chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant women received Adacel/No AE; Initial information was received on 03-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 33 year old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], at 30 weeks of pregnancy, during third pregnancy trimester.  Data regarding this pregnancy were received prospectively, before pregnancy outcome was known.  The date of last menstrual period was reported as 07-May-2019.  The estimated due date is 11-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  On 03-Dec-2019, the patient received a 0.5 cc dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6539AA via intramuscular route in the left deltoid.  It was case of vaccine exposure during pregnancy. The patient was 30 weeks pregnant when she received vaccine.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient aged 63 received Fluzone high dose/ no AE; patient aged 63 received Fluzone high dose/ no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case from a non-health care professional.  This case involves a 63 years old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ274AB and expiration date 26-May-2020) via an intramuscular route in the right deltoid on 21-Oct-2019.  Medical history and concomitant medications were not reported.  It was of an actual medication error case due to inappropriate age at vaccine administration and overdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder'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: FLU3
Symptoms: Myalgia
Clinical narrative: muscle pain in her left upper arm that has lasted for 10 weeks.; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported muscle pain in her left upper arm that has lasted for 10 weeks(myalgia).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious muscle pain in her left upper arm that has lasted for 10 weeks (myalgia) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was muscle pain in her left upper arm that has lasted for 10 weeks..   It was recommended to take aspirin, however the patient did not take aspirin because she had also taken a "blood thinner" and cannot take aspirin so she "toughed it out.  At the time of reporting, the patient outcome was reported as Recovering / Resolving.   Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: in error gave a dose of pentacel to a 4 month old patient that had been drawn up 16 hours previously, it should have been discarded when not used within 30 min due to the lyophilized act hib component, no advesre event; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four months old patient (gender not reported) who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which had been drawn up 16 hours previously, it should have been discarded when not used within 30 min due to the lyophilized Act-Hib (lot number and other dosing details were not reported) on an unknown date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to Wrong technique in product usage process.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: nurse gave a patient the DPT and Polio component of Pentacel, and did not reconstitute the HIB portion,no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a 6 months old female patient who received 0.5 ml dose vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U6615AB via unknown route in unknown administration site., on 05-Dec-2019 was inappropriately reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that nurse gave a patient the DPT and Polio component of Pentacel, and did not reconstitute the HIB portion.  It was unknown whether the patient had any adverse reactions.  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: M
Vaccine: FLUR4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives all over the body; alligator with the injection needle only touching the skin; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient (age not reported) who experienced hives all over the body (urticaria)  and alligator with the injection needle only touching the skin (hypersensitivity), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Eczema and Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma. Notes: allergy to peanuts, and tree allergies    On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives all over the body (urticaria) and alligator with the injection needle only touching the skin (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests were not reported.  Final diagnosis was urticarial and hypersensitivity.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome was not reported.   Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: increased pain and weakness in grip when reaching arm above shoulder level; increased pain and weakness in grip when reaching arm above shoulder level; injection site pain; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 32 year old female patient who experienced increased pain and weakness in grip when reaching arm above shoulder level (muscular weakness) (Pain in extremity), and injection site pain (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 20-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ279AC, expiration date: 30-Jun-2020) via an intramuscular route in the left deltoid.  On an unknown date, the patient developed non-serious increased pain and weakness in grip when reaching arm above shoulder level (muscular weakness) (Pain in extremity) and injection site pain (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  Final diagnosis was vaccination site pain, muscular weakness and Pain in extremity.   The patient was treated with ibuprofen.  The event outcome was unknown for vaccination site pain, muscular weakness and mobility decreased.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: gave Flublok to pregnant woman/No AE; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from non-healthcare professional (office staff).  This case involves female patient of an unknown age who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], while she was pregnant.   Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route, at an unknown administration site.  It was case of vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.  Information on the batch number was requested.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: consumer was given an expired dose of Adacel on 11Dec2019, no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 61 years old female patient who received 0.25 ml to 2 ml dose an expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5793AA and expiry date:01-Nov-2019) via unknown route in unknown administration site, on 11-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RUBELLA VACCINE (RUBELLA) for Immunisation; MUMPS VACCINE (MUMPS VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used. It was reported that consumer was given an expired dose of Adacel on 11Dec2019 in error.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a consumer received an incomplete dose of the ordered Pentacel described as the liquid Dtap-IPV portion was given but the ActHib portion was not given/No AE; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 month old male patient who received only the liquid Dtap-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but the ActHib portion was not given.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 06-Dec-2019, the patient received second 0.5 mL dose of the liquid Dtap-IPV portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UI992AAA via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: A patient was given the liquid DTaP-IPV portion of Pentacel in the right thigh without using it to reconstitute the lyophilized powder portion (Hib) of Pentacel/No AE; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 month old female patient who received the liquid DTaP-IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without using it to reconstitute the lyophilized powder portion (Hib).  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines were received.  On 09-Dec-2019, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot number not reported via unknown route in the right thigh.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pentacel injection in which the diluent was mixed with sterile water instead of the 0.4% NACL solution; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient of an unknown age who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which the diluent was mixed with sterile water instead of the 0.4% NaCl solution.  Medical history, medical treatment, vaccination and family history were not provided.  On 12-Dec-2019, the patient received second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ014ABA via intramuscular route.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  The patient did not experience any other AE.  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: expired dose given to a 3 year old female, no AE; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old female patient who received an expired vaccine 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5254AA and expiry date: 18-Sep-2019) via intramuscular route in the left thigh, on 04-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient recieved HEPATITIS B VACCINE and INFLUENZA VACCINE as concomitant medication.  It was a case of actual medication error due to expired vaccine used. It was reported that expired dose given to a 3 year old female.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: F
Vaccine: FLU4
Symptoms: Ill-defined disorder
Clinical narrative: experiences a week long illness; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA354038 (same reporter)  This case involves a 47 years old female patient who experienced a week long illness (ill-defined disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past vaccination included INFLUENZA VACCINE (Flu Shot) with 2 years in a row. Medical history, medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious a week long illness (ill-defined disorder) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was ill-defined disorder.  It was not reported if the patient received any corrective treatment.  Event outcome is was Unknown for ill-defined disorder.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Ill-defined disorder
Clinical narrative: experiences a week long illness; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to case 2019SA354031 same reporter)  This case involves a 18 year old male patient who experienced a week long illness (ill-defined disorder), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past vaccination included INFLUENZA VACCINE (Flu Shot) with 2 years in a row. Medical history, medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious a week long illness (ill-defined disorder) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was ill-defined disorder.  It was not reported if the patient received any corrective treatment.  Event outcome is was Unknown for ill-defined disorder.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Erythema; Hives; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient who experienced erythema (erythema) and hives (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry dates not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious erythema (erythema) and hives (urticaria) (after 24 hours of vaccine) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was hives and erythema.  The patient was treated with PREDNISONE (PREDNISONE).  On an unknown date, the outcome was reported as recovered after 4 days taking prednisone.  Information on the batch number was requested.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: left shoulder joint pain; left arm pain; unable to raise his arm over his head; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 41 years old male patient who experienced left shoulder joint pain (arthralgia), left arm pain (pain in extremity) and unable to raise his arm over his head (injected limb mobility decreased), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Dec-2019, the patient received a 0.5 ml fourth dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Prefilled syringe) lot UT6713NA and expiry date 30-Jun-2020 via intramuscular route in the left deltoid.  On 18-Dec-2019, the patient experienced a non-serious joint pain (arthralgia), left arm pain (pain in extremity) and unable to raise his arm over his head (injected limb mobility decreased) 14 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included No lab data..) Final diagnosis was injected limb mobility decreased, pain in extremity and arthralgia.  It was not reported if the patient received a corrective treatment.  On an unknown date, the outcome was reported as Unknown for all the events.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: left arm pain; inability to lift her arm over her head; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 77 years old female patient who experienced left arm pain (pain in extremity) and inability to lift her arm over her head (injected limb mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Prefilled syringe) lot UJ285AB and expiry date 02-Jun-2020 via intramuscular route in the left arm.  On 06-Nov-2019, the patient experienced a non-serious left arm pain (pain in extremity) and inability to lift her arm over her head (injected limb mobility decreased) 15 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The HCP prescribed heating and stretching. Because the pain was more in bicep than then the deltoid, the HCP believes that the arm pain is not related to the Fluzone High dose vaccine.  (Other relevant tests included No lab data.)  Final diagnosis was inability to lift her arm over her head and left arm pain.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for both the events.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain lower, Alanine aminotransferase normal, Albumin globulin ratio, Arthralgia, Aspartate aminotransferase normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Basophil count decreased, Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Blood parathyroid hormone normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Blood urea normal, Carbon dioxide normal, Eosinophil count normal, Eosinophil percentage, Globulins decreased
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Glomerular filtration rate, Groin pain, Haematocrit normal, Haemoglobin normal, Hypoaesthesia
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphocyte count normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Monocyte count normal, Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage decreased, Paraesthesia
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count normal
Clinical narrative: I started with lower back pain on both sides of my body along with lower abdominal pain.  There is also pain in my hips, groin and mid back.  Numbness and tingling in my legs and toes.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Dizziness, Palpitations
Clinical narrative: patient states  a few days after the vaccine she woke up with her heart pounding,  she was very dizzy and her blood sugar went up to 210 which she states is unusual for her.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruising not going away 3 weeks after the shot. Bruise is normal brown color with no pain. The bruise is going away and they will contact their doctor on Monday the 30th.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Lymphatic disorder, Oedema
Clinical narrative: Edema, erythema, local increased heat reaction, lymphatic reaction
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Within a couple of hours of the shot, the patient was feeling some itching at the site. The next day there was swelling within several inches of the injection site and redness. Today, 12/27, the patient's upper arm is still swollen with some redness.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Pt developed fever of 100.5at 2:30am, temp of 102.5 at 8:30am, pt arrived to hospital via ambulance at 12:22pm after reported 3-4 minute febrile seizure. Hospital is the one who informed our office of adverse event.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site urticaria
Clinical narrative: Per Mom:  Patient has a welt spot on her right leg where she got an immunization, noticed it on 12/26/19, patient will cry if you touch it. Per Dr:  right lateral upper thigh erythema 3x2cm, there is deep firm tender mass underlying the erythema, no fluctuation baby looks otherwise well.  Treated patient with Keflex 250 mg/5 ml 3ml BID
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Sensory disturbance
Clinical narrative: no range of motion / cannot move shoulder awful pain in shoulder  change in sensation in extremity  temperature changes in extremity Symptoms continue to get worse Doctor tells me to give it time even though it gets worse
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: The pain is present in the right arm. This is a new problem. The current episode started yesterday. There has been no history of extremity trauma. The problem occurs constantly. The problem has been gradually worsening. The quality of the pain is described as aching. The pain is at a severity of 9/10. The pain is severe. Pertinent negatives include no fever or itching. She has tried nothing for the symptoms. The treatment provided no relief.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Patient started experiencing symptoms about 6 hours post vaccine administration including chills headache fever muscle aches and fatigue that lasted a full 24 hours before resolving.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: mother notes that child arm was sore and tender, had bruising and then became swollen.  The red area seemed to be spreading.  They presented to ER.  they were treated and d/c'd home.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle fatigue, Pain
Clinical narrative: Body aches, muscle fatigue
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 22-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA003828: US-009507513-1912USA011815: US-009507513-1912USA011816:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 03-DEC-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.    ; Sender's Comments:  US-009507513-1912USA011814: US-009507513-1912USA003828: US-009507513-1912USA011816:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 26-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA011814: US-009507513-1912USA011815: US-009507513-1912USA003828:
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Lacrimation increased, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: get the flu; sore throat; Runny nose; Runny eyes; Fever was 102; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an elderly female patient who get the flu (Influenza) with symptoms sore throat (oropharyngeal pain), fever was 102 (pyrexia), runny nose and eyes (rhinorrhea) (lacrimation increased) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu shot every year and from the last 15 years (has not gotten a cold or flu). The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (injection) (lot number and expiry date not reported) via unknown route in the arm.  On an unknown date the patient developed a non-serious flu (Influenza), sore throat (oropharyngeal pain), fever was 102 (pyrexia), runny nose (rhinorrhea) and runny eyes (lacrimation increased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient got the Fluzone HD 2 weeks ago and started with a sore throat initially and she thought it was due to the vinegar and oil she eats that caused the sore throat. This continued for 4 days and then woke up on Saturday morning a week ago with fever, runny nose and eyes. Her fever was 102 and next day she did not have fever came back but it has not been over 100.  Relevant laboratory test results included: On an unknown date the body temperature showed that the fever was 102.  Final diagnosis was Influenza.   It was not reported if the patient received a corrective treatment.  The outcome for all the events were not reported.
Sex: F
Vaccine: FLU4
Symptoms: Ageusia, Chills, Fatigue, Headache, Heart rate irregular
Clinical narrative: Nausea; lost a lot of muscle; cannot taste food, 80 percent of her taste buds are gone; some irregular heart beat; headache; extreme fatigue for 2.5 weeks, fatigue was terrible; chills; sick; fever of 101; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Adult female patient who experienced nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache (headache), extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills (chills) and sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included influenza vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.  In September 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AB (Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache, extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills and sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 101 [101 for 2 weeks straight along with the headache and nausea]  Final diagnosis was sick, Severe chills, Severe extreme fatigue for 2.5 weeks, fatigue was terrible, headache, fever of 101, some irregular heart beat, cannot taste food, 80 percent of her taste buds are gone, lost a lot of muscle and nausea.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for headache, chills, nausea, some irregular heart beat, fever of 101, as Not Recovered for extreme fatigue for 2.5 weeks, fatigue was terrible, as Unknown for Loss of taste, sick and lost a lot of muscle.
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Muscle atrophy, Nausea, Pyrexia
Clinical narrative: Nausea; lost a lot of muscle; cannot taste food, 80 percent of her taste buds are gone; some irregular heart beat; headache; extreme fatigue for 2.5 weeks, fatigue was terrible; chills; sick; fever of 101; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Adult female patient who experienced nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache (headache), extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills (chills) and sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included influenza vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.  In September 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AB (Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious nausea, lost a lot of muscle (muscle atrophy), cannot taste food, 80 percent of her taste buds are gone (ageusia), some irregular heart beat (heart rate irregular), fever of 101 (pyrexia), headache, extreme fatigue for 2.5 weeks, fatigue was terrible (fatigue), chills and sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 101 [101 for 2 weeks straight along with the headache and nausea]  Final diagnosis was sick, Severe chills, Severe extreme fatigue for 2.5 weeks, fatigue was terrible, headache, fever of 101, some irregular heart beat, cannot taste food, 80 percent of her taste buds are gone, lost a lot of muscle and nausea.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Recovering for headache, chills, nausea, some irregular heart beat, fever of 101, as Not Recovered for extreme fatigue for 2.5 weeks, fatigue was terrible, as Unknown for Loss of taste, sick and lost a lot of muscle.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: a patient received a dose of Fluzone High Dose which had expired on 22Mar2019/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an unknown demographic patient who received a expired dose of vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] (dosage form: prefilled syringe) lot UI871AB, expiry date: 22-ar-2019 via unknown route in unknown administration site on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is a case of actual medication error due to expired product administered.  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.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Flublock Quadrivalent instead of the Fluzone Quadrivalent/no ae; Flublock Quadrivalent instead of the Fluzone Quadrivalent/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is a linked case with 2019SA339321 (same reporter).  This case involves a 15 years old female patient who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) lot QFAA1923 of Expiration date:30-Jun-2019 via unknown route in right arm on 04Nov2019  instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, vaccinations, family history not reported.  It was a case of actual medication error due to wrong vaccine administered and product administered to patient of inappropriate age.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB mixed it with the diluent from an MMR vaccine which is sterile water, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (age not reported) who received HIB (PRP/T) VACCINE [ACT-HIB], which was mixed with the diluent from  MMR vaccine which is sterile water.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, patient was supposed to receive ActHIB vaccine  and instead of using a ActHIB vaccine the LPN by mistake took out the HIB (PRP/T) VACCINE (ActHIB) vial (Lot # UJ111AA exp 14Oct2020) from a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] box (lot # UJ111AAA exp 14Oct2020) and gave that. She mixed it with the diluent from an MMR vaccine which is sterile water.  It was an actual medication error case due to Wrong solution used in drug reconstitution (product preparation issue).   At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.