chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Hypoaesthesia, Insomnia, Joint injection, Joint range of motion decreased
Clinical narrative: Well the initial reaction I experienced was stiffness swelling a little pain but my pain, and stiffness with swelling increased I have dull pain Can't move the shoulder Nor the forearm but so high tingling and numbness through the fingers I would like to say due to this last vaccination it has caused me undo stress prior to this vaccination I had no experiences with the previous vaccinations in the past my reasons for me taking the flu shots I have bronchitis now I need to find other alternatives because Im/afraid this may happen again I have limited range of motion in my shoulder down my arm through my fingers I had long hair I had to have my hair cut rather short to maintain it I can't whipe myself with my left side nor bathe myself these are really trying times for me I stay in Chronic pain daily I've had physical therapy which help some my therapist told me it wasn't much more they could do for me. I've had several shoulder 'injections' that didn't work several different medicines from the doctor that didn't work I put over the counter pain cream on it that didn't work, pain killers still painful I elevate it still painful on the pillow Can't sleep at night can't lay on my arm which I'm used to doing Not any longer can't do much reaching due to it's limited motion Nor holding different objects my shoulder swells up a lot I had a MRI which shows inflammation in my rotator cuff my doctor says it's tendonitis I also had a ultrasound they were looking for blood clots which I didn't have thank God for that
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Well the initial reaction I experienced was stiffness swelling a little pain but my pain, and stiffness with swelling increased I have dull pain Can't move the shoulder Nor the forearm but so high tingling and numbness through the fingers I would like to say due to this last vaccination it has caused me undo stress prior to this vaccination I had no experiences with the previous vaccinations in the past my reasons for me taking the flu shots I have bronchitis now I need to find other alternatives because Im/afraid this may happen again I have limited range of motion in my shoulder down my arm through my fingers I had long hair I had to have my hair cut rather short to maintain it I can't whipe myself with my left side nor bathe myself these are really trying times for me I stay in Chronic pain daily I've had physical therapy which help some my therapist told me it wasn't much more they could do for me. I've had several shoulder 'injections' that didn't work several different medicines from the doctor that didn't work I put over the counter pain cream on it that didn't work, pain killers still painful I elevate it still painful on the pillow Can't sleep at night can't lay on my arm which I'm used to doing Not any longer can't do much reaching due to it's limited motion Nor holding different objects my shoulder swells up a lot I had a MRI which shows inflammation in my rotator cuff my doctor says it's tendonitis I also had a ultrasound they were looking for blood clots which I didn't have thank God for that
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Paraesthesia, Stress, Swelling, Tendonitis, Ultrasound scan normal
Clinical narrative: Well the initial reaction I experienced was stiffness swelling a little pain but my pain, and stiffness with swelling increased I have dull pain Can't move the shoulder Nor the forearm but so high tingling and numbness through the fingers I would like to say due to this last vaccination it has caused me undo stress prior to this vaccination I had no experiences with the previous vaccinations in the past my reasons for me taking the flu shots I have bronchitis now I need to find other alternatives because Im/afraid this may happen again I have limited range of motion in my shoulder down my arm through my fingers I had long hair I had to have my hair cut rather short to maintain it I can't whipe myself with my left side nor bathe myself these are really trying times for me I stay in Chronic pain daily I've had physical therapy which help some my therapist told me it wasn't much more they could do for me. I've had several shoulder 'injections' that didn't work several different medicines from the doctor that didn't work I put over the counter pain cream on it that didn't work, pain killers still painful I elevate it still painful on the pillow Can't sleep at night can't lay on my arm which I'm used to doing Not any longer can't do much reaching due to it's limited motion Nor holding different objects my shoulder swells up a lot I had a MRI which shows inflammation in my rotator cuff my doctor says it's tendonitis I also had a ultrasound they were looking for blood clots which I didn't have thank God for that
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient (E.L.) received an improperly stored PEDVAXHIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications, drug reactions or allergies were not reported.  On 04-NOV-2019 or 05-NOV-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S000352 with expiration date of 17-OCT-2021 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit (2 degrees Celsius) for 2 hours and 18 minutes. Digital data logger was involved. There were no previous excursions reported. There were no pertinent adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002033: US-009507513-1911USA001926: US-009507513-1911USA002053: US-009507513-1911USA002263: US-009507513-1911USA002388: US-009507513-1911USA002198: US-009507513-1911USA002043: US-009507513-1911USA001946: US-009507513-1911USA001917:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; lhe patient was administered improperly stored PROQUAD (reconstituted with properly stored Merck STERILE DTLUEND; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not provided.  On 25-MAR-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (Albumin status rHA (recombinant Human albumin)) (PROQUAD) (lot number R020678, expiration date 15-JAN-2020, route, dose and frequency unknown) for prophylaxis (Product storage error). The storage temperature was from 15 to 46 degrees Fahrenheit (32.57 degrees Fahrenheit) for a time frame of 22 hours. There was no previous temperature excursion. The call was because of a data logger.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 23-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 16-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 12-months-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004662:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: muscle pain top of her shoulders on both sides; chills; muscle pain/neck muscle pain; could barely move her; prevented her from doing her normal daily activities like working/herself up with a pillow to move in bed; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th October 2019, 2 days after receiving Shingrix, the patient experienced muscle pain and mobility decreased. On 5th October 2019, the patient experienced shoulder pain and chills. In October 2019, the patient experienced activities of daily living impaired. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle pain, mobility decreased, shoulder pain, chills and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the muscle pain, mobility decreased, shoulder pain, chills and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced terrible neck muscle pain on one side of her neck which lasted a couple of days and she could barely move her neck.  The following day, the muscle pain moved to the other side of her neck and then migrated to the top of her shoulders on both sides and she had chills.  The patient took Advil around the clock for the pain which she typically did not take but the side effects prevented her from doing her normal daily activities like working out which she typically did daily.  She had to prop herself up with a pillow to move in bed. All of her symptoms resolved and she stopped taking the Advil. The patient reported that, she was 64 inches in height and 110 pounds in weight and she had concerned that, she could have received too much medication in the vaccination for her size.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain top of her shoulders on both sides; chills; muscle pain/neck muscle pain; could barely move her; prevented her from doing her normal daily activities like working/herself up with a pillow to move in bed; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th October 2019, 2 days after receiving Shingrix, the patient experienced muscle pain and mobility decreased. On 5th October 2019, the patient experienced shoulder pain and chills. In October 2019, the patient experienced activities of daily living impaired. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle pain, mobility decreased, shoulder pain, chills and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the muscle pain, mobility decreased, shoulder pain, chills and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced terrible neck muscle pain on one side of her neck which lasted a couple of days and she could barely move her neck.  The following day, the muscle pain moved to the other side of her neck and then migrated to the top of her shoulders on both sides and she had chills.  The patient took Advil around the clock for the pain which she typically did not take but the side effects prevented her from doing her normal daily activities like working out which she typically did daily.  She had to prop herself up with a pillow to move in bed. All of her symptoms resolved and she stopped taking the Advil. The patient reported that, she was 64 inches in height and 110 pounds in weight and she had concerned that, she could have received too much medication in the vaccination for her size.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash on upper arm of injection; Soreness of arm of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash and injection site pain were unknown.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, after vaccination with dose of Shingrix, the patient had rash and extreme soreness on upper arm . The reporter did not have patient information, batch number and expiry date of Shingrix vaccine. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: He got Prevnar 13 on 28Nov2019 and Prevnar 13 on 02Dec2019; This is a spontaneous report from a contactable other nurse. A 67-year-old male patient received receive pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on 02Dec2019 at a single dose for immunization. The patient previously received flu shot and pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) on 28Nov2019. It was reported that the patient had no documentation of getting the pneumococcal vaccine. The patient said that he got the flu shot last week. It turned out that he got pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) last week. So the patient got pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) on 28Nov2019 and pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) on 02Dec2019.
Age: 17.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Syncope
Clinical narrative: The patient fainted; This is spontaneous case, initially reported by physician via Merck via Communications (reference number: SEQ19-07021) on 25-Nov-2019, concerning an 17-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 09-Nov-2019, the patient was administered the second dose of Gardasil 9 [hpv vaccine vlp rl1 9v (yeast); dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On the same day, the patient was also administered INN Flu Vaccine [Influenza vaccine; dose, route of administration, anatomical location; batch number and expiry date: not reported] for an unknown indication.  On the same day, after vaccination, the patient fainted.  The patient recovered after a few minutes and was given juice. The patient was observed.   The event of faint was considered serious due to the criterion of medical significance (the event is on IME list).  The reporter did not provide causality assessment.  Company Comment: The patient experienced syncope after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Causality was strongly confounded by use of co-suspect product Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant); No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as possibly related.; Sender's Comments: The patient experienced syncope after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Causality was strongly confounded by use of co-suspect product Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant); No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as possibly related.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Magnetic resonance imaging, X-ray limb
Clinical narrative: 4 hrs after injection patient developed severe left shoulder pain and trouble moving the shoulder
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein increased, Contusion, Eosinophil percentage increased, Lymphocyte percentage decreased, Monocyte percentage
Clinical narrative: Patient dx with vasculitis from the trunk down. Patient went to the ER twice and the Doctor twice.  Patient does have some bruising. Patient took  Prednisone for 2.5 weeks.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vasculitis
Clinical narrative: Patient dx with vasculitis from the trunk down. Patient went to the ER twice and the Doctor twice.  Patient does have some bruising. Patient took  Prednisone for 2.5 weeks.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: NOTICED REDNESS AND HEAT WITH SWELLING IN HER ARM THE NEXT NIGHT AFTER RECEIVING THE VACCINE.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Hypoaesthesia, Injection site bruising, Pain in extremity
Clinical narrative: High fever, deep cough, chills lasting 4 hours and then stopped.  Cough, one inch bruise at site, red rash covering all of upper arm, and arm pain (dead arm feeling)  lasting three days..
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: High fever, deep cough, chills lasting 4 hours and then stopped.  Cough, one inch bruise at site, red rash covering all of upper arm, and arm pain (dead arm feeling)  lasting three days..
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received first shingrix vaccine on 9/21/19. On 12/4/19, patient was diagnosed with shingles by FNP-C. Provider requested that this adverse event be reported to VAERS.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Autoimmune disorder, Biopsy cervix, Blood test, Cervical dysplasia
Clinical narrative: After each vaccine, I became acutely ill. I have progressively become worse. Don't feel well in general, tired all the time, joint pain and muscle aches. I was very healthy before the series and have since been diagnosed with multiple autoimmune disorders including fibromyalgia, POTS and another, unknown autoimmune type disorder that mimics rheumatoid arthritis but all tests for RA have come back negative. I have chronic pain with no explanation as to why. I was diagnosed with premature ovarian failure and had to take fertility meds to get pregnant. Previous to the series I had at least 10 normal annual pap smears. After the series, I had an abnormal pap which resulted in a biopsy then a LEEP which led to my cervix being removed for high grade dysplasia that couldn't be removed. I developed endometriosis that I didn't have beforehand. I have lived in pain and am constantly tired for the last 13 years. I was one of the first people to receive the series.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Cervicectomy, Endometriosis, Fatigue, Fibromyalgia, Hysterectomy
Clinical narrative: After each vaccine, I became acutely ill. I have progressively become worse. Don't feel well in general, tired all the time, joint pain and muscle aches. I was very healthy before the series and have since been diagnosed with multiple autoimmune disorders including fibromyalgia, POTS and another, unknown autoimmune type disorder that mimics rheumatoid arthritis but all tests for RA have come back negative. I have chronic pain with no explanation as to why. I was diagnosed with premature ovarian failure and had to take fertility meds to get pregnant. Previous to the series I had at least 10 normal annual pap smears. After the series, I had an abnormal pap which resulted in a biopsy then a LEEP which led to my cervix being removed for high grade dysplasia that couldn't be removed. I developed endometriosis that I didn't have beforehand. I have lived in pain and am constantly tired for the last 13 years. I was one of the first people to receive the series.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Hysterosalpingogram, Loop electrosurgical excision procedure, Malaise, Myalgia, Pain
Clinical narrative: After each vaccine, I became acutely ill. I have progressively become worse. Don't feel well in general, tired all the time, joint pain and muscle aches. I was very healthy before the series and have since been diagnosed with multiple autoimmune disorders including fibromyalgia, POTS and another, unknown autoimmune type disorder that mimics rheumatoid arthritis but all tests for RA have come back negative. I have chronic pain with no explanation as to why. I was diagnosed with premature ovarian failure and had to take fertility meds to get pregnant. Previous to the series I had at least 10 normal annual pap smears. After the series, I had an abnormal pap which resulted in a biopsy then a LEEP which led to my cervix being removed for high grade dysplasia that couldn't be removed. I developed endometriosis that I didn't have beforehand. I have lived in pain and am constantly tired for the last 13 years. I was one of the first people to receive the series.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Premature menopause, Rheumatoid factor negative, Smear cervix abnormal, Ultrasound scan
Clinical narrative: After each vaccine, I became acutely ill. I have progressively become worse. Don't feel well in general, tired all the time, joint pain and muscle aches. I was very healthy before the series and have since been diagnosed with multiple autoimmune disorders including fibromyalgia, POTS and another, unknown autoimmune type disorder that mimics rheumatoid arthritis but all tests for RA have come back negative. I have chronic pain with no explanation as to why. I was diagnosed with premature ovarian failure and had to take fertility meds to get pregnant. Previous to the series I had at least 10 normal annual pap smears. After the series, I had an abnormal pap which resulted in a biopsy then a LEEP which led to my cervix being removed for high grade dysplasia that couldn't be removed. I developed endometriosis that I didn't have beforehand. I have lived in pain and am constantly tired for the last 13 years. I was one of the first people to receive the series.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Joint stiffness, Tinnitus
Clinical narrative: Joint stiffness and arthritic like pain. Ringing in head, (I having ringing in ears, but this was different) Lasted almost 24 hours. Sore arm from injection.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Administration of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA lot number S021092 and expiration date of 18-MAY-2020  intramuscularly, for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature above 47°F / 2°C FOR 37 minutes. There was no previous temperature excursion and it was called because of a "data logger".
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse effect; Patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions was not provided. On 21-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of hepatitis A vaccine, inactivated (VAQTA) (strength, dose, schedule, anatomical location, route of administration was not reported) (lot# S019435 and expiry date: 23-AUG-2020) for prophylaxis. The vaccine underwent a temperature excursion of above 47 degree Fahrenheit/9 degree Celsius (51.8 Fahrenheit) for a duration of 1 hour 25 minutes. There were no previous temperature excursions. There was an involvement of digital data logger. No associated product quality complaint.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; The medical assistant administered properly stored GARDASIL 9 to a female patient. Which expired 10/29/2019; This spontaneous report was received from a medical assistant regarding a 24-year old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were no reported.   On 03-DEC-2019, the patient was vaccinated with properly stored vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was expired: lot number R024264, expiration date 29-OCT-2019, for prophylaxis (dose, and route of administration was not provided) (expired product administered). No additional adverse effect reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Insomnia, Pain in extremity
Clinical narrative: flu like symptoms; achy joints; tiredness; did not sleep well; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included levetiracetam (Keppra).   On 4th November 2019, the patient received the 1st dose of Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, joint pain, tiredness and difficulty sleeping. On 5th November 2019, the patient experienced pain in arm. On an unknown date, the outcome of the influenza-like symptoms, joint pain, tiredness, difficulty sleeping and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, tiredness, difficulty sleeping and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix later that day the the patient experienced flu like symptoms described as achy joints, tiredness and not able to sleep that eveningThe next day, the patient had a sore arm which lasted for 2 days. On an unknown date the patient was recovered from the events. The reporter did not consent to follow-up. This case has been linked with another case US2019209688, reported by same reporter. Note:Discrepancy in onset dates of the achy joints and tiredness.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: 5 month old was administered Quadracel in the left leg.; 5 month old was administered Quadracel in the left leg.; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a Health Care Professional.  This case involves a 5 months old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (QUADRACEL). (lot: C5656AA, expiry date: 13-Aug-2021), via unknown route in the left leg, on 10-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due product administered at inappropriate site, product administered to patient of inappropriate age. It was reported a 5 month old was administered Quadracel in the left leg. The caller stated that their office has DTaP and IPV vaccines in separate forms in their office, but only one of their two vaccine tracking systems flagged Quadracel as not being appropriate in the 5 month old.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered to a patient which was exposed to temperature excursion, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA293402 and 2019SA293404 (same reporter).  This case involves 4 month old female patient who received a dose of vaccine IPV (VERO) [IPOL] which was exposed to a temperature excursion.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and HIB VACCINE (HIB VACCINE) for Immunisation.   On 18-Oct-2019, the patient received second dose of suspect IPV (VERO) (lot P1F491M, Expiry date: 30-Nov-2020) via subcutaneous route in the right thigh.  It was a case of actual medication error due to improper storage of product in use.  It was reported that ActHIB, IPOL opened, Daptacel, Adacel, Fluzone Quadrivalent prefilled syringes 0.25 ml and 0.5 ml and multi dose vial (MDV), for temperature of 33.4 degrees F for 6 hours 48 minutes due to unknown reason. ActHIB (UJ076AA, expiry date: 21-Feb-2020), Daptacel (G5BE3, expiry date: 25-May-2021, Lot: J947T, expiry date: 30MAY2021), Adacel (lot: U6273AA, 24-Apr-2021, Lot: U6321AA, 07-Jun-2021), Fluzone Quadrivalent MDV (UJ223AB, 30-Jun-2020), Fluzone Quadrivalent 0.5 ml prefilled syringes (lot: UJ231AB, 30-Jun-2020) and Fluzone Quadrivalent 0.25 ml prefilled syringes (lot: UT6647JA, expiry date: 30-Jun-2020).  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 0.17
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered to a patient which was exposed to temperature excursion, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA293402 and 2019SA293403 (same reporter).  This case involves 2 month old male patient who received a dose of vaccine IPV (VERO) [IPOL] which was exposed to a temperature excursion.  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) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.   On 18-Oct-2019, the patient received a first dose (0.5 mL) of suspect IPV (VERO) (lot P1F491M, Expiry date: 30-Nov-2020) via subcutaneous route in the left arm.  It was a case of actual medication error due to improper storage of product in use.  It was reported that ActHIB, IPOL opened, Daptacel, Adacel, Fluzone Quadrivalent prefilled syringes 0.25 ml and 0.5 ml and multi dose vial (MDV), for temperature of 33.4 degrees F for 6 hours 48 minutes due to unknown reason. ActHIB (UJ076AA, expiry date: 21-Feb-2020), Daptacel (G5BE3, expiry date: 25-May-2021, Lot: J947T, expiry date: 30MAY2021), Adacel (lot: U6273AA, 24-Apr-2021, Lot: U6321AA, 07-Jun-2021), Fluzone Quadrivalent MDV (UJ223AB, 30-Jun-2020), Fluzone Quadrivalent 0.5 ml prefilled syringes (lot: UJ231AB, 30-Jun-2020) and Fluzone Quadrivalent 0.25 ml prefilled syringes (lot: UT6647JA, expiry date: 30-Jun-2020).  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse administered expired dose of dapatacel inadvertently to the patient, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 years old female patient who received an expired dose (0.5 ml) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot no: C5281AA Expiry date: 05-Oct-2019 ) via Intramuscular route in left thigh on 17-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation.   It was an actual medication error due to expired vaccine used.  Nurse stated that an expired dose of Daptacel was inadvertently given.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Patinet received the vaccine which was delay in shipment with no AE; Patinet received the vaccine which was delay in shipment with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer or non-health professional  This case is linked to cases 2019SA295207, 2019SA295208, 2019SA295209 and 2019SA290919 (same reporter).  This case involves a 8 months old male patient who received 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the right thigh on 17-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to the incorrect product storage and product shipment delay.   It was reported that the shipment of Fluzone QID was received late. On Thursday morning, the office had already given 5 children vaccines from this shipment before they realized that the vaccines were not viable.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of Daptacel single-dose, no AE; Initial information received on 22-OCT-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] at unknown dose (lot number not reported and expiry 05 Oct 2019), via intramuscular route, on 21-Oct-2019.  The patients past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant vaccinations included Influenza vaccine and HIb vacccine  It was an actual medication error due to the expired vaccine used. It was reported that the patient received an expired dose of daptacel single-dose.  At the time of reporting, the patient had no adverse event.  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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel expired on the 23Oct2019 and was administered to a patient on 24Oct2019 with no ae; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consume.   This case involves a 6 years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot no: C507AA Expiry date: 23-Oct-2019 ) via Intramuscular route in right Thigh on 24-Oct-2019.   The past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Expired product administered. It was reported that Daptacel expired on the 23Oct2019 and was administered to a patient on 24Oct2019, with no adverse event   At the time of reporting, the patient had no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Daptacel was given, NO AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19 months old female patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5307AA, expiry date: 23-Oct-2019) via intramuscular route in the left thigh on 25-Oct-2019.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due expired product administered. It was reported that an expired dose of Daptacel was given.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Daptacel, NO AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who expired dose vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant vaccination included Prevnar and ActHIB.  On 25-Oct-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA Expiry Date 23-Oct-2019 via intramuscular route in the left thigh.  It was an actual medication error due to patient received an expired dose of Daptacel. It was reported that the Nurse states that they gave an expired Daptacel to a patient.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent at age 16 and 17 years of age with no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304580, 2019SA304591 and 2019SA304592.  This case involves a 16 years old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1938, expiry date: 30-Jun-2020) unknown route, indication and dosing details in Oct-2019 (not confirmed if 1st, 2nd or 3rd Oct-2019)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product administered to patient of inappropriate age. It was reported that patient received Flublok Quadrivalent at age 16 and 17 years of age.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.