chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Feeling abnormal, Headache, Memory impairment, Ocular discomfort
Clinical narrative: brain fog; memory issues; visual problems; Floaters; Sensitivity to light; headaches; cognitive challenges; vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 18-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 12May2021, when the patient was 18-year-old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 17-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Dec2021, outcome "unknown", described as "vaccine location=Left leg"; VITREOUS FLOATERS (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Floaters"; PHOTOPHOBIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Sensitivity to light"; FEELING ABNORMAL (non-serious) with onset 10Jan2022, outcome "not recovered", described as "brain fog"; COGNITIVE DISORDER (non-serious) with onset 10Jan2022, outcome "not recovered", described as "cognitive challenges"; HEADACHE (non-serious) with onset 10Jan2022, outcome "not recovered", described as "headaches"; MEMORY IMPAIRMENT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "memory issues"; OCULAR DISCOMFORT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "visual problems". The events "brain fog", "memory issues", "visual problems", "floaters", "sensitivity to light", "headaches" and "cognitive challenges" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, memory impairment, ocular discomfort, vitreous floaters, photophobia, headache, cognitive disorder.  Additional information: Patient received treatment with Zithromax, Vitamin Supplements.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia, Product administered at inappropriate site, SARS-CoV-2 test, Vitreous floaters
Clinical narrative: brain fog; memory issues; visual problems; Floaters; Sensitivity to light; headaches; cognitive challenges; vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 18-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 12May2021, when the patient was 18-year-old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 17-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset Dec2021, outcome "unknown", described as "vaccine location=Left leg"; VITREOUS FLOATERS (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Floaters"; PHOTOPHOBIA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Sensitivity to light"; FEELING ABNORMAL (non-serious) with onset 10Jan2022, outcome "not recovered", described as "brain fog"; COGNITIVE DISORDER (non-serious) with onset 10Jan2022, outcome "not recovered", described as "cognitive challenges"; HEADACHE (non-serious) with onset 10Jan2022, outcome "not recovered", described as "headaches"; MEMORY IMPAIRMENT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "memory issues"; OCULAR DISCOMFORT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "visual problems". The events "brain fog", "memory issues", "visual problems", "floaters", "sensitivity to light", "headaches" and "cognitive challenges" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, memory impairment, ocular discomfort, vitreous floaters, photophobia, headache, cognitive disorder.  Additional information: Patient received treatment with Zithromax, Vitamin Supplements.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received first, second and booster dose Pfizer Covid Vaccine; received first, second and booster dose Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received first, second and booster dose Pfizer Covid Vaccine". It was reported that caller started taking Paxlovid yesterday night (01Jun2022) and took second dose of Paxlovid this morning, 02Jun2022. The caller started having a rash all on stomach and both arms. The rash began today, 02Jun2022. She also previously received both doses and booster of Pfizer Covid 19 vaccine and also had a rash after each dose. It was queried that are there any similar ingredients in both products that may be causing the allergy. She mentioned that her doctor already told to stop it, and to take antihistaminic. She just wanted to know if there's something similar because it was basically the same reaction in both, rash in her stomach and arms, that could explain why she was getting this reaction, she was hesitant to get the second booster because this always happen, even with this medicine, she just wanted to know if there's a similar component, maybe the same family or source so that she can bring this information to her allergist. She took Paxlovid this morning, but since she was allergic she cannot take it anymore, she wanted to know if there are reactions between Paxlovid and Advil Cold and Sinus. It was queired that does Paxlovid has any reaction with Advil Cold and Sinus. The caller wants to find out why caller is having this allergy, wants to know if maybe there is something in both Paxlovid and the Pfizer Covid Vaccine. Therapeutic measures were 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: received first, second and booster dose Pfizer Covid Vaccine; received first, second and booster dose Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received first, second and booster dose Pfizer Covid Vaccine". It was reported that caller started taking Paxlovid yesterday night (01Jun2022) and took second dose of Paxlovid this morning, 02Jun2022. The caller started having a rash all on stomach and both arms. The rash began today, 02Jun2022. She also previously received both doses and booster of Pfizer Covid 19 vaccine and also had a rash after each dose. It was queried that are there any similar ingredients in both products that may be causing the allergy. She mentioned that her doctor already told to stop it, and to take antihistaminic. She just wanted to know if there's something similar because it was basically the same reaction in both, rash in her stomach and arms, that could explain why she was getting this reaction, she was hesitant to get the second booster because this always happen, even with this medicine, she just wanted to know if there's a similar component, maybe the same family or source so that she can bring this information to her allergist. She took Paxlovid this morning, but since she was allergic she cannot take it anymore, she wanted to know if there are reactions between Paxlovid and Advil Cold and Sinus. It was queired that does Paxlovid has any reaction with Advil Cold and Sinus. The caller wants to find out why caller is having this allergy, wants to know if maybe there is something in both Paxlovid and the Pfizer Covid Vaccine. Therapeutic measures were 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 70-year-old male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving his Pfizer Covid 19 Vaccine/has already had his first, and second shots and first booster of the Covid vaccine, before he tested positive for the Covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The caller has just completed his last dose of Paxlovid today. Caller was asking once he has tested negative for Covid if there's a recommended time frame that he should receive his second Pfizer Covid 19 Booster. Caller states he has already had his first, and second shots and first booster of the Covid vaccine, before he tested positive for the Covid virus. Caller states he took his last dose of Paxlovid this morning. Caller states in the last 6 days he had tested positive for the Covid virus. Caller states that after he had symptoms, he was prescribed Paxlovid. Caller states that he has taken Paxlovid for 5 days. Caller states Paxlovid did a great job. Caller states that he was previously scheduled for his second Covid booster shot next Thursday. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 27Apr2021 as dose 2, single (Lot number: EW0170) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Nov2021 at 11:45 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; CIPRO [CIPROFLOXACIN HYDROCHLORIDE], start date: Jan2006. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Physician).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "HTN" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]; MONTELUKAST; SIMVASTATIN; LOSARTAN; LEVOTHYROXINE; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: wtih continued positive testing. Therapeutic measures were 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: As there is limited information in the case provided, the causal association between the event Drug Ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain in extremity
Clinical narrative: Sore arm; hurts to touch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; HYPERAESTHESIA (non-serious), outcome "unknown", described as "hurts to touch it".  Additional information:  2 booster dose of Covid vaccine. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Headache, Vaccination site pain
Clinical narrative: At 12:00 pm on 03Jun2022 the joint pain was more intense; mild headache; about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder; about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder; sore arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 13:45 as dose 4 (booster), single (Lot number: 33036BD) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "MDS" (unspecified if ongoing); "bone marrow transplant" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "graves disease" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EL3248), administration date: 03Mar2021, when the patient was 55-year-old, for COVID-19 immunization.BNT162b2 (DOSE 2, SINGLE; Lot nub: EP7534), administration date: 15Apr2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, SINGLE; Lot nub: EW0176), administration date: 22Oct2021, when the patient was 55-year-old, for COVID-19 immunization The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Jun2022 at 16:00, outcome "recovering", described as "sore arm at the injection site"; FATIGUE (non-serious), ARTHRALGIA (non-serious) all with onset 02Jun2022 at 23:00, outcome "recovering" and all described as "about 11:00 pm on 02Jun2022 I noticed fatigue and joint pain in the back, hips and shoulder"; CONDITION AGGRAVATED (non-serious) with onset 03Jun2022 at 12:00, outcome "recovering", described as "At 12:00 pm on 03Jun2022 the joint pain was more intense"; HEADACHE (non-serious) with onset 03Jun2022 at 12:00, outcome "recovering", described as "mild headache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, arthralgia, condition aggravated, headache.  Additional information: Patient noticed events joint pain was more intense and a mild headache.  Follow-up (06Jun2022): This is spontaneous follow-up report received in response to the mail trail sent regarding the confirmation query and the response included:
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: sick diarrhea; Short of breath; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "Short of breath"; DIZZINESS (non-serious) with onset 2022, outcome "unknown"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "sick diarrhea".  Additional information: It was reported that the patient had the covid shot in end of last month May and received a booster.   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: Therapeutic response unexpected
Clinical narrative: intractable pain was gone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), 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: "Intractable pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "intractable pain was gone".  Additional information: The reporter stated that after patient received the COVID vaccine, then the booster, intractable pain was gone for the first time in years.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got my booster; same time, I got my shingles vaccine; I broke out with shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1: Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2: Manufacturer unknown), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "I got my booster; same time, I got my shingles vaccine; I broke out with shingles". The event "i got my booster; same time, i got my shingles vaccine; i broke out with shingles" required physician office visit.  Additional Information: patient got her shingles vaccine the first one and then this week, she broke out with shingles so, she just don't know if there was a combination of two that caused to possibly caused me to get shingles at the Sunday. Expiration: Right. It says the date given was 19May2022. All her other one had sticker, but this one she went to right aid and they wrote it in so, she do not had any additional information than that. the date of event she broke our was Monday, so that was May 30th. I went to my Doctor on 1st and they identify that I had shingles. Patient did not take any medications at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), 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: "GERD" (unspecified if ongoing); "Mild Asthma" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2022, stop date: 05Jun2022; IBUPROFEN, start date: 26May2022, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (May2022) Positive; (26May2022) Negative; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Tested negative and felt better after day 5 of treatment with Paxlovid (26May2022). Negative Covid test on 26May22. Cough and chills returned on 04Jun22 and tested positive on 05Jun22. Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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 included: "Known allergies: multiple" (unspecified if ongoing), notes: Known allergies: multiple. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 04Jun2022, outcome "unknown" and all described as "Pfizer / BioNTech Dose Number: 4/ Treatment of COVID-19 04Jun2022". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Patient received treatment with Paxlovid for COVID-19. Treatment start date=04Jun2022,Treatment stop date=04Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: First Dose: felt tired a lot; First Dose: didn't feel right and didn't feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER6207) at the age of 48 years for covid-19 immunisation. The patient's family history included: "Crohn's Disease with Hereditary Alpha Tryptasemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "recovering", described as "First Dose: didn't feel right and didn't feel well"; FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "First Dose: felt tired a lot".  Additional information: The report related was to a study or programme. HCP Type was reported as Gastric disease doctor. Reporter stated after his First Dose of the Pfizer Covid 19 Vaccine he felt tired a lot and he cried to his mom and partner at the time that he didn't feel right and he didn't feel good. The patient had no additional Vaccines administered on Same Date of the Pfizer Suspect. Reporter stated right after getting the vaccine on Thurs or Friday, that weekend he felt really bad then he was fine, not as bad, and then he knew something was wrong because he was really tired. Reporter stated it was mid-day when he got them both and the side effects started at night and were there when he woke up the next morning, tired. Reporter stated his appetite changed almost immediately. The patient had no prior Vaccinations within 4 weeks.The patient had no AE(s) following prior vaccinations. Reporter stated his sister had some of the symptoms and she was starting to see a doctor for it. No relevant tests were performed. Reporter was unsure of exact dates.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200804232 Same pt/drug, diff event sep in time;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all tested positive for Covid last week. No hospitalizations resulted.; all tested positive for Covid last week. No hospitalizations resulted.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received 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 01Jun2022, outcome "unknown" and all described as "all tested positive for Covid last week. No hospitalizations resulted.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: My wife tested positive on 01Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: As reported His Wife and all three of the children who were all fully vaccinated with Pfizer Covid vaccine all tested positive for Covid last week. No hospitalizations resulted. His wife was 46 years old and has had other medical issues. She was prescribed Paxlovid and reports a foul taste in her mouth after starting the initial does on 02Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Experienced COVID; Experienced COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4419843-00 (Company).  A 14-year-old female patient received BNT162b2 (BNT162B2), on 22Aug2021 as dose 1, single (Batch/Lot number: unknown), on 02Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 14 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for uveitis, polyarthritis, juvenile idiopathic arthritis. 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) all with onset May2022, outcome "recovered" (2022) and all described as "Experienced COVID". The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer with an event of non-serious COVID with Humira (Adalimumab). In May2022, the patient experience COVID. In 2022 the COVID resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was Unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Did Event Abate After Stopping Drug?: NA. The reporter's causality for the event(s) of COVID for Humira was not provided.  The reporter considered "experienced covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and suspected covid 19 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 77.0
Sex: F
Vaccine: COVID19, 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) (Physician) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 77 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "LBBB" (unspecified if ongoing); "allergic+cold induced bronchospasm" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: Oct2019. Past drug history included: Contrast iodine, reaction(s): "Known allergies: Contrast iodine", notes: Contrast iodine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: No immune response to vaccine; No immune response to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. Other Case identifier(s): (RA). A 58-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose number unknown, single (Batch/Lot number: Unknown) at the age of 57 years for covid-19 immunisation. The patient relevant medical history included: "High Blood Pressure" (unspecified if ongoing), "Muscle Spasticity" (unspecified if ongoing), "Psoriasis" (unspecified if ongoing), "Broken Left Hand" (unspecified if ongoing), "Broken Left Ankle" (unspecified if ongoing), "Broken Right Arm" (unspecified if ongoing), "Stitches in Left Ear" (unspecified if ongoing, "Cane use" (unspecified if ongoing), "Multiple Sclerosis" (unspecified if ongoing), notes: Patient's concurrent condition. Concomitant medication(s) included: OCREVUS, LISINOPRIL, HYDROCHLOROTHIAZIDE, BACLOFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "No immune response to vaccine".  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun; Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose number unknown (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID in (withheld) on 01Jun at dinner. Became symptomatic 03Jun, had PCR test done 04Jun and results showed positive on 05Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had PCR test done 04Jun and results showed positive on 05Jun.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure and Covid 19 cannot be completely excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Extreme muscle pain in left hip and thigh region; has worsened over the first three days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 at 18:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Vaccination history included: Bnt162b2 (DOSE 3, SINGLE, Lot number: 32030BD, Anatomical location: Right arm), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: ER8734, Anatomical location: Left Arm), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8727, Anatomical location: Right Arm), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Jun2022 at 07:00, outcome "not recovered", described as "Extreme muscle pain in left hip and thigh region"; PAIN (non-serious) with onset 04Jun2022 at 07:00, outcome "not recovered", described as "has worsened over the first three days". Therapeutic measures were not taken as a result of myalgia, pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within 4 weeks of vaccination. Post vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Skin lesion
Clinical narrative: psoriatic arthritis to get much worse; I used to have a couple of lesions, now my body is covered with 25 percent lesions.; 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), 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: "psoriatic arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis to get much worse"; SKIN LESION (non-serious), outcome "not recovered", described as "I used to have a couple of lesions, now my body is covered with 25 percent lesions.".  Clinical Course: It was reported by the patient that the patient received the first two doses for COVID and it caused psoriatic arthritis to get much worse, patient used to have a couple of lesions, now patients body was covered with 25 percent lesions.  The information on the batch/lot number for BNT162b2 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 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Sx of Covid 19 started 24May and tested positive; (02Jun2022) Negative, notes: Negative on 02Jun; (06Jun2022) Positive, notes: Positive PCR 06Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. It was reported that patient received anti-viral product "Paxlovid" for Covid-19 treatment as treatment start date on 25May2022 and treatment stop date was on 29May2022 via oral route. It was also reported that Sx of covid 19 started 24May2022 and tested positive. Started paxlovid 25May2022-29May2022. Improved sx from 29May2022 onwards. Negative on 02Jun2022. Recurrence of sx 05Jun2022. Positive PCR 06Jun2022. Covid rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Age group was adult (18-64 Years). No other medication were received in 2 weeks. The anti viral product were COVID 19 treatment and brand-Paxlovid on 26May2022 to 30May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: fj9843) at the age of 62 years 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 included: "Stage 4 cirrhosis" (unspecified if ongoing). Concomitant medication(s) included: VEMLIDY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (07Jun2022) Positive, notes: 7 days after completing Paxloid. I again tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: took Paxlovid for 5 days and seemed OK until today which was 7 days after completing Paxlovid, again tested positive for Covid. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), on 21Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Nov2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Atrial septal defect" (unspecified if ongoing); "Low back pain" (unspecified if ongoing); "Cerebral infraction" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE oral; ACYCLOVIR [ACICLOVIR] oral; ASPIRIN [ACETYLSALICYLIC ACID] oral; IVERMECTIN topical; MUPIROCIN topical; DENAVIR topical; UBRELVY oral; VITAMIN B2 [RIBOFLAVIN] oral; MAGNESIUM OXIDE oral; VITAMIN B12 [CYANOCOBALAMIN] oral. Past drug history included: Hydrocodone, reaction(s): "known allergies: Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, 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: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Lot number: Pfizer FK 5217), in left arm, on 26Nov2021 as dose 2, single (Lot number: Pfizer FL0007), in left arm and on 23May2022 at 16:15 as dose 3 (booster), single (Lot number: Pfizer FL 8095) at the age of 8 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022 at 22:45, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility type vaccine: Doctor's office/urgent care. Patient did not received other vaccine in four weeks, other medication in two weeks and If COVID Prior vaccination were reported as no. Patient did not have any other medical history. No known allergies were reported. AE resulted in none of the above.  Product investigation conclusion: The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot FL0007. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.