chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Speech disorder
Clinical narrative: everything shut down,; "pressure at the center of her chest,; she could not breathe; This spontaneous report as received from an 88 year old female consumer reporting by herself.   The patient's pertinent medical history included atrial fibrillation, anal cancer, adrenal mass and adrenal gland operation. The patient did not have drug reactions or allergies. Concomitant therapies included potassium chloride, magnesium (unspecified), pravastatin, metoprolol succinate (TOPROL), cyanocobalamin and warfarin.  On 18-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197)(V114) (reported as pneumonia shot) (the patient stated that the manufacturer of the vaccine was "Merck NU" and that was what she saw on the box, she was not able to confirm the name of the vaccine), 1 shot, injection in the upper right arm, as recommended by physician (route of administration, lot# and expiry date were not provided).  After getting the shot, the patient reported pressure at the center of her chest (chest discomfort), everything shut down (syncope), and she could not breathe (dyspnoea). Subsequently, the pharmacist called to 911 and jabbed an unspecified autoinjector pen into her hip. Then, patient was taken to the hospital and was kept for 4 hours and observed till everything was great. Due to her "AFib" (Atrial fibrillation) condition, the hospital gave her an electrocardiogram (EKG), blood and urine lab work every 6 months (results not provided), while at the hospital. The patient stated the hospital sent her home with prednisone for 5 days. The outcome of the events was reported as recovering.  The causal relatedness between chest discomfort, syncope and dyspnoea and pneumonia shot (pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197)(V114)) was not provided.  Upon internal review syncope was considered a medically significant event.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Dyspnoea, Flushing
Clinical narrative: During my 6 month check-up -my primary doctor ordered a booster shot. I had had a PR13 pneumonia shot two years prior. No problems. Dr. does not give shots in his office so I was sent to to pharmacy. This pharmacy has all my script information. Staff told me they did not have a contract w/Merck - he called another pharmacy and sent me out there. The Pharmacist injected the vaccine in my right arm - as she was preparing to put on the band aid - I had a sudden heavy pressure in my chest - and I could not breath - I could not gasp - I could not speak - I heard her yell "call 911" and her assistant brought 2 Epinephrine injection The dosage was .015 due to my low weight - She had to give me 2 as the first was not doing the job. The second injection worked and I started gulping air. I could not talk - move - NOTHING! The ambulance arrived and took me out on a gurney. They worked on me in the parking lot - EKG - Blood pressure - then transported me to the emergency room at Hospital. Dr. was primary provider. I was kept in the hospital for approximately 5 hours until I was allowed to leave. I was given two auto-injector pens w/with instructions and was told to carry one with me at all times. I was prescribed Prednisone - 2 20mg tabs daily for 5 days. What I am angry about - if I had not had that IMMEDIATE reaction and we had been on our way home - I would be dead - and I bet it would have been attributed to old age and heart problems. IT WAS THE VACCINE!! I contacted Merck and related my story to them - they took the names of my primary doctor and both pharmacists and was going to send them literature on trying to find WHAT TRIGGERED THAT INSTANT anaphylactic reaction. In all of my 88 years I have NEVER had any reaction to vaccines or meds of ANY kind. I am a retired educator - I know nothing about the medical field - I have to trust my doctors and other professionals - so much for that. I have done my best to provide information on this form. If you contact the names I provided you they will clarify what I may have missed.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Syncope
Clinical narrative: During my 6 month check-up -my primary doctor ordered a booster shot. I had had a PR13 pneumonia shot two years prior. No problems. Dr. does not give shots in his office so I was sent to to pharmacy. This pharmacy has all my script information. Staff told me they did not have a contract w/Merck - he called another pharmacy and sent me out there. The Pharmacist injected the vaccine in my right arm - as she was preparing to put on the band aid - I had a sudden heavy pressure in my chest - and I could not breath - I could not gasp - I could not speak - I heard her yell "call 911" and her assistant brought 2 Epinephrine injection The dosage was .015 due to my low weight - She had to give me 2 as the first was not doing the job. The second injection worked and I started gulping air. I could not talk - move - NOTHING! The ambulance arrived and took me out on a gurney. They worked on me in the parking lot - EKG - Blood pressure - then transported me to the emergency room at Hospital. Dr. was primary provider. I was kept in the hospital for approximately 5 hours until I was allowed to leave. I was given two auto-injector pens w/with instructions and was told to carry one with me at all times. I was prescribed Prednisone - 2 20mg tabs daily for 5 days. What I am angry about - if I had not had that IMMEDIATE reaction and we had been on our way home - I would be dead - and I bet it would have been attributed to old age and heart problems. IT WAS THE VACCINE!! I contacted Merck and related my story to them - they took the names of my primary doctor and both pharmacists and was going to send them literature on trying to find WHAT TRIGGERED THAT INSTANT anaphylactic reaction. In all of my 88 years I have NEVER had any reaction to vaccines or meds of ANY kind. I am a retired educator - I know nothing about the medical field - I have to trust my doctors and other professionals - so much for that. I have done my best to provide information on this form. If you contact the names I provided you they will clarify what I may have missed.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Urine analysis
Clinical narrative: During my 6 month check-up -my primary doctor ordered a booster shot. I had had a PR13 pneumonia shot two years prior. No problems. Dr. does not give shots in his office so I was sent to to pharmacy. This pharmacy has all my script information. Staff told me they did not have a contract w/Merck - he called another pharmacy and sent me out there. The Pharmacist injected the vaccine in my right arm - as she was preparing to put on the band aid - I had a sudden heavy pressure in my chest - and I could not breath - I could not gasp - I could not speak - I heard her yell "call 911" and her assistant brought 2 Epinephrine injection The dosage was .015 due to my low weight - She had to give me 2 as the first was not doing the job. The second injection worked and I started gulping air. I could not talk - move - NOTHING! The ambulance arrived and took me out on a gurney. They worked on me in the parking lot - EKG - Blood pressure - then transported me to the emergency room at Hospital. Dr. was primary provider. I was kept in the hospital for approximately 5 hours until I was allowed to leave. I was given two auto-injector pens w/with instructions and was told to carry one with me at all times. I was prescribed Prednisone - 2 20mg tabs daily for 5 days. What I am angry about - if I had not had that IMMEDIATE reaction and we had been on our way home - I would be dead - and I bet it would have been attributed to old age and heart problems. IT WAS THE VACCINE!! I contacted Merck and related my story to them - they took the names of my primary doctor and both pharmacists and was going to send them literature on trying to find WHAT TRIGGERED THAT INSTANT anaphylactic reaction. In all of my 88 years I have NEVER had any reaction to vaccines or meds of ANY kind. I am a retired educator - I know nothing about the medical field - I have to trust my doctors and other professionals - so much for that. I have done my best to provide information on this form. If you contact the names I provided you they will clarify what I may have missed.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Electrocardiogram, Mobility decreased
Clinical narrative: During my 6 month check-up -my primary doctor ordered a booster shot. I had had a PR13 pneumonia shot two years prior. No problems. Dr. does not give shots in his office so I was sent to to pharmacy. This pharmacy has all my script information. Staff told me they did not have a contract w/Merck - he called another pharmacy and sent me out there. The Pharmacist injected the vaccine in my right arm - as she was preparing to put on the band aid - I had a sudden heavy pressure in my chest - and I could not breath - I could not gasp - I could not speak - I heard her yell "call 911" and her assistant brought 2 Epinephrine injection The dosage was .015 due to my low weight - She had to give me 2 as the first was not doing the job. The second injection worked and I started gulping air. I could not talk - move - NOTHING! The ambulance arrived and took me out on a gurney. They worked on me in the parking lot - EKG - Blood pressure - then transported me to the emergency room at Hospital. Dr. was primary provider. I was kept in the hospital for approximately 5 hours until I was allowed to leave. I was given two auto-injector pens w/with instructions and was told to carry one with me at all times. I was prescribed Prednisone - 2 20mg tabs daily for 5 days. What I am angry about - if I had not had that IMMEDIATE reaction and we had been on our way home - I would be dead - and I bet it would have been attributed to old age and heart problems. IT WAS THE VACCINE!! I contacted Merck and related my story to them - they took the names of my primary doctor and both pharmacists and was going to send them literature on trying to find WHAT TRIGGERED THAT INSTANT anaphylactic reaction. In all of my 88 years I have NEVER had any reaction to vaccines or meds of ANY kind. I am a retired educator - I know nothing about the medical field - I have to trust my doctors and other professionals - so much for that. I have done my best to provide information on this form. If you contact the names I provided you they will clarify what I may have missed.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Speech disorder
Clinical narrative: During my 6 month check-up -my primary doctor ordered a booster shot. I had had a PR13 pneumonia shot two years prior. No problems. Dr. does not give shots in his office so I was sent to to pharmacy. This pharmacy has all my script information. Staff told me they did not have a contract w/Merck - he called another pharmacy and sent me out there. The Pharmacist injected the vaccine in my right arm - as she was preparing to put on the band aid - I had a sudden heavy pressure in my chest - and I could not breath - I could not gasp - I could not speak - I heard her yell "call 911" and her assistant brought 2 Epinephrine injection The dosage was .015 due to my low weight - She had to give me 2 as the first was not doing the job. The second injection worked and I started gulping air. I could not talk - move - NOTHING! The ambulance arrived and took me out on a gurney. They worked on me in the parking lot - EKG - Blood pressure - then transported me to the emergency room at Hospital. Dr. was primary provider. I was kept in the hospital for approximately 5 hours until I was allowed to leave. I was given two auto-injector pens w/with instructions and was told to carry one with me at all times. I was prescribed Prednisone - 2 20mg tabs daily for 5 days. What I am angry about - if I had not had that IMMEDIATE reaction and we had been on our way home - I would be dead - and I bet it would have been attributed to old age and heart problems. IT WAS THE VACCINE!! I contacted Merck and related my story to them - they took the names of my primary doctor and both pharmacists and was going to send them literature on trying to find WHAT TRIGGERED THAT INSTANT anaphylactic reaction. In all of my 88 years I have NEVER had any reaction to vaccines or meds of ANY kind. I am a retired educator - I know nothing about the medical field - I have to trust my doctors and other professionals - so much for that. I have done my best to provide information on this form. If you contact the names I provided you they will clarify what I may have missed.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest pain, Injection site rash, Peripheral swelling
Clinical narrative: On 9/23/19 pt received vaccination around 8pm and later reported that she had severe arm swelling and chest tightness and went to the ER and was treated there. On 9/27/2019 pt reported that her face was feeling numb, felt like she was going to faint, then started gasping  and struggling to breath and said chest felt tight, then she started shaking seizure like and was administered epinephrine 0.3mg IM in the right thigh, then care taken over by EMS.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia, Peripheral swelling
Clinical narrative: On 9/23/19 pt received vaccination around 8pm and later reported that she had severe arm swelling and chest tightness and went to the ER and was treated there. On 9/27/2019 pt reported that her face was feeling numb, felt like she was going to faint, then started gasping  and struggling to breath and said chest felt tight, then she started shaking seizure like and was administered epinephrine 0.3mg IM in the right thigh, then care taken over by EMS.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: On 9/23/19 pt received vaccination around 8pm and later reported that she had severe arm swelling and chest tightness and went to the ER and was treated there. On 9/27/2019 pt reported that her face was feeling numb, felt like she was going to faint, then started gasping  and struggling to breath and said chest felt tight, then she started shaking seizure like and was administered epinephrine 0.3mg IM in the right thigh, then care taken over by EMS.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: High fever reaching 103.5 Diarrhea
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Impaired healing, Muscle spasms
Clinical narrative: Fever 102', lege muscle cramps, excessive sweats, a heartbeat in the chest heavy pounding, and strong headache and sound of heart beating also.  Short breath difficulty in healing.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever 102', lege muscle cramps, excessive sweats, a heartbeat in the chest heavy pounding, and strong headache and sound of heart beating also.  Short breath difficulty in healing.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Pyrexia, Rhinorrhoea, Sleep disorder
Clinical narrative: Slight fever, runny nose, lack of appetite, sleep issues
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Insomnia
Clinical narrative: Pain in testicles and prostate. Headache, fever, chills, fast heart beat, stuffy nose and sinus pressure, fatigue & insomnia.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion, Paranasal sinus discomfort, Prostatic pain, Pyrexia, Testicular pain
Clinical narrative: Pain in testicles and prostate. Headache, fever, chills, fast heart beat, stuffy nose and sinus pressure, fatigue & insomnia.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient returned to pharmacy day after immunization to report redness, warmth and itchiness below injection site on left arm. She stated she had taken diphenhydramine tablet yesterday when itching began (in afternoon a few hours after vaccination). After further questioning of patient, she asked if having an allergy to alpha-gal could contribute to her reaction. When I pulled her immunization sheet, she had not listed an allergy. I said it could be a factor in the reaction and told her that I would be reporting the reaction and advised her to watch the reaction site for any changes and to continue diphenhydramine for now. I also counseled her that if the reaction changed or got worse to see medical treatment immediately.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Sore arm, general body ache, slight fever (99.3), accelerated heartbeat, grogginess
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy approximately 7 hours after vaccine administration to report itchiness at injection site. When questioned, she said the area did feel warm to the touch and described the area as slightly "swollen". She did not report any breathing issues or swelling of the tongue. I suggested she take a Benadryl tablet (diphenhydramine) , which she confirmed she had available at home. I instructed her if the reaction changed or got more severe to see medical attention immediately. I also informed her that I would be reporting this as an adverse reaction and incident report.  Patient had received a Fluzone High Dose vaccination on 9/13/19 and a Prevnar 13 vaccination on 9/8/2018 with no reactions to either injection.
Sex: M
Vaccine: MMR, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Patient received MMR II on 8/30/2019 and then again on 9/3/2019.; This spontaneous report was received from a pharmacist referring to a male patient of unknown age.  Information about medical history and concurrent conditions was not provided.   On 30-AUG-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (route subcutaneous; strength, dose, frequency, lot #, expiration date and were not reported) for prophylaxis with sterile diluent (STERILE DILUENT) (unknown lot number and expiration). On 03-SEP-2019 the patient was vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status rHA (recombinant Human albumin) (M-M-R II) (lot # R036582, expiration date 17-DEC-2020) with sterile diluent (STERILE DILUENT) (lot #S003608, expiration date 22-NOV-2020) (inappropriate schedule of vaccine administration). No adverse effects reported.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored PROQUAD (lot R030798 & expiration date 4/22/2020).; PROQUAD used for 18 year old patient; This spontaneous report was received from a administrator referring to a 18 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 11-SEP-2019 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose and route were not provided, lot#R030798, expiration date was 22-APR-2020) (Inappropriate age at vaccine administration). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). The temperature excursions included 6 fahrenheit degree to 14 fahrenheit degree (14 fahrenheit degree) for 200 hours and 15 fahrenheit degree to 46 fahrenheit degree (34.268 fahrenheit degree) for 18 hours (Incorrect product storage). There was no temperature previously excursion. There was a data logger involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 09-SEP-2019, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin(rHA)(PROQUAD)(lot#R030794, expiration date was 22-APR-2019)(exact dose and route of administration were not reported)for prophylaxis. The administered doses experienced a temperature excursion of 1 to 5 degree Celsius(reported as -14 to 10 degree Celsius(-14.37C)) for 30 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. The sterile diluent used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin(rHA)(PROQUAD) was properly stored. No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Product quality issue, Skin laceration, Syringe issue
Clinical narrative: Finger flange of the syringe broke which made a deep cut on the left pointer finger.; Finger flange of the syringe broke which made a deep cut on the left pointer finger.; the finger flange of the syringe broke/ PQC: Yes; The patient "was using a PNEUMOV AX 23 syringe and while injecting PNEUMOVAX 23 on 9/15/2019, the finger flange of the syringe broke which made a deep cut on the left pointer finger; This spontaneous report as received from a 40 year-old male pharmacy technician who is also the patient.   The patient did not have concurrent or historical conditions, drug reactions, allergies, or concomitant medications.    On 15-SEP-2019, the patient was was using a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012244 with expiry date of 09-FEB-2021) syringe and while injecting the vaccine, the finger flange (at the end towards plunger not needle) of the syringe broke (syringe issue) which made a deep cut on the left pointer finger (skin laceration). The finger was treated by washing the site and applying a bandage. Then, another syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered without difficulty. On 16-SEP-2019, the patient was recovered from the events. There was a product quality complaint involved, but the product would not be retrieved as syringe was used. Additionally, it was reported that the syringe tip cap was attached properly prior to use, the syringe tray intact and undamaged, the cellophane cover of the syringe tray intact and completely sealed on receipt and the syringe carton was not damaged prior to use.   The causality assessment between skin laceration, product quality complaint and syringe issue with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's current condition, concomitant medications, pertinent medical history, drug reactions/allergies were not reported. On 21-SEP-2019, the patient was administered with one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number R030924, expiry date 10-JUL-2020 (dose, strength, frequency were unknown) via oral route (defaulted) for prophylaxis which was improperly stored (product storage error). The vaccine underwent a temperature excursion of 0.24 Celsius for time frame of 5 hours 30 minutes. Data logger was involved. There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; Information has been received from lawyers referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On or about 28-APR-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced a bad case of shingles. The patient did not recover from the event. As per the reporter, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The event of post herpetic neuralgia was determined to be disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; an unspecified patient experienced swelling,redness and warmth from her shoulder to her elbow after receiving PNEUMOV AX 23 on an unspecified day.; This spontaneous report has been received from a physician via company representative referring to a 72-year-old female patient. Information about the patient's concurrent conditions, medical history, concomitant therapies and drug reaction or allergies were unknown.     On 23-JUL-2019, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route, lot number and expiration date were not reported)) for prophylaxis.         On an unknown date in July 2019 (reported as after receiving pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) on an unspecified day), the patient experienced welling, redness and warmth from her shoulder to her elbow. The patient had sought medical attention (came back to office). The patient was treated with prednisone therapy pack and benadryl. It was unknown if the lab diagnostics or studies were performed. The outcome of the events was reported as recovered. No cancer and overdose were reported. No product quality complaint (PQC) was reported. The causality between the events and pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Urticaria
Clinical narrative: urticaria lesions; Information has been received from a physician via a company representative, referring to a currently 11 years old male patient. Concurrent condition was not reported. Drug reactions/ allergies included history of environmental and food allergies. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (CRM197) (MENVEO).  On an unknown date, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose detail, strength, lot#, and expiration date were not reported) via intramuscular route for prophylaxis (reported as vaccination).   The patient developed erythema on neck which than spread to the trunk and the back not long after the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (CRM197) (MENVEO) on the same unspecified date. The physician diagnosed the condition as urticaria lesions, prescribed diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC) for 1 day. There were no lab diagnostics/studies performed. The patient was fully recovered on an unspecified date.  Causality assessment was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; expired dose administered; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 06-SEP-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) 1 injection, intramuscularly (lot # R021233, Expiry date : 05-SEP-2019) for prophylaxis (expired product administered). No adverse effects were reported. Nurse declined evaluation of administered dose. There was no product quality complaint.
Sex: U
Vaccine: FLU4
Symptoms: Dyspnoea, Nausea, Ocular hyperaemia, Rash, Vomiting
Clinical narrative: Rashes to neck and trunk; Nausea; Vomiting; Red eyes; Shortness of breath; This case was reported by a nurse and described the occurrence of rash in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced rash, nausea, vomiting, eye red and shortness of breath. On an unknown date, the outcome of the rash, nausea, vomiting, eye red and shortness of breath were unknown.   It was unknown if the reporter considered the rash, nausea, vomiting, eye red and shortness of breath to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, there was Flu immunization where the patient experienced adverse reaction reaction with rashes to neck and trunk, nausea and vomiting red eyes. The patient also experienced shortness of breath. This is 1 of the 10 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Adverse reaction; This case was reported by a nurse and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, there was Flu immunization where the patient experienced flu adverse reaction. This is 1 of the 10 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a nurse and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, there was Flu immunization where the patient experienced flu adverse reaction. This is 1 of the 10 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Chills; Headaches; Arm numbness; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, nausea, chills, headache and numbness of upper extremities. On an unknown date, the outcome of the fever, nausea, chills, headache and numbness of upper extremities were recovered/resolved.   It was unknown if the reporter considered the fever, nausea, chills, headache and numbness of upper extremities to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician on the chat reporting a patient experienced nausea, fever, chills, headaches and arm numbness the day after the first dose.  The events went away within a couple days.  The contact had a patient waiting and left the chat without providing any further information.  No other information captured.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Frequent bowel movements
Clinical narrative: Upset stomach; Frequent Bowel Movements; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th September 2019, less than a day after receiving Shingrix, the patient experienced upset stomach and frequent bowel movements. On an unknown date, the outcome of the upset stomach and frequent bowel movements were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and frequent bowel movements to be related to Shingrix.  Additional information received were as follows: On sunday, in the early afternoon, the patient received Shingrix on right arm. Within 12 hours of receiving the vaccination, the patient began to experience an upset stomach and frequent bowel movements. The patient reported that she had 4 to 5 bowel movements in the last 24 hours and that was more than she normally experienced, The patient stated that it was not diarrhea just increased frequency of bowel movements and indicated that the symptoms were starting to lessen as the day progresses.  The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The patient experienced redness 4 inches wide at the site of injection site and it had been 7 days at the reporting date the redness had still not improved.  No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: fever; chills; pain/ Achiness; flu-like symptoms; headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, chills, pain, influenza-like symptoms and headache. On an unknown date, the outcome of the fever, chills, pain, influenza-like symptoms and headache were unknown.   It was unknown if the reporter considered the fever, chills, pain, influenza-like symptoms and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per vaccine indication. The pharmacist reports that many patients had been complaining that they had worse issues after the second dose of Shingrix. She stated that she had been told by patients that after getting the second dose of Shingrix, the patients had experienced fever, chills, pain, headache, achiness, and flu like symptoms. No specific details regarding patient or products was provided at time of reporting. The reporter had consented to follow up.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness transient, Dizziness, Gait disturbance, Hypoacusis, Vertigo
Clinical narrative: trouble hearing out of left ear; complete loss of vision for short periods of time; trouble walking; extremely dizzy; vertigo; Initial information received on 20-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 82 years old female patient who experienced trouble hearing out of left ear (hypoacusis), complete loss of vision for short periods of time (blindness), trouble walking (gait disturbance), extremely dizzy (dizziness) and vertigo (vertigo), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2019 at 2:09 pm, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB and Exp. Date 01-Apr-2020 via intramuscular route in the left deltoid.  On 13-Sep-2019 at night around 3 am, the patient developed a serious trouble hearing out of left ear (hypoacusis), complete loss of vision for short periods of time (blindness), trouble walking (gait disturbance), extremely dizzy (dizziness) 12 hours 51 minutes following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. patient was diagnosed with vertigo. The patient was hospitalized on the same day these events occurred and discharged on 14-Sep-2019 (hospitalization duration 1 day). She was told to go to emergency room.  Other relevant tests not reported.    Final diagnosis was vertigo, hypoacusis, blindness, gait disturbance and dizziness.  It was not reported if the patient received a corrective treatment.  The patient was recovering from all the events.  List of documents held by sender: none.; Sender's Comments: This case involves a 82 years old female patient who developed vertigo, hypoacusis, blindness, gait disturbance and dizziness after vaccination with FLUZONE HIGH DOSE. Time to onset was compatible. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Light flu like symptoms, acute local reaction To arm. Redness,acute pain ,swelling from injection site to anticubital with heat and redness. Acute swelling
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Light flu like symptoms, acute local reaction To arm. Redness,acute pain ,swelling from injection site to anticubital with heat and redness. Acute swelling
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Skin warm, Swelling
Clinical narrative: She received vaccine in the morning of 9/26/19, yesterday evening began having some fatigue, and over night area below injection site became swollen, red, and very hot to the touch. She is taking Advil/Tylenol for swelling/pain and is going to keep an eye on swelling and redness.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient describes facial swelling on opposite side of body where vaccine was administered.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient presents to the pharmacy very anxious to receive the vaccine. Her mom had filled out the vaccination form without any problems (NKDA, no ill day of vaccination, etc). Quickly after administering the vaccination (about 1-2 minutes), patient said she felt like she needed to 'vomit.' She threw up, was sweating, lost consciousness for 30 seconds, urinated, and then woke up. She was unaware of the event (did not know she lost consciousness or urinated). She was provided some water and began to feel better. She sat until she felt better. Patient and her parent left without letting me know. Unknown if patient improved, called the following morning to follow up but no answer.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After less than 24 hour employee's left arm middle upper portion of tricep toward back  became swollen , red , hot to the touch. per the nurse who administered the vaccine.  After my assessment of the area involved with the reaction was not where the deltoid is located. I believe the vaccine could have been given  in the wrong site. So I recommended that ibuprofen  and benadryl be started immediately since the arm was already the size of a coke can and to reassess the arm in 24 hours.As antiboitics may need to be started . After additional 24 hours there was some improvement and the employee  agreed it had as well- we opted to start  the antibiotics given it was the same size had not gone down. The redness had improved some. Keflex 500mg  2 capsules BID x10 days
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Ocular hyperaemia, Throat irritation
Clinical narrative: Patient reported that 2 hours after receiving injection, his eye started getting very red and painful along with throat irritation.  He reports that he took Ibuprofen and Zyrtec and symptoms resolved shortly after.  He denies any rash, redness at injection site, wheezing, shortness of breath or chest pain.  Notified Medical the next day.  He was then given Claritin and Zantac to take daily for one week
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain in extremity
Clinical narrative: patient reported arm red and still a little sore 6 days after receiving vaccination.  Also stated had chills soon after receiving vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came into pharmacy on 9/26/19 with signs and symptoms of redness on injection site arm. The red area was warm to the touch and was about the size of 2 palms. Patient still had her band-aid on, it was recommended that she remove her band-aid and ice the site. Patient said that she was getting better.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pustule, Injection site rash
Clinical narrative: Redness and hard lump at site. One medium pustule sustained and a few smaller bumps appeared and resolved in two days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT CALLED IN THE PHARMACY AND COMPLAINED ABOUT HAVING ITCHY AND BUMPY SKIN ON BOTH LEGS AND THIGHS. PATIENT HAVE ALREADY USED BENADRYL LIQUID.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: Could not resume activities till 9/23/2019.  Fever as high as 101.8.  Headache, chills, severe stomach pain.  Malaise.  Sore arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Could not resume activities till 9/23/2019.  Fever as high as 101.8.  Headache, chills, severe stomach pain.  Malaise.  Sore arm.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient 19y/o was inadvertently given a state supplied pediatric dose of HepA (0.5ml). No adverse reactions noted. Patient will be revaccinated with the age appropriate adult HepA dose (1ml) as soon as possible. VAERS and Institute error reporting forms are summited. MA who gave the incorrect vaccine has been spoken to. State Board of health is aware of the situation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactoid reaction, Autopsy, Death, Tryptase increased
Clinical narrative: Anaphylactoid reaction based on postmortem tryptase level of 87.1 ng/ml. This postmortem level is elevated.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: chills, headache, body aches, fatigue, sore arm
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: headache, fatigue, red sore arm, chills, body aches
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: headache, fatigue, red sore arm, chills, body aches
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Within hours, my arm began to ache to the point that lifting it to shoulder height was uncomfortable.  By evening, the entire upper arm was swollen (measured about 1.25 inches greater in diameter than it does today), hard to the touch, red and very warm;  the arm ached unbearably unless it was supported on a pillow, and I couldn't lift it without significant pain.  The same remained true on Friday (the next day) and to a lesser degree on Saturday.  By Sunday, I had good range of motion back, but the arm remained warm and redder than usual.  By Monday, I only noticed it when I bumped it.  I was taking 800 mg of ibuprofen (my usual dose for headache pain) three times a day Friday through Sunday.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Within hours, my arm began to ache to the point that lifting it to shoulder height was uncomfortable.  By evening, the entire upper arm was swollen (measured about 1.25 inches greater in diameter than it does today), hard to the touch, red and very warm;  the arm ached unbearably unless it was supported on a pillow, and I couldn't lift it without significant pain.  The same remained true on Friday (the next day) and to a lesser degree on Saturday.  By Sunday, I had good range of motion back, but the arm remained warm and redder than usual.  By Monday, I only noticed it when I bumped it.  I was taking 800 mg of ibuprofen (my usual dose for headache pain) three times a day Friday through Sunday.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope due to immunizations. Event happened around 10:15 am and the child fainted around 10:18 am.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test abnormal, Fatigue, Neuralgia
Clinical narrative: Patient states she started to experience pain, most often in the arm and hand of the injection (left) starting about 5 days after administration. She described the pain as an aching nerve pain, usually from the elbow down to the hand, She states she also experiences pain that moves to the legs and other arms, as well as fatigue, weakness and pain to the touch in the wrist of the left arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states she started to experience pain, most often in the arm and hand of the injection (left) starting about 5 days after administration. She described the pain as an aching nerve pain, usually from the elbow down to the hand, She states she also experiences pain that moves to the legs and other arms, as well as fatigue, weakness and pain to the touch in the wrist of the left arm.