chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Walking aid user
Clinical narrative: severe pain in right buttocks and traveled down her right leg; mobility due to severe pain; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   The patient's past medical history included joint replacement. Concurrent medical conditions included spinal stenosis.   On 3rd July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th July 2019, 1 days after receiving Shingrix, the patient experienced leg pain (serious criteria clinically significant/intervention required) and mobility decreased (serious criteria clinically significant/intervention required). The patient was treated with tramadol and paracetamol (Tylenol). On an unknown date, the outcome of the leg pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the leg pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient developed severe pain that started in her right buttocks and traveled down her right leg.  The patient stated this pain was similar to spinal stenosis pain, but described it as severely worse than usual. The patient sought medical treatment with her MD, received medication (Tramadol and Tylenol) to treat pain and physical therapy, and was using a walker to assist with mobility due to severe pain.  The patient did not consent to healthcare professional follow up.  The patient did not consent to follow up.
Sex: F
Vaccine: RAB
Symptoms: Headache, Myalgia, Product administered at inappropriate site
Clinical narrative: headaches; The injection on Day 7 was not injected into the deltoid muscle. It was injected lower; muscle aches; Initial information received on 05-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced headaches, muscle aches while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received post exposure immunization, injection of doses on Day 0, 3, 7, and 14 of suspect RABIES (HDC) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. (Day 7 injection was given in lower deltoid muscle NOS)  On an unknown date, the patient developed a non-serious headaches (headache) with unknown latency following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious muscle aches (myalgia) with unknown latency following the administration of RABIES (HDC) VACCINE.  It was an actual medication error due vaccine administered at inappropriate site as the injection on Day 7 was not injected into the deltoid muscle. It was injected lower.  Lab data was not provided.  Final diagnosis was muscle aches and headaches.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved for headaches, as Recovered / Resolved for muscle aches (duration 3 days).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Information on lot number was requested for this case.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Discomfort, Erythema, Inflammation, Insomnia
Clinical narrative: discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car); muscle spasms; terrible shaking.; arm became red and swollen. She was unable to sleep on the arm; chills; pain / feeling "pinching & grabbing; felt sick; Initial information received on 10-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car), muscle spasms, terrible shaking, arm became red and swollen. she was unable to sleep on the arm, chills, pain / feeling "pinching & grabbing and felt sick,  while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Hysterectomy on 06-AUG-2012 and Hernia. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car) (discomfort), muscle spasms, terrible shaking. (tremor) , arm became red and swollen. she was unable to sleep on the arm (inflammation), chills, non-serious pain / feeling "pinching & grabbing (pain) and felt sick (malaise)     (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was discomfort, muscle spasms, Shaking, Inflammation localized, chills, pain and Sickness  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Muscle spasms, Pain, Peripheral swelling, Tremor
Clinical narrative: discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car); muscle spasms; terrible shaking.; arm became red and swollen. She was unable to sleep on the arm; chills; pain / feeling "pinching & grabbing; felt sick; Initial information received on 10-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car), muscle spasms, terrible shaking, arm became red and swollen. she was unable to sleep on the arm, chills, pain / feeling "pinching & grabbing and felt sick,  while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Hysterectomy on 06-AUG-2012 and Hernia. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car) (discomfort), muscle spasms, terrible shaking. (tremor) , arm became red and swollen. she was unable to sleep on the arm (inflammation), chills, non-serious pain / feeling "pinching & grabbing (pain) and felt sick (malaise)     (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was discomfort, muscle spasms, Shaking, Inflammation localized, chills, pain and Sickness  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave a 18 year old second dose of Menactra, First Menactra was in 2017/No AE; Initial information received on 10-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18 years old female patient who received two doses of 0.5 mL dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in 2017 and Vial Lot: U5869AA, Box Lot U5869AA, expiry date: 05-Aug-2020 via intramuscular route in the right deltoid on 10-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Extra dose administered. This was the second Menactra the child has had 10-Jul-2019.  There were no side effects.  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: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: a female patient received expired Menactra vaccine; Initial information received on 11-Jul-2019 and additional information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18-year-old female patient who received a 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine lot U5917AA via unknown route in the right deltoid on 10-Jul-2019. It was 2 of 2 in series.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) in left deltoid.  It was an actual medication error due to expired vaccine used.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB, IPV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: 2 patients received Adacel, Pentacel, Ipol and Quadracel vaccine which were exposed to a temperature of 51 degrees Fahrenheit for a total of 5 to 6 minutes due to human error refrigerator door was left open; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves 2 patients who received doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], IPV (VERO) [IPOL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine which were exposed to a temperature of 51 degrees Fahrenheit for a total of 5 to 6 minutes due to human error refrigerator door was left open lot number and expiry date not reported on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: had administered, 2 yo, a Quadracel vaccination of 0.5ml, in the left thigh; Initial information received on 12-Jul-2010 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that patient had administered, 2 yo, a Quadracel vaccination of 0.5ml, in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  On 11-Jul-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA and expiry date: 14-Nov-2019 via unknown route in the left thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to Flu vaccine; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age patient who experienced allergy to flu vaccine, while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown)via unknown route in unknown administration site.  The patient developed a non-serious allergy to flu vaccine (allergy to vaccine) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was allergy to flu vaccine.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergy to flu vaccine.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient had a Daptacel instead of a Adacel today in her left Deltoid IM, Standard, Immunization/ No AE; patient had a Daptacel instead of a Adacel today in her left Deltoid IM, Standard, Immunization/ No AE; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 81 years old female patient who had DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] ] (lot C5281AA, expiry date: 05-Oct-2019) via intramuscular route in the left deltoid, instead of a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], On 11-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included- PNEUMOVAX 23  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  There were no side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Adacel, Menactra that reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 11 years old patient who was vaccinated with  0.5 ml of first doses of vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6273AA and Exp. Date 24-Apr-2021) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines were reached at 33.5C.  The patient's medical history not reported .  Concomitant vaccination included 0.5 ml dose of HPV VACCINE (HPV VACCINE) received via intramuscular route on 09-Jul-2019 (lot number and Exp. Date not reported) for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192618, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a nine weeks old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ013AAA and Exp. Date 10-OCT-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) received 0.5 ml dose via intramuscular route on 09-Jul-2019 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) received 0.5 ml dose via intramuscular route on 09-Jul-2019.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 21.0
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Adacel which reached 33.5 degree Celsius that was vaccines were administered to 11 patients; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.  This case is linked to cases 2019SA192651, 2019SA192618, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 21 years old patient who was vaccinated with  0.5 ml second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6273AA and Exp. Date 24-Apr-2021) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  It was an actual medication error case due to product storage error temperature too high.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menactra that reached 33.5 degree Celsius was administered; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660. (Same reporter).  This case involves a 11 years old patient (gender not reported) who was vaccinated with 0.5 ml first dose of vaccine MENINGOCOCCAL VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines reached at 33.5 degree Celsius on that day.  Medical history: not reported.  Concomitant medications included patient was vaccinated with a dose of HPV VACCINE.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306, 2019SA193307 and 2019SA158240 (same reporter).   This case involves 11 years old male patient with who was vaccinated with dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 31-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction 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 document held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; 14 years old patient recived booster dose of MENACTRA; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193302, 2019SA193307, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 14 years old female patient with who was vaccinated with 0.5 ml first booster dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 30-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and inappropriate schedule of vaccine administered.  It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193307, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).   This case involves 13 years old female patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193307, 2019SA193303, 2019SA193302, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 18 years old male patient with who was vaccinated with 0.5 ml once first booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directiveand Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.   This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193307, 2019SA193306 and 2019SA158240 (same reporter).   This case involves 12 years old male patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 03-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Product storage error
Clinical narrative: second booster dose  of MENACTRA was given to the patient; MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193307 and 2019SA158240 (same reporter).  This case involves an 18 years old female patient with who was vaccinated with 0.5 ml second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 31-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and Extra dose administered.  It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  At the time of reporting, no adverse reaction 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 17 years old male patient who was vaccinated with 0.5 ml first booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 06-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient called 7-17-2019 and said when she woke up, she notice swelling under the arm where the boostrix was administered. The patient said she had been fine prior to 7-17-19. The package insert states that a patient may experience a possible reaction up to 14 days of administration. There are reports stating swelling >20mm 3.9% and >50mm 1.4%, This documentation is on package 9 of package insert. Patient said she is going to contact doctor and I recommended ibuprofen to reduce the swelling .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Vomiting
Clinical narrative: got my 2nd shingles shot at 7:45 am and at 8:00 pm I got the Chills and hour or so later I was throwing up, threw up 3 times and  the chills lasted till about midnight 1:00 am
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills, overall malaise. Called pharmacy and they said to treat with Advil or Tylenol.
Age: 58.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Patient into clinic requesting both meningococcal vaccines prior to starting a new medication for his Myasthenia Gravis. The next evening the spouse reported that the patient experienced extreme head/neck pain and the left arm was painful and weak.  After several days of rest patient reports improvements in symptoms, but reports they are still bothersome. Patient was instructed to follow up with PCP ASAP
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy breast abnormal, Breast mass, Chills, Diagnostic aspiration, Injection site erythema
Clinical narrative: By about 6 PM, started having chills and shaking which lasted until around midnight. Awoke the next morning with virtually confluent maculopapular rash over both feet and lower legs and some sparse areas of rash on torso. The rash resolved over the next 24 hours. Left arm at site of injection had a hard, red, swollen, tender area about 3 by 4 cm for 1 week that then resolved over a few days during the next week.    About June 10, a thickened area in the left breast was discovered.     Another unexplained, virtually confluent maculopapular rash of the feet and lower legs occurred 6/21/2019 (32 days after the Shingrix vaccine) and continued through the next several days resulting in a visit to the internist on 6/25/2019. The internist said that he did not know what the rash was but opted to treat with prednisone 30 mg for 3 days followed by 20 mg for 3 days followed by 10 mg for 3 days. The rash resolved during the first 3 days of this treatment. The breast mass was seen by the gynecologist who referred for an ultrasound. The ultrasound noted a suspicious mass the left breast. This was biopsied 7/3/2019 and found to be ductal carcinoma. Ultrasound examinations on 7/16/2019 found multiple enlarged lymph nodes in the left axilla and supraclavicular area. It was impossible to know whether these were secondary to the carcinoma or were a reaction to the Shingrix vaccine. Fine needle aspiration was required and was inconclusive. It would have been nice if the manufacturer has some published information about lymph node reaction to the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Invasive ductal breast carcinoma, Lymphadenopathy
Clinical narrative: By about 6 PM, started having chills and shaking which lasted until around midnight. Awoke the next morning with virtually confluent maculopapular rash over both feet and lower legs and some sparse areas of rash on torso. The rash resolved over the next 24 hours. Left arm at site of injection had a hard, red, swollen, tender area about 3 by 4 cm for 1 week that then resolved over a few days during the next week.    About June 10, a thickened area in the left breast was discovered.     Another unexplained, virtually confluent maculopapular rash of the feet and lower legs occurred 6/21/2019 (32 days after the Shingrix vaccine) and continued through the next several days resulting in a visit to the internist on 6/25/2019. The internist said that he did not know what the rash was but opted to treat with prednisone 30 mg for 3 days followed by 20 mg for 3 days followed by 10 mg for 3 days. The rash resolved during the first 3 days of this treatment. The breast mass was seen by the gynecologist who referred for an ultrasound. The ultrasound noted a suspicious mass the left breast. This was biopsied 7/3/2019 and found to be ductal carcinoma. Ultrasound examinations on 7/16/2019 found multiple enlarged lymph nodes in the left axilla and supraclavicular area. It was impossible to know whether these were secondary to the carcinoma or were a reaction to the Shingrix vaccine. Fine needle aspiration was required and was inconclusive. It would have been nice if the manufacturer has some published information about lymph node reaction to the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Tremor, Ultrasound breast abnormal
Clinical narrative: By about 6 PM, started having chills and shaking which lasted until around midnight. Awoke the next morning with virtually confluent maculopapular rash over both feet and lower legs and some sparse areas of rash on torso. The rash resolved over the next 24 hours. Left arm at site of injection had a hard, red, swollen, tender area about 3 by 4 cm for 1 week that then resolved over a few days during the next week.    About June 10, a thickened area in the left breast was discovered.     Another unexplained, virtually confluent maculopapular rash of the feet and lower legs occurred 6/21/2019 (32 days after the Shingrix vaccine) and continued through the next several days resulting in a visit to the internist on 6/25/2019. The internist said that he did not know what the rash was but opted to treat with prednisone 30 mg for 3 days followed by 20 mg for 3 days followed by 10 mg for 3 days. The rash resolved during the first 3 days of this treatment. The breast mass was seen by the gynecologist who referred for an ultrasound. The ultrasound noted a suspicious mass the left breast. This was biopsied 7/3/2019 and found to be ductal carcinoma. Ultrasound examinations on 7/16/2019 found multiple enlarged lymph nodes in the left axilla and supraclavicular area. It was impossible to know whether these were secondary to the carcinoma or were a reaction to the Shingrix vaccine. Fine needle aspiration was required and was inconclusive. It would have been nice if the manufacturer has some published information about lymph node reaction to the vaccine.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Musculoskeletal disorder
Clinical narrative: pain in right shoulder worsened  so that by 6 pm it was intensity of 9/10, severe .couldn't lay on that side ,use right arm, unable to sleep at all night of 7-17/18  .was still very sore next morning, intensity 7-18 , 6/10.Reminded me of the aftermath of having been stung by a hornet or wasp, to which I am allergic .Note: there were no other Sx of allergic reactions, "just" the severe pain. Information sheet states that " some people have severe pain in the shoulder and have difficulty moving the arm where a shot was given. This hapens very rarely".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: ARM IS SLIGHTLY SWOLLEN AND RED. IT FEELS WARM TO THE TOUCH AND IS SORE. PATIENT STATES SHE FEELS FINE.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: About 4 to 5 hours after receiving vaccine patient started to developed a rash throughout her body extending from the back of her neck, through her abdomen, to part of the leg. She described the rash as very itchy, red, and raised welts. She explained that it looks like "mosquito bites" throughout her body.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pruritus, Erythema, Herpes zoster, Pruritus
Clinical narrative: On 7/4/19, her right ear started to become warm and itchy. The next day on 7/5/19, she noticed it spreading to her scalp and turning pink. On 7/6/19, it was fire red on her outer ear and she began to see blisters which spread to her scalp and chin. She consulted with a dermatologist over the phone who thought it might be singles. She tried to apply an unknown ointment which did not help. She went to a walk in clinic on 7/15/19 to have somebody look at it, and they confirmed it was shingles and started her on a 5 day course of Valtrex.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: On 7/4/19, her right ear started to become warm and itchy. The next day on 7/5/19, she noticed it spreading to her scalp and turning pink. On 7/6/19, it was fire red on her outer ear and she began to see blisters which spread to her scalp and chin. She consulted with a dermatologist over the phone who thought it might be singles. She tried to apply an unknown ointment which did not help. She went to a walk in clinic on 7/15/19 to have somebody look at it, and they confirmed it was shingles and started her on a 5 day course of Valtrex.