chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patients received an Adacel vaccine which had been frozen and thawed/ no AE; Upon internal review and information received on 07-Aug-2019, significant amendment was performed on 16-Aug-2019 to amend case from non-valid to valid.  Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224141, 2019SA224142 and 2019SA224145 (same reporter).  This case involves a patient who was administered with the dose of 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot C55608AA, Expiration Date: 25-Jan-2021, Lot C5585AA, Expiration Date: 10-Mar-2021, via intramuscular route and site of administration not reported) which had been frozen and thawed between period of 26-Mar-2019 to 24-Jun-2019.   It was also reported that there had been multiple excursions over the course of a few months.  It was case of an actual medication error due to incorrect product storage.  Case details: Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 C range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred.  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.  Addendum 16-Aug-2019: Significant amendment was done to amend case from non-valid to valid.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel Vaccine that had been frozen and thawed/no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional with follow-up on 08-Aug-2019.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224076, 2019SA224137, 2019SA224141, 2019SA224142 and 2019SA224145.  This case involves 12 patients who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that Adacel vaccine that had been frozen and thawed/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C55608AA, C5585AA and expiry date: 25-Jan-2021 and 10-Mar-2021 via intramuscular route in unknown administration site respectively.  It was a case of actual medication error due to incorrect product storage.  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.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel Vaccine that had been frozen and thawed/no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional with follow-up on 08-Aug-2019.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224076, 2019SA224136, 2019SA224141, 2019SA224142 and 2019SA224145.  This case involves 12 patients who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that Adacel vaccine that had been frozen and thawed/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C55608AA, C5585AA and expiry date: 25-JAN-2021 and 10-Mar-2021 via intramuscular route in unknown administration site respectively.  It was a case of actual medication error due to incorrect product storage.  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.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: patient received an Adacel which had been frozen and thawed- multiple excursions over the course of a few months, vaccines dropped to 1.4 C and 1.5 Celsius and same vaccines have gotten down to -4 Celsius/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224143, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224144, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received an Adacel Vaccine that had been frozen and thawed, no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non-health care professional.   This case is linked to cases 2019SA224143, 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224138, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224145 and 2019SA224144 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received an Adacel Vaccine that had been frozen and thawed, no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224141, 2019SA224142 and 2019SA224145 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received an Adacel Vaccine that had been frozen and thawed, No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from consumer/non-health care professional.  This case is linked to cases 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224140, 2019SA224076, 2019SA224136, 2019SA224142, 2019SA224145 and 2019SA224137 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21 or Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received Adacel Vaccine that had been frozen and thawed; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from consumer/non-health care professional.  This case is linked to cases 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224140, 2019SA224141, 2019SA224076, 2019SA224136, 2019SA224137 and 2019SA224145 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21 or Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Product storage error temperature too low.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a non health professional (office staff).   This case is linked to cases 2019SA224138, 2019SA196353, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224144, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot-C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224076, 2019SA224136 and 2019SA224137 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Product quality issue
Clinical narrative: product quality issue; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who reported a product quality issue, while he/she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (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) and family history were not provided.  It was unknown if the patient had any adverse event.  Information on the batch number was requested.  List of document held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccinated with 5 ml of expired Pentacel in the right thigh; Initial information received on 12-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 12 months old female patient who received an expired 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5463AA (Expiry date 26-Jul-2018) via unknown route in the right thigh on 10-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  It was a case of actual medication error due to expired vaccine used.  At a time of reporting 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.  List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Patients hand swelled up and inflammed
Age: 63.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient had pain, swelling and redness at the injection site that lasted 10 days.  He actually reported that on 8/16 (10 days after receiving the vaccines) his pain was radiating from the injection site to his shoulder and all the way to below the elbow. I recommended  that patient see his doctor. I informed him that these side effectts are be expected for 24 to 48 hours after the injection. Having the pain 10 days later is not usual.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Blindness unilateral, Migraine with aura, Ophthalmological examination abnormal, Optic neuritis, Vaccination complication
Clinical narrative: Pt called clinic on 08/14/19 approx 2:00 pm, stated she had a reaction to the vaccine administered the previous day.  Pt stated the reaction was that she had lost her eyesight to her rt eye earlier in the day and had already been examined by a opthalmologist.   The Dr had diagnosed the incident as optic neuritis/optic migraine,caused by reaction to the vaccine.  The pt returned to the opthalmologist on 08/15/19 and after being examined again he advised pt to continue to take her BP meds and to finish the vaccine series.  The optic nerves were a 6.5 and had been 8 at first visit.  I advised pt  to allow the nursing staff to research if she should finish vsccine series and that we would call her back
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin disorder, Swelling, Vaccination site cellulitis
Clinical narrative: Patient mentioned that he had pain, swelling after receiving the vaccine until the night of 8/13/19 he noticed some changing on his skin. He went to be checked up next morning (8/14/19) and was diagnosed with cellulitis at the vaccine site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Insomnia, Nausea, Pain
Clinical narrative: I revived the shot at 8:42 after shot I got a little light headed, set rested for a minute, left clinic got home started feeling sick to my stomach, laid down, slept for 2 hours got up ate dinner at 6:30 - 7:00 pm went to bed at 10:00 pm stared feeling aches and chills and dizzy took Ibuprofen around 6:00am couldn?t sleep, got up at 7:30 started feeling better at 8:00am on 8-16-2019. Still feeling shaky.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I revived the shot at 8:42 after shot I got a little light headed, set rested for a minute, left clinic got home started feeling sick to my stomach, laid down, slept for 2 hours got up ate dinner at 6:30 - 7:00 pm went to bed at 10:00 pm stared feeling aches and chills and dizzy took Ibuprofen around 6:00am couldn?t sleep, got up at 7:30 started feeling better at 8:00am on 8-16-2019. Still feeling shaky.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient ended up getting cellulitis from the injetion site, is current being treated with an antibiotic
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Patient had Gardasil 9 in the right arm as well as Bexsero and Menactra in the left arm at the same time.  Menactra lot number U6521AA Bexero lot number ABXA32AA
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Peripheral swelling
Clinical narrative: pt came to pharmacy reported he got big bruise on his upper right arm on Wdnesday (8/14). He stated right after pharmacist gave him flu shot on 8/12/2019 the arm became swollen (no bruise) so he came back and spoke with pharmacist. Pharmacist instructed him to take IBU overnight. Pharmacist instructed pt to call her back on Tuesday and see docotor if the situation gets worse. However, pt didn't call her back.  The bruise is about 2 inch wide and 4 inches long beneath the injection site. Appologized to pt and instructed pt to see md for futher check up since the bruise is becoming bigger and bigger per pt. Also instructed pt to stop taking IBU. Check on injection site is corrected, wiped with alcohol, pt's hand can still lift up above hand.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: body aches, chills, headache
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling, and bumps at and around the injection site
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis, Blood test normal, Discomfort, Fall, Injection site pain
Clinical narrative: PATIENT COMPLAINED OF EXCRUCIATING PAIN IN ARM/SHOULDER OF PNEUMOVAX INJECTION WHICH BEGAN 2 HOURS AFTER INECTION, PATIENT ACTUALLY SAYS SHE PASSED OUT AND FELL FROM THE PAIN. HAD DIFFICULTY SLEEPING OR GETTING COMFORTABLE. WENT TO EMERGENCY ROOM TWICE, ONCE THE DAY OF, AND ONCE ON 8/15/19. 1ST VISIT THEY GAVE HER NORCO, WHICH SHE DIDNT TOLERATE WELL, 2ND VISIT GAVE MEDROL DOSEPAK, WHICH SHE SAID HELPED, BAD PAIN HAD LASTED 5-6 DAYS, HAS RESOLVED WITH TIME AND MEDROL, BUT SHE IS STILL FEELING THE EFFECTS OF THE SHOT IN THAT ARM.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Loss of consciousness, Pain in extremity, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: PATIENT COMPLAINED OF EXCRUCIATING PAIN IN ARM/SHOULDER OF PNEUMOVAX INJECTION WHICH BEGAN 2 HOURS AFTER INECTION, PATIENT ACTUALLY SAYS SHE PASSED OUT AND FELL FROM THE PAIN. HAD DIFFICULTY SLEEPING OR GETTING COMFORTABLE. WENT TO EMERGENCY ROOM TWICE, ONCE THE DAY OF, AND ONCE ON 8/15/19. 1ST VISIT THEY GAVE HER NORCO, WHICH SHE DIDNT TOLERATE WELL, 2ND VISIT GAVE MEDROL DOSEPAK, WHICH SHE SAID HELPED, BAD PAIN HAD LASTED 5-6 DAYS, HAS RESOLVED WITH TIME AND MEDROL, BUT SHE IS STILL FEELING THE EFFECTS OF THE SHOT IN THAT ARM.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: PATIENT COMPLAINED OF EXCRUCIATING PAIN IN ARM/SHOULDER OF PNEUMOVAX INJECTION WHICH BEGAN 2 HOURS AFTER INECTION, PATIENT ACTUALLY SAYS SHE PASSED OUT AND FELL FROM THE PAIN. HAD DIFFICULTY SLEEPING OR GETTING COMFORTABLE. WENT TO EMERGENCY ROOM TWICE, ONCE THE DAY OF, AND ONCE ON 8/15/19. 1ST VISIT THEY GAVE HER NORCO, WHICH SHE DIDNT TOLERATE WELL, 2ND VISIT GAVE MEDROL DOSEPAK, WHICH SHE SAID HELPED, BAD PAIN HAD LASTED 5-6 DAYS, HAS RESOLVED WITH TIME AND MEDROL, BUT SHE IS STILL FEELING THE EFFECTS OF THE SHOT IN THAT ARM.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Ultrasound scan, X-ray
Clinical narrative: Lump in left thigh after vaccination - persistent and larger than typical
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Musculoskeletal stiffness, Pain in extremity, Somnolence
Clinical narrative: See previous submission for details (VAERS E-Report No: 165559 of 2019-04-30). Briefly, severe ringing in the ears followed by flu like symptoms and fatigue. I took Tylenol 600 mg at 10:30 AM and 6:30 PM. The symptoms lasted approximately 10 to 12 hours starting at about 8 AM on 8/9/19. The night before my arm was quite sore and stiff about 4 to 6 hours after the shot. I slept off and on during the day on 8/9/19 and did not start to feel better until after 4 PM. I do not believe that my symptoms were as severe as the first reaction, but were enough to knock me out for most of the day (sleeping).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: See previous submission for details (VAERS E-Report No: 165559 of 2019-04-30). Briefly, severe ringing in the ears followed by flu like symptoms and fatigue. I took Tylenol 600 mg at 10:30 AM and 6:30 PM. The symptoms lasted approximately 10 to 12 hours starting at about 8 AM on 8/9/19. The night before my arm was quite sore and stiff about 4 to 6 hours after the shot. I slept off and on during the day on 8/9/19 and did not start to feel better until after 4 PM. I do not believe that my symptoms were as severe as the first reaction, but were enough to knock me out for most of the day (sleeping).
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: injection site was red, warm and tender along with body aches and temperature of 100.2 - very sore arm
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: injection site was red, warm and tender along with body aches and temperature of 100.2 - very sore arm
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Erythema, Fatigue, Headache, Influenza
Clinical narrative: battling cold for a few weeks - one month" overall improved. Last OV w/ Dr. on 07/30 had "cold for 3-5 weeks prior to that. One of children received abx. No fever at home. Mild headache yesterday but no neck stiffness. Worsening sore throat. No difficulty breathing/SOB. Ongoing mild dry cough (improved). No tongue swelling or difficulty swallowing. + fatigue. Similar to flu sx. No rash. no myalgias. Felt worse after receiving tetanus shot on 08/15. Reports similar feeling after previous tetanus shot ~10 years prior. In clinic febrile to 101.0, HR 70 BP 118/73. OP notable for posterior erythema but no tonsillar exudate or tongue swelling.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: battling cold for a few weeks - one month" overall improved. Last OV w/ Dr. on 07/30 had "cold for 3-5 weeks prior to that. One of children received abx. No fever at home. Mild headache yesterday but no neck stiffness. Worsening sore throat. No difficulty breathing/SOB. Ongoing mild dry cough (improved). No tongue swelling or difficulty swallowing. + fatigue. Similar to flu sx. No rash. no myalgias. Felt worse after receiving tetanus shot on 08/15. Reports similar feeling after previous tetanus shot ~10 years prior. In clinic febrile to 101.0, HR 70 BP 118/73. OP notable for posterior erythema but no tonsillar exudate or tongue swelling.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Baby was found unresponsive in swing and pronounced dead on 8/10/19
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Gait disturbance
Clinical narrative: Severe lower back pain.  Ability to walk impaired.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain
Clinical narrative: Severe lower back pain.  Ability to walk impaired.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Weakness throughout body for 3 and a half days, swelling at injection site and reddened area at injection site, Left arm very weak and sore.  To raise left arm I had to use the right arm.  Slight dizziness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Weakness throughout body for 3 and a half days, swelling at injection site and reddened area at injection site, Left arm very weak and sore.  To raise left arm I had to use the right arm.  Slight dizziness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Choking, Cough, Crying, Cyanosis, Diarrhoea
Clinical narrative: The patient presents with BRUE (brief resolved  unexplained event).  The onset was around 11:30pm.  The degree at onset was moderate.  The course of symptom(s) is Improving.  Presently, the degree of symptom(s) is improving .  4 mo old  female born at 37 weeks presents to ED to role out BRUE. Aunt (who is at bedside) reports patient was lying in her arms, not feeding nor crying, and suddenly started to choke/gasp for air. Aunt reports cyanosis in between the eyebrows. She reports patients hands and feet went cold. Aunt reports patient then began to lose muscle tone for about 5-10 minutes. Aunt began CPR on patient and patient was slow to respond, then woke up and was crying and fussy. Mother reports patient is at baseline after episode. She reports that patient got two vaccinations today. She reports intermittent diarrhea and cough for the past few days. Denies vomiting, diarrhea, or rashes. .
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Dyspnoea, Hypotonia, Irritability, Peripheral coldness, Resuscitation
Clinical narrative: The patient presents with BRUE (brief resolved  unexplained event).  The onset was around 11:30pm.  The degree at onset was moderate.  The course of symptom(s) is Improving.  Presently, the degree of symptom(s) is improving .  4 mo old  female born at 37 weeks presents to ED to role out BRUE. Aunt (who is at bedside) reports patient was lying in her arms, not feeding nor crying, and suddenly started to choke/gasp for air. Aunt reports cyanosis in between the eyebrows. She reports patients hands and feet went cold. Aunt reports patient then began to lose muscle tone for about 5-10 minutes. Aunt began CPR on patient and patient was slow to respond, then woke up and was crying and fussy. Mother reports patient is at baseline after episode. She reports that patient got two vaccinations today. She reports intermittent diarrhea and cough for the past few days. Denies vomiting, diarrhea, or rashes. .
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Middle ear effusion, Pain, Pyrexia, Rash erythematous
Clinical narrative: on Monday 8/12/19 pt reported 100 degree fever, Tuesday 8/13/19 pt reported 99.3 degree fever, pt had body aches and tiredness.  on Wed 8/14/19 pt went to md for "chest congestion and fluid in ear" - she was given ABX.  on after noon of 8/14/19 pt developed a small red rash on the right side of her right check.  Raised and slightly itchy
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Respiratory tract congestion
Clinical narrative: on Monday 8/12/19 pt reported 100 degree fever, Tuesday 8/13/19 pt reported 99.3 degree fever, pt had body aches and tiredness.  on Wed 8/14/19 pt went to md for "chest congestion and fluid in ear" - she was given ABX.  on after noon of 8/14/19 pt developed a small red rash on the right side of her right check.  Raised and slightly itchy
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: syncopal episode after second injection. 1st injection was HPV right delt. 2nd injection was menactra left delt. Pt began leaning to the right. Medical provider caught patient and lowered to supine position on exam table. Syncopal episode approx. 5sec. Pt then confused for 10 sec. Then alert and oriented x 3. Drank a bottle of water and felt normal. Obseved pt for 15 min after episode. Pt able to ambulate without difficulty at discharge. Pt has had syncopal episode in the past while aunt was trying to put in pt's earing
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Autoimmune disorder, Blood test, Computerised tomogram, Diarrhoea, Drug hypersensitivity
Clinical narrative: sudden allergic reaction to antibiotic could not breath and throat closed up, unknown gut issues and autoimmune disorder. hoigh fever for days so far over 2 months of  vomiting diarrhea cannot hold food or any liquids down past 2 months still testing from drs to find out actual diagnosis
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Gastrointestinal disorder, Pyrexia, Stool analysis, Throat tightness
Clinical narrative: sudden allergic reaction to antibiotic could not breath and throat closed up, unknown gut issues and autoimmune disorder. hoigh fever for days so far over 2 months of  vomiting diarrhea cannot hold food or any liquids down past 2 months still testing from drs to find out actual diagnosis
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: sudden allergic reaction to antibiotic could not breath and throat closed up, unknown gut issues and autoimmune disorder. hoigh fever for days so far over 2 months of  vomiting diarrhea cannot hold food or any liquids down past 2 months still testing from drs to find out actual diagnosis
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, warm to the touch, painful
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: significant swelling, erythema, decreased range of motion at left upper extremity. erythema and swelling spanned approx. 9 cm in length and 5 cm in width
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: slow onset rash beginning in injected arm in first 24 hours then progressing to other areas (neck, trunk) after 48 hours.  patient placed on cortisone therapy (methylprednisolone dosepak) on 8/16/19
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission
Clinical narrative: Vaccine did shed and gave shingles to wife and son.  Son, has had a kidney transplant, and heart surgery, now battling shingles after exposure from his father on August 5, 2019, wife also broke out in shingles when the itching began on August 5, 2019.  It is stated that Shingrix does not "shed"...however we are living proof in fact that Shingrix does and did shed and infect 2 family members with shingles. We currently are battling the aftermath of a filthy infectious vaccine.  Both son and myself are covered in shingles sores, still, as of Aug 16th.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chills
Clinical narrative: episode of shivering but once she put her in a warm bath, shivering stopped
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, pain at injection site
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: I started having headache and slight fever since Thursday morning. It got so severe last night along with nausea that I couldn't fall asleep without taking a headache pill. This morning I can still feel very mild headache. The shot area on my arm started swelling and my entire body has been feeling tired since Thursday(yesterday). Just now I suddenly felt dizzy, couldn't stand on my feet and started sweating and had diarrhea. But it lasted for only a few minutes.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Initial insomnia, Injection site swelling, Nausea, Pyrexia
Clinical narrative: I started having headache and slight fever since Thursday morning. It got so severe last night along with nausea that I couldn't fall asleep without taking a headache pill. This morning I can still feel very mild headache. The shot area on my arm started swelling and my entire body has been feeling tired since Thursday(yesterday). Just now I suddenly felt dizzy, couldn't stand on my feet and started sweating and had diarrhea. But it lasted for only a few minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site swelling
Clinical narrative: Swelling 2 inches below the injection site (not at the injection site and a doctor diagnosed it as a infection from the immunization)
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Injection site erythema
Clinical narrative: chills, fever, nausea, anorexia, head ache, joint aches, swelling and redness at injection site 2 inches by 2 inches
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: chills, fever, nausea, anorexia, head ache, joint aches, swelling and redness at injection site 2 inches by 2 inches
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills and fever  sore all over
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: per patient - she started having severe shivering the night after getting shot and went to the ER. They gave her blankets and shivering stopped after 3 hours. She is back at home and reports no other symptoms. She has spoken with her primary care