chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 patients under 65 years of age accidently received Fluzone High Dose/no AE; 3 patients under 65 years of age accidently received Fluzone High Dose/no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 3 patients under 65 years of age accidently received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patients received a doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  It was of actual medication error due to Inappropriate age at vaccine administration and overdose accidental..  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Immunisation, Syringe issue
Clinical narrative: vaccine liquid running down the patient's skin while injecting/no AE; Syringe Broken During Use/no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who was exposed to vaccine, INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while a nurse was administering to her on 07-Nov-2019 (lot UJ294AA via unknown route in unknown administration site).  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 07-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ294AA via unknown route in unknown administration site.  It was of actual medication error due to exposure via skin contact. It was also a syringe issue case. Nurse saw the vaccine liquid running down the patient's skin. She stopped and removed the needle from the patient's arm, at which point the syringe fell apart (broken during use). Syringe broke at the point where the barrel and luer lock meet. Patient was re-vaccinated immediately. There was no obvious damage to the packaging or carton and had no crack or other defect in this syringe prior to use  Local PTC number was issued: CO2019-00399.  It was unknown whether adverse event was noticed 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 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.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: the vaccine spilled out on arm when the plunger was pressed/no AE; plunger of a Fluzone High-Dose syringe becoming jammed after the needle was inserted into the consumer/no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on skin while the plunger was pressed (lot UJ301AA via unknown route in unknown administration site) on an unknown date.  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was of actual medication error due to exposure via skin contact. It was also a syringe issue case. It was reported that Fluzone High-Dose syringe became  jammed after the needle was inserted into the consumer. The plunger would not press down while injecting but was able to go down after removal of the needle from the skin, during that time, the vaccine spilled out on patient's arm when the plunger was pressed.  A local PTC number CO2019-00390 was issued.  It was unknown whether adverse event was experienced 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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pentacel was given to an adult stem cell transplant patient/no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that an adult was given pentacel to a stem cell transplant, no AE (product administered to patient of inappropriate age), of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE(Suspension for injection) lot number not reported via unknown route in unknown administration site.  It was of actual medication error case due to product administered to patient of inappropriate age.  It was unknown whether adverse event was experienced 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 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.  Information on the batch number was requested.
Sex: F
Vaccine: FLUR4
Symptoms: Accidental exposure to product, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: she did not receive a full dose/no AE; vaccine leaked around the needle hub and ran down the patients arm/ no AE; vaccine leaked around the needle hub and ran down the patients arm/ no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  It was reported that 55 years old female patient did not receive a full dose/no ae (Underdose), vaccine leaked around the needle hub and ran down the patients arm/ no ae (accidental exposure to product) (exposure via skin contact) of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Dec-2019, the patient received less than 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (unknown formulation) lot QFAA1962 via unknown route in unknown administration site.  It was of actual medication error case due to vaccine underdose.  It was unknown whether adverse event was experienced 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 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.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Daptacel was given/no AE; Initial information received on 20-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 months old male patient who he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5307AA and expiry date 23-Oct-2019 via intramuscular route in unknown administration site on 20-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) for Immunisation; and QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) for Immunisation.  It was a case of actual medication error due to expired product used.  It was not reported if 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 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.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient developed a red, circular rash (diameter of ~2.5 inches) at site of injection. The is slightly raised, warm, and itches occasionally. Patient denies any systemic adverse events and denies any pain at the site.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Eye pruritus, Hypersensitivity, Loss of consciousness, Ocular hyperaemia, Swelling
Clinical narrative: Several hours after the shot was given patient had allergic reaction to the vaccine at home. Had swellings, red and itchy eyes. Went to a walk in clinica got steroid shot and collapsed and passed out after returning home from clinic and was taken to ER. Was discharged from hospital and was stable.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Several hours after the shot was given patient had allergic reaction to the vaccine at home. Had swellings, red and itchy eyes. Went to a walk in clinica got steroid shot and collapsed and passed out after returning home from clinic and was taken to ER. Was discharged from hospital and was stable.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Clumsiness, Fall, Gait disturbance, Headache, Migraine
Clinical narrative: Vaccine given Thursday. Sunday while outside playing and doing farm chores patient started falling down repeatedly at a walk and a run.  The next day she started holding her hands in a fist, high stepping in her right leg, limping with an abnormal gait and complaining about a tingling feeling in her feet.  I called doctors office and they told me to give her ibuprofen and not let her run.  10 days later she was evaluated for headaches and referred to neurology for evaluation of headaches and neuro signs that followed vaccines. 3 months later on December 3rd she was evaluated by the pediatric neurology department. She was diagnosed with migraines but by the time she was evaluated her neuro signs were gone with just occasional limping in her right leg and weakness noted in her right hand by School.  This is not the first time she has had issues with neuro signs after her vaccines. On November 11, 2014 she received vaccines at Pediatrics, DTap-Hib-IPV, Rotovirus and pneumococcal. Within an hour of vaccinations she had hemorrhagic diarrhea. Approximately 2 weeks later she loss use of her right arm. It was blown off by the doctor at Pediatrics and later thought to be viral. On 2/26/16 vaccinated for DTap pneumococcal and HIb and continuously fell down. Was told by nurse it was just a clumsy child
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Muscle contractions involuntary, Muscular weakness, Paraesthesia
Clinical narrative: Vaccine given Thursday. Sunday while outside playing and doing farm chores patient started falling down repeatedly at a walk and a run.  The next day she started holding her hands in a fist, high stepping in her right leg, limping with an abnormal gait and complaining about a tingling feeling in her feet.  I called doctors office and they told me to give her ibuprofen and not let her run.  10 days later she was evaluated for headaches and referred to neurology for evaluation of headaches and neuro signs that followed vaccines. 3 months later on December 3rd she was evaluated by the pediatric neurology department. She was diagnosed with migraines but by the time she was evaluated her neuro signs were gone with just occasional limping in her right leg and weakness noted in her right hand by School.  This is not the first time she has had issues with neuro signs after her vaccines. On November 11, 2014 she received vaccines at Pediatrics, DTap-Hib-IPV, Rotovirus and pneumococcal. Within an hour of vaccinations she had hemorrhagic diarrhea. Approximately 2 weeks later she loss use of her right arm. It was blown off by the doctor at Pediatrics and later thought to be viral. On 2/26/16 vaccinated for DTap pneumococcal and HIb and continuously fell down. Was told by nurse it was just a clumsy child
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site haemorrhage, Pain in extremity, Peripheral swelling
Clinical narrative: This was my second shot of the series.  No problems with the first one.  This shot on 12/27 made the arm extremely sore.  Blood detected on bandaid when removed that afternoon.  Arm extremely sore on Saturday morning.  Heat, red, swollen.  Started taking 1000mg  Accetaminophen.  Tried cool packs and heat packs.  Heat seems a little better.  No real relief.  Sunday 12/29 the arm is swollen, red area has increased in size, and is hot and it itches.  Monday, 12/30 went Pharmacy to advise them of the adverse reaction.  It looks more like extravasation than a local reaction.  Has been 72 hours  Lower part of the area looks like a bruise is forming. Still hot, swollen, itches, and hurts.  Can't scratch hard enough to control the itch because of the soreness
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: This was my second shot of the series.  No problems with the first one.  This shot on 12/27 made the arm extremely sore.  Blood detected on bandaid when removed that afternoon.  Arm extremely sore on Saturday morning.  Heat, red, swollen.  Started taking 1000mg  Accetaminophen.  Tried cool packs and heat packs.  Heat seems a little better.  No real relief.  Sunday 12/29 the arm is swollen, red area has increased in size, and is hot and it itches.  Monday, 12/30 went Pharmacy to advise them of the adverse reaction.  It looks more like extravasation than a local reaction.  Has been 72 hours  Lower part of the area looks like a bruise is forming. Still hot, swollen, itches, and hurts.  Can't scratch hard enough to control the itch because of the soreness
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia
Clinical narrative: Patient called 12/30/19 and stated that she has experienced tingling in her left arm ever since she had the flu shot administered.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Pt reports rash on leg the night after receiving flu shot.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, No adverse event, Wrong product administered
Clinical narrative: Child was accidentally given Bexsero instead of TDAP.  Suffered no adverse effect other than discomf from injection. Mom was councilled by Provider concerning pt receiving vaccine sooner than recommended for her. TDaP will be given @ next visit. Told Mom she will not need to get second Bexsero until older. Mom verbalized understanding of this.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: PATIENT IS HAVE SHORTNESS OF BREATH A FEW HOURS AFTER SHOT. SORE ARM. NO OTHER SYMPTOMS
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram abnormal, Heart rate decreased, Hypotonia, Malaise, Ventricular extrasystoles
Clinical narrative: Low pulse Rate, Left arm Limp, malaise after flu shot. Seen by primary MD who sent patient to ER for eval Patient is employee of hospital. Received flu shot 10/17/19 @ 0630. Reported malaise and Limp left arm. Sent to his primary care physician who sent him to the ER for evaluation of Low pulse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient is experiencing pain in the left arm at the injection site.  There is no redness or marks at the site.  She notices the pain five to six times daily and the pain last for approximately 3 seconds.  She has not been able to identify and pattern that triggers the pain.  The pain is located about 5 inches down form the top of the shoulder.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: shingrix #1 to L deltoid 12/24. HA, fatigue, nausea, fever, tingling in legs, swollen face and hands/feet, chills, HA, vomiting within 10 hrs.  soreness/weakness worsening 12/27-28, developing to the inside of arms and back of legs. still has trouble standing/walking for more than a few minutes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness, Nausea, Pain, Pain in extremity
Clinical narrative: shingrix #1 to L deltoid 12/24. HA, fatigue, nausea, fever, tingling in legs, swollen face and hands/feet, chills, HA, vomiting within 10 hrs.  soreness/weakness worsening 12/27-28, developing to the inside of arms and back of legs. still has trouble standing/walking for more than a few minutes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia, Swelling face, Vomiting
Clinical narrative: shingrix #1 to L deltoid 12/24. HA, fatigue, nausea, fever, tingling in legs, swollen face and hands/feet, chills, HA, vomiting within 10 hrs.  soreness/weakness worsening 12/27-28, developing to the inside of arms and back of legs. still has trouble standing/walking for more than a few minutes.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Muscle disorder, Weight bearing difficulty
Clinical narrative: Had the flu shot in left arm --given at pharmacy. Noticed that area was very sore and soreness did not resolve. Approximately 30 days after injection--felt the muscle pop --and had moderate pain --it hurts to lift anything with that arm. PT evaluation of arm/shoulder --no findings --continued muscle pain in left arm when lifting anything.
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Hypotension, Pyrexia
Clinical narrative: hypotension, chills, fever,  sweats and fatigue
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Haemoglobin decreased, Infection, Mobility decreased, White blood cell count normal
Clinical narrative: An 81 year old man with MDS (for which he has received many transfusions over the past 2 to 3 years) received Shingrix vaccine on 12/26/2019. The next morning he was so weak he could not get out of bed or even sit up. 911 was called and took him to the ER. Although the doctors were told about the Shingrix shot the previous day they diagnosed him as having an 'underlying infection' and started him on IV antibiotics. The next day 12/28/2019 he felt much better, could walk unassisted. The doctors then said his white cell count was normal, stopped the antibiotics and discharged him home the next morning 12/29/2019. I do not have access to the lab tests done. It is unknown whether or not Shingrix caused the severe weakness that he experienced but no other cause is known. His hemoglobin was 10 which for him is good.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypotension, Pyrexia
Clinical narrative: fever, hypotension, and headaches
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient called and told one of our technicians that she received her second shingrix injection and her arm still sore from this shot...she told her we would try to contact our clinical team and get back to her.she received her second shingrix shot on December 1st 2019 I called her back to obtain additional information but I had to leave a message.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: shot was given in subcutaneous route when intended for intramuscular
Age: 66.0
Sex: M
Vaccine: FLUR4
Symptoms: Death, Gait inability, Muscular weakness
Clinical narrative: 12/6/19 - Presented to Emergency Rm with acute lower extremity weakness 12/7/19 Presented to ER cannot walk. Sent to Hospital 12/30/19 Expired
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Seizures
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Diarrhoea, Headache, Pyrexia, Tremor
Clinical narrative: Headache, Fever, Diarrhea & SHAKING; WEAKNESS
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: Symptoms: Rash Treatment: Ibuprofen 800 mg TID take one table by mouth three times a day as need for arm pain, cephalexin 500 mg TID take one capsule by mouth three times a day
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever & Skin Rash
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Got fever, flu like symptoms - very sore arm on Dec 24, Dec 25 got a rash on either side of injection site, itchy & sore, on Dec 26 rash still there, Dec 27 rash spread down inside of arm, itchy & warm to touch. Had rash until Dec 29 gone on Dec 30. Pt did nothing to treat it.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Got fever, flu like symptoms - very sore arm on Dec 24, Dec 25 got a rash on either side of injection site, itchy & sore, on Dec 26 rash still there, Dec 27 rash spread down inside of arm, itchy & warm to touch. Had rash until Dec 29 gone on Dec 30. Pt did nothing to treat it.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope after HPV admin.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt c/o redness & swelling and pain at site of vaccination, redness spreading almost to elbow Pt called one day later after vaccine to report spreading redness down (R) arm.  He has called for F/U He came in for assessment to clinic on 6/19/2019. He was given Ibuprofen which he took for 2-3 days. Sx subsided & completely resolved within 7-10 days.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash macular, Rash morbilliform
Clinical narrative: 20 days later developed a splotchy rash consistent with measles rash, no fevers or other symptoms
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Malaise, Mobility decreased, Paraesthesia, Peripheral swelling
Clinical narrative: CUSTOMER COMPLAINED OF BURNING , TINGLING OF ANKLES TO TOES AND GENERAL MALAISE . THIS PROGRESSED OVER COURSE OF TWO DAYS TO SWELLING AND LOSS OF ABILITY TO MOVE LEGS . PER PRIMARY CARE PATIENT REPORTED TO ER DEPT ON AFTERNOON OF 12/26/19 ;
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Erroneous Vaccination administered
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Chills, Pain in extremity, Pyrexia, Stomatitis
Clinical narrative: patient experienced chills, low grade fever, pain in arm, sore in mouth/on lip that lasted about 48 hours. Patient did not seek treatment and states she is completely better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeding disorder, Headache, Myalgia, Nausea, Pain
Clinical narrative: Fever, severe nausea, incapacitated in bed for 36 hours, unable to eat/drink, headache, body aches, severe pain in muscles, especially one hip (right), mild form of symptoms lasted another 24 hours after the first really bad day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, severe nausea, incapacitated in bed for 36 hours, unable to eat/drink, headache, body aches, severe pain in muscles, especially one hip (right), mild form of symptoms lasted another 24 hours after the first really bad day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial paralysis, Hyperacusis, Lacrimation increased, Magnetic resonance imaging
Clinical narrative: Dec 6:  Ear and jaw pain onset Dec 7:  Amplified Noise Dec 8:  Vision Blurry and excessive tearing Dec 9:  Facial paralyzes Dec 9th called the clinic with my concerns and condition.  Spoke to a nurse who consulted with the Dr.  Was told it did not sound like a reaction to the vaccine, that it sounded like Bells Palsy and was coincidental in the timing.   I was not able to get an appt at the clinic until Dec 12th  and was advised to  go to the clinic in the next town.  From there I was advised to go to the ER at their facility.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Vision blurred
Clinical narrative: Dec 6:  Ear and jaw pain onset Dec 7:  Amplified Noise Dec 8:  Vision Blurry and excessive tearing Dec 9:  Facial paralyzes Dec 9th called the clinic with my concerns and condition.  Spoke to a nurse who consulted with the Dr.  Was told it did not sound like a reaction to the vaccine, that it sounded like Bells Palsy and was coincidental in the timing.   I was not able to get an appt at the clinic until Dec 12th  and was advised to  go to the clinic in the next town.  From there I was advised to go to the ER at their facility.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Pain in extremity
Clinical narrative: Patient woke up with achy arm, a small round area progressively got bigger until now . Area of angioedema  is about 6 inches long and 3 inches wide. Patient's arm still feels achy and sore.  Patient has had the 'flu immunization in previous years and nothing like this has happened before.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Dysphemia
Clinical narrative: Flu shot and chicken pox shot was given to my child. The next day, debilitating stuttering began. Child never had history of stuttering or stammering. Child almost unable to speak because of stuttering. Slight improvement almost two weeks out. Hoping to continue to see improvement, otherwise will begin speech therapy
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Amylase normal, Asthenia, Balance disorder, Chest X-ray normal, Colitis
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram pelvis, Confusional state, Cystoscopy normal, Diarrhoea
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count normal, Dizziness, Dyspnoea, Electrocardiogram normal, Full blood count normal
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised anxiety disorder, Haematuria, Headache, Insomnia, Joint stiffness
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Lipase normal, Malaise, Metabolic function test normal, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Neuralgia, Pancreatic enzymes decreased, Platelet count normal, Scan with contrast normal
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Spirometry normal, Ultrasound abdomen normal, Urine analysis abnormal
Clinical narrative: On Tuesday, October 22,  I woke up with weakness (especially in limbs), joint stiffness, aching muscles, shortness of breath, and feeling like I was going to faint.  Within the week, I had visited my general practitioner three times and the emergency room once. Unfortunately, there was no real diagnosis except generalized anxiety, colitis,  hematuria, and low pancreatic enzymes. I continued with all of the above symptoms plus extreme diarrhea for seven days. After the initial seven days, I felt some better for six days and then got sick again. This time, it was many of the same symptoms such as muscle weakness, dizziness, and diarrhea with the addition of  headache, stiffness in neck, insomnia, and confusion when waking up. Also, it felt as if I could feel every nerve ending in my body. It has taken me two months to begin to feel like myself again. I am still having weakness and aching in my muscles particularly in my limbs and neck, along with unsteadiness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient reports pain, redness, swollen bruising at injection site. Injection site is lower than the deltoid muscle
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: ON 12-30-19, PATIENT CALLED PHARMACY IN THE MORNING  AND TOLD PHARMACIST SHE HAD A REACTION TO THE VACCINE IN HER RIGHT ARM. PATIENT SAID SHE HAD A SIMILAR REACTION A FEW YEARS BACK TO A FLU SHOT. PATIENTS ARM HAD PAIN AT THE INJECTION SITE FOR A FEW DAYS, AND HAD PROGRESSING REDNESS AND ITCHING IN AN OVAL SHAPE, NO SWELLING, FROM HER SHOULDER TO HER ELBOW. PATIENT  WAS CONTACTED  SAME NIGHT AT 6:50PM. PATIENT SAID SHE HAD GONE TO HER DOCTOR, AND THE DOCTOR WAS NOT CONCERNED SINCE SHE HAD A SIMILAR REACTION BEFORE. DOCTOR TOLD PATIENT TO USE A MOISTURIZER TO HAVE THE REDNESS AND ITCHING FADE.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chapped lips, Cheilitis, Chest pain, Chills
Clinical narrative: 12/23/2019 at noon, I (the patient) received Shingrix on my left arm At 2PM, I developed a severe pain on my arm, and that I could not move my arm At 4PM, my arm was paralyzed.  At 6PM, the pain was radiating to my chest, neck, back, under my right breast.  At 6PM, I had a severe chest pain. My feet and hands turned very cold. At 8PM, I had a very severe headache, nausea, and vomiting then the chill then fever.   I had a flu like symptoms including muscle aching for the next two days. Then, I have developed a big sore from inside to outside my lower lip.  All the skin on the lips is also broken and peeled.  I had not ever had a flu or a cold sore before the shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lip exfoliation, Monoplegia, Myalgia
Clinical narrative: 12/23/2019 at noon, I (the patient) received Shingrix on my left arm At 2PM, I developed a severe pain on my arm, and that I could not move my arm At 4PM, my arm was paralyzed.  At 6PM, the pain was radiating to my chest, neck, back, under my right breast.  At 6PM, I had a severe chest pain. My feet and hands turned very cold. At 8PM, I had a very severe headache, nausea, and vomiting then the chill then fever.   I had a flu like symptoms including muscle aching for the next two days. Then, I have developed a big sore from inside to outside my lower lip.  All the skin on the lips is also broken and peeled.  I had not ever had a flu or a cold sore before the shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: 12/23/2019 at noon, I (the patient) received Shingrix on my left arm At 2PM, I developed a severe pain on my arm, and that I could not move my arm At 4PM, my arm was paralyzed.  At 6PM, the pain was radiating to my chest, neck, back, under my right breast.  At 6PM, I had a severe chest pain. My feet and hands turned very cold. At 8PM, I had a very severe headache, nausea, and vomiting then the chill then fever.   I had a flu like symptoms including muscle aching for the next two days. Then, I have developed a big sore from inside to outside my lower lip.  All the skin on the lips is also broken and peeled.  I had not ever had a flu or a cold sore before the shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: 12/23/2019 at noon, I (the patient) received Shingrix on my left arm At 2PM, I developed a severe pain on my arm, and that I could not move my arm At 4PM, my arm was paralyzed.  At 6PM, the pain was radiating to my chest, neck, back, under my right breast.  At 6PM, I had a severe chest pain. My feet and hands turned very cold. At 8PM, I had a very severe headache, nausea, and vomiting then the chill then fever.   I had a flu like symptoms including muscle aching for the next two days. Then, I have developed a big sore from inside to outside my lower lip.  All the skin on the lips is also broken and peeled.  I had not ever had a flu or a cold sore before the shot.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month old patient was inadvertently given a dose of Kinrix for dose 2 of IPV and DTaP, though dose 1 was Pediarix.  All minimal intervals were met despite this, and patient did not experience any adverse reaction to the vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Shivering, chills, body aches
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: (Son) called Saturday 12/28 late afternoon to say patient had broken out in a "rash" / "bumps" on arms, legs, torso. Pharmacist recommended Benadryl and follow up with doctor. Son called Sunday 12/29 morning to say "rash" was not getting worse, but was still there. Pharmacist advised follow up with doctor. Pharmacist left message for patient Monday 12/30 morning to follow up. She also contacted the doctor's office. Patient notes at doctor  indicated that she visited the urgent care Sunday, and was feeling better on Monday.
Age: 1.33
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Herpes zoster
Clinical narrative: Patient developed herpes zoster of the L leg and meningitis despite being vaccinated (08/20/2004; 3/2/2009) with varicella vaccine.  This occurred when patient was 16 years old (neearly 10 years post last dose of vaccine). Admitted to hospital and required IV acyclovir.  VZV was identified as vaccine strain by CDC.  Similar case recently reported with 2 cases from hospital.
Age: 1.33
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Immunology test normal, Meningitis, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Patient developed herpes zoster of the L leg and meningitis despite being vaccinated (08/20/2004; 3/2/2009) with varicella vaccine.  This occurred when patient was 16 years old (neearly 10 years post last dose of vaccine). Admitted to hospital and required IV acyclovir.  VZV was identified as vaccine strain by CDC.  Similar case recently reported with 2 cases from hospital.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose, Blood pressure decreased, Seizure, Syncope
Clinical narrative: PATIENT FAINTED ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION AND PROCEEDED TO HAVE A SEIZURE. PATIENT HAD 3 SEIZURE EPISODES. 911 WAS CALLED AND PARAMEDICS ARRIVED. PATIENT WAS ASSESSED FOR BLOOD SUGAR AND BLOOD PRESSURE. BLOOD PRESSURE WAS LOW. PATIENT DECLINED FURTHER TREATMENT AT A HOSPITAL OR URGENT CARE DESPITE EMT ENCOURAGEMENT
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient stated Left arm numbness, pain Limit of movement and Function Affecting Back, Arm, Fingers, Shoulder
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: at injection site: , swelling, splotchy patches that turned to large area of erythema , warmth and pain that lasted 10 days
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site warmth, Rash macular
Clinical narrative: at injection site: , swelling, splotchy patches that turned to large area of erythema , warmth and pain that lasted 10 days
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: at injection site: , swelling, splotchy patches that turned to large area of erythema , warmth and pain that lasted 10 days
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash macular
Clinical narrative: at injection site: , swelling, splotchy patches that turned to large area of erythema , warmth and pain that lasted 10 days
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Feeling of body temperature change, Pyrexia
Clinical narrative: started to get the chills; felt I was on fire all night; went from burning up to freezing; felt I was on on fire all night; This case was reported by a consumer and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 6th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, fever, feeling cold and burning sensation. On an unknown date, the outcome of the chills, feeling cold and burning sensation were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, feeling cold and burning sensation to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, 12 hours after vaccination , the patient started to get the chills, went to bed and literally felt was on fire all night. The patient was went from burning up to freezing and stated that, not until 12 hours later did the fever go away. The reporter stated that, after 1st dose did not have specifics, but felt horrible for 12 hours but did not have fever like had 1st time.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Feeling of body temperature change, Pyrexia
Clinical narrative: started to get the chills; felt I was on fire all night; went from burning up to freezing; felt I was on on fire all night; This case was reported by a consumer and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 6th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, fever, feeling cold and burning sensation. On an unknown date, the outcome of the chills, feeling cold and burning sensation were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, feeling cold and burning sensation to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, 12 hours after vaccination , the patient started to get the chills, went to bed and literally felt was on fire all night. The patient was went from burning up to freezing and stated that, not until 12 hours later did the fever go away. The reporter stated that, after 1st dose did not have specifics, but felt horrible for 12 hours but did not have fever like had 1st time.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling cold, Pyrexia
Clinical narrative: started to get the chills; felt I was on fire all night; went from burning up to freezing; felt I was on on fire all night; This case was reported by a consumer and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 6th December 2019, 12 hrs after receiving Shingrix, the patient experienced chills, fever, feeling cold and burning sensation. On an unknown date, the outcome of the chills, feeling cold and burning sensation were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, feeling cold and burning sensation to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, 12 hours after vaccination , the patient started to get the chills, went to bed and literally felt was on fire all night. The patient was went from burning up to freezing and stated that, not until 12 hours later did the fever go away. The reporter stated that, after 1st dose did not have specifics, but felt horrible for 12 hours but did not have fever like had 1st time.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site bruising, Injection site pain, Musculoskeletal pain
Clinical narrative: NEXT DAY, ARM WAS SORE, NOT ON "ACTUAL DAY" SHOT WAS GIVEN! ARM STARTED GETTING MORE SORE, EVERY DAY, TO WHRE IT ACTUALLY HURTS TO RAISE MY GOOD RIGHT ARM-"UP" OR PUSH CAR DOOR OPEN! RECENTLY, A BASEBALL-SIZE BRUISE APPEARED WHERE SHOT WAS GIVEN! - IT'S BEEN OVER A MONTH!
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site bruising, Pain, Pain in extremity
Clinical narrative: NEXT DAY, ARM WAS SORE, NOT ON "ACTUAL DAY" SHOT WAS GIVEN! ARM STARTED GETTING MORE SORE, EVERY DAY, TO WHRE IT ACTUALLY HURTS TO RAISE MY GOOD RIGHT ARM-"UP" OR PUSH CAR DOOR OPEN! RECENTLY, A BASEBALL-SIZE BRUISE APPEARED WHERE SHOT WAS GIVEN! - IT'S BEEN OVER A MONTH!