chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: PNC13
Symptoms: Allergy to vaccine, Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. An 18-month-old patient of an unspecified gender received the third dose of PREVNAR 13,(lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first and second doses of PREVNAR 13 for immunization. The patient had severe allergies status post 3 doses PCV13. PCV13 tests showed immunity towards only 4 strains of PCV13. The physician was asking when retesting should be performed since the 4th dose had just been administered. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter described the first time pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) was given. The patient experienced extreme swelling on an unspecified date.  The outcome of extreme swelling was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLUR4, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 12 years old female patient who was vaccinated with MENACTRA (lot number and route not reported) and FLUBLOK QIV (lot number QFAA1803) via unknown route in the right deltoid on 05-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Mydriasis, Pain, Tremor
Clinical narrative: Wife reports the following: patient had SHINGRIX vaccine yesterday. He is having some type of reaction. He is shaking uncontrollably, pupils dilated, BP 149/85, seems like he is on some type of speed. Rates his overall pain level as 10 on 1-10 scale. Patient declined to speak to this RN. Wife unable to answer if Patient is shivering or having convulsions. As Patient unwilling to speak with this RN hard to ascertain if he is having a normal reaction or a complication. TEDP triage completed. Uptriaged and advised to go to ER now for eval due to severity of Sxs and inability to further question Patient. Wife verbalized understanding and said she will take him in. He did not present to the ED, no additional documentation found.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticarial rash on trunk, legs, extremities, itchy. Parent sent us pictures which were consistent with urticaria.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: (L) arm around the shot became very red and hot, 101 degree fever. Primary Doctor gave prednisone, KEFLEX. Arm swelled immediately. Had an appointment 3 PM Dr. observed and diagnosed. Get BENADRYL and return to where I received the shot. Saw primary after few days he felt shot was given too high on arm probably in muscle.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: (L) arm around the shot became very red and hot, 101 degree fever. Primary Doctor gave prednisone, KEFLEX. Arm swelled immediately. Had an appointment 3 PM Dr. observed and diagnosed. Get BENADRYL and return to where I received the shot. Saw primary after few days he felt shot was given too high on arm probably in muscle.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin disorder, Wound secretion
Clinical narrative: Arm very swollen from shoulder to fingertips. Skin split open and oozing began. Letter and pictures enclosed. Swelling has gone down on its own but hasn't yet returned to normal after 2 months.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Dyspnoea, Endotracheal intubation, General physical health deterioration, Intensive care
Clinical narrative: Employee received annual flu vaccine which was administered by staff RN per protocol. Within 30 seconds, employee began having difficulty breathing and turned blue. Employee carries an EPI PEN which was administered. Despite this, the employee further deteriorated and a rapid response and subsequent code blue was called. The employee was intubated and ventilated overnight in critical condition. The following morning, she was extubated and remains in the ICU.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Mechanical ventilation
Clinical narrative: Employee received annual flu vaccine which was administered by staff RN per protocol. Within 30 seconds, employee began having difficulty breathing and turned blue. Employee carries an EPI PEN which was administered. Despite this, the employee further deteriorated and a rapid response and subsequent code blue was called. The employee was intubated and ventilated overnight in critical condition. The following morning, she was extubated and remains in the ICU.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Culture negative, Gait inability, Hepatic enzyme increased, Neutropenia, Neutrophil count decreased
Clinical narrative: On 7/14, two days after her vaccine she had a fever of 104 degrees and was unable to bear weight or walk on her right leg. On 7/15 we took her into the ER at hospital. Her fever came down with medicine, continued to be unable to walk or stand on right leg. Doctors ruled out fracture. On 7/16 they diagnosed her with transient synovitis and we were discharged from hospital and told to give her Motrin for the pain and they would continue to monitor her bloodwork. On 7/17 she was able to put some weight on her right leg. Her walking continued to improve over the next few weeks and on 8/1 she was walking normal again. Her blood work continued to show low neutraphils with little improvement. She was referred to a hematologist-oncologist. On 9/11 she was diagnosed with severe neutropenia.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Synovitis, Ultrasound scan normal, Weight bearing difficulty, White blood cell count decreased
Clinical narrative: On 7/14, two days after her vaccine she had a fever of 104 degrees and was unable to bear weight or walk on her right leg. On 7/15 we took her into the ER at hospital. Her fever came down with medicine, continued to be unable to walk or stand on right leg. Doctors ruled out fracture. On 7/16 they diagnosed her with transient synovitis and we were discharged from hospital and told to give her Motrin for the pain and they would continue to monitor her bloodwork. On 7/17 she was able to put some weight on her right leg. Her walking continued to improve over the next few weeks and on 8/1 she was walking normal again. Her blood work continued to show low neutraphils with little improvement. She was referred to a hematologist-oncologist. On 9/11 she was diagnosed with severe neutropenia.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: X-ray normal
Clinical narrative: On 7/14, two days after her vaccine she had a fever of 104 degrees and was unable to bear weight or walk on her right leg. On 7/15 we took her into the ER at hospital. Her fever came down with medicine, continued to be unable to walk or stand on right leg. Doctors ruled out fracture. On 7/16 they diagnosed her with transient synovitis and we were discharged from hospital and told to give her Motrin for the pain and they would continue to monitor her bloodwork. On 7/17 she was able to put some weight on her right leg. Her walking continued to improve over the next few weeks and on 8/1 she was walking normal again. Her blood work continued to show low neutraphils with little improvement. She was referred to a hematologist-oncologist. On 9/11 she was diagnosed with severe neutropenia.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Balance disorder, Chills, Erythema, Laboratory test
Clinical narrative: Local skin reaction - ongoing redness and tenderness. Chills, somnolence, and disequilibrium - resolved by his clinic visit today (9/20/18) at noon. Weakness - almost resolved today at noon, but slight weakness persists.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Skin reaction, Somnolence, Tenderness
Clinical narrative: Local skin reaction - ongoing redness and tenderness. Chills, somnolence, and disequilibrium - resolved by his clinic visit today (9/20/18) at noon. Weakness - almost resolved today at noon, but slight weakness persists.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presents to PCP office with red, swollen, left arm approximately two days after high-dose influenza vaccine injection. Of note, the injection was in the left deltoid and the swelling and redness was significantly lower than the injection site and patient also has redness at baseline. PCP was called in to examine patient and ice pack was placed on arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Chills, fever of 101 to 103.6 for a 24 hour period. Extreme muscle pain and cramping in feet, legs, hands and chest/back. Headache on a scale of one to ten, it was a 10 plus.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Soreness, nausea, and myalgia lasting 4 days.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient presented to the pharmacy with a rash on her left arm starting directly below the injection site and extending down to right above her elbow. Since the rash occurred 2 days previous and was erythematous and warm to the touch, I referred her to her PCP Dr. to rule out infection.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Patient started to feel fatigued and run down the evening of the shot. By the next day she can hardly lift her head off her pillow. Also experiencing chills.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain lower, Back pain, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Difficulty breathing, fast heart beat or dizziness, lower abdominal pain, lower back pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pt. developed flu-like symptoms which included chills, temperature, and body aches the day following the vaccination.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pt. called and stated his arm was red, inflamed, hot to the tough and painful at the site of the injection and under his arm - Instructed pt to take BENADRYL and Ibuprofen and apply cold compress.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Altered state of consciousness, Pyrexia
Clinical narrative: Fever of 103 unable to bring down. Change in level of consciousness. 9-19-18 seen in office and level of consciousness much improved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received on 12-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history included breast cancer (diagnosed September 2012). No information was provided regarding concurrent conditions or concomitant medications. In or around August 2016, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). In 2016 (reported as shortly thereafter), the patient suffered a severe rash on the upper right side of her torso. In or around October 2016, the patient presented to her physician for this injury and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of this condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of this report, the outcome of the shingles was unknown. Causality assessment was related. The lawyer considered shingles to be disabling. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Neck pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. Caller wanted to know if neck pain was related to the administration of a second dose of PREVNAR 13 after a year of the first dose. Caller stated that patient was not sure she received a previous dose of PREVNAR 13, Patients was not sure when she received the dose and where. Outcome of the event was unknown.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 17-year-old female patient received TRUMENBA; (lot T52806, expiration date 31Dec2019), in right arm, at single dose and MENACTRA in left arm, both on 06Sep2018, for immunization, in the Doctor's office. Medical history and concomitant medications were not reported. On an unspecified date in Sep2018 swelling occurred in the right arm. The patient was admitted to the ER for high fever, vomiting and swelling. The events lasted 5 days and resolved on an unspecified date in Sep2018. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect meningococcal group b rlp2086 contributed to the development of the reported events.
Sex: M
Vaccine: HPVX, MENB
Symptoms: Anxiety, Hallucination, Pain, Tachycardia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 19-year-old male patient received the second dose of TRUMENBA on an unknown date, at single dose, for immunization. The patient concomitantly also received the last dose of HPV vaccine, administered at the same office visit. Relevant medical history was unknown. On an unspecified date (at 2:00 AM in the morning), after the vaccination, the patient awoke with whole body pain and tachycardia. He had hallucination and high anxiety. Patient's father, a cardiologist, reported he was better by morning. The patient was recovering from the events at time of this report. The information on the lot number has been requested.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Swelling face, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA at single dose, and the 2nd dose of MENACTRA, both at arm on an unspecified date at around noon for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives and facial swelling (non-serious) in Jul2018, early the following morning after vaccination. Patient went to urgent care and was given steroid shot. The outcome of the events was unknown
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 17 years old male patient who had inadvertently received his booster dose at 14 years old instead of 15 or 16, while he received vaccine MENACTRA. 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 booster dose of suspect MENACTRA (lot number, dose, dose in series, route and site of administration was not reported). This case was actual medication error due to inappropriate age at vaccine administration. 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 and Module VI of the 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: TDAP
Symptoms: Pertussis, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves Adult patient who experienced pertussis since the one member was vaccinated while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported via unknown route. On an unknown date, the patient developed a non-serious pertussis since the one member was vaccinated (pertussis) following the administration of ADACEL. It was also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was pertussis since the one member was vaccinated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for pertussis. 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 and Module VI of the 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: 27.0
Sex: F
Vaccine: RAB
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 27 years old female patient who was vaccinated with 0.5 ml second dose of vaccine IMOVAX RABIES (lot number: N18051M and expiry date: 26-Feb-2019) in the left deltoid (route of administration not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to exposure via skin contact because the vaccine dripped on the patients arm during administration and under dose because patient got only third fourth of the dose. Caller said it was leaking from where the needle attaches. Unknown to the caller if it was cracked because it had already been discarded. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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 the sender: None.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who received vaccine FLUBLOK QIV. 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 FLUBLOK QIV lot QFAA1803. It was a case of actual medication error due to Inappropriate age at vaccine administration. 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 and Module VI of the Good 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two-months old male patient who received a first dose of 0.5 ml of PENTACEL, lot C5324AC, exp date: 05-Sep-2019, via intramuscular route in the left thigh on 10-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was actual medication error case due to product preparation error (it was reported that a dose was given to a patient of the DTaP and IPV but the ACT-HIB was not given. It was not reported if the patient experienced any adverse event. 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 and Module VI of the 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: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 50 years old male patient who had severe shoulder pain for a year after he's had his flu shot, while he received FLUZONE QUADRIVALENT. 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 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date and dose in series was not reported) via intramuscular route in the arm NOS. On an unknown date, following the vaccination the patient experienced shoulder pain for a year. (Other relevant tests included no lab test). Final diagnosis was severe shoulder pain for a year after he's had his flu shot. It was not reported if the patient received a corrective treatment. The outcome of the event was unknown. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from nurse on 12-Sep-2018. This case involves a five-year-old male patient who was vaccinated with a 0.5 ml dose of PENTACEL (Batch number: C5527AA, expiration date: 04-Oct-2019, route: intramuscularly in right thigh on 14-Aug-2018. The patients concomitant medications included was HEPATITIS A VACCINE, VARICELLA VACCINE and MMR. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that the patient was due for his fourth dose of HIB and final dose of DTaP and IPV. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 1.25
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received expired vaccine used with no known reported symptoms, while she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation; PREVNAR 13 for Immunisation; and OKA/MERCK VARIVAX II for Immunisation. On 11-Sep-2018, the patient received 0.5 ml fourth dose of suspect DAPTACEL lot C5041BA, expiry date: 02 Sep 2018 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that the patient did not 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 and Module VI of the 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: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves Infant patient (age and gender not reported), who was vaccinated only the HIB portion (third dose) of PENTACEL via intramuscular route (Batch number, expiry date, dose and site of administration were not reported) on 07-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; and HEPATITIS B VACCINE for Immunisation (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because only the hib portion with the supplied diluent was administered. No adverse event experienced from vaccine. 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 the sender: none.
Age: 0.75
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 9 months old patient (gender unknown) who received 0.5ml vaccine ADACEL lot 597AA, expiry date not provided via intramuscular route in unknown administration site on 21-Aug-2018. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that ADACEL was given to a 9 month old after a dog bite in the emergency room. The hospital stated it was their standard protocol to do so. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 58 years old female patient who experienced a large red area was warm and extremely painful, while she received vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 31-Jan-2018, the patient received injection of suspect ADACEL lot U5726AA, expiry date and dose not provided via intramuscular route in the right deltoid. On an unknown date, the patient developed a non-serious a large red area was warm and extremely painful (vaccination site inflammation) with unknown latency following the administration of ADACEL. The ended up having to seek medical attention that weekend. Lab data was not provided. Final diagnosis was a large red area was warm and extremely painful. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a large red area was warm and extremely painful. List of documents held by sender- none.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 14-Sep-2018. This case involves a 15 months old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE lot UI796AAA via unknown route in the left thigh on unknown date. The patient's medical history and concomitant medications were not reported. Concomitant medications included PREVNAR for Immunisation; and DAPTACEL for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown whether any 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 and Module VI of the 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: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Balance disorder, Dizziness, Nausea
Clinical narrative: Joint pain, nausea -stomach cramp, dizzy/off balance. No treatment.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: 1544 Patient fainted after HPV vaccine given. Patient awoke quickly, icepack wrapped in towel placed on back of neck. B/P taken, 111/69 at 1558 while pt lying down. B/P 99/65 at 1610 while pt sitting. B/P 100/66 at 1630 while pt sitting. No other S/S of distress noted. LPN.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Malaise
Clinical narrative: Patient started to feel ill night of the injection and by the next morning weak and run down with the chills and sweats.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Hyperacusis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: PT started developing abnormal symptoms the day after vaccination. He started with a migraine in the morning that lasted all day. He was light and sound sensitive. Into the night at around 1100p.m. he developed chills and night sweats, it is unknown if he was febrile, and was lethargic. The patient has a localized reaction at the site of injection, the site inflamed, erythema, and warm to touch. It was 5in in diameter.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Lethargy, Local reaction, Migraine, Night sweats, Photophobia
Clinical narrative: PT started developing abnormal symptoms the day after vaccination. He started with a migraine in the morning that lasted all day. He was light and sound sensitive. Into the night at around 1100p.m. he developed chills and night sweats, it is unknown if he was febrile, and was lethargic. The patient has a localized reaction at the site of injection, the site inflamed, erythema, and warm to touch. It was 5in in diameter.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling in right upper arm, started on 9/20/18 when patient woke up- has spread upwards somewhat since this morning.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Erythema
Clinical narrative: SHINGRIX in Right arm, red, swollen (size of deck of cards), sore to touch, muscle aches, temperature, chills, upset stomach, and was weak feeling which started on Monday. Most symptoms gone by Wednesday night. However on Thursday still have red and swollen right arm on injection site (size still pack of cards). Very sore if anything touches it. Have taken TYLENOL and put cool cloth on injection site as it feels hot to touch and itches around the perimeter of area. Did not seek medical help. No reaction from flu shot in left arm.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: SHINGRIX in Right arm, red, swollen (size of deck of cards), sore to touch, muscle aches, temperature, chills, upset stomach, and was weak feeling which started on Monday. Most symptoms gone by Wednesday night. However on Thursday still have red and swollen right arm on injection site (size still pack of cards). Very sore if anything touches it. Have taken TYLENOL and put cool cloth on injection site as it feels hot to touch and itches around the perimeter of area. Did not seek medical help. No reaction from flu shot in left arm.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: SHINGRIX in Right arm, red, swollen (size of deck of cards), sore to touch, muscle aches, temperature, chills, upset stomach, and was weak feeling which started on Monday. Most symptoms gone by Wednesday night. However on Thursday still have red and swollen right arm on injection site (size still pack of cards). Very sore if anything touches it. Have taken TYLENOL and put cool cloth on injection site as it feels hot to touch and itches around the perimeter of area. Did not seek medical help. No reaction from flu shot in left arm.
Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness, warmth and swelling up to 3? X 4? oval across the upper arm. Lasted 7 days, then slight bruising; Hardness at injection site, 1? Slight pain and itching.
Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling up to 3? X 4? oval across the upper arm. Lasted 7 days, then slight bruising; Hardness at injection site, 1? Slight pain and itching.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: 3-4 minutes post flu vaccination, patient fainted. Nurse positioned patient to the floor, offered water, took vitals and monitored for 1 hour. Patient reported feeling better after 1 hour and decided to go home. Nurse advised patient to contact MD or go to ED if symptoms occur.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Product administered at inappropriate site, Rotator cuff syndrome, Tendonitis
Clinical narrative: Patient went to see Dr. today at Orthopedics. The doctor says she has an injury to the rotator cuff, either tendonitis or bursitis, due to a flu shot being given too high. Dr. prescribed a 6 day course of METHYLPREDNISONE 4mg. Patient is confident the condition will resolve.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing
Clinical narrative: Received flu vaccination. Patient reported she felt head rush. Her face was flushed. Nurse did not observe respiratory distress or difficulty swallowing. Patient was seated, vitals taken, monitored patient until she decided to leave clinic with her husband.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Decreased appetite, Diarrhoea, Hyperhidrosis, Malaise
Clinical narrative: Patient received the flu shot on Wednesday afternoon and everything was fine at that point. She started to notice symptoms of 'not feeling well' on Sunday morning. Symptoms listed were increasing nausea with a slight amount of diarrhea. She was not feeling well enough to eat. By Wednesday about 12:00 PM she was 'sweating bullets' and went into the doctors where they had a blood test drawn and an urine analysis completed. Nothing was found according to patient. By Thursday she was feeling well enough to eat and had a large meal and was feeling better. She never had any injection site pain or issues.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urine analysis normal
Clinical narrative: Patient received the flu shot on Wednesday afternoon and everything was fine at that point. She started to notice symptoms of 'not feeling well' on Sunday morning. Symptoms listed were increasing nausea with a slight amount of diarrhea. She was not feeling well enough to eat. By Wednesday about 12:00 PM she was 'sweating bullets' and went into the doctors where they had a blood test drawn and an urine analysis completed. Nothing was found according to patient. By Thursday she was feeling well enough to eat and had a large meal and was feeling better. She never had any injection site pain or issues.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Injection site mass, Pharyngeal oedema
Clinical narrative: Lump at site of injection, patient felt throat swelling and hard to breath or swallow. Patient took BENADRYL and felt better in the morning.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test, Injection site pain, Pain, Pain in extremity, X-ray
Clinical narrative: Severe pain in left arm and shoulder approx four hours after the vaccine, with lingering pain as of two weeks later. Primary care MD ordered physical therapy and referred to orthopedic specialist.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia, Feeling hot, Flushing, Heart rate increased
Clinical narrative: 1-2 minutes post flu vaccination, patient reported face flushed, tingling sensation on her entire face, increased heart rate (per patient) weird taste in mouth, dizzy/shaky and hot all over. Nurse assessed patient, and offered BENADRYL. Patient declined. Within 2 minutes symptoms subsided. Nurse suggested patient see PCP for next flu vaccination and advised she seek medical attention if symptoms return.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Tremor
Clinical narrative: 1-2 minutes post flu vaccination, patient reported face flushed, tingling sensation on her entire face, increased heart rate (per patient) weird taste in mouth, dizzy/shaky and hot all over. Nurse assessed patient, and offered BENADRYL. Patient declined. Within 2 minutes symptoms subsided. Nurse suggested patient see PCP for next flu vaccination and advised she seek medical attention if symptoms return.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-DEC-2010, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent of herpes zoster, also known as shingles and other complications. In 2011, the patient was treated at a hospital (did not specify whether admitted; therefore, considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 03-FEB-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent of herpes zoster, also known as shingles, and other complications. On or about 30-NOV-2016, the patient was treated at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about September 2015 for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. "Shortly after" receiving the ZOSTAVAX, the patient was diagnosed as suffering from shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI980AA and expiry date: 30-Sep-2019) (dose in series and route of administration were not reported) in the left deltoid on 05-Sep-2018 instead of FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. Patient wanted to know how he should get high dose and should he be re-vaccinated. Pharmacist wanted to know if there would be a High Dose with 4 antigens. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.