chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness
Clinical narrative: Felt like they had the flu; Bedridden; This case was reported by a physician via call center representative and described the occurrence of influenza like illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza like illness and bedridden. On an unknown date, the outcome of the influenza like illness and bedridden were unknown.   It was unknown if the reporter considered the influenza like illness and bedridden to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The Medical director reported that patients had side effects for a few days and they were in bed after receiving Shingrix.  It was about 2 to 3 patients that had to be in bed for 2 to 3 days because they felt like they had the flu. No additional details were available The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: similar to chicken pox; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The anonymous individual who identifies themselves as a healthcare provider reported that got the Shingrix vaccine 10 days ago and experienced  rash similar to chicken pox. The follow up consent was not granted.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dermatitis contact, Nausea, Pain
Clinical narrative: came in contact with poison ivy; joint aches; body aches; Nausea; This case was reported by a consumer via call center representative and described the occurrence of poison ivy rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than 5 months after receiving Shingrix, the patient experienced poison ivy rash. On an unknown date, the patient experienced joint pain, general body pain and nausea. On an unknown date, the outcome of the poison ivy rash and nausea were unknown and the outcome of the joint pain and general body pain were recovered/resolved.   It was unknown if the reporter considered the poison ivy rash, joint pain, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient did not receive the 2nd dose until 26th November 2019. Since she came in contact with poison ivy in August 2019 and held off on getting the 2nd dose. Less than 9 months after receiving the 1st dose, the patient developed achy joints, body aches and nausea.  These symptoms were lasted for approximately 3 days. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 1st December 2021) and (batch number 9557F ?, expiry date unknown) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix. On 16th December 2019, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The registered nurse reported that the patient experienced Shingles after receiving the dose of Shingrix. The reporter did consent to follow up.
Age: 4.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Rash, Urticaria
Clinical narrative: 15-20 minutes after nurse administered each vaccine,  the patient was noted to have developed hives and a rash on her right cheek. There was no additional treatment provided to the patient and the rash was not bothersome. There were NO signs of anaphylaxis (i.e. facial edema, airway involvement, etc). The patient was monitored for an additional 1 hour and the rash resolved.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: The injection site and  3-4" around it was incredibly sore  had difficulty moving that arm. Patient reports to be drowsy last night, went to bed early, awoke this morning after about 10 hours of sleep with body aches, extreme chills, headache and exhausted.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Somnolence
Clinical narrative: The injection site and  3-4" around it was incredibly sore  had difficulty moving that arm. Patient reports to be drowsy last night, went to bed early, awoke this morning after about 10 hours of sleep with body aches, extreme chills, headache and exhausted.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever to 102.1 rectally. No rash, no other symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immunodeficiency, Rash vesicular, Urticaria
Clinical narrative: Redness in the area, according to the patient presented with welts in the vaccinated arm like shingles. From the deltoid to the forearm. This is the second dose and the patient is immunocompromised due to a medical condition.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient got purplish blisters on opposite arm the vaccine was given. Went to urgent care and got acyclovir.  Patient symptoms resolved and feels better.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm turned red & swelled - continued to spread 5days later ok
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Sensation of foreign body, Throat irritation
Clinical narrative: Patient reported lump in throat & scratchyness indicative of a similar anaphylactic reaction that she had to wasps. She received an Epi pen within 10 min of vaccine administration. Pt given prednisone in ER.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Redness and warmth to Rt deltoid area slight itching 2-4 welts near area of injection site. Apply ice pack as needed Benadryl tablets for itching as needed
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Patient had pain and swelling in her left arm about 5 hours after  the injection, said it did not hurt when it went in. Patient stated it was a significant amount of pain. A few days later was still a little swollen with some yellow discoloration. Spoke with the patient on 02/12/2020 she said it was all healed.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Patient received the vaccines on 2/12/2020. She noticed some itching on 2/13/2020. There is a 30mm x 50mm area of induration on the back of the left upper arm. It itches her and is warm to the touch and hard. A thin layer of hydrocortisone was applied and ice pack suggested. Encouraged her to not scratch at it. The left arm is where the Varicella vaccine was administered. The MMR vaccine administration site has a small red area, approximately 15mm x 15mm, Not warm or hard. Not bothersome.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received second Tdap vaccination on 2/13/2020 at our clinic but had already received another Tdap at a outside hospital on 09/09/2019.   Patient was informed yesterday about this and was advised to monitor her left arm injection site for swelling or redness and to monitor for fever or other concerns.  She was feeling well the day of her visit on 2/13/2020.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: patient's right deltoid shows  red, itchy rash  with no fever or any other symptoms which started 5 days after shot. patient was advised to take Benadryl and to monitor any other possible allergic reactions including shortness of breath and to see doctor if it doesn't go away or spreads or appears in other areas
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF test, Computerised tomogram head, Computerised tomogram spine, Demyelinating polyneuropathy, Guillain-Barre syndrome
Clinical narrative: developed Acute demyelinating polyneuropathy or Guillian Barre syndrome on 12/14/19 requiring hospitalization and treatment with Intravenous immunoglobulin. Hospitalized 12/15-12/21/19
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging brain, Magnetic resonance imaging spinal
Clinical narrative: developed Acute demyelinating polyneuropathy or Guillian Barre syndrome on 12/14/19 requiring hospitalization and treatment with Intravenous immunoglobulin. Hospitalized 12/15-12/21/19
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improper stored administered vaccine; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included sterile diluent. On 09-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R014690 and 23-MAY-2020 (strength, dose, route were not reported) for prophylaxis, for following a temperature excursion (product storage error). No additional adverse effects reported and no product quality complaint. The vaccine stored at highest temperature above 47-degree Fahrenheit/ 9 degree Celsius (14C) at time frame 9 hours. There was no temperature excursion and digital data logger yes.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; Stomach cramping; This case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included binimetinib (Mektovi) unknown (batch number W002993, expiry date 12th January 2020) for malignant melanoma.   Concurrent medical conditions included malignant melanoma, globulin and allergy to chemicals.   On an unknown date, the patient received the 1st dose of Shingrix. On 7th January 2020, the patient started Mektovi (oral) 45 mg at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced diarrhea and stomach cramps. The patient was treated with loperamide hydrochloride (Imodium) and hyoscyamine. The action taken with Mektovi was unknown. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the stomach cramps was unknown.   It was unknown if the reporter considered the diarrhea and stomach cramps to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and Metkovi vaccine and experienced diarrhea and stomach cramping. The provider decreased the dose of Metkovi until it was temporarily interrupted for two to three days and the diarrhea subsided. Gradually, the provider increased the dose until the patient was back on Metkovi. The patient had been feeling much better at time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced influenza-like symptoms. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that she had heard from several of her patients whom she had administered the Shingrix vaccine that they have experienced flu like symptoms for a couple days after injection. Tylenol and ibuprofen have helped to alleviate the symptoms. This case has been linked to US2020019996, reported by the same reporter.
Age: 51.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Axillary pain, Chills, Localised oedema, Pain, Pyrexia
Clinical narrative: some pain and tenderness associated with it and fills as if it's full of liquid; he felt a large swelling in his left arm pit; feverish; chills; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 30th January 2020, the patient received Shingrix (intramuscular) .5 ml and Tdap Vaccine (intramuscular). On 31st January 2020, 1 days after receiving Shingrix and Tdap Vaccine, the patient experienced fever, chills and pain. On 4th February 2020, the patient experienced axillary pain and localized edema. On 1st February 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the axillary pain and localized edema were recovering/resolving.   It was unknown if the reporter considered the fever, chills, pain, axillary pain and localized edema to be related to Shingrix and Tdap Vaccine.  Additional information was provided as follows: The patient received vaccine on his left arm. The patient felt feverish and had chills, he also had some general aches and pains. The symptoms were resolved. However, the patient still got chilly at night which was unusual for him. At the time of reporting, 5 days after vaccination, the patient took a shower and when he applied deodorant, he felt a large swelling in his left arm pit. It had some pain and tenderness associated with it and filled as if it's full of liquid. The reporter did not consent to follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was given without being reconstituted/diluent HIB portion not given/No AE; Based on information received on 06-Feb-2020, the report previously considered as non-valid became valid as patient identifier details were updated.  Initial information received on 24-Dec-2019 regarding an unsolicited non-valid non-serious case received from a consumer (office staff) in the United States.  This case involves a two years old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without being reconstituted with diluent HIB portion (lot UJ015AAA) via intramuscular route in an unknown administration site on 23-Dec-2019 for prophylactic vaccination.  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  Patient was re-immunized one month later.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.  Follow up information received on 06-Feb-2020 from the Nurse (nursing supervisor).  Case validity, patient demographic, reporter, product and event details were updated.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. the vaccine was given to the patient inspite of being compromised / no AE; Based on information received on 07-Feb-2020, the report previously considered as non-case became valid case because of patient information given in follow up: [reason for non-validity and validity].  Follow up information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473 and 2020SA038474.  This case involves a 2 years old patient who received a dose of 0.5 ml of (once) INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left thigh for Prophylactic vaccination on 13-JAN-2020 which was exposed to the temperature of 29.1 F (Product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient received Quadracel.who was 9 years old/no AE; Medical Assistant selected Quadracel with the intention of reducing the number of injections/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2020SA034519 (same reporter).  This case involves a 09-year-old female patient (first patient out of twins) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was administered by a Medical Assistant with the intention of reducing number of injections (Off label use; Product administered to patient of inappropriate age).  Patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) (no dosing details reported).  On 11-Dec-2019, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA (expiry date: 09-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration and off label use.  It was unknown whether adverse event was noted in the patient 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.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Child received dose of Act HIB that was mixed with sterile water instead of .4% saline/NoAE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case from nurse.  This case involves a 16 month old male patient who received HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) that was mixed with sterile water instead of 0.4 percent saline.  Medical history, medical treatment, vaccination and family history were not provided.   On 07-Feb-2020, the patient received 0.5ml of suspect HAEMOPHILUS INFLUENZA B Conjugate (ACT-HIB) VACCINE (lot UJ161AA and expiry date 26-Nov-2020) via an intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution.  Child received dose of Act HIB that was mixed with sterile water instead of .4% saline.  At the time of report, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the vaccine was administered to a patient 8 days after the expiration date, no adverse event; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-month-old female patient who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiration date 30-Jan-2020) via an intramuscular route in the left thigh on 07-Feb-2020 for prophylactic vaccination.  Medical history was not reported and the patient did not receive any other vaccine.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel administered,No AE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 34 month old (unknown gender) patient who received expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for prophylactic vaccination.  On 07-Feb-2020, the patient received third 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA and expiry date 30-Jan-2020) via intramuscular route in the thigh NOS 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired Daptacel vaccine, NO AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.   This case involves an 18 months old female patient who received an expired Daptacel vaccine (expired product administered), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included VARICELLA ZOSTER VACCINE (varicella vaccine).   On 05-Feb-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA and expiry date: 30-Jan-2020 via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site nodule, Injection site pain
Clinical narrative: a nickel sized knot at the injection site on left deltoid; sore at the site; the patient was 30 weeks and 5 days pregnant at time of vaccination; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036190, 2020SA036199 and 2020SA036186 (same reporter).  This case involves a 31 year old female patient of unknown age who experienced a nickel sized knot at the injection site on left deltoid (vaccination site mass), sore at the site (vaccination site pain) and reported that the patient was 30 weeks and 5 days pregnant (exposure during pregnancy), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period was 30 week and 5 days.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's previous pregnancy was unknown.  On 06-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE prefilled syringes lot U6518AA and expiry date: 05-Nov-2021 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious nickel sized knot at the injection site on left deltoid (vaccination site mass) and sore at the site (vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that the patient had no redness and bruising.  On an unknown date, the patient had exposure during pregnancy.  Laboratory data was not reported.  Final diagnosis was vaccination site lump and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.   Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Induration, Swelling
Clinical narrative: raised rock hard size of a golf ball; raised bright red the size of a golf ball; a 27 weeks and 6 days pregnant female patient received a dose of Adacel vaccine; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036161, 2020SA036199 and 2020SA036190 (same reporter).  This case involves a 25 years old female patient who experienced raised rock hard bright red the size of a golf ball (induration) and (erythema), when she received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The patient was 27 weeks and 6 days pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA, expiry date: 05-NOV-2021 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious raised rock hard bright red the size of a golf ball (induration) and (erythema) two weeks following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was case of vaccine exposure during pregnancy. A 27 weeks and 6 days pregnant female patient received a dose of Adacel vaccine.  No lab data reported.  Final diagnosis was induration and erythema.   It was not reported if the patient received a corrective treatment.  The patient was recovering from the events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given ActHIB with two diluents instead of vaccine/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 month old female patient who was vaccinated with two diluents of HIB (PRP/T) VACCINE [ACT-HIB] instead of vaccine (lot number: UJ135AB, expiry date: 26-Nov-2020) via an unknown route in the left vastus lateralis for prophylactic vaccination on 03-Jan-2020.  Medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It is an actual medication error case due to Active ingredient not added to diluent. It was reported that patient was given Act-HIB with two diluents instead of vaccine.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site discolouration, Injection site reaction, Skin reaction
Clinical narrative: slight discoloration of the skin on the upper thigh like a birthmark; child will need cosmetic surgery due to the event; skin started to dimple and became a concave area; doctor stated the vaccine was given in the fatty tissue in error; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old female patient who experienced slight discoloration of the skin on the upper thigh like a birthmark (Skin discolouration) and will need cosmetic surgery due to the event (Skin cosmetic procedure), skin started to dimple and became a concave area (Skin reaction), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 25-Nov-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AAA via unknown route in unknown administration site for prophylactic vaccination .  On an unknown date, The patient developed a non-serious slight discoloration of the skin on the upper thigh like a birthmark (skin discolouration) and skin started to dimple and became a concave area (skin reaction) 1week following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient will need cosmetic surgery due to the event (skin cosmetic procedure).   The patient developed a non-serious doctor stated the vaccine was given in the fatty tissue in error (vaccination error) <<Unknown latency>> following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was also of actual medication error due to vaccination error. Doctor stated the vaccine was given in the fatty tissue in error.  No lab test reported.  Final diagnosis was skin discolouration, skin reaction, skin cosmetic procedure.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Daptacel was inadvertently administered to 16 month old, no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 month old male patient who was received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA) via intramuscular route in the right thigh for prophylactic vaccination on 10-Feb-2020, that was expired on 30-Jan-2020.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Ipol went down to 29.1F. After that excursion, injections administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473 and 2020SA038474 (same reporter).  This case involves a 3 month old patient of unknown gender who received 0.5 ml first single dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) via unknown route in the left deltoid for Prophylactic vaccination.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), HEPATITIS B VACCINE (HEPATITIS B VACCIN), HIB VACCINE (HIB), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error case due to Product storage error temperature too low (Product storage error).  Patient did not have adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350 and 2020SA038352.  This case involves a 2 months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) via unknown route in the Left Thigh for Prophylactic vaccination on 20-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included Dtap (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID), ActHIB (HIB VACCINE CONJ (TET TOX)), Prevnar 13 (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)), HepB (HEPATITIS B VACCINE), Rotavirus (ROTAVIRUS VACCINE)  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. After that excursion, injections administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case was linked to cases 2020SA032577, 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038467, 2020SA038474 and 2020SA038473 (same reporter)  This case involves a 6 years old patient of unknown gender who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left Deltoid for Prophylactic vaccination which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low (Product storage error).  Patient did not receive any adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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: 9.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. the vaccine was given to the patient inspite of being compromised / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473, 2020SA038474,  and 2020SA038467.  This case involves a 9 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the right arm for prophylactic vaccination on 15-Jan-2020, which was exposed to the temperature of 29.1F (incorrect product storage).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351 and 2020SA038352.  This case involves a 6 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left deltoid for Prophylactic vaccination on 14-Jan-2020.which was exposed to the temperature of 29.1F (incorrect product storage).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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