chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Anaemia, Blood test, Cataract, Cataract operation
Clinical narrative: precancerous polyp; during this surgery, she began to hemorrhage and lost "half her blood."; liver numbers went from 35 to 1,000; as a result of the transfusion she developed anemia; bad reaction to the transfusion; outpatient surgery for cataracts; arm was sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of polyp in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced polyp (serious criteria hospitalization), hemorrhage (serious criteria hospitalization and GSK medically significant), elevated liver enzymes (serious criteria hospitalization), anemia (serious criteria hospitalization), adverse event (serious criteria hospitalization), cataract (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the polyp, hemorrhage, cataract and pain in arm were recovered/resolved and the outcome of the elevated liver enzymes and adverse event were unknown and the outcome of the anemia was not recovered/not resolved.   It was unknown if the reporter considered the polyp, hemorrhage, elevated liver enzymes, anemia, adverse event, cataract and pain in arm to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient's arm was sore to the touch for a couple of weeks.  On 05th November 2019, the patient was admitted to the hospital for a colectomy to remove a small portion of her colon due to a precancerous polyp. The reporter stated that during this surgery, she began to hemorrhage and lost half her blood. The reporter stated at that time her liver numbers went from 35 to 1,000 and that she had to have a blood transfusion.  She said that she had a bad reaction to the transfusion and as a result of the transfusion she developed anemia. She stated that while in the hospital she had to have all kinds of medical procedures including blood tests and a sonogram. The reporter stated that in November 2019, she also had outpatient surgery for cataracts.  The reporter consented to follow up. This case had been linked to the case US2020AMR015681, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Colectomy, Hepatic enzyme increased, Large intestine polyp, Pain in extremity, Precancerous cells present
Clinical narrative: precancerous polyp; during this surgery, she began to hemorrhage and lost "half her blood."; liver numbers went from 35 to 1,000; as a result of the transfusion she developed anemia; bad reaction to the transfusion; outpatient surgery for cataracts; arm was sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of polyp in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced polyp (serious criteria hospitalization), hemorrhage (serious criteria hospitalization and GSK medically significant), elevated liver enzymes (serious criteria hospitalization), anemia (serious criteria hospitalization), adverse event (serious criteria hospitalization), cataract (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the polyp, hemorrhage, cataract and pain in arm were recovered/resolved and the outcome of the elevated liver enzymes and adverse event were unknown and the outcome of the anemia was not recovered/not resolved.   It was unknown if the reporter considered the polyp, hemorrhage, elevated liver enzymes, anemia, adverse event, cataract and pain in arm to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient's arm was sore to the touch for a couple of weeks.  On 05th November 2019, the patient was admitted to the hospital for a colectomy to remove a small portion of her colon due to a precancerous polyp. The reporter stated that during this surgery, she began to hemorrhage and lost half her blood. The reporter stated at that time her liver numbers went from 35 to 1,000 and that she had to have a blood transfusion.  She said that she had a bad reaction to the transfusion and as a result of the transfusion she developed anemia. She stated that while in the hospital she had to have all kinds of medical procedures including blood tests and a sonogram. The reporter stated that in November 2019, she also had outpatient surgery for cataracts.  The reporter consented to follow up. This case had been linked to the case US2020AMR015681, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Procedural haemorrhage, Transfusion, Ultrasound scan
Clinical narrative: precancerous polyp; during this surgery, she began to hemorrhage and lost "half her blood."; liver numbers went from 35 to 1,000; as a result of the transfusion she developed anemia; bad reaction to the transfusion; outpatient surgery for cataracts; arm was sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of polyp in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced polyp (serious criteria hospitalization), hemorrhage (serious criteria hospitalization and GSK medically significant), elevated liver enzymes (serious criteria hospitalization), anemia (serious criteria hospitalization), adverse event (serious criteria hospitalization), cataract (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the polyp, hemorrhage, cataract and pain in arm were recovered/resolved and the outcome of the elevated liver enzymes and adverse event were unknown and the outcome of the anemia was not recovered/not resolved.   It was unknown if the reporter considered the polyp, hemorrhage, elevated liver enzymes, anemia, adverse event, cataract and pain in arm to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient's arm was sore to the touch for a couple of weeks.  On 05th November 2019, the patient was admitted to the hospital for a colectomy to remove a small portion of her colon due to a precancerous polyp. The reporter stated that during this surgery, she began to hemorrhage and lost half her blood. The reporter stated at that time her liver numbers went from 35 to 1,000 and that she had to have a blood transfusion.  She said that she had a bad reaction to the transfusion and as a result of the transfusion she developed anemia. She stated that while in the hospital she had to have all kinds of medical procedures including blood tests and a sonogram. The reporter stated that in November 2019, she also had outpatient surgery for cataracts.  The reporter consented to follow up. This case had been linked to the case US2020AMR015681, reported for same patient.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Rash, Skin abrasion
Clinical narrative: vaccination failure; Thinks she contracted shingles; Itching on her back and it appears as 4 linear dots; burning over that area (back); thought it may be bra rubbing skin; Itching on her back and it appears as 4 linear dots; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number T4952, expiry date unknown) for prophylaxis.   On 6th February 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, the patient received the 2nd dose of Shingrix. On 3rd August 2019, 178 days after receiving Shingrix and 108 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, burning sensation, chafed skin and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient experienced itching on her back and it appeared as 4 linear dots (2 on top and 2 below). She stated that she has burning over that area. Initially, the patient thought it might be bra rubbing skin but later she thought she contracted Shingles.  The patient worked at a facility and might have contracted Shingles at work.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: vaccination failure; Thinks she contracted shingles; Itching on her back and it appears as 4 linear dots; burning over that area (back); thought it may be bra rubbing skin; Itching on her back and it appears as 4 linear dots; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number T4952, expiry date unknown) for prophylaxis.   On 6th February 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, the patient received the 2nd dose of Shingrix. On 3rd August 2019, 178 days after receiving Shingrix and 108 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, burning sensation, chafed skin and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation, chafed skin and pruritus to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient experienced itching on her back and it appeared as 4 linear dots (2 on top and 2 below). She stated that she has burning over that area. Initially, the patient thought it might be bra rubbing skin but later she thought she contracted Shingles.  The patient worked at a facility and might have contracted Shingles at work.  The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site rash, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Patient noted tightness in her left arm and found it hard to take her jacket off. She noticed that the injection site appeared to be swollen and felt warm to the touch. She took ibuprofen which did seem to help a little. The next morning she noticed a rash. Her mother put ice on the injection site and patient wore a sling. The next day the rash appeared worse so Mother circled the swelling with a marker ( 02/01/2020). Today, 02/03/2020, the redness is noted to have spread beyond the marker.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe pain and stiffness in arm.  Loss of range of motion
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Agitation, Erythema, Fatigue
Clinical narrative: fatigue, face red, agitation
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Chest pain, Epistaxis, Pain in extremity, Peripheral swelling
Clinical narrative: The day after receiving the 2nd dose of her shingrix the patient started experiencing arm pain. Over the course of the next couple of days her left arm (the site of administration) began to swell. She also started experiencing nose bleeds from her left nostril and had left sided chest pain. Two weeks after receiving the immunization shes still experiencing visible whole arm swelling, left nostril nose bleeds and clots and chest pain. She went to the dr and was prescribed steroids.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 5 year old M or F patient complains of a 1 day history of:  rash s/p immunizations yesterday: Dtap, MMR, polio, Chicken Pox.  rash at site diffuse redness about 6 x 3" wrapping medially around thigh.  smaller erythema at other R lateral thigh site 1" diameter
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Large red bruise covering they whole thigh
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: FEVER OF 105 DEGREES AND SWELLING. FEVER GONE NEXT DAY. SWELLING A COUPLE OF DAYS.
Age: 3.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Purpura, Rash
Clinical narrative: patient with rash that developed 10+ hours after vaccination with Hep A, Hib-PRP-OMP, and PCV13 while ill with presumed viral URI. Description of rash and pictures provided appear to be purpura, non-urticarial, and non-life-threatening. Mother reports rash was not responsive to Tylenol, Decadron, Benadryl, Orapred, or Claritin. This is not consistent with an IgE-mediated reaction due to vaccination. Rather, rash may be related to an alternative immune-mediated process most likely associated with his concurrent illness, and less likely but possibly associated with vaccination.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: seizure (without fever)
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Decreased appetite, Intensive care, Malaise, Renal failure
Clinical narrative: After 2-3 weeks of malaise and poor appetite, patient was admitted to hospital intensive care on 1/31/2020 with ANCA Vasculitis and renal failure.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Insomnia, Migraine, Musculoskeletal pain
Clinical narrative: Moderate neck and shoulder pain, increasing 2-3 days after injection. Still persisting at 5 days post injection. Nightmares and difficulty sleeping, still persisting 5 days post injection.  Migraine 3-4 days post injection. Intermittent headaches.  Arm soreness at injection site, still persisting 5 days post injection. Overall muscle soreness, not limited to injection site.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Neck pain, Nightmare
Clinical narrative: Moderate neck and shoulder pain, increasing 2-3 days after injection. Still persisting at 5 days post injection. Nightmares and difficulty sleeping, still persisting 5 days post injection.  Migraine 3-4 days post injection. Intermittent headaches.  Arm soreness at injection site, still persisting 5 days post injection. Overall muscle soreness, not limited to injection site.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any symptoms.; the patient was administered one dose of ROTATEQ from a shipment that was received late (one day past the "must be received by date" on the box).; the patient was administered one dose of ROTATEQ from a shipment that was received late (one day past the "must be received by date" on the box).; This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical condition, concurrent condition and concomitant therapy were not reported.  On 16-JAN-2020, the patient received one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1660151 with expiration date: 17-SEP-2020; strength and frequency unknown) orally for prophylaxis, which was from a shipment that was received late (one day past the "must be received by date" on the box) (product distribution issue and inappropriate schedule of product administration). The patient did not experience any symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 23-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S022755, expiration date 22-JUL-2021 (exact dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. The vaccine underwent a temperature excursion of negative 11.9 Celsius degrees for 35 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event information were provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-DEC-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R021077, expiration date 11-JUN-2021, (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.2 degrees Fahrenheit for 15 hours and 35 minutes. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient was inadvertently administered one dose of PNEUMOV AX 23, which had expired on 10/24/2019; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-JAN-2020, the patient was inadvertently vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot # R006465 and expiration date 24-OCT-2019 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: left sore arm; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA006336.  This case involves an elderly female patient who experienced left sore arm (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant,  medical treatment, vaccination and family history were not provided.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, (lot number not reported, of unknown Expiration date, via unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious left sore arm (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not provided.  Final diagnosis was pain.   It was not reported if the patient received any corrective treatment.  The patient recovered after 1 day.  Information on the batch number is requested.
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Needle issue
Clinical narrative: shoulder pain; the needle was too long; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 60 years old female patient who experienced shoulder pain (musculoskeletal pain), the needle was too long (needle issue) and dose 0.1ml administered (underdose), while she received vaccine INFLUENZA VACCINE TRIVALENT [FLUZONE INTRADERMAL].  Medical history, medical treatment, vaccination and family history were not provided.   On 22-Oct-2014, the patient received a 0.1 ml dose of suspect INFLUENZA VACCINE TRIVALENT lot UT4993AA (suspension for injection) via intradermal route in the left shoulder.  On an unknown date, the patient developed a non-serious shoulder pain (musculoskeletal pain) (unknown latency) following the administration of INFLUENZA VACCINE TRIVALENT.  It was a case of actual medication error due to needle issue (the needle was too long)  Final diagnosis musculoskeletal pain.  It was not reported if the patient received a corrective treatment.  Outcome of the events were 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.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: next dose of Imovax is due over the weekend; Received first Imovax on next day after was bitten by a stray dog/ No AE; Initial information was received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves adult female patient who was vaccinated with first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on next day after was bitten by a stray dog (inappropriate schedule of vaccine administered) and patient reported that next dose of Imovax is due over the weekend (Product dose omission).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for animal bite and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination on 15-Jan-2019.  On 16-Jan-2020, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number not reported) via unknown route in unknown administration site for post exposure Immunisation (bitten by a stray dog).  The reporter states that on 15-Jan-2020 she was bitten by a stray dog and she went to the ED where she was given Adacel and told that she needed Imovax and Imogam, but it was not available at that ED. The next day on 16-Jan-2020, she went to a different ED and received Imogam and her first Imovax (inappropriate schedule of vaccine administered). Consumer also states that her next dose of Imovax is due over the weekend and there are not any doctors open that day.  It was an actual medication error case due to inappropriate schedule of vaccine administered and Product dose omission .   At a time of reporting no adverse event reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: pain at the injection site; female patient was given a second vaccination of Fluzone Quad of 0.5 ml, in the right deltoid on 10/212019 and first being on 1/24/2020; Initial information was received on 24-Jan-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 32 years old female patient who experienced pain at the injection site (injection site pain), while she received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 21-Oct-2019, the patient received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED via an unknown route at an unknown administration site, for prophylactic vaccination. On 24-Jan-2020 ,she received another dose of the same vaccine (lot: UJ254AC, expiry date: 30-Jun-2020) via an unknown route in the right deltoid, for prophylactic vaccination.  On an unknown date, the patient developed injection site pain following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED for prophylactic vaccination.  It was also a case of actual medication error due to extra dose administered.  No laboratory tests were reported.  Final diagnosis was injection site pain.   It was not reported if the patient received any corrective treatment.  The patient outcome was reported as unknown injection site pain.  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 is requested (first dose).
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok QIV administer to 17 years old female patient / no AE; Initial information received on 24-Jan-2020 regarding an unsolicited valid non-serious case received from a non-hcp (other).  This case involves a 17 years old female patient who received 0.5 ml vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number-QFFAA and Expiry date unknown) via unknown route in the left deltoid on 21-Nov-2019 for Prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The batch number information was requested.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Daptacel dose that was given to patient/ No AE; Initial information was received on 24-Jan-2020 regarding an unsolicited valid non-serious case from other-healthcare professional.  This case involves a 20 month old male patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 23-Jan-2020, the patient received the first 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5Z06AA, expiry date - 17-05-2019) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: product was exposed to a temperature of up to 49.4 F for 1 hour 30 minutes/no AE; one of their staff still inadverently administered a dose of IPOL to a patient/no AE; Initial information was received on 27-Jan-2020 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 9 years old male patient who received a dose of IPV (VERO) [IPOL] that was not suitable for use after it was exposed to a temperature of up to 49.4 f for 1 hour 30 minutes.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE) for Immunisation.  On 27-Jan-2020, the patient received 0.5 ml dose of suspect IPV (VERO) (lot T1F541M) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to incorrect product storage and poor quality vaccine administered.  It was reported that opened IPOL multi-dose vial (MDV) should not be used, and instructed the staff not to use the opened IPOL MDV that was exposed to a temperature of up to 49.4 F for 1 hour 30 minutes due to the refrigerator door being left ajar during vaccine counting, but instead to use an unopened IPOV MDV. However, one of their staff still inadvertently administered a dose of IPOL to a patient using the MDV that had been opened, and which was exposed to that temperature excursion.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: red and raised area around the injection site; raised area around the injection site; red area around the injection site; itching area around the injection site; Initial information received on 27-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 34 years old female patient who experienced red and raised area around the injection site (vaccination site inflammation) with its symptom  raised area around the injection site (vaccination site swelling) and red area around the injection site (vaccination site erythema) and itching area around the injection site (vaccination site pruritus), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6539AA and expiry date: 13-Nov-2021) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious red and raised area around the injection site (vaccination site inflammation) with its symptom  raised area around the injection site (vaccination site swelling) and red area around the injection site (vaccination site erythema) and itching area around the injection site (vaccination site pruritus), (Unknown latency), following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that, patient last menstrual period was 13-Jan-2019.  No lab data was data.  Final diagnosis was vaccination site pruritus and vaccination site inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for vaccination site pruritus and vaccination site inflammation.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Ultrasound scan normal
Clinical narrative: Day following shot my right arm was sore, red & I felt bad. Now its 1-30-20, some 33 days later & my arm is still very sore to any slight touch and hurts all the time particularly sleep. My Primary care Dr. Prescribed Ultra Sound done 1-28-20 which negative.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Dec 23 - When given vaccination, lots of stinging at site of injection. Dec 25 - Approx 36 hours later, woke up with redness on skin (ie, torso between shoulders and waist), small bumps on skin, and skin hot. Episodes of itching. Worst episodes for next 5 to 8 hours. Didn't take any medication. Dec 26-Symptoms had cleared up within 24 hours except for slight redness at site of injection (ie, size of large Band-Aid), which cleared up entirely within next 24 hours (by Dec 27). NOTE: Discussed later with pharmacist who suggested Benadryl for allergic reaction. This was first dose. Second dose is due after Feb 20, 2020.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Dec 23 - When given vaccination, lots of stinging at site of injection. Dec 25 - Approx 36 hours later, woke up with redness on skin (ie, torso between shoulders and waist), small bumps on skin, and skin hot. Episodes of itching. Worst episodes for next 5 to 8 hours. Didn't take any medication. Dec 26-Symptoms had cleared up within 24 hours except for slight redness at site of injection (ie, size of large Band-Aid), which cleared up entirely within next 24 hours (by Dec 27). NOTE: Discussed later with pharmacist who suggested Benadryl for allergic reaction. This was first dose. Second dose is due after Feb 20, 2020.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient reported pain at injection site on same day the shot was administered.  Patient went on vacation and the pain did not subside. The pain persisted on and off . Sometimes the area gets numb. The area affected was localized but not visible at this time and was about the size of 2 quarters as per patient.  Patient has no problems  moving the arm in any direction. The pain did not move down the arm.  Patient did not come in for me to see the injection site. Patient has not seen any doctor. I advised patient to consult with his Doctor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Imms done on 1/23/2020. On 1/31/2020, mom noted a red spot on his leg where he got the shot. Initially no induration or warmth. Did not seem painful. On 2/2/2020 noticed it was hard and warm, temp 99.5. Office visit on 2/3/2020. Mom states it looks better today - no longer warm and not as hard.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Fatigue, Flushing, Loss of personal independence in daily activities
Clinical narrative: Patient reports feeling fever and chills as well as mental status changes 2 hours after receiving vaccine. Since then, patient reports intermittent chills with or without fever that correspond with worsening daytime fatigue and a sense of sleepiness, as well as cold sweats and flushing. These symptoms have continued for almost 4 months, with the patient noting persistence of symptoms at 3 separate emergency department visits and 3 separate primary care visits. Most recently, this reaction has been described as a severe urticarial reaction by her primary care physician. Patient reporting that these symptoms are threatening every day life, that they are too much on her system, she can only sleep, and cannot get anything done. Patient has been counseled multiple times that symptoms will resolve with time, but patient continues to have symptoms almost 4 months since vaccination.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mental status changes, Pyrexia, Somnolence, Urticaria
Clinical narrative: Patient reports feeling fever and chills as well as mental status changes 2 hours after receiving vaccine. Since then, patient reports intermittent chills with or without fever that correspond with worsening daytime fatigue and a sense of sleepiness, as well as cold sweats and flushing. These symptoms have continued for almost 4 months, with the patient noting persistence of symptoms at 3 separate emergency department visits and 3 separate primary care visits. Most recently, this reaction has been described as a severe urticarial reaction by her primary care physician. Patient reporting that these symptoms are threatening every day life, that they are too much on her system, she can only sleep, and cannot get anything done. Patient has been counseled multiple times that symptoms will resolve with time, but patient continues to have symptoms almost 4 months since vaccination.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, UNK, UNK, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Cyst, Emotional distress, Feeling abnormal
Clinical narrative: LEFT THE CLINIC AFTER 5 INJECTS THAT DAY HE WAS SCREAMIN INCONSOLIBLE,  GOT HOME WITH IN 2 HOURS HE STARTED HIS FEVER, IT CLIMBED TO 104 .3F I STARTED TRYING TO LOWER  IT IMMEDIATLY! LOWEST I COULD KEEP IT WAS 102. BUT STAYED TRYING AND DID CLIMB BACK UP OFF AND ON NEXT CAME THE NASTIEST I'VE EVER SEEN THEN THE RASH FROM HEAD TO TOE THAT WE WENT TO THE DOCTOR FOR YES I SHOULD HAVE WENT THE FIRST DAY I'LL ALWAYS BE SORRY!!!! ANYWAY SHE SAID IT FROM THE VACCINES SHOULD BE FINE YEA RIGHT THEN HE QUITE TALKING COMPLETELY, HE SIT IN A DAZE FOR HOURS AND NEVER MAKE A SOUND.  I TOOK HIM BACK TO DOCTOR AND I AM GETTING THE COMPLETE RUN AROUND IT I NEED TO KNOW IF HE IS OK  OR IF HIS BRAIN IS SWOLLEN AND INJURED ASAP
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, UNK, UNK, VARCEL
Symptoms: Pyrexia, Rash, Screaming, X-ray
Clinical narrative: LEFT THE CLINIC AFTER 5 INJECTS THAT DAY HE WAS SCREAMIN INCONSOLIBLE,  GOT HOME WITH IN 2 HOURS HE STARTED HIS FEVER, IT CLIMBED TO 104 .3F I STARTED TRYING TO LOWER  IT IMMEDIATLY! LOWEST I COULD KEEP IT WAS 102. BUT STAYED TRYING AND DID CLIMB BACK UP OFF AND ON NEXT CAME THE NASTIEST I'VE EVER SEEN THEN THE RASH FROM HEAD TO TOE THAT WE WENT TO THE DOCTOR FOR YES I SHOULD HAVE WENT THE FIRST DAY I'LL ALWAYS BE SORRY!!!! ANYWAY SHE SAID IT FROM THE VACCINES SHOULD BE FINE YEA RIGHT THEN HE QUITE TALKING COMPLETELY, HE SIT IN A DAZE FOR HOURS AND NEVER MAKE A SOUND.  I TOOK HIM BACK TO DOCTOR AND I AM GETTING THE COMPLETE RUN AROUND IT I NEED TO KNOW IF HE IS OK  OR IF HIS BRAIN IS SWOLLEN AND INJURED ASAP
Age: 31.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Worsening left shoulder pain and decreasing range of motion in the 14 days after vaccination with influenza and HPV without signs of cellulitis, no bursitis appreciated. Possible tendon injury or possible frozen shoulder. Will be taking nonsteroidal anti-inflammatory medication and doing home physical therapy exercises. Will follow-up to assess improvement or need for further work-up/referral.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus & Hives on upper thigh that went away after one day
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: SkinRash & Rash and blisters over face, TACROLIMUS Small Amount EVERY DAY
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; inadvertently administered a dose of PROQUAD on 1/20/2020 that had been improperly stored; This spontaneous report was received from a nurse practitioner regarding a 5-years-old patient of unknown gender. The patient's pertinent medical history , concurrent conditions and drug reactions or allergies were not provided.  On 20-JAN-2020, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA))(PROQUAD) injection (strength, dose number, and anatomical site of vaccination were not reported; lot number S027461 has been verified to be valid, expiration date on 02-MAR-2021) as prophylaxis.  The improperly dose experienced a temperature of -13 degrees Celsius (C), for a time frame of 5 minutes and 4.69 degrees C for a timeframe of 1 hour 45 minutes; without a previous temperature excursion. The temperatured was recorded by a data logger. It was reported that the sterile diluent (DILUENT MERCK) injection and used for reconstitution of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: the patient "is on trealment with Cosentyx (manufacturer unspecified) for arthritis; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. No information regarding the patient's medical history, or concurrent conditions was provided. The patient's concomitant therapies included sterile diluent(manufacturer unknown).    On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis.   The registered nurse reported that the patient "is on treatment with Cosentyx (manufacturer unspecified) for arthritis, however, stopped treatment for 3 months prior to receiving the dose of MMR II and has not yet restarted treatment." (contraindicated product administered).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number 1660112 (had not been valid upon internal validation) and expiration date 18-OCT-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the site of injection; Pain and swelling at the site of injection; This spontaneous report was received from a nurse referring to a 41-year-old female patient. The patient's concurrent conditions were not reported. The patient's medical history included herpes virus infection. Concomitant therapies included ethinyl estradiol, norgestimate (TRI-SPRINTEC) and valacyclovir hydrochloride. On 22-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular (dose 1, lot# R024259, expiry date: 30-MAY-2021) for prophylaxis. On 09-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular (dose 2, lot # S026372, expiry date: 01-APR-2020) for prophylaxis. On 25-JAN-2020, the patient developed pain (injection site pain) and swelling at the site of injection (injection site swelling). The patient did not receive any treatment for the event but called the nurse and sought medical attention. The outcome of injection site pain and injection site swelling was not recovered. The causality of the events was not reported with respect to suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The first dose less than 6 months prior had no adverse reaction other than a sore arm.  This time the area turned bright red and about the circular size of an egg. It was raised slightly and  was very hot and sore.  This lasted for probably about 4-5 days.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: My 6-year old daughter had her Varicella booster shot and broke out 17 days later with a Chickenpox rash on her face near her mouth and in her nostrils, as well as two spots on her forearm.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Arm went numb, pain in shoulder in front and back.  Next day still numb. Not red, not swollen, not itching.  Went to ER on 1/30.  No tests ran, MD evaluated and gave pain med and anti-inflammatory med.  As of today, 2/3/2020 pain is gone, still "just a little tingly" in the fingers.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram normal, Computerised tomogram normal, Erythema, Facial pain, Headache
Clinical narrative: I awoke on 12/19/2019 with a headache and facial pain on the left side of my face and head. After 24 hours I felt like I had the flu and spent 3 days in bed with a swollen arm I had to ice as it was very red. Headache continued and I was hospitalized the week of 1/13/2020 late in the evening until my release around 6:20 pm on 1/17 2020. I was treated with a lot of migraine medication and drip bags of Valporic Acid which helped my headache some but my facial pain has continued and does even as I write this report. The headache comes and goes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Peripheral swelling
Clinical narrative: I awoke on 12/19/2019 with a headache and facial pain on the left side of my face and head. After 24 hours I felt like I had the flu and spent 3 days in bed with a swollen arm I had to ice as it was very red. Headache continued and I was hospitalized the week of 1/13/2020 late in the evening until my release around 6:20 pm on 1/17 2020. I was treated with a lot of migraine medication and drip bags of Valporic Acid which helped my headache some but my facial pain has continued and does even as I write this report. The headache comes and goes.