chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient experienced no symptoms; a patient who had completed a series of GARDASIL was administered a dose of GARDASIL 9; a patient who had completed a series of GARDASIL was administered a dose ofG ARDASIL 9; This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.      On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) (GARDASIL) as prophylaxis (concentration, dose, frequency of vaccination scheme, route and anatomical location of vaccination, lot number and expiry date were not reported).   On an unknown date in 2020 (reported as within the past few weeks), after completing a series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) (GARDASIL), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), one dosage form as prophylaxis (circumstance or information capable of leading to medication error, inappropriate schedule of product administration) (concentration, route and anatomical location of vaccination were not reported; frequency of vaccination scheme, lot number and expiry date were unknown to the reporter).  The patient experienced no symptoms.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; Medical assistant called to report that on 2/25/2020 patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.  On 25-FEB-2020, the patient received the first dose of an improperly stored (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number S014947 and expiration date 10-DEC-2020 for prophylaxis (strength, frequency, route of administration and anatomical location were not reported).  The vaccine was stored at a temperature below 36 degree Fahrenheit (34 Fahrenheit) for a timeframe of 27 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No adverse reactions were reported.; Sender's Comments:  US-009507513-2002USA010005: US-009507513-2002USA009991:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported.; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 24-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S014947, expiration date: 10-DEC-2020; dose details and route were unknown) for prophylaxis (product storage error).           The vaccine was stored below 36 degrees Fahrenheit (34 degrees Fahrenheit) for 27 minutes. There were no previous temperature excursions. The digital data logger was involved. No further adverse effect reported.
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a two month old patient was administered adose of PROQUAD in error on 2/26/2020; This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 26-FEB-2020, the patient was vaccinated in error with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously, lot # S015092 has been verified to be not valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (with expiration date reported as 15-MAY-2021 for this lot #; albumin status not established) for prophylaxis. The vaccine was reconstituted with a sterile diluent.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Toe patient experienced no symptorns; on 2/25/2020 a patient was administered a dose of PROQUAD via the intramuscular route; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 25-FEB-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # S022104, expiration date 12-JAN-2021 via intramuscular route for prophylaxis. The vaccine was reconstituted with a sterile diluent.  The patient experienced no symptoms.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she received one dose ofGARDASIL-9 on both 8/30/2019 and on 12/3/2019, not in accordance with the prescribing information; No additional adverse effects; This spontaneous report was received from a female physical therapist refering to herself. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 30-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 dosage form for prophylaxis (dose number, strength, frequency, route of administration, lot# and expiration date were not provided). The patient reported she received another dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) on 03-DEC-2019, 1 dosage form for prophylaxis (dose number, strength, frequency, route of administration, lot# and expiration date were not provided), not in accordance with the prescribing information (inappropriate schedule of product administration).  No additional adverse effects were reported in the patient.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse event; the patient received the 4th dose of PEDVAXHIB that was expired; the patient received the 4th dose of PEDVAXHIB; This spontaneous report was received from a nurse practitioner, via company representative, regarding a 15-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 26-FEB-2020, the patient was vaccinated with the fourth dosage of an expired haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route of administration were not reported; lot number N034005 was verified to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date was on 31-JAN-2020) as prophylaxis (expired product administered and incorrect dose administered). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: right eye herpes dendritic keratitis; herpes dermatitis of the eyelid; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 13-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving Zoster Vaccine Live (ZOSTAVAX) the patient suffered from right eye herpes dendritic keratitis and herpes dermatitis of the eyelid. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, right eye herpes dendritic keratitis was determined to be medically significant. The events right eye herpes dendritic keratitis and herpes dermatitis of the eyelid were considered to be disabling.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; the patient received a fourth dose of GARDASIL 9; on 16-AUG-18 the patient received the first dose of GARDASIL 9/ the patient received the third dose of GARDASIL 9 on 21-AUG-2019; This spontaneous report was received from a health care professional (HCP), referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 16-AUG-2018, at the age of 22-year-old 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) (strength, route of administration, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis.   On 19-OCT-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis.   On 21-AUG-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis (inappropriate schedule of product administration).   On 12-FEB-2019, the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) as prophylaxis (extra dose administered).  No additional adverse events.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product dose omission
Clinical narrative: No symptoms being reported; patient received first dose GARDASIL 9 in April 11, 2019 but missed second dose. Patient to receive second dose in office today, 3/2/2020; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 11-APR-2019 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The patient missed the second dose schedule and received second dose in the reporter's office on 02-MAR-2020 (inappropriate schedule of product administration). First dose was administered at another facility. No symptoms were being reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: increasing pain in his head; This case was reported by a physician and described the occurrence of headache in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (a possible h/o atypical facial zoster on the left), pain (with not much prodomal pain) and pustular rash (pustular rash).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On an unknown dats patient received 2 doses of shingrix vaccine and experienced increasing pain in his head that was not restricted to the left side where the rash was present. The lot number and injection site was not known. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in her hands and feet; This case was reported by a nurse via sales rep and described the occurrence of peripheral neuropathy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and umeclidinium bromide, vilanterol trifenatate (Anoro Ellipta) unknown for chronic obstructive pulmonary disease.   Concurrent medical conditions included chronic obstructive pulmonary disease and osteopenia.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. In November 2019, the patient started Anoro Ellipta 25 mcg/mg once daily (25 mcg/mg daily). On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and Anoro Ellipta, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). Anoro Ellipta was discontinued. On an unknown date, the outcome of the peripheral neuropathy was unknown.   It was unknown if the reporter considered the peripheral neuropathy to be related to Influenza vaccine Quadrivalent 2019-2020 season and Anoro Ellipta.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with chronic obstructive pulmonary disease (COPD) and the patient was put on ANORO. The patient also received flu shot and pneumonia vaccine the patient suffered from neuropathy in her hands and feet. The patient had never been on any other medications ever until her diagnosis of COPD and osteopenia. The patient was discontinued ANORO after 3 doses. The reporter agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Rash
Clinical narrative: hard nodule at injection site; the shot was also very painful; rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a adult female 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 injection site induration, injection site pain and rash. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the injection site pain and rash were unknown.   It was unknown if the reporter considered the injection site induration, injection site pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the family member between ages of 55 to 60 received 1st dose of Shingrix. The patient developed a hard nodule in the left arm deltoid muscle which persisted for a few weeks and also the shot was very painful. The patient also developed a rash. The pharmacist did not know where the location of the rash or how long it lasted.  The pharmacist would call back with follow up information regarding the rash and when the patient received the injection. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral sensory neuropathy
Clinical narrative: sensory neuropathy / started in lips and inside mouth and progressed to involve; This case was reported by a physician via call center representative and described the occurrence of sensory neuropathy 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, 1 month after receiving Shingrix, the patient experienced sensory neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the sensory neuropathy was unknown.   It was unknown if the reporter considered the sensory neuropathy 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 patient receved 1st dose of Shingrix and after one month experienced sensory neuropathy, lips and inside mouth and progressed to involve extremities. The follow up consent was not granted.
Age: 74.0
Sex: F
Vaccine: PPV, UNK, VARZOS
Symptoms: Asthenia, Bronchitis, Dizziness, Influenza, Malaise
Clinical narrative: diagnosed with pneumonia; weakness; dizziness; arm pain; head cold; sinus trouble; Sick; bronchitis; Flu; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and PERTUSSIS TOXOID (WHOOPING COUGH VACCINE) for prophylaxis.   The patient's past medical history included cold, influenza, bronchitis and pneumonia (experinced before 1984).   In December 2019, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and WHOOPING COUGH VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), weakness, dizziness, pain in arm, head cold, sinus disorder, sickness, bronchitis and influenza. On an unknown date, the outcome of the pneumonia, bronchitis and influenza were unknown and the outcome of the weakness, dizziness, pain in arm, head cold and sinus disorder were recovering/resolving and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the pneumonia, weakness, dizziness, pain in arm, head cold, sinus disorder, sickness, bronchitis and influenza to be related to Shingrix.  Additional details were provided as follows: The patient had not a cold, flu, bronchitis, or pneumonia since 1984 and she was totally healthy. The patient had a pneumonia vaccine in the beginning of December 2019, Shingrix was administered in mid of December and a whooping cough vaccine was given in late December.  The sinus, head cold, dizziness and weakness presented first. Exact time frame of onset was not known.  The arm pain presented a while after the first symptoms.  The arm was described as a circle or band of pain in both arms above the bicep. The patient had never had a vaccination during that time.  The patient had so sick ever since, diagnosed with pneumonia, with bronchitis, with a head cold, with the flu, on and on, and she did not have any of those. The patient did not start feeling sick until after she had the shingles vaccination. And she stilled sick.  This was three months now. And there appears to be no antidote, plus she supposed to go back and get another one of these shots.
Age: 74.0
Sex: F
Vaccine: PPV, UNK, VARZOS
Symptoms: Nasopharyngitis, Pain in extremity, Pneumonia, Sinus disorder
Clinical narrative: diagnosed with pneumonia; weakness; dizziness; arm pain; head cold; sinus trouble; Sick; bronchitis; Flu; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and PERTUSSIS TOXOID (WHOOPING COUGH VACCINE) for prophylaxis.   The patient's past medical history included cold, influenza, bronchitis and pneumonia (experinced before 1984).   In December 2019, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and WHOOPING COUGH VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), weakness, dizziness, pain in arm, head cold, sinus disorder, sickness, bronchitis and influenza. On an unknown date, the outcome of the pneumonia, bronchitis and influenza were unknown and the outcome of the weakness, dizziness, pain in arm, head cold and sinus disorder were recovering/resolving and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the pneumonia, weakness, dizziness, pain in arm, head cold, sinus disorder, sickness, bronchitis and influenza to be related to Shingrix.  Additional details were provided as follows: The patient had not a cold, flu, bronchitis, or pneumonia since 1984 and she was totally healthy. The patient had a pneumonia vaccine in the beginning of December 2019, Shingrix was administered in mid of December and a whooping cough vaccine was given in late December.  The sinus, head cold, dizziness and weakness presented first. Exact time frame of onset was not known.  The arm pain presented a while after the first symptoms.  The arm was described as a circle or band of pain in both arms above the bicep. The patient had never had a vaccination during that time.  The patient had so sick ever since, diagnosed with pneumonia, with bronchitis, with a head cold, with the flu, on and on, and she did not have any of those. The patient did not start feeling sick until after she had the shingles vaccination. And she stilled sick.  This was three months now. And there appears to be no antidote, plus she supposed to go back and get another one of these shots.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Enteritis infectious
Clinical narrative: intestinal infection; This case was reported by a pharmacist via call center representative and described the occurrence of ill-defined intestinal infections in a female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant). On an unknown date, the outcome of the ill-defined intestinal infections was unknown.   It was unknown if the reporter considered the ill-defined intestinal infections to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix and had intestinal infection. The patient took medication for the infection hence reporter wanted to know whether patient could receive 2nd dose of vaccine or not. The batch number of Shingrix was reported as 29759, However, as per sales data sheet the batch number was updated to 29T59. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cancer in remission, Inappropriate schedule of product administration, Neoplasm malignant
Clinical narrative: cancer / cancer went into remission; received a late 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number HG4P3, expiry date 13th July 2020) and (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 1st May 2018, the patient received the 1st dose of Shingrix. On 6th November 2019, the dose was an unknown dose. On 6th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine and was later diagnosed with cancer. The cancer went into remission and the patient received a late 2nd dose of Shingrix. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The outcome of the event cancer was reported in source document as fatal, however it was reported as recovering/ resolving in database. No symptoms reported. after 2nd dose administration. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired daptacel vaccine to a patient/NO AE; Initial information was received on 27-Feb-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient of an unknown age who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination 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 an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used. (expired dose administered)  At the time of report, 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 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 lot number was requested.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel expired on 07-FEB-2020 and was given on 21-FEB-2020/no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient (unknown age) who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 21-Feb-2020 which was expired on 07-Feb-2020 (expired product administered)  for prophylactic vaccination via an intramuscular route [ dosing details 0.5 ml , expiry date: 07-FEB-2020, lot number and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient expired Daptacel today by mistake/no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 21 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Expired vaccine used).  The patient's past vaccination(s) included three doses of Pentacel (no doing details reported).  The patient medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and HEPATITIS A VACCINE (HEPATITIS A).  On 27-Feb-2020, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA (expiry date: 07-FEB-2020) via intramuscular route in the left thigh.  It was of actual medication error due to Expired vaccine used (Expired product administered).  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Fluzone HD to a 44 year-old woman rather than the indicated Fluzone Quadrivalent, No AE; administered Fluzone HD to a 44 year-old, No AE; administered Fluzone HD to a 44 year-old , No AE; Initial information was received on 27-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 44 years old female patient who was vaccinated with 0.5 ml of dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ252AA and expiry date: 01-May-2020) via intramuscular route in the left deltoid rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 26-Feb-2020 for prophylactic vaccination (PT: Overdose, Product administered to patient of inappropriate age and Wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination.  It was actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.  At the time of report 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.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: 4-month old received a dose of IPOL and also a dose of Inactivated Poliovirus Vaccine contained in the Pediarix vaccine/No AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old female patient who received IPV (VERO) [IPOL] and also a dose of inactivated poliovirus vaccine contained in the DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] vaccine (extra dose administered), on the same day for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included Rotateq and Pneumococcal vaccine (Pneumonia vaccine).  On 27-Feb-2020, the patient received a second dose of suspect IPV (VERO) [lot P1F491M, expiry date: 30-NOV-2020] via an intramuscular route at left leg and a dose of suspect PEDIARIX (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site.  It was a case of actual medication error due to on same day, greater than 0.5mL dose or duplicate doses administered to patient (extra dose administered).  At the time of report, 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 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.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: only the diluent of the Pentacel was delivered to the patient / no AE; Initial information received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received only diluent from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] batch number U6257AA (expiry date 27-Oct-2020) via intramuscular route in the left vastus lateralis for Prophylactic vaccination And Box Lot UJ056AA (expiry date 27-Oct-2020) (PT inappropriate reconstitution technique).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCIN).  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that only the diluent of the Pentacel was delivered to the patient)  At a time of reporting no adverse events 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 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 thirdparty has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 62 years old patient received a Fluzone High Dose, no AE; 62 years old patient received a Fluzone High Dose, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA057096 and 2020SA057137.  This case involves a 62 year old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date (PT: Overdose and Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report 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.  Information on the batch number was requested.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 59 years old patient received Fluzone High Dose/no AE; 59 years old patient received Fluzone High Dose/no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2020SA057067 and 2020SA057137 via same reporter.  This case involves a 59 years old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site) on an unknown date for prophylactic vaccination(PT: Overdose and Product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report 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.  Information on the batch number was requested.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 61 years old patient received a Fluzone High Dose/no AE; 61 years old patient received a Fluzone High Dose/no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case was linked to cases 2020SA057096 and 2020SA057067 via same reporter.  This case involves a 61 years old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site) on an unknown date for prophylactic vaccination(PT: Overdose and Product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report 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.  Information on the batch number was requested.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: administered 0.25 ml Fluzone Quadrivalent to 4 year old, No AE; Initial information was received on 28-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a four year old female patient who was vaccinated with 0.25 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date: not reported) via intramuscular route in the left thigh on 28-Feb-2020 for prophylactic vaccination (PT: underodse).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to vaccine underodse.  At the time of report 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.  Information on the batch number was requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Mass, Rash, Skin warm
Clinical narrative: Local rash, hot skin, lump underneath skin, bruising  3 days after, patient stated that it was healing  so no treatment was necessary
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Myofascitis, Neck pain
Clinical narrative: Severe left arm pain at injection site. Pain radiates to the neck and back.  Patient unable to lift arm >90 degrees in any direction without severe, shooting pain.  Initially treated with PT fro presumed frozen shoulder.  Patient came to see me without any improvement after several treatments.  We shifted treatment to presumed diagnosis of macrophagic myofasciitis given her symptoms and patient has started to improve.  Currently at 50% improvement in subjective pain and able to lift arm > 90 degrees in abduction, but not flexion.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Severe left arm pain at injection site. Pain radiates to the neck and back.  Patient unable to lift arm >90 degrees in any direction without severe, shooting pain.  Initially treated with PT fro presumed frozen shoulder.  Patient came to see me without any improvement after several treatments.  We shifted treatment to presumed diagnosis of macrophagic myofasciitis given her symptoms and patient has started to improve.  Currently at 50% improvement in subjective pain and able to lift arm > 90 degrees in abduction, but not flexion.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cyanosis, Eye movement disorder, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: After the administration of vaccines, patient and mother went to a dental clinic room.  After 5 minutes, the patient was in the mothers lap when the patient lost color and went completely pale. Initially, this was thought to be a possible syncopal episode. However, the patient started to have circumoral cyanosis. Spo2 at this time was 98%. It was then indicated to have our nurse practitioner check him out. His lips were still a blue tint and patient was not speaking once in the exam room . Patient was still alert. Patient was checked out by our Nurse Practitioner, who indicated the need for EMS due to his pale color, diaphoresis, cyanosis to lips and circumoral area, as well as his eyes with repetitive lateral movement, and his lack of response to commands or touch. Patient at this time was still breathing and had an spo2 of 96% on room air and a blood pressure of 82/56.  While performing a  second try for a blood pressure, the patients response improved when speaking to mother, and was able to fixate on her and speak to her. Overall cyanosis improved along with paleness at the time.  EMS arrived for transport to take child to the hospital to be examined.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Immobile, Myalgia
Clinical narrative: Overnight 4 Feb. Right back muscle pain. dinner plate sized. Felt like ribs were broken also 4 Feb Pain immobilzed me on the couch 5 Feb Up and around a bit. Could sit on chair. 6 Feb still better. could drive a car. 7-9 Feb mostly gone except in torso areas that were not originally involved 10 Feb Fully recovered. Throughout all just cranked up the ibuprofen
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: In the evening after getting the vaccine there was redness, swelling, and intense itching. The redness and swelling has progressed down past the elbow, itching has subsided. Patient has used ice packs, and may consult with primary care provider for further treatment.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection arm was red from shoulder to elbow. Redness remain for 5 days. Itching started 1 day after redness and lasted for 4 days
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: headache; body aches; malaise; low grade fever
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever up to 102.5 three hours after getting immunizations. 2 days later developed redness, swelling and increased warm in the same arm. Redness extends from site of inject to elbow. Fever has persisted without any URI symptoms  Patient also previously had febrile seizure after Dtap immunization 2 years ago prior to coming to our office.