chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient had COVID-19 positive test or diagnosis on 08Jun2022; The patient had COVID-19 positive test or diagnosis on 08Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDLA22-00100 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Sep2021 as dose 2, single (Lot number: 024D21A) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (gam-coviD-vac) (SPUTNIK V), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have any allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "The patient had COVID-19 positive test or diagnosis on 08Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 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) all with onset 2021, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive. Clinical course: She was already fully vaccinated with second booster however she was tested positive last year. Mentioned she already consulted a healthcare provider and was advised to get another booster shot. Second booster for 05Oct. She was fully vaccinated and boosted but she also had COVID on 05Jan.  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 the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing with white crystals; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: COUGH (non-serious), outcome "unknown", described as "coughing with white crystals".  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-PV202200028309 Same reporter/ drug, different patients/ events;US-PFIZER INC-202200998496 Same reporter/ drug, different patients/ events;
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Headache
Clinical narrative: memory loss; terrible headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed., Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "memory loss"; HEADACHE (non-serious), outcome "unknown", described as "terrible headaches".  Additional Information: Caller said he is experiencing terrible headaches and memory loss for two hours after the first booster shot and after the second booster he just became terribly sick. Caller also mentioned that his wife was coughing with white crystals.  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: Electrocardiogram ambulatory, Magnetic resonance imaging, Sinus arrhythmia, Syncope
Clinical narrative: Syncope/ episodes of syncope; although his heart has a normal rhythm, it slows down and then pauses; This is a spontaneous report received from a contactable reporter (physician) from the Medical Information Team.  A 45-year-old male patient received BNT162b2 (BNT162B2), in 2021 as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown" described as "Syncope/ episodes of syncope"; SINUS ARRHYTHMIA (non-serious), outcome "unknown" described as "although his heart has a normal rhythm, it slows down and then pauses." The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: heart has normal rhythm, notes: holter monitor showed that although his heart has a normal rhythm it slows down and then pauses; Magnetic resonance imaging: unknown results.  Additional information: The reporter (physician in (Withheld) dermatology) reported that her husband, an otherwise healthy male was vaccinated with the Pfizer vaccine in 2021 and received a booster from Moderna in Nov2021. 2 months later he has started having episodes of syncope. A holter monitor showed that although his heart has a normal rhythm, it slows down and then pauses. "MRI nl." There are cases of this phenomenon as a result of the vaccine. The reporter asked for more evidence of this and outcomes.   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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Colitis microscopic, Endoscopy, Investigation, White blood cell count
Clinical narrative: microscopic lymphocytic colitis; This is a literature report for the following literature source(s).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gastro esophageal reflux disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: COLITIS MICROSCOPIC (medically significant), outcome "recovered", described as "microscopic lymphocytic colitis". The patient underwent the following laboratory tests and procedures: C-reactive protein: Normal; Endoscopy: patchy erythema in the descending colon, notes: and rectosigmoid; Mucosal evaluation: lymphocytic colitis; White blood cell count: Normal. Therapeutic measures were taken as a result of colitis microscopic.; Sender's Comments: Based on the information in the case, an association between the reported event Microscopic Colitis and the suspect product bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis, Vaccination site pain
Clinical narrative: Kidney stones; Vaccine caused sore arm; 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-163-4475283-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEPHROLITHIASIS (medically significant), outcome "recovering", described as "Kidney stones"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccine caused sore arm". The action taken for adalimumab was unknown.  Clinical Information: It was reported that, solicited report from the USA by a consumer of an adult male with events of gxcv non-serious kidney stones and vaccine caused sore arm with Humira (Adalimumab). On unknown dates, the patient experienced kidney stones and vaccine caused sore arm. On an unknown date, vaccine caused sore arm resolved. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "kidney stones" and "vaccine caused sore arm" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of kidney stones" and "vaccine caused sore arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Paranasal sinus discomfort, Pneumonia, Rheumatoid arthritis, Tooth abscess
Clinical narrative: Rheumatoid arthritis flare up; Lung infection; Cyst; Sinus pressure; Tooth abscess; 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-163-4475112-00 (Agency).  A 67-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in May2021 as dose 2, single (Batch/Lot number: unknown) and on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; PNEUMONIA (medically significant), outcome "unknown", described as "Lung infection"; CYST (non-serious), outcome "unknown"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "recovering", described as "Sinus pressure"; TOOTH ABSCESS (non-serious), outcome "unknown". The action taken for adalimumab was dosage not changed.  The reporter considered "rheumatoid arthritis flare up", "lung infection", "cyst", "sinus pressure" and "tooth abscess" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association and lack of effect the causal association  of suspect  cannot be excluded for reported  events .The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Joint stiffness, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; stiff joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51-year-old patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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; Covid-19 vaccine (1st Booster dose, Batch/Lot: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "stiff joints".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal
Clinical narrative: dramatic hair growth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A male 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: HAIR GROWTH ABNORMAL (non-serious), outcome "unknown", described as "dramatic hair growth".   Additional information: Patient understand that renewed hair growth for men is a potential side effect of the Covid-19 vaccine. Patient response has been dramatic hair growth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site swelling
Clinical narrative: fever; badly swollen armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-019344.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: cashews" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "Brain injury" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "fever"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "badly swollen armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, vaccination site swelling that included Tylenol.  Additional information: The patient stated her first three shots were Pfizer, then she got a Moderna second booster. She did that because she reacted pretty strongly to the Pfizer shots with a fever of 102. She had a badly swollen armpit with the Pfizer booster. After the Moderna booster, the patient did not react as harshly. Her fever only went up to 100.5 F. Her other armpit got swollen, but within a week, it was pretty much gone. At that time she was experiencing (she had not with Pfizer) was an ongoing elevated temperature. She was wondering if that was normal. Her normal temperature was between 97.5-98.5, but then it was between 98.5-99.6 F. she had been dealing with that for 10 days. The patient stated that on the third day, her temperature dropped down to 99, what she was experiencing at that time. she took Tylenol for it, but it did not seem to help, so she stopped taking Tylenol.  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: Laboratory test, Multiple allergies, Pruritus
Clinical narrative: horrible itching from the inside out. My own sweat makes me itch; I have never had skin allergies in my life and I took a test and I reacted to everything even the saline; 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 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: MULTIPLE ALLERGIES (non-serious) with onset Nov2021, outcome "not recovered", described as "I have never had skin allergies in my life and I took a test and I reacted to everything even the saline"; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "horrible itching from the inside out. My own sweat makes me itch". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: headache; shoulder pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 23Jul2022 as dose 1, single (Lot number: FP4554) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jul2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset Jul2022, outcome "unknown", described as "shoulder pain". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Haemorrhage
Clinical narrative: described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series; described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-613316 (MODERNA). A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Primary immunization complete), for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), GASTROINTESTINAL DISORDER (non-serious), outcome "not recovered" and all described as "described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series". Reporting an AE related to an individual who described GI events and bleeding after receiving the Pfizer COVID 19 vaccine primary series. She expressed that this also continued after switching to Moderna for her booster dose and did not resolve. This individual has provided her name and is willing to further describe this incident if necessary.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Face injury, Limb injury
Clinical narrative: My face and hands are blown up right now; My face and hands are blown up right now; 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 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: LIMB INJURY (medically significant), FACE INJURY (medically significant), outcome "unknown" and all described as "My face and hands are blown up right now". Patient had a severe and extended reaction to the Pfizer COVID vaccine. This has been confirmed by Dermatologist, Rheumatologist, and primary care doctor.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test positive, Allergy to animal, Eczema, Impaired work ability
Clinical narrative: My face and hands are blown up right now; My face and hands are blown up right now; 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 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: LIMB INJURY (medically significant), FACE INJURY (medically significant), outcome "unknown" and all described as "My face and hands are blown up right now". Patient had a severe and extended reaction to the Pfizer COVID vaccine. This has been confirmed by Dermatologist, Rheumatologist, and primary care doctor.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: Experienced an allergic reaction to PREVNAR-13; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02206758 (Merck).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Experienced an allergic reaction to PREVNAR-13". Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal oedema, Nasopharyngitis, Renal surgery
Clinical narrative: intestine was swollen; cold; kidney surgery; 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-163-4477013-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590) at weekly (citrate free, weekly (1 in 1 wk)), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL SURGERY (medically significant) with onset 27Jun2022, outcome "recovered" (2022), described as "kidney surgery"; GASTROINTESTINAL OEDEMA (medically significant), outcome "unknown", described as "intestine was swollen"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The action taken for adalimumab was unknown.  The reporter considered "kidney surgery", "intestine was swollen" and "cold" related to BNT162b2.  The reporter's assessment of the causal relationship of the events with suspect product (Bnt162b2) for renal surgery, Intestinal edema and cold was possible.  The reporter's assessment of the causal relationship of the events with the suspect product Humira (adalimumab) for renal surgery, Intestinal edema was no reasonable possibility and for cold was not assessable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information in the case , the reported events intestinal edema and kidney surgery is most likely due ot intercurrent medical condition and not related to the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Uterine cancer
Clinical narrative: Got diagnosed with Carcinosarcoma of uterus stage 4; 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), on 21Mar2021 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: UTERINE CANCER (medically significant) with onset Nov2021, outcome "unknown", described as "Got diagnosed with Carcinosarcoma of uterus stage 4". Event Awareness Date: 25Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, HPV9
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 02201176 (Agency).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot".  Clinical course: A Nurse Practitioner was asking for any information we have on a patient receiving the GARDASIL 9 vaccine after experiencing a blood clot after the COVID vaccine manufactured by Pfizer. The patient seems to be worried that the GARDASIL 9 vaccine may cause her to have a blood clot as well.  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 THROMBOSIS and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Device issue, Immunisation reaction, Incorrect dose administered
Clinical narrative: Vaccination adverse reaction; Inappropriate dose of drug administered; Device issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4474900-00 (Agency).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose number unknown, single (Lot number: EL0142) at the age of 84 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Sep2019 (ongoing) (Lot number: 1161756) at 40 mg (40 mg (in 2 wk)), subcutaneous for psoriasis. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Tobacco use/a pack and a half of cigarettes per week", stop date: 1980, notes: Tobacco use/a pack and a half of cigarettes per week (stopped 1980); "Heart murmur" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Unspecified substance allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (hospitalization) with onset 12Jan2021, outcome "not recovered", described as "Vaccination adverse reaction"; DEVICE ISSUE (non-serious) with onset 19Jul2022, outcome "not recovered"; INCORRECT DOSE ADMINISTERED (medically significant) with onset 19Jul2022, outcome "not recovered", described as "Inappropriate dose of drug administered". The patient was hospitalized for immunisation reaction (hospitalization duration: 1 day(s)). The action taken for adalimumab was dosage not changed.  Additional information: The patient wife stated that the patient experienced unspecified adverse reactions from PFIZER COVID 19 VACCINE where in he was hospitalized for one day. His wife refused to provide his concomitant medications and other information. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. Took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective   Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporters causality for the event(s) of adverse reactions to PFIZER COVID 19 VACCINE with HUMIRA 40mg/0.4ml(ADALIMUMAB) was no reasonable possibility. The reporters causality for the event(s) of took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective onset 19Jul2022 and took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective onset 19Jul2022 was not provided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; 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-163-4476265-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. 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) all with onset Jul2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "covid-19 virus test positive" related to BNT162b2. The reporter's assessment of the causal relationship of "covid-19 virus test positive" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of covid-19 virus test positive with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of covid-19 virus test positive with JANSSEN COVID-19 VACCINE was possible.  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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was just diagnosed for the 3rd time with Covid; I was just diagnosed for the 3rd time with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing) notes: Hard time breathing; "M.S." (unspecified if ongoing); "Lymes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Chemo for Breast Cancer" (unspecified if ongoing), notes: Ended a five-year Chemo for Breast Cancer.; "Chemo for Breast Cancer" (unspecified if ongoing), notes: Ended a five-year Chemo for Breast Cancer. 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 "I was just diagnosed for the 3rd time with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was just diagnosed for the 3rd time with Covid.  Clinical information: Patient was in need of help from Covid. Hard time breathing. Had Asthma, M.S., Lymes, Fibromyalgia, Osteoarthritis. And just ended a five year Chemo for Breast Cancer. She was just diagnosed for the 3rd time with Covid. She have had both Vaccines and 1 booster.  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, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.; In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4476265-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis, uveitis; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular 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 Jul2022, outcome "recovered" (Jul2022) and all described as "In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. The action taken for adalimumab was unknown.  The reporter considered "in jul2022 patient experienced covid positive. in jul2022, the covid positive resolved." related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of COVID Positive with Humira (Adalimumab) was no reasonable possibility and Janssen covid-19 vaccine was related.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe pain in the arm that was vaccinated; 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), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "severe pain in the arm that was vaccinated".  Additional information: Patient had covid vaccines for over a year and am still struggling with severe pain in the arm that was vaccinated. The pain was chronic and runs up and down the left arm up to the neck and shoulder. Primary doctors won't do much.  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: Vaccination site pain
Clinical narrative: mild ache in the muscle of my arm which lasted a few days before the ache disappeared; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (Dose: 1, batch No: 000074A), administration date: Feb2021, for Covid-19 immunization, reaction(s): "mild ache in the muscle of my arm which lasted a few days before the ache disappeared"; Vaxzevria (Dose: 2), administration date: Apr2021, for Covid-19 immunization, reaction(s): "mild ache in the muscle of my arm which lasted a few days before the ache disappeared". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild ache in the muscle of my arm which lasted a few days before the ache disappeared".   Additional information: On 01Mar2022 patient had the Moderna vaccine [batch no 000074a]. The Moderna jab was my 4th vaccine [booster]. The previous being two Astrazeneca in Feb2021 & Apr2021 and a pfizer at the end of Sep2021. Each vaccine produce a mild ache in the muscle of my arm which lasted a few days before the ache disappeared. since the moderna jab of 1st march the ache has not gone away. the ache is noticeable all the time [ on a pain scale of 1 - 10 around a 3] i now find that mobility in my arm can cause more pain in certain positions i.e. if i have been sleeping on it or trying to lift arm above shoulder level or showering. [pain level of 1 - 10 around an 8] the reason i an writing is to enquire if you know of other people who have had / do have similar ? I am a (withheld) Aged Yours ()  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash pruritic
Clinical narrative: itchy rash between thighs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (1 in 2 wk), subcutaneous. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS], start date: May2020, stop date: 14Jul2022; MULTIVITAMINS + IRON unknown, start date: May2020, stop date: 14Jul2022; OMEPRAZOLE, start date: Jan2020, stop date: 14Jul2022; NATURE'S BOUNTY ADULT MULTIVITAMIN, start date: May2022, stop date: 14May2022; ACETAMINOPHEN, start date: 13Jul2022, stop date: 13Jul2022; EVUSHELD. Past drug history included: Ampicillin, reaction(s): "Allergy: Ampicillin"; Vicodin, reaction(s): "Allergy: vicodin". Vaccination history included: moderna covid-19 vaccine ((Elasomeran), Dose: 1, Route of Admin: Intramuscular), administration date: 30Mar2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Route of Admin: Intramuscular), administration date: 15Aug2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (Dose: 3 BOOSTER, Route of Admin: Intramuscular), administration date: 02Mar2022, when the patient was 62-year-old, for Covid-19 immunization; moderna coviD-19 vaccine ((Elasomeran), Dose: 4 BOOSTER, Route of Admin: Intramuscular), administration date: 27Apr2022, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose: 5 BOOSTER, Route of Admin: Intramuscular), administration date: 03Jul2022, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 16Jul2022, outcome "not recovered", described as "itchy rash between thighs". The action taken for adalimumab was unknown.  Causality: Humira(Adalimumab) 1) Itchy rash  Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A   Causality: Pfizer Biontech Covid-19 Vaccine 1) Itchy rash  Action(s) taken with drug: Not Applicable Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: ~~~
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Drug ineffective, Fatigue
Clinical narrative: Patient contracted Covid, despite being double vaxxed; patient contracted Covid, despite being double vaxxed; Fatigue; Fever; Loss of taste and smell; Nausea; Loss of taste and smell; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (COMIRNATY), 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 was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Patient contracted Covid, despite being double vaxxed"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "patient contracted Covid, despite being double vaxxed"; FATIGUE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of fatigue, pyrexia, ageusia, nausea, anosmia, dizziness.  Clinical information: Patient was a 48-year-old female, around 130lbs, and 5'3 in very healthy condition due to regular exercise and healthy diet. The patient is double vaccinated with Pfizer Covid 19 vaccine. The patient contracted Covid, despite being double vaxed, and is experiencing intense symptoms - significant fatigue, fever, loss of taste and smell, nausea, and dizziness. Patient was healthy 48-year-old female with no underlying conditions and was typically resistant to taking any medication, including OTC analgesics. Currently taking ibruprophen to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Suspected COVID-19
Clinical narrative: Patient contracted Covid, despite being double vaxxed; patient contracted Covid, despite being double vaxxed; Fatigue; Fever; Loss of taste and smell; Nausea; Loss of taste and smell; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (COMIRNATY), 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 was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Patient contracted Covid, despite being double vaxxed"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "patient contracted Covid, despite being double vaxxed"; FATIGUE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of fatigue, pyrexia, ageusia, nausea, anosmia, dizziness.  Clinical information: Patient was a 48-year-old female, around 130lbs, and 5'3 in very healthy condition due to regular exercise and healthy diet. The patient is double vaccinated with Pfizer Covid 19 vaccine. The patient contracted Covid, despite being double vaxed, and is experiencing intense symptoms - significant fatigue, fever, loss of taste and smell, nausea, and dizziness. Patient was healthy 48-year-old female with no underlying conditions and was typically resistant to taking any medication, including OTC analgesics. Currently taking ibruprophen to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.