chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jul2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 as prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 05:00 the patient experienced muscle aches and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event muscle aches and chills was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Joint swelling
Clinical narrative: Left deltoid area swollen; Left deltoid area red; Fluid-filled blisters; This is a spontaneous report from a contactable nurse. the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via intramuscular route of administration in the left arm on 25Jun2021 at 08:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jun2021, the patient experienced left deltoid area swollen, red and fluid-filled blisters. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left deltoid area swollen, red and fluid-filled blisters was resolved on an unknown date in 2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth almost immediately after administration of the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 15Jul2021 at 18:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naproxen sodium (ALEVE) from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took clindamycin (MANUFACTURER UNKNOWN) and experienced allergy. On 15Jul2021 at 18:15, immediately after the vaccination, the patient experienced a metallic taste in the mouth. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in the mouth was not recovered at the time of the report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity, Urinary tract infection
Clinical narrative: urinary tract infection; a little pain in the arm the day of; This is a spontaneous report from a contactable consumer.   This 76-year-old female consumer reported for herself that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208) via an unspecified route of administration into the left arm on 17Mar2021 at 14:00 (at the age of 76-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203) via an unspecified route of administration into the left arm on 26Feb2021 at 2PM (at the age of 76-year-old) as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced urinary tract infection and a little pain in the arm the day of. The patient underwent lab tests which showed antibody test as negative on 15Jul2021, no antibodies on Covid antibody test. She requested from her doctor to have an antibody test. She had the test yesterday and the results were returned to her as negative. The caller states she was recently on Cipro for 2 weeks for a urinary tract infection and did not know if that could affect the result of the test. She states at the time she did not have any reactions or anything and everything has been fine, a little pain in the arm the day of. Caller asked her doctor if she could get the antibody test, they called her and told her she had no antibodies as if she never got the shot. Outcome was unknown for both the events.  Follow-up(16Jul2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported which included dose details.  Follow-Up (02Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Myalgia, Vaccination site pain
Clinical narrative: is_pregnant: Yes; Mild headache; sore arm muscle around injection site; inexplicable pain in muscle on underside of upper arm, near armpit. Cannot extend arm fully, feels as if muscle is shortened or very tense/strained/muscle pain; This is a spontaneous report from a non-contactable consumer. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-years-old pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 37 year). Medical history included systemic lupus erythematosus, pregnancy, depression, anxiety. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), prenatal vita, D3. No other vaccine in four weeks. No covid prior vaccination. No Known allergies. No covid tested post vaccination. On 16Jul2021 20:45 patient experienced mild headache, sore arm muscle around injection site, inexplicable pain in muscle on underside of upper arm, near armpit. cannot extend arm fully, feels as if muscle is shortened or very tense/strained/muscle pain and patient was pregnent. The mother reported she became pregnant while taking bnt162b2. The mother was 18 Weeks pregnant at the onset of the event. The mother was due to deliver on 15Dec2021. The mother delivered the pregnancy on 15Dec2021. No treatment required for AE. The outcome for pregnancy was unknown for all other events it was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Heart rate, Heart rate increased, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Dose Number: 1/Date of start of drug: 03Jul2021/Dose Number: 2/Date of start of drug: 24Apr2021; Increase in the heart rate; The first symptoms were a rash on the torso, which formed into blisters; The first symptoms were a rash on the torso, which formed into blisters; Felt the same pain in the lymph nodes in the right arm as I did when receiving the vaccine; Tingling pain in arm; Tingling pain; Swollen lymph nodes; First traces of shingles became evident; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 03Jul2021 08:00 (Batch/Lot Number: EW0150) (at the age of 21-years-old) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications was reported as none. If covid prior vaccination and covid tested post vaccination was reported as no. Known allergies as N/A. If other vaccine in four weeks as No. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 24Apr2021 10:00 (Batch/Lot Number: EW0175) as SINGLE for covid-19 immunization. He never had chickenpox, and he vaccinated against the varicella virus. On 08Jul2021 at 08:30, the first event recorded was an increase in the heart rate, which led to me visiting local urgent care for treatment. The first symptoms were a rash on the torso, which formed into blisters. Felt the same pain in the lymph nodes in the right arm as he did when receiving the vaccine. Currently experiencing sharp tingling pain and swollen lymph nodes. Upon that a week later in Jul2021, the first traces of shingles became evident. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with Valtrex for all events. The outcome of all events was recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Paraesthesia, Rash
Clinical narrative: Dose Number: 1/Date of start of drug: 03Jul2021/Dose Number: 2/Date of start of drug: 24Apr2021; Increase in the heart rate; The first symptoms were a rash on the torso, which formed into blisters; The first symptoms were a rash on the torso, which formed into blisters; Felt the same pain in the lymph nodes in the right arm as I did when receiving the vaccine; Tingling pain in arm; Tingling pain; Swollen lymph nodes; First traces of shingles became evident; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 03Jul2021 08:00 (Batch/Lot Number: EW0150) (at the age of 21-years-old) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications was reported as none. If covid prior vaccination and covid tested post vaccination was reported as no. Known allergies as N/A. If other vaccine in four weeks as No. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 24Apr2021 10:00 (Batch/Lot Number: EW0175) as SINGLE for covid-19 immunization. He never had chickenpox, and he vaccinated against the varicella virus. On 08Jul2021 at 08:30, the first event recorded was an increase in the heart rate, which led to me visiting local urgent care for treatment. The first symptoms were a rash on the torso, which formed into blisters. Felt the same pain in the lymph nodes in the right arm as he did when receiving the vaccine. Currently experiencing sharp tingling pain and swollen lymph nodes. Upon that a week later in Jul2021, the first traces of shingles became evident. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with Valtrex for all events. The outcome of all events was recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Tremor on left foot; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Jul2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, in Jul2021, the patient experienced tremor on left foot. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Jul2021, patient underwent lab test and procedure which included Nasal swab COVID-19 test and the result was unknown. The clinical outcome of the event tremor on left foot was unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dry eye, Flushing, Musculoskeletal stiffness
Clinical narrative: Dizziness; Dry eyes; Arm pain and stiff arm on side of injection (left); Pain near right collarbone; Fever 99.6; Arm pain and stiff arm on side of injection (left); Facial flushing/ tingling; Facial flushing/ tingling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 16Jul2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, mitral valve prolapse (MVP), melanoma 20 years ago from an unknown date in 2001 and allergy to sulfas and decongestants. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), calcium/ magnesium/ zinc (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), selenium (MANUFACTURER UNKNOWN), iodine (MANUFACTURER UNKNOWN) and curcuma longa rhizome (TUMERIC); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jun2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient previously received doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 17Jul2021 at 04:30, the patient experienced fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness were unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Dizziness; Dry eyes; Arm pain and stiff arm on side of injection (left); Pain near right collarbone; Fever 99.6; Arm pain and stiff arm on side of injection (left); Facial flushing/ tingling; Facial flushing/ tingling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 16Jul2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, mitral valve prolapse (MVP), melanoma 20 years ago from an unknown date in 2001 and allergy to sulfas and decongestants. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), calcium/ magnesium/ zinc (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), selenium (MANUFACTURER UNKNOWN), iodine (MANUFACTURER UNKNOWN) and curcuma longa rhizome (TUMERIC); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jun2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient previously received doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 17Jul2021 at 04:30, the patient experienced fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness were unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the right arm on 21Apr2021, at 16:30 (at the age of 41 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: cillin based medicine. She was not pregnant at the time of report. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. The patient reported that her arm was sore after shot 1. The pain subsided and then came back. It was reported that the onset of the event was on 19May2021, at 16:45. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient has not recovered from the event at the time of report. She also received the second dose of BNT162B2 on 21Apr2021 (as reported; being clarified) (at the age of 41 years old) for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100911353 same patient, drug, and event; different dose
Sex: U
Vaccine: DT
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: An adult patient received pediatric doses, no AE; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient (unknown demographics, adult) who received pediatric doses of suspect DIPHTHERIA AND TETANUS TOXOIDS (product administered to patient of inappropriate age).  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a pediatric dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  It was reported that "I explained to the customer that it had to be reported and I transferred the call to the Medical call queue. The customer was short on time so I do not know if she stayed on the phone to speak to someone."  It is unknown if the patient experienced any additional symptoms/events.  It was a case of actual medication error due to Inappropriate age at vaccine administration (latency same day).  At time of reporting, no adverse events were 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 the 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Drug hypersensitivity, Dyspnoea, Injection site induration, Injection site swelling
Clinical narrative: feverish; hardness at injection site; Swelling at injection site; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 78-year-old female patient who was feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) while receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history Drug hypersensitivity (penicillin and aspirin  allergy).  It is unknown if the patient had any other medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that "The patient had not received the covid -19 vaccine yet, hence it is not captured in the structured field. Patient had drug allergy and hence ended up in the hospital with anaphylaxis, swelling of the face and throat and difficulty breathing, it is not captured as event. She had no hives, no shortness of breath but her doctor was apprehensive about her getting the covid vaccine without calling us. She also has allergies to penicillin and aspirin. She has ended up in the hospital with aspirin for experiencing anaphylaxis, swelling of the face and throat and difficulty breathing. She wants to know if its okay for her to receive the first dose of the Pfizer BIoNTech Covid 19 vaccine. Also referred her back to her healthcare professional (HCP).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal swelling, Pyrexia, Swelling face
Clinical narrative: feverish; hardness at injection site; Swelling at injection site; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 78-year-old female patient who was feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) while receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing medical history Drug hypersensitivity (penicillin and aspirin  allergy).  It is unknown if the patient had any other medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feverish (pyrexia), had hardness at injection site (vaccination site induration) and swelling at injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that "The patient had not received the covid -19 vaccine yet, hence it is not captured in the structured field. Patient had drug allergy and hence ended up in the hospital with anaphylaxis, swelling of the face and throat and difficulty breathing, it is not captured as event. She had no hives, no shortness of breath but her doctor was apprehensive about her getting the covid vaccine without calling us. She also has allergies to penicillin and aspirin. She has ended up in the hospital with aspirin for experiencing anaphylaxis, swelling of the face and throat and difficulty breathing. She wants to know if its okay for her to receive the first dose of the Pfizer BIoNTech Covid 19 vaccine. Also referred her back to her healthcare professional (HCP).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Autoimmune thyroid disorder, Condition aggravated, Fatigue, Pain
Clinical narrative: exacerbation of her thyroid autoimmune condition; exacerbation of her thyroid autoimmune condition; fatigue; aches; weakness; Initial information received on 11-Aug-2021 regarding an unsolicited valid serious case from a consumer.  This case is linked to case 2021SA266989.  This case involves a 47-year-old female patient who experienced exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder and condition aggravated), fatigue, aches (pain) and weakness (asthenia), after receiving INFLUENZA VACCINE.  Medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Autoimmune thyroid disorder.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious fatigue, aches (pain), weakness (asthenia) and exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder and condition aggravated), (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 47-year-old female patient with autoimmune thyroid disorder who had her condition aggravated with fatigue, pain and asthenia, after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's other medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: DTP, IPV
Symptoms: Paralysis, Vaccination complication
Clinical narrative: was paralyzed for months; awful reactions; Initial information was received on 12-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a child (5 or 6 year old) female patient who was paralyzed for months (paralysis) and had awful reaction (adverse reaction) after receiving vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and POLIO VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Information of concomitant medications was not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect POLIO VACCINE not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. She received the vaccines after birth and at 5 or 6 years old in 1955 or 1956, when she was going into Kindergarten.  On an unknown date, the patient developed a serious event reported as paralyzed for months (paralysis) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and POLIO VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious awful reaction (adverse reaction) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and POLIO VACCINE.  It was reported the patient had the polio and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE (DPT) vaccines many years ago and had awful reactions from both and was scared to get the vaccine. She was paralyzed for months at the age of 5 or 6 years old, when she received it going into kindergarten or first grade. The patient's immunologist informed the patient that it was the fourth generation that has had this.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the events.  At time of this report, the outcome of the events was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case concerns a five or six-year-old female patient who was paralysis and had adverse reaction after vaccination DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE (unknown manufacturer) and POLIO VACCINE. The time to onset was unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: swelling pretty much right away; hives; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and nurse.  This case involves an (unknown age) female patient who experienced swelling pretty much right away (swelling) and hives (urticaria) when received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown, if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Solution for injection, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swelling pretty much right away (swelling) and hives (urticaria) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "Nurse calling on behalf of patient is wondering if the patient can receive the Pfizer BioNTech Covid 19 vaccine after having an allergic reaction to Menactra. Component of the vaccine that she is allergic to is unknown, and hasn't reacted like this to any other vaccine. Can she receive the Pfizer BioNTech Covid 19 vaccine if she is allergic to Menactra?"  It was unknown, if the patient experienced any additional symptoms/events.  It was unknown, if there were lab data/results available.  It was not reported, if the patient received a corrective treatment for all the events.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: child patient gave an expired dose of IPOL with no reported adverse event; Initial information received on 16-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves child patient of an unknown age and gender who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 02-Aug-2021, the patient received a 0.5 ml fourth (one dosage form) dose of suspect IPV (VERO) (lot R1D97 and expiry date: 17-Jul-2021) (Frequency: once) (Suspension for injection) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Patient age greater than one year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (tuberculin) skin test-0.5ML, Strength: standard except for Fluzone HD-STANDARD, Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, Vaccine presentation (for example specific flu vaccine), If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug admiration) requirement. Reporter relationship: HCP (health care professional) Product used: used, first time product used: no, still using product: no HCP can be contacted Yes/No: No".  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: She states that she had written an order for Bexxero, a Men B vaccine, however when the order came across the front desk, they interpreted it as Menactra and that is what was given in error without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received via physician via Medical Information (Reference number- 00693586) and transmitted to Sanofi on 22-Jul-2021.   This case involves a 16-year-old female patient who states that she had written an order for bexxero (a men b vaccine), however when the order came across the front desk, they interpreted it as MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and that is what was given in error (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 02-May-2016, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  On 22-Jun-2021 she also received a dose 2 of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U6920AB and expiry date: 15-Apr-2022] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  On 22-Jul-2021 she also received a dose 3 of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  At the time of report, no adverse event was reported.  It was reported that "a patient, was given Menactra vaccines 3 times with the last 2 Menactra vaccines being exactly 1 month apart at age 16. The physician asks what can happen as a result of this. She states that she had written an order for Bexxero, a Men B vaccine, however when the order came across the front desk, they interpreted it as Menactra and that is what was given in error. The Physician also asks if it is acceptable for the patient to go ahead and get the Men B vaccine as that is the vaccine that she was supposed to get in the first place. "  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Product storage error
Clinical narrative: A temperature excursion of unopened PENTACEL and ACT-HIB at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes, the patient had been given ACTHIB post-excursion/ No AE; Initial information was received on 05-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via phone (under Global medical information (GMI) Inquiry Number: 00712270 and 00712270).  This case involves a 25 months old male patient.  This case involves a temperature excursion of unopened DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot UJ434ABA, expiry date: 08-MAR-2022 and HIB (PRP/T) VACCINE [ACT-HIB] at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes that occurred 11-Jun-2021, and the patient had been given ACT-HIB vaccine post-excursion (product storage error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  On 27-Jul-2021, the patient received a 0.5 ml third dose of suspect HIB (PRP/T) VACCINE lot UJ437ABB, expiry date: 03-MAY-2022, frequency: once, strength: standard via intramuscular route in the left thigh for prophylactic vaccination.  Emergency Room/ Doctor visit and date: 27-Jul-2021.  It was a case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "Medical assistant reported temperature excursion for unopened: PENTACEL and ACTHIB reported several temperature excursions: first was 46.7 Fahrenheit for total excursion of 30 minutes, second was 46.5 Fahrenheit for total excursion of 30 minutes and third was 46.5 degrees Celsius for total excursion of 30 minutes cause of temperature excursions is unknown. Medical assistant asking for stability information. Caller reports she had called previously regarding a temperature excursion. Caller states that she needs to report another temperature excursion that occurred 11-Jun-2021, temperature excursion was for unopened: PENTACEL and ACTHIB temperature excursion was 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes. Caller does report that a patient has been given ACT-HIB post-excursion. Product used, First time product used: No".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: 19 weeks pregnant female received Adacel/ no AE; they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant/no AE; Initial information regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00704218) and transmitted to Sanofi on 30-Jul-2021.  This case involves a 15-year-old pregnant female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at her 19 weeks of pregnancy she was not supposed to give this vaccine until she was 27 weeks pregnant (exposure during pregnancy and inappropriate schedule of product administration).  Data regarding this pregnancy were received prospectively. The gestation period at onset 19 weeks. The date of last menstrual period was reported as March 2021. The estimated due date was not reported. The patient's past vaccination(s) included TETANUS TOXOID in 2019. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided. The patient had unknown previous pregnancy.  On 29-Jul-2021, the patient received a first dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6621BA, expiry date: 31-Mar-2022) a via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of exposure during pregnancy (latency same day).  It was actual medication error case due to inappropriate schedule of vaccine administered (latency same day).  It was reported that, "the vaccine was given to a patient who is 19 weeks pregnant, and they realized that they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant. Caller would like to know if there is anything they need to tell the patient or if there are any adverse effects".  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given PENTACEL as well as ACT-HIB on the same day/ no AE; Initial information was received on 30-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Global Medical Information (GMI) (Reference number- 00704764) and transmitted to Sanofi on 30-Jul-2021.  This case involves a two-month-old male patient reported that patient was given HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on the same day (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for prophylactic vaccination, HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) for prophylactic vaccination and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for prophylactic vaccination.  On 30-Jul-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ415AAA and expiry date 12-May-2022] via intramuscular route in unknown administration site for prophylactic vaccination and a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date 28-May-2022] via unknown route in unknown administration site for prophylactic vaccination.  It was reported that, "Nurse stated 2 month old child was given PENTACEL as well as ACT-HIB today. Caller is requesting to know if child will be ok and what to do".  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.