chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 17-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 17-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1906USA011674:
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: "cut herself' on a broken syringe of GARDASIL 9/Finger flange broke, and a piece of glass got stuck inside the nurses finger; Broken syringe of Gardasil 9; "cut herself' on a broken syringe of GARDASIL 9/Finger flange broke, and a piece of glass got stuck inside the nurses finger; This spontaneous report as received from an office manager via a company representative, refers to a female patient of unknown age who was a nurse. The patient's medical history, concurrent conditions or concomitant medication were not reported.  On 03-JUN-2019, while the nurse was injecting the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R023606, expiration date 06-MAY-2021, for prophylaxis (route, strength, and dosage information were not informed), the finger flange broke (half of the circle of finger), and a piece of glass got stuck in side the nurses finger and she "cut herself'. It was unknown if treatment was given or if laboratory diagnostics or studies were performed. It was also reported that the needle was able to be attached securely to the syringe and it tip cap attached properly prior to use.   The outcome of limb injury was reported as recovered on an unknown date in June 2019. The outcome of product quality issue was unknown. The causality assessment between limb injury and product quality issue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Fainted; headache; tired; chills; blood pressure was low; area was sore; This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (on an unknown date received 1st dose and experienced headache, sore arm, tired, and felt out of sorts, refer case US2019AMR116527).   On 22nd June 2019, the patient received the 2nd dose of Shingrix. On 22nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 23rd June 2019, the patient experienced fainting (serious criteria GSK medically significant), headache, tiredness, chills and low blood pressure. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, injection site pain, chills and low blood pressure were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the fainting, headache, injection site pain, tiredness, chills and low blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Less than a day after receiving Shingrix vaccine, at evening, the patient experienced soreness in area of injection.  The patient also experienced chills, headache, tiredness, fainted on the morning of reporting date and had low blood pressure. This case has been linked with the case US2019AMR116527 for the same patient reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Hypotension, Injection site pain, Pain in extremity, Syncope, Vaccine positive rechallenge
Clinical narrative: Fainted; headache; tired; chills; blood pressure was low; area was sore; This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (on an unknown date received 1st dose and experienced headache, sore arm, tired, and felt out of sorts, refer case US2019AMR116527).   On 22nd June 2019, the patient received the 2nd dose of Shingrix. On 22nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 23rd June 2019, the patient experienced fainting (serious criteria GSK medically significant), headache, tiredness, chills and low blood pressure. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, injection site pain, chills and low blood pressure were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the fainting, headache, injection site pain, tiredness, chills and low blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Less than a day after receiving Shingrix vaccine, at evening, the patient experienced soreness in area of injection.  The patient also experienced chills, headache, tiredness, fainted on the morning of reporting date and had low blood pressure. This case has been linked with the case US2019AMR116527 for the same patient reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: sore; redness; headache; tired; felt out of sorts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm 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, unknown after receiving Shingrix, the patient experienced pain in arm, erythema, headache, tiredness and feeling abnormal. On an unknown date, the outcome of the pain in arm, erythema, headache, tiredness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema, headache, tiredness and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The patient experienced headache, a sore arm, redness that lasted for weeks, and felt out of sorts and tired. For tolerance of 2nd dose of Shingrix, refer case US2019AMR114601.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: Fatigue; drowsiness; This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and drowsiness. On an unknown date, the outcome of the fatigue and drowsiness were recovered/resolved.   It was unknown if the reporter considered the fatigue and drowsiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was approximately 60 years old at time of this report. At the time of receiving 2nd dose of Shingrix, the patient reported that, he experienced fatigue and drowsiness after vaccination with 1st dose for one to one and half days. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: swelling at injection site; fever; redness at injection site; headache; muscle pain in neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, fever, injection site erythema and headache. On 20th June 2019, the patient experienced muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the fever, muscle pain and headache were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, injection site erythema, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The patient had never had measles.  The patient wanted to know how long after receiving Shingrix she had to wait to get Measles Mumps Rubella shot.  The patient received Shingrix vaccine in the right deltoid muscle and it knocked her for a loop. The patient got a fever of 101 degree F and got a baseball size swelling and redness at the injection site.  On 20th June 2019, 1 day after receiving Shingrix, she woke up with muscular pain in the neck and shoulder that lasted for 3 days and was treated with ibuprofen.  The patient also experienced a headache.  The patient's right deltoid muscle and was still red and swollen but her other symptoms had resolved, at the the time of reporting. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: swelling at injection site; fever; redness at injection site; headache; muscle pain in neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, fever, injection site erythema and headache. On 20th June 2019, the patient experienced muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved and the outcome of the fever, muscle pain and headache were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, injection site erythema, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The patient had never had measles.  The patient wanted to know how long after receiving Shingrix she had to wait to get Measles Mumps Rubella shot.  The patient received Shingrix vaccine in the right deltoid muscle and it knocked her for a loop. The patient got a fever of 101 degree F and got a baseball size swelling and redness at the injection site.  On 20th June 2019, 1 day after receiving Shingrix, she woke up with muscular pain in the neck and shoulder that lasted for 3 days and was treated with ibuprofen.  The patient also experienced a headache.  The patient's right deltoid muscle and was still red and swollen but her other symptoms had resolved, at the the time of reporting. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: RA; Joint pain/symptoms of RA; Swelling in hands and upper extremities/symptoms of RA; Stiffness in hands and upper extremities; This case was reported by a physician via call center representative and described the occurrence of rheumatoid arthritis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), joint pain, peripheral swelling and limbs stiffness. On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the joint pain, peripheral swelling and limbs stiffness were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, joint pain, peripheral swelling and limbs stiffness to be related to Shingrix.  Additional details were received as follows: The patient experienced joint pain, swelling and stiffness in hands and upper extremities.  The physician reported that, the patient had symptoms of rheumatoid arthritis (RA) and had RA as of February 2019. The physician called in just to report adverse event.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: soreness; redness; bruise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and bruising of arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and bruising of arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and bruising of arm to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on an unknown arm and his arm was very sore after getting the first dose of Shingrix. The patient also had a big red mark on his arm and there was a bruise. The patient thought that the symptoms lasted for about 1 week. The patient gave consent to be followed up. In the narrative outcome of all events were reported as resolved with sequel, however in structured field it was reported as resolved.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Very sore arm. Lasted a week Full body aches and extreme fatigue
Age: 84.0
Sex: F
Vaccine: PPV, TD
Symptoms: Pain in extremity, Swelling
Clinical narrative: (L) Arm pain 12 hours after receiving vaccine. Pain & swelling worsening over 2 days. Treatment: Prednisone 20mg, 2 tablets daily Benadryl 25 mg q4" starting today.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling redness warm to touch moved from injection sit to a large fluid filled bump on inner elbow
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: vomitting
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient at 32 weeks 6 days EGA received Tdap as part of her routine prenatal care. Over the following 7 days developed worsening shoulder pain and decreased ROM.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Pain and swelling at site started a few hours after the shot was administered. It was quite bad about 11 hours later, and I could not lie on that side. The day after the vaccination, I have a headache, slight nausea, and muscle aches.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness, Urticaria
Clinical narrative: Pt had localized redness, swelling, with hives and itching on bilateral antecubital space. Painful to touch. Pt was seen by provider, administered 25mg of Benadryl IV, observed for 1 hour post treatment. Symptoms cleared, ensured patient had ride home.
Age: 18.0
Sex: U
Vaccine: HEPA, MENB
Symptoms: Blood glucose normal, Diarrhoea, Fall, Feeling abnormal, Head injury
Clinical narrative: patient given Bexsero first and then Vaqta, he stated "I don't feel good" and immediately fainted (patient was sitting in chair), he fell to the floor and bumped the right side of his head. Ammonia salt used to wake patient up, helped him to sit up, provided cold compress to back of his neck and forehead. Water and crackers were given, as patient said he had only eaten breakfast. After 5-10 minutes he stated he was not feeling good again, c/o nausea and dizziness. Call was placed to 911 for EMS transport to Hospital. VS 73/40, 52, 100% spo2, BS 80
Age: 18.0
Sex: U
Vaccine: HEPA, MENB
Symptoms: Nausea, Syncope
Clinical narrative: patient given Bexsero first and then Vaqta, he stated "I don't feel good" and immediately fainted (patient was sitting in chair), he fell to the floor and bumped the right side of his head. Ammonia salt used to wake patient up, helped him to sit up, provided cold compress to back of his neck and forehead. Water and crackers were given, as patient said he had only eaten breakfast. After 5-10 minutes he stated he was not feeling good again, c/o nausea and dizziness. Call was placed to 911 for EMS transport to Hospital. VS 73/40, 52, 100% spo2, BS 80
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV1, UNK
Symptoms: Speech disorder developmental
Clinical narrative: My verbal baby who would make sounds and say mama, dada, ball, nenna, and a few other words/sounds stopped talking. She recently started saying mama again and has been evaluated by Early Childhood Intervention and has an expressive speech delay. She will begin speech therapy for the next 6 months.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site mass, Neuralgia
Clinical narrative: Generalized nerve ending pain, golf ball size lump at injection site, flu like symptoms
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: The Patient is a 11 year old male.  Source of patient information was patient.  Source of patient information was mother.  Presents for L arm vaccine reaction. Had Mcv vaccine 2 days ago. Yesterday mother noted small area of redness. Today redness, swollen, hot and hard, significantly worse. Intermittent itching. Pain only with pressure and hyperextension. Motrin, not effective. Good ROM of arm. Denies fever, numbness or tingling. Good appetite and energy level. Denies NVD. No other concerns.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling, Tenderness
Clinical narrative: The Patient is a 11 year old male.  Source of patient information was patient.  Source of patient information was mother.  Presents for L arm vaccine reaction. Had Mcv vaccine 2 days ago. Yesterday mother noted small area of redness. Today redness, swollen, hot and hard, significantly worse. Intermittent itching. Pain only with pressure and hyperextension. Motrin, not effective. Good ROM of arm. Denies fever, numbness or tingling. Good appetite and energy level. Denies NVD. No other concerns.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Influenza like illness, Injection site pain, Lethargy
Clinical narrative: 1. flu-like symptoms for 24 hours which kept me in bed--body aches, headache, lethargy, loss of apetite 2. soreness at injection site
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 1. flu-like symptoms for 24 hours which kept me in bed--body aches, headache, lethargy, loss of apetite 2. soreness at injection site
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: developed a complex seizure.  Was also febrile at the time.  Admitted to hospital and started on anti seizure medications with follow up with Neurology outpatient
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Pt experienced fever, headache, vomiting, dizziness, sore throat, and tiredness. Duration unknown. Symptoms fully resolved.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt experienced fever, headache, vomiting, dizziness, sore throat, and tiredness. Duration unknown. Symptoms fully resolved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: Patient complained up injection site pain, neck pain and unable turn head to left, back pain, Nausea, headache, fatigue
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain
Clinical narrative: Patient complained up injection site pain, neck pain and unable turn head to left, back pain, Nausea, headache, fatigue
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Pyrexia, Rash, Sluggishness
Clinical narrative: nurse from dr's office reported that the patient developed puffy eyes, a torso rash from neck to groin, and a feeling of being sluggish and feverish. symptoms improved with benadryl administration
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Pain in extremity, Peripheral swelling, Tenderness, Varicella
Clinical narrative: she got a hugh swollen arm and it was tender and painful and had to go to hospital and it got infected and she got chicken pox out of the vaccine had to be in the hospital for a day or two
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received Daptacel vaccine after it expired/ no adverse event; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to case 2019SA179271, same reporter.  This case involves a 20 months old patient with unknown gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided. Concomitant medication was not received.   On 29-May-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019 via intramuscular route in right quad.  It was an actual medication error due to expired vaccine used.  It was reported that patient received Daptacel vaccine after it expired.  The patient did not experience any adverse reaction after the vaccination.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received Daptacel vaccine after it expired/ no adverse event; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to case 2019SA179270, same reporter.  This case involves an 18 months old patient with unknown gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided.  Concomitant medication was not received.   On 11-Jun-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019 via intramuscular route.  It was an actual medication error due to expired vaccine used.  It was reported that patient received Daptacel vaccine after it expired.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 years old patient got Daptacel instead of Adacel; 11 years old patient got Daptacel instead of Adacel; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5523AA expiry date 20-Sep-2020  via intramuscular route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] On 28-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether patient experienced any adverse reaction.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Anaphylactic reaction, Reaction to food additive
Clinical narrative: had an anaphylactic reaction; Seriousness criteria: Other- Important medical event- anaphylactic reaction.  Initial information received on 28-Jun-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown age female patient who experienced an anaphylactic reaction, while she received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE INTRADERMAL].  The patients past medical history, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing allergic to Agar.  Notes: Patient does not have an allergy to gelatin or eggs  On an unknown date, the patient received a dose of injection of suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE (the 2012 to 2013 formulation) lot number, expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious had an anaphylactic reaction (anaphylactic reaction) with unknown latency following the administration of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE. This event was assessed as medically significant.  Relevant laboratory test results included: On an unknown date: [allergist tested with saline and 1:100, 1:10 ratio of the Fluzone Intradermal and patient reacted to the 1:100 ratio]  Final diagnosis was had an anaphylactic reaction.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for had an anaphylactic reaction.  List of documents held by sender: None. Information on batch number was requested for this case.; Sender's Comments: This case concerns an adult patient who developed anaphylactic reaction after vaccination with FLUZONE INTRADERMAL. The patient is allergic to Agar. The time to onset is unknown. Moreover, there is no information regarding patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies, Based upon information reported, the role of the vaccine cannot be assessed in this case.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Fatigue, Feeling hot, Pyrexia
Clinical narrative: After getting the vaccine the customer stayed in the store for 15 minutes; he was fine at the time he left the store.  No bleeding or  any reactions. About an hour later, he called stating he felt tired and warm inside but the skin was normal to the touch.  Pharmacist advised him to contact his doctor  or go to urgent care for further help. On 7/2/19, patient called in the evening, saying that his condition has stayed the same: low-grade fever, slight dizziness, bruised arm. We told him to seek medical attention as soon as possible.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Rosacea
Clinical narrative: Patient called me at the pharmacy on the morning  of Saturday (4-20-19) to say that her arm was red and swollen at the injection site and warm to the touch.  I then advised her to go to a clinic  to get it checked out to be on the safe side.  She came back with a prescription for an antibiotic ( Bactrim DS) which I filled and dispensed.  I then found out that 3 days later her arm still wasn't improving so she sought additional medical attention.  This time she was given prescriptions for a Medrol Dose Pak and Loratadine.  After these meds were finished I thought that everything had been resolved.  Then on 7-1-19 I received another call from the pt stating that she was still having  issues that she felt was related to the shot ( rosacea and joint pain).  So I thought best to report all of the information I was presented with.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Alanine aminotransferase increased, Anion gap increased, Crying, Differential white blood cell count, Eye movement disorder
Clinical narrative: seen in ED 7/1 for episode that occurred about 4 PM that day, lying in crib, "eyes rolling back and then patient having shaking of the trunk and arms.  Patient was not responsive at that time.  After shaking patient began crying immediately" Episode lasted about 10 sec and seemed normal immediately after
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Full blood count, Lipase decreased, Metabolic function test, Platelet count increased, Tremor
Clinical narrative: seen in ED 7/1 for episode that occurred about 4 PM that day, lying in crib, "eyes rolling back and then patient having shaking of the trunk and arms.  Patient was not responsive at that time.  After shaking patient began crying immediately" Episode lasted about 10 sec and seemed normal immediately after
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: seen in ED 7/1 for episode that occurred about 4 PM that day, lying in crib, "eyes rolling back and then patient having shaking of the trunk and arms.  Patient was not responsive at that time.  After shaking patient began crying immediately" Episode lasted about 10 sec and seemed normal immediately after
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Crying, Hypersensitivity, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient is a 12 month old female who presents today for reaction to vaccine. Patient received PCV 13 vaccine, MMR vaccine, and Varicella vaccine approximately 10 minutes ago. Since then, developed erythema surrounding injection sites and rash to trunk and face. She has not had allergic reactions to vaccinations in the past, no food allergies.    Patient Active Problem List:     Twin liveborn by cesarean    Screening for endocrine, metabolic and immunity disorder    Newborn product of IVF pregnancy    Newborn affected by breech presentation     No current outpatient medications on file. Current Facility-Administered Medications: diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg 12.5 mg Oral Once Lia Rosenberg acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg 121.6 mg Oral Once Lia Rosenberg    Review of Patient's Allergies indicates:  No Known Allergies    I have reviewed the past medical, social, and family history. All pertinent historical factors are mentioned in the HPI. The remainder are non-contributory.      Objective      Appearance: Crying, able to be calmed by father.  Skin: Swelling and erythema to b/l lateral thigh surrounding injection site, R>L.  Mildly erythematous macules to patches to trunk and face. Cardiac: RRR, no M/R/G.  Respiratory: CTA bilaterally, no W/R/R. Normal work of breathing, no signs of respiratory distress  Neuro: Alert   ASSESSMENT&PLAN:   Problem List Items Addressed This Visit    None   Visit Diagnoses    Need for prophylactic vaccination with measles-mumps-rubella (MMR) vaccine       Relevant Orders   IMMUNIZATION ADMIN SINGLE, RN (Completed)   MEASLES MUMPS RUBELLA VIRUS VACCINE LIVE SUBQ (Completed)   Need for prophylactic vaccination and inoculation against varicella       Relevant Orders   VARIVAX (CHICKEN POX VACC) LIVE SC (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Need for prophylactic vaccination against Streptococcus pneumoniae (pneumococcus)       Relevant Orders   PCV13 VACCINE FOR INTRAMUSCULAR USE (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Allergic reaction, initial encounter       Relevant Medications   diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg (Completed) (Start on 7/3/2019  4:45 PM)   acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg (Completed) (Start on 7/3/2019  4:45 PM)     Allergic reaction: Normal pulm exam, no respiratory distress. Anaphylaxis unlikely. Likely due to varicella vaccine given degree of swelling and erythema surrounding this injection site was more severe than the other injection site. Rash and swelling improved with Benadryl, patient now calm. Discussed given repeat dose of Benadryl tonight, and another dose tomorrow if needed. Told parents to seek emergency care if Patient's rash significantly worsens or she has stridor, cyanosis, lethargy, or other signs of respiratory distress.    VAERS completed.   Patient also assessed by Dr., who agrees to the above assessment and plan.  PA-C
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash macular
Clinical narrative: Patient is a 12 month old female who presents today for reaction to vaccine. Patient received PCV 13 vaccine, MMR vaccine, and Varicella vaccine approximately 10 minutes ago. Since then, developed erythema surrounding injection sites and rash to trunk and face. She has not had allergic reactions to vaccinations in the past, no food allergies.    Patient Active Problem List:     Twin liveborn by cesarean    Screening for endocrine, metabolic and immunity disorder    Newborn product of IVF pregnancy    Newborn affected by breech presentation     No current outpatient medications on file. Current Facility-Administered Medications: diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg 12.5 mg Oral Once Lia Rosenberg acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg 121.6 mg Oral Once Lia Rosenberg    Review of Patient's Allergies indicates:  No Known Allergies    I have reviewed the past medical, social, and family history. All pertinent historical factors are mentioned in the HPI. The remainder are non-contributory.      Objective      Appearance: Crying, able to be calmed by father.  Skin: Swelling and erythema to b/l lateral thigh surrounding injection site, R>L.  Mildly erythematous macules to patches to trunk and face. Cardiac: RRR, no M/R/G.  Respiratory: CTA bilaterally, no W/R/R. Normal work of breathing, no signs of respiratory distress  Neuro: Alert   ASSESSMENT&PLAN:   Problem List Items Addressed This Visit    None   Visit Diagnoses    Need for prophylactic vaccination with measles-mumps-rubella (MMR) vaccine       Relevant Orders   IMMUNIZATION ADMIN SINGLE, RN (Completed)   MEASLES MUMPS RUBELLA VIRUS VACCINE LIVE SUBQ (Completed)   Need for prophylactic vaccination and inoculation against varicella       Relevant Orders   VARIVAX (CHICKEN POX VACC) LIVE SC (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Need for prophylactic vaccination against Streptococcus pneumoniae (pneumococcus)       Relevant Orders   PCV13 VACCINE FOR INTRAMUSCULAR USE (Completed)   IMMUNIZATION ADMIN EACH ADD, RN (Completed)   Allergic reaction, initial encounter       Relevant Medications   diphenhydrAMINE (BENADRYL) 12.5 MG/5ML elixir 12.5 mg (Completed) (Start on 7/3/2019  4:45 PM)   acetaminophen (TYLENOL) 160 MG/5ML liquid 121.6 mg (Completed) (Start on 7/3/2019  4:45 PM)     Allergic reaction: Normal pulm exam, no respiratory distress. Anaphylaxis unlikely. Likely due to varicella vaccine given degree of swelling and erythema surrounding this injection site was more severe than the other injection site. Rash and swelling improved with Benadryl, patient now calm. Discussed given repeat dose of Benadryl tonight, and another dose tomorrow if needed. Told parents to seek emergency care if Patient's rash significantly worsens or she has stridor, cyanosis, lethargy, or other signs of respiratory distress.    VAERS completed.   Patient also assessed by Dr., who agrees to the above assessment and plan.  PA-C
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chiropractic, Feeling of body temperature change, Muscle contractions involuntary, Musculoskeletal pain
Clinical narrative: This is copied directly from what patient wrote down for us.  Symptoms started the afternoon of 5/2/19. "First started feeling very hot,then within a few minutes, cold. Then pain went up my arm to shoulders, neck and down back.  Arm was sore-pain went from arm up to shulders and neck then down back. the pain/toxins keep moving from muscle of one area to muscle in another area.  It is still on-going-pain remains in areas of back, neck and shoulders-has gone to glutes also."  Patient also described it feeling as like her muscles were contracting/stiff all over.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity
Clinical narrative: This is copied directly from what patient wrote down for us.  Symptoms started the afternoon of 5/2/19. "First started feeling very hot,then within a few minutes, cold. Then pain went up my arm to shoulders, neck and down back.  Arm was sore-pain went from arm up to shulders and neck then down back. the pain/toxins keep moving from muscle of one area to muscle in another area.  It is still on-going-pain remains in areas of back, neck and shoulders-has gone to glutes also."  Patient also described it feeling as like her muscles were contracting/stiff all over.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Redness, pain, heat. Referred pt to urgent care for exam, pt returned with rx for Cephalexin 500 mg bid x 7 days
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Contusion, Erythema, Irritability, Pain, Swelling
Clinical narrative: Pt had swelling, redness, fussy, painful, bruised
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood pressure increased, Chills, Headache
Clinical narrative: Excrusiating pain in left arm, unable to move or raise arm, muscle pain all over body, joint paint all over body, fever (sweats and shills} for three days, headache, nausea, red, rectangular rash two inches below injection site, numbness and tingling of left arm including hand, swelling of left arm and hand. Excrusiating left, lower back pain and left side of neck, including shoulder, shoulder blade and back.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site rash
Clinical narrative: Excrusiating pain in left arm, unable to move or raise arm, muscle pain all over body, joint paint all over body, fever (sweats and shills} for three days, headache, nausea, red, rectangular rash two inches below injection site, numbness and tingling of left arm including hand, swelling of left arm and hand. Excrusiating left, lower back pain and left side of neck, including shoulder, shoulder blade and back.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: Excrusiating pain in left arm, unable to move or raise arm, muscle pain all over body, joint paint all over body, fever (sweats and shills} for three days, headache, nausea, red, rectangular rash two inches below injection site, numbness and tingling of left arm including hand, swelling of left arm and hand. Excrusiating left, lower back pain and left side of neck, including shoulder, shoulder blade and back.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Excrusiating pain in left arm, unable to move or raise arm, muscle pain all over body, joint paint all over body, fever (sweats and shills} for three days, headache, nausea, red, rectangular rash two inches below injection site, numbness and tingling of left arm including hand, swelling of left arm and hand. Excrusiating left, lower back pain and left side of neck, including shoulder, shoulder blade and back.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema
Clinical narrative: red area around injection about the size of the hand, inflammation  patient given antibiotics
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient returned to pharmacy that she had received the vaccine from presenting with swelling, pain and warm to the touch, in the same arm the vaccine was given. It occurred 2 days after receiving vaccine. It was located further down the arm than where the vaccine was given. I advised her to take benadryl and monitor the swelling/pain. If it continues to worsen, go to ER.  She should advise her MD of reaction and weigh risk vs benefit of receiving 2nd dose. Advised her not to get 2nd dose.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: pt started soreness on the same day pt received the shot on 7/1, but it was a little more intense the second day 7/2.  She looked at the site of injection and noticed the swelling and redness as well.  Pt came to the pharmacy to report the event on 7/3 with a little less severity compared to the day before.  Pt was instructed to take some NSAIDs & Tylenol, and report to MD if symptoms get worse or infection starts on the site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: On Friday, 6/14 I saw a Doctor for right earache.  The doctor told me I needed a TB Booster and that they had Shingles vaccine available.  I told the doctor I had the Shingles vaccine in 2014 (with no adverse reaction).  Doctor suggested I get the new vaccine because it's more effective and in short supply (got a new supply).  I agreed and received both shots, one in each arm. I woke up Monday, 6/17 with shingles on my face.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: cellulitis redness and swelling spreading from injection site received a course of doxycycline 100mg bid for 7 days
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: She states her left arm was a little bit sore but she is mainly concerned about the right.  She states she had a large area that was swollen and red that seems to be a lot better today.  She felt like she was hot yesterday but did not think she had a fever.  She thinks she's had pneumonia vaccines in the past without any history of reaction.  She denies shortness of breath or swelling to her throat.  No other concerns
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received dose of prevnar 13 before the age of 65 with no indications. Pt did not report any adverse events or side effects. It was discovered today 7/3/19.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient was running a low grade fever since the shots. However on July 3rd 1/3rd  to 1/2 of her upper arm turned really red and was extremely hot to the touch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Immediate post-injection reaction, Pain
Clinical narrative: Pt stated she had some bruising immediately and pain after administration (6/25/2019).  Pt presented today and stated she still had some soreness and bruising, but it appeared to be getting better(7/3/2019).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Fever of 101.7, chills, pain in every joint, shooting pain down the front of my right high & into my ankles, which lasted approx. 12 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation, Mobility decreased, Pain
Clinical narrative: Red, Swollen, Inflamed, Hard to lift arm, Painful, Hot
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Red, Swollen, Inflamed, Hard to lift arm, Painful, Hot