use it. I (pharmacist) apologized that the administering pharmacist had not counseled him on this potential side effect beforehand. I let him know that this vaccine can cause some pain at the injection site but that it should be relieved by taking acetaminophen or ibuprofen (whichever his doctor has said he is okay to take) and applying a warm compress. Pt came in on Wednesday (3 days later) to report he still could not use his arm and it was still store. He mentioned he is used to getting vaccines in his shoulder muscle (pointing to his deltoid) but said this shot was given higher up, in his shoulder joint area (pointed to that area). The pharmacist who spoke with him the second time said it may take few more days to heal and that we will be contacting him to follow up on this progress.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Middle insomnia, Pain in extremity, Tremor
Clinical narrative: Patient said she woke up in middle of night and had chills and shook for about 30 minutes. She also had a very sore arm on 12/5/2018.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Malaise, Retching, Stool analysis normal, Vomiting
Clinical narrative: PT reported feeling sick dry heaving and vomiting.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Asthenia, Blood gases, Blood lactic acid, Chest pain
Clinical narrative: Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Death, Decreased appetite, Differential white blood cell count, Dyspnoea
Clinical narrative: Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Endotracheal intubation, Fatigue, Full blood count, Headache, Malaise
Clinical narrative: Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Metabolic function test, Peripheral swelling, Pulse absent, Pupil fixed, Pyrexia
Clinical narrative: Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Resuscitation, Unresponsive to stimuli, Vomiting
Clinical narrative: Completed based on review of ER note from 29 November 2018: Patient's father reported on the morning of 28 November she started feeling weak and fatigued with some generalized malaise, anorexia, and subjective fevers. Per the father's report no significant headache, cough, difficulty breathing, chest pain, abdominal pain, leg swelling. Her father stated that at one point he gave her a bath because she was feeling ill then placed her into bed and went to get her something to drink. While he was in the other room he heard her vomiting, rushed back into the room, and found her lying unresponsive and pulseless. He started CPR and called for his wife to call 911. Patient was transported by ambulance to the ER; while in the ambulance she received a dose of epinephrine and chest compressions were continued. On arrival to the ER she was noted to be in PEA. She was emergently intubated and resuscitation efforts to include multiple rounds of epinephrine, continuous chest compressions, multiple doses of bicarbonate, atropine, epinephrine drip, calcium gluconate, and glucose were administered. Following discussion with family after approximately one hour and 15 minutes of chest compressions and resuscitation in the ED, not including the prehospital chest compression time, since patient had no signs of life with fixed and dilated pupils the decision was made to discontinue resuscitative efforts. Time of death listed at 0120.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash macular
Clinical narrative: Approximately 18 hours after receiving the PNEUMOVAX 23 vaccine the patient's left arm became painful with a "blotty" rash the size of a grape initially. Then it progressed to be the size of 4x4 inches plus slightly under her arm. She took 2 TYLENOL tabs one time and it seems to have helped with the pain. Today is better but still slightly raised. Suggested ice topically to help with pain and swelling and monitor for worsening symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Large raised rash red and itchy on left side near waistline.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, cant lift a blanket off body at night time, needed medication and PT to this day.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Tremor
Clinical narrative: Patient presented as an acute walk-in for involuntary body shaking with cold sweats. Vitals WNL Immediately administered BENADRYL 25mg tab po #2 at 1500 as a precaution. Vitals WNL. Administered LR 1L R AC. Pt tolerated procedure well. At approximately 1622 1L of LR has been infused, and patient's shaking has stopped
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient came to the pharmacy today (12/06/2018) and reported the pain that she got from the vaccinations. The patient said after she got the flu and PNEUMOVAX 23 shots, she got a lot pain on her left arms on that day. She said there were no rash or swelling on the sites of vaccination. She called her family doctor, and the doctor did not give her any medications, just recommended her to exercise on her left arms.The pain get better now but she wonder why the pain last so long.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Lethargy, Pallor
Clinical narrative: Pt received the influenza on 11/21/2018 at 1350. Pt went to the waiting room and sat down for 5 mins. Employee looked over and pt was very pale, and lethargic. Pt also cool and clammy. Pt is awake and did not lose consciousness. Pt provided water and ice pack for comfort. Pt placed on a bed and recovered with no other interventions.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium decreased, Delirium, Nausea, Pain in extremity, Pulmonary thrombosis
Clinical narrative: 12/1-Nausea/Vomiting, Fever, Arm Pain; 12/2-Delirium--was transported to hospital-low potassium, 2 small blood clots in lung (PE)-patient started on Eliquis
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: 12/1-Nausea/Vomiting, Fever, Arm Pain; 12/2-Delirium--was transported to hospital-low potassium, 2 small blood clots in lung (PE)-patient started on Eliquis
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Mobility decreased, Muscular weakness
Clinical narrative: Weakness of left arm. Unable to raise arm above the horizontal. Diminished range of motion of the left arm.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Day 1: approx 12 hrs after receiving shot, started feeling "out of sorts" and developed a headache. Overnight got feverish, chills, body aches. Day 2: continuation of fevers, chills, body aches, fatigue, loss of appetite, injection site pain and swelling - took TYLENOL and ADVIL all day. Day 3: same as Day 2, only less severe "flu like" symptoms, injection sight swelling = size of softball, very hard, hot and painful to touch, arm stiffness. Day 4: symptoms lessening, called doctor's office to report reaction. Day 5: no chills or fever, body aches almost gone, still tired and no appetite, injection sight same except swelling size = baseball. Day 6: flu-like symptoms gone, developed headache and sore, stiff neck, injection sight swelling size = golf ball, pain and stiffness subsided.