chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Chest discomfort
Clinical narrative: weird in stomach; heavy chest; This case was reported by a pharmacist via call center representative and described the occurrence of upset stomach in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH DOSE) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE HIGH DOSE. On 13th September 2019, less than a day after receiving Shingrix and FLUZONE HIGH DOSE, the patient experienced upset stomach and chest heaviness. On an unknown date, the outcome of the upset stomach and chest heaviness were unknown.   It was unknown if the reporter considered the upset stomach and chest heaviness to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist who administered first dose of Shingrix along with hi-dose flu shot and experienced stomach feeling weird and heavy chest. The caller unable to further define feeling weird in stomach or heavy chest that patient described to her.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix about 8 weeks ago and she experienced arm pain that had not resolved. The patient had been seen by her physician due to the pain. Emergency room visit required. The outcome of the event was reported as recovering/resolving in source document but as per narrative the outcome of the event was taken as not recovered/not resolved.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary mass, Extra dose administered
Clinical narrative: a lump in his left arm pit; Extra dose administered; This case was reported by a nurse via call center representative and described the occurrence of axillary lump in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menactra (had Menactra 2 years ago).   On 9th September 2019, the patient received the 1st dose of Menveo (intramuscular). On 9th September 2019, less than a day after receiving Menveo, the patient experienced axillary lump and extra dose administered. On an unknown date, the outcome of the axillary lump was recovering/resolving and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the axillary lump to be related to Menveo.  Additional details were provided as follows: The reporter was the mother of the patient. The patient had Menactra 2 years ago from the date of reporting and did not had any issue. The patient received dose of Menveo in the left arm. The reporter stated that, the patient received dose of Menveo past monday of the date of reporting, and developed a lump in his left arm pit, in the night of the day of vaccination. The patient received Menactra 2 years ago and again received Menveo, which led to extra dose administered. The reporter reported that, the lump was decreased some in size. The reporter stated that, the patient needed another dose of Menveo. The patient's mother did call in the event to the physician but hasn't been seen by the doctor. The reporter did not consent to follow up, but open to authiorization form sent later.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: left arm pain / arm pain at the injection site; pain spread around shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd August 2019, 1 hr after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter reported that, after vaccination, the patient experienced pain at the injection site. On 12th September 2019, the patient informed to pharmacist that, the arm pain continued and had spread to the back of the arm and around the shoulder and still persisted The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lyme disease, Product supply issue
Clinical narrative: Lyme disease; Supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of lyme disease in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lyme disease (serious criteria hospitalization and GSK medically significant) and product supply issue. On an unknown date, the outcome of the lyme disease was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received the first dose of Shingrix and she had not yet received the second dose, partly due to the supply issue and partly due to hospitalized for about 15 days due to Lyme disease. Lot number was not available at the time of reporting. No further information was provided.  The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash
Clinical narrative: broke out in flat rashes in the back of his neck and right ear; This is a spontaneous report from a contactable physician.   An infant male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at single dose, diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), in right thigh and hepatitis b vaccine in right thigh, all via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broke out in flat rashes in the back of his neck and right ear on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient received expired Ipol vaccine; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19 years old male patient who received vaccine IPV (VERO) [IPOL] and reported that patient received expired Ipol vaccine (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).  On 02-Aug-2019, the patient received 1st dose of suspect 0.5 ml IPV (VERO) lot N1F181M and expiry date: 23-Jun-2019 via unknown route in the left deltoid.  It was reported that the vaccine was approximately 5 weeks expired when it was administered.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: mixed the DTaP/IPV component but did not mix the Acthib portion of this vaccine and administered to a patient, no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown demographics who received a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ071AA, expiry date: 13-Jun-2020, route and site of administration were not reported) which was reconstituted incorrectly on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported patient received a dose of Pentacel but did not mix the powder. Only administered the liquid portion from the vial. Mixed the DTaP/IPV component but did not mix the Acthib portion of this vaccine.  At the 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB diluent was administered without the Hib lyophilized powder/ No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a male patient of an unknown age who received 0.5 mL dose of ActHIB diluent without the Hib lyophilized powder (Product preparation error) of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ112AAC, expiry date- 21-06-2020 via unknown route in unknown administration site on 26-Aug-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 Product preparation error.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Consumer is pregnant and received the Adacel vaccine, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who was received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, route and site of administration were unknown) on an unspecified date, while she was pregnant.  Data regarding this pregnancy were received prospectively i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date is 27-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Reporter did not know the dose. She did not receive any other medication or vaccinations.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.  List of documents held by sender- none.
Sex: F
Vaccine: MNQ, UNK
Symptoms: Condition aggravated, Mast cell activation syndrome
Clinical narrative: flare of mass cell activiation syndrome; Initial information received on 27-Aug-2019 regarding an unsolicited valid serious case received from a non-health care professional  This case involves a 18 years old female patient who experienced flare of mass cell activation syndrome (Condition aggravated), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and TUBERCULIN TEST (TUBERSOL).  The patient was found to have an egg and corn allergy and mass cell activation syndrome (mast cell activation syndrome.).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 30-Jul-2019, the patient received a 0.5 ml booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site and was treated with TUBERCULIN TEST (TUBERSOL) (lot number, expiry date, dose, route and site of administration were not reported).  On an unknown date, the patient developed flare of mass cell activation syndrome (condition aggravated) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TUBERCULIN TEST.   Details of lab data not reported.  Final diagnosis was flare of mass cell activiation syndrome and flare of mass cell activiation syndrome.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient did not recover from the event.  Batch number of Tubersol was requested.  List of documents held by sender: none.; Sender's Comments: This case concerns a 18 years old female patient with history of egg and corn allergy and mast cell activation syndrome who developed flare of mast cell activation syndrome after vaccination with MENACTRA and Tubersol. The time to onset is unknown. However, Lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they gave a 17 yr old FluBlok/ no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported that they gave a 17 year old Flublok/ no AE (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 20-Aug-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1901 and expiry date: 17-May-2020 via intramuscular route in the right arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  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: 39.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received the vaccine which had been shipped more than 2 days/ No AE; Initial information and additional information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to case 2019SA241338 and 2019SA243238 (same reporter).  This case involves a 39 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number UJ211AA expiry date 30-JUN-2020 not reported via intramuscular route in the left deltoid on 27-Aug-2019 the vaccine that was shipped more than 2 days.  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.  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: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: a 74 years old male patient received a dose of Fluzone HD which had been shipped more than 2 days thus not valid/No AE; Initial information received on 27-Aug-2019 and additional received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to cases 2019SA243159 and 2019SA241338 (same reporter).  This case involves a 74 years old male patient who a 0.5 ml received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] which had been shipped more than 2 days thus not valid lot UJ221AB, expiry date: 01-APR-2020 via intramuscular route in the left deltoid on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  No side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: IPV, UNK
Symptoms: Wrong product administered
Clinical narrative: a patient received IPOL intradermally instead of Tubersol as intended, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 49 years old male patient who received 0.1 mL dose of vaccine IPV (VERO) [IPOL] lot P1A171M via intradermal route in the left arm on 26-Aug-2019 instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccines received.  It was a case of actual medication error due to wrong vaccine administered. Medical assistant stated that a vial of IPOL was in a bin with Tubersol and administered interdermally to the patient instead of Tubersol.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Inappropriate schedule of product administration
Clinical narrative: student received 2 dose, 6 weeks apart, no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 years old female patient who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that student received 2 dose, 6 weeks apart (inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medication included TUBERCULIN PPD.   On 16-Jul-2019, the patient received 1st dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site. On 27-Aug-2019 she also received 2nd dose of the same vaccine 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6021AA and expiry date: 29-Jul-2020 via unknown route in the right deltoid.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a four months old male patient was received the liquid DTaP and IPV of the Pentacel vaccine with out Lyophilizing ActHIB powder/No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who received the liquid DTAP and IPV of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine without lyophilizing ACT-HIB powder dose (Product preparation issue): 0.5ml, lot UJ014AAA, expiry date: 10-OCT-2020 via intramuscular route in the right thigh on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was an actual medication error due to inappropriate reconstitution technique (Product preparation issue).  It was unknown if adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: left arm pain; limited mobility; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown demography who experienced left arm pain (pain in extremity) and limited mobility (mobility decreased), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced left arm pain (pain in extremity) and limited mobility (mobility decreased).  (Other relevant tests included no lab data.)  Final diagnosis was pain in arm and mobility decreased.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Pentacel was inadvertently administered to a patient, no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who inadvertently administered with 0.5 ml dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: C5466AB, Expiry Date: 05-Sep-2019) via intramuscular route in the right thigh on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site bruising, Injection site discharge, Injection site swelling
Clinical narrative: oozing at site, it was like an open wound; bump at injection site larger than usual; bruising at injection site; pregnant patient vaccinated with Adacel; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA260889 (same reporter).  This case involves a 20 years old female patient who experienced oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in pregnancy.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported events occurred at unknown gestation period. The date of last menstrual period was not reported but reported as 31 weeks ago. The estimated due date is 10-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2019, the patient received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5602AA, expiry date: 19-Mar-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising).  Patient was advised to keep site clean and dry and take Benadryl. Keep eye on sute in case fever, growing in size and then go to ER if needed.  The outcome of the events was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site bruising, Injection site discharge, Injection site swelling
Clinical narrative: oozing at site, it was like an open wound; bump at injection site larger than usual; bruising at injection site; pregnant patient vaccinated with Adacel; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA260880 (same reported).  This case involves a 29 years old female patient who experienced oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported events occurred at unknown gestation period. The date of last menstrual period was not reported but reported as 27 weeks ago. The estimated due date is 04-Dec-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2019, the patient received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5602AA, expiry date:19-Mar-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising)  (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising).  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: delayed in transit/no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA260949.  This case involves a 18 month old male patient who received 0.5 ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6645LA, expiry date:30-Jun-2020) via intramuscular route in the left thigh), on 13-Sep-2019 which was delayed in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Contamination therapy included Pentacel on 13-Sep-2019.   It was an actual medication error due to Incorrect product storage.  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 documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: redness, hardness, hotness in a large circle around the injection site
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: After vaccine administration, patient was bleeding from site and a bump under the skin was left on deltoid muscle.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient received Tdap vaccination and had fever for a day then the fever went away.  The day after vaccination she had arm pain and had limitation in range of motion til today, 9/23/19.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Hypoaesthesia
Clinical narrative: Within 5 minutes of injection, Dr. complained of a sensation of coldness going down the arm to the hand.  When checked on roughly 15 minutes later, reported numbness that started at anterior crease of the elbow that continued to the palm of the hand and the posterior aspect of the hand.  Mobility not affected.  Followed up roughly one hour post injection.  Reported no change.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: patient felt feverish, had a red, tender and inflamed area a little smaller than the size of a baseball at injection site. Patient went to urgent care 9/22/19 and was given triamcinolone cream and told to mark red area and contact primary care doctor if it enlarged and also to come tell us.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Urticaria
Clinical narrative: Patient said that she developed a hive about 3-4 inches in size that was warm, red, and gradually growing late Saturday evening. Today (Monday) she reported that it had grown to about 5-6 inches. She was going to the doctor today for an appointment and was going to have it checked out. Patient also reported a low grade fever that she was taking advil for.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Mobility decreased, Skin warm
Clinical narrative: patient reporting redness, warness, and difficulty raising arm over head. Called pharmacy to report adverse event. Informed patient needed to seek treatment if does not improve.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: tingling and prickling on skin,  doctor confirmed shingles
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Insomnia, Joint range of motion decreased, Pain in extremity, Tenderness
Clinical narrative: Arm tenderness, arm ache (dull ache), loss of strength in arm, very limited range of motion. Loss of sleep due to ache.
Age: 52.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chest pain, Discomfort, Dyspnoea, Pain in extremity
Clinical narrative: Patient perceived about shore arms, shorness of breath and chest pain and feeling very uncomfort
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SOME RED AND SLIGHTLY SWOLLEN AT THE INJECTION SITE THE NEXT MORNING. NO DISCOMFORT REPORTED. I ASKED THE PATIENT TO CONTACT ME THE NEXT DAY IF THE AREA HAS NOT IMPROVED. I DID NOT RECEIVE A CALL BACK FROM HER. I REACHED OUT TO HER TODAY AGAIN, BUT WAS UNABLE TO SPEAK WITH HER.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Nausea, Skin discolouration, Tinnitus
Clinical narrative: Pt looked like she had fallen asleep and slumped in the chair. After arousing her, her skin turned green/grey. She reported dizziness, ringing in her ears, and nausea. Pt was given water to sip, a sucker, and observed for approximately 20-30 minutes. Mother took pt home after observation period. I followed up on 9/21/19 with a phone call. Mom was not home but pt was reported to be fine.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported experiencing arm redness that started at the upper arm where the vaccine was given and spread down to the elbow. He said that it felt warm to the touch, but was not overly painful. He denied having a fever or any sort of open sores on the arm.  Pharmacist told patient to go see his doctor for follow up to monitor
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: Pt was given Tdap (unknown manufacturer however above field was required. Pt will call  hospital for specific manufacturer.) the day after delivering her child at Hospital. She woke the next morning with complaint of inability to use L arm. States she couldn't move her L arm and had severe shooting pain into L arm for ADLs. States this severity lasted about 2 months then use of arm slightly improved. Now complains of diffuse pain, weakness and fatigue throughout B hips and lower extremities. Continues with sharp pain and weakness in L shoulder. Complains about constant aching in wrists and arm as well as generalized fatigue.  After consultation with primary care, orthopedics, and rheumatologist pt was referred to Physical Therapy to address shoulder pain and weakness.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal disorder, Musculoskeletal pain, Pain
Clinical narrative: Pt was given Tdap (unknown manufacturer however above field was required. Pt will call  hospital for specific manufacturer.) the day after delivering her child at Hospital. She woke the next morning with complaint of inability to use L arm. States she couldn't move her L arm and had severe shooting pain into L arm for ADLs. States this severity lasted about 2 months then use of arm slightly improved. Now complains of diffuse pain, weakness and fatigue throughout B hips and lower extremities. Continues with sharp pain and weakness in L shoulder. Complains about constant aching in wrists and arm as well as generalized fatigue.  After consultation with primary care, orthopedics, and rheumatologist pt was referred to Physical Therapy to address shoulder pain and weakness.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Tendon disorder, X-ray normal
Clinical narrative: Pt was given Tdap (unknown manufacturer however above field was required. Pt will call  hospital for specific manufacturer.) the day after delivering her child at Hospital. She woke the next morning with complaint of inability to use L arm. States she couldn't move her L arm and had severe shooting pain into L arm for ADLs. States this severity lasted about 2 months then use of arm slightly improved. Now complains of diffuse pain, weakness and fatigue throughout B hips and lower extremities. Continues with sharp pain and weakness in L shoulder. Complains about constant aching in wrists and arm as well as generalized fatigue.  After consultation with primary care, orthopedics, and rheumatologist pt was referred to Physical Therapy to address shoulder pain and weakness.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Paraesthesia
Clinical narrative: 2 hours after receiving the vaccine, patient complained of right shoulder pain and immobility, and tingling in right arm
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Headache, Immediate post-injection reaction, Injection site bruising, Nausea
Clinical narrative: Immediate swelling in arm and mild bruising. Had the patient sit for 20 minutes or so to ensure she was okay.  Followed up with patient the following day and  the patient explained she had some nausea, headache, and vomiting after eating dinner that night. The headache persisted for 2 days as well. Other than bruising, all other side effects were gone when I followed up on 9/23/19. Her arm was feeling fine just bruising at injection site remained.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Immediate swelling in arm and mild bruising. Had the patient sit for 20 minutes or so to ensure she was okay.  Followed up with patient the following day and  the patient explained she had some nausea, headache, and vomiting after eating dinner that night. The headache persisted for 2 days as well. Other than bruising, all other side effects were gone when I followed up on 9/23/19. Her arm was feeling fine just bruising at injection site remained.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: local redness, soreness, swelling, warmth inside the body, diarrhea.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient came in today and mentioned that his right arm felt sore and warm after receiving the Flu-HD vaccine on the 17th. He also reported that a few days later that arm felt even more sore at the joint especially when he tried to raise his arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The patient states she has raised and "blood red" skin from right upper shoulder down to elbow area.  It is hot to the touch.  The left arm is sore but has no swelling or redness (Adacel only).  The patient states she got the same reaction last year, but included more swelling.  Last year she received the flu vaccine from the doctor's office.  She noted this prior to receiving the shot but thought perhaps it was the doctor's office that was the issue as she received it before, multiple times, from another pharmacy, with no issues.  The patient has been taking Benadryl for the swelling.   It has now been 5 days from the injections.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Flushing, Myalgia, Pyrexia
Clinical narrative: Patient reported high fever (did not take her temp), chills, flushing, vomiting, diarrhea, muscle aches.  Lasted approximately 36 hours.  No medical treatment was sought.  The symptoms were gradual onset and gradual increase in intensity.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient reported high fever (did not take her temp), chills, flushing, vomiting, diarrhea, muscle aches.  Lasted approximately 36 hours.  No medical treatment was sought.  The symptoms were gradual onset and gradual increase in intensity.
Age: 61.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluad for 65+ when not over 65 yo.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth, Pain, Tenderness
Clinical narrative: Employee has erythema and warmth at site of second Hep-B immunization, some localized pain and tenderness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient showed up and showed us her arm today 9/23/2019.  It was red at the location of the shot. She said it was itchy and hot.  She was advised to follow up with Dr whose information was provided in this form (her primary care doctor). We do not know if the patient will follow up with the doctor or not. We do not know the outcome.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Dysstasia, Immediate post-injection reaction, Malaise
Clinical narrative: Immediate severe dizziness, lightheaded, weakness, couldn?t stand, turned pale. Had to sit down and wait 20 minutes before I could leave the store. Felt weak and general malaise for 24 hours.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pallor
Clinical narrative: Immediate severe dizziness, lightheaded, weakness, couldn?t stand, turned pale. Had to sit down and wait 20 minutes before I could leave the store. Felt weak and general malaise for 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash developed about 1 - 2 inches below the site of injection
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Moderate arm pain, chills, nausea, tiredness, low-grade fever - within 24 hours
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chapped lips, Chills, Injection site reaction, Pain, Paraesthesia oral
Clinical narrative: Patient states that very early the next morning she had extreme chills.  When she woke up the next AM she had aches everywhere.  She said after taking Tylenol, the aches were tolerable.  What she was most concerned about was that early Monday AM ( 1 and 1/2 days post vaccination)  she had lots of itchy red spots on her chest and arm.  She also said her lips felt very rough and a little bit tingly. She said that they were not swollen and that her tongue was not involved.  She presented at the pharmacy 9/23/19 at 6PM and had multiple red, blotchy spots on her left arm about 3 inches below the injection site. She asked if she could take Benadryl and I said yes that she should take.   Patient did not want to run to urgent care and said thought not getting worse but I did tell her if her tongue or any part of her face was to start to swell to seek immediate help./
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Patient states that very early the next morning she had extreme chills.  When she woke up the next AM she had aches everywhere.  She said after taking Tylenol, the aches were tolerable.  What she was most concerned about was that early Monday AM ( 1 and 1/2 days post vaccination)  she had lots of itchy red spots on her chest and arm.  She also said her lips felt very rough and a little bit tingly. She said that they were not swollen and that her tongue was not involved.  She presented at the pharmacy 9/23/19 at 6PM and had multiple red, blotchy spots on her left arm about 3 inches below the injection site. She asked if she could take Benadryl and I said yes that she should take.   Patient did not want to run to urgent care and said thought not getting worse but I did tell her if her tongue or any part of her face was to start to swell to seek immediate help./