chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673181, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673869 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673181:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: vomiting twice today; bad headache; nauseous; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. D13H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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 16-Nov-2022, the patient experienced VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous). At the time of the report, VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous) outcome was unknown.            No concomitant drug was reported. Patient did not feel well enough to report her medications. The patient received first Moderna Covid 19 vaccine primary series on 9-Feb-2021 Lot number (024M20A) expiration date was not known, Right arm of administration. The patient received second Moderna Covid 19 vaccine primary series on 12-Mar-2021 Lot number (031A21A) expiration date was not known Right arm of administration.  The patient received first Moderna Covid 19 vaccine booster dose on 10-Nov-2021 Lot number (067F21A), expiration date was not known right arm of administration. The patient received second Moderna Covid 19 vaccine booster dose on 9-Mar-2022, Lot number was not available no expiration date was not known, right arm of administration. Patient reported no adverse reactions to dose 1, dose 2, first booster and second booster dose. No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure timing unspecified, SARS-CoV-2 test
Clinical narrative: COVID-19; It was stated that the patient was 4 months pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (COVID-19) and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant). At the time of the report, COVID-19 (COVID-19) outcome was unknown and MATERNAL EXPOSURE TIMING UNSPECIFIED (It was stated that the patient was 4 months pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had symptoms including sore throat, runny nose, and body aches.  Concomitant and treatment medications were not provided.  Company comment This spontaneous case concerns a female patient of an unknown age with Maternal exposure timing unspecified and no medical history reported, who experienced the unexpected, non-serious event of COVID-19. The patient received the first and second dose of mRNA-1273 vaccine. It was reported that the patient was experiencing symptoms including sore throat, runny nose, and body aches and tested positive for COVID 19. She reported also that she was four months pregnant. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Vaccination failure could not be assessed since the exact vaccination dates are unknown.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with Maternal exposure timing unspecified and no medical history reported, who experienced the unexpected, non-serious event of COVID-19. The patient received the first and second dose of mRNA-1273 vaccine. It was reported that the patient was experiencing symptoms including sore throat, runny nose, and body aches and tested positive for COVID 19. She reported also that she was four months pregnant. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Vaccination failure could not be assessed since the exact vaccination dates are unknown.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna monovalent for 12+ that was given to a four year old for a second primary dose.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent for 12+ that was given to a four year old for a second primary dose.).    No concomitant medication was reported. No treatment information was provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Dementia Alzheimer's type, SARS-CoV-2 test
Clinical narrative: Covid-19 virus test positive; Alzheimer's disease; anxiety; This spontaneous case was reported by a nurse and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was unknown if the patient was taking any over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination.  Concurrent medical conditions included Drug allergy (Niacin), Drug allergy (Oxybutin) and Type 2 diabetes mellitus (no recent change in condition status) since 14-May-2021.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) (seriousness criterion medically significant) and ANXIETY (anxiety). On 16-Feb-2022, the patient experienced COVID-19 (Covid-19 virus test positive). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Alzheimer's disease) and ANXIETY (anxiety) had not resolved and COVID-19 (Covid-19 virus test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment drug information was provided. Company comment: This spontaneous case concerns a 91-year-old male patient, with current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) unexpected event of DEMENTIA ALZHEIMER'S TYPE (among other non-serious events), 2 days after the third dose of of mRNA- 1273 vaccine. No further clinical information was available for medical review. Patient´s age and previous Type 2 diabetes mellitus could be risk factors for the event. The benefit-risk relationship of mRNA- 1273.214 vaccine is not affected by this report.   This case was linked to MOD-2022-665372, MOD-2022-674143 (Patient Link).; Sender's Comments: This spontaneous case concerns a 91-year-old male patient, with current condition of Type 2 diabetes mellitus, who experienced the serious (medically significant) unexpected event of DEMENTIA ALZHEIMER'S TYPE (among other non-serious events), 2 days after the third dose of of mRNA- 1273 vaccine. No further clinical information was available for medical review. Patient´s age and previous Type 2 diabetes mellitus could be risk factors for the event. The benefit-risk relationship of mRNA- 1273.214 vaccine is not affected by this report.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Type 2 diabetes mellitus
Clinical narrative: type 2 diabetes; This spontaneous case was reported by a nurse and describes the occurrence of TYPE 2 DIABETES MELLITUS (type 2 diabetes) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Niacin Allergy) and Drug allergy (Oxybutin Allergy).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced TYPE 2 DIABETES MELLITUS (type 2 diabetes) (seriousness criterion medically significant). At the time of the report, TYPE 2 DIABETES MELLITUS (type 2 diabetes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a  90-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event type 2 diabetes mellitus, 3 months after the second dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2022-665372, MOD-2022-674132 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a  90-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event type 2 diabetes mellitus, 3 months after the second dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A patient was administered a dose of the Moderna COVID-19 vaccine monovalent as a booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine monovalent as a booster) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine monovalent as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine monovalent as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was administered a dose of the Moderna COVID-19 vaccine monovalent as a booster).    No concomitant information provided No treatment information provided
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Herpes zoster, Muscle spasms, Rash
Clinical narrative: states the rash is on his back and the back of his legs; first case of shingles; Legs Cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:30 as dose 2, single (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Nov2020 (unspecified if ongoing), notes: He states he had contracted Covid in Nov2020; "sleep" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN taken for sleep disorder; CANNABIDIOL taken for sleep disorder; TETRAHYDROCANNABINOLS NOS taken for sleep disorder. Vaccination history included: BNT162b2 (Dose: 1, Time: 10:30, Anatomical Site of injection: Unknown Arm, Route of Administration: Standard Dose Injection into Arm, Batch/Lot number: EN6201), administration date: 11Feb2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "skin rash", "heart problems", "low heart rate", "tachycardia", "sick". The following information was reported: HERPES ZOSTER (non-serious) with onset 06Apr2021, outcome "recovered" (30Apr2021), described as "first case of shingles "; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "recovered" (Jun2021), described as "Legs Cramps"; RASH (non-serious), outcome "unknown", described as "states the rash is on his back and the back of his legs". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was diagnosed with shingles when he went to a routine appointment at his Rheumatologist on 12Apr2021, but the Shingles started the previous week. The cramps would never stop for 15-20 minutes and he has never had an experience like that before. He stated he thought his leg was going to tear. They lasted several months and they would come and go. Family Medical History Relevant to Adverse Events was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300313 same product, patient, different AEs, different dose.;US-PFIZER INC-202201300370 same product, patient, different AEs, different dose.;
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.; Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: 6H9694) at the age of 70 years for covid-19 immunisation; 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 included: "Diabetes", start date: 2018 (ongoing), notes: Diagnosed 5 years ago. Still takes medication for it. Concomitant medication(s) included: LIPITOR; XANAX; METFORMIN; PHENELZINE; ACIPHEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2022, outcome "unknown" and all described as "Caller mentions he has had 4 Pfizer Covid 19 vaccines and still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2022) Positive; (15Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, took PAXLOVID. Clinical course: Had 5 Pfizer COVID-19 Vaccines total. Two of the primary series shots and 3 boosters. Stated not shocked by that as a lot of people get COVID-19 after vaccination.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: another neurological side effect in another patient.; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), outcome "unknown", described as "another neurological side effect in another patient.".  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-PV202200104466 same reporter/drug, different patient/AE;
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Day 1: Tested negative 1 and 3 days  after stopping Paxlovid; (Nov2022) Negative, notes: Day 3: Tested negative 1 and 3 days after stopping Paxlovid; (Nov2022) Positive, notes: tested positive again on day 4 after stopping Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid taken as treatment from 03Nov2022 to 08Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 22Mar2021, when the patient was 79-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EP6955), administration date: 19Apr2021, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness in hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the patient took the Pfizer Covid-19 vaccine and then she got the virus this year and now she got over that but she had side effects from the virus. It kept on lingering. The husband could not use his right hand at all because of the numbness and the wife had the same thing but not as severe as husband.   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-202201304945 same product/event, different patients;
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Hypoaesthesia
Clinical narrative: Numbness in hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the first case out of two split cases.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; TELMISARTAN; CARVEDILOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 22Mar2021, when the patient was 83-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 22Mar2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, when the patient was 83-year-old, for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took Pfizer Covid-19 vaccine and then got the virus this year and now got over that but had side effects from the virus. It kept on lingering. Side effects: first was numbness in hand and he cannot use his right hand at all because of the numbness. The patient had investigations as his doctor was looking at the antibodies.  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-202201304866 same product, different patient/event;US-PFIZER INC-202201304927 same product/event, different patients;
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Numbness in hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the first case out of two split cases.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; TELMISARTAN; CARVEDILOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 22Mar2021, when the patient was 83-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 22Mar2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Apr2021, when the patient was 83-year-old, for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in hand". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took Pfizer Covid-19 vaccine and then got the virus this year and now got over that but had side effects from the virus. It kept on lingering. Side effects: first was numbness in hand and he cannot use his right hand at all because of the numbness. The patient had investigations as his doctor was looking at the antibodies.  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-202201304866 same product, different patient/event;US-PFIZER INC-202201304927 same product/event, different patients;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule
Clinical narrative: On all four injection sites I had knots underneath my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 at 14:00 as dose 2, single (Lot number: El8a82) at the age of 66 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occlusion", start date: 01Aug2018 (ongoing), notes: eyelea injection every 4 to 6 weeks; "High blood pressure" (ongoing), notes: Onset date: 10 years ago, metoprolol succinate 100 mg 1x a day; "Thyroid" (ongoing), notes: Onset date: 10 years ago, Levothyroxine sodium 25 mcg. The patient's family history included: "stroke" (unspecified if ongoing); "Alzheimer's" (unspecified if ongoing); "Arthritis (RA)" (unspecified if ongoing); "eye disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM taken for thyroid disorder (ongoing); METOPROLOL SUCCINATE oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EL0142; Route of administration: Intramuscular; Anatomical Site of injection: Right upper arm; vaccination time:10:00), administration date: 04Jan2021, for COVID-19 immunization, reaction(s): "pain that radiates down my arm to my right thumb/ pain on occasion traveling down my arm into my right thumb", "My right upper arm where two of the injections were given stay sore", "knots underneath my skin". The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "On all four injection sites I had knots underneath my skin".  Additional information: the patient did not received any prior vaccination within 4 weeks of suspect vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200104772 Same patient, different dose/ AE;US-PFIZER INC-PV202200089180 Same patient, different dose/ AE;US-PFIZER INC-202201304975 Same patient, different dose/ AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nerve stimulation test, SARS-CoV-2 test, Vaccination site nodule
Clinical narrative: On all four injection sites I had knots underneath my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0186) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occulusion", start date: 01Aug2018 (ongoing), notes: Pertinent details: eye lea injection every 4 to 6 weeks; "High blood pressure" (ongoing), notes: Onset date: 10 years ago, Pertinent details: metoprolol succinate 100 mg 1x a day; "Thyroid" (ongoing), notes: Onset date: 10 years ago, Pertinent details: Levothyroxine sodium 25 mcg. The patient's family history included: "Stroke" (unspecified if ongoing); "Alzheimers" (unspecified if ongoing); "Arthiritis (RA)" (unspecified if ongoing); "Eye Dieases" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Both are decreased. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01,Time: 10:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL0142), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin", "Pain that radiates down, my arm to my right thumb.", "Pain that radiates down, my arm to my right thumb."; BNT162b2 (Dose:02, Time: 14:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL8a82), administration date: 26Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin". The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "On all four injection sites I had knots underneath my skin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not received any prior vaccination within 4 weeks of suspect vaccine. Patient had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 & 26Jan2021. Then two Pfizer boosters on 20Aug2021 & 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down her arm into her right thumb. This had been ongoing for quite awhile and she thought it was her side sleeping but bought a spinal alignment pillow and it still persists. The pain was not severe but was there.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nerve conduction studies, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On all four injection sites I had knots underneath my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0186) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occulusion", start date: 01Aug2018 (ongoing), notes: Pertinent details: eye lea injection every 4 to 6 weeks; "High blood pressure" (ongoing), notes: Onset date: 10 years ago, Pertinent details: metoprolol succinate 100 mg 1x a day; "Thyroid" (ongoing), notes: Onset date: 10 years ago, Pertinent details: Levothyroxine sodium 25 mcg. The patient's family history included: "Stroke" (unspecified if ongoing); "Alzheimers" (unspecified if ongoing); "Arthiritis (RA)" (unspecified if ongoing); "Eye Dieases" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Both are decreased. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01,Time: 10:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL0142), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin", "Pain that radiates down, my arm to my right thumb.", "Pain that radiates down, my arm to my right thumb."; BNT162b2 (Dose:02, Time: 14:00, Anatomical site of injection: Right upper arm, Route of administration: Intramuscular, Lot number: EL8a82), administration date: 26Jan2021, for Covid-19 immunization, reaction(s): "On all four injection sites I had knots underneath my skin". The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "On all four injection sites I had knots underneath my skin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not received any prior vaccination within 4 weeks of suspect vaccine. Patient had 2 vaccines for COVID that were Pfizer on dates 04Jan2021 & 26Jan2021. Then two Pfizer boosters on 20Aug2021 & 01Oct2022. Her right upper arm where two of the injections were given stay sore along with pain on occasion traveling down her arm into her right thumb. This had been ongoing for quite awhile and she thought it was her side sleeping but bought a spinal alignment pillow and it still persists. The pain was not severe but was there.
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Cardiovascular disorder
Clinical narrative: They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems". The following information was reported: CARDIOVASCULAR DISORDER (non-serious), outcome "not recovered", described as "They thought it was the heart at first, but they think it's a thinning vessel. It can create all kinds of stuff and cause issues and problems". The events "they thought it was the heart at first, but they think it's a thinning vessel. it can create all kinds of stuff and cause issues and problems" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had the first and second vaccine and first booster, she had concerns that have gotten worse after she got the first vaccine. The doctor sent her "to all kinds of places to be checked out." "They had found stuff that patient had researched online that other people have had as well. They got issues after getting the vaccine that they never had before. They have found something that is totally similar to everyone else's issue when they took the vaccine. They though it was the heart at first, but they thought it was a thinning vessel. It could create all kinds of stuff and cause issues and problems.  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-202201307946 same patient/drug/AE,differnt doses;
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Pain
Clinical narrative: Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest; Feeling lasted about 6 hours, which was how long the achiness feeling lasted.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 19-year-old male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "recovered", described as "Experienced an "electrical fire or electric jolt" in the left shoulder to upper left quadrant of his chest"; PAIN (non-serious), outcome "recovered", described as "Feeling lasted about 6 hours, which was how long the achiness feeling lasted.".  Additional information: Event took place after use of product.  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-PV202200105161 same reporter/AE/SD, different patient;
Sex: U
Vaccine: COVID19-2
Symptoms: Head discomfort, Headache
Clinical narrative: Had a slight headache all day today; head felt like it was just heavy like heavy head; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset Nov2022, outcome "unknown", described as "head felt like it was just heavy like heavy head"; HEADACHE (non-serious) with onset 16Nov2022, outcome "unknown", described as "Had a slight headache all day today".  Additional information: Consumer stated, "Well, I want to know if this is normal, I had a slight headache all day today (16Nov2022) and then my head felt like it was just heavy like heavy head." Product Name: Consumer stated, "Yes, I got my shot on Monday. Yes the omicron or something." When probed to clarify if consumer has any query: Consumer stated, "That is what I have a questions is that, was it normal if I had a, I mean like a heavy head." Consumer stated, "So is that normal? I am asking you if is it normal because I got this (Pfizer COVID-19 Vaccine) on Monday and it should be wearing off and I should be doing good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: "Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event."
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient did not remember getting a COVID BIVALENT BOOSTER already , and received a 2nd  Bivalent booster 2 months after the first.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Confusional state, Cough
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/3/2021. On 5/5/2022, I had a cough, body aches, and a severe headache. On 5/6/2022, a coworker informed me that she had tested positive for COVID-19. On 5/7/2022, I took a home test and got a positive result. I then isolated. My symptoms continued, plus I developed chest congestion, fatigue, mental confusion, and a loss of taste and smell. At the time of this writing, I still have coughing, chest congestion, and brain fog. I still have difficulty tasting food, because food usually doesn't taste right. I think I also probably still have trouble with my sense of smell, but it's not as noticeable as the issue I'm having with my sense of taste. I had a telehealth visit with my doctor on 5/12/2022. He did not prescribe me Paxlovid, because he said that it was too late, since more than 5 days had already passed since the onset of symptoms. I treated myself with hot tea, Robitussin, Tylenol for body aches, and ibuprofen. I began to finally feel better around a month and a half after the onset of the symptoms.  However, I did return to work around 5/23/2022. With regard to the symptoms I still have, I try to treat them with Robitussin, Tylenol, ibuprofen, and hot tea. They help me feel better temporarily, but the symptoms always return.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/3/2021. On 5/5/2022, I had a cough, body aches, and a severe headache. On 5/6/2022, a coworker informed me that she had tested positive for COVID-19. On 5/7/2022, I took a home test and got a positive result. I then isolated. My symptoms continued, plus I developed chest congestion, fatigue, mental confusion, and a loss of taste and smell. At the time of this writing, I still have coughing, chest congestion, and brain fog. I still have difficulty tasting food, because food usually doesn't taste right. I think I also probably still have trouble with my sense of smell, but it's not as noticeable as the issue I'm having with my sense of taste. I had a telehealth visit with my doctor on 5/12/2022. He did not prescribe me Paxlovid, because he said that it was too late, since more than 5 days had already passed since the onset of symptoms. I treated myself with hot tea, Robitussin, Tylenol for body aches, and ibuprofen. I began to finally feel better around a month and a half after the onset of the symptoms.  However, I did return to work around 5/23/2022. With regard to the symptoms I still have, I try to treat them with Robitussin, Tylenol, ibuprofen, and hot tea. They help me feel better temporarily, but the symptoms always return.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: I received my first Pfizer booster for COVID-19 on 11/3/2021. On 5/5/2022, I had a cough, body aches, and a severe headache. On 5/6/2022, a coworker informed me that she had tested positive for COVID-19. On 5/7/2022, I took a home test and got a positive result. I then isolated. My symptoms continued, plus I developed chest congestion, fatigue, mental confusion, and a loss of taste and smell. At the time of this writing, I still have coughing, chest congestion, and brain fog. I still have difficulty tasting food, because food usually doesn't taste right. I think I also probably still have trouble with my sense of smell, but it's not as noticeable as the issue I'm having with my sense of taste. I had a telehealth visit with my doctor on 5/12/2022. He did not prescribe me Paxlovid, because he said that it was too late, since more than 5 days had already passed since the onset of symptoms. I treated myself with hot tea, Robitussin, Tylenol for body aches, and ibuprofen. I began to finally feel better around a month and a half after the onset of the symptoms.  However, I did return to work around 5/23/2022. With regard to the symptoms I still have, I try to treat them with Robitussin, Tylenol, ibuprofen, and hot tea. They help me feel better temporarily, but the symptoms always return.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient did not remember getting a flu shot already this year, and received a 2nd flu shot 1 month after the first.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: "Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event."
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: "Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event."
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose too early, no reaction