chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, FLU3, HIBV, IPV, MNQ, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: vaccines excursion for 31.1F for 30 minutes on March 15th which was received by 35 pediatric patients; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 35 patients (age and gender unknown) who received dose of IPV (VERO) [IPOL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and TUBERCULIN TEST [TUBERSOL]. (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date.  Information on the batch number was requested.  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. Vaccines excursion for 31.1F for 30 minutes on March 15th which was received by 35 pediatric patients  Adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: received a DTaP/IPV from a Pentacel without the HIB/ no side effects; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on 24-Apr-2019  On 24-Apr-2019, the patient received a second dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AB, expiry date 13-Jun-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that the patient received a DTaP/IPV from a Pentacel without the HIB.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: female patient received one dose of pre-exposure prophylaxis then and,on Day 21, came to pharmacy for the second dose; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient who was vaccinated with one dose RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection, Information on the batch number was requested) via unknown route in unknown administration site.  It was reported that the patient received pre-exposure prophylaxis and she is now at Day 21 and has not received the second dose.  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 inappropriate schedule of vaccine administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Quadracel vaccine was inadvertently administered today (25 Apr 2019) to a 12 month old patient instead of Pentacel, no adverse event; Quadracel vaccine was inadvertently administered today (25 Apr 2019) to a 12 month old patient instead of Pentacel, no adverse event; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a 12 months old female patient who was inadvertently administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of 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.  Patient received one other vaccination today, which was for hepatitis A.  On 25-Apr-2019, the patient received a 0.5 ml dose of QUADRACEL (lot number: C5497AA and expiry date: 17-Jul-20120) via unknown route in unknown administration site instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Todays dose was the third dose in the DTaP series and the third dose in the IPV series  It was an actual medication error due to wrong vaccine administered and Product administered to patient of inappropriate age.   No adverse event was reported following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: She gave the dtap portion and tried to give the Acthib but realized it was a powder; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (pharmacy-other).  This case 35 week old male patient who was vaccinated with only DTAP portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (formulation: Suspension for injection, Information on the batch number was requested) via unknown route in unknown administration site.  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 inappropriate reconstitution technique.  It was reported that nurse didn't realize that she had to reconstitute both vials and thought that both were already reconstituted. She gave the DTAP portion and tried to give the ACTHIB but realized it was a powder.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: adminstered a dose of Menactra that was mixed with sterile water/ they have not heard from the parents about an issue; Initial information received on 25-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was reconstituted incorrectly.  The patients past medical history, concomitant medication and family history were not provided.   On 23-Apr-2019, the patient received a first dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6204AA, expiry date 08-May-2020 via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique. It was reported that nurse adminstered a dose of Menactra that was mixed with sterile water and they have not heard from the parents about an issue.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Product preparation error, Wrong product administered
Clinical narrative: Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case involves a eight months old male patient for whom it was reported that Dtap IPV part of Pentacel was mixed with Rotavirus by mistake instead of Acthib and gave the mixture to the patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   On an unknown date the patient was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with Rotavirus without Acthib (Batch number: C5444AA and expiry date: 27-Oct-2019).   It was a case of actual medication error due to Wrong solution used in drug reconstitution and wrong vaccine administered.  No PTC.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only received the DTaP/IPV of the Pentacel/no AE; Initial information received on 27-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient who onlyreceived DTaP/IPV portion of 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 27-Apr-2019, the patient received a dose 3  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA via intramuscular route in the left thigh.  It was of actual medication error due to  Inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: will give Adacel to a 75 year old female patient; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist via phone.  This case involves a 75 years old female patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Information on the batch number was requested, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history included Rubber sensitivity.  Concomitant medications were not reported.   It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: on 15Apr2019 a dose of Fluzone Quad pediatric prefilled 0.25ml was given and on 26 Apr another dose of the Fluzone Quad pediatric 0.25ml was given by mistake,  No AE symptoms; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old female patient who was vaccinated with a 0.25 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 15-Apr-2019 and a 0.25 ml second dose of same vaccine on  26-Apr-2019 (lot UT6315SA and Exp. Date 30-JUN-2019) via intramuscular route in the left thigh(reported as left leg).  The patient's past medical treatment included Flurex on 23-JAN-2019 vaccinated with 0.5 ml dose and concomitant medications were not given.  It was an actual medication error case due to extra dose administered.  No AE symptoms occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Fluzone High-Dose given to a patient; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a unknown demographic patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI999A and expiry date: 06-Apr-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.   Expired Fluzone High-Dose given to a patient.  Adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Fluzone High Dose 26Apr2019 that expired on 06Apr2019. No AE's were noted; Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who received a 0.5ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI999AA, expiry date: 06-Apr-2019 via intramuscular route in the right arm on 26-Apr-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 vaccine used.  Pharmacist states that he accidentally administered Fluzone High Dose on 26-Apr-2019 to a patient that expired on 6-Apr-2019.  No 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Daptacel was given to a patient; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown age and gender who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot not reported; expiry date: 24-Apr-2019 via unknown route in unknown administration site. (Information on the batch number was requested)  It was an actual medication error case due to expired vaccine used.   It was not reported whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: they gave an expired dose of Daptacel; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that they gave an expired dose of DAPTACEL.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  Information on the batch number was requested.  It was a case of actual medication error due to expired product administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Red hard lump on left thigh, warm to the touch size of a quarter. Dose not bother child, recc. to be seen if not improving in 5 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Malaise, Tenderness
Clinical narrative: Local reaction, redness 3x6 cm and tender to touch. Temp was 100.2 and stated just does not feel well. Denies shortness of breath and denies any chest pain. Alert and Orient x3. Lungs are clear and heart rate was 77 apical. O2 was 95%. Patient wanted to keep an eye on the redness and agreed to return to clinic or be seen in the ER if she developed any chest pain or worsening symptoms.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient stated had no pain or discomfort until 10 pm the evening of the vaccine. Patient stated pain came fast after it began and was severe. Patient called morning after vaccine and stated pain was better but not resolved. Patient stated he looked on internet to find a reason for pain. Immunizing pharmacist asked patient if he was experiencing any radiating pain into the shoulder joint, shoulder blade area or down the arm. Patient denied any radiating pain stated pain is only at injection area. Patient denied any redness or swelling at injection site. Immunizing pharmacist called family doctor and his physician assistant, felt it typical pain and asked we communicate to patient if pain worsen or swelling is seen in shoulder immunizing pharmacist communicated this message on 05/02/19.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: The patient came in for sick visit he had fever and sore throat, so the doctor prescribed him with amoxicillian 500mg TID, he was also due for his immunization, was given to him on 4-29-2019 at 12:00.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Herpes zoster, Injection site rash, Pain
Clinical narrative: Large rash blistering on right leg below knee. Swelling occurred.  Very painful.  PC treated as shingles on 4/22/2019 with Valacyclovir and cephalexin 500 mg and hydrocodone.  Went back to pc on 4/24/2019. Received shot of Rocephin.  On 4/28/2019. Swelling was worse and rash was spreading  along first site.  Was admitted to hospital began antibiotic therapy by IV.  Left hospital after big improvements on 5/1/19. To return home with oral antibiotics sulyfamethoxazole tmp along with cephalexin for 7 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Swelling, Ultrasound scan
Clinical narrative: Large rash blistering on right leg below knee. Swelling occurred.  Very painful.  PC treated as shingles on 4/22/2019 with Valacyclovir and cephalexin 500 mg and hydrocodone.  Went back to pc on 4/24/2019. Received shot of Rocephin.  On 4/28/2019. Swelling was worse and rash was spreading  along first site.  Was admitted to hospital began antibiotic therapy by IV.  Left hospital after big improvements on 5/1/19. To return home with oral antibiotics sulyfamethoxazole tmp along with cephalexin for 7 days.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: PATIENT CALLED PHARMACY AND SAYS SHE HAD A RASH ALL OVER AND IS GOING TO SEE HER DOCTOR
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient presented to clinic 2 days later with red swollen arm, with tenderness, heat, and itching.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Hypoaesthesia, Injection site pain, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: On 11/13/18, the patient reportedly began to have symptoms reported as following: Severe pain in Left Deltoid area and most of upper left arm/shoulder the night of the injection followed by several weeks of the same symptoms. Pain reportedly decreased some at about one month and decreased more at about 2 months. Recovery reportedly plateaued and has not gotten any better since at about the 2 month mark. There was reportedly no redness, or inflammation present at the injection site. Inject was thought to have been given high when band aid was removed to shower that same night. Pain is reportedly described as an extremely sore muscle with sharp stabbing pain when extending in several different directions or when pushing up on the arm. Pt reports a dull achy pain even when at rest for several months. Which stopped and led to a sense of numbness feeling inside arm area with some tingling down to the pinky. Pt reports some muscle weakness as well. Pt was seen by OT with reports of continued discomfort with range of motion. (approximately 21 visits). MRI results reviewed by Dr on 3/20/19 with plan for surgical intervention planned.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Tendon disorder
Clinical narrative: On 11/13/18, the patient reportedly began to have symptoms reported as following: Severe pain in Left Deltoid area and most of upper left arm/shoulder the night of the injection followed by several weeks of the same symptoms. Pain reportedly decreased some at about one month and decreased more at about 2 months. Recovery reportedly plateaued and has not gotten any better since at about the 2 month mark. There was reportedly no redness, or inflammation present at the injection site. Inject was thought to have been given high when band aid was removed to shower that same night. Pain is reportedly described as an extremely sore muscle with sharp stabbing pain when extending in several different directions or when pushing up on the arm. Pt reports a dull achy pain even when at rest for several months. Which stopped and led to a sense of numbness feeling inside arm area with some tingling down to the pinky. Pt reports some muscle weakness as well. Pt was seen by OT with reports of continued discomfort with range of motion. (approximately 21 visits). MRI results reviewed by Dr on 3/20/19 with plan for surgical intervention planned.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient presented with arm redness, swelling, itching and pain day after immunization.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Back pain, Fatigue, Flank pain, Headache
Clinical narrative: New developement of ITP, platelet count dropped from 324 10*3uL to single digit 7 10*3uL in less than two months. Experienced chronic fatiuge, left side pain at site of spleen, lower back pain, abdominal pain, muscle cramps, and severe headaches among other associated symptoms.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Immune thrombocytopenic purpura, Laboratory test, Muscle spasms, Platelet count decreased, Ultrasound abdomen
Clinical narrative: New developement of ITP, platelet count dropped from 324 10*3uL to single digit 7 10*3uL in less than two months. Experienced chronic fatiuge, left side pain at site of spleen, lower back pain, abdominal pain, muscle cramps, and severe headaches among other associated symptoms.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound scan
Clinical narrative: New developement of ITP, platelet count dropped from 324 10*3uL to single digit 7 10*3uL in less than two months. Experienced chronic fatiuge, left side pain at site of spleen, lower back pain, abdominal pain, muscle cramps, and severe headaches among other associated symptoms.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: fever, chills, body aches, emesis for 2 days
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Blood sodium decreased, Chills, Facial paralysis, Hyperglycaemia
Clinical narrative: Extreme chills and body aches. Could find no comfortable position. Also soreness at injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Laboratory test, Neurological symptom, Pain
Clinical narrative: Extreme chills and body aches. Could find no comfortable position. Also soreness at injection site.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain right arm , at injection site.  large, warm,  circular erythematous lesion slightly raised, moderate erythema. tender to touch and unable to raise arm. tx: advised warm compresses 4 times a day, hot water shower massage once a day.  expect to ressolve within a weeks time.  dx cellulitis of deltoid region
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injection site warmth
Clinical narrative: pain right arm , at injection site.  large, warm,  circular erythematous lesion slightly raised, moderate erythema. tender to touch and unable to raise arm. tx: advised warm compresses 4 times a day, hot water shower massage once a day.  expect to ressolve within a weeks time.  dx cellulitis of deltoid region
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: CELLULITIS, REDNESS, SWELLING
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: Redness and swelling at site evening after injection then the next day fever 102, chills, nausea and vomiting, rash, muscle aches, on 4/27/19-4/28/19 fever and chills resolved but rash progressed in size(erythematous and raised at border, hot and sensitive to touch) Patient being monitored daily started on oral antibiotics on 4/29/19 Augmentin. Rash improving but spreading
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Redness and swelling at site evening after injection then the next day fever 102, chills, nausea and vomiting, rash, muscle aches, on 4/27/19-4/28/19 fever and chills resolved but rash progressed in size(erythematous and raised at border, hot and sensitive to touch) Patient being monitored daily started on oral antibiotics on 4/29/19 Augmentin. Rash improving but spreading
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Redness and swelling at site evening after injection then the next day fever 102, chills, nausea and vomiting, rash, muscle aches, on 4/27/19-4/28/19 fever and chills resolved but rash progressed in size(erythematous and raised at border, hot and sensitive to touch) Patient being monitored daily started on oral antibiotics on 4/29/19 Augmentin. Rash improving but spreading
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Hypoaesthesia
Clinical narrative: Pt received a flu shot Sept 2016 and reported arm numbness and back pain within a week of injection that continues today.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Back pain, Blood test, Epstein-Barr virus infection, Feeling hot, Fibromyalgia
Clinical narrative: Pt received a flu shot Sept 2016 and reported arm numbness and back pain within a week of injection that continues today.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Muscle tightness, Muscular weakness, Musculoskeletal chest pain, Myalgia
Clinical narrative: Pt received a flu shot Sept 2016 and reported arm numbness and back pain within a week of injection that continues today.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Peripheral coldness, Peripheral swelling, Tremor
Clinical narrative: Pt received a flu shot Sept 2016 and reported arm numbness and back pain within a week of injection that continues today.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Donor returned to center on 05/02/2019 with red circle approximately 4.5" X 3.5" with warmth in it. A smaller, darker red circle within larger circle of approximately 1.5" X 1" in the center of the larger circle. This is noted to be approximately 4.5" below the injection site. States arm is itchy. Advised to see PCP or HCP is symptoms worsen.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Pt received the vaccine between 4 to 5pm on 5/1/2019 and noticed  a red raised patch on her left arm (below the injection site to the area above the elbow). Pt came to the pharmacy around 11:45 am on 5/2/2019 to report the adverse event. The patch was hard and warm. Pt didn't have any fever or didn't feel itchiness on the area around the injected site.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody, Arthralgia, Blood creatinine, Blood thyroid stimulating hormone, Differential white blood cell count
Clinical narrative: The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Full blood count, Metabolic function test, Mobility decreased, Pain
Clinical narrative: The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dysstasia, Fatigue, Hypersomnia, Laboratory test
Clinical narrative: The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vision blurred
Clinical narrative: The day after getting the vaccine the patient felt extremely tired, had extreme body and joint pains, and was unable to really get out of bed for several days after getting the vaccine. Adverse affects have lasted longer than a week and are still going on today.  Labs were done to rule out other causes. Tylenol and Advil, rest and time.  Pt told not to get the second dose of the shot.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Foreign travel, Transfusion, Weight decreased
Clinical narrative: On 02/12 pt was not able to swallow anything no drink or food. Was only able to breathe. He was in country @ the moment. He had to come back to country and admitted to hosp. lost 25 lbs. and got 5 plasma transfusions. He was just released from hospital.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient presented to the pharmacy on 05/02/19 after noticing a diffuse redness/swelling on her left arm above her elbow and below the immunization site (the patient was still wearing the bandage on the location where the shot was given).  She stated that her arm was not itchy, hot, or particularly sore. I informed her that some redness/swelling was fairly common. I helped the patient take pictures of her arm with her camera phone so she could watch over the next few days to ensure that the redness was not spreading. I also advised her to let her doctor know if she developed any hives, difficulty breathing, if the redness spread, etc.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Rash, Skin warm, Swelling
Clinical narrative: pt started 2x3 inch redness and swelling rash, starting second day of vaccination with a little bit of warmness in the area.  No fever reported, but arm is still sore.  So far, no oozing, discharge or blister.  Pt was informed to watch and report to md if any worsening symptoms or further concerns.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Heart rate increased, Middle insomnia, Musculoskeletal pain
Clinical narrative: Patient present to pharmacy complaining of extreme pain in upper shoulder. Says he was awoken the night of the vaccine with a very high heart rate and spiking blood pressure. he was kept awake feeling very anxious from 1am-4am approximately. He went to work the next day where the nurse there checked his pressure, heart rate and evaluated him. The nurse recommended icing the vaccination area and taking ibuprofen. Patient came to pharmacy consultation window at 4:30pm to discuss. he said the pain had subsided some with ibuprofen and he has not felt tachycardic since the event. I advised the patient that if symptoms return that he should seek a physicians evaluation.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Pyrexia, Syncope
Clinical narrative: Per pt, high fever, shortness of breath, fainted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Pain
Clinical narrative: on 5/2/19 pt advised pharmacist she had reaction to 2nd shingrix dose administered 04/18/2019, experienced soreness on day of administration, the day following administration an itching, sore welt began to develop on the patients left upper arm, by day 3 swelling had expanded to emcompass the upper left arm from elbow to shoulder, patient self medicated with diphenhydramine, swelling slowly subsided over the following week, patient did not contact her doctor or Pharmacy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: on 5/2/19 pt advised pharmacist she had reaction to 2nd shingrix dose administered 04/18/2019, experienced soreness on day of administration, the day following administration an itching, sore welt began to develop on the patients left upper arm, by day 3 swelling had expanded to emcompass the upper left arm from elbow to shoulder, patient self medicated with diphenhydramine, swelling slowly subsided over the following week, patient did not contact her doctor or Pharmacy
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Ear swelling, Erythema, Lip swelling, Pruritus generalised, Rash
Clinical narrative: about 10:30 am MMR was given on left arm SQ and monitored for 15 min, at about 11:00 am patient returned complaint was itching all over body developing mild rash, swelling of upper lip and right ear swelling and redness. at 11:05 first Epi was given then dose of Benadryl was also administered area was massaged at this time 911 was called and patient was monitored at 11:10 patient continues to complain of itchiness and swelling of lip and second dose of Epi administered and 11:25 am EMS arrived and resumed patient care. Patient to follow with Benadryl q 6h po  prn.
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Wrong product administered
Clinical narrative: Patient order was for Proquad  and Kinrix.  Patient received wrong vaccine of Pediarix.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Kinrix vaccine at 6 months on 4/23/2019. On 5/2/2019 I  called and spoke with mother of patient. I inquired as to how the patient was doing after her 6 month well child check and immunizations. Patient?s mother stated ?She is doing absolutely wonderful! She handled her 6 month vaccines much better than her 4 month vaccines.? I inquired as to if the patient seemed fussy or sore at all after her vaccines. Patient mother advised ?Not at all, she has been trucking along just fine.? I stated I was happy to hear that and advised patient mother the reason I wanted to know how patient was doing was because she received the combination vaccine Kinrix (dtap-ipv) and children under the age of 4 years old do not get that combination they get dtap and polio via separate injections  or Pediarix combination. Patient mother stated that patient is fine and has no complaints. Advised patient mother she may contact our office at any time if she has further questions and concerns. I provided callback number. Patient mother inquired if the patient has to get shots at 9 months. Advised that the vaccine schedule would not have vaccines scheduled at 9 months unless the patient is behind in vaccines. Patient mother had no further questions. ?
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pruritus, Rash, Skin warm
Clinical narrative: patient said later that evening her left arm was red and hot. she experienced pain from site of injection to shoulder. she also had a rash on both arms. right arm however was not itchy, but left side itched. patient had seen dr who had given her an injection to help with the allergic reaction.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Papule, Pruritus, Scab, Skin lesion
Clinical narrative: New onset of lesions 10-days post SPV. Several, slightly pruritic papules (axilla, elbow and abdomen) with no vesicles, but one crusted lesion in axilla. No systemic symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Eructation, Feeling of body temperature change, Laboratory test, Nausea
Clinical narrative: My office note 5/2/19: Had Shingrix  7 days ago - no local reaction. That night had belching. 6 days ago had nausea - did not eat breakfast. Felt hot and cold - left work. Then developed nausea, vomiting, and diarrhea with hives which started in groin, then abdomen, arms and legs. Took diphenhydramine and put oregano oil on feet. Hives resolved within hours and nausea and vomiting resolved also. OK until 2 days ago - at 1 pm had sudden severe diarrhea, then recurrent vomiting. Developed itching of hands, felt hot and cold, then recurrent urticaria on legs, trunk, arms, and face. Seen in ER, had labs. Got IV steroid, ondansetron, oral diphenhydramine. Hives and facial swelling cleared within hours and nausea and vomiting resolved.  No shortness of breath, dysphagia,  or stridor. Took prednisone 50 mg yesterday and today. Now feels back to normal - no further urticaria.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling face, Urticaria, Vomiting
Clinical narrative: My office note 5/2/19: Had Shingrix  7 days ago - no local reaction. That night had belching. 6 days ago had nausea - did not eat breakfast. Felt hot and cold - left work. Then developed nausea, vomiting, and diarrhea with hives which started in groin, then abdomen, arms and legs. Took diphenhydramine and put oregano oil on feet. Hives resolved within hours and nausea and vomiting resolved also. OK until 2 days ago - at 1 pm had sudden severe diarrhea, then recurrent vomiting. Developed itching of hands, felt hot and cold, then recurrent urticaria on legs, trunk, arms, and face. Seen in ER, had labs. Got IV steroid, ondansetron, oral diphenhydramine. Hives and facial swelling cleared within hours and nausea and vomiting resolved.  No shortness of breath, dysphagia,  or stridor. Took prednisone 50 mg yesterday and today. Now feels back to normal - no further urticaria.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: After injection, the patient claims to have had arm soreness. The day after the injection, and continuing through 2 weeks post-injection, patient complains of continuous body aches, chills, and headache. The patient was advised to report to her PCP and was provided with GSK's 800-phone number to contact them, report her s/s, and ask about recommendations on their end.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain starting an hour after the injection (injection was at 2:30 pm 4/30/2019) Swelling starting  the next day , pain continued Redness was noticed two days later, pain slowly decreasing
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site erythema, Administration site swelling, Administration site warmth
Clinical narrative: At the site of administration the next day there was an erythematous coloration, swelling and localized heat.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood test, Electroencephalogram, Gene mutation identification test, Infantile spasms, Nuclear magnetic resonance imaging
Clinical narrative: Infantile Spasms started within 24 hours of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Myalgia, Pain in extremity
Clinical narrative: On 4/26/19 Patient states she has severe flu-like symptoms including fever, chills, muscle aching, lethargy. On 4/27/19 Patient continued to be shaking (no chills) and sore arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: On 4/26/19 Patient states she has severe flu-like symptoms including fever, chills, muscle aching, lethargy. On 4/27/19 Patient continued to be shaking (no chills) and sore arm.