chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Patient may have received bivalent Moderna Covid-19 vaccine for patients age 12 to 17; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have received bivalent Moderna Covid-19 vaccine for patients age 12 to 17) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have received bivalent Moderna Covid-19 vaccine for patients age 12 to 17) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have received bivalent Moderna Covid-19 vaccine for patients age 12 to 17) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient may have received bivalent Moderna Covid-19 vaccine for patients age 12 to 17).    No concomitant medications were reported. On 27-JAN-2021,patient received first Moderna Primary Series dose of Lot 011J20A ,expiration date was unknown. On 24-FEB-2021,patient received second Moderna Primary Series dose of Lot number 010A21A on left deltoid. Expiration date was unknown. On 16-NOV-2021,patient received first Moderna Covid-19 booster dose of Lot number 014F21A.Expiration date was unknown. On 27-JUL-2022 ,patient received Second Moderna Covid-19 booster dose of Lot number 055A22A, expiration date was 2-NOV-2022 . Patient did not reported adverse reactions for all doses. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: she had a side effect related to the moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had a side effect related to the moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a side effect related to the moderna vaccine). At the time of the report, IMMUNISATION REACTION (she had a side effect related to the moderna vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had first, second and third dose of moderna vaccines and a Pfizer bivalent 5th vaccine. No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Reporter wanted to know who they contact if he had a potential adverse event to report. Dosage text reported as Unknown. No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Nervous system disorder
Clinical narrative: HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine). At the time of the report, NERVOUS SYSTEM DISORDER (HCP states that he is calling on behalf of his boss who may be experiencing neurological issues after receiving the Moderna COVID-19 bivalent vaccine) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure, Drug ineffective, Suspected COVID-19
Clinical narrative: I have got COVID; I have got COVID; I have Heart disease; I can never work again because I have heart failure because of your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: CARDIAC FAILURE (medically significant), outcome "unknown", described as "I have Heart disease; I can never work again because I have heart failure because of your vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have got COVID".  Clinical course: Consumer stated, "I have heart disease from Vaccine and in order to find anybody to help I have to speak somebody. Patient had heart failure because of vaccine that was supposed to save the world. Consumer was informed about the role of Pfizer Drug Safety. Consumer was informed about the Pfizer Legal Department and offered the fax number and the address of that department. Consumer further stated that they have got COVID. Then got heart disease and now getting a run around from somebody. When probed to clarify the suspect as Pfizer COVID 19 vaccine: Consume stated, "I am talking about your mRNA COVID-19 vaccine that came online in 2021. Consumer stated, "Drug safety is so bad. That worst or worst you all suffer, and all should be in prison. Consumer stated, "Yes here's the safety report. It's not safe. It was not inoculated. You all lied and now I am going to die in the prime of life and then what Just no more. Thank you, Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastritis" (unspecified if ongoing); "Known allergies: Yes" (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 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid, oral, from 18Apr2023 to 23Apr2023).; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; 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 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 at 16:00 as dose number unknown (booster), single (Lot number: GL2042, Expiration Date: 23May2023) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for autoimmune thyroiditis. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 28Apr2023, outcome "not recovered", described as "Blurred vision". Therapeutic measures were not taken as a result of vision blurred.  Additional information: The patient stated that on yesterday afternoon she got the Pfizer Bivalent Vaccine and she was having really bad blurred vision today. Patient asked if it is common, should she see a doctor. Facility type reported as Grocery store, it is a pharmacy at the grocery store. It was asked if treatment for AE patient stated she had not done anything. She just wanted to know, how do she know if this is normal or do, she need to seek treatment. Patient did not received any vaccine (4 weeks prior).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Course: It was reported that 80 year old male and female patient received the Pfizer Bivalent COVID vaccine back in Oct2023 (Late clarified as Oct2022) and in the past months they got a positive PCR test so they were positive for COVID. The reporter had called to question about when they should get the Bivalent Booster now if they had their original Bivalent Booster back in October, when now should they (Incomplete sentence) now they are advising over age 65 to get a second Bivalent Booster. The patient was vaccinated in a clinic somewhere else and the reporter did not have any other details about the vaccine the patient received.  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 events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175805 same reporter/drug/AE, different patients;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; 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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: Fm7553), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Nov2021 as dose 2 (booster), single (Lot number: 066F21A), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 07Apr2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; HYDROXYCHLOROQUINE; LUTEIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26May2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (22Apr2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2023) Negative; (24Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 17Apr2023 to 22Apr2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175542 same patient, different drug and event.;
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "Diabetes" (unspecified if ongoing); "high blood pressure" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not have known allergies. Treatment start and stop date: 17Apr2023 and 21Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175485 Same reporter/patient, different product/AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month; an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "an 80y/o male and female patient who received their 1st dose of the Pfizer Bivalent COVID Vaccine in Oct2023 were positive for their PCR test in the past month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (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. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 15Apr2023 to 20Apr2023. Clinical course: The patient did not had other medication in 2 weeks and did not had Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175786 same reporter/patient, different drug/event;
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Sexually transmitted disease test
Clinical narrative: test for microscopic chlamydia came back positive; recurring yeast infections; all of my lymph nodes became swollen/it became very apparent/my lymph nodes had become all infected; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 32-year-old patient received BNT162b2 (BNT162B2), on 25Jan2022 at 14:00 as dose 3 (booster), single (Lot number: FR9896) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overactive immune system" (unspecified if ongoing); "Gene mutation" (unspecified if ongoing), notes: Cold Urticaria; "Cold Urticaria" (unspecified if ongoing); "known allergies " (unspecified if ongoing), notes: many things long list. Concomitant medication included: ALLEGRA 24 HOUR. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 12Mar2021, for COVID-19 immunization. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination. She tested covid post vaccination and got a negative result. After patient received the covid-19 booster all of her lymph nodes became swollen since 25Jan2022 and within the next couple of weeks it became very apparent that she needed to get to it hospital or urgent Care. She reached out to the CDC and recently they reached back out to her and told her to report to here. She was treated for the lymph nodes (antibiotics for the lymph nodes/ shot) they said that her lymph nodes had become all infected, the lymph nodes then went down everything appeared normal. She then started to experience recurring yeast infections, she was then tested for Sexually transmitted diseases (STDs). She stated that she has not been sexually active with absolutely anybody since 2018 and she was tested for STDs before that and she tested negative for absolutely everything. But after she received this booster and after she had that reaction, her test for microscopic chlamydia came back positive. She then tried to reach out to see if the people who participated in the creation of the vaccine had been tested for microscopic chlamydia mycoplasma. Patient reported that the events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent the following laboratory tests and procedures: Chlamydia test: came back positive; SARS-CoV-2 test: Negative; Sexually transmitted disease test: negative, notes: tested negative for absolutely everything. Therapeutic measures were taken as a result of lymph gland infection. Outcome of lymph nodes became swollen, lymph nodes had become all infected was recovering, outcome of other events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna on 12May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiovascular disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "vaccine brand other=Moderna on 12May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that patient had taken Paxlovid as COVID-19 treatment from 15Apr2023 to 20Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175794 same reporter/patient, different drug/event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Apr2023 at 14:30 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "recovered"; COVID-19 (medically significant) with onset 20Apr2023, outcome "recovered" (26Apr2023); DRUG INEFFECTIVE (medically significant) with onset 20Apr2023, outcome "recovered" (26Apr2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2023) Positive, notes: I first tested positive; (26Apr2023) Negative, notes: I tested negative on the evening of Wednesday 26Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies. On 20Apr2023, the patient tested positive, immediately started Paxlovid treatment and finished it the evening of 24Apr2023. The patient tested negative on the evening of 26Apr2023 (day 7) and hoped she was in the clear.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175661 same reporter/patient, different drug/AE;US-PFIZER INC-202300175985 same reporter, different drug/patients/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), on 24Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 19Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP. The patient's concomitant medications were not reported. Past drug history included: Quinine, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Apr2023 to 24Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175975 same reporter/patient, different drug/event;US-PFIZER INC-202300176021 Same patient/product, different dose/events (Dose 2);
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: the right arm is so sore; swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the right arm is so sore"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen". Therapeutic measures were taken as a result of pain in extremity, peripheral swelling.  Additional information: It was reported that Patient just had last booster, Patient guess they call, the one that was out there now, does that make sense. Patient just calling to say that patient used to do the opposite arm patient usually do because the one patient used it for which one was patient left, patient did some shoveling and patient arm was so sore from shoveling it monotonously, Patient put it on opposite arm and patient  would advise nobody to change arms because patient right arm was so sore and swollen because patient never had it done in that arm, patient have always done the left arm, was there better way for your arm to be better?" Consumer stated, shouldn't move them out, but patient other arm was so sore from muscle ache from shoveling still, patient  don't know where you live but patient was shoveling so it just pulled my muscle, so patient not going to have more pain in it, but now patient got both arms with pain. What could patient , as patient asked it hurts to lift arm, do patient put cold ice or heat or just do what feels good. Consumer stated, "Well that was really bad, vaccines are just out there now and people are getting and that was awful, patient have to wait till Monday. Consumer stated, "May be patient will call a pharmacist that might be what patient have to do. patient don't have time, patient got to get ice on it, it hurts too much. patient going to call pharmacist to see, patient better put cold."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2021 as dose 2, single (Lot number: EW0177), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FE3594), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Gallbladder problems" (unspecified if ongoing); "Steroids allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175979 Same reporter/patient, different drug/event (Paxlovid);
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment / Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Adenomyosis" (unspecified if ongoing); "bowel obstructions" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nulev, reaction(s): "Known allergies: Nulev". The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19 "; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Apr2023 to 22Apr2023.  The information on the batch/lot number for (BNT162B2 NOS), has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  drug ineffective and COVID 19 and the suspect drug  cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202300175646 same reporter/patient, different drug/AE;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 41 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: "Penicillin allergy" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GF5571) for treatment of COVID-19 from 20Apr2023 to 21Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300175614 same patient/reporter, different drug/event.;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dizziness, Enzyme activity normal, Malaise
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 41 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: "Penicillin allergy" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GF5571) for treatment of COVID-19 from 20Apr2023 to 21Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300175614 same patient/reporter, different drug/event.;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Renal function test normal, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 41 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: "Penicillin allergy" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GF5571) for treatment of COVID-19 from 20Apr2023 to 21Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300175614 same patient/reporter, different drug/event.;
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment / Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: AS7165B) at the age of 76 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), 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 had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Apr2023 to 15Apr2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300175647 same reporter/patient, different drug/AE;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Vaccination failure
Clinical narrative: Got Covid; Got Covid; 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 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 16Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 08Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 128; 153; 149/56. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient got 5 of the Pfizer shots for Covid. She got Covid after being on a plane while out of town and was prescribed Paxlovid on Apr2023.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A fib" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodein, reaction(s): "Allergy"; Flagyl, reaction(s): "Allergy"; Cipro, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 18Apr2023 to 23Apr2023.  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-202300175656 same patient/reporter, different drug/event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 had no relevant medical history. Concomitant medication(s) included: SERTRALINE, start date: Mar2013; CLONIDINE, start date: Mar2013. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took COVID-19 treatment PAXLOVID on 26Apr2023. The patient had no known allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175658 same patient/reporter, different drug/event;
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 12:00 as dose 4 (booster), single (Lot number: GS3275) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorders" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 17Apr2023 to 21Apr2023. Clinical course: It was unknown if the patient had other medication in 2 weeks. The patient had no known allergies. Took and completed 5 days of Paxlovid on day 3 of Covid 19 symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175652 same patient/reporter, different drug/event;