chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (vaccination adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (vaccination adverse reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (vaccination adverse reaction) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Forehead would get very warmed when out in sun) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB for Psoriasis. Concurrent medical conditions included Psoriasis. In August 2022, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced FEELING HOT (Forehead would got very warmed when out in sun) and HEADACHE (Headache). At the time of the report, FEELING HOT (Forehead would got very warmed when out in sun) was resolving and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Encephalopathy
Clinical narrative: Encephalopathy; Covid-19; This literature-non-study case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) in a 94-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criterion medically significant) and COVID-19 (Covid-19) (seriousness criterion medically significant). At the time of the report, ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered ENCEPHALOPATHY (Encephalopathy) and COVID-19 (Covid-19) to be related.    No concomitant and treatment product reported. Company comment: This is a literature-non-study case concerning a 94-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected AESI of COVID-19 and the serious (due to medically significant), unexpected event of Encephalopathy. As per source document, she developed COVID-19 encephalopathy four month after the second dose of mRNA-1273. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a literature-non-study case concerning a 94-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant), unexpected AESI of COVID-19 and the serious (due to medically significant), unexpected event of Encephalopathy. As per source document, she developed COVID-19 encephalopathy four month after the second dose of mRNA-1273. No information on previous Covid-19 vaccination available. No further details on clinical course, lab test results or treatment were reported. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Minor pain after vaccination shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor pain after vaccination shot) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Minor pain after vaccination shot). At the time of the report, VACCINATION SITE PAIN (Minor pain after vaccination shot) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Fatigue, Gastrooesophageal reflux disease, Inappropriate schedule of product administration, Pain
Clinical narrative: Acid reflux (esophageal); Asthma; Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021; Ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), ASTHMA (Asthma), PAIN (Ache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced PAIN (Ache) and FATIGUE (Fatigue). On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and ASTHMA (Asthma). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), ASTHMA (Asthma), PAIN (Ache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021) outcome was unknown.            The reporter causality of Humira for events FATIGUE, ACID REFLUX, ASTHMA and ACHINESS was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were provided by the reporter.  No treatment medications were reported.   This case was linked to MOD-2022-621812 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Saddle pulmonary embolus; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Saddle pulmonary embolus) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE: Emergency room imaging findings in patients presenting after COVID-19 vaccination. Imaging Sci. 2022;12     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Saddle pulmonary embolus) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Saddle pulmonary embolus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PULMONARY EMBOLISM (Saddle pulmonary embolus) to be related.    Concomitant and treatment medications were not reported.  This study was carried out on vaccinated patients who underwent imaging studies in the ER between December 2020 and August 2021.  Chest pain, cough, shortness of breath and headache are the most common presenting symptoms in the ER after COVID-19 vaccination.  Company comment-This literature-non-study case concerns a 30 year old female patient with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Pulmonary embolism (reported as Saddle pulmonary embolus) that occurred 4 days after first dose of mRNA-1273 vaccination. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to US-MODERNATX, INC.-MOD-2022-629822 (E2B Linked Report).; Sender's Comments: This literature-non-study case concerns a 30 year old female patient with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Pulmonary embolism (reported as Saddle pulmonary embolus) that occurred 4 days after first dose of mRNA-1273 vaccination. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-629822:Patient 2 (82-year-old man)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (REACTION TO COVID VACCINE), COUGH (Cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days). In June 2022, the patient experienced COUGH (Cough). On an unknown date, the patient experienced VACCINATION COMPLICATION (REACTION TO COVID VACCINE). At the time of the report, VACCINATION COMPLICATION (REACTION TO COVID VACCINE) and COUGH (Cough) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days) outcome was unknown. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was sick in Jun 2022 with a terrible cough. The patient had a terrible reaction to the Covid vaccine. No treatment medication was reported. The reporter's causality for the event(s) of REACTION TO COVID VACCINE and COUGH with SKYRIZI (RISANKIZUMAB) was no reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus, Seasonal allergy
Clinical narrative: her seasonal allergies were terrible like they were when she was a kid; after the second booster she got more spots; This spontaneous case was reported by a patient and describes the occurrence of MELANOCYTIC NAEVUS (after the second booster she got more spots) and SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 058H21A, 017B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced MELANOCYTIC NAEVUS (after the second booster she got more spots). On an unknown date, the patient experienced SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid). At the time of the report, MELANOCYTIC NAEVUS (after the second booster she got more spots) and SEASONAL ALLERGY (her seasonal allergies were terrible like they were when she was a kid) outcome was unknown.            No concomitant drug information was provided. Patient's year of birth was reported. It was reported that the patient felt that her immune system had messed -up as she experienced terrible allergies.  No treatment drug information was provided.   This case was linked to MOD-2022-629684 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: She got the 2nd Moderna booster & experienced a cough & congestion.; She got the 2nd Moderna booster & experienced a cough & congestion.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.). At the time of the report, COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.) had not resolved.            Allergies were Unknown. No concomitant medications were reported. No treatment details were reported. AE did not caused patient to seek medical care. It was reported that the Symptoms were worsened.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: weird rash after vaccine injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (weird rash after vaccine injection) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (weird rash after vaccine injection). At the time of the report, RASH (weird rash after vaccine injection) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; administration of a booster dose of Moderna vaccine to a 5 year old patient; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if patient had any allergies or any medical history relating to mentioned adverse event and both Acute and chronic illnesses at the time of vaccination and ever had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose, Lot number: FK5127, Expiration date: 31-Jan-2021, Route Intramuscular) on 11-Nov-2021, Pfizer vaccine (2nd dose, Lot number: FK5127 and Expiration date: 31-Jan-2021) on 02-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 11-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of a booster dose of Moderna vaccine to a 5 year old patient).    It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if the patient was under any concomitant or regular medication. No treatment  medications were reported. It was unknown if there was any AE as a result of the misadministration.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)) in a 65-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)). At the time of the report, PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. This case was linked to MOD-2022-629155 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 2, single (Lot number: EW0162) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have controlled reflux" (unspecified if ongoing), notes: I have controlled reflux; "autoimmune disease ITP" (unspecified if ongoing), notes: autoimmune disease ITP that has been in remission for about 8-10 years; "intersistial cystitis" (unspecified if ongoing), notes: intersistial cystitis; "known allergies: antibiotics" (unspecified if ongoing), notes: Yes, most antibiotics; "known allergies: pain meds" (unspecified if ongoing), notes: pain meds,; "known allergies: spicy or acid foods" (unspecified if ongoing), notes: spicy or acid foods; "known allergies: seasonal allergies" (unspecified if ongoing), notes: have seasonal allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 that includes: Paxlovid from 11May2022 to 12Aug2022 for COVID-19 treatment.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR; LIPITOR, stop date: 06Aug2022; EFFEXOR; PREVACID. 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, notes: strong positive; Negative, notes: almost negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks reported as Lopressor, Lipitor, Effexor XR and Prevacid. It was reported that Covid-19 treatment from 06Aug2022 to 11Aug2022.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Heart Rhythm" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 04Aug2022 to 08Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9263), on 17Feb2021 as dose 2, single (Lot number: EL9264), on 17Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 12Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "DIABETES" (unspecified if ongoing); "HIGH BLOOD PRESSURE" (unspecified if ongoing); "HIGH CHOLESTEROL" (unspecified if ongoing); "GERD" (unspecified if ongoing); "REFLUX" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; METOPROLOL; NORVASC; PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Neosporin eye drops, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment Paxlovid from 01Aug2022 to 06Aug2022.
Age: 51.0
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 a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; CYTOMEL; DESVENLAFAXINE; DULERA; FLUTICASONE; IMMUNE GLOBULIN; LAMOTRIGINE; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment PAXLOVID from 03Aug2022 to 07Aug2022.  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 known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Lactose intolerance" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptomatic rebound infection with positive test; 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 53-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 at 15:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Feb2021 at 16:15 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: None except overweight; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "not recovered", described as "COVID 19 Treatment "; DISEASE RECURRENCE (medically significant) with onset 15Aug2022, outcome "not recovered", described as "Symptomatic rebound infection with positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: Symptomatic rebound infection with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 04Aug2022 to 09Aug2022.  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: Drug ineffective, Nasopharyngeal swab, Suspected COVID-19
Clinical narrative: Breakthrough COVID illness; Breakthrough COVID illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Breakthrough COVID illness". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Unknown result. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201064256 Same patient and product, different dose and event;
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), on 08Apr2021 as dose 2, single (Lot number: ER8733) and on 15Oct2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No known allergies. The following information was reported: VACCINATION FAILURE (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: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: face and lips swelled; face and lips swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "face and lips swelled".  Additional information: The reporter was patient's grandmother. Stated that her granddaughter had a reaction, her face swelled up and her lips swelled up and luckily her throat did not close. Wanted to know if a patient had a reaction to the first dose of the vaccine that they should not get the second one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Product administered at inappropriate site, Pyrexia
Clinical narrative: Patient developed a fever; Vaccine location: Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 2-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Aug2022 at 12:00 as dose 1, single (Lot number: FT9142) at the age of 2 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 12Aug2022 at 12:00, outcome "unknown", described as "Vaccine location: Left leg"; PYREXIA (non-serious) with onset 13Aug2022 at 17:00, outcome "not recovered", described as "Patient developed a fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: It was reported that the patient developed a fever in the afternoon on 13Aug2022. Fever got to 102 Fahrenheit and was treated with Tylenol; the patient still had temperature in the morning on 16Aug2022. Tylenol did decrease the temperature. There was nothing known about patient's allergies. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination. AE did not result in physician office visit or emergency room visit. The reporter classified the event as non serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia rheumatica" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Mar2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took other medication in 2 weeks. Patient took COVID 19 Treatment include Paxlovid. Treatment start date was 04Aug2022. Treatment stop date was 08Aug2022. Rebound of COVID respiratory symptoms from 04Aug2022 with outcome recovering, but no other symptoms. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures Paxlovid were taken as a result of vaccination failure, covid-19. Patient started Paxlovid on 01Aug2022.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ, start date: 07Aug2019; WELLBUTRIN, start date: 08Jan2020. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19 included Paxlovid from 05Aug2022 to 09Aug2022. 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 currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had covid (vaccines x4 pfizer); Patient had covid (vaccines x4 pfizer); This is a spontaneous report received from contactable reporter(s) (Nurse).  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 30 ug single (Batch/Lot number: unknown), as dose 2, 30 ug single (Batch/Lot number: unknown), as dose 3 (booster), 30 ug single (Batch/Lot number: unknown) and as dose 4 (booster), 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Nickel" (unspecified if ongoing), notes: Allergies: Nickel. The patient's concomitant medications were not reported. Vaccination history included: Pertussis vaccines (Allergies: Pertussis Vaccines), reaction(s): "Allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient had covid (vaccines x4 pfizer)". 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 known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Left arm swelled up after first dosage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2022 as dose 1, single (Lot number: FE3592) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: Jul2021 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid " (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. The following information was reported: PERIPHERAL SWELLING (disability) with onset 2022, outcome "unknown", described as "Left arm swelled up after first dosage". The event "left arm swelled up after first dosage" required physician office visit. No covid tested post vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acarodermatitis, Infection, Pain
Clinical narrative: After second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected; After second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected/Severe body aches; After second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2022 as dose 2, single (Lot number: FM0698) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: Jul2021 (unspecified if ongoing), notes: Heart attack Jul2021; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, prev dose lot number=FE3592, Prev dose vaccine location= Left arm), administration date: 27Jan2022, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "Left arm swelled up after first dosage". The following information was reported: ACARODERMATITIS (disability), INFECTION (disability) all with onset 22Feb2022, outcome "not recovered" and all described as "After second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected"; PAIN (disability) with onset 22Feb2022, outcome "not recovered", described as "After second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected/Severe body aches". The events "after second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected" and "after second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected/severe body aches" required physician office visit. Therapeutic measures were not taken as a result of acarodermatitis, pain, infection. The report was assessed as serious and Seriousness criteria-Disabling/Incapacitating. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Left arm swelled up after first dosage after second whole body broke out in scabies like sores all over body, still has sores today, some broke open and got infected severe body aches after third, elbow blew up like a golf ball under it and turned black and blue. even worse body aches. Events resulted in: [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage]. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Skin discolouration
Clinical narrative: elbow blew up like a golf ball under it and turned black and blue; elbow blew up like a golf ball under it and turned black and blue; Even worse body aches; This is a spontaneous report received from contactable consumer. The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose 3 (booster), single (Lot number: FP7150) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: Jul2021 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: FE3592 , Location of injection: Arm Left), administration date: 27Jan2022, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Left arm swelled up"; BNT162b2 (Dose Number: 2 , Batch/Lot No: FM0698 , Location of injection: Arm Left, ), administration date: 22Feb2022, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Whole body broke out in scabie like sores all over body", "Whole body broke out in scabie like sores all over body", "Whole body broke out in scabie like sores all over body". The following information was reported: PAIN (disability) with onset Aug2022, outcome "not recovered", described as "Even worse body aches"; JOINT SWELLING (disability), SKIN DISCOLOURATION (disability) all with onset Aug2022, outcome "not recovered" and all described as "elbow blew up like a golf ball under it and turned black and blue". Events were reported with seriousness criteria-disabling/incapacitating. Event details reported as follow: After third dose, elbow blew up like a golf ball under it and turned black and blue. Even worse body aches. AE resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were not taken as a result of joint swelling, skin discolouration, pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201065138 same patient/drug, different dose (2nd)/event;US-PFIZER INC-202201065128 same patient/drug, different dose (1st)/event;