chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal discomfort, Nausea, Pain, Pyrexia, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 80-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 17th April 2019, the patient received the 1st dose of SHINGRIX and the 1st dose of PNEUMOVAX 23 .5 ml. On 17th April 2019, 12 hrs after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, nausea, discomfort in joints, influenza-like symptoms and pain. On 18th April 2019, the patient experienced appetite lost. On 20th April 2019, the patient experienced fainting (serious criteria GSK medically significant). The patient was treated with paracetamol (Tylenol), nutritional supplement nos (Ensure) and antiemetics and antinauseants (Nausea Medication (Nos)). On 19th April 2019, the outcome of the shivering and nausea were recovered/resolved. On 20th April 2019, the outcome of the fainting, fever, discomfort in joints, influenza-like symptoms and pain were recovered/resolved. On 21st April 2019, the outcome of the appetite lost was recovered/resolved. On 26th April 2019, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fainting, fever, shivering, fatigue, appetite lost, nausea, discomfort in joints, influenza-like symptoms and pain to be related to SHINGRIX. Addtional details were provided as follows: The patient received 1st dose of SHINGRIX on left arm. In the evening of vaccination day, the patient experienced fever of 101. 8 degree F, shivering, fatigue, nausea, joint discomfort or achy flu-like symptoms. One date after vaccination, the patient experienced loss of appetite. Three days after vaccination, in the morning, the patient passed out in bathroom because, the patient went to bathroom to use commode but woke up on floor. Fatigue lasted about a week after seeing doctor. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Tinnitus
Clinical narrative: diziness; worsening tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. In December 2018, 1 min after receiving Shingrix, the patient experienced dizziness. On an unknown date, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved and the outcome of the dizziness was unknown.   The reporter considered the tinnitus to be related to Shingrix. It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experience dizziness within 60 seconds. It also caused her tinnitus to kick up and it has persisted for five months. Call notes stated that the patient did not wish to provide her demographics or additional information at the time of reporting
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; Injection site pain/ sore right arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in 2018).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 30 days after receiving Shingrix, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received Shingrix on right arm, intramuscularly about 4-5 weeks ago and he has been extremely tired which started about a month ago. He was also sore for a day or two at the injection site. The patient was over age 60 but refused to provide a date of birth. The reporter consented to follow-up. Call notes stated that can follow-up with the patient.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Circumoral swelling, Lip swelling, Swelling face
Clinical narrative: face is all swollen/ face is all swollen around the mouth, lips and up the left side of his face; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   Concomitant products included benadryl (nos) (Benadryl).   On 4th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, 3 days after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reported that she gave a patient their second dose of Shingrix on Saturday. On 07 May 2019, the patient had his face was all swollen around the mouth, lips and up the left side of his face, which was the side he had the immunization. The patient was fine that morning and he went to the golf course and came home and the left side of his face was swollen and he took Benadryl.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hepatic enzyme increased, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of elevated liver enzymes in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included crohn's. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th May 2019, 64 days after receiving SHINGRIX, the patient experienced elevated liver enzymes (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced headache (serious criteria clinically significant/intervention required), intermittent fever (serious criteria clinically significant/intervention required), fatigue (serious criteria clinically significant/intervention required) and malaise (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the elevated liver enzymes was unknown and the outcome of the headache, intermittent fever, fatigue and malaise were not recovered/not resolved. It was unknown if the reporter considered the elevated liver enzymes, headache, intermittent fever, fatigue and malaise to be related to SHINGRIX. Additional details were provided as follows: The reporter wife received her 1st dose of SHINGRIX. She started having intermittent fever, malaise, fatigue, and headache one week ago, treated with tylenol. On 9th May 2019, the reporter stated that she was told that her liver enzymes were exceptionally high. The reporter was consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: redness at the injection site; warm at injection site; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and muscle pain. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the injection site erythema, injection site warmth and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and muscle pain to be related to Shingrix.  Additional details were reported as follows: Late into the night of vaccination, the patient started having the following symptoms as red at the injection site, she said that the redness was 3 inches long by 1.5 inches wide, injection site was warm to the touch, pain in her muscles. She had taken an aspirin the day of reporting.  She had the injection at her physician's office. The outcome reported for all AES in the structured field of database is RECOVERING/RESOLVING instead of not resolved (outcome uploaded in database)
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain
Clinical narrative: redness; soreness; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 9th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient developed redness and soreness at the injection site again. The reporter consented to follow up.  The reporter consents to follow up with physician.  The reporter did not have all the adverse events details.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: redness; soreness; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 9th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient developed redness and soreness at the injection site again. The reporter consented to follow up.  The reporter consents to follow up with physician.  The reporter did not have all the adverse events details.
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Achy; Lethargic; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and lethargy. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain and lethargy were unknown.   It was unknown if the reporter considered the fever, pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced a fever over 100 degree F for two days after the first dose of Shingrix and during that time the patient was achy and lethargic. Call notes stated that agent was filing limited report Additional details was not obtained.      Lab Comments: Lab test performed on an unknown date
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: high fever; This case was reported by a physician via call center representative and described the occurrence of fever in a unspecified number of patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.  On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not provided. The physician reported that seeing high fevers in Pediarix compared with monovalent vaccine products. No additional information provided. Call notes stated that specific number of patients/incidence was not mentioned. No additional information provided.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching inner elbow; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a elderly female patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) for prophylaxis.   On 29th January 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in an unknown deltoid. The patient had experienced itching/ continuous itch on the inside elbow.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: redness; soreness; itchiness; warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included prednisone.   On 7th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site itching and injection site warmth. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, injection site pain, injection site itching and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm and later that day developed a palm sized red, itchy, sore, warm injection site on her left arm that persists.  The patient had treated it with hydrocortisone cream with some relief.  The patient had consented to follow up. The patient consented to healthcare professional follow up but did not know pharmacist's name. The patient did not have vaccine information for this adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced mobility decreased (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). On an unknown date, the outcome of the mobility decreased and walking difficulty were unknown. It was unknown if the reporter considered the mobility decreased and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced difficulty getting up from chair and walking and had to be hospitalized. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2019, the patient received the 1st dose of Shingrix. On 14th May 2019, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and developed shingles, which was diagnosed on 14th May 2019 by a physician. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness; itch; hot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 19th September 2021) for prophylaxis.   On 5th May 2019, the patient received the 1st dose of Shingrix. On 11th May 2019, 6 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  This case was reported by the Registered Pharmacist (RPh). The patient experienced red, itchy and hot at the injection site.  The reporter consented to follow up. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per fields.
Sex: U
Vaccine: TDAP
Symptoms: Wound
Clinical narrative: wound; received a Tdap(Adacel) when he was 9 years of age; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a physician and additional information received on 15-May-2019.   This case involves a 09-years-old age patient who experienced wound while he/she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious wound following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of actual medication error due to Inappropriate age at vaccine administration. As per PI: Adacel vaccine is not approved for individuals less than 10 years of age.  No lab test was reported.  Final diagnosis was received a tdap(adacel) when he was 9 years of age and wound.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for wound.  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 holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: male patient received Imovax on 03May2019 or 04May2019, he missed his day 3 Imovax and received it on 09May2019 which the nurse considered day 6/ no AE; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves male patient (age unknown) who experienced received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On 09-May-2019, the patient received post exposure vaccination (5 dose series) a second dose 1ml of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in unknown administration site and on 03 or 04-May-2019, the patient had received a first dose 1ml of suspect RABIES (HDC) VACCINE lot number not reported via intramuscular route in unknown administration site.  It was an actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that male patient received Imovax on 03-May-2019 or 04-May-2019, he missed his day 3 Imovax and received it on 09-May-2019 which the nurse considered day 6.  The patient did not experience 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.  Information on the batch number was requested
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Fluzone HD; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Pharmacy-Other).   This case involves patient (age and gender unknown) who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was reported that patient received an expired dose of Fluzone HD.  It was unknown if patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: expired dose of Fluzone HD was inadvertently administered to 59 years male patient; expired dose of Fluzone HD was inadvertently administered to 59 years male patient; expired dose of Fluzone HD was inadvertently administered to 59 years male patient; Initial information received on 13-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant medication and family history were not provided.  On 11-May-2019, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported, expiry date 02-May-2019 via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used, overdose and inappropriate age at vaccine administration.  It was reported that expired dose of Fluzone HD was inadvertently administered to 59 years male patient.  It was unknown if 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.  Information on the batch number was requested  List of documents held by sender- none.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Ipol was inadvertently administered to a patient/ no adverse event; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 3 months old male patient who received an expired 0.5 ml dose of suspect IPV (VERO) [IPOL] lot number N1A461M via (Expiry date 09-Feb-2019) intramuscular route in the left thigh, On 09-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to expired vaccine used.  The patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be 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: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Physician accidently ordered for a pregnant patient to get a second dose of Adacel within a month, the patient already had a dose at 27 weeks; Physician accidently ordered for a pregnant patient to get a second dose of Adacel within a month, the patient already had a dose at 27 weeks; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18 years old pregnant female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5566AA, expiry date- 13-Feb-2021 via intramuscular route in the right arm on an unknown date, while she was 31 weeks pregnant. the patient already had a dose of same vaccine at 27 weeks.  The date of last menstrual period was reported as 07-Oct-2018.  The estimated due date is 14-Jul-2019.  Previous pregnancy not known.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine exposure during pregnancy.  it was also a case of actual medication error due to extra dose administered.  Prenatal test not reported.  case details: The patient was 27 months pregnant when she received vaccine. Doctor states she inadvertently gave a verbal order for a patient to have Adacel today and the patient is 31 weeks pregnant but the patient had had a dose at 27 weeks. Patient was in for her regular 31 week check up. No other vaccines were given during this visit.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none
Sex: F
Vaccine: HEP, TDAP
Symptoms: Wrong product administered
Clinical narrative: newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth and Adacel was intended for the mother; newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a  new born female patient who received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of HEPATITIS B VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.  The patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: 33T42) via unknown route in unknown administration site instead of HEPATITIS B VACCINE (formulation: unknown).  It was an actual mediaction error due to Inappropriate age at vaccine administration (newborn was given adacel by mistake instead of hepatitis B vaccine when in the hospital at birth and adacel was intended for the mother) and wrong vaccine administered (newborn was given Adacel by mistake instead of hepatitis B vaccine when in the hospital at birth)  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: U
Vaccine: MNQ
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: dosage of expired menactra given to a patient; extra dose administered; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves unknown age and gender of patient who received expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used and extra dose administered. It was reported that a dosage of expired menactra was given to a patient.  It was not reported whether the patient had any adverse event 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.  Information on the batch number was requested  List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 08 year old patient received first booster dose of Menactra; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 8 years old female who received first booster dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate schedule of vaccine administered( it was reported that 08 year old patient received first booster dose of Menactra )  It was not reported that if any adverse reaction was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Information on the batch number was requested  Documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: child was administered an expired Pentacel vaccine, no adverse event reported; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves child patient who was vaccinated with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to expired vaccine used.  It was reported that a child that was administered an expired Pentacel vaccine.  It was not reported if the 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: patient was administered Pentacel but was only given the liquid portion and not the HIB powder/ no adverse event; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves 2 year old patient (gender not reported) who was vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: UJ1088A or UJ062A, expiry date: 24-Jul-2020, ActHIB lot-UJ062AAdose in series not reported) via intramuscular route in right leg on 14-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 (PNEUMOCOCCAL CONJUGATE VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported patient was administered Pentacel but was only given the liquid portion and not the HIB powder  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.   Documents held by the sender: none.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Papule
Clinical narrative: about 11 days after vaccine as given patient developed urticarial like lesion around injection site with scattered papules on torso and face.  improved with diphenhydramine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: The day of the vaccine, I felt flu-like symptoms.  1 day after I received the vaccine, I had deep muscle pain in my armpit (same arm as shot received).  Then 2 days after the vaccine, I developed a rash - red welts surrounding the injection site.  I have had swelling and heat at the injection site for 3 days now.  I didn't have this reaction with the 1st dose - just pain, heat, and swelling at the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Urticaria
Clinical narrative: The day of the vaccine, I felt flu-like symptoms.  1 day after I received the vaccine, I had deep muscle pain in my armpit (same arm as shot received).  Then 2 days after the vaccine, I developed a rash - red welts surrounding the injection site.  I have had swelling and heat at the injection site for 3 days now.  I didn't have this reaction with the 1st dose - just pain, heat, and swelling at the injection site.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Croup infectious, Hypotonia, Pyrexia, Respiration abnormal
Clinical narrative: Patient received vaccination on 1/18/19- patient was later taken to ED for gaggin, became "floppy" and possibly had a bluish color around lips but still breathing. After the episode he was sleepy, parent claim the episode lasted about 5 minutes. AT ED presentation, patient was back to baseline, no diagnosis at visit. On 1/27/19 patient returned to ED for fevers, cough and noisy breathing and diagnosed with viral croup. Treated with vaponefrin and Decadron.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Retching, Somnolence, Viral infection
Clinical narrative: Patient received vaccination on 1/18/19- patient was later taken to ED for gaggin, became "floppy" and possibly had a bluish color around lips but still breathing. After the episode he was sleepy, parent claim the episode lasted about 5 minutes. AT ED presentation, patient was back to baseline, no diagnosis at visit. On 1/27/19 patient returned to ED for fevers, cough and noisy breathing and diagnosed with viral croup. Treated with vaponefrin and Decadron.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site scab, Injection site vesicles, Pruritus, Rash papular
Clinical narrative: On sat 5/11/19 had flu like symptoms, devleopment of notable blister over site of injection and fine papular rash on ipsilateral side of her body. All symptoms are resolving and left with scabbed blister 1in diameter over site of injection. No redness, swelling, pain or concerning drainage to suggest infection. Itchy, using top hydrocortisone. Discussed monitoring for signs of infection, expect to continue to improve.    Reaction does not sounds like IgE mediated allergy. Tolerated shingrix #1 without side effects.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Pt presents to OHS to report possible reaction to the varicella vaccine received on 5/3/19 in OHS.  She has red pumps that are itchy that developed 5/15/19  to her back, arms, chest and behind her ear.  2 appeared on the train on her way to work.  She works as a CASS and has direct patient contact.  The site is red and itchy. Felt "warm" yesterday with a runny nose.  Has had chicken pox in the past but did not have full immunity on titer.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Pt presents to OHS to report possible reaction to the varicella vaccine received on 5/3/19 in OHS.  She has red pumps that are itchy that developed 5/15/19  to her back, arms, chest and behind her ear.  2 appeared on the train on her way to work.  She works as a CASS and has direct patient contact.  The site is red and itchy. Felt "warm" yesterday with a runny nose.  Has had chicken pox in the past but did not have full immunity on titer.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site rash, Pain
Clinical narrative: Pt received Shingrix Thursday morning. Later that afternoon pt started with severe fatigue, body aches, chills, fever, and headache. Also with arm pain and "circular rash" approximately 6 inches below injection site. All symptoms resolved by Saturday. Husband also received shingrix injection that morning  and only with arm pain and rash. Both symptoms resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt received Shingrix Thursday morning. Later that afternoon pt started with severe fatigue, body aches, chills, fever, and headache. Also with arm pain and "circular rash" approximately 6 inches below injection site. All symptoms resolved by Saturday. Husband also received shingrix injection that morning  and only with arm pain and rash. Both symptoms resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Pt received Shingrix on Friday. States she had pain and swelling in left arm. Swelling traveled down left arm. Resolved Sunday. Still with some slight tenderness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Retching
Clinical narrative: nausea, dry heaves, diarrhea. Probably fever (but too sick to get up to take temperature). No treatment.  Totally resolved by 5:30am on 5/20.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: possible cellulitis, unconfirmed
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Axillary pain, Cellulitis, Oedema peripheral
Clinical narrative: 4/18/19 - 9:30 a.m. - Phone call received from mother, states armpit of left arm swollen and painful, not red, began evening of 4/15/19. Recommended follow-up with primary physician.   4/24/19 - Spoke with mother on phone, states saw Dr. and received antibiotic.  He felt better in 1-2 days.  Dr. Health Dept. Clinic Pediatrician notified. Spoke with Dr. patient's primary physician, localized cellulitis treated with antibiotic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Pain in extremity, Skin warm
Clinical narrative: At approximately 7pm  Friday (4 hours post vaccine), patient experienced pain in arm.  On the next day (Saturday),  redness noted on arm, she felt ill- fever, body aches.  Monday AM,  2.5x2.5 inch   area on arm is red and hot to touch ; remains very sore to touch.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: At approximately 7pm  Friday (4 hours post vaccine), patient experienced pain in arm.  On the next day (Saturday),  redness noted on arm, she felt ill- fever, body aches.  Monday AM,  2.5x2.5 inch   area on arm is red and hot to touch ; remains very sore to touch.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Vaccine was in frig with a temperature excursion of higher temperature than package insert recommended.  Was reported to manufacturer.   Sonofi representative said because this was a multi-dose vial it should be considered "not viable".
Age: 48.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EFFECTS; The patient was inadvertently administered an expired Pneumovax 23; This spontaneous report was received from a medical assistant regarding a 48-year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions or allergies were not reported. On 16-MAY-2019, the patient inadvertently administered expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency were not reported) (lot number: N027624 and expiration date: 11-MAY-2019) intramuscularly for prophylaxis (Expired product administered). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial asymmetry, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial asymmetry in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced facial asymmetry (serious criteria GSK medically significant), shingles and red face. The patient was treated with famciclovir (Famvir) and ophthalmologicals (Eye Drop Medication {Nos}). On an unknown date, the outcome of the facial asymmetry and red face were unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the facial asymmetry, shingles and red face to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX on another location. The patient's age at vaccination was not reported but it could be 76 years or 77 years. The patient was started on Famvir and steroidal eye drops in February 2019 due to the shingles being close to their eye. The patient had almost like a bells palsy to one side of face from the shingles, which was chronically red. In 2019, the patient was recovered from shingles bout.