chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received a Typhim VI shot on 30-Oct-2019, Typhim VI expired on 19-Oct-2019 with no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received TYPHOID VI POLYSACCHARIDE VACCINE (lot number unknown, expiry date: 19-Oct-2019) via unknown route on 30-Oct-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 expired product administered. It was reported that an individual was given an expired Typhim VI vaccine on 30-Oct-2019, Typhim VI expired on 19-Oct-2019.  At the time of reporting, the patient had no adverse event.  Additional information regarding the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm / no AE; vaccine dripped out on her arm / no AE; it started to leak between the plastic collar and the syringe / no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 25-Oct-2019.  This case involves an unknown age female patient for whom it was reported that he was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm (syringe issue, exposure via skin contact, underdose), while she received vaccine influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a single Dose (dose unknown) of suspect influenza usp trival a-b subvirion no preservative vaccine lot UJ292AB via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to (exposure via skin contact and underdose). It was also a case of syringe issue.  case details: Pharmacist states that he was administering a Fluzone HD injection and he was injecting the shot and it started to leak between the plastic collar and the syringe. He was not able to tell how much dripped out but it was enough that it was on her arm  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: U
Vaccine: FLU4, FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pediatric patient that inadvertently received a second dose of influenza vaccine this season, no adverse event; Initial information received regarding an unsolicited valid non-serious case received from a pharmacist and was transmitted to Sanofi on 06-Nov-2019.  This case involves a pediatric patient who inadvertently received a second dose 0.5 ml of influenza quadrival a-b vaccine [Fluzone Quadrivalent], pre-filled syringe UT6645LA via intramuscular route in arm on 05-Nov-2019. The patient had received first dose of Influenza vaccine (unknown manufacturer) (dosing details unknown, batch number not reported) via unknown route an site on an unknown date this year.  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 Inappropriate schedule of vaccine administered.   No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: arms began flaying uncontrollably; Initial information received on 04-Nov-2019 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case is linked to cases 2019SA308265 (same reporter)  This case involves a 73 years old female patient whose arms began flaying uncontrollably (skin exfoliation), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Breast cancer female.  On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site.  On an unknown date in 2016 (in the afternoon), the patient's arms began flaying uncontrollably (skin exfoliation), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was flaying uncontrollably.   The patient was taken to urgent care and was placed on fluids; and that the next morning the arms began flaying again; that she was placed on fluids and it resolved self in.  On an unknown date, the patient recovered from the event.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: shipment of Adacel vaccine arrived on 07-Nov-2019, shipment of vaccine was 1 day late with no AE; shipment of Adacel vaccine arrived on 07-Nov-2019, shipment of vaccine was 1 day late with no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 41-year-old female patient who received a 0.5 dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6539AA, expiry date: 13-Nov-2021 via intramuscular route in the right deltoid on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to the incorrect product storage and product distribution issue. It was reported that the shipment of vaccine was 1 day late. The shipment of Adacel vaccine arrived on 07-Nov-2019. It was shipped on 04-Nov-2019, exceeding the 2 day delivery time. An office personnel unpacked the delivery and 2 patients inadvertently received the Adacel vaccine on 07-Nov-2019.  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 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.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Quadracel was administered with no AE; Initial information received on 11-Nov-2019 regarding an unsolicited non-serious case received from health-care professional.  This case involves a 5-years old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] (lot: C5248AA, expiry date: 21-AUG-2019), via intramuscular route in unknown administration site on 02-Oct-2019.  The patient's past medical history was unknown.  List concomitant: flu vaccine and MMRV  It was an actual medication error due to the expired product administered.  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 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.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with an expired dose of Typhim Vi vaccine with no adverse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown demographics who received an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot N1K901, Expiry date- 24-Oct-2019) via unknown route in unknown administration site on 28-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  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 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.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: administered expired typhim to a patient, no adverse event; Initial information received on 19-Nov-2019 and follow up information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown patient who was administered expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Nov-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported expiration date: 27-Oct-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired product administered.   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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Antibody test negative
Clinical narrative: blood work showed no immunity to the flu.; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 36 years old female patient who showed no immunity to the flu (antibody test negative), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  No other vaccine was given.  On 10-Oct-2019, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6654KA Expiry date- 30-Jun-2020 via intramuscular route in the left deltoid.  on 11-NOv-2019 and on 12-Nov-2019, one month one day and one month two days after, blood work was performed and patient showed no immunity to the flu (antibody test negative).  No other events was reported.  Lab data included antibody test negative.  No corrective treatment was reported.  outcome is not applicable.
Age: 7.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received Infanrix instead of the indicated ( as part of catch-up schedule) Adacel, no AE; Initial and follow-up information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old patient who received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (unknown lot number, expiry date and dosing details) on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was an actual medication error due to wrong product administered. It was reported that the patient received Infanrix instead of the indicated ( as part of catch-up schedule) Adacel.  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 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.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: vaccine ran down the patient's arm during administration; vaccine ran down the patient's arm during administration but patient got most of the vaccine; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case, from a pharmacist.  This case involves a female patient of an unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686NA, expiry date: Jun-2020), via unknown route in the arm  not otherwise specified (NOS), on 20-Nov-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to vaccine underdose. It was also a case of Exposure via skin contact.  t was reported that the pharmacist administered Fluzone Quadrivalent on 20Nov2019 and the vaccine ran down the patient arm during administration (Preferred Term: Syringe issue and Preferred Term: Underdose). The dose to be given was 0.5ml. The pharmacist feels as though the patient got most of the vaccine. Patient stated the liquid that ran down her arm was clear with blood per the usual.  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 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.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Fluzone High Dose on 06nov2019 and another today in the same site left arm, no AE; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ301AA, expiry date: 24-Jun-2020 via intramuscular route in the left arm on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered. It was reported that the patient received a Fluzone High Dose on 06nov2019 and another today.  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.
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Injection site erythema, Pain in extremity, Vaccination site pain
Clinical narrative: back. pain; not being able to lay on the left arm due to pain in arm; chest pain; injection site reaction of redness to the left arm; Initial information was received on 26-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-HCP.  This case involves an 84 year old female patient who experienced pain in arm (pain in extremity), chest pain (chest pain), back pain (back pain) and injection site reaction of redness to the left arm (vaccination site pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, past medical treatments, vaccinations and family history were not provided. It was reported that patient is having macular eye issue and having a hard time with reading.   On 16-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via intramuscular route in the left arm.  On an unknown date, the patient developed non-serious pain in arm (pain in extremity), chest pain (chest pain), back pain (back pain) and injection site reaction of redness to the left arm (vaccination site erythema) (unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not reported.  Final diagnosis was pain in extremity, chest pain, back pain and vaccination site pain.   The patient did not receive any corrective treatment.  The events were ongoing at the time of this report.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: received his first Fluzone Quadrivalent vaccine 0.5mL on 21Oct2019 and then received his second Fluzone Quadrivalent vaccine 0.25mL vaccine on 18Nov2019 with no AE; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 8 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that patient received his first Fluzone Quadrivalent vaccine 0.5ml on 21oct2019 and then received his second Fluzone Quadrivalent vaccine 0.25ml vaccine on 18nov2019 with no AE (underdose).   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 21-Oct-2019 he also received 1st dose of the same vaccine lot UT6709MA via intramuscular route in the right deltoid. On 18-Nov-2019, he also received 2nd dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6709MA via intramuscular route in the right deltoid  It was a case of actual medication error due to vaccine underdose.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle; redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle; induration at the injection site; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 11 years old male patient who experienced redness, swelling, extreme pain, warmth and induration at the injection site, this reaction goes from the top of the shoulder to beyond the deltoid muscle (inflammation), (vaccination site reaction) and (induration), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) (guardasil as reported) in the right deltoid.  On 26-Nov-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6455CB and expiration date: 15-NOV-2020 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious redness, swelling, extreme pain, warmth and induration at the injection site, this reaction goes from the top of the shoulder to beyond the deltoid muscle (inflammation), (vaccination site reaction) and (induration) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The physician thinks that it is either cellulitis or an immune response.  Other relevant test not provided.  Final diagnosis was induration at the injection site, redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle and this reaction goes from the top of the shoulder to beyond the deltoid muscle.   No corrective treatments reported.  The outcome for all the events was unknown.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired adacel was administered to a patient, no adverse event; Initial information was received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves an 11 year old male patient who was vaccinated with a 0.5 ml expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5829BA and expiration date 24-Nov-2019) via intramuscular route in the right deltoid on 26-Nov-2019.  Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for unknown indication.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 65 year old woman received Fluzone High-Dose vaccine today, then realized that she had already received Fluzone Quadrivalent this past september, no adverse event; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65 years old female patient who was vaccinated with a 0.5 ml first dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ308AA and expiration date 30-Jun-2020) via an intramuscular route in the left arm on 27-Nov-2019. Also patient was vaccinated with a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date of this September.  Medical history not reported and no other vaccines were received by patient   It was an actual medication error case due to extra dose administered.  No adverse event reported at the time of reporting.  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.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist vi other company Merck.  This case involves an unknown demographic patient who experienced soreness of the arm (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, past vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and other dosing details were not reported).  On an unknown date, the patient experienced non-serious soreness of the arm (pain in extremity) following the day of administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was soreness of the arm.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event.  Information on the batch number was requested.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Daptacel, no AE; Initial information was received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient who received an expired dose DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route in unknown administration site, on an unknown date.   The patient's medical history, past medical treatments, vaccinations and family history were not provided.   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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Nausea
Clinical narrative: Extremely tired, severe upset stomach, severe nausea, dizzy on both sets of two series hepatitis b shot
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Disorientation, Head injury, Loss of consciousness, Syncope
Clinical narrative: The patient presented to receive 4 vaccines- HPV, Influenza, Meningococcal ACWY, and TDAP. During the administration of the 4th vaccine (HPV), the patient had a syncopal episode. He lost consciousness and hit head on the counter in the exam room. He immediately regained consciousness and was slightly disoriented upon awakening. At this time, the patient was put back on exam room table and laid flat. He was given an ice pack for his head and juice. Patient reported feeling better within minutes of episode. He was examined by several other RNs and one MD immediately following the episode. He was released home after 10 minutes of monitoring.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: pt woke up day after vaccine administration with redness, heat to the area
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient received vaccine in office 12/3/2019 4:42 PM, returned to office 12/4/2019  1:30pm with reaction. reaction site was red warm, firm to touch and measured 13 by 14 cm
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Back pain, Inflammation, Pain in extremity
Clinical narrative: Patient came into pharmacy today and informed that after she had the vaccine that day , her whole arm was sore and inflamed. Also couple days later she felt a sharp pain for few seconds in her back and down to her leg. She is feeling ok now, but she just wanted to inform us. She thought it was the flu vaccine but she also had Pnuemovax 23 which usually painful.
Age: 5.0
Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: CAREGIVER, BROUGHT CHILD INTO THE CLINIC. RIGHT DELTOID AND RIGHT UP OUTER ARM IS HOT TO THE TOUCH. TWO DISTINCT AREAS ARE LIGHT PINK. AREA IS SWOLLEN. PT HAVING NO TROUBLE SWALLOWING. NO SWELLING AROUND THE NECK.  CG REPORTED DR. WAS NOTIFIED. CURRENTLY GIVING IBUPROPHEN P.O FOR PAIN/FEVER. CURRENT TEMP AT CLINIC TODAY 98.1.  RECOMMENDED CG TAKE PT TO URGENT CARE OR HOSPITAL DOWN THE ROAD FOR A PHYSICIAN TO LOOK AT. CG STATED PRIMARY PHYSICIAN COULD NOT GET HER IN AN TOLD HER TO TAKE TO URGENT CARE. CG UNHAPPY WITH URGENT CARE SERVICES. CG DECIDED TO WAIT A FEW MORE DAYS TO SEE IF THERE IS IMPROVEMENT. CG STATED SHE WILL TAKE PT TO ER IF SYMPTOMS WORSEN.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Student presented at Student Health Service on 12/3/2019 c/o of L deltoid redness, itchiness, rash.  Student states he received Menactra vaccine at home on 11/27/2019.   Below scrip from office visit to student health service on 12/3/2019: "The patient got his meningitis vaccine about a week ago. The area felt bruised after the vaccine, but today he noticed a rash on the area. Mildly itchy, not painful. At the same time, he is taking Keflex for a paronychia (he is down to the last 2 days). No fevers or chills. No breathing difficulties or mouth or throat swelling"
Age: 3.0
Sex: M
Vaccine: TYP
Symptoms: Abnormal behaviour, Hyperhidrosis, Vomiting
Clinical narrative: Patient received a typhoid vaccine, and within 5 minutes after patient started vomiting, not acting right was standing by mom and froze with hands up. NP requested PCT to call the squad, NP went to pharmacy to get pharmacist for help, Came back to the room, patient is sweating, decided to give the patient a shot of benadryl, 0.25 mg IM, Squad arrived and assessed patient o2 sats were good, lung sounds good, recommended that he be checked out at the ED, mom refused transport. Educated mom on watching patient for the next few hours. She agreed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Haemorrhage, Immediate post-injection reaction, Pain, Skin discolouration
Clinical narrative: The patient experienced some bleeding with the injection (it stopped quickly with applied pressure), however immediately after the injection the patient developed a fairly large bump that was beginning to turn black and blue. I had the patient wait a little bit after the administration to make sure it did not expand. It did go down slightly before the patient left the store but the bump was still there. I called and followed up with the patient later on in the day and she said it was a little bit sore but not more so than she would expect after a vaccine. She said the bump was still there and it was still black and blue but she thought it would be ok and that it had not worsened since he had been here. I had recommended ice to see if it would help with the swelling but she had not gotten a chance to try that option yet as of when I spoke to her
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: The patient experienced some bleeding with the injection (it stopped quickly with applied pressure), however immediately after the injection the patient developed a fairly large bump that was beginning to turn black and blue. I had the patient wait a little bit after the administration to make sure it did not expand. It did go down slightly before the patient left the store but the bump was still there. I called and followed up with the patient later on in the day and she said it was a little bit sore but not more so than she would expect after a vaccine. She said the bump was still there and it was still black and blue but she thought it would be ok and that it had not worsened since he had been here. I had recommended ice to see if it would help with the swelling but she had not gotten a chance to try that option yet as of when I spoke to her
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient returned to clinic 7 hours later with a deltoid that was swollen and warm to the touch.  Provider examined arm and advised patient to ice and take ibuprofen. Instructions given that should patient experience any swelling of the lips, redness at the site or any respiratory distress to take diphenhydramine and either return to the clinic or dial 911.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Enema administration, Haematochezia, Intussusception, Laboratory test
Clinical narrative: Patient was taken to the ER on Sunday July 15, 2019  & again on Monday July 16, 2019 in extreme pain, vomiting, and bloody stool.  He was ultimately diagnosed with Intussusception and life flighted to Hospital on Monday July 16, 2019.  Upon arrival, he received a barium enima which successfully reduced the Intussusception.  The next morning he re-intussuscepted and had another barium enima procedure.  Which again was sucessful.    Patient has since had a third episode of Intussusception in Nov. 2019.  This time it was corrected successfully with a air enima.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Pain, Vomiting
Clinical narrative: Patient was taken to the ER on Sunday July 15, 2019  & again on Monday July 16, 2019 in extreme pain, vomiting, and bloody stool.  He was ultimately diagnosed with Intussusception and life flighted to Hospital on Monday July 16, 2019.  Upon arrival, he received a barium enima which successfully reduced the Intussusception.  The next morning he re-intussuscepted and had another barium enima procedure.  Which again was sucessful.    Patient has since had a third episode of Intussusception in Nov. 2019.  This time it was corrected successfully with a air enima.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Nausea, Skin exfoliation
Clinical narrative: Headache, fatigue and nausea for 2 days, which I expected.  On the 3rd day, both arms (from wrist to shoulder), both thighs and chest became bright red and very, very warm.  This lasted for 2 full days.  After 2 weeks, the dead skin flaked off of these areas.  Similar to when you get a sunburn which later heals.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Headache, fatigue and nausea for 2 days, which I expected.  On the 3rd day, both arms (from wrist to shoulder), both thighs and chest became bright red and very, very warm.  This lasted for 2 full days.  After 2 weeks, the dead skin flaked off of these areas.  Similar to when you get a sunburn which later heals.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dysphagia, Fatigue, Myalgia, Pain in extremity
Clinical narrative: She felt well immediately after vaccinations, but began to feel pain on inner left arm several hours after vaccination.  She awoke next morning with marked fatigue, and muscle aches in both upper arms, thighs, lower abdomen, and neck.  She reports no specific fever but "always has low-grade temperature of 99F."   Also reports dysphagia, "like lump in chest after swallowing, that might feel better after vomiting."  She has not vomited and has no specific nausea.  Ate some rice and drank water today without specific problems.  No diarrhea or blood in stool.  No URI sxms.  No SOB or CP, other than the discomfort after swallowing.  No neuro sxms other than diffuse aching pains and fatigue.  She reports similar challenges with achiness and fatigue after prior flu vaccines, although current sxms are more than she expected.  She "avoids vaccines when possible" but is concerned about infections, like flu, and generally receives recommended vaccines.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection was given in the upper left arm at shoulder area. Swollen upper arm down to my elbow, redness down to my elbow, warmth in upper arm to elbow, soreness down to the elbow, itching down to my elbow, discoloration of upper arm to yellow,  faint feeling and nauseated for 2 hours the day after vaccination, and limited range of motion in left arm. Symptoms began about 1 hour after the injection and lasted 4 days except for the soreness which is ongoing at 5 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Joint range of motion decreased, Nausea
Clinical narrative: Injection was given in the upper left arm at shoulder area. Swollen upper arm down to my elbow, redness down to my elbow, warmth in upper arm to elbow, soreness down to the elbow, itching down to my elbow, discoloration of upper arm to yellow,  faint feeling and nauseated for 2 hours the day after vaccination, and limited range of motion in left arm. Symptoms began about 1 hour after the injection and lasted 4 days except for the soreness which is ongoing at 5 days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Ear discomfort, Ear infection, Ear pain
Clinical narrative: symptoms like the flu, pain in the ear, what seemed like a clogged ear, reduced hearing in the right ear,  pressure in the ear like climbing in an airplane
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Eustachian tube dysfunction, Hypoacusis, Influenza like illness, Sudden hearing loss
Clinical narrative: symptoms like the flu, pain in the ear, what seemed like a clogged ear, reduced hearing in the right ear,  pressure in the ear like climbing in an airplane
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersensitivity, Rash, Swelling
Clinical narrative: Pt parents messaged PA saying that they think she is having an allergic reaction. They said that she was breaking out in a rash and starting to swell up. PA suggested that they go to the ER. At the ER they confirmed that it was an allergic reaction and gvae her steroids.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Insomnia, Vasculitis
Clinical narrative: Pt had a hard time sleeping that night; in am noticed bruising on arm and veins up neck/collar bone; went to ER and was dx with vasculitis; was told to ice arm and take ibuprofen.
Age: 54.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Major shivering with fever; extremely sore muscles; no energy. Onset about 12 hours after vaccine; lasting >15 hours (still in effect).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient received vaccine and sat on the bench waiting for his wife to get hers.  Approximately 5 minutes later, he got dizzy then his eyes rolled back and he past out started seizing.  EMS was called immediately and patient was laid on his side.  He came to in approximately 30 seconds.  He was noticeably sweating but did not lose any bodily fluids and said he felt better than he did right before the incident.  I checked his blood sugar while waiting for EMS to arrive and it was 99.  Patient has no previous medical history of fainting or seizures and was taken to hospital via ambulance to get checked out.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Patient received vaccine and sat on the bench waiting for his wife to get hers.  Approximately 5 minutes later, he got dizzy then his eyes rolled back and he past out started seizing.  EMS was called immediately and patient was laid on his side.  He came to in approximately 30 seconds.  He was noticeably sweating but did not lose any bodily fluids and said he felt better than he did right before the incident.  I checked his blood sugar while waiting for EMS to arrive and it was 99.  Patient has no previous medical history of fainting or seizures and was taken to hospital via ambulance to get checked out.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: ITCHING, PAIN AT INJECTION SITE THAT STARTED RIGHT AFTER VACCINATION AND IS CONTINUING 2 MONTHS LATER
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No addtional adverse event reported; Unspecified child was given an adult VAQTA formulation; This spontaneous report was received from an nurse regarding a 6 months male patient via company representative. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 03-DEC-2019, the patient received an adult Hepatitis A Vaccine, Inactivated (VAQTA) lot number S012250, expiration date 07-JUL-2020 (dose, and route of administration was not reported) (product administered to patient of inappropriate age). No additional adverse event reported. The patient did not received medical intervention.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: pt had red whelps & small bruise on the right arm after immunization that went away after 2-3days. Pt has muscle pain in her right arm, up to shoulder, across back, down spine, and shoulder blade. She also has pain down right arm & right palm. The pain is constant, but worse at night. Pt is unable to sleep on her right side. Pt has tried aleve/ibuprofen/bengay/heat/and ice. But she is still having pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: pt had red whelps & small bruise on the right arm after immunization that went away after 2-3days. Pt has muscle pain in her right arm, up to shoulder, across back, down spine, and shoulder blade. She also has pain down right arm & right palm. The pain is constant, but worse at night. Pt is unable to sleep on her right side. Pt has tried aleve/ibuprofen/bengay/heat/and ice. But she is still having pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Fever of 101.5, body aches, chills, headache, fatigue, no appetite. Started in evening day of injection. Got much worse during the night culminating in fever. Took Tylenol which didn't do anything. Took Advil which relieved the fever, but not the aches. The aching stopped by end of third day. Still extremely fatigued as of 4th day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101.5, body aches, chills, headache, fatigue, no appetite. Started in evening day of injection. Got much worse during the night culminating in fever. Took Tylenol which didn't do anything. Took Advil which relieved the fever, but not the aches. The aching stopped by end of third day. Still extremely fatigued as of 4th day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: The injection was administered high on the shoulder of the left arm.  It caused extreme pain, more than is normal.  Pain continued at a level 4 for 2 days and diminished to a level 2.  After 2 weeks patient still could not raise her arm without pain.  Injection site continued to be painful.  Sleeping on the left side cause pain in left arm and shoulder.  Patient saw doctor on December 4, 2019 at which time he prescribed oral steroids and physical therapy.   He said he had never heard of SIRVA.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site rash
Clinical narrative: The vaccine was supposed to be given intramuscularly but was given subcutaneously instead. A patient is having tenderness and rash on her injection site.
Age: 19.0
Sex: M
Vaccine: HEP, HPV9, MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Per the provider the patient was given HPV and Tdap per a verbal order and registry results . These immunizations were not needed after further investigation. The patient had two records. There has been no known reaction.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: pt had reported HA, lymph node swelling  neck , sore throat , and erythema 1/2 dollar size at site and chills
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Tachycardia
Clinical narrative: Patient reports experiencing tachycardia that required a hospital visit approximately 24 hours after vaccination with Flucelvex.  Provider at hospital advised patient that this may have been a reaction to the vaccination.  He was treated (specific treatment unknown) and has not experienced any complications.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: CMA pulled wrong Diluent. She used the sterile water for the MMR /VAR
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: development of "lump" at injection site in the week following vaccine, which patient states is very tender to touch