chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; received expired doses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l21b) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     No concomitant medications were reported. No treatment medications were reported.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered on 22-Jul-2022, after the expiration date 05-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered on 22-Jul-2022, after the expiration date 05-Jul-2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered on 22-Jul-2022, after the expiration date 05-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered on 22-Jul-2022, after the expiration date 05-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. No treatment information were reported.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Gave Moderna COVID-19 vaccine after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had acute and chronic illnesses at the time of vaccination.     On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave Moderna COVID-19 vaccine after the expiration date).    No concomitant medication was reported by reporter.  A total of 7 doses were used post expiration date. Vial did not undergo any temperature excursion.  It was also unknown whether patient seek medical care.  No treatment medication was reported by reporter.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (6 year old patient received vaccine from a 6 months to 5 year vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that the patient does not have any allergy, the patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The reporter stated that a 6-year-old patient at one of the clinics came in for a well child visit. During that visit the patient received the Moderna COVID-19 Vaccine. After the vaccine was administered it was discovered that the patient was given 0.5mLfrom the Moderna vial that was intended for those aged 6 months through 5 years. The reporter was reaching out to determine next steps for the patient if the patient need to restart the vaccine series, or to continue with the 2nd dose in 4-8weeks. The patient had received COVID-19 Moderna 50mcg/0.5mL. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2022: Follow up received included anatomical location of vaccine administration was added and narrative was updated.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.). At the time of the report, ACCIDENTAL UNDERDOSE (Nurse went to administer the vaccine in his thigh the pediatric patient pushed away and then most of the dose trailed down his leg.) outcome was unknown.      Concomitant medications details were not reported by the reporter.  The reporter reported that she had a son in the 6 month thru 5 year old age range who received Moderna Covid-19 vaccine, when the Nurse went to administer the vaccine on  thigh the pediatric patient pushed away and then most of the dose trailed down his leg. This was due to the patients reaction and not due to the Moderna Covid-19 vaccine.  Treatment details were not reported by the reporter.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient had no side effect after the first dose/No adverse event; Patient never received the second dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine) and NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies related to medications, food, and other products.  Concurrent medical conditions included Asthma (Patient is asthmatic.). Concomitant products included ALBUTEROL [SALBUTAMOL] and MONTELUKAST for an unknown indication.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine) and NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (Patient had no side effect after the first dose/No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received the second dose of the vaccine).    The reporter was calling on a behalf of a patient. The patient stated he only received the first dose of the Moderna a year ago. The reporter wanted to know if patient need to restart the series or 5 months down the line get the booster shot. The patient height was reported as 5 feet 10 inch.  The patient vaccination location, lot number, and route were unknown.  No treatment information was provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), MYALGIA (muscle pain), HYPERSENSITIVITY (allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy NOS (had allergies once and never again) in 2009. On 08-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced PAIN (body aches) and HYPERSENSITIVITY (allergies). On 26-Jul-2022, the patient experienced MYALGIA (muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in July 2022 for Adverse event, at a dose of yesterday night. At the time of the report, PAIN (body aches), MYALGIA (muscle pain) and HYPERSENSITIVITY (allergies) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.  No concomitant medication was reported. Patient never had COVID positive test or diagnosis. It was reported that symptoms have worsened.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rushes / rushes kept showing up on my skin in different zones and in different forms; This spontaneous case was reported by a patient and describes the occurrence of RASH (skin rushes / rushes kept showing up on my skin in different zones and in different forms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced RASH (skin rushes / rushes kept showing up on my skin in different zones and in different forms). At the time of the report, RASH (skin rushes / rushes kept showing up on my skin in different zones and in different forms) had not resolved.            No concomitant medications were reported.  It was reported that patient took two doses of the vaccine with no side effects on skin.  10 days post booster shot of Moderna patient developed skin rashes, which never happened before. Patient went to emergency  and got injected with antistaminic with cortisone . But again rash showed up in different skin zones in different forms. Later on patient consulted specialist in dermatology and had done blood test to check if any type of allergy or if it's urticaria or dermatitis that was triggered by the booster shot.  Treatment medication included antistaminic drug with cortisone.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received expired vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 000134A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Palpitations, Pruritus, Rash
Clinical narrative: Patient had a reaction to the shoot; itchiness; chest fluttering; rash that started on her breast; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had a reaction to the shoot), PRURITUS (itchiness), PALPITATIONS (chest fluttering) and RASH (rash that started on her breast) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005a22a) for COVID-19 vaccination.     The patient had never ever had COVID + test or diagnosis. The patient did not have any medical history relating to mentioned adverse events and both acute and Chronic illnesses at the time of vaccination.  Concomitant products included TETANUS VACCINE for an unknown indication.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2022, the patient experienced PRURITUS (itchiness), PALPITATIONS (chest fluttering) and RASH (rash that started on her breast). On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a reaction to the shoot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Patient had a reaction to the shoot) outcome was unknown and PRURITUS (itchiness), PALPITATIONS (chest fluttering) and RASH (rash that started on her breast) had not resolved.            Concomitant medication was reported as unknown 20 pills a day. The patient wanted to know if there was something to stop the reaction which she had with vaccine shoot. The patient did not seek medical care (office visit, Urgent care, ER, hospitalized) since she did not know what she had. The patient did not experience a similar event in the past. The symptoms were ongoing.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake) 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 ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake).    No concomitant medications was provided. The patient was not immunocompromised.  All 3 shots were Moderna COVID-19 vaccines. No treatment medications was reported.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2021 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (19Jul2022) Negative; (20Jul2022) Negative; (21Jul2022) Negative; (22Jul2022) Negative; (23Jul2022) Negative; (24Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication administered in 2weeks was unknown. Anti-viral details: Product=COVID 19 treatment, brand= paxlovid, treatment start date= 13jul2022; treatment stop date= 17Jul2022; indication=treatment of covid-19; administrator route= oral. Adverse event: Rebound infection following negative antigen test. Patient tested negative for Covid on 19Jul2022 following 5 day course of Paxlovid which ended on 17Jul2022. No treatment was received. No known allergies. Other medical history= DM, hypertension, BPH.  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 information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022; Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN; ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech 17Nov2021 / Paxlovid Treatment of COVID-19 11Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound infection or rapid reinfection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks. Anti viral details product COVID 19 Treatment (brand=Paxlovid) on 11Jul2022 to 16Jul2022 for treatment of 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: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "MS" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "history of PE" (unspecified if ongoing); "Factor V Lieden" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; BACLOFEN; METFORMIN; NEURONTIN; PROVIGIL [MODAFINIL]; PROTONIX [OMEPRAZOLE]; SINGULAIR; TREXIMET. Past drug history included: Celexa for Known allergies: Celexa; Avonex for Known allergies: Avonex; Copaxone for Known allergies: Copaxone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 17Jul2022 to 22Jul2022 for treatment of COVID-19. Adverse event reported as took Paxlovid and today tested positive again with worsening symptoms. Her doctor says not indicated to start another dose even with diabetes, history of PE, MS, asthma and Graves Disease and adverse event start date was 27Jul2022, ae resulted in none of the above, patient was not recovered for the adverse events and no treatment for the AE.  Product investigation summary conclusion on 28Jul2022 included, the complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the ssociated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS (Site name)  concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed." PR ID of Previously completed Inv: 7142808, PR Link (Previously investigated CR): 7142605.
Age: 38.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE ER; METFORMIN; WELCHOL; METOPROLOL; LOSARTAN/HCTZ; VITAMIN D3; IRON; FOLIC ACID; VITAMIN B12 [VITAMIN B12 NOS]. Past drug history included: Gluten, reaction(s): "known allergies Gluten". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical Course:Women's daily multivitamin.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she had tinnitus.; 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), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; NASONEX; ALBUTEROL [SALBUTAMOL]; PULMICORT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "she had tinnitus."  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: Alopecia, Drug ineffective, Madarosis, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling on her arms and legs"; ALOPECIA (non-serious), MADAROSIS (non-serious), outcome "unknown" and all described as "her hair was falling out as well as her eyelashes and eyebrows". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. 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: Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling on her arms and legs"; ALOPECIA (non-serious), MADAROSIS (non-serious), outcome "unknown" and all described as "her hair was falling out as well as her eyelashes and eyebrows". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FL3209) at the age of 74 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Prostate Cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received treatment of Covid-19 (Brand: Pfizer) from 12Jul2022 to 16Jul2022. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022; Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had sore throat, then lots of mucus and a low fever. I am still having effects four days later and tested positive yesterday; Positive, notes: 11 days after first testing positive. Therapeutic measures were taken as a result of covid-19. Patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 49 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "prior breast cancer" (unspecified if ongoing); "controlled asthma" (unspecified if ongoing). The patient did not have known allergy. There were no concomitant medications. The patient did not receive any other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Negative, notes: 3 days after end of course and negative test result; (Jul2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient received Paxlovid from 19Jul2022 to 24Jul2022 for the treatment of COVID-19. Three days after end of course, negative test result the patient developed chest and nasal congestion and sore throat, which she assumed was a rebound of the previous infection.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: New onset urticaria and angioedema; New onset urticaria and angioedema; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant), URTICARIA (non-serious) all with onset 05Jul2022, outcome "not recovered" and all described as "New onset urticaria and angioedema". The events "new onset urticaria and angioedema" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of angioedema, urticaria.  Clinical course: On 15Jul2022 patient took dose 2 covid-19 Pfizer vaccine through intramuscular, left arm location, lot number was not available or not provided to reporter at the time of report completion. Antihistamines, Montelukast, prednisone, Xolair are the treatment received for the adverse events. Prior to COVID Patient took vaccination. No Covid test was performed post vaccination. No known allergies. Other medications in two weeks: No. Facility type vaccine: Pharmacy or Drug Store.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event urticaria and angioedema Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", MALAISE (non-serious), outcome "recovered" and all described as "achy and was not feeling great for a brief period after the shot but it was not anything too bad; states someone else she works with had this same experience and got the shot and this went away"; FATIGUE (non-serious), outcome "unknown", described as "got maybe a little tired and thinks a fever 24 hours after the event then clarified it was not fever but achy and was not feeling great for a brief period". Additional information: It was reported that the patient herself got might be a little tired and thinks a fever 24 hours after the event then clarified that was not fever but achy and was not feeling great for a brief period after the shot but it was not anything too bad; states someone else she works with had this same experience and got the shot and this went away and that was all this person she works with got and this person had the Pfizer vaccine and everyone at the facility had the shot too and she has no patient details to provide or any lots, expiry dates or NDC numbers to provide for her coworker. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 53.0
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 53-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish allergy" (unspecified if ongoing), notes: known allergies: Shellfish allergy. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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.  Clinical course: Paxlovid dosage was given as treatment for COVID-19 symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jul2022 at 09:30 as dose 4 (booster), single (Lot number: FR2588) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; SERTRALINE HCL; HYDROCHLOROTHIAZIDE; VIT E [TOCOPHEROL]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 3, unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering", described as "felt extremely tired"; HEADACHE (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering", described as "the injection side on my left arm became very sore". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain. Additional information: The patient stated, at approximately 7 pm, 9.5 hours post receiving my final booster (2), She developed a headache, felt extremely tired and the injection side on her left arm became very sore. AE was not resulted in physician office or emergency room visit. If covid prior vaccination reported as No. If covid tested post vaccination reported as No. Known allergies reported as No. Facility type vaccine reported as Workplace clinic. If other vaccine in four weeks reported as No.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: feel off; not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 25Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: tetanus (She did the tetanus on 14Jul2022 and had no reaction with it), administration date: 14Jul2022, reaction(s): "No reaction"; Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Jul2022, outcome "unknown", described as "feel off"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "not feeling well".  Additional information: It was reported that patient got her first booster this past Monday and she was scheduled to get the MMR vaccine today. She also wants to know if Pfizer covid shot was a live organism. It was also reported that she needed to talk to right person and she was concerned. Her employer needed a complete vaccine because it was a health care provider. She did the tetanus on 14Jul2022 and had no reaction with it. She did PCV vaccine or Hepatitis C vaccine she was not sure but it was every 10 years for one of them and that she got last Monday. She was also asking asks if MMR was a live vaccine. She declined a safety report stating that she did not even feel like going to the clinic right now because it might be booster reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: feverish; maybe just her allergy; 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), on 25Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TETANUS VACCINE taken for immunisation, on 14Jul2022 as single dose. Vaccination history included: Bnt162b2 (Caller said she had the vaccine dose 1 and 2 of the Pfizer-BioNTech COVID-19 Vaccine., Dose 1), for COVID-19 Immunization; Bnt162b2 (Caller said she had the vaccine dose 1 and 2 of the Pfizer-BioNTech COVID-19 Vaccine., Dose 2), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "feverish"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "maybe just her allergy".  Additional information: Caller said she had the vaccine dose 1 and 2 of the Pfizer-BioNTech COVID-19 Vaccine. Her first booster dose was last Monday, 25Jul2022. Caller also mentioned she just had a vaccine from the 14Jul2022 and 25Jul2022. Clarified with Caller, and explained she had the Tetanus shot and the Pfizer-BioNTech COVID-19 booster Vaccine respectively.  Caller also reported feeling a little bit feverish today, but said that this could be maybe just her allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 09Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LINZESS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received vaccine. The patient did not have any known allergies. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 21Jul2022, treatment stop date: 25Jul2022, indication: Treatment of COVID-19. Adverse event: When I took Paxlovid I had a metal taste the entire time in my mouth. Adverse events start date: 21Jul2022.The patient did not receive any treatment for ae.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.