chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Feeling hot, Tachycardia
Clinical narrative: after each one became hot; tachycardic; lightheaded; weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic), ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins) and DIZZINESS (lightheaded) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 929904, 001B21A and 006M20a) for COVID-19 vaccination.     The patient had no allergies (medications, food and other products). The patient never had COVID positive test or diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins). On an unknown date, the patient experienced FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic) and DIZZINESS (lightheaded). In October 2021, ASTHENIA (weak-feeling starting approx. 10 minutes after the injection, lasted about 30 mins) had resolved. At the time of the report, FEELING HOT (after each one became hot), TACHYCARDIA (tachycardic) and DIZZINESS (lightheaded) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not receive other vaccines which was given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication of the patient was not reported.  The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No treatment information was provided by the reporter.  The patient decided to try Pfizer as second booster and did not develop those reactions.   This case was linked to MOD-2022-566669, MOD-2022-566610 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Upon live follow-up, significant information was reported which included addition of reporter's details (contact number and address), patient demographics (height, age, DOB and gender), suspect product information (date and lot number of all 3 doses), medical history information and event details (prior history and outcome for 3 events (except Feelings of weakness)). Event description was updated accordingly.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was initially refrigerator on 11-May-2022; Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. The vaccine got expired on 03-May-2022. Expired vaccine was initially refrigerator on 11-May-2022. The vial did not undergo any temperature excursions. Treatment Not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was initially refrigerator on 11-May-2022; Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on 03-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was initially refrigerator on 11-May-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  No treatment medication information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: After vial was needle punctured it was immediately returned to fridge; Dose administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12(hours post puncture) and PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (After vial was needle punctured it was immediately returned to fridge) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported.  It was reported that the vial was initially stored in the refrigerator on 05 May 2022.  It was reported that the vial was first punctured 09 May 2022 at 5:00 P.M  It was reported that the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F a few seconds  after vial was needle punctured and it was immediately returned to fridge.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenitis, Pain in extremity
Clinical narrative: like the ones previous I suffered from the typical arm soreness, fatigue and inflammation of lymph nodes; like the ones previous I suffered from the typical arm soreness, fatigue and inflammation of lymph nodes; like the ones previous I suffered from the typical arm soreness, fatigue and inflammation of lymph nodes; This is a spontaneous report received from a 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 30Dec2020 at 07:30 as dose 1, single (Lot number: ER5730), in left arm and on 20Jan2021 at 08:00 as dose 2, single (Lot number: EL8982), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Leg weakness and shakiness", start date: 2021 (ongoing); "Drop in blood sugars", start date: 2021 (ongoing); "PSA" (unspecified if ongoing); "Low Thyroid" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Weekend immnune system" (unspecified if ongoing). Concomitant medication(s) included: RASUVO intramuscular taken for prostatic specific antigen (ongoing); COSENTYX intramuscular taken for prostatic specific antigen (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); CRESTOR oral taken for blood cholesterol increased (ongoing). The following information was reported: LYMPHADENITIS (non-serious), PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "like the ones previous I suffered from the typical arm soreness, fatigue and inflammation of lymph nodes".  Additional Information: Patient received my Booster shot 22Oct2021. And like the ones previous she suffered from the typical arm soreness, fatigue and inflammation of lymph nodes along side which took about 7 days to go away.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive.  Clinical course: The patient tested positive for Corvid and her all family member went for testing and also tested positive. They all had received Pfizer inoculations and boosters and although their tests are positive, all are functioning very well.  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-202200676409 Same product/reporter/AEs, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She was diagnosed with Covid 19; She was diagnosed with Covid 19; 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 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She was diagnosed with Covid 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid. Caller states she has previously been vaccinated with Pfizer Covid 19 vaccine 2 doses and had her booster dose last Oct2022. She was diagnosed with Covid 19 and prescribed Paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid 19; covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysphagia" (unspecified if ongoing); "Dementia" (unspecified if ongoing). Concomitant medication(s) included: NAMENDA.The following information was reported: DRUG INEFFECTIVE (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: (07May2022) Positive.   clinical course: Therapeutic measures were taken as a result of covid-19.Clinical information: Reporter was informed, in case of Emergency may contact prescribing HCP or the Pharmacy. In response, reporter stated, "Truly I have done both of the thing they don't know any your question, you don't know and Pfizer doesn't know anything beyond what they are publishing then why this medication can't be chewed."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penecillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient had no other medication in 2 weeks. The patient took COVID-19 treatment (Brand: pfizer) from 25Apr2022 to 30Apr2022. The patient had not experienced any adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of drug effect; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4380396-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown) and on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Lack of drug effect"; COVID-19 (medically significant), outcome "not recovered".  The reporter's assessment of the causal relationship of "lack of drug effect" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The 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 events cannot be totally excluded.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, Rhinorrhoea
Clinical narrative: tested Covid positive; tested Covid positive; bad runny nose; cough; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group received via COVID-19 Adverse Event Self-Reporting. The reporter is the parent.  A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 2, single (Lot number: FK5618) at the age of 6 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. No other vaccine in four weeks. There were no concomitant medications. No other medications in two weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Nov2021, when the patient was 6-year-old, for COVID-19 Immunization. The patient was not pregnant at the time of vaccination.   The following information was reported: RHINORRHOEA (non-serious) with onset 06May2022, outcome "not recovered", described as "bad runny nose"; NASAL CONGESTION (non-serious) with onset 06May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 06May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 06May2022, outcome "not recovered", COVID-19 (medically significant) with onset 06May2022, outcome "not recovered" and all described as "tested Covid positive". Patient on 06May2022 started to experience really bad runny nose, cough and congestion. On 07May2022 was tested Covid positive. The events "tested covid positive", "bad runny nose", "cough" and "congestion" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Therapeutic measures were taken as a result of covid-19, rhinorrhoea, cough, nasal congestion. AE treatment: Acetaminophen and Mucinex. No covid prior vaccination. Patient tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events of covid-19 and drug ineffective.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested Covid positive; tested Covid positive; bad runny nose; cough; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group received via COVID-19 Adverse Event Self-Reporting. The reporter is the parent.  A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 2, single (Lot number: FK5618) at the age of 6 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. No other vaccine in four weeks. There were no concomitant medications. No other medications in two weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Nov2021, when the patient was 6-year-old, for COVID-19 Immunization. The patient was not pregnant at the time of vaccination.   The following information was reported: RHINORRHOEA (non-serious) with onset 06May2022, outcome "not recovered", described as "bad runny nose"; NASAL CONGESTION (non-serious) with onset 06May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 06May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 06May2022, outcome "not recovered", COVID-19 (medically significant) with onset 06May2022, outcome "not recovered" and all described as "tested Covid positive". Patient on 06May2022 started to experience really bad runny nose, cough and congestion. On 07May2022 was tested Covid positive. The events "tested covid positive", "bad runny nose", "cough" and "congestion" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Therapeutic measures were taken as a result of covid-19, rhinorrhoea, cough, nasal congestion. AE treatment: Acetaminophen and Mucinex. No covid prior vaccination. Patient tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events of covid-19 and drug ineffective.
Sex: F
Vaccine: COVID19
Symptoms: Chronic hepatitis, Liver function test
Clinical narrative: chronic hepatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC HEPATITIS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Liver function test: Spiked. Clinical course includes, adverse event: 15-year-old of received 2 Pfizer COVID-19 vaccines. Her liver numbers spiked and she now has chronic hepatitis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Report with Pfizer-BioNTech Vaccine administered.; report with Pfizer-BioNTech Vaccine administered.; 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 male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04May2022, outcome "unknown" and all described as "report with Pfizer-BioNTech Vaccine administered.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: tested negative on day seven; Positive, notes: positive antigen test.  Clinical Course: Patient started Paxlovid on day two, felt better on day four, tested negative on day seven, but relapsed on day nine with a terrible head cold, exhaustion, and a positive antigen test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), on 06Mar2021 as dose 2, single (Lot number: EP6955) and on 26Sep2021 as dose 3 (booster), single (Lot number: FF8125) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: BUSPIRONE; SERTRALINE. Past drug history included: Thimerosal, reaction(s): "Allergy: thimerosal", notes: Known allergies: thimerosal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.
Age: 68.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR oral. 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.  Clinical Course: It was reported that the patient took other medications within 2 weeks of covid-19 treatment was reported as Yes. The patient previously received a COVID-19 Vaccine. She had diarrhea vomiting bad taste in her mouth. She was not able to complete her regiment. She only took the first dose and could not continue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 16:00 as dose 1, single (Lot number: EN6203), in right arm, on 27Mar2021 at 16:00 as dose 2, single (Lot number: EN6207), in left leg and on 27Dec2021 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Jul2021 as dose 3 (booster), single (Lot number: 206A21A), in left leg for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Apr2022 at 12:00 as dose 5 (booster), single (Lot number: 001Mz1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: Other medical history: Lymphoma. Known allergies: No. Other medication in 2weeks: Yes. Concomitant medication(s) included: ATORVASTATIN; ZOLPIDEM; FINASTERIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event start date: 05May2022 at 06:00 PM. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 26Apr2022, Treatment stop date: 30Apr2022 and Indication: Treatment of COVID-19. Adverse event: patient took 5 days of Paxlovid and felt all better and tested negative on day 7, then got congested on day 11 and tested positive again.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of 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 64-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 16:00 as dose 1, single (Lot number: EN6203), in right arm, on 27Mar2021 at 16:00 as dose 2, single (Lot number: EN6207), in left leg and on 27Dec2021 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Jul2021 as dose 3 (booster), single (Lot number: 206A21A), in left leg for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Apr2022 at 12:00 as dose 5 (booster), single (Lot number: 001Mz1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing), notes: Other medical history: Lymphoma. Known allergies: No. Other medication in 2weeks: Yes. Concomitant medication(s) included: ATORVASTATIN; ZOLPIDEM; FINASTERIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; negative, notes: tested negative on day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event start date: 05May2022 at 06:00 PM. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 26Apr2022, Treatment stop date: 30Apr2022 and Indication: Treatment of COVID-19. Adverse event: patient took 5 days of Paxlovid and felt all better and tested negative on day 7, then got congested on day 11 and tested positive again.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Anaemia, Blood test
Clinical narrative: Second vaccine dose caused gastric bloating; Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9265) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: Verbatim: High BP; "Arterial plaque" (unspecified if ongoing), notes: Verbatim: Arterial plaque. Concomitant medication(s) included: IRON. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL0142, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 13Jan2021, when the patient was 68-year-old, for Covid-19 immunization. The following information was reported: ABDOMINAL DISTENSION (non-serious), outcome "recovered", described as "Second vaccine dose caused gastric bloating"; ANAEMIA (non-serious), outcome "recovered", described as "Anemia". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal distension, anaemia.  Additional information: Second vaccine dose caused gastric bloating and ultimately anaemia. After seeing a half-dozen MDs, convinced my GP to prescribe a steroid dose. Have been taking iron pills for a year. Blood levels after the steroid dose began climbing and are back to normal. Had Covid rebound. After negative tests on 17Apr2022 and 20Apr2022 felt a bad cold hit me on 25Apr2022. Tested positive on 26Apr2022. Began a steriod and antibiotic dose with minerals and vitamins. Tested negative 04May2022. Patient did not receive any medication two weeks prior vaccination. The patient had no known allergies. Dose 3 on 17Dec2021 at 10:00, vaccine lot number=33130BA, vaccine location=Right arm.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nodular melanoma surgery Nov2020", start date: Nov2020 (unspecified if ongoing), notes: Nodular melanoma surgery Nov2020. Concomitant medication(s) included: MIMVEY, start date: Nov2016; DORZOLAMIDE + TIMOLOL, start date: Feb2022. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Apr2022, outcome "recovered with sequelae" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested, bright line positive; negative, notes: Tested negative, twice. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Took Paxlovid, as directed Treatment start date: 17Apr2022, Treatment stop date: 22Apr2022, Singulair. Toward end of treatment, Felt better for several days. Felt well, healthy. Started to feel ill a couple days later. Chest tightness. Next day felt flulike. Was quite ill for a solid 10 days after. Very bad cough. 3 weeks from initial positive test - Still experiencing residual tiredness, ear and sinus congestion, minor cough.  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, Suspected COVID-19
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical Information: Report about covid treatment. No Other medication in 2weeks. Antiviral details reported as, Product- COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 27Apr2022 and Treatment stop date was reported as 02May2022, Indication reported as Treatment of COVID-19. Vaccine lot unknown reason mentioned as Misplaced/discarded. Adverse event reported as, I had about 12 days after testing and feeling better after completion of Paxlovid, I became very tired, noticed my glands were swollen and sore in my neck on the right side. Again started coughing, and having nasal congestion and night sweats, Adverse event start date reported as 06May2022, Patient was Recovering, No treatment AE.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid; testing positive for Covid; 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 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mold and lyme" (unspecified if ongoing), notes: Mold and lyme; "Mold and lyme" (unspecified if ongoing), notes: Mold and lyme. There were no other medication in 2weeks. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "testing positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I felt better Day 5, 6 and 7 after testing positive for Covid and taking Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient felt better Day 5, 6 and 7 after testing positive for Covid and taking Paxlovid. On day 8 however her headache returned along with stomach pains and vomiting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 17Nov2021 as dose 3 (booster), single (Lot number: FH8939) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details: Treatment start date 13Apr2022, treatment stop date 18Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2587) at the age of 59 years, in right arm for covid-19 immunisation. The patient did not have any known allergies. The patient's relevant medical history included: "Thyroid cancer", start date: 2009 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 05Nov2009, stop date: 07May2022. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022 at 08:00, outcome "recovered" (02May2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested negative 3 days with an antigen test and then tested positive for the following 12 days until finally testing negative with a rapid antigen test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that from 09Apr2022 to13Apr2022, the patient was given treatment for COVID-19.  Clinical course: After completing 5 days of paxlovid, I tested negative 3 days with an antigen test and then tested positive for the following 12 days until finally testing negative with a rapid antigen test.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
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 contactable reporter physician. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07May2022 at 10:00, outcome "unknown", COVID-19 (medically significant) with onset 07May2022 at 10:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information:-Recurrence of symptomatic covid infection after apparent resolution. Symptoms fully resolved with treatment by 02May22 and began with symptoms again 07May22 with positive antigen testing. Anti-viral details includes that product-Covid 19 treatment, treatment start date was 29Apr2022,treatment stop date was 03May2022, via oral route of administration. No other medication in 2weeks. Patient had no Known allergies.   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 available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID - 19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200705502 Same article/ drug/event and different patient:;US-PFIZER INC-202200706126 Same article/ drug/event and different patient:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Oropharyngeal pain, Pain
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; Fever; sore throat; head congestion; body aches; cough (less severe); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm and on 23Sep2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiry date: unknown) at the age of 62 years, in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19"; PYREXIA (non-serious), outcome "not recovered", described as "Fever"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered", described as "head congestion"; PAIN (non-serious), outcome "not recovered", described as "body aches"; COUGH (non-serious), outcome "not recovered", described as "cough (less severe)". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, upper respiratory tract congestion, pain, cough.  Clinical course: The patient received Paxlovid as COVID 19 Treatment from Apr2022 to 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.