chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Friday (11/2/18) around supper experienced severe pain in left arm. Later same evening arm went numb down to fingertips. On Saturday (11/3) experienced entire body aches (not face). Sunday (11/4) was bedridden due to all the pain. Monday (11/5) called into work due to severe pain, especially left foot. Says had to crawl as she could not walk. Began taking pain medications. Tuesday (11/6) returned to work but still experienced some pain. Wednesday (11/7) reported information to Health Dept Immunization Clinic; not in as much pain. Says continues to take pain medication but pain is not as severe; gets still if she does not keep moving.
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a 31 year old female patient who is also a physician. The patient had no pertinent medical history and drug reactions/allergies were none. Concomitant medications included birth control (unspecified name) started over 12 years ago. On 22-OCT-2018 at 16:00, the patient was vaccinated with GARDASIL 9 injection, via intramuscular route (strength, dose, lot # and expiry date were not reported) for prevention of disease. On 23-OCT-2018 after waking up in the morning, the patient experienced swelling, redness and heat in her right index finger, right hand, right large toe and right foot. It was reported that redness from foot was extending upward. The patient was given treatment for the adverse events. On 23-OCT-2018, the patient was seen by physician and advised to "monitor symptoms". No lab diagnostics/studies was performed. The patient sought medical attention. The outcome of peripheral swelling, erythema and feeling hot was reported as not recovered/not resolved. The causality assessment was not provided. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about August 2016, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about November 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention  of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a patient (gender and age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a health care provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zostr-related injuries. On or about 2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302794 (same reporter). This case involves a 6 months old female patient (reported as 6 month 25 day old) who inadvertently received single 0.5 ml of vaccine FLUZONE (lot UJ005AD and expiry date: 30-Jun-2019) instead of 0.25 ml on 22-Oct-2018 in left thigh via unknown administration site. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to overdose. Patient was given 0.5 ml of FLUZONE QIV in error instead of 0.25 ml as the administering physician did not know needle size and gauge. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA302863 (same reporter). This case involves a patient (age and gender unknown) who received expired dose of vaccine, MENACTRA. The patient's past medical history and concomitant medication were not provided. On 09-Jul-2018, the patient received a single dose of suspect MENACTRA lot U5462AB via (Expiry date: 19-Jan-2018) via unknown route in unknown administration site. It was a case of actual medication error due to issue with how the imprint of the expiration date on the vials was written (two-digit year) which was different than previous vaccinations that they had received (Product label confusion) which eventually led to administration of the expired vaccine (expired vaccine used). It was unknown whether 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 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: F
Vaccine: HIBV
Symptoms: Antibody test negative, Malaise
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient (age was not reported) who was sick and her HIB titter was drawn and it was low, while she received vaccine HIB VACCINE. The patient's past medical history included anaphylactic reaction to Latex (Rubber sensitivity). The patient's past 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 HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced sickness. It was reported that she kept getting sick. It was also reported that her HIB titer was drawn and it was low. Relevant tests were not reported. Final diagnosis was sick. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old male patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PCV 13 and ROTARIX vaccine on unknown date. On 30-Oct-2018, the patient received a 0.5ml dose of suspect PENTACEL lot C5440AA, expiry date 29-Oct-2018 via intramuscular route in the left thigh. It was an actual medication error case due to expired vaccine used. It was reported that patient child was vaccinated with PENTACEL on 30-Oct-2018 but the expiration date was 29-Oct-2018. 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: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304367 (same reporter). This case involves six months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL (batch number: C5456AA, expiration date: 31-Dec-2018) via intramuscular route in the left thigh, on 25-Oct-2018, which was not stored in appropriate temperature ranges. Concomitant medications included PREVNAR 13. The patient's medical history was not reported. It was an actual medication error due to incorrect product storage. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304355 (same reporter). This case involves a six- months old male patient who was vaccinated with a dose of PENTACEL (lot number: C5324AC) via intramuscular route in the left thigh on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and FLULAVAL for Immunisation. It was a case of actual medication error due to incorrect product storage and poor quality product administered since vaccines were not stored in appropriate temperature ranges. It was not reported whether the patient has experienced any adverse events or not. 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: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304475. This case involves a 11 years old female patient who had administered MENACTRA that were not stored in appropriate temperature ranges. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX for Immunisation; and FLULAVAL for Immunisation. On 22-Oct-2018, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, expiry date- 06-Oct-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for administered doses of MENACTRA that were not stored in appropriate temperature ranges. 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.
Age: 7.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA304677. This case involves a 7 years old female patient who had expired dose, while she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included TYPHIM VI on the same day in right arm. On 30-Oct-2018, the patient received a 0.5 ml once dose of suspect IMOVAX RABIES lot M13911M via intramuscular route, expiry date- 24-Jul-2018 in left arm. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient received a corrective treatment. 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.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from an other non health professional (reported as office staff). This case involves a 5 years old patient of unknown age who had egg allergy received a dose of vaccine FLUBLOK QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was occurred or not. It was also reported that Officer Manager refused to provide any AE information. Stated that they have their own internal way of managing these events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 09 months old patient (gender not reported) who was vaccinated with 0.5 ml expired dose of ACT-HIB (Batch number: UI787AA, expiration date: 11-May-2018, site was not reported) via intramuscular route on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Disorientation, Loss of consciousness, Pallor
Clinical narrative: Patient passed out as she was walking out of the exam room, Mom caught her and leaned her against the wall and eventually into a chair. Nursing staff as well as ARNP entered the room quickly after mom called out for help. Patient was awake but disoriented and very pale. BP was 76/33 and HR was 50. Child was instructed to remain seated and offered sips of water. Patient was rechecked after 8 minutes; Patient's lips appeared pink and slowly color was coming back to patient's face. HR went up to 76 and repeat BP was 93/55.Patient walked out to waiting room to sit for a few more minutes before being escorted home by mom. A handout from the CDC was given to mother on syncope with TDaP and MCV vaccines.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Peripheral swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Mom noticed left arm swelling the evening of 11/6/18, drew circle around, noted today (11/7/18) spreading beyond pen marks, appears like welts, hot to touch, and very itchy. Oral BENADRYL.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Lymphadenopathy, Non-cardiac chest pain
Clinical narrative: THREE TO FOUR HOURS AFTER VACCINE PATIENT STATED THAT UNDERNEATH HER ARMPIT WAS SWOLLEN "FOUR TIMES THE SIZE". PATIENT HAD PAIN BETWEEN ARMPIT AND CHEST. SWELLING HAS SINCE DISSIPATED AND PAIN IS IMPROVING.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Coarse red raised rash resembling Pityriasis rosea on trunk and extremeties.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: 4 hours after injection soreness at site of injection. 8 hours after tiredness/sleepiness. 12 hours after extreme tremors/shivering, fever, muscle soreness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: 4 hours after injection soreness at site of injection. 8 hours after tiredness/sleepiness. 12 hours after extreme tremors/shivering, fever, muscle soreness.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Nerve injury, Pain in extremity, Sleep disorder
Clinical narrative: Patient states within hours of receiving injection had sharp pain in left arm and cannot life arm up need to use. Has to use other hand to help lift arm still has sharp pain that effects her sleep. Has been seen by primary care physician how has diagnosed her with left axillary arm nerve damage, was given 2 prescriptions on 11/5 1 for pain 1 for a steroid. Patient has been to physical therapy and still has difficulty and pain with arm is being referred to a neurologist for further care.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Patient states within hours of receiving injection had sharp pain in left arm and cannot life arm up need to use. Has to use other hand to help lift arm still has sharp pain that effects her sleep. Has been seen by primary care physician how has diagnosed her with left axillary arm nerve damage, was given 2 prescriptions on 11/5 1 for pain 1 for a steroid. Patient has been to physical therapy and still has difficulty and pain with arm is being referred to a neurologist for further care.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, X-ray limb abnormal
Clinical narrative: Patient states within hours of receiving injection had sharp pain in left arm and cannot life arm up need to use. Has to use other hand to help lift arm still has sharp pain that effects her sleep. Has been seen by primary care physician how has diagnosed her with left axillary arm nerve damage, was given 2 prescriptions on 11/5 1 for pain 1 for a steroid. Patient has been to physical therapy and still has difficulty and pain with arm is being referred to a neurologist for further care.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Headache, Nausea, Photophobia
Clinical narrative: Nausea, dizziness, headache and photophobia.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Ultrasound scan abnormal
Clinical narrative: Painful shot...daughter cried. Within a month she had an ultrasound and found mass on left arm where shot had been given. Going to Orthopedic surgeon next week. Unsure if connected however I believe it is.
Age: 44.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Client came for influenza and second Hep A on 11/7/18. She was anxious and reported when she had vaccines on 01/18/2018 her left arm became bruised and painful around shoulder, very red between her mid humerus area to elbow region (outer skin area), and she had a great deal of trouble moving her arm. Condition has since resolved. She did not have it checked out medically but did take pictures which she showed to nurse. Bruising was from injection sites very high on arm (shoulder???). Because incident resolved no further action has been taken. Injections on 11/7/18 were given IM in deltoid. Client will report any adverse reactions to health department. Client stated today's immunizations did not cause discomfort at time they were given.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: Patient states that she developed chills and high fever (105) one day after receiving vaccine. States she was unable to lift arm up and arm where vaccine was received was red and swollen. Patient states that fever lasted for 5 days. Patient states that she self medicated with ADVIL for 5 days until fever broke. States that she engaged in bed rest and had plenty fluids to aid in recovery. Patient has fully recovered. Does not currently have fever and is able to move arm without pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe left upper arm pain for 3-4 days after getting injection. Continued left upper arm for 4 weeks since injection. Left upper arm pain in triceps, worse with abduction and superior movements.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: My son had bruising from the injection and an initial site reaction. The site reaction (redness) resolved and then a red rash appeared on his left thigh and continued to get larger until it covered most of his thigh, area was red, warm to the touch (warmer than surrounding skin), and was hard to the touch.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: My son had bruising from the injection and an initial site reaction. The site reaction (redness) resolved and then a red rash appeared on his left thigh and continued to get larger until it covered most of his thigh, area was red, warm to the touch (warmer than surrounding skin), and was hard to the touch.
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from nurse who is also the patient, referring to herself, a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-NOV-2018, the nurse administered a PROQUAD lot # R015739 with expiration date 02-DEC-2019, for prophylaxis to a patient (route of administration was not reported). Other suspect therapies included MERCK STERILE DILUENT lot # R006343 with expiration date 01-DEC-2019 (also reported as "01-DEC-2020"). It was stated that the patient inadvertently kicked the nurse's hand while she was still holding the used syringe of PROQUAD and an small amount of the vaccine that was still in the syringe got in the nurse's eye (exposure via eye contact and accidental exposure to product). The nurse immediately flushed her eye with water. The nurse stated that was a "normal, very small amount" of PROQUAD remaining in the syringe and she believed the patient received a full dose. No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a male patient. The patient's age was reported as "under 18 years old". Information about concurrent condition, concomitant medication and medical history were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for HPV prevention (route and lot # were not provided). On an unknown date, the patient "passed out". The outcome of the event was recovered on an unspecified date. The causality assessment was not reported. No product quality compliance was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Facial paralysis, Lagophthalmos, Surgery
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 an unknown date in 2016, for routine health maintenance and for the prevention of shingles. On an unknown date after receiving the ZOSTAVAX, the patient began to experience facial drooping. In response to these complaints, the patient presented to an emergency room and was diagnosed as suffering from Bell's palsy (outcome unknown). The patient later suffered from the inability to close her left eye. In response to this complaint, on an unknown date, the patient presented to her primary care physician and was diagnosed with lagophthalmos, which required surgery to correct. Because of ZOSTAVAX, 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. Upon internal review, Bell's palsy was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Pneumonia, Pulmonary oedema
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported for a 70-year-old male patient (Pharmacist' father) that received first and second dose of PREVNAR 13, both via an unspecified route of administration unspecified dates at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. Pharmacist father received pneumococcal 13-val conj vac (dipht crm197 protein) twice. Shortly after used of product, he was sent to the hospital for 3 weeks with pneumonia. The patient experienced chest pain and lungs filled with fluid. The outcome of the events pneumonia, chest pain and lungs filled with fluid was unknown. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical assessment.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (unknown trade name) lot number and expiration date unknown at a single dose and influenza vaccine (FLU VACCINE), at an unknown dose, both administered on patient's arm via unspecified routes of administration on an unspecified date for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's bad cold started last week (date unspecified) and it has been 10 days now since she had a pneumonia shot and a flu shot. It was reported that right after she got that the pharmacist told her that the flu shot was fine, but the pneumonia shot will be uncomfortable for a few days. Her arm on the side where she got the shot makes her feel drained out and then after that she got the cold and she has been taking paracetamol (TYLENOL). Outcome of the events was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302866. (Same reporter). This case involves a 28 month old female who received 0.5 ml of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UJ009AA)  (expiry date:30-Jun-2019) (dose in series were not reported) instead of 0.25 ml via intramuscular route in right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to Overdose. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a four-years old male patient who was vaccinated once with a 0.5 ml fifth dose of PENTACEL (lot number: C5553AB; expiry date: 02-Nov-2019) via intramuscular route in the Left thigh on 29-Oct-2018 instead of getting vaccinated with QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Wrong vaccine administered and extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304444. This case involves a 14 years old female patient and reported that administered doses of MENACTRA that were not stored in appropriate temperature ranges, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE). On 25-Oct-2018, the patient received a dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6015AA and expiry date: 06-Oct-2019) via intramuscular route in right deltoid. It was a case of actual medication error due to incorrect product storage. 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. List of documents held by sender: none.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 69 years old patient who was vaccinated with 0.5 ml dose of vaccine FLUZONE HIGH DOSE (batch number: UJ042AB and expiry date: 19-May-2019) via intramuscular route in the deltoid on an unknown date (reported as today). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or no other vaccines- none. It was a case of actual medication error due to wrong technique in product usage process and vaccine under dose. It was reported as she did not screw on needle tight enough and it leaked. The patent may only have gotten a very little or not any FLUZONE at all. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 98 years old female patient who received 0.5 ml, 2 doses of vaccine FLUZONE HIGH DOSE on 22-Oct-2018 (injection site unknown, Batch number and expiry date were not provided) and on 25-Oct-2018 in the left deltoid (Batch number: UJ010AC and expiry date: 22-Apr-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2018SA304966, 2018SA304965, 2018SA304935, 2018SA304936 and 2018SA304935. This case involves 82 years old female patient who was vaccinated with 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI842AB, expiration date:04 Apr 2018) via intramuscular route in left upper arm on 15-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired product administered. It was unknown if patient had 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 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: 1.67
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lip swelling, Rash erythematous, Rash macular, Swelling face, Vaccination complication
Clinical narrative: Blotchy red rash, puffiness to face and lips, without oral swelling or trouble breathing. Went to ER on 09/20/2018 and given one dose of steroid (there though more likely viral reaction). Rash worsened over next 24 hours so went to hospital 09/21/2018 and felt more likely delayed MMR vaccine response, given antihistamine cetirizine/ranitidine, particularly given similar responses in past for father and father's family to MMR vaccines (though they have completed them).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pain, Vomiting
Clinical narrative: Started with headache, body aches at 3am. Progressed to dizziness, vomiting around 10:30am. By 7-8 pm, I was feeling much better.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms (fever, aches).
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Left arm pain and decreased range of motion.
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Headache, Influenza, Injection site pain, Pain in extremity
Clinical narrative: Flu Symptoms: 101' fever, aching joints, headaches. Sore arm at injection site. Lasted one day Note 1: After 1st dose, only sore arm was experienced. Note 2: Spouse had same reaction on first does that I experienced on 2nd. Her reactions to second dose was more signficant - 103' fever, headaches, shaking, aching joints, sore arm. Lasted 2 days.
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Flu Symptoms: 101' fever, aching joints, headaches. Sore arm at injection site. Lasted one day Note 1: After 1st dose, only sore arm was experienced. Note 2: Spouse had same reaction on first does that I experienced on 2nd. Her reactions to second dose was more signficant - 103' fever, headaches, shaking, aching joints, sore arm. Lasted 2 days.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Influenza like illness, Migraine, Motion sickness, Nausea
Clinical narrative: Patient received flu shot on Saturday 9/29/2018, on Monday or Tuesday of the following week she developed flu like symptoms and sore throat. The following Friday she developed a severe migraine headache. She has continued nausea, lightheadedness, and car sickness.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Oropharyngeal pain
Clinical narrative: Patient received flu shot on Saturday 9/29/2018, on Monday or Tuesday of the following week she developed flu like symptoms and sore throat. The following Friday she developed a severe migraine headache. She has continued nausea, lightheadedness, and car sickness.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm after vaccination.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site discolouration, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient had excessive swelling and a white color around injection site, this went away after 3 days. Patient developed a hives like rash on neck and upper chest which she still has and placed hydrocortisone topical cream to the area to help with itching. Patient had a headache for about 5 days in which she took naproxen to help with this. The rash has not gotten worse and patient will follow up with doctor if it does not go away.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in arm after vaccination.
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Fall, Humerus fracture, Injection site erythema, Injection site pain, Lower limb fracture
Clinical narrative: This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2017, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). The patient was re-vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) on 25-OCT-2018. On an unknown date in October 2018 (also reported after re-vaccination), the patient experienced redness and pain at injection site. The patient mentioned that on 25-OCT-2018, she had the second vaccination at rehab and after having it, she fell in the basement and experienced a plateau fracture in her right knee and humerus and ulna fractures. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Ulna fracture
Clinical narrative: This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2017, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). The patient was re-vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) on 25-OCT-2018. On an unknown date in October 2018 (also reported after re-vaccination), the patient experienced redness and pain at injection site. The patient mentioned that on 25-OCT-2018, she had the second vaccination at rehab and after having it, she fell in the basement and experienced a plateau fracture in her right knee and humerus and ulna fractures. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2017, the patient was vaccinated with a first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). The patient was re-vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) on 25-OCT-2018. On an unknown date in October 2018 (also reported after re-vaccination), the patient experienced redness and pain at injection site. The patient mentioned that on 25-OCT-2018, she had the second vaccination at rehab and after having it, she fell in the basement and experienced a plateau fracture in her right knee and humerus and ulna fractures. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.