chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the covid; got the covid; 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 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "has inflammation" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "fibroid" (unspecified if ongoing); "left shoulder pain" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing); "for her stomach" (unspecified if ongoing); "for yeast and inflammation and all that stuff" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE oral taken for fungal infection, inflammation (ongoing); NAPROXEN taken for arthralgia, inflammation; PRILOSEC [OMEPRAZOLE] taken for abdominal discomfort (ongoing); SYNTHROID oral taken for thyroid disorder (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "unknown" and all described as "got the covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (05Aug2023) Positive. On 05Aug2023 tested positive for Covid. She got it from her husband. Patient started getting ill on Saturday and was having a lot of coughing, sneezing, she had a little bit of fever, sinuses get all filled up with stuff, sore throat, headache. So, the primary doctor ordered the Paxlovid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272418 same patient/AE,different vaccine doses;
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Magnetic resonance imaging heart, Movement disorder, Musculoskeletal chest pain
Clinical narrative: myocarditis; feeling pain in my body/ pain all over her body; My ribs pain me; can't sleep; sick; I can't hardly use my arms/ I almost lose my legs; 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), as dose 1, 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: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling pain in my body/ pain all over her body"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "My ribs pain me"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I can't hardly use my arms/ I almost lose my legs". The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: myocarditis in my heart; Positron emission tomogram: find it in my heart.  Clinical course: The caller requested information on what to do with myocarditis that happened after receiving the Pfizer Biontech COVId-19 vaccine. Patient got two shots of the Pfizer vaccine and she got one shot of the booster. Every time she went to the ER like she got a heart attack I never get one. Patient had been going on feeling pain in her body. Her ribs pain her. Every real pain just pain. Really can't sleep(?). They did MRI in her heart and they find the myocarditis in her heart they did a PET scan and they found it in her heart. The myocarditis almost killed her. Pfizer should tell people you can get that. She almost lost my life. (Unintelligible) When she took the first vaccination she could walk, the second one she creep. She almost lost her legs. When she took the booster she was so sick. Patient could not hardly use her arms. The caller proceeded to complain about the pamphlet not being sent with the vaccine so people who get it know what could potentially happen to them. Caller mentions that on Tik Tok and you tube are people complaining about adverse events of the vaccine and how they got sick from it. Caller got 2 vaccines and booster, had myocarditis, calling to have that reported. She had myocarditis, in heart, got from Pfizer. She stated, the only thing she called for was to report and saw what she can do for it. Has disease on her body, germs and, pain all over her body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272054 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300272055 same patient/vaccine, different vaccine dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pain, Positron emission tomogram
Clinical narrative: myocarditis; feeling pain in my body/ pain all over her body; My ribs pain me; can't sleep; sick; I can't hardly use my arms/ I almost lose my legs; 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), as dose 1, 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: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling pain in my body/ pain all over her body"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "My ribs pain me"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I can't hardly use my arms/ I almost lose my legs". The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: myocarditis in my heart; Positron emission tomogram: find it in my heart.  Clinical course: The caller requested information on what to do with myocarditis that happened after receiving the Pfizer Biontech COVId-19 vaccine. Patient got two shots of the Pfizer vaccine and she got one shot of the booster. Every time she went to the ER like she got a heart attack I never get one. Patient had been going on feeling pain in her body. Her ribs pain her. Every real pain just pain. Really can't sleep(?). They did MRI in her heart and they find the myocarditis in her heart they did a PET scan and they found it in her heart. The myocarditis almost killed her. Pfizer should tell people you can get that. She almost lost my life. (Unintelligible) When she took the first vaccination she could walk, the second one she creep. She almost lost her legs. When she took the booster she was so sick. Patient could not hardly use her arms. The caller proceeded to complain about the pamphlet not being sent with the vaccine so people who get it know what could potentially happen to them. Caller mentions that on Tik Tok and you tube are people complaining about adverse events of the vaccine and how they got sick from it. Caller got 2 vaccines and booster, had myocarditis, calling to have that reported. She had myocarditis, in heart, got from Pfizer. She stated, the only thing she called for was to report and saw what she can do for it. Has disease on her body, germs and, pain all over her body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272054 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300272055 same patient/vaccine, different vaccine dose/event;
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Aug2023 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: COVID-19 (non-serious) with onset 07Aug2023 at 02:00, outcome "recovered", described as "Tested Positive for Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.  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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Expired product administered, SARS-CoV-2 test
Clinical narrative: tested positive with COVID; tested positive with COVID; took expired Pfizer COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID:. The reporter is the patient. A 93-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive with COVID"; EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "took expired Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course details: The patient reported that she had taken took expired Pfizer COVID-19 vaccine and has now, tested positive with COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Vaccine brand other=Moderna, Vaccine administration date=10May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 11Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10May2022 as dose 4 (booster), single (Lot number: 0561721A), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Sep2022 as dose 5 (booster), single (Lot number: 042H22A), in right arm and on 25Apr2023 as dose 6 (booster), single (Lot number: A57145B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "premature ventricular contractions" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Mar2023, stop date: 30Jul2023; METOPROLOL SUCCINATE, start date: 01Feb2022; ASA, start date: 01Feb2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10May2022, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine administration date=10May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2023) Positive, notes: positive antigen test 5 days after completing a course of Paxlovid; (2023) Negative, notes: tested negative; (2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as Covid-19 treatment from 30Jul2023 to 03Aug2023. After symptoms resolved and tested negative, patient experienced a return of sinus congestion and scratchy throat and positive antigen test 5 days after completing a course of Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech /Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 12:30 as dose 1, single (Lot number: PAA165969), in left arm and on 01May2021 at 12:30 as dose 2, single (Lot number: EW0167) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 013F21A), in left arm and on 23May2022 at 10:00 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 30Oct2022 at 11:00 as dose 5 (booster), single (Lot number: 013H22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Pfizer / BioNTech /Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Jul2023 to 30Jul2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body height, Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the covid; got the covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed maybe, she doesn't know 2000 or around 1996. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got the covid". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5 foot 8 or 5 foot 9, notes: his height is about 5 foot 8 or 5 foot 9; Body temperature: (unspecified date) Fever around 99-101; SARS-CoV-2 test: (02Aug2023) Positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started feeling sick on Wednesday, he was very sick Thursday and Friday and Saturday started getting better. Patient started feeling crummy with a little coughing and little runny nose Wednesday and by end of day felt worse and had sticks up the nose, and he did and had a fever. He tested positive. Thursday and Friday he was very sick. Saturday he was feeling a little better. Now has a little coughing little sneezing. They got Mucinex liquid, take a cup and helps with coughing and sneezing. It's a big help. Wednesday he was at work and figured he had a little cough and runny nose until he felt worse. Got fever around 99-101. He tested positive for Covid by home test on Wednesday 02Aug2023. He was given prescription Paxlovid but started feeling better and didn't take it. He is diabetic and on a lot of those medications but doesn't know names of them.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272391 same patient, different vaccine doses/event;US-PFIZER INC-202300272392 same patient, different vaccine doses/event;US-PFIZER INC-202300271922 same reporter/AE/vaccine,different patients;
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body temperature, COVID-19 pneumonia, Chest X-ray, Drug ineffective
Clinical narrative: Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid; Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stones" (unspecified if ongoing), notes: few years back he had kidney stones; "Diabetec" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid"; COVID-19 PNEUMONIA (medically significant), outcome "not recovered", described as "Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid ". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5 foot 8 or 5 foot 9; Body temperature: (unspecified date) around 99-101, notes: fever around 99-101; Chest X-ray: (unspecified date) viral pneumonia; SARS-CoV-2 test: (02Aug2023) Positive; (unspecified date) Positive, notes: He tested positive; (unspecified date) Negative, notes: he was negative. Clinical course: Once when he got Covid one time, she tested positive and he was negative, she got x-ray and told no pneumonia and the following week he was coughing, coughing, coughing, and went back a week later positive for Covid. Didn't have any medicines and they were ok. He had chest x-ray and was told he had viral pneumonia caused by Covid and nothing to give him. Was a good over a year ago when this happened. She found interesting when they said viral pneumonia and couldn't give anything. Weren't put on any medication that was before this Paxlovid that came out later. It was all before they had the booster. They had a couple of shots, 1 or 2 before this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid; Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney stones" (unspecified if ongoing), notes: few years back he had kidney stones; "Diabetec" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid"; COVID-19 PNEUMONIA (medically significant), outcome "not recovered", described as "Once when he got Covid one time, she tested positive and he was negative/had chest x-ray and was told he had viral pneumonia caused by Covid ". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5 foot 8 or 5 foot 9; Body temperature: (unspecified date) around 99-101, notes: fever around 99-101; Chest X-ray: (unspecified date) viral pneumonia; SARS-CoV-2 test: (02Aug2023) Positive; (unspecified date) Positive, notes: He tested positive; (unspecified date) Negative, notes: he was negative. Clinical course: Once when he got Covid one time, she tested positive and he was negative, she got x-ray and told no pneumonia and the following week he was coughing, coughing, coughing, and went back a week later positive for Covid. Didn't have any medicines and they were ok. He had chest x-ray and was told he had viral pneumonia caused by Covid and nothing to give him. Was a good over a year ago when this happened. She found interesting when they said viral pneumonia and couldn't give anything. Weren't put on any medication that was before this Paxlovid that came out later. It was all before they had the booster. They had a couple of shots, 1 or 2 before this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body temperature, Chest X-ray, Nephrolithiasis, X-ray
Clinical narrative: kidney stones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he is diabetic" (ongoing), notes: Diagnosed maybe, she doesn't know 2000 or around 1996. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 3), for Covid-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: NEPHROLITHIASIS (medically significant) with onset 06Aug2023, outcome "not recovered", described as "kidney stones". The patient underwent the following laboratory tests and procedures: Body height: 5 foot 8 or 5 foot 9; Body temperature: fever around 99-101; Chest X-ray: he had viral pneumonia caused by Covid; X-ray: no pneumonia. Clinical course: She was reading all the information it can affect other conditions you have it can add to those conditions and one condition he hasn't had in a long time but is in pain and has had his share of kidney stones. When passing through it is very painful. They assume it's kidney stones. That started up with him being sick. Pain started like she would say 06Aug2023. Pain came maybe late Saturday. Pain is going from one to the other really hurting and then will be ok. Guess stones he has had over years but hasn't had in years. It's the stones going through bladder and tubes.   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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, X-ray
Clinical narrative: Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this; Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this; 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 79-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "Stomach problem" (unspecified if ongoing), notes: for her stomach; "left shoulder pain and inflammation" (unspecified if ongoing); "left shoulder pain and inflammation" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "fibroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID oral taken for thyroid disorder (ongoing); PRILOSEC [OMEPRAZOLE MAGNESIUM] taken for abdominal pain upper (ongoing); FLUCONAZOLE oral (ongoing); NAPROXEN taken for arthralgia, inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Once when he got Covid one time, she tested positive and he was negative/It was all before they had the booster. They had a couple of shots, 1 or 2 before this". When the patient got this COVID it was mild. Stated that the patient has never been on heart medication. The patient was not put on any medication and this occurred before Paxlovid came out. This happened before they had the booster. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative most of the time; positive; X-ray: no pneumonia. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271922 same patient/AE, different vaccine doses;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint dislocation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Augmentin [amoxicillin sodium;clavulanate potassium], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), JOINT DISLOCATION (non-serious) all with onset 01Dec2022, outcome "not recovered" and all described as "Left arm and shoulder pain and subluxation". The events "left arm and shoulder pain and subluxation" required physician office visit and emergency room visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint dislocation.  Additional information: the patient received physical therapy as treatment. 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Colonoscopy, Drug ineffective, Electromyogram, Endoscopy
Clinical narrative: Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Augmentin [amoxicillin sodium;clavulanate potassium], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), JOINT DISLOCATION (non-serious) all with onset 01Dec2022, outcome "not recovered" and all described as "Left arm and shoulder pain and subluxation". The events "left arm and shoulder pain and subluxation" required physician office visit and emergency room visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint dislocation.  Additional information: the patient received physical therapy as treatment. 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: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound joint, X-ray
Clinical narrative: Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; Left arm and shoulder pain and subluxation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Augmentin [amoxicillin sodium;clavulanate potassium], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, manufacturer unknown, Location of injection: Arm Left.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), JOINT DISLOCATION (non-serious) all with onset 01Dec2022, outcome "not recovered" and all described as "Left arm and shoulder pain and subluxation". The events "left arm and shoulder pain and subluxation" required physician office visit and emergency room visit. Laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint dislocation.  Additional information: the patient received physical therapy as treatment. 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient, different dose/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jun2023 at 12:00 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Raynauds syndrome" (unspecified if ongoing); "Known allergies: Sulfa medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Jul2023 to 01Aug2023.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters; I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, 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) all with onset 06Aug2023, outcome "unknown" and all described as "I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2023) positive, notes: positive COVID-19 result.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Fully vaccianated against COVID (Moderna) plus 2 boosters (Moderna, Pfizer); COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LISINOPRIL; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Fully vaccianated against COVID (Moderna) plus 2 boosters (Moderna, Pfizer)". Therapeutic measures were taken as a result of drug ineffective, covid-19 which include PF-07321332, Ritonavir (Paxlovid) started on 25May2023.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; 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), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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 "COVID". 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: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: make people sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: ILLNESS (non-serious), outcome "unknown", described as "make people sick".  Additional information: Reporter reported that pfizer sells products that make people sick. Reporter consider event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". Clinical courses: the patient now has COVID. The patient has lost sense of smell and taste. Very tired. The patient need a booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious courtesy case received from a other health professional.  This case involves patient of age 16 (units unspecified) who was administered trumenba and bexsero by the tech but the doctor ordered trumenba and meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] 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 meningococcal vaccine B RFHBPA/FHBPB (Trumenba) for annual physical (Immunisation).  On 28-Jul-2023 at 12:05 pm, the patient was administered trumenba and bexsero (expiry date: 31-Jan-2027) (dose, formulation; strength; lot number unknown) by the tech but the doctor ordered trumenba and meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (dose, strength, lot number; expiry date not reported) via unknown route at unknown administration site for Prophylactic vaccination with no reported adverse event (wrong product administered) (latency: same day).   It was reported, "The patient has had no reactions. It w as their annual physical for the patient and at certain times according to age you give certain vaccines and the doctor decided since the patient is age 16, wanted to prescribe for the patient the Trumenba and Menactra for the yearly annual physical."  Action taken was 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.
Age: 4.0
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion product administered to the patient with no reported adverse event; Initial information was received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA239960 (CLUSTER).  This case involves a 4 years old female patient who experienced temperature excursion product administered to the patient with no reported adverse event after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient had temperature excursion product administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, caller would like to find out if the vaccines involved in the previous excursion would need to be readministered.  She would like to find out if the vaccines involved in the previous excursion would need to be readministered. POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO Does extended stability data cover the excursion: NO And in case of negative advice: Was the product used by/ administered to the patient: YES 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. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023. ADACEL, MENQUADFI administered.  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.