chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of expired Daptacel was inadvertently administered to a patient, no adverse event; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5190AA, expiry date: 24-Apr-2019 via intramuscular route in the right thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  Dose of expired Daptacel was inadvertently administered to a patient on 20May2019.  No adverse event 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.  Documents held by sender: none.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally injected with a Daptacel vaccine 0.5mL on 17May2019 that expired on 16May2019/no AE; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old male patient who received an expired dose (0.5 mL) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-May-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA and expiry date: 16-May-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  No adverse event was 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
Symptoms: Expired product administered
Clinical narrative: administered Daptacel to a patient 3 days after its expiration date.; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a patient of unknown demography who received expired vaccine of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-MAY-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE expiry date: 17-May-2019 lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if 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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient had received a dose of Dapatacel that was one day expired; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if 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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was given to a patient one day passed the expiration date.; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  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 DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was of actual medication error due to expired vaccine used..  No adverse event was 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: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Tenivac(td) shot on the 30th of last month and her job needed her to get the Adacel(tdap) shot; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA141943.  This case involves Adult patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS  It was of actual medication error due to  wrong vaccine administered..  No adverse event was 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.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: 1 week of intermittent fevers, highest 100.7 degrees after immunizations
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Incomplete course of vaccination, Pain
Clinical narrative: Patient received recombinant zoster vaccine on 5/8/19. Per telephone call with provider on 5/13/19, patient declines completing the vaccine series due to severe pain, chills, and fatigue after first dose. Per patient, couldn't get out of bed for two days due to fatigue. Symptoms improved by time of telephone appointment. & Pain, chills, fatigue
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia
Clinical narrative: patient had right torso sensitivity starting 5/20/19 and broke out in shingles multiple dermatones 5/29/19
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Odynophagia, Swelling face
Clinical narrative: Boostrix - Not clear if this is the source - multiple vaccinations received - but having pain with swallowing, right facial swelling, within 30 minutes of vaccinations
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling in area where shot given started the next day after the shot, large 2 cm  wheal with hard central in-duration, slightly elevated, appeared 3 days later with no relief after icing. Pt placed on antihistamines 3x/day and asked to use 1% hydrocortisone on the area. Pt will follow up in 48 hours
Age: 52.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Fatigue
Clinical narrative: Naseau, stomach pain, chills. Fatigue , lack of appetite, pain in joints
Age: 52.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Nausea
Clinical narrative: Naseau, stomach pain, chills. Fatigue , lack of appetite, pain in joints
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect; 7 year old patent was given an adult dose of VAQTA; This spontaneous report as received from an office manager refers to a 7 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 24-APR-2019 the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/milliliter injection (lot # S001832, expiry date: 12-MAY-2020) intramuscularly for prophylaxis (product administered to patient of inappropriate age). No adverse effect was reported. No product quality complaint was involved.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patients received a dose of Prevnar 13 and then 2 doses of pneumovax23; one dose of prevnar and 2 doses of pneumovax 23; patients received a dose of Prevnar 13 and then 2 doses of pneumovax23; This spontaneous report was received from a consumer via other company Pfizer (# 2019225777) refers to unspecified number of patients older than 65 years of age with unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received a dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dosing details unspecified) followed by 2 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, vaccination site, route, # lot, expiry date unspecified) for prophylaxis.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of PNEUMOVAX 23; No adverse effects; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S009945, intramuscular.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: LIGHTHEADNESS POST VACCINATION; This spontaneous report was received from a pharmacist via company representative referred to a female patient of an unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date, the pharmacist reported that her son's girlfriend experienced lightheadedness(Dizziness) after receiving a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dosing details, route, frequency and lot were unknown) for human papilloma virus immunization. It was reported that the patient had this happened with other unspecified vaccinations or medication administered by injection. The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) immunization series was unknown. Outcome of dizziness was unknown. Causality assessment was not provided. No PQC found.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Product supply issue, Pyrexia
Clinical narrative: Fever; Chills; Product supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number N9CA2, expiry date 2nd July 2021) 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, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills and product supply issue. On an unknown date, the outcome of the fever, chills and product supply issue were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for the 2nd dose. The pharmacist called in to report that he had a couple come in greater than 6 months before the reporting date to receive first Shingrix immunization.  The 2nd dose was unavailable till the time of reporting.  This case has been linked with US2019081362, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Product supply issue, Pyrexia
Clinical narrative: Fever; Chills; Product supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number N9CA2, expiry date 2nd July 2021) 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, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, chills and product supply issue. On an unknown date, the outcome of the fever, chills and product supply issue were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for the 2nd dose. The pharmacist called in to report that he had a couple come in greater than 6 months before the reporting date to receive first Shingrix immunization.  The 2nd dose was unavailable till the time of reporting. Additional details were reported as follows: The age at vaccination was not applicable for the 2nd dose. The pharmacist called in to report that he had a couple come in greater than 6 months before the reporting date to receive first Shingrix immunization.  The 2nd dose was unavailable till the time of reporting.  This case has been linked with US2019081367, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient's DOB (date of birth) was not available.  The age at vaccination was not reported. One month back in April 2019, the patient received 1st dose of Shingrix vaccine. One week after receiving the vaccine, the patient was diagnosed with Shingles by physician. Shingles had resolved at the time of reporting.  The patient consented to follow up.  No other information available.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: elevated heart rate; fever; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. In 2019, couple of months before the date of reporting, the patient received Shingrix. In 2019, the patient experienced elevated heart rate and fever and went to the emergency room due to the severity of the reaction. It was reported that the that patient was not admitted, stabilized at the emergency room (ER) and was sent home. C The patient's prescriber advised the patient not to receive the 2nd dose of Shingrix due to the severity of the reaction. The reporter consented to follow up. The outcome reported for all the adverse events AES in the structured field of database is "recovered with sequele" instead of  "resolved" (outcome uploaded in database).      Lab Comments: on an unknown date, the heart rate was elevated
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site abscess, Rash pruritic
Clinical narrative: 3 or 4 Days after vaccination, Pt noticed raised itchy rash on (L) arm where injection was given. Pt states it is itchy still on 5-18. Pt picked up some Hydrocortisone 1% cream to apply QID. Also, suggested Benadryl PO if it is excessively itchy.
Age: 38.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event. PT given injection by subcutaneous route, specific manufacturer guidelines instruct IM injection.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: Sick for 2 weeks - symptoms started that night late -Nausea -Sick to stomach No arm pain, chest pain
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Ant thigh redness + swelling 2 days after vaccine (R) ant leg (DTaP) 8.5 x 9 cm erythema (L) ant thigh (Varicela) 3.5 x 2.5 cm erythema No fever
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; M-M-R II administered to a patient intramuscularly; This spontaneous report as received from a pharmacy intern/healthcare student refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent(STERILE DILUENT)  On 22-MAY-2019 the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 ml) (lot # R029513, expiry date: 14-OCT-2020) intramuscularly for prophylaxis (incorrect route of product administration). No adverse effect was reported. No product quality complaint was involved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test negative, Burning sensation, Cellulitis, Chest X-ray normal, Computerised tomogram abnormal
Clinical narrative: Initially soreness at injection site, headache, flu-like symptoms. Lasted 3 days, followed by swelling in face and hands, yellow fluid leaking from skin on face, and rash on face and left arm. Right eye swollen almost shut. Went to ER on 4/29/2019 at 7:30 a.m.  CT revealed preceptal cellulitis of right eye. Admitted to hospital same day. Rash spread all over face, chest, arms, hands, torso, and right leg. Was given IV Vancomycin, Cefapime, Rocephin, Acyclovir. Swelling of face resolved after 5 days. Released from hospital and given oral amoxicillin 500 mg t.i.d. for 7 days. Rash on face and chest crusted up and resolved to a tolerable level two weeks later, with residual itching, irritation, tingling and
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture negative, Headache, Influenza like illness, Injection site pain, Paraesthesia
Clinical narrative: Initially soreness at injection site, headache, flu-like symptoms. Lasted 3 days, followed by swelling in face and hands, yellow fluid leaking from skin on face, and rash on face and left arm. Right eye swollen almost shut. Went to ER on 4/29/2019 at 7:30 a.m.  CT revealed preceptal cellulitis of right eye. Admitted to hospital same day. Rash spread all over face, chest, arms, hands, torso, and right leg. Was given IV Vancomycin, Cefapime, Rocephin, Acyclovir. Swelling of face resolved after 5 days. Released from hospital and given oral amoxicillin 500 mg t.i.d. for 7 days. Rash on face and chest crusted up and resolved to a tolerable level two weeks later, with residual itching, irritation, tingling and
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Parasite stool test negative, Periorbital cellulitis, Periorbital swelling, Peripheral swelling, Polymerase chain reaction
Clinical narrative: Initially soreness at injection site, headache, flu-like symptoms. Lasted 3 days, followed by swelling in face and hands, yellow fluid leaking from skin on face, and rash on face and left arm. Right eye swollen almost shut. Went to ER on 4/29/2019 at 7:30 a.m.  CT revealed preceptal cellulitis of right eye. Admitted to hospital same day. Rash spread all over face, chest, arms, hands, torso, and right leg. Was given IV Vancomycin, Cefapime, Rocephin, Acyclovir. Swelling of face resolved after 5 days. Released from hospital and given oral amoxicillin 500 mg t.i.d. for 7 days. Rash on face and chest crusted up and resolved to a tolerable level two weeks later, with residual itching, irritation, tingling and
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Scan with contrast abnormal, Secretion discharge
Clinical narrative: Initially soreness at injection site, headache, flu-like symptoms. Lasted 3 days, followed by swelling in face and hands, yellow fluid leaking from skin on face, and rash on face and left arm. Right eye swollen almost shut. Went to ER on 4/29/2019 at 7:30 a.m.  CT revealed preceptal cellulitis of right eye. Admitted to hospital same day. Rash spread all over face, chest, arms, hands, torso, and right leg. Was given IV Vancomycin, Cefapime, Rocephin, Acyclovir. Swelling of face resolved after 5 days. Released from hospital and given oral amoxicillin 500 mg t.i.d. for 7 days. Rash on face and chest crusted up and resolved to a tolerable level two weeks later, with residual itching, irritation, tingling and
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation, Swelling face, Swelling of eyelid, Viral test negative
Clinical narrative: Initially soreness at injection site, headache, flu-like symptoms. Lasted 3 days, followed by swelling in face and hands, yellow fluid leaking from skin on face, and rash on face and left arm. Right eye swollen almost shut. Went to ER on 4/29/2019 at 7:30 a.m.  CT revealed preceptal cellulitis of right eye. Admitted to hospital same day. Rash spread all over face, chest, arms, hands, torso, and right leg. Was given IV Vancomycin, Cefapime, Rocephin, Acyclovir. Swelling of face resolved after 5 days. Released from hospital and given oral amoxicillin 500 mg t.i.d. for 7 days. Rash on face and chest crusted up and resolved to a tolerable level two weeks later, with residual itching, irritation, tingling and
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash generalised
Clinical narrative: RASH ALL OVER BODY WITH ITCHING
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient has not had an adverse reaction. Patient was given DTap and Engerix-B at the same time during her office visit today. Patient did not exhibit any signs of adverse reaction before leaving the clinic.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Had nothing to eat or drink prior to the appointment, after the vaccine was doing errands with mom and had a wrap 1/ 2 hour after the visit, then developed nausea ,lightheaded, dizziness, and headache.Came home and rested
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Peripheral swelling, Skin discolouration, Tenderness
Clinical narrative: Patient noticed a few hours after getting vaccine that arm was very red and swollen but did hurt all around the inside of  her elbow area. Pt described the swollen arm as looking like an "egg" and being extremely red. Pt said each day the arm seems to have been getting less swollen. Pt presented to pharmacy today. Inside of elbow is still swollen, red, and almost looks a little black and blue. Pt said arm is giving her pain now when she touches it.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Abnormal behaviour, Aggression, Depressed mood, Personality change, Sleep terror
Clinical narrative: Per mom patient experienced change in attitude, behavior and personality lasting over the last 1 year+.  Woke up with night terrors and was aggressive in behavior, no longer happy.  Mom attempted to report this to her child's PCP and they refused to report.  I assured mom I would report this as requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: 5/25 - Pt developed a fever for 2 days and was irritable.  Temperature was up to 104 and his fever reduced after giving him Tylenol 5/29 -  Rash developed over pt body at 11:00am Our doctor has been notified and we are waiting for next steps.  He is in good spirits now and does not appear to have a fever so we are going to watch and see what happens.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Her arm was painful and started to swell 2 hours after receiving vaccine, then next day she had swelling from elbow to shoulder reaching part of torso. She called her PCP. He said to go to an urgent care clinic. The urgent care clinic said to wait and see if goes in forearm, ice and elevate. Second day she was still worried. PCP called her and told her to call pharmacy to make us aware of issue and for her to take Zyrtec.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy to report that she has redness and swelling with pain and warmth surrounding the injection site. Directed patient to treat with ice and ibuprofen/acetaminophen and to call the doctor to rule out infection.
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: 39 year old female patientwas administered one dose of Gardasil 9; This spontaneous report has  been received from a nurse referring to a 39 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.     On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date in May 2015, the patient was vaccinated by a pharmacist with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced heart failure and other Zoster related injuries and was treated by a healthcare provider. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the events is unknown. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event heart failure was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 65-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 12-JAN-2014, at the age of approximately 60-year-old, the patient was administered with zoster vaccine live (ZOSTAVAX) by a pharmacist for the long-term prevention of shingles and zoster-related conditions (lot#, expiration date, dosage and route of administration not specified). On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered that shingles was related to Zoster Vaccine Live (ZOSTAVAX).   Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Asthenia, Disturbance in attention, Eye movement disorder
Clinical narrative: Information has been received from a consumer referring to her currently 24-year-old daughter via the company representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date on the patient's 13 years old, she was vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient experienced "tiredness, weakness, unable to complete normal activities, eyes rolling back in her head, her teachers could not get her attention, she was in a daze" on unspecified dates following administration of this first dose. The patient visited a physician, who diagnosed patient's symptoms as "silent seizures" and prescribed unspecified medication as treatment. The patient received a second dose of a GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) vaccine on an unspecified date; it was unspecified whether the second dose was GARDASIL or GARDASIL 9. The patient experienced "migraines, headaches, vomiting, stomach pain, and hair loss" on unspecified dates following administration of this second dose. The patient visited the same doctor, who referred the patient to visit a neurologist. The patient never received a third dose of a GARDASIL vaccine. The patient sought medical attention. The outcome of all the events was not provided. The "silent seizure" was not related to GARDASIL 9. The reporter did not provide the rest of causal relationship between reported events and suspected vaccines. Upon internal review, the event "silent seizure" was considered to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Incomplete course of vaccination, Loss of personal independence in daily activities
Clinical narrative: Information has been received from a consumer referring to her currently 24-year-old daughter via the company representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date on the patient's 13 years old, she was vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient experienced "tiredness, weakness, unable to complete normal activities, eyes rolling back in her head, her teachers could not get her attention, she was in a daze" on unspecified dates following administration of this first dose. The patient visited a physician, who diagnosed patient's symptoms as "silent seizures" and prescribed unspecified medication as treatment. The patient received a second dose of a GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) vaccine on an unspecified date; it was unspecified whether the second dose was GARDASIL or GARDASIL 9. The patient experienced "migraines, headaches, vomiting, stomach pain, and hair loss" on unspecified dates following administration of this second dose. The patient visited the same doctor, who referred the patient to visit a neurologist. The patient never received a third dose of a GARDASIL vaccine. The patient sought medical attention. The outcome of all the events was not provided. The "silent seizure" was not related to GARDASIL 9. The reporter did not provide the rest of causal relationship between reported events and suspected vaccines. Upon internal review, the event "silent seizure" was considered to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Seizure, Vomiting
Clinical narrative: Information has been received from a consumer referring to her currently 24-year-old daughter via the company representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date on the patient's 13 years old, she was vaccinated with GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient experienced "tiredness, weakness, unable to complete normal activities, eyes rolling back in her head, her teachers could not get her attention, she was in a daze" on unspecified dates following administration of this first dose. The patient visited a physician, who diagnosed patient's symptoms as "silent seizures" and prescribed unspecified medication as treatment. The patient received a second dose of a GARDASIL (strength, dose, frequency, route, lot # and expiration date were not reported) vaccine on an unspecified date; it was unspecified whether the second dose was GARDASIL or GARDASIL 9. The patient experienced "migraines, headaches, vomiting, stomach pain, and hair loss" on unspecified dates following administration of this second dose. The patient visited the same doctor, who referred the patient to visit a neurologist. The patient never received a third dose of a GARDASIL vaccine. The patient sought medical attention. The outcome of all the events was not provided. The "silent seizure" was not related to GARDASIL 9. The reporter did not provide the rest of causal relationship between reported events and suspected vaccines. Upon internal review, the event "silent seizure" was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered improperly stored VAQTA; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On 22-MAY-2019, the patient received an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R034339 with expiration date 23-NOV-2019 (strength, dose, route of administration were not reported), for prophylaxis. The dose of hepatitis a vaccine, inactivated (VAQTA) was exposed to a temperature excursion above 47 Fahrenheit degrees (°F) (9 Celsius degrees (°C)) (49.3 °F) during a timeframe of 44 minutes, which was not detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.    This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011144:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Expired dose of VAQTA; This spontaneous report as received from an office manager (also a vaccine coordinator) refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 23-MAY-2019 the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency: not reported) (lot # N032753, expiry date: 23-MAR-2019) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccines; 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-MAY-2019, the patient was inadvertently administered doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(Dosing details, route, frequency and indication were unknown) with lot number S000623 and expiry date 06-JUL-2020 and lot# R030799 and expiry date 22-APR-2020)(product storage error). Concomitant therapies included sterile diluent. All lots of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored diluent. No adverse effects were reported(No adverse event). There was no previous temperature excursion. The temperature was - 10 degree Celsius and time frame was 3 hours. No further information was provided.  This is one of the three reports received from the same reporter.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect reported; three year old patient was administered the first dose of VAQTA with the adult formulation; This spontaneous report was received from a Nurse refers to a 3 year old patient of unknown gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On 08-APR-2019, the patient was vaccinated with first dose of hepatitis a vaccine, inactivated(VAQTA) vial (of lot # R006342 with expiry date 21-APR-2019) (strength, frequency, route of administration) with the adult formulation for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. The outcome of events was unknown. No product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The nurse reported that the patient was administered PROQUAD by intramuscular injection; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 28-MAY-2018, the nurse reported that the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, frequency, lot number, and expiration date were not reported) for prophylaxis, by intramuscular injection (incorrect route of product administration). No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA013121:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccines; 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-MAY-2019, the patient was vaccinated with inadvertently administered doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) that were improperly stored (Dosing details, route, frequency and indication were unknown) lot number R034394 and expiry date 27-NOV-2020 and R030614 and expiry date 23-OCT-2020 (product storage error). Concomitant therapies included sterile diluent. All lots of varicella virus vaccine live (Oka/Merck)(VARIVAX) was reconstituted with properly stored diluent. No adverse effects were reported(No adverse event). There was no previous temperature excursion. The temperature was - 10 degree Celsius and time frame was 3 hours. No further information was provided.  This is one of the three reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccines; This spontaneous report as 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-MAY-2019, the patient was vaccinated with inadvertently administered doses of varicella virus vaccine live (Oka/Merck)(VARIVAX) that were improperly stored (Dosing details, route, frequency and indication were unknown) lot number R034394 and expiry date 27-NOV-2020 and R030614 and expiry date 23-OCT-2020 (product storage error). Concomitant therapies included sterile diluent. All lots of varicella virus vaccine live (Oka/Merck)(VARIVAX) was reconstituted with properly stored diluent. No adverse effects were reported(No adverse event). There was no previous temperature excursion. The temperature was - 10 degree Celsius and time frame was 3 hours. No further information was provided.  This is one of the three reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported; The nurse reported that the patient was administered PROQUAD by intramuscular injection; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 28-MAY-2018, the nurse reported that the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dosage, frequency, lot number, and expiration date were not reported) for prophylaxis, by intramuscular injection (incorrect route of product administration). No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012997:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Rash erythematous
Clinical narrative: Quarter size red rash about an inch below the injection site was detected around 8am on 5/29/2019.  By 3:30pm 5/29/2019, the rash was about the size of a silver dollar and a secondary rash about the size of a nickel appeared near it. Mild muscle ache exists, but it is much less than when I had the first vaccine in March 2019. Vaccine number 1 had no side effects, just sore muscle.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Impaired work ability, Injection site pain
Clinical narrative: The first few hours after the shot, I was fine other than the typical soreness at the needle site.  However, by 11 p.m, I developed severe achiness/pain everywhere on my body - toes/fingers, legs, everywhere, as well as a very strong headache.   I didn't take my temperature, but also had severe chills.  This severity of symptoms lasted throughout the night.  Every 3 hours, I took 2 extra-strength Tylenol, so I reached my limit of meds for a 24-hour period within 10 hours.   The next morning, I still felt awful and stayed home from work.  Around 5:00 p.m, I felt like my pain had subsided from a 9.5 to a 5, and by 11:00 pm, at about a 3.  The next morning (today), I would say about 2.  By mid-afternoon, I am fine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The first few hours after the shot, I was fine other than the typical soreness at the needle site.  However, by 11 p.m, I developed severe achiness/pain everywhere on my body - toes/fingers, legs, everywhere, as well as a very strong headache.   I didn't take my temperature, but also had severe chills.  This severity of symptoms lasted throughout the night.  Every 3 hours, I took 2 extra-strength Tylenol, so I reached my limit of meds for a 24-hour period within 10 hours.   The next morning, I still felt awful and stayed home from work.  Around 5:00 p.m, I felt like my pain had subsided from a 9.5 to a 5, and by 11:00 pm, at about a 3.  The next morning (today), I would say about 2.  By mid-afternoon, I am fine.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Extreme tiredness Headache Chilly then extreme chills By 6:00pm Fever spiked to 102.1 Vomiting  & Diarrhea Convulsions Trouble breathing Called ambulance and taken to ER Sent home 4 hours later after being on IV. Next morning, huge welts were coming and going across my back, arms, legs. Went to see my regular doctor, who prescribed steriods for 4 days.  Only took steroids for2 days.  Felt extremely tired for the following week.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Feeling cold, Headache, Pyrexia, Seizure, Urine analysis
Clinical narrative: Extreme tiredness Headache Chilly then extreme chills By 6:00pm Fever spiked to 102.1 Vomiting  & Diarrhea Convulsions Trouble breathing Called ambulance and taken to ER Sent home 4 hours later after being on IV. Next morning, huge welts were coming and going across my back, arms, legs. Went to see my regular doctor, who prescribed steriods for 4 days.  Only took steroids for2 days.  Felt extremely tired for the following week.