chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site pruritus, Product administered at inappropriate site, Wrong product administered
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073918 and 2019SA073919 (same reporter). This case involves a 53 years old patient (gender not reported) who was vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in left forearm instead of receiving TUBERSOL on 13-Mar-2019 and experienced itching at the injection site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date, the patient developed a non-serious itching at the injection site following the vaccination. It was also a case of actual medication error due to wrong vaccine administered. No Lab data was reported. Final diagnosis was itching at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the 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. Documents held by the sender: none.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site pruritus, Product administered at inappropriate site, Wrong product administered
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073917 and 2019SA073919 (same reporter). This case involves a 76 years old male patient who experienced itching at the injection site, while he was accidentally vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in left forearm, instead of TUBERSOL on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date, the patient developed a non-serious itching at the injection site, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also a case of actual medication error due to wrong vaccine administered. No lab data was reported. Final diagnosis was itching at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the 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. Documents held by the sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old patient (gender unknown) who received a 0.5ml dose of FLUBLOK QIV, lot QFAA1833, expiration date: 30-Jun-2019 via unknown route in the right thigh on 07-Mar-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 inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: FLU4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 10 years old patient who accidentally received an expired 0.5 ml dose of FLUZONE QUADRIVALENT (lot UT5911KA and Exp. Date 30-Jun-2018) via unknown route in the left deltoid, on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX for Immunisation; and MENVEO for Immunisation. It was a case of actual medication error due to expired vaccine used. It was reported that MA accidentally gave an FLUZONE QD 0.5 ml pre-filled syringes to a patient yesterday with the expiration date of 2018.It was in the box that had an expiration date of 2019. (Carton Lot UT6375JA exp date: 30-JUN-2019). No adverse reactions reported. 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: U
Vaccine: DTAP, HIBV, MENB, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (with unknown demographic) who received HIB (PRP/T) VACCINE  lot UI901AAA (Expiry date17-Sep-2019) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA (Expiry date26-Nov-2018) via intramuscular route in the right thigh, PREVNAR 13 (lot number: T36366, exp date: 28 Feb 2020) 0.5mL, injection intramuscularly left thigh and TRUMENBA that had a cold chain deviation on 03 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLUX, HPVX, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received 0.5mL dose of vaccine MENACTRA lot U5833AA, expiration 25-Feb-2019 via unknown route in the right deltoid on 15-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE for Immunisation; INFLUENZA VACCINE for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation. It was a case of actual medication error due to Expired vaccine used. It was reported that a patient received a dose of MENACTRA on 15-Mar-2019, that was expired on 25Feb2019. It was unknown if any adverse event was occurred. 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: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who was vaccinated with FLUBLOK QIV (batch number, expiration date was not reported) via intramuscular route in the left deltoid, on 27-Feb-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 inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a patient (with unknown demographics) who experienced allergy, while he/she received vaccine FLUZONE QUADRIVALENT, Lisinopril and ZOMIG. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. On an unknown date, the patient started taking Lisinopril and ZOMIG dosage unknown route unknown (with an unknown batch number) for unknown indication. On an unknown date, the patient developed a non-serious allergy (allergy to vaccine) following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious allergy (drug hypersensitivity) following the intake of Lisinopril and Zolmitriptan. Other relevant tests not reported. Final diagnosis was allergy. Lisinopril and ZOMIG action taken was not reported. It was not reported if the patient received a corrective treatment. The outcome for allergy was not reported. List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Wrong technique in product usage process
Clinical narrative: Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who received a 0.5 ml dose of ACT-HIB (lot C5576A8 and Exp. Date 18-OCT-2019) via intramuscular route in the deltoid, on 15-Mar-2019. The ACT-HIB part was taken from PENTACEL package and 0.4 % nacl from an ACTHIB package. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE and HEPATITIS B VACCINE for Immunisation. It was an actual medication error case due to wrong technique in product usage process. It was reported that they ordered ACTHIB for a bone marrow transplant patient and received, ACTHIB from the PENTACEL package and a 0.4 % nacl from an ACTHIB package. ACTHIB from PENTACEL lot # C5576A8 exp date: 10/18/2019 NDC: 49281-545-15 0.4 % sodium Chloride from ACTHIB lot# U6178AA exp date: 3/13/2020. It was unknown whether the patient had any adverse reactions. 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: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 65 years old patient who was vaccinated with expired dose FLUZONE HIGH DOSE (lot: UI977AC, expiry date: 09-Mar-2019) in the right deltoid, on 15-Mar-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 expired vaccine used. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 53.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Wrong product administered
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073917 and 2019SA073919 (same reporter). This case involves a 82 years old patient (gender not reported) who was accidentally vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in right forearm, instead of TUBERSOL on 13-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. Documents held by the sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional on 12-Mar-2019. This case is linked to case 2019SA072764. This case involves a female patient (nurse) who received a tetanus shot and it hurt and pain, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious received a tetanus shot and it hurt following the administration of TETANUS TOXOID. On an unknown date, the patient developed a non-serious pain following the administration of TETANUS TOXOID. No lab test reported. Final diagnosis was pain and received a tetanus shot and it hurt. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for received a tetanus shot and it hurt and as Recovered / Resolved on an unknown date for pain.
Sex: U
Vaccine: DTAP, HIBV, MENB, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves unknown age and gender of child for whom at the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees/ACTHIB and DAPTACEL that the patient received on 03oct2018 was also involved in the temperature excursion was reported, while he/she received vaccines TRUMENBA, PREVNAR 13, ACT-HIB and DAPTACEL. The patient's had no past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 03-Oct-2018 at 06:47 pm, the patient received a dose  0.5 ml of suspect PREVNAR 13 not produced by Sanofi Pasteur lot T36366 expiry date: 28-Feb-2020 via intramuscular route in the left thigh. On 03-Oct-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI901AAA Expiry Date: 17 Sep 2019 via intramuscular route in the right thigh. On 03-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA Expiry Date: 26 Nov 2018 via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was reported that the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees Celsius for 20 minutes. Caller states that within the 20 minutes the temperature went back to normal. There 6 patients who received the vaccines after the excursion and also stated the ACTHIB and DAPTACEL that the patient received was also involved in the temperature excursion. The patient was not visit emergency room as well as physician office. It was an actual medication error due to product storage error. There was no lab test was done. Final diagnosis was the lowest temperature for the PREVNAR 13 and TRUMENBA was -1.32 degrees/acthib and DAPTACEL that the patient received on 03oct2018 was also involved in the temperature excursion. It was not reported if the patient received a corrective treatment. The outcome of event was not applicable. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a 17 years old female patient received an expired dose of vaccine MENACTRA. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 14-Mar-2019, the patient received injection of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5835AB, expiry date 27-Feb-2019 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient received MENACTRA vaccine on 14-Mar-2019, which was expired on 27-Feb-2019. 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.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain and tactile warmth at left arm injection site. Mother did not report until it had resolved, no Tx attempted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash, Rash pruritic, Varicella post vaccine
Clinical narrative: Patient develops an itchy rash on 3/19/19. Rash present on wrist/finger/hands and arms/trunk/neck. Provider considered varicella rash although no blisters and no other symptoms.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling, Penile swelling, Swelling of eyelid, Urticaria
Clinical narrative: Patient was at Dr.'s office on 3/19/19 for 18 month wellchild checkup Hep A #2 was given with no complications. Parent states the reaction started at 4:30pm with swollen eyelids, puffy eyes, hives and penis swelling, no fever. Patient was taken to ER. Patient was prescribed Diphenhydramine and was advised to F/U with PCP, Mom was instructed to apply calamine lotion topically and to give BENADRYL every 8 hrs as needed. Patient F/U with Dr. Today 3/20/2019.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Aggression, Blood thyroid stimulating hormone normal, Fatigue, Full blood count normal, Irritability
Clinical narrative: Episodes of staring into space, lasting 2-15 minutes at a time, he would look up and to the side, and sometimes have repetitive head movements back and forth. Would not respond to name, noise, visual stimulus, or physical stimulus. Would spontaneously come out of it and act as if nothing happened. This has been occurring daily, sometimes multiple times a day. Patient also having episodes where he repetitively move hands and head, and lips, lasting about 30 seconds to 2 minutes. No loss of bowel or bladder control. Patient has also been more fatigued, going to bed earlier, falling asleep at dinner table, sleeping longer. Also more irritable and throwing more temper tantrums, with resolution only when being put to bed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Somnolence, Staring, Stereotypy, Unresponsive to stimuli
Clinical narrative: Episodes of staring into space, lasting 2-15 minutes at a time, he would look up and to the side, and sometimes have repetitive head movements back and forth. Would not respond to name, noise, visual stimulus, or physical stimulus. Would spontaneously come out of it and act as if nothing happened. This has been occurring daily, sometimes multiple times a day. Patient also having episodes where he repetitively move hands and head, and lips, lasting about 30 seconds to 2 minutes. No loss of bowel or bladder control. Patient has also been more fatigued, going to bed earlier, falling asleep at dinner table, sleeping longer. Also more irritable and throwing more temper tantrums, with resolution only when being put to bed.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: Fever started on 3/20/19 (8 days after immunization).
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported as of this time. Patient was given KINRIX at 4 months of age in error.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm was red, raised and warm at injection site. Patient also reported "heat flares" on side of her torso.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Per Mom immediately after immunization patient had itching and slight redness at site. Swelling and redness at site has grown since date she had immunization. Mother became concerned and returned today to have rechecked on day 5. Upon inspecting site, on left deltoid area it is red, and slightly raised in circular pattern around site. Approx 2 inch in diameter or the size of a small apple. Slightly warm to touch. Site was being actively scratched by patient. Advised to use cold compress for site reaction. TYLENOL is needed for discomfort. Mother is to report back if symptoms do not lesson or if she is concerned or has questions.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Significant pain in right arm x's 1 week.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: VESICULAR LESION ON THE BODY.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hive like rash in a dermatomal distribution on the contralateral side of the body (L lower abdomen).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Achy muscles.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fever of 101.6, shivering, nausea, total body muscle aches, tired, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101.6, shivering, nausea, total body muscle aches, tired, headache.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance
Clinical narrative: Evening of shot back hurt. Patient took a pain pill and went to bed. Patient woke at 4am and needed to urinate. Legs felt wobbly patient needed to grab on doors to walk. Patient went back to bed and awoke at 9am. Legs were very rubbery. Patient tried not to walk. This lasted for 24 hours. Gradually got better.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Foaming at mouth, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: Seizure without fever last 5-6 minutes eyes rolled back, foaming at the mouth shaking and was unresponsive.
Age: 12.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-valid spontaneous report was received from an office staff representative and refers to a patient of unknown age and gender. On 19-FEB-2019, the patient was inadvertently vaccinated with an expired dose of PROQUAD (exact dose, strength, route of administration, lot#, expiration date and therapy type were not reported) for prophylaxis. There were no adverse effects reported. Follow-up information has been received from the physician on 18-MAR-2019. This case refers to a 12 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient received second dose of dose of PROQUAD, which was expired (lot# N021726, expiry date 06-FEB-2019, anatomical location: subcutaneously in leg). Previous doses were reported as 1. Illness at the time of vaccination and adverse event following a prior vaccination were reported as none. The vaccine was purchased with public funds. The patient was vaccinated at private doctor's office/hospital. No treatment was required for the adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 07-DEC-2018, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot# and expiry were not reported) for prophylaxis, reconstituted with expired sterile diluent (strength, dose, frequency were not reported) lot #M019891 and expiry date reported 11-OCT-2018 and no adverse effects were reported. This is one of the 3 reports concerning same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia, Death
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning to a 21-year-old female patient. The patient's concurrent conditions, medical history, drug reaction or allergies and concomitant medications were not reported. On an unspecified day in 2007 (reported as 12 years ago), the patient received a dose of GARDASIL (dose number, route of administration, lot# and expiration date were not reported). The pharmacist stated that he heard about a court case where the female patient died from arrhythmia after the administration of GARDASIL. It was unknown if an autopsy was performed. No additional information was provided. The causal relationship between de patient's death and GARDASIL was unknown.; Reported Cause(s) of Death: developed a heart arrhythmia that caused death.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Herpes zoster, Pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 02-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered pneumonia, exacerbation of chronic obstructive pulmonary disease, and later was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Pneumonia, exacerbation of chronic obstructive pulmonary disease, and shingles were considered disabling. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent condition and concomitant medication was not reported. On 18-MAR-2019 the patient was inadvertently vaccinated with an expired VARIVAX lot # N008828, expiration date 16-MAR-2019, for prophylaxis (strength, dose and route of administration were not provided). No adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per SHINGRIX indication. The patient received the 2nd shot and 5 days later, they had an injection site reaction. The injection site reaction was not resolved. Pharmacist reported that, they had no data because the patient left the pharmacy.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient had vaccine on Monday and Noticed Tuesday that he has redness and swelling of the upper arm. Patient states that the ability to move the upper arm was decreased. Area around the elbow is warm to touch. Patient has a 15 cm erythema area that starts at elbow and radiates upward.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient came in a few days after receiving immunization with a large red lump on arm where the shot was administered. He said there was a little bit of pain and itching but not too much. He stated that the reaction occurred almost immediately after administration and that it has slowly been getting better over the last few days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm got swelled badly.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt is stating arm hurt soon after the injection and continued to feel pain in the arm through the weekend. It got so severe that he cannot move his arm and neck is very stiff.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Skin warm
Clinical narrative: When I woke up 3/18/2019 at 5 AM I noticed that my neck, chest & under the breasts were all red. It went all the way up the back of my neck & in the hair and all the front of my neck. It was hot to touch but didn't itch. I felt very warm all day but did not have a fever. I put a cold wash cloth on my neck when I got home from work at 3:30 PM. My neck was still red the next day but better but my noon it started to itch alittle. On 3/20/2019 it wasn't as red and was feeling better. Arm was sore & red at the site on 3/17/2019. Little tender still on 3/20/2019.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV, HEPA, HIBV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was due for four vaccinations in Clinic at 9:00 AM on Tuesday 03/20/2019. Patient was due for Hep A, Hep B, DTap and Hib. Pt had erroneous administration of KINRIX and PEDIARIX. There is no signs or symptoms from patient after receiving the wrong vaccinations. Right after the vaccinations, the patient presented normal; walking and holding mother's hand leaving the clinic. Provider, patient, patient's mother and all staff involved was made aware of the event and aware that there is no increased risk or danger to the child after receiving extra dose of DTaP and 2 extra doses of IPV.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Peripheral swelling, Rash
Clinical narrative: Patient experienced severe swelling/edema on left FOREARM, as well as rash at elbow crease.
Age: 0.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: 1 day old infant Male given a adult flu vaccine that was intended for the mother. No adverse reaction has occurred and infant is doing well, but flu vaccine is not recommended in patients this young.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient came in on 3/19/19 and stated she had been having awful pains in her arm since the date of the injection. She has had decreased range of motion in her left arm, especially when moving her arm behind her or over her head. She reported no swelling or redness at the injection site and no bleeding.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain
Clinical narrative: Extreme chills, aces, no energy.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Muscle spasms, Myalgia
Clinical narrative: Initially swelling and pain at injection site, progressing to fever, chills and myalgia with severe back spasms. Protracted recovery with NSAIDs and rest.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Initially swelling and pain at injection site, progressing to fever, chills and myalgia with severe back spasms. Protracted recovery with NSAIDs and rest.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient stated that she had severe body aches that was relieved by the next day with no residual symptoms.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: The patient received all four vaccines and was asked to wait in the store for 10-15 minutes to make sure everything is good. The patient let me know she is waiting for another prescription and I had the patient come to the drop off window to check. The patient then sat on the bench to wait for the prescription to be completed. More than 15 minutes had passed I checked in with the patient and asked how she was doing and she said she was fine and noticed her prescription is almost ready for the patient. The prescription is done for the patient and she picked up and walked out of the store. The patient was in the store for over 30 minutes almost an hour after the immunizations are completed before leaving the store.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Swelling, soreness, or redness where I got the shot. Mild fever. Fussiness or irritability. Loss of appetite. Sore muscles.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Swelling, soreness, or redness where I got the shot. Mild fever. Fussiness or irritability. Loss of appetite. Sore muscles.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Reaction - Red and swollen, warm to touch, itching - currently not as red, swollen, not itching Treatment - ice pack, ibuprofen, allegra, hydrocortisone.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Symptoms of left shoulder pain started the next day. Ibuprofen has not helped and if anything it has gone from a generalized shoulder joint pain to possible rotator-cuff injury. My left shoulder was fine before the vaccine but I had right shoulder rotator-cuff surgery about 18 months ago.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: I have the first shot at August 3rd 2018, since then, my left arm muscles are in sore status. Now after 7 months, I can not lift my arm since the muscle is so painful from the shot. I have the second shot on my right arm at 10/09/2018, which is ok, not much muscle so far.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dermatitis, Pruritus, Rash vesicular
Clinical narrative: I have a shingles type rash with blisters on my right ankle. I have been treating it with cortisone cream, OTC. It has been getting worse for 11 months now. Now it is showing up on my left ankle. And in the last week, my right ankle has been itching more and has developed fever blister type blisters. That is why I postponed getting the second required dose which I went ahead and did 3/20/2019.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Aspiration, Crying, Dysphagia, Facial paralysis, Hypotonia
Clinical narrative: Crying for hours, lethargic, within one week patient had facial paralysis on the right side of his face and mouth. This caused oral dysphagia, aspirating, and speech delayed. He also has hypotonia.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Oral disorder, Speech disorder developmental
Clinical narrative: Crying for hours, lethargic, within one week patient had facial paralysis on the right side of his face and mouth. This caused oral dysphagia, aspirating, and speech delayed. He also has hypotonia.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Shivers, fever, headache.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Large, localized swelling in arm where injection was given.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Approximately 24 hours after Hep A and PREVNAR given in left upper thigh, red firm area developed-continued to spread. Afeb no other symptoms. Eval'd at our office on 3/20/19 - 4.5x2.5cm red, warm, ERM, irregular even on (L) thigh. Rx'd AUGMENTIN.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at injection site. Dr. prescribed clindamycin because he thought it seemed infected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Headache, Impaired work ability, Lethargy
Clinical narrative: 01.24.19 6 AM feeling of malaise, soreness left arm injection site. 9 AM to 2 PM increasing soreness of left arm, including left side of neck and across shoulders. Severe headache, muscle and joint pain. Ibuprofen 400 mg was taken without any relief. Went home to bed and slept to about 7:30 PM. Awakened with same intensity of symptoms. 01.25.19 Same symptoms continued. Spent the day sleeping and drinking fluids during wakeful periods. 01.26.19 Headache, muscle and joint pain subsided. Local pain at injection site continued and due to this pain not raising arm with full range of motion. Felt weak but began to take bland solid foods. 01.27.19 Returned to normal routine but local pain at injection site took about 2 weeks to diminish.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: 01.24.19 6 AM feeling of malaise, soreness left arm injection site. 9 AM to 2 PM increasing soreness of left arm, including left side of neck and across shoulders. Severe headache, muscle and joint pain. Ibuprofen 400 mg was taken without any relief. Went home to bed and slept to about 7:30 PM. Awakened with same intensity of symptoms. 01.25.19 Same symptoms continued. Spent the day sleeping and drinking fluids during wakeful periods. 01.26.19 Headache, muscle and joint pain subsided. Local pain at injection site continued and due to this pain not raising arm with full range of motion. Felt weak but began to take bland solid foods. 01.27.19 Returned to normal routine but local pain at injection site took about 2 weeks to diminish.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Limb discomfort, Malaise
Clinical narrative: 01.24.19 6 AM feeling of malaise, soreness left arm injection site. 9 AM to 2 PM increasing soreness of left arm, including left side of neck and across shoulders. Severe headache, muscle and joint pain. Ibuprofen 400 mg was taken without any relief. Went home to bed and slept to about 7:30 PM. Awakened with same intensity of symptoms. 01.25.19 Same symptoms continued. Spent the day sleeping and drinking fluids during wakeful periods. 01.26.19 Headache, muscle and joint pain subsided. Local pain at injection site continued and due to this pain not raising arm with full range of motion. Felt weak but began to take bland solid foods. 01.27.19 Returned to normal routine but local pain at injection site took about 2 weeks to diminish.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: 01.24.19 6 AM feeling of malaise, soreness left arm injection site. 9 AM to 2 PM increasing soreness of left arm, including left side of neck and across shoulders. Severe headache, muscle and joint pain. Ibuprofen 400 mg was taken without any relief. Went home to bed and slept to about 7:30 PM. Awakened with same intensity of symptoms. 01.25.19 Same symptoms continued. Spent the day sleeping and drinking fluids during wakeful periods. 01.26.19 Headache, muscle and joint pain subsided. Local pain at injection site continued and due to this pain not raising arm with full range of motion. Felt weak but began to take bland solid foods. 01.27.19 Returned to normal routine but local pain at injection site took about 2 weeks to diminish.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Feeling abnormal, Insomnia, Irritability, Motor developmental delay
Clinical narrative: On 1/5/18 patient was given PENTACEL for his first dose. Patient was seen again on 1/19/18 for another immunization but was given another dose of PENTACEL. Few short days after I (his mother) noticed a change in behavior. Patient at that time no longer wanted to sleep for more than 2-3hrs at a time. He was more fussy and not his happy self. Here now at 17 months he has a delay in motor skills and speech.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Speech disorder developmental
Clinical narrative: On 1/5/18 patient was given PENTACEL for his first dose. Patient was seen again on 1/19/18 for another immunization but was given another dose of PENTACEL. Few short days after I (his mother) noticed a change in behavior. Patient at that time no longer wanted to sleep for more than 2-3hrs at a time. He was more fussy and not his happy self. Here now at 17 months he has a delay in motor skills and speech.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Eating disorder, Erythema, Eye pain, Fatigue
Clinical narrative: 10 days after receiving the MMR vaccine my daughter became very fatigued and had excessive thirst, drinking 4 or more liters of water per day. On day 11 she developed a severed pain behind her eyes. She said it felt like the connection between her eyes and her brain were being squeezed. The pain increased when she turned her head or turned her eyes. The fatigue and thirst continued. She also had low appetite. On evening of day 12 I called her doctor. Ibuprofen was recommended. On the morning of day 13 I spoke to the doctor again and she suggested we go to the emergency room. She had a thorough examination but they decided not to do a CT scan. They gave her IV TORADOL and compazine to reduce any inflammation and pain. The medication made her headache better but made her very sleepy for the next 15 hours. On day 14 she developed a flat red/pink rash on her face, neck and chest. As well as raised bumps and redness on her hands. The lower part of her face was puffy. She also complained of a mild sore throat. Her nose was runny for days 13, 14 and 15. On day 15 she complained of a sore on the side of her tongue. I finally looked at on day 16 because it was making it hard for her to talk or eat. It was white bump with a blue center. On day 16, 3/3/19, she started having pain in the joints of one finger on each hand. On day 17 she woke up with both hands being puffy and all finger joints being very painful. Each symptom resolved in about 3 days.