chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection; Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" and all described as "Had all the vaccines and boosters except for the newest one/completed Paxlovid for Covid-19 infection". The patient underwent the following laboratory tests and procedures: Body temperature: (Sep2022) 102.9 Fahrenheit; SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller states he completed Paxlovid for Covid-19 infection. Caller states he had all the vaccines and boosters except for the newest one. Caller states he was waiting until he fully recovered from Covid-19 to get the new booster. Caller states when he had Covid-19 he experienced 102.9 F (Fahrenheit) fever. Caller states, "It felt like an truck parked on my chest." Caller states he took Paxlovid and tested positive for at least 3 or 4 days before he tested negative. Caller states he feels like Paxlovid helped keep him out of the hospital.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallstones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, latency 1 year 5 months 16 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: I had mild COVID symptoms for two days before finally testing positive on 07Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has received vaccine and two of boosters. She had mild COVID symptoms for two days before finally tested positive on 07Oct2022. She started taking Paxlovid 07Oct2022 to 12Oct2022. She felt better but not 100 percent and tested negative as of 13Oct2022. The evening of 16Oct2022, she started having symptoms again and the evening of 17Oct2022 she tested positive again. Other medication she took was reported as Iburprofen from 07Oct2022 to 09Oct2022.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Cholesterol" (ongoing), notes: she takes a cholesterol pill; "High Blood pressure" (ongoing), notes: High blood pressure medication. Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (Dose 1, lot EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness"; BNT162b2 (Dose 2, lot looks like EL9266), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "a little soreness".  Additional information: Phone-in 3:26 pm from reporter (consumer/patient) in response to phone-out 10:16 am to clarify whether the statement, "initial shot part" that is reported in Initial (13Oct2022) is referring to the first dose of the Pfizer COVID-19 vaccine (Dose 1) or the primary series of vaccination (Dose 1 and Dose 2). Reporter stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID-19 Vaccine. Reporter stated that with Dose 1, Dose 2, Dose 3 and Dose 4, that she did not experience any adverse events, that she just experienced a little soreness when she initially received those 4 shots and added that it was nothing and the soreness went away right away and that she does not consider "a little soreness" an adverse event. Concomitant Medication was states she takes a cholesterol pill and as of recently she had to start a high blood pressure medication, it's not that high but they want to make sure.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "COPD" (unspecified if ongoing); "Menopause" (unspecified if ongoing), notes: it was like menopause again but worse. Concomitant medication(s) included: WIXELA INHUB taken for chronic obstructive pulmonary disease. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Batch Number: EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "a little soreness"; BNT162b2 (DOSE 2,SINGLE, Batch Number: EL9266), administration date: 15Feb2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "a little soreness"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Batch Number: 330308D or 3303080), administration date: 26Nov2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "a little soreness".  Additional information: Patient stated that with the other 4 she had within the last year she had absolutely no ill effects except a little soreness with the initial shot part. She stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID -19 Vaccine and she stated that with Dose 1, Dose 2, Dose 3 and Dose 4 she did not experience any adverse events, that she just experienced a little soreness. She stated that when she initially received those 4 shots and it was nothing and the soreness went away right away and she did not considered a little soreness as an adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Prostatic specific antigen, Suspected COVID-19
Clinical narrative: I contracted Covid 19; I contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted Covid 19". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: High/Go up, notes: show high PSA levels/every time I got a vaccine or a booster, my PSA readings go up. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: It was also reported that patient had 2 vaccines and 2 boosters and then the paxlovid, every time he got a vaccine or a booster, his PSA readings go up because he contracted Covid 19, he have a chart. He taken the vaccine and when got back his PSA readings back and every time I got a vaccine or a booster, my PSA readings go up. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. He took Paxlovid took 2 months ago, on 12Aug2022 also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: I contracted Covid 19; I contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted Covid 19". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: High/Go up, notes: show high PSA levels/every time I got a vaccine or a booster, my PSA readings go up. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: It was also reported that patient had 2 vaccines and 2 boosters and then the paxlovid, every time he got a vaccine or a booster, his PSA readings go up because he contracted Covid 19, he have a chart. He taken the vaccine and when got back his PSA readings back and every time I got a vaccine or a booster, my PSA readings go up. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. He took Paxlovid took 2 months ago, on 12Aug2022 also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive; Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller who got all four shots of the Pfizer covid-19 vaccine was prescribed Paxlovid and after taking it for five days he still tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Prescribed Paxlovid and after taking it for five days he still tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Imaging procedure, Investigation, Lymphadenopathy, Respiratory disorder
Clinical narrative: cough; enlarged lymphnodes; long term breathing issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "enlarged lymphnodes"; RESPIRATORY DISORDER (non-serious) with onset 2022, outcome "unknown", described as "long term breathing issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the first booster, the patient developed a cough that has turned into long term breathing issues with enlarged lymph nodes. Patient received Pfizer vaccine as second booster dose   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: she administered the Orange cap Covid-19 vaccine that expired a day before it was administered.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "she administered the Orange cap Covid-19 vaccine that expired a day before it was administered."  Additional information: The patient received orange cap Covid-19 vaccine that expired a day before it was administered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: she went to the hospital this July 26 because she had a total knee replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: KNEE ARTHROPLASTY (hospitalization) with onset 26Jul2022, outcome "unknown", described as "she went to the hospital this July 26 because she had a total knee replacement". The patient was hospitalized for knee arthroplasty (start date: 26Jul2022). Clinical course: The patient received her 1st and 2nd dose. She also had the other dose last 27Sep2021 and then she went to the hospital this 26Jul because she had a total knee replacement and before she left the hospital, they gave her a Pfizer shot with the lot number of FP7150 on her vaccination card. She just wanted to know if the shot she received was the new Bivalent vaccine because she does not want to be doubled doses. Created manual AE Form-parent case: 00933109 - related case: 00933112. Medical inquiry was not forwarded.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test 17Sep2022; Positive COVID test 17Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B3 (ongoing); TYLENOL; IBUPROFEN. Past drug history included: Penicillin, reaction(s): "Allergy to Penicillin"; Sulfa, reaction(s): "Allergic to Sulfa". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Sep2022, outcome "unknown" and all described as "Positive COVID test 17Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient tested positive with minor symptoms, Patient received treatment for COVID-19 with ritonavir (Paxlovid), Lot/Batch number: 2815238, 150mg twice a day, started on 17Sep2022 and stop date was 21Sep2022 and Mucinex DM, started date was 17Sep2022 and stop date was 21Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Lip swelling, Pharyngeal swelling, Throat tightness
Clinical narrative: throat swelling/closing; throat swelling/closing; Interchange of vaccine products; lip swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lisinopril (LISINOPRIL), (Batch/Lot number: unknown) for blood pressure abnormal. The patient's relevant medical history included: "BP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (All prior COVID vaccine doses were Moderna doses., Dose Number unknown), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Oct2022, outcome "unknown"; LIP SWELLING (medically significant) with onset 13Oct2022, outcome "unknown"; PHARYNGEAL SWELLING (medically significant), THROAT TIGHTNESS (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "throat swelling/closing". The events "lip swelling" and "throat swelling/closing" required emergency room visit. The action taken for lisinopril was temporarily withdrawn. Therapeutic measures were taken as a result of lip swelling, pharyngeal swelling, throat tightness.  Clinical course: Patient received Pfizer bivalent booster shot on 13Oct2022 in the AM. She also takes lisinopril and has for 5-7 years. She started experiencing lip swelling by Thursday PM and took benedryl. Still had lip swelling Friday day and Friday evening began to experience throat swelling/closing. Went to ER and received steroids and more benedryl. She will no longer be on lisinopril for her BP as a precaution. No determination was made as to which product may have triggered the reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: severe stomach pain; diarrhea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 23Aug2022, outcome "unknown", described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Aug2022, outcome "unknown", described as "severe stomach pain"; VOMITING (non-serious) with onset 23Aug2022, outcome "unknown".  Additional information: The reporter reported that, Dose 2 date: 24Aug2022 (Time: 7 Am - 5 Pm); Dose 3 date: 24Aug2022 (Time: 5 pm - 7 am); Dose 4 date: 25Aug2022 (Time: 7 Am - 5 Pm). Patient visited Pharmacy or drug store as a facility for administration of 1st and 2nd dose of COVID-19 vaccine. Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine and stated specific relevant test for thromboembolic events with thrombocytopenia was none. Patient reported that, she started having severe stomach pain, diarrhea, Vomiting about 2hr after taking the first dose. (illegible) until at 3 days after last dose urgent care nurse stated to stop taking the meds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 3.0
Sex: U
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an additional dose of pentacel was given in error with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old and unknown gender patient who received an additional dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] in error with no reported adverse event.  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 extra dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (dose, formulation, strength and lot number: unknown) via unknown route in unknown administration site for Prophylactic vaccination in error with no reported adverse event (extra dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Sex: U
Vaccine: TDAP
Symptoms: Immobile, Pain, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: immobility in their arm; severe pain after receiving Adacel injection; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender (3 out of 4) patients who experienced severe pain after receiving adacel injection and immobility in their arm after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  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  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot 2CA18C; Expiry date: 29-Nov-2024) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed immobility in their arm and severe pain after receiving Adacel injection (vaccination site pain) (vaccination site movement impairment) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Sex: M
Vaccine: FLUX
Symptoms: Chiropractic, Malaise, Muscle atrophy
Clinical narrative: lose all of his muscular ability; got violently ill; Initial information received  on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a Patient.  This case is linked to cases 2022SA424503, 2022SA425041, 2022SA424529 and 2022SA422349.  This case involves Adult male patient who experienced got violently ill and lose all of his muscular ability after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2021, the patient received o.5 ml, total dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, lot number: unknown) via unknown route in unknown administration site for immunization.  Patient stated that the last two years that he had a flu shot, he got violently ill (malaise)(unknown latency). He stated that his last flu vaccine he received on 13-Oct-2021, caused him to lose all of his muscular ability by (muscle atrophy) 15-Oct-2021 (latency: 2 days). Caller believes he had neuromuscular disease. The problems with his muscles lasted 5 months. He was asked if he was hospitalized, which he denied. Doctor ordered an "Electromyography (EMG)" test, but he refused due to having a defibrillator. He went to a chiropractor and all of a sudden it improved after that. His primary care doctor thinks his symptoms are improving, but he indicated he still has some effect.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (got violently ill, lose all of his muscular ability).  At time of reporting, the outcome was Recovering / Resolving for both events.
Age: 75.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Atrial fibrillation, COVID-19, Cardiac assistance device user, Cardioversion, Heart rate increased
Clinical narrative: atrial fibrillation; heart rate became elevated; has a defibrillator; received a shock in his chest; ill with Covid infection; Initial information received on 12-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.  This case is linked to cases 2022SA422349 and 2022SA425046.  This case involves a 77 years old male patient who has a defibrillator, experienced shock in his chest, atrial fibrillation and  ill with covid infection after receiving vaccines Tozinameran[ pfizer biontech covid-19 vaccine] and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in, 2019 followed by another dose in 2021,  the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported at an unknown dose via an unknown route in an unknown administration site as prophylactic vaccination.  On an unknown date of 2021 followed by another dose in 2021, the patient received dose number 1  of suspect Tozinameran not produced by Sanofi Pasteur lot number not reported at an unknown dose via an unknown route in an unknown administration site for covid -19 vaccination.  On an unknown date(latency: approximately 3 years for all events), the patient had a defibrillator ( Cardiac assistance device user), and after vaccination, he received a shock in his chest (Cardioversion). His heart rate became elevated (heart rate increased), and he went into atrial fibrillation (Atrial fibrillation). The atrial fibrillation resolved and he felt good that summer. The patient stated that he reported his experience after the 2nd Pfizer vaccine dose to the Pfizer hotline. Sometime after 13Oct2021, he became ill with Covid infection (Covid 19).  Action taken: not applicable for both suspect drugs for all events.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown for Cardioversion and Cardiac assistance device user and recovered for all other events.  Seriousness criteria: medically significant for atrial fibrillation and heart rate increased, Disability of Cardiac assistance device user; Sender's Comments: Sanofi Company comment dated 20-Oct-2022:This case involves 77 years old male patient who was vaccinated with Influenza vaccine (produced by unknown manufacturer)and Pfizer Biontech Covid-19 Vaccine (not manufactured by Sanofi) and experienced atrial fibrillation, heart rate increased and has a defibrillator . The time to onset is compatible with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup would be needed for a complete assessment of the case. The case is confounded by multiple vaccines administered same time . Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: small amount of blood was noted at injection site; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 78 years old female patient who experienced small amount of blood was noted at injection site while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received a  dose of suspect quadrival a-b high dose hv vaccine  at dose of 0.7ml lot UJ895AB Expiration Date: 30-jun-2023  via intramuscular route in the deltoid nos.  On 11-Oct-2022 the patient developed a non-serious small amount of blood was noted at injection site (injection site haemorrhage)(latency same day) following the administration of quadrival a-b high dose hv vaccine.  It was reported  "A small amount of blood was noted at injection site post-injection and a bandage was applied. This morning she called to report an orange substance on the band-aid".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (small amount of blood was noted at injection site).  At time of reporting, the outcome was Unknown for the event small amount of blood was noted at injection site.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired TENIVAC was administered to a patient after the expiration date, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 67-year-old female patient to whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient after the expiration date, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine) PCV 23 for Immunisation.  On 11-Oct-2022, the patient received 2nd dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: standard, at 0.5ml (formulation, route: unknown) (lot number: U6852AA and expiry date: 07-Oct-2022) in unknown administration site for Immunization and an expired tenivac was administered to a patient after the expiration date, with no reported adverse event (expired product administered) (latency: same day).  This situation is reported as a medication error.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was 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 guidelines. 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: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event; vaccine administered to patients after temperature excursion with no reported adverse event; Expired vaccine administered with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 54 years old and unknown gender patient and reported temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event, vaccine administered to patients after temperature excursion with no reported adverse event and expired vaccine administered with no reported adverse event while receiving vaccine influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved Suspension for injection (lot UJ899AA, expiry date- 30-Jun-2022) with an unknown strength via unknown route in unknown administration site for prophylactic vaccination.  On 22-Sep-2022, the patient had developed a non-serious temperature excursion that exceeded the stability data documented in the local labelling administered to patients with no reported adverse event (product storage error), vaccine administered to patients after temperature excursion with no reported adverse event (poor quality product administered) and vaccine administered with no reported adverse event (expired product administered),  latency same day following the administration of influenza quadrival a-b vaccine.  Action taken - not applicable.  Outcome - Unknown for all the events  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: 48.0
Sex: U
Vaccine: FLU3, TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: TENIVAC and FLUZONE QUADRIVALENT exceeded the stability data and were administered to patients with no reported AE; poor quality dose administered with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 48 years old (unknown gender) patient who reported tenivac and fluzone quadrivalent exceeded the stability data and were administered to patients with no reported adverse event and poor quality dose administered with no adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Sep-2022, the patient received a  dose of suspect  INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED  (lot UJ899AA; 30-Jun-2023) via unknown route in unknown administration site and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, dose, formulation, route: unknown) both for Immunization.  On 23-SEP-2022 the patient developed a non-serious event tenivac and fluzone quadrivalent exceeded the stability data and were administered to patients with no reported adverse event (product storage error) and poor quality dose administered (poor quality product administered)  with no adverse event following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.; Sender's Comments:  01318334: 01318560: 01318700: 01318713: 01318730: 01318644: 01318635: 01318655: 01318686: 01318695: 01318744: 01318785: 0131881: 01318811: 01318509: 01318553: 01318603: 01318593: 01318613: 01318624:
Age: 49.0
Sex: U
Vaccine: FLU3, TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event involving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (product storage error) (latency: unknown) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Action taken : not applicable.  Outcome: 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: 56.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 56-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] multidose vial was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, dose , route: unknown) (lot number: UJ899AA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and on the same day fluzone quadrivalent multidose vial was administered to patient, with no reported adverse event (poor quality product administered) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency).  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED was not applicable for both events.  At time of reporting, the outcome was Unknown for both events.  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: 52.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-Healthcare professional (hcp).  This case involves a 52 years old and unknown gender patient to whom vaccine administered post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event for vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength, expiry date: unknown) lot UJ899AA via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported adverse event (poor quality product administered) (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.