chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Aches mostly in her upper legs but also a little in her arms; Extreme feeling reaction like her muscles or bones were petrifying; Night sweats; Achiness; Headache; Slight fever, fever of 102 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms), IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying), NIGHT SWEATS (Night sweats), PAIN (Achiness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (before 1st booster in the fall). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Drug allergy (codeine and derivates), Hypercholesterolaemia (Started 35 or 40 years ago, no change in status such as improvement or worsening), Esophageal reflux (Started 25 or 30 years ago, no change in status such as improvement or worsening) and Asthma (Started 25 or 30 years ago, no change in status such as improvement or worsening). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Esophageal reflux, SIMVASTATIN for High cholesterol, FLUOXETINE HYDROCHLORIDE (PROZAC), PRIMIDONE, CALCIUM and VITAMINS NOS for an unknown indication.    On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms), IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying), NIGHT SWEATS (Night sweats), PAIN (Achiness), HEADACHE (Headache) and PYREXIA (Slight fever, fever of 102 degree F). On 10-Apr-2022, NIGHT SWEATS (Night sweats), PAIN (Achiness), HEADACHE (Headache) and PYREXIA (Slight fever, fever of 102 degree F) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches mostly in her upper legs but also a little in her arms) and IMMUNISATION REACTION (Extreme feeling reaction like her muscles or bones were petrifying) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2022, Body temperature: 102 102°F.   No treatment was given   This case was linked to MOD-2022-607733 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hip fracture
Clinical narrative: in the hospital because he fell and broke his hip; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HIP FRACTURE (in the hospital because he fell and broke his hip) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Fall.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (in the hospital because he fell and broke his hip) (seriousness criteria hospitalization and medically significant). At the time of the report, HIP FRACTURE (in the hospital because he fell and broke his hip) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. Reporter mentioned that patient did not have his vaccine card which he needed to go to a facility for rehab on his hip. No treatment drug was reported.  Company comment: This spontaneous case concerns a male patient (age and gender unspecified), with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Hip fracture, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had a fall and sustained the injury. The outcome was reported as unknown. Details of medical history/circumstances that led to fall, concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient (age and gender unspecified), with no medical history reported, who experienced the unexpected serious (hospitalization, medically significant) event of Hip fracture, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had a fall and sustained the injury. The outcome was reported as unknown. Details of medical history/circumstances that led to fall, concurrent conditions, concomitant medications, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am; HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 8:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 8:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that number of doses/vials were 3 doses. On 30-JUN-2022 10:00am vial was first punctured. Vial stored post puncture in room temperature in the machine. Vial did not undergone any temperature excursions. For roughly 24 hours vial was exposed to room temperature range. Treatment medication was not provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2022 at 2:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022 at 2:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna Covid-19 vaccine to a patient from a vial of Moderna Covid-19 vaccine that had been punctured more than 12 hours ago.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vial was initially stored in the refrigerator 07-Jul-2022. It was reported that time vial was first punctured 12-Jul-2022 at 12:33 PM and time of administration of vaccine 13JUL2022 at 2:54PM (booster dose). The vial was stored post puncture at room temperature. The vial did not undergone any temperature excursions. It was reported that the pharmacist did not have any information on the patient's primary series and the patient's first booster shot other than that all of the shots are Moderna Covid-19 vaccine shots. No treatment were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Magnetic resonance imaging, Mobility decreased, Pain in extremity
Clinical narrative: Pain in her legs; Can't walk; Limited mobility; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her legs), GAIT DISTURBANCE (Can't walk) and MOBILITY DECREASED (Limited mobility) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her legs), GAIT DISTURBANCE (Can't walk) and MOBILITY DECREASED (Limited mobility). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in her legs) and MOBILITY DECREASED (Limited mobility) had not resolved and GAIT DISTURBANCE (Can't walk) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2022, SARS-CoV-2 test positive: Positive. On an unknown date, Blood test: Got blood tested but every test comes out fine.. On an unknown date, Magnetic resonance imaging: Patient had 8 MRIs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient consulted visited 2 Neurologist,one Orthopedic specialist. Patient is an Athletic trainer and her mobility is so limited that it's hard to do her job. Concomitant medications was not provided by the reporter. Patient received a Moderna covid-19 vaccine and a month after she stated to feel pain in her legs and started to use crutches so that she can walk. Patient had no allergies. Treatment Crutches, Gluten Dairy and Sugar free diet, Homeopathic medicines, PT, Acupuncture were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pain in her legs; Can't walk; Limited mobility; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her legs), GAIT DISTURBANCE (Can't walk) and MOBILITY DECREASED (Limited mobility) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her legs), GAIT DISTURBANCE (Can't walk) and MOBILITY DECREASED (Limited mobility). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in her legs) and MOBILITY DECREASED (Limited mobility) had not resolved and GAIT DISTURBANCE (Can't walk) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2022, SARS-CoV-2 test positive: Positive. On an unknown date, Blood test: Got blood tested but every test comes out fine.. On an unknown date, Magnetic resonance imaging: Patient had 8 MRIs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient consulted visited 2 Neurologist,one Orthopedic specialist. Patient is an Athletic trainer and her mobility is so limited that it's hard to do her job. Concomitant medications was not provided by the reporter. Patient received a Moderna covid-19 vaccine and a month after she stated to feel pain in her legs and started to use crutches so that she can walk. Patient had no allergies. Treatment Crutches, Gluten Dairy and Sugar free diet, Homeopathic medicines, PT, Acupuncture were provided.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M2017) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: SIMVASTATIN. Past adverse reactions to the above products included No adverse event with SIMVASTATIN.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction). At the time of the report, VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) outcome was unknown.            No concomitant medication was reported. Patient did not take any medication for any adverse reactions.   This case was linked to MOD-2022-607759 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation reaction, SARS-CoV-2 test
Clinical narrative: got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; got a reaction after the vaccines, bad red mark, big one on arm, slight reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M2017) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: SIMVASTATIN. Past adverse reactions to the above products included No adverse event with SIMVASTATIN.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction). At the time of the report, VACCINATION SITE REACTION (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) and VACCINATION SITE ERYTHEMA (got a reaction after the vaccines, bad red mark, big one on arm, slight reaction) outcome was unknown.            No concomitant medication was reported. Patient did not take any medication for any adverse reactions.   This case was linked to MOD-2022-607759 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Erythema, Pruritus, Rash
Clinical narrative: could see under the skin on her ankle and it was all red; She is going crazy with the rash on her legs and scratching it; rash that blossomed / horrific rash / horrific rash, like eczema or psoriasis; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (could see under the skin on her ankle and it was all red), PRURITUS (She is going crazy with the rash on her legs and scratching it) and RASH (rash that blossomed / horrific rash / horrific rash, like eczema or psoriasis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (could see under the skin on her ankle and it was all red), PRURITUS (She is going crazy with the rash on her legs and scratching it) and RASH (rash that blossomed / horrific rash / horrific rash, like eczema or psoriasis). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) in December 2021 at an unspecified dose and frequency. At the time of the report, ERYTHEMA (could see under the skin on her ankle and it was all red), PRURITUS (She is going crazy with the rash on her legs and scratching it) and RASH (rash that blossomed / horrific rash / horrific rash, like eczema or psoriasis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: (Negative) Negative.         No concomitant medications were reported. she had tried some holistic stuff after getting the booster shot because she developed a horrific rash, like eczema or psoriasis. she only has one kidney. HCP reported that going to back in Jan to have the laser done.  She went to a dermatologist and had all kinds of tests performed.  she went to an allergist as well and everything was negative.  Patient did holistic thing with coconut oil and aloe, but the rash still flares up. She did not take any medications at all.  She saw something about Cibinqo and its not a steroid it was a pill for shingles or something.Cibinqo product has not been prescribed to patient.  she had a light treatment. She also tried, Triamcinolone Acetonide Cream 0.1%: It was a steroid, it worked to a degree but when the rash blossoms it makes her skin thin, and she can't use it all the time. NDC: 45802-064-36, She filled it ages ago in Dec 2021, she used it sparingly.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Injection site reaction 2 hours after first booster; Pain on injection site  2 hours after first booster/Pain on injection site continued to linger; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 028A21A and 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger). At the time of the report, VACCINATION SITE REACTION (Injection site reaction 2 hours after first booster) outcome was unknown and VACCINATION SITE PAIN (Pain on injection site  2 hours after first booster/Pain on injection site continued to linger) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had Injection site reaction 2 hours after first booster vaccination, also patient had lingering pain on Injection site 8 months after first booster. Patient had not discussed the issue with doctor. Patient called the pharmacist and asked what should be done. Unspecified treatment received on 14 Nov 2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after vaccination; tested positive after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram abnormal, Arterial disorder, Dizziness, Facial paralysis, Hemiparesis
Clinical narrative: PATIENT SUDDENLY BECAME DIZZY AND PASSED OUT. HAD ACUTE ONSET OF RIGHT SIDED WEAKNESS WITH FACIAL DROOP. RECEIVED A CTA SHOWING FENESTRATION OF THE LEFT VERTEBRAL ARTERY. PATIENT WAS GIVEN TPA.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PATIENT SUDDENLY BECAME DIZZY AND PASSED OUT. HAD ACUTE ONSET OF RIGHT SIDED WEAKNESS WITH FACIAL DROOP. RECEIVED A CTA SHOWING FENESTRATION OF THE LEFT VERTEBRAL ARTERY. PATIENT WAS GIVEN TPA.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 at 15:00 as dose 1, single (Lot number: EH9889), on 10Jan2021 at 07:00 as dose 2, single (Lot number: EL3302) and on 30Sep2021 at 18:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16May2022 at 18:00 as dose 4 (booster), single (Lot number: O59M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Menopausal" (unspecified if ongoing); "Gilbert's syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13May2015, stop date: 06Jul2022; PREMPRO, start date: 07Jun2021, stop date: 06Jul2021; MOTRIN [IBUPROFEN], start date: 21Jun2022, stop date: 30Jun2022; ATORVASTATIN, start date: 12Aug2015, stop date: 21Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Weight loss; 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-163-4359071-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Route of Administration : Intramuscular), administration date: 12Feb2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose 2, single, Route of Administration : Intramuscular), administration date: 11Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: WEIGHT DECREASED (non-serious) with onset Mar2022, outcome "unknown", described as "Weight loss". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was not known if the patient enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Report type updated as spontaneous report.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 at 07:00 as dose 2 (booster), single (Lot number: 3313OBA) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 09Apr2021 at 08:00 as dose 1, single (Lot number: 042A21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies:gluten" (unspecified if ongoing); "Known allergies:dairy" (unspecified if ongoing); "Known allergies:mri dyes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Delaudid, reaction(s): "Known allergies: Delaudid"; Cardura, reaction(s): "Known allergies: Cardura". The following information was reported: DRUG INEFFECTIVE (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: Positive; positive, notes: Began getting symptoms again and tested positive 17 days after first positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid has been taken for the treatment of COVID 19 from 21Jun2022 to 25Jun2022. Adverse event start date: 05Jul2022. Adverse event start time: 06:00 AM
Sex: U
Vaccine: PNC13
Symptoms: Vaccination site bruising, Vaccination site mass
Clinical narrative: bruises at injection site/tiny bruise; persistent lumps/lump on their right thigh about 1.5cm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2022, outcome "not recovered", described as "bruises at injection site/tiny bruise"; VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "persistent lumps/lump on their right thigh about 1.5cm".  Additional information: Agent reports caller is a Licensed Practical Nurse with a question about Prevnar 13. Agent states caller wants to know if persistent lumps or bruises at injection site have been reported? States she is calling from a Pediatrician's Office and they have a 6 month old patient that received a dose of Prevnar 13 on 03Mar2022 and they still have a tiny bruise/lump on their right thigh about 1.5cm. States she wanted to ask if there are any reports of persistent bruises/lumps after this vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2020 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: "dm2" (unspecified if ongoing), notes: Other medical history: dm2, htn; "htn" (unspecified if ongoing), notes: Other medical history: dm2, htn. Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE; LISINOPRIL; LISPRO INSULIN. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: Known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Negative test After 2 days from last Dose; (05Jul2022) faint Positive, notes: It was faint Positive. 05Jul2022 is day 0; (06Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient took antiviral treatment from 24Jun2022 to 29Jun2022. Patient took Paxlovid. On 06Jul2022 patient started coughing, Recovering, No treatment. 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 in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200938396 Same patient, different product and event;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (COMIRNATY), on 09Aug2021 at 12:00 as dose 1, single (Lot number: ew0198), in left arm, as dose 2, single (Lot number: FD8448), in left arm and on 01Feb2022 at 12:00 as dose 3 (booster), single (Lot number: FK9896) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GBS", start date: 2014 (unspecified if ongoing), notes: In 2014 after receiving the flu vaccine I developed GBS. Concomitant medication(s) included: TAMSULOSIN, start date: 02Jan2018, stop date: 07Jul2022. Past drug history included: Flu vaccine, start date: 2014, stop date: 2014, for Immunization, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (2022) Negative, notes: 5 day paxlovid treatment I tested negative for about 4-5 days; (2022) Positive, notes: then tested positive; (07Jul2022) Positive, notes: I am still positive as of 7Jul2022. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 28Dec2020, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot: EL3248), administration date: 18Jan2021, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE ; Lot: FC3182), administration date: 28Aug2021, when the patient was 65-year-old, for COVID-19 Immunization; Flu vaccine (Has gotten the flu vaccine, pneumonia vaccine and no reactions that she can remember, nothing extreme); Pneumonia vaccine (Has gotten the flu vaccine, pneumonia vaccine and no reactions that she can remember, nothing extreme). The following information was reported: DIZZINESS (non-serious) with onset 30Jun2022, outcome "not recovered". Therapeutic measures were not taken as a result of dizziness.  Additional information: Dizziness started same day she received the vaccination. Was very pronounced at first and the first couple of days, it was very pronounced. Outcome is still going on and has varied in intensity. Had stayed about the same and when it happens, it lasts for a couple of seconds, then it is gone. Sometimes, it depends on how she moves her head. If she shifts her head really fast, she gets dizzy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Sleep disorder, Swelling of eyelid
Clinical narrative: His eyelids have been swollen, and are showing swelling on both upper and lower lids of both eyes.; had a fever of 101-102; was not able to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 18:00 as dose 3 (booster), single (Lot number: FL8096) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot number: FK5127), administration date: 20Nov2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Lot number: FK5127), administration date: 01Dec2021, when the patient was 9-year-old, for Covid-19 immunization, reaction(s): "First dose given on 20Nov2021, FK5127/Second dose given on 01Dec2021, FK5127". The following information was reported: SWELLING OF EYELID (non-serious) with onset 06Jul2022, outcome "recovering", described as "His eyelids have been swollen, and are showing swelling on both upper and lower lids of both eyes."; PYREXIA (non-serious) with onset 06Jul2022, outcome "recovered" (07Jul2022), described as "had a fever of 101-102"; INSOMNIA (non-serious) with onset 06Jul2022, outcome "recovered" (Jul2022), described as "was not able to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: A couple doses of Tylenol and one dose of Motrin was given for fever. The fevers are gone. Reporter informed that the patient's swelling started on night of 06Jul2022. He also had a fever of 101-102. He was trying to sleep around 9-10pm but not able to sleep. He went to the kitchen when the reporter noticed he was swollen in the face all around his eye. It started in one eye, and then the second eye started to swell. He was able to sleep. Next morning, the swelling was not completely gone, but it has improved. Patient took no other vaccinations prior (within 4 weeks) of Covid-19 vaccine. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site rash, Vaccination site warmth
Clinical narrative: rash spread all the way down to elbow and close to shoulder; redness at insertion site; Warm area on arm; uncertain if allergic reaction; Rash and redness at insertion site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 30Jun2022, outcome "unknown", described as "Rash and redness at insertion site"; VACCINATION SITE WARMTH (non-serious) with onset 30Jun2022, outcome "not recovered", described as "Warm area on arm; uncertain if allergic reaction"; RASH (non-serious) with onset 30Jun2022, outcome "unknown", described as "rash spread all the way down to elbow and close to shoulder"; VACCINATION SITE ERYTHEMA (non-serious) with onset 30Jun2022, outcome "unknown", described as "redness at insertion site".  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30May2022 at 16:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 65 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.   Additional information: Patient didn't receive any other medication in 2 weeks. Patient had no known allergies.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: Tested positive at home rapid antigen test for covid 8 days after the stop of paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication was not taken in 2 weeks by the patient. From 22Jun2022 he received COVID 19 Treatment, he used Pfizer Paxlovid, till 26Jun2022. Rebound: Tested positive at-home rapid antigen test for covid 8 days after the stop of paxlovid treatment. No known allergies. Other medical history was none.  No follow-up attempts are Possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Thrombosis
Clinical narrative: where people are getting blood clots and mentioned she have had them all; now I feel so bad; 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 female patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster), booster shot by Jun), administration date: Jun2021, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose 1), administration date: Jan2021, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "where people are getting blood clots and mentioned she have had them all"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "now I feel so bad".  Clinical course: Patient stated that she was "very concern with the four pages article about the new study and confidential Pfizer COVID vaccine where people are getting blood clots" and mentioned she have had them all and she have had her neighbors all get them and now she feel so bad." Patient confirmed that she had her Pfizer covid vaccine "last year Jan, Feb, booster shot by Jun, and another one this year." Caller mentioned that the article says infectious particles can be seared through respiratory and nasal fluids, the virus rules the whole mechanism to immunity maybe manifest it to aerosol transfer to antibodies between immune and unimmune host. She don't know what was this all about. They say it's just a scam that made millionaires out of these guys that came up with it. "Patient stated that the article was from "22Jul" which says that the vaccine was "giving people blood clot", "killing people" and was "dangerous".  Patient also added that her "husband has a heart condition working with asbestos and died 17Feb and maybe it was her fault because she got the vaccine. As per caller, the article if from a magazine by "(name Withheld) " which makes report on damaging products that kills people. After providing the response caller stated that "I don't get sick from them but it scared me.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: asthma has been "real bad"; can't go to work or walk 10 feet with an asthma attack; can't go to work or walk 10 feet with an asthma attack; 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 61-year-old male patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 2, single (Lot number: FW01F0) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Comments: Asthma history of asthma. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FC3183), administration date: 25Aug2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset Oct2021, outcome "not recovered", described as "asthma has been "real bad""; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), GAIT DISTURBANCE (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "can't go to work or walk 10 feet with an asthma attack". Therapeutic measures were taken as a result of asthma.  Additional information: The reporter stated the patient had a history of asthma and the patient was fine for about a month after receiving the vaccines but after receiving the vaccines his asthma has been "real bad", so much so that he can't go to work or walk 10 feet with an asthma attack. The patient "never had a problem of  asthma".  It was reported that the patient was using Prednisone, Trilogy and nebulizer before the Pfizer Covid-19 vaccines and had been taking them for a long time and had taken them after the vaccines.