chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Wed. Nov 6, 2019:  9:20am Received Injection, area soar. Hot.              Thurs. Nov 7, 2019: Left arm red, hot, swollen.                                      Fri  Nov 8, 2019:  Visit to Dr 3:30pm. Reaction continuing.   Upper arm very swollen and very hot and very red, painful. Sent home, take Benedryl, apply cold packs.                           Thurs Nov 14, 2019   Arm began to throb, left hand began hurting, sharp pain followed by hand swelling to point of not being able to close. Red. Fingers swelling.        Fri. Nov 15, 2019:  4:10pm visit to Dr  regarding hand. Cellulitis, red line traveling upper arm. Given shot, Rosephin 1000mg and prescribed Amoxicillin-clavulante and Prednisone.  Pain so intense could not function with sleep or work.  Saturday Nov 16, 2019 instructed to go to Urgent Care to verify progress of hand and red line movement. Went in at 8:54 am.  Checked and red line stopped told to continue with medications.  Keep arm elevated cold compress as needed.  Right hand beginning to react with swelling and pain.  Told to use compression gloves to aid in swelling.   Nov 17, 2019: Face inflamed with red dots especially eye area. Went to ER. Did a lung xray found infection starting. Stopped taking Amox.  Was given prescription for Azithromycin 250 mg to start.    Mon. Nov 18, 2019: contacted Dr office regarding hands and upper back pain, chest tight, muscle on right side of shoulder very stiff. Arm still hot.          Wed Nov 20:  left hand swelling down able to use but pain continuing in arm and hand. Hand continues to swell at times.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Rash erythematous, Skin warm
Clinical narrative: Wed. Nov 6, 2019:  9:20am Received Injection, area soar. Hot.              Thurs. Nov 7, 2019: Left arm red, hot, swollen.                                      Fri  Nov 8, 2019:  Visit to Dr 3:30pm. Reaction continuing.   Upper arm very swollen and very hot and very red, painful. Sent home, take Benedryl, apply cold packs.                           Thurs Nov 14, 2019   Arm began to throb, left hand began hurting, sharp pain followed by hand swelling to point of not being able to close. Red. Fingers swelling.        Fri. Nov 15, 2019:  4:10pm visit to Dr  regarding hand. Cellulitis, red line traveling upper arm. Given shot, Rosephin 1000mg and prescribed Amoxicillin-clavulante and Prednisone.  Pain so intense could not function with sleep or work.  Saturday Nov 16, 2019 instructed to go to Urgent Care to verify progress of hand and red line movement. Went in at 8:54 am.  Checked and red line stopped told to continue with medications.  Keep arm elevated cold compress as needed.  Right hand beginning to react with swelling and pain.  Told to use compression gloves to aid in swelling.   Nov 17, 2019: Face inflamed with red dots especially eye area. Went to ER. Did a lung xray found infection starting. Stopped taking Amox.  Was given prescription for Azithromycin 250 mg to start.    Mon. Nov 18, 2019: contacted Dr office regarding hands and upper back pain, chest tight, muscle on right side of shoulder very stiff. Arm still hot.          Wed Nov 20:  left hand swelling down able to use but pain continuing in arm and hand. Hand continues to swell at times.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest X-ray, Chest pain, Chills, Electrocardiogram
Clinical narrative: massive sweating, chest pain radiating from chest to back, fever, chills
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia, Troponin
Clinical narrative: massive sweating, chest pain radiating from chest to back, fever, chills
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: C-reactive protein, Eschar, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: The patient called in and spoke with one of our triage nurses on 11-6-19 and was advised to be seen in Urgent Care.  She was seen in urgent care and was advised it looked like a vaccine reaction, and to continue to monitor.  She sent a message to us on 11-16-19, along with pictures of the wound, which was very concerning. She did see one of our providers on 11-18-19 and a wound was noted on her Left deltoid.  There was a resurfaced lesion black eschar, no drainage. It was tender to palpation, warm and there was about 1 cm erythema surrounding the wound. Irregular shaped wound measures 3.5 cm long by 2 cm at widest.  She was started on Kelflex and referred to wound care.  She presented to the Emergency Room on 11-19-19 where it was decided she will have outpatient debridement and will refer to Plastic Surgery.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Metabolic function test, Skin lesion, Ultrasound scan
Clinical narrative: The patient called in and spoke with one of our triage nurses on 11-6-19 and was advised to be seen in Urgent Care.  She was seen in urgent care and was advised it looked like a vaccine reaction, and to continue to monitor.  She sent a message to us on 11-16-19, along with pictures of the wound, which was very concerning. She did see one of our providers on 11-18-19 and a wound was noted on her Left deltoid.  There was a resurfaced lesion black eschar, no drainage. It was tender to palpation, warm and there was about 1 cm erythema surrounding the wound. Irregular shaped wound measures 3.5 cm long by 2 cm at widest.  She was started on Kelflex and referred to wound care.  She presented to the Emergency Room on 11-19-19 where it was decided she will have outpatient debridement and will refer to Plastic Surgery.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vaccination complication, Wound
Clinical narrative: The patient called in and spoke with one of our triage nurses on 11-6-19 and was advised to be seen in Urgent Care.  She was seen in urgent care and was advised it looked like a vaccine reaction, and to continue to monitor.  She sent a message to us on 11-16-19, along with pictures of the wound, which was very concerning. She did see one of our providers on 11-18-19 and a wound was noted on her Left deltoid.  There was a resurfaced lesion black eschar, no drainage. It was tender to palpation, warm and there was about 1 cm erythema surrounding the wound. Irregular shaped wound measures 3.5 cm long by 2 cm at widest.  She was started on Kelflex and referred to wound care.  She presented to the Emergency Room on 11-19-19 where it was decided she will have outpatient debridement and will refer to Plastic Surgery.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Osteoarthritis, Pain in extremity, X-ray limb abnormal
Clinical narrative: Patient called the office on 10/9/19 to report left arm pain since receiving the flu vaccine
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Pain in extremity, Syncope
Clinical narrative: PATIENT COMPLAINED OF ARM PAIN AND STIFFNESS AFTER VACCINATION, THEN AFTER ABOUT 1 MINUTE THE PATIENT FAINTED.  HE WOKE UP ALMOST IMMEDIATELY AND WAS SEATED IN VACCINATION ROOM AND OBSERVED FOR AROUND THE NEXT 30 MINUTES. PATIENT WAS DIZZY AND COMPLAINED OF HEADACHE.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red patch on arm approximately 2 inches beneath site of injection, warm and painful to the touch, oval in shape, approximately 4in by 2.5 in in size; Patient has applied ice and heat and taken Aleve for the pain;  Patient reports that it has not gotten worse or improved since she noticed it on 11/19/19.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 5 inch diameter redness around injection site.
Age: 87.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: itchy  red raised bumps  for almost a week
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not have an adverse reaction to the immunization.  Patient was due to Hib vaccine and polio vaccine was administered. Called Health department and mother notified.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Middle insomnia, Pruritus, Rash, Rash erythematous
Clinical narrative: Beginning at 5 p.m. the day of the vaccine, patient noticed itching and red rash under neck, and  on upper chest. In the middle of the night, patient awoke with itching and noted that rash had spread over more of upper chest and into left axillary area. She took Benadryl which helped the itch. Rash disappeared after 2-3 days.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient's mother reports that approximately 2 to 3 hours after vaccine administration, child began to break out in hives. Hives started on child's abdomen but spread systemically. Mother administered over the counter Benadryl and reports that the reaction resolved by morning. After administration of Benadryl, child was laid down for bed near mother for further monitoring. Child has recovered and there does not appear to be any lasting adverse side effects.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: awoke the next morning with a numb arm. Couldn't move it without the assistance of the other arm. It was similar in feeling as to when i had the rotator cuff surgery. The symptoms took a very long time to get better. Came back to work on Mon and asked the company nurse if anyone else has had this issue. She said this was a first. After a week the numbing was better but to  this day i still have some tingling in my fingers on that hand
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: stated today 11/21/19 during phone call that right arm has continued to hurt since day of vaccination.  she did notice that when she tried to lift up an item that she felt she could not do so. she stated she took Ibuprofen for first few nights after vaccination, but has not done so since or other pain relieving therapies.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose of Pentacel before 9 months old instead of giving 3 doses before 6 months old; Initial information received on 09-Oct-2019 and Additional information received on 11-Oct-2019  regarding an unsolicited valid non-serious case received from a Non-HCP (Office Staff).  This case involves male patient who received 0.5 ml dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ065AA (Expiry date unknown) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that vaccination intervals for Pentacel. Caller stated they give an extra dose of Pentacel before 9 months old instead of giving 3 doses before 6 months old  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Dtap/IPV component of Pentacel instead of Quadracel/ no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (5th dose) instead of QUADRACEL lot UI952ABA (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included INFLUENZA VACCINE (INFLUENZA VACCINE), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Fluzone High Dose vaccine was ordered on 12-Oct-2019 and it did not come off the following day like it should have so it was ordered again on 13-Oct-2019 with no AE; Initial information received on 14-Oct-2019 and follow-up information receive on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 86-year-old male patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] prefilled syringe (lot: UJ242AA and expiry: 04-May-2020) via intramuscular route and in left deltoid on 12-Oct-2019 and in left interior deltoid on 13-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was an actual medication error due to extra dose administered. It was reported that Fluzone High Dose vaccine was ordered on 12-Oct-2019 and it did not come off the following day like it should have so it was ordered again on 13-Oct-2019 (extra dose administered). The patient has not experienced any adverse effects at this time.  At the time of reporting, the patient had no adverse event.  It was reported that the patient was in the hospital for an infection not related to the Fluzone High dose vaccine.  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: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: a little injection site pain; Fluzone HD was administered to a 54 year-old woman; Fluzone HD was administered to a 54 year-old woman; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 54 years old female patient who experienced a little injection site pain (Vaccination site pain) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  This case involves a 54 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ29688, expiry date: 06-Jun-2020), via intramuscular route in the right deltoid on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unspecified date, unknown latency post vaccination, the patient experienced a little injection site pain (Vaccination site pain).  It was an actual medication error due to Inappropriate age at vaccine administration. It was also a case of overdose.  It was not reported if the patient received a corrective treatment.  The outcome of the event injection site pain was not 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: 0.58
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was given and it was not mixed with the powder, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ018AAA, expiry date: 12-Oct-2020 via intramuscular route in the right deltoid on 21-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 case due to inappropriate reconstitution technique. It was reported that the diluent part of Pentacel was given and it was not mixed with the powder.  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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a four month old patient was received an expired dose of Pentacel today, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who was vaccinated with a second dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5553AC, expiry date: 18-Oct-2019, via intramuscular route in the left thigh on 24-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.   A 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: had a medication error with Pentacel administration described as the DTAP-IPV portion was administered and the ActHIB portion was not administered; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received DTAP-IPV portion HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only and Hib portion was not administered.  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) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 24-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (BOX: Lot #: UJ109ABA, exp:14Oct2020,DTAP-IPV: U6396AA, exp: 14Oct2020,ActHIB: LOT: UJ109AB, exp:14Oct2020) via intramuscular route in the right thigh.   It was a case of actual medication error due to Inappropriate reconstitution technique.  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.  Information on the batch number was requested
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Exposure during pregnancy, Malaise
Clinical narrative: little bit of chest tightness; like she was suppressing a cough; did not feel 100%,; drug exposure during pregnancy; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced little bit of chest tightness [PT: Chest discomfort], like she was suppressing a cough [PT Cough], did not feel 100% [PT: Malaise], and reported drug exposure during pregnancy [PT: Exposure during pregnancy], while she received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported drug exposure during pregnancy occurred at 21 Weeks of pregnancy.   The date of last menstrual period was not reported.  The estimated due date is 16-Mar-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Oct-2019, the patient received a 0.5 ml once dose of suspect influenza quadrival a-b vaccine lot UT6686JA via intramuscular route in the right arm for Prophylactic vaccination.  The patient developed a non-serious little bit of chest tightness (chest discomfort); like she was suppressing a cough (cough); did not feel 100%, (malaise) latency 1 day for all these events and reported drug exposure during pregnancy (exposure during pregnancy) latency unknown following the administration of influenza quadrival a-b vaccine.  Final diagnosis was drug exposure during pregnancy, did not feel 100%,, like she was suppressing a cough and little bit of chest tightness.  It was not reported if the patient received a corrective treatment.  Event outcome was not applicable for exposure during pregnancy and recovered for other events.  No other information was reported.
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 15 months old male patient was administered Pentacel instead of Daptacel/No AE; Initial information received on 06-Nov-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves a 15 months old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/I PV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included IPOL POLIO VACCINE, ACT-HIB and PENTACEL three doses was received.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) and HEPATITIS A VACCINE (HEPATITIS A).  On 05-Nov-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ123AA and Expiry date: 20-Sep-2019) in the left vastus lateralis instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  It was an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: by mistake gave the Dtap/IPV part yesterday and did not give the AcHib part of the Pentacel to patient/NO AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received only the Dtap/IPV part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and was not given the AcHib part.  The medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of only the Dtap/IPV part of the suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Box Lot number UJ124AAA, expiry date 29-Sep-2020; Datp/IPV Lot U6397AA, expiry date 29-Sep-2020; ActHIB- UJ124AA, expiry date 29-Sep-2020) via unknown route in unknown administration site without the AcHib part.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: administered Pentacel  that was not reconstituted, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was not reconstituted.  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) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)); HEPATITIS B VACCINE (HEPATITIS-B); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 07-Nov-2019, the patient received a dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U63996AA, expiry date- 14-Oct-2020 via intramuscular route in the right thigh that was not reconstituted.  It was actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to a patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316262, 2019SA316263, 2019SA316286, 2019SA316289, 2019SA316290 (same reporter).  This case involves a 69 years old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms 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: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High Dose was administered to 3 patients after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female was administered with a 05. ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020, via intramuscular route in the left arm) after too long in transit on 11-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 due to incorrect product storage.  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.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High Dose was administered to 3 patients after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA318341 and 2019SA318343 (same reporter).  This case involves a 77 years old female was administered with a 05. ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020, via intramuscular route in the right upper arm) after too long in transit on 11-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 due to incorrect product storage.  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.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone High Dose was administered to a patient after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA318341 and 2019SA318342 (same reporter).  This case involves a 65 years old female was administered with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020) via intramuscular route in the left upper arm, after too long in transit on 11-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 due to incorrect product storage.  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.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: without reconstituting it with the lyophilized powder/no Ae; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who reported without reconstituting it with the lyophilized powder/no AE while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) , PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number unknown at unknown route in the unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: allergic reaction; 8cm sized hive at the injection site; redness and swelling to about 10 cm; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old patient who experienced allergic reaction [Hypersensitivity], while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ058AB via intramuscular route in left leg in vaccine subcutaneous layer.  On 17-Jun-2019 he/she also received a dose 1 of the same vaccine lot UJ058AB via intramuscular route in left leg in vaccine subcutaneous layer.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) along with symptoms of 8cm sized hive at the injection site (injection site urticaria) and redness and swelling to about 10 cm (injection site swelling) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Other tests included no lab data.  Final diagnosis was allergic reaction.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Recovered / Resolved on an unknown date for allergic reaction, as Recovered / Resolved on an unknown date for 8cm sized hive at the injection site and as Recovered / Resolved on an unknown date for redness and swelling to about 10 cm.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Fall, Grip strength decreased, Guillain-Barre syndrome, Limb discomfort
Clinical narrative: Woke on the morning of 11/30 with inability to grip and weakness in feet. Progressed through day leading to fall. Referred to the Medical Center ER where I was admitted and diagnosed with Guillian Barre syndrome. Hospitalized for one week and transferred to Rehabilitation. Released 12/19/18. Continues to have pain and discomfort in feet and toes as of 11/21/19.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Muscular weakness, Pain in extremity
Clinical narrative: Woke on the morning of 11/30 with inability to grip and weakness in feet. Progressed through day leading to fall. Referred to the Medical Center ER where I was admitted and diagnosed with Guillian Barre syndrome. Hospitalized for one week and transferred to Rehabilitation. Released 12/19/18. Continues to have pain and discomfort in feet and toes as of 11/21/19.
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia, Insomnia, Pyrexia
Clinical narrative: Hip Joint pain, Shoulder Joint Pain (opposite from injection site). Knee Joint Pain, numbness in fingers, slight fever. Starting at 3:30 am pain in joints prevented sleep, joint condition made walking difficult. Second day pain in joints diminished, finger numbness remains malady remains.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Muscle tightness
Clinical narrative: redness of neck/face; neck tightness - denied shortness of breath
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Morning after immunization entire right upper arm bright red, firm and hot to touch.  Swelling and redness continued through the third day after immunization.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edema, erythema, and warmth at site of injection, as well as pain and tenderness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: LOW GRADE FEVER AND STARTED BREAKING OUT WITH RASH ON FACE ABOUT 3-4 HRS AFTER IMMUNIZATION    THEN SPREAD ALL OVER BODY, NO MORE FEVER, PARENTS GAVE TYLENOL FOR FEVER AND CALLED OFFICE  ON 11/20/19 TOLD HER TO GIVE BENADRYL  TIL COULD BRING CHILD IN TO OFFICE,  OR IF GETS IN DISTRESS TO GO TO NEAREST HOSPITAL.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received incorrect vaccination of High Dose Flu shot. A second vaccination was given in place of Shingrix vaccination. Patient notified of incorrect vaccination being administered and incident report was completed.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Insomnia, Pain, Pain in extremity
Clinical narrative: NEXT DAY, PATIENT EXPERIENCED DEEP BONE PAIN IN UPPER LEG PELVIS PUSLATING PAIN AND COULDN'T SLEEP. LASTED ALL NIGHT. SUNDAY DISAPPEARED AND THEN TUESDAY WENT TO WORK AND AROUND NOON HAD SHARP PAIN IN THE ANKLE AND COULDN'T PUTWEIGHT ON IT. LAST WEEK HAD SOME LEG PAIN. PAIN MAINLY IN LEGS.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: NEXT DAY, PATIENT EXPERIENCED DEEP BONE PAIN IN UPPER LEG PELVIS PUSLATING PAIN AND COULDN'T SLEEP. LASTED ALL NIGHT. SUNDAY DISAPPEARED AND THEN TUESDAY WENT TO WORK AND AROUND NOON HAD SHARP PAIN IN THE ANKLE AND COULDN'T PUTWEIGHT ON IT. LAST WEEK HAD SOME LEG PAIN. PAIN MAINLY IN LEGS.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Hypersomnia, Incoherent, Memory impairment
Clinical narrative: Patient received a singles shot on 11/19/19. Patient's wife called me today 11/21/19 to tell me patient has not been acting himself the last two days (since morning of 11/20/19 until now 11/21/19 ). He slept most of the day yesterday (11/20/19) and has been acting strange, forgetful, and not making sense. I asked patient's wife to take him to the Emergency room ASAP to make sure he wasn't dealing with an infection, rare side effect, or a possible stroke. Patient's wife agreed and asked me to call the Hospital ER to let them know what we had talked about and tell them that he had received a shingles shot on 11/19/19. I got off the phone with her and called ER to tell them and let them know that she was on her way with patient at 1522.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site swelling
Clinical narrative: Red rash near injection site, swelling and feels like a knot
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Rash macular
Clinical narrative: Left leg was swollen and red, blotchy.  Skin felt warm.   PA-C looked at leg and told patient it was not infected.  Patients dad was educated to apply ice and administer ibuprofen.  Patient to follow up if redness gets worse or runs a fever greater than 100.4.  Dad verbalized understanding.  Patient was walking normally.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Left leg was swollen and red, blotchy.  Skin felt warm.   PA-C looked at leg and told patient it was not infected.  Patients dad was educated to apply ice and administer ibuprofen.  Patient to follow up if redness gets worse or runs a fever greater than 100.4.  Dad verbalized understanding.  Patient was walking normally.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site haemorrhage
Clinical narrative: pt came in to have me look at bruise on arm. Large bruise roughly 3 by 4 inches has developed. pt denies falling or hitting arm. pharmacist who gave shot remembers that it bleed when gave shot. Pt denies taking warfarin or other blood thinners. No redness warmth or swelling to the touch. pt states small deposit under skin but I couldn't feel it. Recommended that pt follow up with doctor about why it bled so much.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: All over body muscle aches (shoulders, neck, arms, back, hip flexors) and feeling feverish, nauseated and fatigued, for just over 24 hours from when I received the vaccination.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt brought for redness, swelling around injection site
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: swelling of the eyes for 2-3 days, self resolved
Age: 9.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Asthenia, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Child developed fever, vomiting and weakness the evening of the vaccination on 11/12/19.  Vomiting persisted for 5 days. Fever persisted for 1 day. Weakness for 3 days. Poor appetite for 7 days.  Supportive therapy with hydration recommended. Improving clinically by day 10.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt with red, swollen injection site
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray, Cough, Dyspnoea, Lung hyperinflation, Nasopharyngitis
Clinical narrative: A day after receiving this vaccine, Patient came down with a fever, nausea and severe cold symptoms, runny nose, cough, and felt like he couldn't breathe. The cough progressed more severe and he felt his airways constricted. He lost weight from not being able to hold down food, and was constantly nauseous.  He saw Dr. on 9/17/2019, where she examined him, and prescribed Ondansetron for nausea, and advised him to take claritin in addition to an over the counter antacid. He was instructed to use his Albuterol inhaler to open up airways. Patient's symptoms persisted and we came back in 10/23/2019.   His cough very persistent and his airways tight. He still has runny, stuffy nose and is still nauseous each day, especially in the morning. A chest x-ray was ordered. He was prescribed a round of Prednisone, Singular and Ondansetron.   Upon calling on 11/8/2019 to find out x-ray results, I was notified of hyperinflation of the lungs by the medical assistant. After speaking to the doctor, she referred him the Pulmonary department for further testing. He was prescribed more Ondansetron, Symbicort and Albuterol.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Obstructive airways disorder, Pyrexia, Rhinorrhoea, Weight decreased
Clinical narrative: A day after receiving this vaccine, Patient came down with a fever, nausea and severe cold symptoms, runny nose, cough, and felt like he couldn't breathe. The cough progressed more severe and he felt his airways constricted. He lost weight from not being able to hold down food, and was constantly nauseous.  He saw Dr. on 9/17/2019, where she examined him, and prescribed Ondansetron for nausea, and advised him to take claritin in addition to an over the counter antacid. He was instructed to use his Albuterol inhaler to open up airways. Patient's symptoms persisted and we came back in 10/23/2019.   His cough very persistent and his airways tight. He still has runny, stuffy nose and is still nauseous each day, especially in the morning. A chest x-ray was ordered. He was prescribed a round of Prednisone, Singular and Ondansetron.   Upon calling on 11/8/2019 to find out x-ray results, I was notified of hyperinflation of the lungs by the medical assistant. After speaking to the doctor, she referred him the Pulmonary department for further testing. He was prescribed more Ondansetron, Symbicort and Albuterol.