chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: This is an serious observational study case, initially received on 31-Oct-2018, concerning a 22-year-old, pregnant female, subject of Body mass index:  40.8, weight: 216 lbs and height: 61 inch, enrolled in a study. This was the subject's first pregnancy. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 01-Feb-2018. The gestational age of the subject was 37 weeks. The subject's current condition included hypothyroidism. The subject's concomitant medication included LEVOXYL [start date: 10-Apr-2018, dose:  200 mcg, frequency: four times a day (qid), route: oral] for hypothyroidism. On 10-Apr-2018, the subject underwent ultrasound test and no major congenital malformation was noted. On 08-May-2018, the subject underwent nuchal translucency test and no major congenital malformation was noted. On 08-May-2018, the subject underwent first trimester screening test and no major congenital malformation was noted.  On 05-Jun-2018, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP)/serum markers test and no major congenital malformation was noted. On 23-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, and left pelviectasis was noted. The subject's estimated date of delivery was reported as 14-Nov-2018. At the time of this report, the outcome of the events left pelviectasis was not reported. This case was linked to the original case: 201805222.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Influenza, Influenza A virus test positive, Malaise, Pain
Clinical narrative: This spontaneous case, initially received from the other non-health professional (consumer) on 31-Oct-2018, concerns a 56-year-old, adult male patient. On 19-Oct-2018, around 1 PM, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252674, expiry date: 30-Jun-2019 and anatomical location: not reported). Roughly 24 hours after vaccination, the patient experienced mild flu-symptoms. In the subsequent 15 hours, the patient became quite ill with fever, body aches and cough. On 22-Oct-2018, the patient visited urgent care facility where he received the vaccine. Clinic staff performed a point of care flu test which was reactive for Influenza Type A. The reporter believed that, the FLUCELVAX QIVc contained infectious influenza. At the time of report, the outcome of the events was not reported. The reporter assessed the case as serious (medically significant).
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received from the other non-health professional (consumer) on 31-Oct-2018, concerns a 56-year-old, adult male patient. On 19-Oct-2018, around 1 PM, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252674, expiry date: 30-Jun-2019 and anatomical location: not reported). Roughly 24 hours after vaccination, the patient experienced mild flu-symptoms. In the subsequent 15 hours, the patient became quite ill with fever, body aches and cough. On 22-Oct-2018, the patient visited urgent care facility where he received the vaccine. Clinic staff performed a point of care flu test which was reactive for Influenza Type A. The reporter believed that, the FLUCELVAX QIVc contained infectious influenza. At the time of report, the outcome of the events was not reported. The reporter assessed the case as serious (medically significant).
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal growth restriction, Gestational hypertension, Prenatal screening test, Ultrasound antenatal screen
Clinical narrative: This is an observational study case, concerning a 30-year-old, adult pregnant female, subject of body mass index: 26.1, weight: 182 lbs and height: 70 in, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject did not have any history of offspring with major congenital malformation. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 22-Feb-2018. On 18-May-2018, the subject underwent nuchal translucency scan and first trimester screen test performed showed, no major congenital malformations. On 16-Jul-2018, the subject underwent targeted ultrasound which showed no major congenital malformations. On 18-Oct-2018 (34 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject developed gestational hypertension and had intrauterine growth retardation (reported as history). The subject's estimated date of delivery was reported as 29-Nov-2018.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: This is an observational study case, concerning a 30-year-old, adult pregnant female, subject of body mass index: 26.1, weight: 182 lbs and height: 70 in, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject did not have any history of offspring with major congenital malformation. The subject had no maternal/paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 22-Feb-2018. On 18-May-2018, the subject underwent nuchal translucency scan and first trimester screen test performed showed, no major congenital malformations. On 16-Jul-2018, the subject underwent targeted ultrasound which showed no major congenital malformations. On 18-Oct-2018 (34 weeks gestational age), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, expiry date and anatomical location: not reported). On an unspecified date in 2018, the subject developed gestational hypertension and had intrauterine growth retardation (reported as history). The subject's estimated date of delivery was reported as 29-Nov-2018.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal growth restriction, Prenatal screening test, Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: This is an serious observational study case, initially received on 31-Oct-2018, concerning a 26-year-old, pregnant female, subject of Body mass index: 21.3, weight: 120 lbs and height: 63 inch. This is the subject's first pregnancy. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 07-Mar-2018. The gestational age of the subject was 31 weeks. On 20-Jun-2018, the subject underwent nuchal translucency and no major congenital malformation was noted. On 20-Jun-2018, the subject underwent first trimester screening and no major congenital malformation was noted. On 04-Sep-2018, the subject underwent targeted ultrasound and no major congenital malformation was noted. On 10-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, and intrauterine Growth restriction (IUGR) was noted. The subject's estimated date of delivery was reported as 29-Dec-2018. At the time of this report, the outcome of the event intrauterine growth restriction was not reported. This case was linked to the original case: 201805222.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Nausea
Clinical narrative: Per Patient: I had the vaccination on Thursday around 9:30 am - at 7:00 pm that night I started having chills and had a fever all night. I also had a loss of appetite and nausea. Friday morning I had a terrible headache and was still not hungry. By around mid-day on Friday I finally got rid of the headache and was able to eat (though the nausea persisted a couple more days whenever I ate). And, my arm was really sore until Sunday (though it's still tender today (Monday)). I did not develop any kind of welt or anything at the injection site - it was just a little red around the immediate area on Friday and Saturday.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Per Patient: I had the vaccination on Thursday around 9:30 am - at 7:00 pm that night I started having chills and had a fever all night. I also had a loss of appetite and nausea. Friday morning I had a terrible headache and was still not hungry. By around mid-day on Friday I finally got rid of the headache and was able to eat (though the nausea persisted a couple more days whenever I ate). And, my arm was really sore until Sunday (though it's still tender today (Monday)). I did not develop any kind of welt or anything at the injection site - it was just a little red around the immediate area on Friday and Saturday.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Huge red, itchy, red, swollen patch on my upper arm extended down to my elbow. Since urgent care was not open, my husband took me to the ER at Hospital where i was given a 10 day prescription of KEFLEX.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: I got the Pneumonia shot that you get normally at age 65 so I guessed on the shot which one it was. At first it just got sore around the injection area which I knew was normal. Then it got really painful. It was hard, red, and hot an kept getting bigger to the size of a softball and another spot 1 in. away bigger than a golf ball. Between my bones of my shoulder and arm became very painful and went down my back. I had a fever of 100 and was having chills. I was taking ibuprofen and icing the areas. When I would ice it my arm would be cold to touch but the red area would stay hot to touch.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: I got the Pneumonia shot that you get normally at age 65 so I guessed on the shot which one it was. At first it just got sore around the injection area which I knew was normal. Then it got really painful. It was hard, red, and hot an kept getting bigger to the size of a softball and another spot 1 in. away bigger than a golf ball. Between my bones of my shoulder and arm became very painful and went down my back. I had a fever of 100 and was having chills. I was taking ibuprofen and icing the areas. When I would ice it my arm would be cold to touch but the red area would stay hot to touch.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: "On Friday October 5th around 8:30 am I completed my health screen assessment which included a flu vaccination. A few hours later I started to feel a bit wheezy, however I ignored my feelings then around 2pm that day I had a feeling of shortness of breath which lasted from 60-90 seconds, I continued on with my daily activities and assume it was typical fatigue. Later that evening at around approximately 6pm, I couldn't breathe, my chest tightened up, I felt a sharp throbbing pain in my chest area, which intensified. I felt pressure in my entire upper mid chest area, I couldn't breathe and my heart was pounding and beating rapidly, felt like I was having a mini heart attack. I moved from the chair onto the ground to remove my toddler from my hands, laid on my left side and called out for my husband. The pain, shortness of breathe and  tightening of chest lasted for a few minutes. I remained on the ground until the pain subsided and breathing patterns returned to normal , then remained seated for the next 20 to 30 minutes. Shortly after my breathing returned to normal however my chest still felt tight, abnormal." per employee injury report.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: "On Friday October 5th around 8:30 am I completed my health screen assessment which included a flu vaccination. A few hours later I started to feel a bit wheezy, however I ignored my feelings then around 2pm that day I had a feeling of shortness of breath which lasted from 60-90 seconds, I continued on with my daily activities and assume it was typical fatigue. Later that evening at around approximately 6pm, I couldn't breathe, my chest tightened up, I felt a sharp throbbing pain in my chest area, which intensified. I felt pressure in my entire upper mid chest area, I couldn't breathe and my heart was pounding and beating rapidly, felt like I was having a mini heart attack. I moved from the chair onto the ground to remove my toddler from my hands, laid on my left side and called out for my husband. The pain, shortness of breathe and  tightening of chest lasted for a few minutes. I remained on the ground until the pain subsided and breathing patterns returned to normal , then remained seated for the next 20 to 30 minutes. Shortly after my breathing returned to normal however my chest still felt tight, abnormal." per employee injury report.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Patient reports "feeling tired and achy after receiving vaccines." Reports having "red spots on stomach 7-10 days after vaccines."  Went to physician and was diagnosed with Shingles per patient. Was given Antiviral medication.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intestinal obstruction, Intussusception, Lethargy, Ultrasound abdomen abnormal
Clinical narrative: Intussusception: presented with vomiting and lethargy on 10/26/2018; ultrasound revealed right lower quadrant intussusception with obstruction; reduced by interventional radiology with air enema
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Intussusception: presented with vomiting and lethargy on 10/26/2018; ultrasound revealed right lower quadrant intussusception with obstruction; reduced by interventional radiology with air enema
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: The evening after receiving FLUZONE, patient developed a 1 inch area around the injection site which was itchy. Patient was given TYLENOL and hydro cortisone cream at home. Patient then developed swelling in left thigh from injection site down to knee. No fever or rash noted currently.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspepsia, Erythema, Glossitis, Oropharyngeal pain, Paraesthesia
Clinical narrative: Pin prick sensations in hand and neck, tingling/irritaiton of tongue, throat soreness, feeling of heartburn, face became red.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral
Clinical narrative: Pin prick sensations in hand and neck, tingling/irritaiton of tongue, throat soreness, feeling of heartburn, face became red.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Left Shoulder pain. The pain was immediate after the individual slapped (not an exaggeration) the plunger, injecting the flu vaccine into the wrong muscle group. Since then I've had muscular pain in my left shoulder when raising my arm over my head, I'm also experiencing reduced flexibility in my left shoulder. I do not experience pain when my arm is at a resting position.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: X-ray limb normal
Clinical narrative: Left Shoulder pain. The pain was immediate after the individual slapped (not an exaggeration) the plunger, injecting the flu vaccine into the wrong muscle group. Since then I've had muscular pain in my left shoulder when raising my arm over my head, I'm also experiencing reduced flexibility in my left shoulder. I do not experience pain when my arm is at a resting position.
Age: 33.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Injection site pain
Clinical narrative: Left Shoulder pain. The pain was immediate after the individual slapped (not an exaggeration) the plunger, injecting the flu vaccine into the wrong muscle group. Since then I've had muscular pain in my left shoulder when raising my arm over my head, I'm also experiencing reduced flexibility in my left shoulder. I do not experience pain when my arm is at a resting position.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: ROTATEQ (route: oral, lot # N007759, expiration date 24-OCT-2019 or lot # N022173, expiration date 15-MAR-2019, exact dose details were not reported) or VARIVAX (lot# N020016, expiration date 17-JUL-2019 or lot #N019133, expiration date 22-JUN-2019, route of administration and exact dose details were not provided) for prophylaxis. The vaccines were stored in the refrigerator at -1.2 degrees Celsius for 5 minutes and in freezer at the temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. There was previous temperature excursion in the freezer in temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. It was registered by the data logger. No adverse events were reported. This is a non-valid case due to unspecified patient. Telephone call was made on 01-NOV-2018. The reporter stated she would find the requested information and fax the patient identifiers and dates of vaccination. This case was initially considered as non valid, upon receipt of follow-up information on 09-NOV-2018 the case is valid as the patient identifiers were added. Follow-up information was received from the medical assistant on 09-NOV-2018. It was reported that none of the patients were vaccinated with VARIVAX. The 6 month old patient was vaccinated with ROTATEQ on 08-MAY-2018.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter, a female patient of less than 12 months-old. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported), prior to being 12 months-old; however, no adverse events were experienced.
Sex: F
Vaccine: DTAP, MMR
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer and refers to her 12-month-old daughter. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On an unknown date, the patient passed away due to an unknown cause. It was not reported in an autopsy was performed. The relatedness between the event and M-M-R II or diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was not reported.
Age: 0.75
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines: ROTATEQ (route: oral, lot # N007759, expiration date 24-OCT-2019 or lot # N022173, expiration date 15-MAR-2019, exact dose details were not reported) or VARIVAX (lot# N020016, expiration date 17-JUL-2019 or lot #N019133, expiration date 22-JUN-2019, route of administration and exact dose details were not provided) for prophylaxis. The vaccines were stored in the refrigerator at -1.2 degrees Celsius for 5 minutes and in freezer at the temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. There was previous temperature excursion in the freezer in temperature range from -9 degrees Celsius to 8 degrees Celsius for 5 minutes. It was registered by the data logger. No adverse events were reported. This is a non-valid case due to unspecified patient. Telephone call was made on 01-NOV-2018. The reporter stated she would find the requested information and fax the patient identifiers and dates of vaccination. This case was initially considered as non valid, upon receipt of follow-up information on 09-NOV-2018 the case is valid as the patient identifiers were added. Follow-up information was received from the medical assistant on 09-NOV-2018. It was reported that none of the patients were vaccinated with VARIVAX. The 9 month old patient was vaccinated with ROTATEQ on 02-MAY-2018. This is one of the two reports.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 25-year-old female patient. The patient's medical history were not reported. The patient's concurrent conditions included multiple psychiatric disorders and concomitant medications included multiple psychiatric medications. On an unknown date (also reported as "when the patient was 11 years old"), the patient was vaccinated with the first and only dose of GARDASIL injection (route of administration, lot# and expiration date were not reported) for immunisation. On an unknown date (also reported as "a couple weeks after receiving GARDASIL"), the patient experienced a systemic autoimmune response. No laboratory tests were performed. The outcome of the event was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of systemic immune activation was considered to be medically significant.
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PPV, RVX
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-months old male patient who was vaccinated with a dose of ACT-HIB] and 0.5 ml dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 18-Oct-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5530AA; expiry date: 04-Oct-2019 via intramuscular route in the left thigh. On an unknown date (reported as same-visit), the patient received a dose of suspect HIB (PRP/T) VACCINE lot UIN07AA via intramuscular route in the right thigh. On an unknown date (reported as same-visit), the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID; HIB VACCINE CONJ (TET TOX); PERTUSSIS VACCINE ACELLULAR 1-COMPONENT; POLIO VACCINE INACT; TETANUS VACCINE TOXOID not produced by Sanofi Pasteur lot number not reported. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be 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: Extra dose administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves unknown demographic patient who was two time vaccinated with a dose of FLUZONE QUADRIVALENT lot number and Exp. Date not reported via unknown route in unknown administration site on unspecified dates in last year. Patient was Immunosuppressed. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. No information about adverse event 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old patient of unknown gender who received a dose of previously frozen vaccine FLUZONE QUADRIVALENT (Batch number, expiry date, dose, dose in series, route and site of administrated 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 were not reported. It was a case of actual mediation error due to incorrect product storage. It was also reported that Recently, our organization had a portion of 2018-2019 FLUZONE QUADRIVALENT vaccines inadvertently frozen and a patient received one of the previously frozen vaccines. It was not reported that 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. List of documents held by sender: none.
Age: 91.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 91-year-old male patient who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE (batch number: UI879AA, expiration date: 30-Jun-2018) via intramuscular in left deltoid, on 06-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The 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 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: Expired product administered
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional (Infection Control). This case involves a patient of unknown demographics who received an expired dose of vaccine FLUZONE QUADRIVALENT (batch number: UT5934NA, expiry date: 30-Jun-2018) (dose, dose in series, route and site of administration were not reported) on an unknown date which was from last year's. 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 Expired vaccine used. It was not reported that if any adverse event 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (details not reported) who was vaccinated with PENTACEL (batch number, expiration date, dose, route and site of administration was not reported) and one of their offices reconstituted the ACTHIB portion of PENTACEL with sterile water, on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 72 years old female patient who was vaccinated with a 0.5 ml second dose of FLUZONE QUADRIVALENT (Batch number: UT6258MA, expiration date: 30-Jun-2019, route and site of administration was not reported) instead of FLUZONE HD on unknown date. The patients medical history and concomitant medications were not reported.It was an actual medication error due to wrong vaccine administered (patient received FLUZONE HIGH DOSE reports the lot number is for FLUZONE QUADRIVALENT). 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: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age ten months old patient who was vaccinated with a 0.25 ml second dose of FLUZONE QUADRIVALENT (Batch number: UT6259LA, expiration date: 30-Jun-2019, site of administration: left thigh and route was not reported) on 06-Nov-2018 and on 15 Oct 2018 patient had also received same vaccine (Batch number, expiration date, dose, route and site of administration was not reported). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate schedule of vaccine administered (a ten month old received second FLUZONE QUAD 0.25 ml vaccination a week early). 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.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 91 years old female patient who was vaccinated twice with 0.5 ml dose of FLUZONE HIGH DOSE (lot UI981AA and Exp. Date 16-MAR-2019) via intramuscular route in the left arm on 04-Sep-2018 and (lot UJ010AC and Exp. Date 22-APR-2019) via intramuscular route in the right arm on 29-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: FLU3
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (reported as office Staff). This case involves a 66 years old male patient who received expired dose of vaccine FLUZONE HIGH DOSE (batch number: UI884AA, expiry date: 24-May-2018) (dose, dose in series, route and site of administration was not reported) which was expired (last season) and had been out of proper storage temperature on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no concomitant vaccines. It was a case of actual medication error due to Expired vaccine used and incorrect product storage. It was not reported that 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. List of documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 64 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ036AA, expiration date: 09-May-2019, route: intramuscular and site of administration: left deltoid) on 06-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (64 year old male, given a FLUZONE HD vaccine). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 11 years old female patient who was administered 0.5 ml MENACTRA that was expired on 11-Oct-2018 (Batch number: U5712AB, expiration date: 11-Oct-2018, route and site of administration was not reported) on 01-Nov-2018. The patient's medical history was not reported. Concomitant vaccines included DAPTACEL and GARDASIL. It was an actual medication error due to expired vaccine used. The patient had no AE. 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: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV1
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who was vaccinated with 0.5 ml PENTACEL (batch number: C5506AA, expiration date: 05-Sep-2019, route: intramuscular and site of administration: right thigh) but only the HIB portion was administered to the child, on 29-Aug-2018. The patient's medical history was not reported. Concomitant medications included PREVNAR 13, PEDIARIX, ROTARIX on 29-Aug-2018. It was an actual medication error due to inappropriate reconstitution technique. The 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 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: FLU3
Symptoms: Blood test normal, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old female patient who experienced throat was sore and fever was 100, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included was injection site warmth and pruritus. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown dtae, the patient experienced a non-serious throat was sore and fever was 100 two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included was blood test done that was negative for infection. Final diagnosis was fever was 100 and throat was sore. The patient was treated with ADVIL 12HOUR for Product used for unknown indication and KEFLEX for Product used for unknown indication. On 15-Oct the patient visited for urgent care. On an unknown date, the patient was recovered for fever was 100 and unknown for other event. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Asthenia, Chills, Dysstasia, Fatigue, Injection site pain
Clinical narrative: Extreme soreness at injection site. Beginning within 1 day after injections, developed extreme weakness, fatigue, severe chills. Unable to get of out bed for two day. Took extreme effort just to stand up. Today is day 4 post injection. Symptoms are beginning to resolve.
Age: 61.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Mobility decreased
Clinical narrative: Extreme soreness at injection site. Beginning within 1 day after injections, developed extreme weakness, fatigue, severe chills. Unable to get of out bed for two day. Took extreme effort just to stand up. Today is day 4 post injection. Symptoms are beginning to resolve.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: The adverse event was that the vaccine was mixed with sterile diluent instead of the diluent that is provided with the vaccine.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Flatulence, Irritability, Poor quality sleep
Clinical narrative: Son received oral vaccine on Friday morning and started to get really fussy on Saturday afternoon. He wasn't sleeping well during the day, wouldn't let you put him down, stomach was working overtime (gassy sounds), and he was having very loud and stinky farts. It's now Tuesday and he is still experiencing these symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 72yr old patient was ordered Flu vaccine, 65 yr high dose IM (Trivalent) vaccine. CMA prepared and administered vaccine IM in patient's right deltoid on 11/7. On 11/9, patient contacted office complaining of swollen right arm, redness size of baseball, warm to touch, no fever, no shortness of breath. Symptoms started on 11/8. Patient presented for MD followup on 11/9. MD noted "erythema and swelling right upper arm about 15 x 9 cm in size. area is warm, no streaking". No evidence of systemic allergic reaction. MD recommended ice, OTC hydrocortisone cream, loratadine/ZYRTEC for itching. MD prescribed prednisone 20 mg tablets, take 2 tabs PO daily x 3 days if symptoms worsened. Allergies updated to include Influ.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Fever- 101.2 degrees, flu-like symptoms, fatigue, headache, loss of appetite, chills, very sore arm I'm now about 24 hours post vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever- 101.2 degrees, flu-like symptoms, fatigue, headache, loss of appetite, chills, very sore arm I'm now about 24 hours post vaccination.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchoscopy normal, C-reactive protein increased, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: On October 16, 2018, I received the flu vaccine at Hospital as required by employer. That evening around 10:00pm I developed body aches. From October 17, 2018 to October 22, 2018, I developed severe body aches, rib pain, jaw pain, facial edema, shortness of breath, and night sweats. There was no irritation, swelling, or redness at the injection site. On October 19, 2018, I presented to Express Care Clinic and no definitive diagnosis was given. Symptoms worsened and on October 21, 2018, I presented to Express Care Clinic again. A chest XR was obtained and found to have innumerable pulmonary nodules scattered throughout all four lobes. I was sent to ER. While at ER, many labs were ordered along with chest CT and head CT. Chest CT confirmed innumerable pulmonary nodules indicating sarcoidosis, Wegener's granulmatosis, metastatic disease, or atypical bacterial/fungal infection. While in ER, I was seen by pulmonologist and recommended follow up with rheumatologist and pulmonologist. I followed up with rheumatologist on October 23, 2018, and was not found to have an autoimmune disorder. I followed up with the ER pulmonologist on October 24, 2018, and he ordered a bronchoscopy. On October 31, 2018, I had  bronchoscopy and per Dr., was found to have a influenza vaccine reaction.