chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Rash, Rash erythematous, Tenderness
Clinical narrative: Patient stated that the day after her injection she had a very small "pin-point" spot like you would with any vaccination. Then over days, she developed a Red Rash like area not at the inj site but further down the arm. She went to the ER, where they treated her for possible Cellulitis (Clindamycin 150 mg every 6 hours for 7 days). However, the area did not improve and a "soft lump" developed in the same area. Not at the injection site, but further down the arm. Patient states that her arm is still sore to touch 21 days later.
Age: 63.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Tuesday evening fever swelling entire arm bodyaches. She put ice on arm took ADVIL that evening. She started to feel better Wednesday. Swelling went down some on Thursday. Swelling reduced some everyday. Still sore still swollen red and warm to touch.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Electromyogram, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Marked (R) upper arm swelling and pain noted next AM. Swelling resolved over 4-5 days. Pain persisted. Also noted (R) outer arm pain/numbness (like limb starting to "go asleep"): extends to forearm. May get numb/tingling feeling in fingers. On exam has weakness abduction and adduction. Sensation grossly intact.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nerve conduction studies, Pain in extremity, Paraesthesia
Clinical narrative: Marked (R) upper arm swelling and pain noted next AM. Swelling resolved over 4-5 days. Pain persisted. Also noted (R) outer arm pain/numbness (like limb starting to "go asleep"): extends to forearm. May get numb/tingling feeling in fingers. On exam has weakness abduction and adduction. Sensation grossly intact.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Computerised tomogram, Dizziness, Influenza, Migraine, Muscle twitching
Clinical narrative: Fever and flu symptoms within 8 hours; Next day: Severe dizziness, migraines, vertigo, severe nausea, muscle twitching; These symptoms have not gone away.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: Fever and flu symptoms within 8 hours; Next day: Severe dizziness, migraines, vertigo, severe nausea, muscle twitching; These symptoms have not gone away.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Incisional drainage, Injection site reaction, Nodule, Staphylococcus test negative
Clinical narrative: Patient is a 28 year-old male who presents for evaluation of right arm injection site reaction. Patient states he had an influenza vaccination injection in his proximal right upper extremity on 10/3/18. Patient states he noticed a knot appear at proximal right upper extremity on 11/13/18. Patient states that Dr. prescribed him BACTRIM and prednisone for the knot on 11/16/18. Patient states that the knot on his proximal right upper extremity was lanced, cultured and drained on 11/20/18. Patient states that cultures came back negative for MRSA, and he was told to stop his BACTRIM and prednisone. Patient states the lesion continued to drain until about 3 weeks ago. Describes the drainage as pus-like at first, but states it progressed to a yellow/orange clear fluid. Denies fever, sweats, chills. Rates pain 1/10. Follow up as needed
Age: 2.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two years old female patient who received dose of vaccine QUADRACEL (lot number and Expiry date unknown) via unknown route in unknown administration site on 14-JAN-2019. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (it was reported that QUADRACEL was administered incorrectly to a two year old patient today). It was not reported that if any adverse reaction was experienced. 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: 2.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two years old female patient who received dose of vaccine QUADRACEL (lot number and Expiry date unknown) via unknown route in unknown administration site on 14-JAN-2019. The patients' medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (it was reported that QUADRACEL was administered incorrectly to a two year old patient today). It was not reported that if any adverse reaction was experienced. 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Chest pain, Headache, Immediate post-injection reaction, Induration, Lymphadenopathy
Clinical narrative: After Meningococcal conjugate vaccine 4-valent IM shot she reported headache immediately after reaching home in about 30-40 minutes. Headaches were continues along with chest pain and swollen lymph nodes for over a week. After that chest pain reduced and went away. She continued to have swollen nodes on and off very hard. Her headaches developed into on and off migraines every day. She is continuing to have the headaches almost every day. Severity level changes.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Migraine
Clinical narrative: After Meningococcal conjugate vaccine 4-valent IM shot she reported headache immediately after reaching home in about 30-40 minutes. Headaches were continues along with chest pain and swollen lymph nodes for over a week. After that chest pain reduced and went away. She continued to have swollen nodes on and off very hard. Her headaches developed into on and off migraines every day. She is continuing to have the headaches almost every day. Severity level changes.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Chills
Clinical narrative: Intense Shivering for about 10 minutes then subsided.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Pt had 6 cm x 6.5 cm area of erythema post SQ vaccine.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: HIVES AND FEVER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Information has been received from a 67 years old female patient referring to herself. Concomitant medication included other unspecified medications. The patient had none medical history, drug reactions or allergies. In December 2017, the patient received her first dose with PNEUMOVAX 23 (reported as PNEUMOVAX) (strength, dose, lot# and expiration date were not reported) intramuscularly for prophylaxis with no adverse effect. On 17-DEC-2018, the patient received her 2nd dose of PNEUMOVAX 23 (strength, dose, lot# and expiration date were not reported) intramuscularly for prophylaxis. On 18-DEC-2018 (reported as the day after vaccination with her second dose of PNEUMOVAX 23, the patient experienced redness, pain, and swelling beginning about an inch below the injection site down the bicep area towards her elbow. On an unknown date in December 2018, the patient was itching in the bicep area. The patient spoke with physician for medical attention. The patient treated the symptoms with ice and by taking ibuprofen, which helped to alleviate the symptoms. There was no lab diagnostics/studies performed. At the time of reported, the only thing that still lingers was itching and occasional soreness in that bicep area which she was still experiencing. Causality assessment was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse (also reported as a medical assistant) referring to a currently 13 months old patient of unknown gender. The patient's medical history, current condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with VARIVAX (lot # R017642, expiration date 20-JUN-2020, dose and route unknown) and M-M-R II recombinant Human albumin (rHA) (lot # R000550, expiration date 08-JAN-2020, dose and route unknown) for prophylaxis following a temperature excursion (temperature: 50.7 Fahrenheit, Time frame: 5 hours 58 minutes) (product storage error). There were no temperature excursion issues previously. No adverse effects were reported. Data logger was involved.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Aggression, Asthma, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Condition aggravated
Clinical narrative: This spontaneous report, was received from a consumer, concerning his son, a currently 5 year old male patient. The patient's pertinent medical history was not provided. The patient's concurrent conditions included asthma, allergy to latex, peanuts, gluten, sugar, red dye and dairy. The patient did not have any concomitant medication to report. On 20-MAR-2014, the patient was vaccinated with M-M-R II as routine vaccination, lot #J000154 and expiration date 09-JAN-2015 (strength, dose, frequency, anatomical location and route of administration were not reported). On 14-AUG-2014 the patient was vaccinated VARIVAX as routine vaccination, lot #J013905 and expiration date 30-OCT-2015 (strength, dose, frequency, anatomical location and route of administration were not reported). On 22-MAR-2018, the patient was vaccinated with PROQUAD as routine vaccination, lot #N028443 and expiration date 09-APR-2019. (strength, dose, frequency, anatomical location and route of administration were not reported). On an unknown date, reported as "after the administration of all three vaccinations", the patient was diagnosed with attention deficit/hyperactivity disorder (ADHD), autism and oppositional defiant disorder. The reporter stated that the patient showed aggressive behavior. It was also informed that on four different unspecified dates, the patient had been hospitalized due to asthma attacks. At the time of reporting, the patient had not recovered from ADHD, autism, oppositional defiant disorder and asthma attacks. The patient did not received any treatment for the adverse events. The patient had been evaluated by several psychologists and was referred to 10 hours of occupational therapy a week. The causal relationship between the vaccination with M-M-R II, vaccinated VARIVAX, PROQUAD and the events was not provided by the reporter. Upon internal review, autism was determined to be a medically significant adverse event.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Oppositional defiant disorder
Clinical narrative: This spontaneous report, was received from a consumer, concerning his son, a currently 5 year old male patient. The patient's pertinent medical history was not provided. The patient's concurrent conditions included asthma, allergy to latex, peanuts, gluten, sugar, red dye and dairy. The patient did not have any concomitant medication to report. On 20-MAR-2014, the patient was vaccinated with M-M-R II as routine vaccination, lot #J000154 and expiration date 09-JAN-2015 (strength, dose, frequency, anatomical location and route of administration were not reported). On 14-AUG-2014 the patient was vaccinated VARIVAX as routine vaccination, lot #J013905 and expiration date 30-OCT-2015 (strength, dose, frequency, anatomical location and route of administration were not reported). On 22-MAR-2018, the patient was vaccinated with PROQUAD as routine vaccination, lot #N028443 and expiration date 09-APR-2019. (strength, dose, frequency, anatomical location and route of administration were not reported). On an unknown date, reported as "after the administration of all three vaccinations", the patient was diagnosed with attention deficit/hyperactivity disorder (ADHD), autism and oppositional defiant disorder. The reporter stated that the patient showed aggressive behavior. It was also informed that on four different unspecified dates, the patient had been hospitalized due to asthma attacks. At the time of reporting, the patient had not recovered from ADHD, autism, oppositional defiant disorder and asthma attacks. The patient did not received any treatment for the adverse events. The patient had been evaluated by several psychologists and was referred to 10 hours of occupational therapy a week. The causal relationship between the vaccination with M-M-R II, vaccinated VARIVAX, PROQUAD and the events was not provided by the reporter. Upon internal review, autism was determined to be a medically significant adverse event.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent condition, concomitant medication and historical condition was unknown. On 11-JAN-2019 the patient was vaccinated with pneumococcal PNEUMOVAX 23 injection, intramuscularly (also reported as subcutaneous) (therapy type, dose, dose unit, strength, frequency, lot #, expiry date unspecified) for prophylaxis (immunization for the prevention of pneumococcal disease (pneumococcal immunization)). On the same day of vaccination, the patient experienced Pain and swelling in injection arm from the shoulder to the elbow (pain in extremity and peripheral swelling) and a rash at injection site (injection site rash). Patient did not receive any treatment for the events till the time of this report. The outcome of pain in extremity, injection site rash and peripheral swelling was reported as not recovered. Causality assessment was not provided. It was reported that no PQC was present.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. In October 2014, the patient was administered ZOSTAVAX by a healthcare provider (lot# and route unknown). In November 2014, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 78 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-AUG-2011, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 09-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 15-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 18-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 27-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 08-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 14-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 06-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 15-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 04-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician regarding a 14-and-a-half-year-old patient. The patient's relevant medical history, concurrent conditions and concomitant medications drug reactions/allergies were not reported. On an unknown date in July-2018, the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiry date not reported) 1st dose for prophylaxis. On an unknown date in July-2018, immediately after the vaccination the patient experienced "dizziness and lightheaded-ness for 4 days. The outcome of dizziness was reported as recovered. Causality assessment was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: This spontaneous report was received from an other non-healthcare professional via company representative concerning to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included steroids (unspecified). On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (dosing details, route, frequency, lot# and expiration date unknown) for prophylaxis on unknown date (might be the reason of vaccination) the patient was hospitalized twice for unspecified period of time (length of stay in the hospital). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) by the neurologist. The patient was seen by the physician and it was unknown if she had received any treatment. The outcome of the event acute disseminated encephalomyelitis was unknown. The reporter did not provide the causality assessment. Upon internal review, the event acute disseminated encephalomyelitis was assessed as medically significant.
Sex: F
Vaccine: TYP
Symptoms: Needle issue, Underdose
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who received a partial dose of vaccine TYPHIM VI (batch number: N1K811M, expiry date: 19-Oct-2019) (dose in series, route and site of administration were not reported) 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 vaccine under dose as part of the pre-filled syringe dose leaked out and down the patient's arm and she did not get a full dose. 0.5 mL was attempted to be given. It was also a case of Needle issue as the needle leaked between the hub and the attachment site of the pre-filled syringe. It was also reported She said that she had tightened it on the syringe appropriately. No damage noted to the needle or syringe. It was not reported if any adverse reaction was reported or not. 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. Follow up information was received on 14-Jan-2019 from a pharmacist. Suspect lot number updated. List of documents held by sender- none.
Sex: F
Vaccine: TTOX
Symptoms: Drug hypersensitivity
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves Adult female patient (age was not reported) who experienced drug allergies, while she received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid 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 drug allergy. (Other relevant tests included no lab data.) Final diagnosis was drug allergies. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for drug allergies. List of documents held by sender: none.
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 18 months old patient (gender not reported) who was vaccinated with a dose of ADACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves child male patient was received vaccine QUADRACEL lot C5500CA and Exp. Date 16-Aug-2020 via unknown route in the right thigh that was not properly stored during shipment on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PROQUAD for Immunisation. It was an actual medication error case due to incorrect product storage. It was reported that the vaccine was shipped on the 7th 2 days fed ex ground, should have arrived on the 9th but not delivered until the 10th. No reported reaction or side effects. 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: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11.5 years old patient of unknown gender who experienced itching and redness at the site, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious itching and redness at the site one minute following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious itching and redness at the site one minute following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab data was reported. Final diagnosis was itching and redness at the site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for itching and redness at the site.
Sex: M
Vaccine: FLUX
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves male patient (age not reported) who was vaccinated with a dose of vaccine INFLUENZA VACCINE (lot number, Exp. Date, dose, route, site and date of administration not reported) which was packaged too warm and then too cold after they were sent by the medical center staff to other affiliate clinics. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. 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 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: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PPV, RVX
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received 0.5 ml first dose of vaccine FLUZONE QUADRIVALENT instead of 0.25ml (lot number: UJ068AB, expiry date: 30-Jun-2019) via unknown route in the left thigh on 26-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ACTHIB for Immunisation; PNEUMOCOCCAL CONJUGATE VACCINE for Immunisation; PEDIARIX for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to overdose. 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.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional by phone. This case involves adult female patient (age not reported) who experienced I received the Sanofi flu vaccine this year, and I still got diagnosed with the flu type A, while she received vaccine INFLUENZA VACCINE (Sanofi flu vaccine). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unspecified date, the patient developed a non-serious flu type A following the administration of INFLUENZA VACCINE. No Lab data was reported. Final diagnosis was received the Sanofi flu vaccine this year, and I still got diagnosed with the flu type A. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for I received the Sanofi flu vaccine this year, and I still got diagnosed with the flu type A. Documents held by the sender: none.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 7 months old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UJ087AA, expiry date, dose in series and route of administration were not reported) in the left thigh on 15-Jan-2019 at 11:30. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were given. It was a case of actual medication error due to overdose because a 7 month old patient was administered 0.5 ml dose of vaccine instead of 0.25 ml. It was reported that nurse grabbed the FLUZONE QUADRIVALENT 0.5 ml prefilled syringe in error, instead of a 0.25 ml pediatric dose, and administered it as the second dose of Flu Vaccine. It was unknown if any adverse event was occurred or not following the vaccination (Plan was to notify the parents and monitor for side effects). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case involves a 7 years old patient who experienced an allergic reaction to last year's FLUZONE QUADRIVALENT, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unspecified date, the patient developed a non-serious an allergic reaction to last year's FLUZONE QUADRIVALENT following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No Lab data was reported. Final diagnosis was an allergic reaction to last year's FLUZONE QUADRIVALENT. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for an allergic reaction to last year's FLUZONE QUADRIVALENT. Documents held by the sender: none.
Sex: U
Vaccine: FLUX, TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 36 years old patient who received a dose of vaccine TENIVAC (lot U5525AA and expiration date 07-Jan-2019) via unknown route in the left deltoid on 15-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. Patient had no 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.
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 15 months old male patient who received an 0.5 ml dose of vaccine ACT-HIB (lot U6111AA) reconstituted with sterile water instead of 0.4 NaCl, via intramuscular route in thigh (unknown what side), on 14-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; and VARIVAX II for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blister, Erythema, Pain in extremity, Wound secretion
Clinical narrative: Patient presented to walk in clinic on 1/15/2019 and it is documented that she has had pain in her left arm, was reddened, had blistering and weeping from the lesions. Treated with BACTROBAN ointment by walk in clinic staff.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site reaction, Nodule, Pain, Purulent discharge
Clinical narrative: Patient is a 41-year-old female who presents for evaluation of left arm injection site reaction. Patient states she had the hepatitis A vaccination injection given her left arm on 10/8/18. Patient states about 3 weeks after getting the injection, she noted a knot appear near injection site on her proximal left upper extremity. Patient states that the knot increased in size and became erythematous. Per patient, the area continued to swell and drained. States the drainage was a brownish/yellow malodorous drainage. Denies fever, chills, sweats. Rates pain 1/10. Denies any problems since it drained originally.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling
Clinical narrative: Patient is a 41-year-old female who presents for evaluation of left arm injection site reaction. Patient states she had the hepatitis A vaccination injection given her left arm on 10/8/18. Patient states about 3 weeks after getting the injection, she noted a knot appear near injection site on her proximal left upper extremity. Patient states that the knot increased in size and became erythematous. Per patient, the area continued to swell and drained. States the drainage was a brownish/yellow malodorous drainage. Denies fever, chills, sweats. Rates pain 1/10. Denies any problems since it drained originally.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to tetanus, diphtheria and acellular pertussis vaccine possible injection reaction. Allergy list updated. Review treatment options. Patient and family defer steroids for treatment. They were agreeable to below treatment. Review medications with patient and family. Instructed to go to the ER if develops new symptoms or symptoms worsen which patient and family understood this. Monitor blood sugar readings and report them to this office. Check lab work order at previous visit. Start hydroxyzine HCl 10 mg tablet 1 mg every 8 hours. Start loratadine 10 mg tablet 1 tablet every day.