chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Breath sounds abnormal, Chest X-ray abnormal, Confusional state, Fatigue
Clinical narrative: My mother realized suddenly as she was leaving church on Sunday, May 19, 2019, that she felt terrible.... she felt a bit faint and had NO energy, and just overall felt terrible.  I visited her the following day (5/20/2019) at about 2:30 pm, and she was really out of it.  It took her 5 minutes to walk across the living room to open the sliding glass door to let me in, and after she let me in, she stood there leaning against the door, hunched over, for over 10 minutes before I led her into her bedroom.  She was utterly exhausted.  I called my brother for back up, and he contacted the nurse at her retired living place.  The nurse arrived 5 minutes later, and found my Mom had a temperature of 102.1 degrees, and a fast pulse.  He suggested we take her to Urgent Care, and we did.  Because my Mom seemed so confused, he also suggested we request they check for a UTI as well as addressing the severe cough she had.  My Mom doesn't remember having a cough during the week prior to this, but I think she did, because she sounded terrible and would cough when I spoke to her on the phone during the week of May 13th.  The Urgent Care place took chest X-rays and checked for a UTI. The doctor said her X-Rays were positive for pneumonia, and he heard rattles in the same area of her chest where he saw pneumonia on the X-Ray (the mid-right side, I believe).  However, the radiologist felt that her chest X-Ray was negative for pneumonia.  Because of the rattles, the doctor chose to start my Mom on antibiotics for pneumonia, and also started her on antibiotics for a probable UTI.  She was started on an Albuterol inhaler as well (she says today, 5/30/2019, is the first day she hasn't struggled with her cough, although it's still there, she says "it's not terrible"), and she received an injection in her hip of an antibiotic. She was started on a 7 to 10 day course of cefuroxime, plus a three-day course of what I believe was Augmentin.  She has more or less recovered from the event... she's in the last days of it, but still has a slight cough and is easily fatigued.  She followed up with her regular Internist on Wednesday, May 22, 2019.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Heart rate increased, Nasopharyngitis, Pneumonia, Presyncope
Clinical narrative: My mother realized suddenly as she was leaving church on Sunday, May 19, 2019, that she felt terrible.... she felt a bit faint and had NO energy, and just overall felt terrible.  I visited her the following day (5/20/2019) at about 2:30 pm, and she was really out of it.  It took her 5 minutes to walk across the living room to open the sliding glass door to let me in, and after she let me in, she stood there leaning against the door, hunched over, for over 10 minutes before I led her into her bedroom.  She was utterly exhausted.  I called my brother for back up, and he contacted the nurse at her retired living place.  The nurse arrived 5 minutes later, and found my Mom had a temperature of 102.1 degrees, and a fast pulse.  He suggested we take her to Urgent Care, and we did.  Because my Mom seemed so confused, he also suggested we request they check for a UTI as well as addressing the severe cough she had.  My Mom doesn't remember having a cough during the week prior to this, but I think she did, because she sounded terrible and would cough when I spoke to her on the phone during the week of May 13th.  The Urgent Care place took chest X-rays and checked for a UTI. The doctor said her X-Rays were positive for pneumonia, and he heard rattles in the same area of her chest where he saw pneumonia on the X-Ray (the mid-right side, I believe).  However, the radiologist felt that her chest X-Ray was negative for pneumonia.  Because of the rattles, the doctor chose to start my Mom on antibiotics for pneumonia, and also started her on antibiotics for a probable UTI.  She was started on an Albuterol inhaler as well (she says today, 5/30/2019, is the first day she hasn't struggled with her cough, although it's still there, she says "it's not terrible"), and she received an injection in her hip of an antibiotic. She was started on a 7 to 10 day course of cefuroxime, plus a three-day course of what I believe was Augmentin.  She has more or less recovered from the event... she's in the last days of it, but still has a slight cough and is easily fatigued.  She followed up with her regular Internist on Wednesday, May 22, 2019.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bone pain, Dizziness, Headache
Clinical narrative: fast heart beat, dizziness, weakness, hypothermia,joins and bones ache and headache
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hypothermia
Clinical narrative: fast heart beat, dizziness, weakness, hypothermia,joins and bones ache and headache
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Hypotonia, Seizure, Tremor
Clinical narrative: Seizure with full body shaking after going limp, lasting around a minute
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Nausea
Clinical narrative: fever 101 degrees, shivering, chills, injection site pain,  fatigue, weakness, nausea .Resolved in 24 hours with fatigue lasting about 24 more hours. Injection site painful for approx. 1 week.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever 101 degrees, shivering, chills, injection site pain,  fatigue, weakness, nausea .Resolved in 24 hours with fatigue lasting about 24 more hours. Injection site painful for approx. 1 week.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Upon waking on 5/29/2019, patient noticed that her arm was swollen and hurting. She took Tylenol and took Allegra without relief. She stated that she swelling increased throughout the day and the pain increased throughout the day. She took Benadryl at 9pm last without relief and then decided to go to Urgent Care the next day at around lunch time. She was given a steroid shot at that time and sent home. After speaking with patient on the telephone I requested that she come to the clinic for myself and my nursing supervisor to view her arm. The area was red and warm to touch and approximately the size of a baseball, no rash or lesions were seen. Marked the parameters of the site and requested that she return to the clinic tomorrow 5/31/2019 to allow us to view the site for healing, she was agreeable to this.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Tingling and numbing in feet. Body aches which required bed rest for 3 days. Chills, sweats, and a rash developed for about 5 days and still has not cleared.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Tingling and numbing in feet. Body aches which required bed rest for 3 days. Chills, sweats, and a rash developed for about 5 days and still has not cleared.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: (L) upper arm swelling, pain & fatigue 1-2 d. after vaccination then supraclavicular node noted ipsilateral about 4 days later low grade fever also noted. Seen in office 12/17/18 and started on Cefdinir with subsequent resolution but lymph node took few weeks for resolution.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Rash
Clinical narrative: Rash @ injection site and on other thigh where previous vaccine was given that patient reacted to.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: mobility decreased; pyrexia/fever; pain in extremity; headache; nausea; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 18-year-old female patient. She had no known other medications, current illnesses, medical history or prior vaccinations.  On 18-JUL-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm, lot # N004798, expiry date 31-OCT-2019, for prophylaxis, withsecond dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in the right arm, lot # M036458, expiry date not provided, for prophylaxis, with second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) intramuscularly in the left arm, lot # U5514AC (expiry date not provided) for prophylaxis and with first dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) intramuscularly in the left arm, lot #169701A (expiry date not provided) for prophylaxis.  On 18-JUL-2017, patient's mother called to state that 1 day after receiving the vaccines, the patient complained of severe left arm pain, fever, nausea, and headache. Fever lasted about 24 hours, resolved with ibuprofen (MOTRIN). The mother stated the patient was unable to get out of bed due to the amount of pain she was in. She was not having any pain in her right arm at all. Mother did not give to the patient anything except one dose of ibuprofen (MOTRIN). She was advised to alternate ibuprofen (MOTRIN)/acetaminophen (TYLENOL), and to use a heating pad or to apply ice to the injection sites. She was contacted the following day for follow up, she stated all of the patient's symptoms had resolved on an unknown date in an approximately July 2017. No laboratory data were provided.  The relatedness between the events and suspected vaccines was not provided.  Follow-up information has been obtained on request by the Company from the FDA under the Freedom of Information Act on 15-APR-2019. The patient was female. She was not pregnant at the time of vaccination. She had no known allergies and no known chronic or long-standing health conditions.   Follow up information was received from a vaccine provider on 29-MAY-2019.  The patient's information were updated.  The reporter confirmed, that the patient complained of nausea, headache, fever and arm pain after receiving four vaccines. The reporter stated, that the patient's mother tried one dose of acetaminophen (TYLENOL) in 48 hours. She confirmed, that the patient was advised to alternate acetaminophen (TYLENOL)/ibuprofen (MOTRIN) and apply ice and or heat. No further symptoms were reported. The patient did not receive any prescription drug treatment. Medical/surgical intervention was not required.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, RV5
Symptoms: Rash, Rash macular
Clinical narrative: Macular rash(not pruritic) over torso, arms & legs, Sparing palms, soles & face
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body ache, tiredness and some fever
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old female patient . The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 17-FEB-2009, the patient was vaccinated by a physician with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a heathcare provider for shingles. The outcome of the events was not reported. The reporter considered the events to be related to ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-DEC-2013 (at the age of 64 years), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot #, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse for shingles. The outcome of the event not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician at the physician's office for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of currently 55 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 11-JUL-2017, the pt was vaccinated at a pharmacy/drug store with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed herpes zoster and as a result was treated by a healthcare provider. The outcome of herpes zoster was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (at the age of 69 years) (lot #, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia, Tremor
Clinical narrative: Information has been received regarding a case in litigation from a lawyer concerning a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was inoculated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. On an unspecified date, the patient suffered tremors, followed by a numbness in his feet which then progressed up both legs. As a result of these symptoms, he presented to a medical provider and was diagnosed with ascending paresthesia and was treated with a 3 day of course intravenous immunoglobulin (IVIG) for presumed Guillain Barre Syndrome. Thereafter, he had continued to suffer the effects of his paresthesia. As a result, the patient had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the Guillain Barre Syndrome was not recovered. The causal relationship between the event and ZOSTAVAX was related. Upon internal review, the event of Guillain Barre Syndrome was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient found out she was pregnant after receiving one dose of GARDASIL 9; no adverse effects; This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. Patient's medical history drug allergies and concomitant medications were unknown. On 02-APR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule was not reported, lot # R004689, route: intramuscular) for prophylaxis. It was reported that, the patient found out she was pregnant after receiving one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (maternal exposure before pregnancy) and no adverse events were reported. Last menstrual period (LMP) was on 17-MAR-2019 with an estimated date of delivery (EDD) on 22-DEC-2019. The patient did not seek medical attention. Pregnancy Outcome was outcome pending. The outcome of maternal exposure before pregnancy was unknown. Product quality complaint was not involved.  Lot No. R004689 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-NOV-2020.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a 67 year old female physician via a field representative referring to herself. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On Monday,14-JAN-2019, the physician was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). It was not specified if the physician had previously received PNEUMOVAX 23 prior to the dose on 14-JAN-2019. On 22-JAN-2019 (reported as the following Tuesday), she went to the emergency room because she was swollen and red at the injection site on her left arm behind her deltoid all the way up to her wrist. She thought it was cellulitis. At the time of the report, the outcome of the event was unknown. No causality assessment was provided. Upon internal review, cellulitis was considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Underdose
Clinical narrative: Less than full dose given; This spontaneous report as received from a nurse referred to a unspecified child of an unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the nurse reported that at least one patient received less than a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), .5 milliliter, subcutaneous. The unspecified child moved and some of the dose might have squirted out (incorrect dose administered). Nurse reported that, the nurse in the practice that administered the dose routinely only withdrawn and administered 0.5 ml of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) instead of all contents as directed in the prescribing information so they believed that the less than full dose was given. No further information was provided.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: completed that GARDASIL series with four administered doses of the vaccine; then received one dose of GARDASIL 9; then received one dose of GARDASIL 9; No adverse effects reported; This spontaneous report was received from a nurse referring to a non-pregnant female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On an unknown date, at the age of 12-year-old, the patient was vaccinated with the first dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) intramuscularly for prophylaxis (anatomical location, lot # and expiration date were not reported). It was stated that the patient completed the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series with four administered doses of the vaccine.   Then, on an unknown date, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, for prophylaxis (anatomical location, lot # and expiration date were not reported). No additional doses were administered to the patient. No adverse effects were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse effects were reported; patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant concerning to a 31 year old male patient. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 29-MAY-2019, the patient was inadvertently administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) by subcutaneous route (strength, dose and anatomical location were not reported; Lot number N014631 and expiration date 11-MAY-2019) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Pruritus
Clinical narrative: circular lump on her; red; itching; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included latex.   On 19th May 2019, the patient received the 2nd dose of Shingrix. On 20th May 2019, 1 days after receiving Shingrix, the patient experienced erythema, pruritus and upper extremity mass. On an unknown date, the outcome of the erythema, pruritus and upper extremity mass were recovering/resolving.   It was unknown if the reporter considered the erythema, pruritus and upper extremity mass to be related to Shingrix.  Additional details were provided as follows: The patient reported no reaction after the 1st dose. The patient experienced erythema, pruritus and upper extremity mass.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: inappropriate route; pain; swelling; redness; headache; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, headache and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, headache and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The nurse administered Shingrix subcutaneously to four patients. One patient developed redness, pain and swelling at the injection site. No additional details were provided. The reporter declined to provide identifiers or additional adverse event information until she would discuss the issue with her supervisor. This is one of the 4 cases, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Hypertension
Clinical narrative: High blood pressure; Feeling cold; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 20th May 2019, less than a day after receiving Shingrix, the patient experienced feeling cold. On 21st May 2019, the patient experienced blood pressure high. On 21st May 2019, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the feeling cold and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of the Shingrix vaccine and she felt cold, but now she was fine. Till the date of reporting, the patients blood pressure had been high and it was180/78 mmHg. The reporter did not consented to follow up. No further details were provided
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: nurse accidentally injected Daptacel that expired on 16May2019 to a patient on 21-May-2019/no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143977 and 2019SA143962 (same reporter).  This case involves a 5 years old male patient who was vaccinated with an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 21-May-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date: 16-May-2019, via intramuscular route in the left thigh (reported as left leg).  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Patient was given a dose of Fluzone MDV from a vial that was at 18.6 degrees Celsius for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144006 (same reporter).  This case involves a 17 years old male patient who received a 0.5ml first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multi dose vial that was at 18.6 degrees Celsius for 6.5 hours (lot UJ005AE, expiration date: 30-Jun-2019) via intramuscular route in the right deltoid on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE), MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) (MCV 4) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  It was an actual medication error due to incorrect product storage.  Adverse event was not 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: FLU3
Symptoms: Product storage error
Clinical narrative: a 9 year old patient received a dose of Fluzone MDV from a vial stored at 18.6 degrees celsius for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144008, 2019SA144007 and 2019SA144005 (same reporter).  This case involves a 9 years old female patient who received a 0.5ml first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] multi dose vial that was at 18.6 degrees Celsius for 6.5 hours lot UJ005AE, expiration date: 30-Jun-2019 via intramuscular route in the right deltoid on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown if any adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Patient was given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144005, 2019SA144006, 2019SA144008 and 2019SA144005. (same reporter).  This case involves a 13 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (1st dose this year).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE and Exp. Date 30-Jun-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Patient was given a dose of Fluzone MDV from a vial that was at 18.6 C for 6.5 hours; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143997, 2019SA144003, 2019SA144004, 2019SA144005, 2019SA144006, 2019SA144007 and 2019SA144005. (same reporter).  This case involves a 10 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was at 18.6 C for 6.5 hours.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the patient received a first 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE and Exp. Date 30-Jun-2019 via intramuscular route in the left arm.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether the patient had any adverse reactions.  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
Symptoms: Expired product administered
Clinical narrative: expired Daptacel was given to a 1 year old; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that expired Daptacel was given to a 1 year old.  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 DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a 4 months old patient accidentally received DTAP and Ipol portion of the Pentacel vaccine, however the ActHIB portion was not mixed /No AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who accidentally received dtap and ipol portion of the pentacel vaccine, however the acthib portion was not mixed, while he received a 0.5ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] lot UJ061AA, Expiration Date: 04-OCT-2020 via intramuscular route in the left thigh On 22-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient presented and requested a rabies vaccine 0.5ml was administered for puppy bite but  previously vaccinated with the vaccoine was not pre-exposure prophylaxis; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 27 year old male patient who previously vaccinated but that was not pre-exposure prophylaxis, and then received RABIES (HDC) VACCINE [IMOVAX RABIES]. It turns out that the consumer was trying to treat a dog bite.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-May-2019, the patient received a 0.5 ml dose of suspect RABIES (HDC) VACCINE (formulation: unknown, lot: N1L13 expiry date: 14-Nov-2019) via intramuscular route in the left arm.  It was an actual medication error due to Inappropriate schedule of vaccine administered.   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.; Sender's Comments: This case was considered valid only so that we can query regarding the schedule followed in this patient. In case no deviation from schedule is reported on a later date, case will be downgraded.
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: given Fluzone Quadrivalent MDV instead of the Aplisol; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male patient of age 28 to 30 years who received 0.1 ml of vaccine Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] (lot UI998AE, expiry date 30-Jun-2019) instead of APLISOL (TUBERCULIN PPD) not produced by Sanofi Pasteur (lot number not reported) via SD (subdermal) route in the left forearm on 21-May-2019 for PPD patch test. The patient later received the PPD skin test at another site with the Aplisol  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong product administered.  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: DTAP
Symptoms: Expired product administered
Clinical narrative: administered expired Daptacel to a 15 month old child; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient who had expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported, expiry date May-2017) via unknown route in unknown administration site on 22-May-2019.  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 expired vaccine used.  It was not reported if the patient had any adverse event.  Information on the batch number was requested.  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: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Homeopathy, Underdose
Clinical narrative: patient received only about 1/2 to 3/4 of the Quadracel vaccine because the child was moving; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 5 year old child patient who vaccinated with 1/2 to 3/4 DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] since the child was moving.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and AESCULUS HIPPOCASTANUM (VARIVAX [AESCULUS HIPPOCASTANUM]) for Immunisation.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-May-2019, the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation: unknown, lot number C5500CA, expiry date 16 Aug 2020) via unknown route in unknown administration site.  Today's Quadracel dose was the patient's fifth in the DTaP series, and the fourth in the IPV series.  It was a case of actual medication error due to vaccine underdose (patient received only about 1/2 to 3/4 of the quadracel vaccine because the child was moving.  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 document held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: involving Tetanus Vaccine (Allergy); Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) (under reference number: 2019221592).  This case involves adult patient of unknown demographics who experienced involving tetanus vaccine (allergy), while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID 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 involving tetanus vaccine (allergy) (allergy to vaccine) following the administration of TETANUS TOXOID.  No Lab data was reported.  Final diagnosis was involving tetanus vaccine (allergy).   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for involving tetanus vaccine (allergy).  Documents held by the sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadverently administered/no ae; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case is linked with 2019SA145256.  This case involves a 4 years old male patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  On 23-May-2019, the patient received a 0.5 ml third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: C5190AA and expiry date: 24-Apr-2019) via intramuscular route in left thigh.  It was an actual medication error due to expired vaccine used (expired dose of Daptacel was inadverently administered).  None adverse event symptoms 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.