chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Joint dislocation, Muscular weakness, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: Pain the left arm rated 10/10, loss of range of motion, tender to touch.
Age: 73.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Pain the left arm rated 10/10, loss of range of motion, tender to touch.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 19 years old patient of unknown gender. The concomitant medication and pertinent medical history of the patient were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA (dose detail, strength, route of administration, lot# and expiration date were not reported) for prophylaxis (Incorrect dosage administered). No adverse symptoms were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a 15 years old patient of unknown gender. The patient's concurrent conditions, concomitant medications, other pertinent medical history, drug reactions and allergies were not provided. On 27-JUL-2018, the patient was vaccinated with the first dose of VAQTA (lot #, expiration date, strength and route of administration were not provided) for prophylaxis. On 21-JAN-2019 (reported as 6 days too early), the patient received the second dose in the hepatitis A vaccination series with HAVRIX lot # 79D57 with expiration date 26-JUL-2020 (strength and route of administration were not provided) for prophylaxis; which was considered an interchange of vaccine products. No adverse effect was reported. By the reporting time, it was unknown if the patient recovered from the interchange of vaccine products. The causality assessment was not provided.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a 15-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JAN-2019, the patient was inadvertently vaccinated with less than recommended dose of M-M-R II (dose, strength, frequency, lot# and expiration date were not reported) subcutaneously for prophylaxis. No adverse effects were reported.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This is a non-serious spontaneous case (prospective) pregnancy case, initially received from other non-health professional (consumer), concerning a 30-year-old, adult female pregnant patient. The patient had 3 previous pregnancies in which second pregnancy was miscarriage. The patient's relevant maternal medical history included ulcerative colitis (on an unspecified date). The patient had no relevant paternal medical history and the patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies. The concomitant medication used prior and during pregnancy included REMICADE and sulfasalazine for unknown indications. It was reported that patient's husband did not use any medications prior to conception. The patient's last menstrual period date (LMP) was 13-Sep-2018 and estimated delivery date (EDD) was provided (20-Jun-2019). There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. On 16-Oct-2018, at approximately 04 weeks gestation (first trimester of pregnancy) the pregnant patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252676 and expiry date: 31-May-2019] (explicitly coded as vaccine exposure during pregnancy). No treatment measures were taken. It was reported that, after vaccine administration, the patient did not experience any adverse event.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Influenza virus test negative, Injection site erythema, Injection site warmth
Clinical narrative: Injection site- warmth and redness. Systemic symptoms- fever, body aches, fatigue, decreased appetite, urinary frequency.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pollakiuria, Pyrexia, Urine ketone body present
Clinical narrative: Injection site- warmth and redness. Systemic symptoms- fever, body aches, fatigue, decreased appetite, urinary frequency.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia, Pruritus
Clinical narrative: CAN'T CLOSE RIGHT HAND ALL THE WAY, NUMBNESS, TINGLING AND ITCHING.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Emotional distress, Full blood count, Hypophagia, Irritability, Pyrexia
Clinical narrative: Fever to 104 today after waking from nap-- TYLENOL given night before, and every 6 hours while awake (last dose of TYLENOL was 2 hours prior to highest temp). Fussy, difficult to console (very different from normal disposition). Pulling at ears and hair/back of head. Poor oral intake today (taking 0-1 oz of formula/feed--normal amt is 4 oz). Decreased wet diapers (only 1 all day--only slightly wet).
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine output decreased, White blood cell count increased
Clinical narrative: Fever to 104 today after waking from nap-- TYLENOL given night before, and every 6 hours while awake (last dose of TYLENOL was 2 hours prior to highest temp). Fussy, difficult to console (very different from normal disposition). Pulling at ears and hair/back of head. Poor oral intake today (taking 0-1 oz of formula/feed--normal amt is 4 oz). Decreased wet diapers (only 1 all day--only slightly wet).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Beginning about seven hours after receiving the vaccination  I experienced muscle and joint aches, and chills. By morning (9 am) The next morning I had headache, dizziness, fatigue , general flu-like symptoms. When I received my first dose and October 2018 other than a sore arm my only reaction was short term fever and extreme chills about eight hours after administration.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Beginning about seven hours after receiving the vaccination  I experienced muscle and joint aches, and chills. By morning (9 am) The next morning I had headache, dizziness, fatigue , general flu-like symptoms. When I received my first dose and October 2018 other than a sore arm my only reaction was short term fever and extreme chills about eight hours after administration.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: 7x5 cm lesion surrounding needle stick on left quadricep area with slightly firm and dusky center, surrounding erythema. Began 1 week post-vaccination, already resolving in 2 days.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Client called the clinic this morning stating "a couple of hours after getting Tdap and Hepatitis A vaccines, I felt nauseous and started having diarrhea. I looked it up and think it is from the shots. Work told me to call you. I feel fine otherwise." Client denies fever but states her arm "really hurts." This nurse suggested she eat bananas, rice, applesauce and toast. Also, she could put a cool washcloth on her arm for the arm pain. This nurse told her if the nausea and diarrhea don't go away after a few days, she should see a doctor. Client voiced understanding.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tinnitus
Clinical narrative: Ringing in ears, fever, shivering.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Significant swelling/redness involving R arm. Patient reports started day after injection. Resolved within 24h. Was slightly tender when swollen.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site pain, Pain, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Developed pain and weakness at right shoulder after injection. Had a rotator cuff tear which was repaired in May 2018. Still has chronic pain and weakness after this injection.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Condition aggravated, Malaise, Pain in extremity, Palpitations
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional (consumer) via Merck (reference number: 01056278) on 22-Jan-2019, concerning a female patient of unknown age. On 31-Oct-2017, the patient was administered Influenza vaccine, dose: 1 DF (reported as 1 shot), route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, after administration of vaccine, the patient experienced hand, wrist, feet and leg pain. The patient also experienced worsening of rheumatoid arthritis and felt very sick all the time. The patient was treated with prednisone for the events and she experienced racing and pounding heart after treatment. The outcome of the events was not reported. Reporter's Comments: A female patient of unspecified age experienced worsening of rheumatoid arthritis, unspecified period after receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and worsening of rheumatoid arthritis, company assessed the causality as unassessable. The event palpitations was assessed as not related to vaccine as the event appeared with plausible temporal relationship with prednisone. The company assessed the case as serious (medically significant).
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional (consumer) via Merck (reference number: 01056278) on 22-Jan-2019, concerning a female patient of unknown age. On 31-Oct-2017, the patient was administered Influenza vaccine, dose: 1 DF (reported as 1 shot), route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, after administration of vaccine, the patient experienced hand, wrist, feet and leg pain. The patient also experienced worsening of rheumatoid arthritis and felt very sick all the time. The patient was treated with prednisone for the events and she experienced racing and pounding heart after treatment. The outcome of the events was not reported. Reporter's Comments: A female patient of unspecified age experienced worsening of rheumatoid arthritis, unspecified period after receipt of INN flu vaccine. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and worsening of rheumatoid arthritis, company assessed the causality as unassessable. The event palpitations was assessed as not related to vaccine as the event appeared with plausible temporal relationship with prednisone. The company assessed the case as serious (medically significant).
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Site redness and inflammation extending approximately 10 cm in size.
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Psoriasis, Rash
Clinical narrative: Skin rash, rash and psoriasis worsened after vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Pain in extremity
Clinical narrative: Asthma exacerbation about 24 hours after receiving vaccine. Sore arm for over 2 weeks. Required use of extra nebulizer treatments.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This patient was administered the pediatric dose instead of the adult dosage of Hepatitis B vaccine.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Was having minor symptoms of dizziness related to Bell's Palsy prior to flu vaccination. Within 24 hrs, of receiving her flu shot she eveloped severe vertigo. She was given Acyclovir and Diazepam.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Chills, Headache, Myalgia
Clinical narrative: Back aches. Muscle aches. Light pain in stomach. Slight head ache. Chills.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autism spectrum disorder, Developmental delay, Eating disorder, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Two weeks after his immunizations, pt spiked a high fever ( 103-105) which would not respond to medication. He was rushed by ambulance to hospital where he spent 9 days of testing. He was finally diagnosed with Kawasaki disease. He was treated with an aspirin regime and IV immunoglobulin. He spent a year following up with specialists. Pt had speech and eating difficulties, developmental delays and is now diagnosed Autism Spectrum Disorder and receives speech, occupational therapy and ABA therapy.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Laboratory test, Pyrexia, Speech disorder
Clinical narrative: Two weeks after his immunizations, pt spiked a high fever ( 103-105) which would not respond to medication. He was rushed by ambulance to hospital where he spent 9 days of testing. He was finally diagnosed with Kawasaki disease. He was treated with an aspirin regime and IV immunoglobulin. He spent a year following up with specialists. Pt had speech and eating difficulties, developmental delays and is now diagnosed Autism Spectrum Disorder and receives speech, occupational therapy and ABA therapy.
Sex: U
Vaccine: TTOX
Symptoms: Ulcerative keratitis
Clinical narrative: Upon internal review on 25-JAN-2019, a significant amendment was performed to upgrade the case from non serious to serious (due to medically significant event). Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Healthcare professional via other company (Pfizer). This case involves an unknown age patient who experienced ulcers on cornea, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a non-serious ulcers on cornea (ulcerative keratitis), this event was assessed as medically significant following the administration of TETANUS TOXOID. (Other relevant tests included No lab data.) Final diagnosis was ulcers on cornea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ulcers on cornea. List of documents held by sender: none. Sender's Comments: Sanofi company comment 30-Jan-2019: The association of the suspect drug with the adverse events cannot be excluded based on the temporal relation.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Left upper arm pain with erythema and swelling from deltoid to biceps with tenderness to palpation. Redness occured within 10 minutes of receiving injection, swelling noticed the next day on 1/30/19. Abdominal pain/nausea/vomiting within 30 minutes of injection, resolved by next day.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Vomiting
Clinical narrative: Left upper arm pain with erythema and swelling from deltoid to biceps with tenderness to palpation. Redness occured within 10 minutes of receiving injection, swelling noticed the next day on 1/30/19. Abdominal pain/nausea/vomiting within 30 minutes of injection, resolved by next day.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Mobility decreased
Clinical narrative: States that evening (1/3/19) she had severe pain and swelling in her Right shoulder. Pain continues, decr ROM, unable to raise her arm high enough to put her coat on. Woke drenched in sweat the first night. She understands this could have been from getting the vaccine. Dr talked to her in detail. Couldn't lift her arm for a few days. Now can lift her arm to chest level. Pain is more in shoulder then arm.
Age: 47.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Abdominal X-ray, Abdominal tenderness, Induration, Liver function test, Liver tenderness
Clinical narrative: RUQ tenderness. Hard to touch. Liver sensitivity.
Age: 47.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Ultrasound scan
Clinical narrative: RUQ tenderness. Hard to touch. Liver sensitivity.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Autism spectrum disorder, Hyperacusis, Hyperaesthesia, Pain, Photophobia
Clinical narrative: Shortly after this vaccine, patient began covering her ears and screaming in pain when she encountered certain noises, lights, textures, clothing. These were normal day to day activities, but to her they were excruciating. Instead of getting better, she got worse and was diagnosed with Autism Spectrum disorder on January 7, 2019.
Age: 1.58
Sex: F
Vaccine: DTAP, HEP
Symptoms: Abnormal behaviour, Electroencephalogram normal, Eye movement disorder, Glassy eyes, Seizure like phenomena
Clinical narrative: Abnormal eye movements, abnormal behavior, Seizure like symptoms for months. Trouble waking. Glazed over eyes.
Age: 1.58
Sex: F
Vaccine: DTAP, HEP
Symptoms: Somnolence
Clinical narrative: Abnormal eye movements, abnormal behavior, Seizure like symptoms for months. Trouble waking. Glazed over eyes.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 12 hours after receiving the vaccine shivering began and increased to the point of severe full body shaking and lasted about 2 hours. Then a fever of 101.5, with a throbbing headache. There was localized redness and swelling at the injection point which occurred shortly after the injection.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: 12 hours after receiving the vaccine shivering began and increased to the point of severe full body shaking and lasted about 2 hours. Then a fever of 101.5, with a throbbing headache. There was localized redness and swelling at the injection point which occurred shortly after the injection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: Pt received SHINGRIX vaccine at approx. 1430 30 Jan 2019. Pt reported having a minor headache around 1530 30 Jan 2019. Wife of patient reported patients headache feeling worse and patient 'not feeling right' which prompted him to go to bed earlier than usual. Wife of patient called today 31 Jan 2019 at 1400 saying patient is still in bed complaining of fatigue, fever, and a severe headache.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site swelling, Injection site warmth
Clinical narrative: Pt. came into the clinic (IMMS Dept.) and stated that the next day after she received the vaccine, she noticed redness, swollen and warm to touch on the injection site. Pt. denies any fever or SOB. Advised pt. to apply cold compress on the injection site and take pain medication over the counter. Advised pt. to call the clinic or go to ER if the symptoms get worst. Pt. verbalized understood.
Age: 42.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Vomiting, fever, headache, chills, joint pain, severe stomach pain, diarrhea, severe pain at injection site over 96 hours after injection.
Age: 42.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, headache, chills, joint pain, severe stomach pain, diarrhea, severe pain at injection site over 96 hours after injection.
Sex: F
Vaccine: PPV
Symptoms: Cardiac disorder, Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient refused to provide any information regarding her pertinent medical history, drug reactions, allergies or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # R007721, with expiration date 01-MAR-2020, for prophylaxis (dose, anatomical location and route of administration were not provided). The patient stated that this was the second dose of "the pneumococcal vaccine", however, she could not confirm if the first dose was also PNEUMOVAX 23. On an unspecified date, after receiving PNEUMOVAX 23 the patient developed a rash and an unspecified heart issue. By the time of reporting the patient had not recovered from the events. She did not assess the causal relationship between the events and PNEUMOVAX 23.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 26 years old female patient who was administered with a 0.5ml dose of TUBERCULIN TEST [TUBERSOL] (Exp. Date, lot number and site of administration not reported) intramuscularly instead of INFLUENZA VACCINE (Flu shot) on 23-Jan-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to wrong vaccine administered, overdose and inappropriate route of vaccination as Flu shot and TB skin test mixed up. At the time of reporting, no symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 33 years old patient of unknown demographics who received 0.25 ml instead of 0.5 ml FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was added. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to vaccine underdose. It was not reported whether 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 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: DTAPIPVHIB, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old female patient who received fourth in series dose of PENTACEL (lot number: C5551AA and expiry date: 10-Oct-2019, liquid vial C5409AA,expiry date 10 Oct 2019, package lot C5551AA, expiry date 10 Oct 2019) (dose and dose in series was not reported) via intramuscular route in the right thigh on 22 Jan 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; and PROQUAD. It was a case of actual medication error due to extra dose administered as patient didn't need was the IPV portion of the vaccination. She was not due until the July 2020 for the IPV, the last dose was given in 2017. There were no reported reactions to the shot. 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: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown demographics who received Hib component with sterile water for injection of suspect vaccine PENTACEL (lot number: C5573AA and expiry date: 13-Oct-2019) (dose, dose in series, route and site of administration was 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 case of actual medication error due to wrong solution used in drug reconstitution. It was reported that the patient was given the ActHib portion with sterile water for injection and not the DTaP IPV portion. It was not reported if any adverse reaction 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. Documents held by sender- none.
Age: 39.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Incorrect product formulation administered, No adverse event, Off label use, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old female patient who was given diluent without the lyophilized powder portion of vaccine ACT-HIB Diluent Lot: U6073AA and Exp. Date: 14-Nov-2019 via unknown route in the left deltoid, on 11-Jan-2019. Powder: Lot UI913AA exp: 22-Nov-2019, Package: Lot number UI913AAA exp date: 14-Nov-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was diagnosed with Immunodeficiency with Predominant Antibody defects. Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration, off label use and product preparation issue. It was reported that the 39 years old received dose given off label due to - Immunologist requested she have this because of a diagnosis of Immunodeficiency with Predominant Antibody defects. The diluent was given without the lyophilized powder portion. No adverse events were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to case 2019SA024673 (same reporter). This case involves a 14 years old male patient who received a 0.5ml dose of FLUBLOK QIV batch number: QFAA1833, expiration date: 30-Jun-2019 via unknown route in the left deltoid on 26-Dec-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 15 months old patient (one of the twin) who received an expired dose of 0.5 ml of vaccine DAPTACEL (lot C5102AA and expiry date 04-Dec-2018)  via unknown route in the right thigh on 22-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A). It was a case of actual medication error due to expired vaccine used. It was not reported 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 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: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves two child patient who received vaccine IPV (VERO) [IPOL] lot number not reported via unknown route in unknown administration site on an unknown date after a temp excursion. 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 incorrect product storage. It was reported that she called about viability of Ipol and was told not to use it so she put it in another refrigerator and told the other nurse to put a note on it but it was during the Christmas break and it was used for 2 children. It was unknown if any adverse event was 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 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: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with case 2019SA024908 (same reporter). This case involves a 15 years old female patient who was vaccinated with a dose of IPOL that was stored outside of acceptable ranges had temperature excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; MMR; BOOSTRIX; TDAP; and MENACTRA. On 14-Jan-2019, the patient received a dose of suspect 0.5 ml IPV (VERO) (lot number: P1A371M and expiry date: 27-Apr-2020) (dose in series and route was not reported) in the left deltoid. It was a case of actual medication error due to incorrect product storage. The IPOL administered had been stored outside of acceptable ranges. The vaccine was initially at a different location where the original reporter is located. That clinic had the temperature excursion. The vaccines from that clinic were then sent on 20Dec2018 to the Department of Public Health for storage because there was no backup generator at the school. 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: F
Vaccine: FLUX
Symptoms: Diarrhoea, Productive cough, Pyrexia
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient of an unknown age who experienced high fever, diarrhea, lots of coughing and mucus, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious high fever, diarrhea and lots of coughing and mucus within hours following the administration of INFLUENZA VACCINE. (Other relevant tests included no lab data.) Final diagnosis was lots of coughing and mucus, diarrhea and high fever. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as Unknown. Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case is linked to case 2019SA024680 (same reporter). This case involves a 10 years old male patient who received a 0.5 ml dose of FLUBLOK QIV batch number: QFAA1833, expiration date: 30-Jun-2019 via unknown route in the left deltoid on 26-Dec-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were given. It was an actual medication error due to inappropriate age at vaccine administration. A 10 year old patient received FLUBLOK QUADRIVALENT. No symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involve 16 years old female patient who received IPOL (batch number P1A371M, expiry date 27 April 2020) in left deltoid which had been stored outside of acceptable ranges. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included second dose of HEPATITIS B VACCINE for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) for Immunisation. It was an actual medication error due to incorrect product storage and Deteriorated drug administered as patient given from the same IPOL vial that was unacceptable for use due to prior temperature excursion. Patient had emergency department visit on 09 Jan 2019. On an unknown date, the patient was performed PPD test, where the result was unknown. It was unknown if any 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 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: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Induration, Pain, Soft tissue swelling
Clinical narrative: Redness, induration and soft tissue swelling day after immunization. Minimal pain.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Wrong product administered
Clinical narrative: Provider order PENTACEL and pt was give PEDIARIX, asked the provider to check vaccine with me and she did and said it was the correct one.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain, Pyrexia, Tachycardia
Clinical narrative: Extreme ache at injection site; gastrointestinal discomfort; fever; tachycardia.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Full blood count, Metabolic function test, Pyrexia, Upper respiratory tract infection
Clinical narrative: On 4/1/17 patient sustained two Complex febrile seizures within 24 hours of each other with an URI and fever of 100.7F.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt reports extreme pain from site of injection up to shoulder compared to any other vaccination she has ever received.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Dizziness, Fall, Headache, Injected limb mobility decreased
Clinical narrative: EXTREME PAIN IN LEFT TRICEPS MUSCLE BEGAN 2-3 HOURS AFTER VACCINES ON 11/12/18.  I COULD NOT LIFT LEFT ARM FOR 2 DAYS, DUE TO TRICEPTS MUSCLE SORENESS. BLACKED OUT TWICE IN BATHROOM 10 HOURS AFTER SHOTS, FALLING TO THE TILE FLOOR. FELT ONLY BRUISED RIGHT ELBOW, CRAWLED BACK TO BED. AWAKENED IN MORNING WITH VERTIGO, FEELING NAUSOUS AND DIZZY. CALLLED NEIGHBOR. NEIGHBOR TOOK BLOOD PRESSURE (68/51), TEMPERATURE (NORMAL). I CALLED DR.'S OFFICE, WHO ADVISED VISIT TO ER, OR HIS OFFICE, OR SEE HOW IT GOES. FRIENDS STAYED WITH ME ALL DAY. LEFT UPPER ARM SWOLLEN, WARM, SLIGHTLY BRUISED WHICH LASTED FOR ABOUT 5 DAYS. FEVER OF 99.6 DEGREES 24 HOURS AFTER VACCINES, OTHERWISE NORMAL TEMPERATURE. SORE HEAD DISCOVERED 8 HOURS AFTER BLACKOUT INCIDENTS (NO "GOOSE EGG") LASTING FOR ABOUT 25 DAYS AFTER VACCINES, INCLUDING MILD HEADACHES. SORE RIGHT AND LEFT NECK MUSCLES, AKIN TO WHIPLASH, AFTER BLACKOUT INCIDENTS, LASTING FOR 2 DAYS. FOLLOW-UP APPOINTMENT ON 12/5/18 WITH DR. TO DISCUSS LINGERING EFFECTS OF ADVERSE REACTION.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Loss of consciousness, Myalgia
Clinical narrative: EXTREME PAIN IN LEFT TRICEPS MUSCLE BEGAN 2-3 HOURS AFTER VACCINES ON 11/12/18.  I COULD NOT LIFT LEFT ARM FOR 2 DAYS, DUE TO TRICEPTS MUSCLE SORENESS. BLACKED OUT TWICE IN BATHROOM 10 HOURS AFTER SHOTS, FALLING TO THE TILE FLOOR. FELT ONLY BRUISED RIGHT ELBOW, CRAWLED BACK TO BED. AWAKENED IN MORNING WITH VERTIGO, FEELING NAUSOUS AND DIZZY. CALLLED NEIGHBOR. NEIGHBOR TOOK BLOOD PRESSURE (68/51), TEMPERATURE (NORMAL). I CALLED DR.'S OFFICE, WHO ADVISED VISIT TO ER, OR HIS OFFICE, OR SEE HOW IT GOES. FRIENDS STAYED WITH ME ALL DAY. LEFT UPPER ARM SWOLLEN, WARM, SLIGHTLY BRUISED WHICH LASTED FOR ABOUT 5 DAYS. FEVER OF 99.6 DEGREES 24 HOURS AFTER VACCINES, OTHERWISE NORMAL TEMPERATURE. SORE HEAD DISCOVERED 8 HOURS AFTER BLACKOUT INCIDENTS (NO "GOOSE EGG") LASTING FOR ABOUT 25 DAYS AFTER VACCINES, INCLUDING MILD HEADACHES. SORE RIGHT AND LEFT NECK MUSCLES, AKIN TO WHIPLASH, AFTER BLACKOUT INCIDENTS, LASTING FOR 2 DAYS. FOLLOW-UP APPOINTMENT ON 12/5/18 WITH DR. TO DISCUSS LINGERING EFFECTS OF ADVERSE REACTION.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Nuclear magnetic resonance imaging brain, Pyrexia, Scan with contrast, Vertigo
Clinical narrative: EXTREME PAIN IN LEFT TRICEPS MUSCLE BEGAN 2-3 HOURS AFTER VACCINES ON 11/12/18.  I COULD NOT LIFT LEFT ARM FOR 2 DAYS, DUE TO TRICEPTS MUSCLE SORENESS. BLACKED OUT TWICE IN BATHROOM 10 HOURS AFTER SHOTS, FALLING TO THE TILE FLOOR. FELT ONLY BRUISED RIGHT ELBOW, CRAWLED BACK TO BED. AWAKENED IN MORNING WITH VERTIGO, FEELING NAUSOUS AND DIZZY. CALLLED NEIGHBOR. NEIGHBOR TOOK BLOOD PRESSURE (68/51), TEMPERATURE (NORMAL). I CALLED DR.'S OFFICE, WHO ADVISED VISIT TO ER, OR HIS OFFICE, OR SEE HOW IT GOES. FRIENDS STAYED WITH ME ALL DAY. LEFT UPPER ARM SWOLLEN, WARM, SLIGHTLY BRUISED WHICH LASTED FOR ABOUT 5 DAYS. FEVER OF 99.6 DEGREES 24 HOURS AFTER VACCINES, OTHERWISE NORMAL TEMPERATURE. SORE HEAD DISCOVERED 8 HOURS AFTER BLACKOUT INCIDENTS (NO "GOOSE EGG") LASTING FOR ABOUT 25 DAYS AFTER VACCINES, INCLUDING MILD HEADACHES. SORE RIGHT AND LEFT NECK MUSCLES, AKIN TO WHIPLASH, AFTER BLACKOUT INCIDENTS, LASTING FOR 2 DAYS. FOLLOW-UP APPOINTMENT ON 12/5/18 WITH DR. TO DISCUSS LINGERING EFFECTS OF ADVERSE REACTION.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Pain in extremity, Pruritus, Swelling
Clinical narrative: Redness, swelling itching,arm sore tired.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Lip swelling, Pyrexia, Streptococcus test positive, Swelling face
Clinical narrative: On 1/24/19 mother noticed red cheeks that over the next two days progressed to fever, swollen face and lips and hives over entire body. On 1/26/19 they took him to the emergency room and they gave him a dose of liquid BENADRYL and did a Rapid Strep screen that was postitive. He was treated with Liquid Amoxicillin every 12 hours for 10 days.
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: On 1/24/19 mother noticed red cheeks that over the next two days progressed to fever, swollen face and lips and hives over entire body. On 1/26/19 they took him to the emergency room and they gave him a dose of liquid BENADRYL and did a Rapid Strep screen that was postitive. He was treated with Liquid Amoxicillin every 12 hours for 10 days.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Flu shot was high on the left arm. Experiencing pain in upper arm area. Can't lift my arm up without pain, and it won't go away even 3 months later. Especially hurts lifting my arms out to the side and up and over. Never thought my problem was related to the flu shot until I mentioned it to someone at the gym, and they were having the same issues. Hence filing this report.
Age: 93.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Pain
Clinical narrative: Patient had migratory pains the night after the vaccination. He died within 24 hours of unknown cause, unknown if related to vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1/17/19 Client called and reported redness/warmth/discomfort below injection site that started on 1/16/19. Instructed to take ibuprofen and ice area for comfort. Instructed we would check on her tomorrow. 1/18/19 Client came in to office for redness, warmth and pain to Rt upper arm below injection sites. Stated she slept a lot on Wed. and Thurs. Area of redness 10 cm vertical by 19.5 cm horizontal around lower to mid upper arm. Client stated it was not as red as previous day but wanted someone to see it. Advised we would recontact next week. 1/22/19 Client contacted via phone. Reported decreased redness but stated area continued to be sore. 1/31/19 Client contacted and reports redness is gone but area remains sore.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Feeling abnormal, Lethargy, Pyrexia, Rash
Clinical narrative: About 5 minutes after receiving the above 4 vaccines, patient's head started shaking like he was having a seizure. His head seized once per day for 5 consecutive days accompanied by fevers. The day after receiving vaccines he broke out in a rash on his stomach and chest. Patient started vomiting and explosive diarrhea 5 days after receiving vaccines. He continued to vomit for 7 days straight and he still has diarrhea. Patient has been miserable and lethargic since receiving those vaccines.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure, Tremor, Vomiting
Clinical narrative: About 5 minutes after receiving the above 4 vaccines, patient's head started shaking like he was having a seizure. His head seized once per day for 5 consecutive days accompanied by fevers. The day after receiving vaccines he broke out in a rash on his stomach and chest. Patient started vomiting and explosive diarrhea 5 days after receiving vaccines. He continued to vomit for 7 days straight and he still has diarrhea. Patient has been miserable and lethargic since receiving those vaccines.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Back pain, Erythema, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called at 1530 today and stated her left arm was painful, red, swollen bigger than a half dollar, nauseated and her back hurt.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itchiness, and swelling around injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle aches entire body for approx 24 hours. Fever for approx 8 hours. Fatigue for approx 48 hours. 1 extra strength Tylenol, 2 doses over first 24 hours.