chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 04-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 10-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: near syncopal episode
Age: 79.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Dizziness, Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Dr prescribed The injection nurse stated that my arm would be a little swollen and painful for a day or so, but I noticed the reaction right away but waited til the 2nd day then I called the advice nurse who told me to put cold compresses on it (my arm) & if it was no better or gets worse to call and make an appointment. By then it was the weekend; I text Dr. to let her know what was going on. Dr. was on vacation and Dr. responded on her behalf; made an appointment to see me the next day (5/7/19). By that time not only were the hives on my arm and around the injection site, pain and redness was from my left shoulder down my upper arm. I felt dizzy all weekend and stayed close to the bed. As soon as Dr. saw my arm he ordered the medication, doxycycline monohydrate 100mg to be taken for seven (7) days along with an antihistamine (Zyrtec) 10mcg for the allergic reaction.
Age: 79.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Injection site urticaria, Pain in extremity, Peripheral swelling
Clinical narrative: Dr prescribed The injection nurse stated that my arm would be a little swollen and painful for a day or so, but I noticed the reaction right away but waited til the 2nd day then I called the advice nurse who told me to put cold compresses on it (my arm) & if it was no better or gets worse to call and make an appointment. By then it was the weekend; I text Dr. to let her know what was going on. Dr. was on vacation and Dr. responded on her behalf; made an appointment to see me the next day (5/7/19). By that time not only were the hives on my arm and around the injection site, pain and redness was from my left shoulder down my upper arm. I felt dizzy all weekend and stayed close to the bed. As soon as Dr. saw my arm he ordered the medication, doxycycline monohydrate 100mg to be taken for seven (7) days along with an antihistamine (Zyrtec) 10mcg for the allergic reaction.
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product leakage
Clinical narrative: No adverse effects were reported.; Patient reported she experienced leakage of the GARDASIl 9 following the second dose administered in her left upper arm on 31-MAY-2019; Patient reported she experienced leakage of the GARDASIl 9 following the second dose administered in her left upper arm on 31-MAY-2019; This spontaneous report was received from a female nurse of an unknown age referring to herself. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 01-APR-2019, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were not reported) for prophylaxis.   On 31-MAY-2019, the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5ml, intramuscularly in her left upper arm (lot # and expiration date were not reported) for prophylaxis.  On the same date, the patient experienced leakage of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) following the second dose administered in her left upper arm (product leakage and circumstance or information capable of leading to medication error). No adverse effects were reported. The outcome of product leakage was not reported. The causality assessment between product leakage and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported either.
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 referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
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 referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 22-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC Found.  This is one of several reports received from the same reporter.
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 referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
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 referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).
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 referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-JUN-2019 , the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 26-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2020) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product supply issue, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; shot was not available /Product supply issue; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 274 days after receiving Shingrix and 61 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and product supply issue. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and product supply issue were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 7 months after the 1st dose, because the demand for shot was greater than the supply.  At the time of reporting, 2 months after vaccination with 2nd dose the patient experienced shingles. The reporter contacted GlaxoSmithKline (GSK) when shot was not available and asked if the patient should start the series over. The patient was assured that the patient should not restart, as the patient received 2nd dose within 12 months after 1st dose. The patient was seen by the primary care physician (PCP) and had been given antiviral prescription. The patient asked if this was occurring due to delay in getting the 2nd dose. This case was considered as suspected vaccination failure since confirmatory laboratory test were unknown at the time reporting.
Sex: M
Vaccine: PNC13
Symptoms: Intensive care, Pneumonia streptococcal
Clinical narrative: diagnosed with strep pneumonia and is currently in picu; diagnosed with strep pneumonia and is currently in picu; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A 16-month-old male patient received four doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), all via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with strep pneumonia and was in  Intensive Care Unit. The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: I received this vaccine on 6/28/2019.  On 7/1/2019 about 4:30 pm I realized that I could not bend my index finger on my right hand without pain.  The next day I woke up and my right hand was twice the size of my left hand.  Pins and needles feeling in my hand.  Arm pain from elbow to shoulder blade.  I provided my er doctors info in a previous question.  Er diagnosed me with either adverse reaction to vaccine and/or cellulitis.  I've not had any issues before this with any vaccines.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Vaccination complication
Clinical narrative: I received this vaccine on 6/28/2019.  On 7/1/2019 about 4:30 pm I realized that I could not bend my index finger on my right hand without pain.  The next day I woke up and my right hand was twice the size of my left hand.  Pins and needles feeling in my hand.  Arm pain from elbow to shoulder blade.  I provided my er doctors info in a previous question.  Er diagnosed me with either adverse reaction to vaccine and/or cellulitis.  I've not had any issues before this with any vaccines.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: red, raised, bump
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Syncope
Clinical narrative: Patient called the day after receiving the shot and told me about a reaction that she had. She stated that she had no issues after getting the shot on 7/1/19 until just before she was going to bed. Then she developed shivers, which lasted a couple hours . Then she said the following morning on 7/2/19 when she awoke she fainted and needed assistance from the facility that she lives in. Upon calling the pharmacy on 7/2 she stated she was starting to feel better but wanted to report the incident as it wasn't expected. She was offered to go to the hospital from the facility, but she declined and was able to stay home.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Laboratory test, Myalgia, Neck mass
Clinical narrative: Severe muscle ache from waist to ankles in both legs. Severe muscle ache in left arm and left ribs. lump formed on right side of neck.  Severe chest pains and shortness of breathe resulted in getting a heart condition called pericarditis.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: Severe muscle ache from waist to ankles in both legs. Severe muscle ache in left arm and left ribs. lump formed on right side of neck.  Severe chest pains and shortness of breathe resulted in getting a heart condition called pericarditis.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Breath sounds abnormal, Nausea, Respiratory rate increased
Clinical narrative: At 11:55 am this nurse summoned by another nurse as she was bringing client to treatment area as client feeling nauseated. Accompanied by three nurses in examination room. Client BP at arrival to treatment room 140/92 right arm in sitting position. Heart rate 68, SPO2 97% on room air. Respirations slight elevation at 23. No wheezing detected, no cyanosis. Noted with diminished breath sounds RLL, however client states,  "I have had allergies or a cold, but I've had this before the shot". Please note client remained alert throughout this event. Initial symptom nausea, no emesis. At 12:05pm client states, " I'm ok I feel better, I'm fine:". Reports is going to work (animal shelter), discourage, asked if anyone at home reports her mom is in hospital, client does have a husband. Reviewed anaphylactic symptoms/explained this is emergency 911 to be called IMMEDIATLY/verbalized understanding. States, " I will not be alone I have coworkers".  No respiratory symptoms. Left facility with no issues.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pruritus, Rash
Clinical narrative: Pt. reported soreness around injection site after 1 day. Then around day 2 or 3 started developing a rash. On day 4 pt. presented to pharmacy. Rash was on a large area of upper arm and pt. complained of itching. Now reporting on day 4.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: May 13 the SHINGRIX vaccine was given.  June 1 shingles developed on the right torso from chest to spine along the the underarm line.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Myalgia, Pain
Clinical narrative: Muscle pain and decreased range of motion after 1 week, pt says pain "comes and goes" but that can be an "8" on a scale of 0-10 and that it really hurts when she moves her arm. She says that it has not improved at all over the last week and that ibuprofen has not really helped.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: 6:00 am - shivers All day - muscle aches, fatigue, headache, sore arm Treatment - ibuprofen
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: After giving injection, I realized I gave patient an expired vaccine that occurred this morning around 11 am. The expiration date on the HPV was 06/03/2019. Patient was contacted and notified.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: About 12 hours after receiving the injection, I felt nauseous, tired, achy, and had chills. The next morning, I had a temperature of 100.6, headache, nausea, fatigue, body aches, and pain and swelling at injection site. Fever lasted 24 hours, and all other symptoms continued for 4 more days. Swelling in arm got worse each day. I alternated Tylenol and Ibuprofen for pain and body aches, and iced the injection site. On 6th day, only pain and arm swelling remains. I spoke with my doctor's office several times throughout the week, and visited a walk-in clinic to look at the injection site on the weekend, when it got worse.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: About 12 hours after receiving the injection, I felt nauseous, tired, achy, and had chills. The next morning, I had a temperature of 100.6, headache, nausea, fatigue, body aches, and pain and swelling at injection site. Fever lasted 24 hours, and all other symptoms continued for 4 more days. Swelling in arm got worse each day. I alternated Tylenol and Ibuprofen for pain and body aches, and iced the injection site. On 6th day, only pain and arm swelling remains. I spoke with my doctor's office several times throughout the week, and visited a walk-in clinic to look at the injection site on the weekend, when it got worse.
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 referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions  and concomitant were not reported. On 03-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).  This is one of the several reports received from the same reporter.
Sex: U
Vaccine: 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 referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Adacel was administered to patients; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to 2019SA178356 and 2019SA178358 (same reporter).  This case involves male patient (normal age) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was reportedly given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Adacel was administered to patient, no symptoms reported; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (normal age) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was reportedly given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: INJECTION SITE SERIOUS SWELLING, ERYTHMA AND PAIN "HIVES". PATIENT REPORTED SIZE AS 15 CENTIMETER DIAMETER AROUND THE INJECTION SITE. TREATMENT: ICE, IBUPROFEN AND HYDROCORTISONE CREAM (NONE WORKED)
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports that she was sleeping and was awoken with a very intense sharp pain in the left arm. She is unable to lift or flex the arm and there is slight swelling around the deltoid muscle. No redness has been noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Breath sounds abnormal, Dyspnoea, Erythema, Ocular hyperaemia, Respiratory distress
Clinical narrative: 10 MINUTES AFTER RECEIVING VACCINES, PT STATES THAT HE IS HAVING DIFFICULTY BREATHING. PTS FACE BECAME VERY RED AND EYES BLOOD SHOT, APPEARS TO BE IN DISTRESS. PTS 02 SATS 90% ON ROOM AIR WITH COARSE BREATH SOUNDS THROUGH OUT. PT STARTED ON OXYGEN WHERE SATS ROSE TO 98%, AMBULANCE CALLED AND PT TRANSFERED BY AMBULANCE TO HOSPITAL.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Hypersomnia, Pyrexia
Clinical narrative: Child slept for 6 hours straight following vaccination , and ran a fever for almost 48 hours (vaccination took place on Thursday -fever from Thursday until Saturday). Child had diarrhea for two weeks following.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Chorea, Emotional disorder, Emotional distress, Movement disorder
Clinical narrative: Patient developed tics, movement disorder,  shaking, choreiform movements, anxiety, OCD, separation fears and severe emotional swings. none of these were present prior to the flu shot. She got her flu shot  even though she was in the doctor's office not feeling well. several days later she tested positive for strep throat and began antibiotics. The movements continued and patient further declined and when we went back to Dr he told us on 11/29/2016 that patient had other Myelitis,  and something called PANDAS.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Myelitis, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Separation anxiety disorder, Streptococcus test positive
Clinical narrative: Patient developed tics, movement disorder,  shaking, choreiform movements, anxiety, OCD, separation fears and severe emotional swings. none of these were present prior to the flu shot. She got her flu shot  even though she was in the doctor's office not feeling well. several days later she tested positive for strep throat and began antibiotics. The movements continued and patient further declined and when we went back to Dr he told us on 11/29/2016 that patient had other Myelitis,  and something called PANDAS.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Tic, Tremor
Clinical narrative: Patient developed tics, movement disorder,  shaking, choreiform movements, anxiety, OCD, separation fears and severe emotional swings. none of these were present prior to the flu shot. She got her flu shot  even though she was in the doctor's office not feeling well. several days later she tested positive for strep throat and began antibiotics. The movements continued and patient further declined and when we went back to Dr he told us on 11/29/2016 that patient had other Myelitis,  and something called PANDAS.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Rotator cuff syndrome, X-ray
Clinical narrative: My left shoulder ached after the shot, then slowly my rotator cuff started hurting.  The pain steadily got worse and movement became impossible without pain.  I went to an Orthopedic doctor and got a cortisone shot.  This helped a little, but not much.  I went back 2 weeks later and was prescribed an anti inflammatory and physical therapy.  I have been through 12 sessions and have gained most of my movement back, but still have some pain.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm when it is lifted above the patient's head
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLUR4, HEP, RV5
Symptoms: Decreased appetite, Food allergy, Immediate post-injection reaction, Pyrexia, Somnolence
Clinical narrative: Child slept for more than 6 hours immediately following vaccination, and ran fever for 48 hours (from Friday to Sunday).  Was not eating/breastfeeding as normal.  Parents were unaware that the flu shot contained eggs.  Child obtained allergy to eggs following vaccination and now has an Epi-Pen for allergy to eggs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: pt states that she has a red swollen arm that burns. she also has a fever.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Condition aggravated, Diarrhoea, Eczema, Lethargy, Rash generalised
Clinical narrative: Child had diarrhea for 2 weeks, lethargy for 5-7 days, and eczema rash all over body- lasted for 5-6 weeks, worsened drastically.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Audiogram abnormal, Deafness neurosensory
Clinical narrative: Unilateral sensorineural hearing loss, sudden onset 9 days after vaccination.  Confirmed by audiography.  Persistent at 8 weeks despite nasal and oral corticosteroids.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: fever (101.2), myalgia, fatigue
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain
Clinical narrative: severe bruise and pain. patient states he takes a blood thinner received from another pharmacy.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Lip blister, Oral mucosal blistering, Pruritus, Swelling
Clinical narrative: Pt reported swelling, blisters in and out of mouth, whelps on legs with blisters, and itchy hands. Pt used steroid cream and put her hands in cold water to help the itching.  She called her doctor Monday, July 1st in the morning and was waiting on a return call.  She called the pharmacy around 10:30 am on 7/1/19.  I spoke with her again around 4 pm.  Her blisters and whelps on her legs had improved.  She still have blisters on her upper lip and inside her mouth.  She was still waiting on her doctor to call her back.  I suggested she call him again before they closed. Called pt on 7/2/19, blisters on lips and inside mouth are slowly improving.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt reported swelling, blisters in and out of mouth, whelps on legs with blisters, and itchy hands. Pt used steroid cream and put her hands in cold water to help the itching.  She called her doctor Monday, July 1st in the morning and was waiting on a return call.  She called the pharmacy around 10:30 am on 7/1/19.  I spoke with her again around 4 pm.  Her blisters and whelps on her legs had improved.  She still have blisters on her upper lip and inside her mouth.  She was still waiting on her doctor to call her back.  I suggested she call him again before they closed. Called pt on 7/2/19, blisters on lips and inside mouth are slowly improving.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Lip blister, Pruritus, Rash, Urticaria
Clinical narrative: Pt reported swelling, blisters in and out of mouth, whelps on legs with blisters, and itchy hands. Pt used steroid cream and put her hands in cold water to help the itching.  She called her doctor Monday, July 1st in the morning and was waiting on a return call.  She called the pharmacy around 10:30 am on 7/1/19.  I spoke with her again around 4 pm.  Her blisters and whelps on her legs had improved.  She still have blisters on her upper lip and inside her mouth.  She was still waiting on her doctor to call her back.  I suggested she call him again before they closed. Called pt on 7/2/19, blisters on lips and inside mouth are slowly improving.
Age: 20.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Psoriasis
Clinical narrative: I have developed severe plaque psoriasis after getting these shots, I hadn?t been vaccinated in a while & I never had this issue before.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Muscular weakness, Myalgia
Clinical narrative: Muscle pain and weakness.  Numbness I hand.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Myalgia, Screaming
Clinical narrative: Screaming headache, extreme myalgia, fatigue until about 5pm on 7/2/19
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient came in on 5/28/19 and received the first vaccine, then on 7/2/19 she received the second vaccine which is too soon
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropathy, Bone disorder, Incomplete course of vaccination, Joint noise, Loss of personal independence in daily activities
Clinical narrative: Substantial pain in R shoulder, which started with vaccination along with clicking noises and, on exertion scraping sensation in joint. On June 17 received Prednisone orally for 5 days.  This provided substantial relief.  Saw an orthopedist on June 24. Some bone on bone contact in the shoulder,  but prior to the vaccination there was no pain or motion limitation in the joint.  For my age, I'm very physically active with weight lifting (for over 60 years) and rock climbing.  Following vaccination, I was very limited in what I could do. I appear to be slowly healing, but will not get the second injection.  The disruption to my life from the first shot was too great.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Substantial pain in R shoulder, which started with vaccination along with clicking noises and, on exertion scraping sensation in joint. On June 17 received Prednisone orally for 5 days.  This provided substantial relief.  Saw an orthopedist on June 24. Some bone on bone contact in the shoulder,  but prior to the vaccination there was no pain or motion limitation in the joint.  For my age, I'm very physically active with weight lifting (for over 60 years) and rock climbing.  Following vaccination, I was very limited in what I could do. I appear to be slowly healing, but will not get the second injection.  The disruption to my life from the first shot was too great.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Nodule, Paraesthesia
Clinical narrative: The patient came to the pharmacy and said that Saturday the 29th of July she woke up and had a bruised arm. she said when she props the arm up she has tingling in her hands but when she puts the arm down it goes away. She had the vaccine two weeks ago and didnt have any problems until Saturday.  There were three separate bruises going down her arm in a circular pattern. She said it felt like there were knots in the arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Feels body aches and soreness, feels feverish and has NOT measured temperature, sore injection site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling, and redness at injection site beginning ~2 hours after injection; has persisted since then (it's currently ~60 hours since I received the vaccine). Significant muscle pain in back, neck, arms, and legs beginning ~8 hours after injection and continuing for approximately 18 hours; did not respond to OTC painkillers, but did respond to a low dose of hydrocodone/acetaminophen (half a 5-325 tablet) .  Fatigue beginning ~6 hours after injection; significant for the first two days (~36 hours), somewhat less so during the following day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Soreness, swelling, and redness at injection site beginning ~2 hours after injection; has persisted since then (it's currently ~60 hours since I received the vaccine). Significant muscle pain in back, neck, arms, and legs beginning ~8 hours after injection and continuing for approximately 18 hours; did not respond to OTC painkillers, but did respond to a low dose of hydrocodone/acetaminophen (half a 5-325 tablet) .  Fatigue beginning ~6 hours after injection; significant for the first two days (~36 hours), somewhat less so during the following day.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Child presented to clinic with parents with complaints of reaction to either the menveo and bexsero vaccine she received on 6/29/19 by her PCP.   Reports pain in the left arm immediately following the injection with tingling down left arm. Denies any problems with right arm.  Reports fatigue, HA, chills, diarrhea and myalgias.  Unable to abduct left arm.  States she woke in the middle of the night short of breath, took some advil and returned to sleep.   Denies any further sob or difficulty breathing.  Pain has been worsening the last couple of days.  She is taking ibuprofen 400 mg every 4-5 hours.  Also taking tylenol PM at night.  Sleeping well.  Reports experiencing an adverse reaction from the menactra vaccine earlier this year requiring an ER visit.  She was prescribed a muscle relaxer which helped her pain and allowed her return to normal activity level.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Child presented to clinic with parents with complaints of reaction to either the menveo and bexsero vaccine she received on 6/29/19 by her PCP.   Reports pain in the left arm immediately following the injection with tingling down left arm. Denies any problems with right arm.  Reports fatigue, HA, chills, diarrhea and myalgias.  Unable to abduct left arm.  States she woke in the middle of the night short of breath, took some advil and returned to sleep.   Denies any further sob or difficulty breathing.  Pain has been worsening the last couple of days.  She is taking ibuprofen 400 mg every 4-5 hours.  Also taking tylenol PM at night.  Sleeping well.  Reports experiencing an adverse reaction from the menactra vaccine earlier this year requiring an ER visit.  She was prescribed a muscle relaxer which helped her pain and allowed her return to normal activity level.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever of 101 degrees F and body aches. Fully resolved within 24 hours.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash generalised
Clinical narrative: Body-wide rash with blistering and itching. Still breaking out over a month later. Has had multiple rounds of oral and topical steroids
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: patient felt "a little weird" after first 2 shots - Tdap and meningococcal.   HPV was given and patient was checking out in the lobby of the office.  She passed out at the front desk and MA was immediately called to the patient.  Dr. was then called.  At this point, patient was awake and reported to feeling week and lightheaded prior to passing out.  VS were stable.  Patient was placed back in examination room and monitored for 30 minutes.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PATIENT RECEIVED THE PREVNAR 13 SHOT ON 5/29/19. SHE RETURNED TO THE PHARMACY ON 06/04/19 WITH A SWOLLEN LEFT ARM THAT SHE SAYS HAS BEEN PAINFUL, RED AND WARM AFTER SHE GOT HER SHOT. SHE WAS ADVISED TO GO TO THE MINUTE CLINIC AT THE SAME LOCATION TO BE EVALUATED BY THE NURSE OR TO SEE HER PCP
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Bexsero given @ 10:30 am on 7/28/19. At 12 noon pt experienced fever, headache, muscle + joint pain. 2 pm. Temp 100.7 severe headache, joint pain. Swelling + pain @ injection site. Couldn't move (L) arm
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia
Clinical narrative: Bexsero given @ 10:30 am on 7/28/19. At 12 noon pt experienced fever, headache, muscle + joint pain. 2 pm. Temp 100.7 severe headache, joint pain. Swelling + pain @ injection site. Couldn't move (L) arm
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Body temperature increased, Loss of personal independence in daily activities
Clinical narrative: Bexsero given on 7/1/19 @ 2:30 pm increased temps + joint pain to arms + legs developed @ 6 pm. Temp 101 this am (7/2/19) aches persist - unable to attend sports camp starting today
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient came to the pharmacy on 06/29/2019 and notified me that she had developed an adverse reaction months ago when she was given her pneumonia vaccination. She stated her arm was swollen, red, and extremely painful and showed a picture from her cell phone and described the red rash as going down her arm. Her orthopedic doctor referred her to her primary or the emergency room when he saw it the next day during her appointment. She went and saw Dr. who diagnosed her with cellulitis and prescribed her Keflex. She then saw Dr. (her primary doctor) for the follow up. I asked her current status and her arm is healed now.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Vaccination complication
Clinical narrative: Patient came to the pharmacy on 06/29/2019 and notified me that she had developed an adverse reaction months ago when she was given her pneumonia vaccination. She stated her arm was swollen, red, and extremely painful and showed a picture from her cell phone and described the red rash as going down her arm. Her orthopedic doctor referred her to her primary or the emergency room when he saw it the next day during her appointment. She went and saw Dr. who diagnosed her with cellulitis and prescribed her Keflex. She then saw Dr. (her primary doctor) for the follow up. I asked her current status and her arm is healed now.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Blood culture, Chest X-ray, Full blood count, Lymphadenopathy, Metabolic function test
Clinical narrative: Presents to clinic 6/19 for well check. Vaccines administerd. On 6/26 c/o fever, rash, neck pain, sore throat and adenopathy. Treated and released. Instructed to follow up if condition worsens. 6/28 presents to ED c/o fever and unable to move neck. Admitted to hospital for observation.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Mobility decreased, Musculoskeletal discomfort, Neck pain, Nuclear magnetic resonance imaging spinal, Oropharyngeal pain
Clinical narrative: Presents to clinic 6/19 for well check. Vaccines administerd. On 6/26 c/o fever, rash, neck pain, sore throat and adenopathy. Treated and released. Instructed to follow up if condition worsens. 6/28 presents to ED c/o fever and unable to move neck. Admitted to hospital for observation.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Pyrexia, Rash, Urine analysis
Clinical narrative: Presents to clinic 6/19 for well check. Vaccines administerd. On 6/26 c/o fever, rash, neck pain, sore throat and adenopathy. Treated and released. Instructed to follow up if condition worsens. 6/28 presents to ED c/o fever and unable to move neck. Admitted to hospital for observation.