chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071156, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071155 (same reporter). This case involves a Pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) during the 2018- 2019 Flu Season, (lot UJ043AB, expiry date 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT (lot number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects had been 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. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE lot UJ043AB via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071154 and 2019SA071155, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who was vaccinated with a 0.5 ml third dose of expired vaccine ACT-HIB (lot UI822AAA and Exp. Date 05Jan2019 for box) (ACTHIB lot UI822AA and Exp. Date 02Jun2019 for vial) via intramuscular route in the right deltoid on 12-Feb-2019. The patient's medical history not reported and concomitant medications included DAPTACEL; IPOL; PREVNAR 13; and HEPATITIS B VACCINE all received on 12-Feb-2019 for Immunization. It was an actual medication error case due to expired vaccine used. It was reported that, patient received a ACTHIB with an expired diluent. It was unknown whether the patient 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 18 years old male patient who was vaccinated with 0.5 ml first dose of MENACTRA (batch number: U4288AA and expiry date: 07-Oct-2013) via intramuscular route in the left deltoid on 02-Aug-2012. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient was vaccinated with a first dose of TDAP on an unspecified date. It was a case of actual medication error due to missed dose because a booster dose prior to 16 years old acne be given which was missed. It was reported that the patient was getting ready to receive second dose shortly at age 18. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Wound
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA074207 (same reporter). This case involves a 46 years old female patient who experienced arm pain and wound, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Dec-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U5729BA, Exp. Date 21-Jul-2019) via unknown route in the right arm. On an unknown date, the patient developed a non-serious arm pain (vaccination site pain) and wound (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Other relevant tests not reported. Final diagnosis was arm pain and wound. It was not reported if the patient received a corrective treatment. The patient outcome was not recovered for arm pain and not reported for wound. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient of unknown gender who was administered the diluent (dtap/IPV) portion from vaccine PENTACEL (lot C5593AA, expiry date 27-Oct-2019) via unknown route in the right thigh on 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTATEQ. It was a case of actual medication error due to inappropriate reconstitution technique staff member only administered the diluent (Dtap/IPV) portion from PENTACEL. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Pain - couldn't lift arm more than 5" - very red at injection site; swollen at site; felt like I had flu; muscle aches, no appetite; super tired; headache for 3 days; shivering so bad the bed shook.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Myalgia, Pain
Clinical narrative: Pain - couldn't lift arm more than 5" - very red at injection site; swollen at site; felt like I had flu; muscle aches, no appetite; super tired; headache for 3 days; shivering so bad the bed shook.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: State vaccine was given.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Nausea, Paraesthesia
Clinical narrative: Chills, headache, nausea followed 12 hours later by vomiting, associated with possible vasovagal reaction as diagnosed by the telephone advice nurse (intense lower back pain, extreme tingling in both arms).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Chills, headache, nausea followed 12 hours later by vomiting, associated with possible vasovagal reaction as diagnosed by the telephone advice nurse (intense lower back pain, extreme tingling in both arms).
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flushing, Rash, Rash macular
Clinical narrative: Approx 5-10 minutes after vaccines were administered, patient developed facial flushing and a few blotchy macules on right lower leg then spread to Trunk. Patient was well appearing, lung exam normal, no labored breathing, no swelling of lips, face or extremities. No Urticaria. Patient was monitored for 30 minutes, rash faded but did not fully resolve. Mom given instructions to call if symptoms persist or worsen.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling hot, Injection site pain
Clinical narrative: Upper right arm where  treatment was injected very sore and painful; in back lower left lung and left side pain full; upper left arm painful. Usually my termperature runs around 96.3 to 97.6; but around 6:30 became very hot and took my temperature and it was 99.2. By 7:30 it was 101.8. I was very warm all evening and thru out the night which I had to lay on my back because both sides were in pain that I could not lay on them. In the morning the fever had subsided; but I was in pain though. I was feeling much better by this morning (3-19-19).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes simplex, Rash pruritic, Vasculitis
Clinical narrative: Pruritic skin rash across forehead with clinical concern for vasculitis, genital hsv outbreaks.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Several hours after vaccine administration left arm became itchy, red, swollen and hard to touch. Symptoms lasted 2 days and resolved without any other issues.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Hypersomnia, Injection site erythema
Clinical narrative: Generalized aches and pains with headache, anorexia, chills (temperature not taken); and redness at injection site covering more than 1/2 the upper arm that was firm and tender. I slept 15 hours a day for three days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Pain
Clinical narrative: Generalized aches and pains with headache, anorexia, chills (temperature not taken); and redness at injection site covering more than 1/2 the upper arm that was firm and tender. I slept 15 hours a day for three days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropathy, Dehydration, Gait disturbance, Loss of consciousness, Musculoskeletal disorder
Clinical narrative: At home the night of the shot before bed he felt a pain in his left heel and his "ankle didn't want to work" (pt words). The next AM (03/13/19) he woke up and his whole left leg "didn't want to work". He went to get back into bed and figures he must have passed out while he sat as he ended up sitting on the floor. His wife could not get him to answer/respond so she called 911. He came to but ambulance took him to ER. He reported he had a hard time walking (left side didn't want to work). They put him through testing, diagnosed no heart attack/stroke. They said he was slightly dehydrated. They gave him some anti-inflammatory shot (he didn't know what) but it helped. He has since been back on his ibuprofen (OTC) and/or Meloxicam which seems to help.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: At home the night of the shot before bed he felt a pain in his left heel and his "ankle didn't want to work" (pt words). The next AM (03/13/19) he woke up and his whole left leg "didn't want to work". He went to get back into bed and figures he must have passed out while he sat as he ended up sitting on the floor. His wife could not get him to answer/respond so she called 911. He came to but ambulance took him to ER. He reported he had a hard time walking (left side didn't want to work). They put him through testing, diagnosed no heart attack/stroke. They said he was slightly dehydrated. They gave him some anti-inflammatory shot (he didn't know what) but it helped. He has since been back on his ibuprofen (OTC) and/or Meloxicam which seems to help.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: The soreness in my arm developed about 6 hours after receiving vaccine. The next afternoon 3/9/2019 at about 2:30 pm I started to feel very lethargic to the point I had to lay down to take a nap. Slept about 4 hours. When I woke up I felt better, no lethargy but the soreness in my arm was getting worse. I also noticed it was very red and swollen around injection site. I went out  to dinner that evening but started developing a low grade fever during dinner. I felt better by the next day, no actual symptoms other than my arm was red a swollen for another 6 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Discomfort, Fibromyalgia, Gait inability
Clinical narrative: Had symptoms of fibromyalgia ramp up. She had a generalized inflammation and pain in body. She experienced acute pain in her hip, buttocks, left leg to the point she could not walk. After 6 days she was well enough to visit pharmacy but was in obvious discomfort. She saw her doctor Monday and plans to see doctor on Wednesday. Md thinks 2nd dose SHINGRIX triggered a fibromyalgia flair.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Had symptoms of fibromyalgia ramp up. She had a generalized inflammation and pain in body. She experienced acute pain in her hip, buttocks, left leg to the point she could not walk. After 6 days she was well enough to visit pharmacy but was in obvious discomfort. She saw her doctor Monday and plans to see doctor on Wednesday. Md thinks 2nd dose SHINGRIX triggered a fibromyalgia flair.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: My L arm became sore about 2 hrs after injection. An area, about 2" below injection site, became red and sore.....this was about 2" long and 1" wide. At about 2am that night I awoke with chills, body aches, joint aches....even my skin hurt! It felt like a really bad case of the flu. Able to sleep off and on....lo grade temp in the morning. Exhausted, no appetite and slept a good part of the day on Thursday. Felt pretty much back to normal by Friday, March 8th. Took TYLENOL x2.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: My L arm became sore about 2 hrs after injection. An area, about 2" below injection site, became red and sore.....this was about 2" long and 1" wide. At about 2am that night I awoke with chills, body aches, joint aches....even my skin hurt! It felt like a really bad case of the flu. Able to sleep off and on....lo grade temp in the morning. Exhausted, no appetite and slept a good part of the day on Thursday. Felt pretty much back to normal by Friday, March 8th. Took TYLENOL x2.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Clumsiness, Feeling abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Hives all over torso, developed neurological symptoms as though my nervous system was hyper on all over my body, tingling and numbness, heavy metal toxicity, blurred vision, swollen glands and lymph nodes, twitching, mental fog, clumsiness, tripping, joint pain.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Metabolic function test, Metal poisoning, Muscle twitching, Neurological symptom
Clinical narrative: Hives all over torso, developed neurological symptoms as though my nervous system was hyper on all over my body, tingling and numbness, heavy metal toxicity, blurred vision, swollen glands and lymph nodes, twitching, mental fog, clumsiness, tripping, joint pain.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Toxicologic test, Urticaria, Vision blurred
Clinical narrative: Hives all over torso, developed neurological symptoms as though my nervous system was hyper on all over my body, tingling and numbness, heavy metal toxicity, blurred vision, swollen glands and lymph nodes, twitching, mental fog, clumsiness, tripping, joint pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-JAN-2008, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 13-MAR-2019, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # N030364, expiration date 06-MAR-2019; dosage schedule and frequency were not provided) orally as prophylaxis (expired product administered). No adverse effects were reported. No clarifying or additional information was provided.
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA071987 (same reporter). This case involves a six months old male patient who was vaccinated with a once dose of vaccine PENTACEL which had experienced a temperature excursion (lot C5574AA and Exp. Date 13-Oct-2019) via unknown route in the thigh vastus lateralis on 12-Mar-2019. The patient's medical history not reported and concomitant medications included HEPATITIS B VACCINE and FLUARIX for Immunization. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: TDAP, UNK
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 18 months old male patient (at the time of reporting patient was 9 year old) who developed a rash after receiving, vaccine ADACEL. The patient's past medical history included Milk allergy with anaphylactic milk allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious developed a rash (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It is also a medication error case due to inappropriate age at vaccine administration. It was reported that the patient was vaccinated when he was 18 months old and was given with concomitant vaccines. Other relevant tests were not reported. Final diagnosis was developed a rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for developed a rash. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV, MENB, PNC13
Symptoms: Product storage error
Clinical narrative: Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse via an other health care professional. This case involves 6 patients (gender unknown) who received vaccines ACT-HIB lot UI901AAA, expiry date: 17-Sep-2019 via intramuscular route in the right thigh and DAPTACEL lot C5101AA, expiry date: 26-Nov-2018 via intramuscular route in the right thigh. The patient's does have any past medical history, medical treatment(s), vaccination(s) and family history. On 03-Oct-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI901AAA, expiry date: 17-Sep-2019 via intramuscular route in the right thigh. On 03-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA, expiry date: 26-Nov-2018 via intramuscular route in the right thigh. Concomitant medications included was 0.5ml PREVNAR 13 lot number: T36366, expiry date: 28-Feb-2020 via intramuscular route in left thigh on 03-Oct-2018 and TRUMENBA. It was an actual medication error due to product storage error. It was reported that 6 patients received ACT-HIB, DAPTACEL, PREVNAR 13 and TRUMENBA vaccines after the temperature excursion which was at -1.32 degrees Celsius for 20 minutes.  It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased eye contact, Rash generalised, Unresponsive to stimuli
Clinical narrative: Rash all over, loss of eye contact, stopped responding to audible stimuli, stopped babbling and conversing.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Computerised tomogram, Hypoaesthesia, Joint swelling, Metabolic function test
Clinical narrative: Neurological symptoms, tingling numbness, blurred vision, joint pain and swelling,
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Neurological symptom, Paraesthesia, Vision blurred
Clinical narrative: Neurological symptoms, tingling numbness, blurred vision, joint pain and swelling,
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever of 102.9 for about 12 - 16 hours.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Seizure
Clinical narrative: Seizures, high fever, red rash all over body.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Pt was supposed to receive Dtap but Tdap was given.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: PATIENT CAME INTO STORE THE NEXT DAY AND COMPLAINED OF A RED AND SWOLLEN LEFT ARM. PATIENT DECLINED HAVING TROUBLE BREATHING. RECOMMENDED TO PATIENT TO CONTACT HER PCP TO SEE IF SHE WOULD NEED TO BE SEEN AND WHAT RECOMMENDATIONS TO TAKE CARE OF HER ARM WOULD BE RECOMMENDED.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: Began developing chills, shivering at 7 pm. Continued until 3am accompanied by fever to 101, nausea, headache. Fever abated by 11 am as well as nausea and headache.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Pain at injection site almost immediately. Two days later his wife noticed that his arm was red, also hot to the touch. Went to clinic and saw Dr. He prescribed 7 days of Clindamycin.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Pain in jaw
Clinical narrative: ARM SORE, RED SWOLLEN AT INJECTION SITE, JAW SORE, BODY ACHES.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Hives - redness, bumps, and itching on hands, back, chest, and face.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Mobility decreased, Pruritus, Skin warm
Clinical narrative: COULD NOT MOVE HER ARM, GETTING A POKE FEELING AT LEASE ONCE A DAY, ITCHING, HOT ARM, RED PATCH AND SWELLING.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: COULD NOT MOVE HER ARM, GETTING A POKE FEELING AT LEASE ONCE A DAY, ITCHING, HOT ARM, RED PATCH AND SWELLING.
Age: 29.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Cough, Erythema, Lip swelling, Palpitations, Wheezing
Clinical narrative: A few hours after the patient received tdap and typhoid vaccine. Patient had symptoms of cough, wheezing, redness, palpitations and mild swelling around lips. Patient took BENADRYL 25 mg. and symptoms calmed. But, patient came back into the office several hours later (12:30pm) and was seen again. After an exam, the patient was given a KENALOG shot, and water to hydrate. Patient was observed in the office, after 15 minutes, patient was feeling better, after 30 minutes, even better. Patient vitals were monitored during this time and stabilized. After 1 hour, the patient was discharged with no symptoms.
Age: 52.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Erythema
Clinical narrative: Redness of arm halfway to elbow reported 2 days after immunization.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza virus test
Clinical narrative: Muscle aches, fever, chills, headache, tired, upset stomach.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, chills, headache, tired, upset stomach.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Blisters all over arms, legs, very painful.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Agitation, Discomfort, Moaning, Pyrexia, Rash
Clinical narrative: Mother states that within a few hours of the vaccines he started running a high fever to 101 (with ibuprofen), was agitated (he is non-verbal), appeared uncomfortable and moaning. Fever lasted for 5 days and was then back to his self. Also had a rash that started on the arm of the vaccines 72 hours after injection which spread across chest. Lasted about 3 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle spasms, Pain
Clinical narrative: CANNOT LIFT ARM, IN PAIN, MUSCLE SPASMS, HURT WHEN GAVE SHOT.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: Stiff, sore right upper arm. In the night, terrible stomach ache, nausea, headache. Next day: nausea, fatigue, headache. I took a 3 hour nap in afternoon and I never take a nap unless I don't feel well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: Stiff, sore right upper arm. In the night, terrible stomach ache, nausea, headache. Next day: nausea, fatigue, headache. I took a 3 hour nap in afternoon and I never take a nap unless I don't feel well.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: On 1/25 (day after vaccination in left thigh) patient developed an area of redness in the location of the vaccination. Patient was seen in clinic on 1/28 for evaluation of rash. Area of redness 5x5 cm, somewhat firm to touch. No fevers at that time, otherwise well-appearing. Diagnosed with a localized exaggerated reaction to vaccine and advised to return if fever develops or if rash continues to worsen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt called to report pain and swelling at injection site. Reports of no pain down arm or movement issues.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: The soreness after the flushot never went away. The pain is dull, and achy at rest or when there is movement. The pain gets worse when trying to use the arm for simple taks like driving, or even picking up something light. Arm weaknes, and shoulder stiffness. Pain is severe when doing any type of exercises.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dyskinesia, Muscle twitching, Paraesthesia
Clinical narrative: Patient states that she has tingling under her feet at night, sharp twitch jerk in body and GI upset.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Amenorrhoea, Anti-Muellerian hormone level
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody positive, Atypical pneumonia, Blood follicle stimulating hormone increased, Blood luteinising hormone increased
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Bronchial hyperreactivity, Constipation, Cough, Dyspnoea, Enteritis
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperaesthesia, Ileus, Impaired gastric emptying, Oestrogen therapy, Pain
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity, Pancreatitis, Pharyngitis streptococcal, Premature menopause, Thoracic outlet syndrome
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.