chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 7 years old male patient received a dose of Adacel in NOV-2018 and DEC-2018/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a seven years old (8 years, 5 months, 23 days also reported) male patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in Nov-2018 and Dec-2018 (lot number and expiry date not reported) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), HEPATITIS B VACCINE (HEPATITIS B VACCINE) on NOV-2018 and PARACETAMOL (PEDIATRIX).  It was an actual medication error due to inappropriate age at vaccine administration.  Adverse event was not reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: FEVER TO 104 WITHIN 12 HOURS OF VACCINES
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: After immunization given, patient experienced more than usual bleeding. I was able to control bleeding with extra cotton ball and bandage. After bleeding subsided, patient's arm had swelling at injection site. I advised the patient to stay with us for 15 minutes to make sure no other adverse reaction occurred. After 15 minutes, bleeding has stopped but swelling at injection site was still present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Flu like symptoms, shivers, headache, tiredness, aches especially legs, arm pain at shot sight, fever, weakness, dizziness for 5 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Flu like symptoms, shivers, headache, tiredness, aches especially legs, arm pain at shot sight, fever, weakness, dizziness for 5 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Flu like symptoms, shivers, headache, tiredness, aches especially legs, arm pain at shot sight, fever, weakness, dizziness for 6 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Flu like symptoms, shivers, headache, tiredness, aches especially legs, arm pain at shot sight, fever, weakness, dizziness for 6 days.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient said that within a few hours of receiving the vaccination he felt serious soreness, which turned into limited range of motion (basically none) and extreme pain by late evening.  Patient took Ibuprofen 400 mg the following day and range of motion returned and reported decrease in pain.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: 3 welts and redness noted on patient's left deltoid. Patient stated she received Tdap vaccine in that area 2 days prior. Patient has been having fever 102.8 to 104 for past 24 hours.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, fever, shivering, body aches, weakness, tiredness, pain at injection site for 5 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Flu like symptoms, headache, fever, shivering, body aches, weakness, tiredness, pain at injection site for 5 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, fever, shivering, body aches, weakness, tiredness, pain at injection site for 6 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Flu like symptoms, headache, fever, shivering, body aches, weakness, tiredness, pain at injection site for 6 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient said her arm was very sore and her whole upper arm was swollen and red.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; One female child received improperly stored ROTATEQ; Information has been received from a medical assistant referring to a 3 months old female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 06-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033485, expiration date: 24-JUN-2020, strength and dose were unknown) orally for prophylaxis (product storage error). No adverse effect was reported.  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to total time and lowest temperature below 36 Fahrenheit degrees (32.3 Fahrenheit degrees) for 1 hour and 58 minutes. Previous temperature excursion was total time and lowest temperature below 36 Fahrenheit degrees (32.1 Fahrenheit degrees) for 21 hours and 58 minutes. The temperature excursion was detected by a data logger.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Patient states she started to get a headache several hours after receiving this vaccine. She said she had a small episode of dizziness that evening which went away but headach lasted 3 days. Patient notified the clinic 3 days later. When nurse talked to the patient, the patient said these symptoms may or may not have been caused by the vaccine because she experienced these symptoms before in the past (9 moths ago). Patient said she feels fine today but is not sure if she should get the second dose of Shingrix.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pruritus, Swollen tongue
Clinical narrative: Patient became violently nauseated, developed severe diarrhea and abdominal cramping. Also experienced total body itching as well as tongue swelling.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Cold sweat, Dyspnoea
Clinical narrative: Reporter was informed after the fact that patient experienced shortness of breath and clamminess after going through the checkout line and paramedics were called. Patient had flu shot prior to shopping and believed it may be involved in her symptoms. Reporter was informed that patient was recovering prior to arrival of paramedics. Per store management, paramedics took patient's vitals and they were normal. Patient declined to go with the paramedics and went home with husband.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Ill-defined disorder, Influenza like illness
Clinical narrative: severe illness, flu like symtoms
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Vomiting
Clinical narrative: After receiving vaccines patient began vomiting at 1036, blood pressure taken at the time 67/42 HR 66. Had the patient lay down with legs up in a chair, at 1040 had the patient sit up, patient states he is "feeling better". BP 83/56 HR 85 at 1047 patient ambulated back to chair BP 104/73 HR 77. Patient is sitting up eating crackers and drinking coke at this time. Patient ambulated out of clinic with his grandmother.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Differential white blood cell count normal, Dizziness, Full blood count normal, Injection site swelling, Insomnia
Clinical narrative: Pt received both vaccines in left upper arm on 9/4/19 and also had blood drawn.  Immediately after receiving vaccines and having blood drawn, pt became dizzy and needed to lay down.  (He has history of syncope in the past after mom had blood drawn in the ED).  He felt better in about 15 minutes and was able to leave the clinic and go home.  Vaccines received about 8 pm. The next morning mom called and stated pt's arm and shoulder were very painful, he was only able to sleep for 2 hours due to the pain, mild swelling, and that he had tingling down the back of his arm.  Pt was seen in clinic later in the morning (9/5/19) and exam revealed minimal swelling of left upper arm, no erythema at injection site.  Pt holding left arm flexed and in toward body, mom assisted him in removing his sweatshirt for examination of his left shoulder and arm.  Vitals were normal.    Recommended ibuprofen, warm compresses, soaking in bathtub.  Pt voiced that he wanted to go back to school for the day.  Discussed that severe shoulder pain is a rare side effect of the vaccine.  Provided written information of side effects from CDC regarding both meningitis vaccines.  Provided reassurance that in a few days his symptoms would likely significantly improve.  Mom or pt to call if symptoms worsening or persisting.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Musculoskeletal pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pt received both vaccines in left upper arm on 9/4/19 and also had blood drawn.  Immediately after receiving vaccines and having blood drawn, pt became dizzy and needed to lay down.  (He has history of syncope in the past after mom had blood drawn in the ED).  He felt better in about 15 minutes and was able to leave the clinic and go home.  Vaccines received about 8 pm. The next morning mom called and stated pt's arm and shoulder were very painful, he was only able to sleep for 2 hours due to the pain, mild swelling, and that he had tingling down the back of his arm.  Pt was seen in clinic later in the morning (9/5/19) and exam revealed minimal swelling of left upper arm, no erythema at injection site.  Pt holding left arm flexed and in toward body, mom assisted him in removing his sweatshirt for examination of his left shoulder and arm.  Vitals were normal.    Recommended ibuprofen, warm compresses, soaking in bathtub.  Pt voiced that he wanted to go back to school for the day.  Discussed that severe shoulder pain is a rare side effect of the vaccine.  Provided written information of side effects from CDC regarding both meningitis vaccines.  Provided reassurance that in a few days his symptoms would likely significantly improve.  Mom or pt to call if symptoms worsening or persisting.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Iridocyclitis, Slit-lamp tests abnormal
Clinical narrative: Left eye anterior uveitis
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received both shots in left arm evening of 9/4. Returned to pharmacy morning with painful, swollen, red, warm arm. Affected are reached from shoulder to elbow. Pt saw his provider and was advised to use ice, elevation and NSAIDS to treat.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: PAINLESS NODULE (HARDENING UNDER THE SKIN) AT INJECTION SITE; DID NOT APPEAR UNTIL 30 DAYS AFTER TIME OF INJECTION; PATIENT HAS NO OTHER COMPLAINTS
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site discolouration, Vaccination site warmth
Clinical narrative: Patient states that within 24 hours of vaccination, her arm developed a red mark, the size of a softball, around the vaccination site. The site of immunization had a slightly darker color than the rest of the red mark. When she came to pharmacy, the mark had gotten smaller. She states the area was warm to the touch but did not cause any discomfort or pain.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patients mother complained of Patients Left arm being swollen and Red.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to TDAP in Left Deltoid.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Patient was ordered to receive Polio, Varicella & Influenza vaccines. A dose of MMR was inadventently administered along with ordered vaccines. Mother notified immediately.
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Periorbital oedema, Swelling, Throat irritation, Urticaria
Clinical narrative: Hives (L) forearm w/swelling Hives (R) forearm w/swelling Mild periorbital edema Scratchy throat 60mg prednisone PO 25mg benadryl RX Zantac 150mg BID RX Epi pen
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Depressed level of consciousness, Eye movement disorder, Fall
Clinical narrative: Employee reported that patient and mother were leaving the patient area and at the counter paying the visit bill. Patient felt weak then blacked out and proceeded to fall, mother caught her, and assisted to chair. Care team was called, Dr., RN, and MA. After Dr. and MA arrived, patient was observed stiffening and arching back, eyes rolled back, and then went limp. Very difficult to arouse. Non responsive.  O2 given. RN arrived. BG done- 124. Vitals were taken, BP of 74/42, HR 58-80. O2  99-100 % RA. Pt just had  Tdap, HPV and MCV.  Came to after about 20 min. Became alert and oriented x 3 after 20 min.   Ambulance arrived  and transported to ER. Assessed Dystonic Reaction (likely dt HPV) vs Seizure episode as comment only
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypotonia, Loss of consciousness, Musculoskeletal stiffness, Opisthotonus, Unresponsive to stimuli
Clinical narrative: Employee reported that patient and mother were leaving the patient area and at the counter paying the visit bill. Patient felt weak then blacked out and proceeded to fall, mother caught her, and assisted to chair. Care team was called, Dr., RN, and MA. After Dr. and MA arrived, patient was observed stiffening and arching back, eyes rolled back, and then went limp. Very difficult to arouse. Non responsive.  O2 given. RN arrived. BG done- 124. Vitals were taken, BP of 74/42, HR 58-80. O2  99-100 % RA. Pt just had  Tdap, HPV and MCV.  Came to after about 20 min. Became alert and oriented x 3 after 20 min.   Ambulance arrived  and transported to ER. Assessed Dystonic Reaction (likely dt HPV) vs Seizure episode as comment only
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nervousness, Rash
Clinical narrative: IN FoR 7th gRade shots 0 acted NeRvouse all quesTions No oN secReening FoRm - seemed. NeRvouse - asked IF WaNTed to LaydowN He Did - seemed FiNe after shoTs - 12 NooN Mom called. Rash oN ToRso - 3pm Rash oN Neck & Race - Did NoT go To ER - over oN Back 8/26/19 815 AM Call To mom FoR Followup - gave Oatmeal Bath a BeNedry. Is DoiNg BeTTeR Now Face PuFFy - ModeRaTe Body Rash. Everything sTaRTed Within 2 hrs after shoT given Mom was going To check with SchooL NuRse & see IF any oTheRs Had same ReacTion- Will check oN Tuesday To call schooL - schooL NuRse - Said No pRoblems From Him & No oTheR children Had any ProbLems
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Seizure
Clinical narrative: 15 minute seizure approx. 21 hours after receiving Proquad and Kinrix vaccines. Seizure responded to Diastat. Has had 12 febrile seizures in past and seen Neurology.
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: next day 9/5/19 after having vaccine (R) arm swollen + red, hot to touch No fever Pt went to the ER Clindamycin 75 mg/5 ml take 30 mL TID x 7 days if reaction area worsen prescribed. Followed up with primary  doctor 9/6/19, will start antibiotic
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fear, Feeling cold, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediate paiN, Moderate soreNess, swelliNg, redNess aT siTe of injecTioN - lasTed 3-5 days. Approx 6 hous laTer, 12:30 AM. MidNighT - awoke froM sleep by exTreMe shiveriNg - freeziNg - cold; Took 30-45 MiNuTes To calM dowN. Really FrighTeNiNg, uNprecedeNTed!
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Immediate paiN, Moderate soreNess, swelliNg, redNess aT siTe of injecTioN - lasTed 3-5 days. Approx 6 hous laTer, 12:30 AM. MidNighT - awoke froM sleep by exTreMe shiveriNg - freeziNg - cold; Took 30-45 MiNuTes To calM dowN. Really FrighTeNiNg, uNprecedeNTed!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Migraine
Clinical narrative: Rash on my arm & soreness of where The shot was given & also had migraine headaches
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Abnormal behaviour, Aggression, Anger, Initial insomnia, Screaming
Clinical narrative: Mother report fit of rage in The evening after immunization apt. Biting, knawing her teeth, Hitting, kicking & screaming for an hour. Next day 1/2 as bad. Mother stated she isn't herself & acts as if she isn't sure what is going on. No fever. Hard to fall asleep at night.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness for a couple of days; This spontaneous report was received from a physician who referred to his son, a male patient in age between 2-6 years old. The patient's pertinent medical history included immunocompromised condition. The information regarding his concomitant therapies, drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with a one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis by another unspecified healthcare provider. On an unknown date (also reported as 09-AUG-2019), the patient experienced mild arm soreness. On an unknown date (reported as a couple of days post vaccination), the patient recovered from the event.  The causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One patien received one dose of improperly stored ROTATEQ; This spontaneous report was received from the office manager (also reported as "health care business professional) referring to a patient of unknown age and gender. The medical history, his historical medication, current conditions, allergies and drug reactions were not reported.    On 08-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot # R025713 with expiration date on 20-JUN-2020; one dose was administered orally, for prophylaxis, which was discovered through the digital data logger that it was improperly stored with lowest temperature below 36 degrees Fahrenheit (°F) (33.9F) for 40 minutes (previously reported 20 minutes) time frame. There was a previous temperature excursion with total time and lowest temperature below 36°F (30.5F) for 1 hour 45 minutes and total time and lowest temperature below 36°F (35.2F) for 2 hours 5 minutes. No adverse effects were reported. No additional doses were administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 09-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated for shingles. And on an unknown date the patient was hospitalized.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date, the patient was hospitalized.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse Effects; Improperly stored dose of GARDASIL9 was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The reporter stated that, on either 16-JUL-2019, 22-JUL-2019 or 29-JUL-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020947, expiration date 04-MAY-2021, for prophylaxis (dose, route and site of administration were unknown). No adverse effects reported. The outcome of the event was not reported.  Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit/ 9 degrees Celsius (9.12 degrees Celsius) for 3 hours and 15 minutes and below 36 degrees Fahrenheit/ 2 degrees Celsius (-13.33 degrees Celsius) for 2 minutes. There were no previous excursions reported.; Sender's Comments:  US-009507513-1909USA001880:
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: an 11 year old female, NN, received a dose of Adacel on 20AUG2019, had had a Tdap on 20AUG2018; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that an 11 year old female, received a dose of Adacel on 20 Aug 2019, had had a TDAP on 20aug2018 (Inappropriate schedule of product administration (10081572).  The patient's past vaccination(s) included Tdap on 20-AUG-2018.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 20-Aug-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA and expiry date: 04-Apr-2021 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was not reported if any adverse event occurred 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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Product administered at inappropriate site
Clinical narrative: patient received a dose of Daptacel that was expired/ No AE; 5 year old received vaccine in thigh, no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5206AA, expiry date 17-May-2019 via intramuscular route in the Left Quadricep on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included POLIO VACCINE (POLIO) right quadricep intramuscular) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (right vastus lateralis) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) (left vastus lateralis) for Immunisation.  It was a case of actual medication error due to expired vaccine used and Vaccine administered at inappropriate site.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Adacel started to leak while administering it; Adacel started to leak while administering it; Initial information received on 28-Aug-2019 and additional information received on 29-AUG-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 52 years old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but it started to leak while administering, lot U6103AA, expiry date: 25-10-2020 via intramuscular route in the left deltoid on 27-Aug-2019.  The patient's past vaccination(s) included adacel 10 or 15 years ago.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of vaccine underdose and syringe issue.  Final diagnosis was adacel started to leak while administering it and adacel started to leak while administering it.  Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Quardacel was given to a patient Subcutaneously/no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 28-Aug-2019, the patient received a single 0.5 ml dose (5th dose series) of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5656AA via subcutaneous route in the right arm.  It was a case of potential medication error due to Inappropriate route of vaccination.  It was reported that no adverse event was experienced by the patient.  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: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: a 58 years old male patient received a dose of Adacel which had been arrived a day late and the temperature in the packaging was not in the red/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 58 years old male patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that had been arrived a day late and the temperature in the packaging was not in the red lot U56401AA, expiry date: 26-Jul-2021 via intramuscular route in the left deltoid on 29-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a four years old female patient received a expired dose of Quadracel on 28-Aug-2019/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a four years old female patient who received a expired 0.5 ml dose of IPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5248AA, expiry date: 21-Aug-2019 via unknown route in the left thigh on 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error due to Expired vaccine used.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration, No adverse event
Clinical narrative: a patient received a fourth dose of Typhim Vi via oral route one day too soon/No AE; a patient received a fourth dose of Typhim Vi via oral route one day too soon/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographics patient who received a fourth dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] via oral route one day too soon lot 3003279, expiry date: May-2020 via oral route in unknown administration site on an unknown date.   The patient's past vaccination(s) included TYPHIM VI three doses.  The patient's past medical history, medical treatment(s) and family history were not provided.   It was an actual medication error due to inappropriate schedule of vaccine administered and inappropriate route of vaccination.  Symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient experienced cellulitis and is being treated by her primary care physician. She expressed concern the immunizing pharmacist did not change gloves between unlocking /opening the door to the consultation room, and injecting her.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: He felt irritated and inflamed the same day and rested for most of the next day. Seeing his arm on the 6th I saw about 2 inch red zones around the injection sites. He had a shingrix in the right shoulder with no problems and flu & pneumonia in the left arm. No unusual pains, just uncommonly inflamed left arm where he got the flu & pneumonia. A nurse the other day said it felt hot and was raised he said.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Irritability
Clinical narrative: He felt irritated and inflamed the same day and rested for most of the next day. Seeing his arm on the 6th I saw about 2 inch red zones around the injection sites. He had a shingrix in the right shoulder with no problems and flu & pneumonia in the left arm. No unusual pains, just uncommonly inflamed left arm where he got the flu & pneumonia. A nurse the other day said it felt hot and was raised he said.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy, hives on left leg on inside of upper groin on sunday around lunch patient says now getting on right leg
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Cardiac flutter, Chest pain, Muscular weakness
Clinical narrative: Client reported to health department today 9/6/19 at 2:30pm. Stating at approx. 8pm last night she began having chest pain. Rated 7 on 0-10 pain scale. Stating her legs felt weak and felt as if they would give out. She denied shortness of breath, denied feeling faint. She stated she did not go to emergency room because she did not have child care for her toddler. She denied taking any medication last night.  She stated she came to health department today to report her symptoms because she was unsure if it was from the vaccine she received.  Client denied having chest pain today. She stated her legs still felt weak. She stated she is now having bilateral lower back pain. Client denied any other concerns or problems. Client stated she has taken 400mg of Ibuprofen today. Client was encouraged to seek medical attention for her symptoms. Client stated she would if it persists or she has chest pain again. Client denied wanting her BP checked today at her visit. Client stated she also had some heart fluttering feelings last night. Client denied having those symptoms today. Client was encouraged to seek medical attention in the event symptoms return. Client verbalized understanding.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received the Tdap immunization; however was to receive the Hep A instead. Patient was not due for the Tdap according to Registry until 2024. Both orders were in the patient's chart, however the Tdap was only given and should have been canceled prior to reconciling. As a result the Hep A was not given to the patient. The provider, PAC was notified and stated that the patient would not be harmed as an outcome. The father of the patient was also notified and verbalized understanding that there would be no harm to the patient; but he should not receive a bill for the vaccine. He may bring his son back at any time to receive the Hep A.  Report on the Company Intranet is also completed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: first sign sunday morning (09/01/2019) rash on both hands rash is clearing up on hans but on Monday morning (09/02/2019) patient says different type of rash started on both legs
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swelling and pain of both wrists. Right worst than left. Resolved four days later.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: 24 hours after the vaccine I developed a painful 4" circle rash, headache, fever, chills, tiredness ,  The  chills, tiredness that lasted 36 hours however the rash is still there at the same size with a fever on it is still ongoing.  I still have the  headache and fever however it lower in pain-level.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reports laying in bed with chills and a fever for 3 days straight.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphagia, Erythema, Eye swelling, Ocular hyperaemia
Clinical narrative: The below statements were per patient. Received vaccine around 8am and within 2 hours after vaccination had dry cough and slight sore throat.   As day continued eyes became bloodshot and felt very swollen.  Denied hives or rash, however said face and neck were reddened.  Throat became swollen and became hard to swallow. Went to ER around 1:15pm and was given a bag of fluids, IV steriods, and an antihistamine.  Was discharged around 3:30p and was given a 10 day dose of steriods and benadryl prn.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: The below statements were per patient. Received vaccine around 8am and within 2 hours after vaccination had dry cough and slight sore throat.   As day continued eyes became bloodshot and felt very swollen.  Denied hives or rash, however said face and neck were reddened.  Throat became swollen and became hard to swallow. Went to ER around 1:15pm and was given a bag of fluids, IV steriods, and an antihistamine.  Was discharged around 3:30p and was given a 10 day dose of steriods and benadryl prn.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: aches and pains after shot, round red spot on arm that was warm to the touch
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Cardiac discomfort, Crying, Eye swelling, Lip swelling
Clinical narrative: Mom states a few minutes after receiving the immunizations he began crying his stomach hurt, his heart was going to "explode" and his eyes/lips began to swell.  Mom was told by a triage nurse at Pediatrics to give benadryl and claritin.  Mom states shortly after giving these his symptoms went away.  Per Dr he did still have a rash to legs on 9/6/19.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Mom states a few minutes after receiving the immunizations he began crying his stomach hurt, his heart was going to "explode" and his eyes/lips began to swell.  Mom was told by a triage nurse at Pediatrics to give benadryl and claritin.  Mom states shortly after giving these his symptoms went away.  Per Dr he did still have a rash to legs on 9/6/19.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Ophthalmological examination
Clinical narrative: Pt reports that she went to read a magazine and then realized she couldn't see anything out of her right eyes. She states she remembered she has mono vision so she covered her left eye and was unable to see out of the right eye at all. She states that everything was black.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Fever started a few hours after injection and became very high the morning after, lasted till about 5 pm the day after injection and then went away. Dr did say it will last a short time and go away.  Muscles and joint ache. No other symptoms like one would have with cold or flu (i.e., no runny nose, throat pain, etc. Took 2 Tylenol pills ever four hours.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Lymph node pain
Clinical narrative: Non-demarcated erythema, warmth, and tenderness at the injection site and right axillary lymph nodes without edema.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Non-demarcated erythema, warmth, and tenderness at the injection site and right axillary lymph nodes without edema.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Acute kidney injury, Adrenal mass, Atrial fibrillation, Chronic kidney disease, Dehydration
Clinical narrative: Malaise, Fatigue, nausea, fever (101.2); arm swelling; leukocytosis.  Final diagnosis: SIRS due to noninfectious process with acute organ dysfunction.  Other final diagnoses for same admit: Fever; primary hyperaldosteronism; paroxysmal atrial fibrillation; nontraumatic acute kidney injury due to dehydration; DM2 with CKD stage 3; left adrenal mass; major depressive disorder (in full remission); GERD; HTN; Hx of thyroid cancer - postoperative hypothyroidism; hyperlipidemia.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Gastrooesophageal reflux disease, Hypertension, Leukocytosis, Major depression
Clinical narrative: Malaise, Fatigue, nausea, fever (101.2); arm swelling; leukocytosis.  Final diagnosis: SIRS due to noninfectious process with acute organ dysfunction.  Other final diagnoses for same admit: Fever; primary hyperaldosteronism; paroxysmal atrial fibrillation; nontraumatic acute kidney injury due to dehydration; DM2 with CKD stage 3; left adrenal mass; major depressive disorder (in full remission); GERD; HTN; Hx of thyroid cancer - postoperative hypothyroidism; hyperlipidemia.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Malaise, Nausea, Organ failure, Peripheral swelling, Primary hyperaldosteronism
Clinical narrative: Malaise, Fatigue, nausea, fever (101.2); arm swelling; leukocytosis.  Final diagnosis: SIRS due to noninfectious process with acute organ dysfunction.  Other final diagnoses for same admit: Fever; primary hyperaldosteronism; paroxysmal atrial fibrillation; nontraumatic acute kidney injury due to dehydration; DM2 with CKD stage 3; left adrenal mass; major depressive disorder (in full remission); GERD; HTN; Hx of thyroid cancer - postoperative hypothyroidism; hyperlipidemia.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Systemic inflammatory response syndrome, Type 2 diabetes mellitus
Clinical narrative: Malaise, Fatigue, nausea, fever (101.2); arm swelling; leukocytosis.  Final diagnosis: SIRS due to noninfectious process with acute organ dysfunction.  Other final diagnoses for same admit: Fever; primary hyperaldosteronism; paroxysmal atrial fibrillation; nontraumatic acute kidney injury due to dehydration; DM2 with CKD stage 3; left adrenal mass; major depressive disorder (in full remission); GERD; HTN; Hx of thyroid cancer - postoperative hypothyroidism; hyperlipidemia.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Donor developed redness, swelling, tenderness, and a nodule at the injection site about 24 hours after immunization. Symptoms still present.