chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse Event; patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 06-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent).    No concomitant medication was reported. Vaccination date of first and second dose was unknown. Patient did not report any adverse event. It was unknown whether patient received treatment or not.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: both arms are sore/flu shot in one arm and COVID in the other; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Knee replacement (trying to rest from left knee replacement) on 23-Sep-2022.   On 06-Oct-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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other). At the time of the report, PAIN IN EXTREMITY (both arms are sore/flu shot in one arm and COVID in the other) outcome was unknown.            No Concomitant medications were provided.  It was reported that patient had a booster, fifth one.  Patient was trying to get over the shot from yesterday 06 Oct 2022. Patient got the flu shot in one arm and the COVID shot in the other. Both arms were sore.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator beyond use date of 25-Sep-2022 and administration of vaccine was on 06-Oct-2022; No adverse event; given vaccine which was past beyond the use date of 25-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine which was past beyond the use date of 25-Sep-2022), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator beyond use date of 25-Sep-2022 and administration of vaccine was on 06-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was past beyond the use date of 25-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator beyond use date of 25-Sep-2022 and administration of vaccine was on 06-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine which was past beyond the use date of 25-Sep-2022), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator beyond use date of 25-Sep-2022 and administration of vaccine was on 06-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine which was past beyond the use date of 25-Sep-2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator beyond use date of 25-Sep-2022 and administration of vaccine was on 06-Oct-2022).    No concomitant medication were reported. Patient was administered with monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator beyond the use date of 25-Sep-2022 The vaccine was administered on 06-Oct-2022, early afternoon. The dose administered after 30-day use by date or after manufacturer date of expiry. The manufacturer's expiration date - 24-Nov-2022 Reporter was not sure if there were short duration of excursion. The temperature logger needed to be checked. No treatment information was provided by the reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product administration interrupted
Clinical narrative: Patient got sick; More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine). At the time of the report, ILLNESS (Patient got sick) and PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days have passed since he received the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient medical history information included no allergies. Patient never tested positive for COVID-19. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had COVID) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Sep-2022, the patient experienced COVID-19 (had COVID). At the time of the report, COVID-19 (had COVID) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 034405, 012M20A and 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-656385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656385:(sons case)
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Headache, Illness, Tinnitus
Clinical narrative: within 2 days she felt really sick; ears hurt; ear feels full; ears ringing, tinnitus; head hurts; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, ILLNESS (within 2 days she felt really sick), EAR PAIN (ears hurt), EAR DISCOMFORT (ear feels full), TINNITUS (ears ringing, tinnitus) and HEADACHE (head hurts) had not resolved.            No concomitant medication were reported.  After receiving the second dose, within 2 days she felt really sick, her ears hurt and started ringing, and her head hurts, her left ear feels full and she is experiencing tinnitus. This has continued up until the day of reporting.  Patient received steroids including Dexamethasone and been to the hospital twice since then. Patient does not know the lot numbers of this vaccine, but has found them on Bad Batch a website dedicated to addressing lot specific side effects   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb deformity, Limb injury
Clinical narrative: Every time i have had a vaccine or booster i would get "useless arm syndrome".my lifting capacity would drop in the arm (by about 30 percent to 50 percent, or more...); It got so bad my should took over for lifting to the point where I nearly hurt my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Every time i have had a vaccine or booster i would get "useless arm syndrome"."; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "my lifting capacity would drop in the arm (by about 30 percent to 50 percent, or more...)"; LIMB INJURY (non-serious), outcome "not recovered", described as "It got so bad my should took over for lifting to the point where I nearly hurt my shoulder".  Additional information: It was reported that, the patient was messaging to find out if Pfizer/Biontech had fixed an issue with the covid-19 vaccine. Every time he had a vaccine or booster the reporter would get a useless arm syndrome. His lifting capacity would drop in the arm (by about 30% to 50% or more) that it was given in for 3-4 days after day 2 of the vaccine being in the arm. Yes, he had already reported this side effect. So, had this been fixed yet.  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-PV202200075548 same patient/events, different vaccine;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb deformity, Limb injury
Clinical narrative: Every time i have had a vaccine or booster i would get "useless arm syndrome". my lifting capacity would drop in the arm (by about 30 percent to 50 percent, or more...); It got so bad my should took over for lifting to the point where I nearly hurt my shoulder; 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 male patient received BNT162b2 (BNT162B2), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Every time i have had a vaccine or booster i would get "useless arm syndrome"."; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "my lifting capacity would drop in the arm (by about 30 percent to 50 percent, or more...)"; LIMB INJURY (non-serious), outcome "not recovered", described as "It got so bad my should took over for lifting to the point where I nearly hurt my shoulder".  Additional information: It was reported that, the patient was messaging to find out if Pfizer/Biontech had fixed an issue with the covid-19 vaccine. Every time he had a vaccine or booster the reporter would get a useless arm syndrome. His lifting capacity would drop in the arm (by about 30% to 50% or more) that it was given in for 3-4 days after day 2 of the vaccine being in the arm. Yes, he had already reported this side effect. So, had this been fixed yet.  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-202201201412 same patient/events, different vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Optic neuropathy
Clinical narrative: Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine; This is a literature report for the following literature source(s):   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: OPTIC NEUROPATHY (medically significant), outcome "unknown", described as "Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine". Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. Linked Report(s): US-PFIZER INC-PV202200076321 Same article /drug /event and different patient; US-PFIZER INC-202201206165 Same article /drug /event and different patient.
Sex: U
Vaccine: COVID19
Symptoms: Optic neuropathy
Clinical narrative: presumed autoimmune optic neuropathy - 3 patients/presumed autoimmune optic neuropathy after pfizer-biontech (bnt162b2) covid-19 vaccine; This is a literature report for the following literature source(s):   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: OPTIC NEUROPATHY (medically significant), outcome "unknown", described as "presumed autoimmune optic neuropathy - 3 patients/presumed autoimmune optic neuropathy after pfizer-biontech (bnt162b2) covid-19 vaccine".; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report.,Linked Report(s) : US-PFIZER INC-PV202200076321 Same article /drug /event and different patient;US-PFIZER INC-202201206056 Same article /drug /event and different patient;US-PFIZER INC-PV202200076321 same article /drug /event and different patient;
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Sinus rhythm
Clinical narrative: atrial fibrillation; 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 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GJ5342) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fibrillation", start date: 2003 (unspecified if ongoing), notes: Patient was diagnosed with Atrial Fibrillation 20 years ago thinks around 2003. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot: FJ6369), administration date: 30Mar2022, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "atrial fibrillation"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot: FE3592), administration date: 20Sep2021, when the patient was 75-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot: EN5318), administration date: 07Sep2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "inappropriate schedule of vaccine administered"; BNT162b2 (DOSE 1, SINGLE; Lot: EN6198), administration date: 28Feb2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 30Sep2022 at 16:00, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Sinus rhythm: (01Apr2022) regular rhythm. Therapeutic measures were taken as a result of atrial fibrillation which includes diltiazem 240 mg, 24 hour release. Clinical course: the patient's first 3 dose had no issue. He got the 4th booster dose on 30Mar2022, and on 01Apr2022 he went into atrial fibrillation and then got it corrected and went back to sinus rhythm (regular rhythm). On 30Sep2022 about 11:30 am, he went in for the omicron booster dose and on 4:00 pm, he went into atrial fibrillation, and was still in it. He was going to get it corrected in a few weeks. This was not his first time having atrial fibrillation, he confirmed that he had a chronic history of atrial fibrillation, and was diagnosed with atrial fibrillation 20 years ago around 2003. He called about latest booster shot for omicron. He needed information and asked if there has been any indication that the booster can cause an atrial fibrillation event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201206684 same patient/event, different dose;US-PFIZER INC-PV202200078293 same patient, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Oedema peripheral
Clinical narrative: Pitting Edema in both legs; sharp shooting pains in chest occasionally; Trouble catching my breath when walking 20-30 feet.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 15:00 as dose 3 (booster), single (Lot number: GJG739), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cough" (unspecified if ongoing); "Asthma with Exercise" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL QUADRIVALENT, on 30Aug2022 as dose 1, 0.5 ml single; NORTRIPTYLINE; AMBIEN; TOPAMAX; ZOLOFT; BUTRANS. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: pfizer (Dose 2, Batch/Lot No: EL1203, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 26Jan2021, when the patient was 32-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; pfizer (Dose 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 05Jan2021, when the patient was 32-year-old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "Pitting Edema in both legs"; DYSPNOEA EXERTIONAL (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "Trouble catching my breath when walking 20-30 feet."; CHEST PAIN (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "sharp shooting pains in chest occasionally". Therapeutic measures were not taken as a result of oedema peripheral, chest pain, dyspnoea exertional.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: FIC9894) at the age of 66 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Lot number: 011M20A), in left arm, on 13Mar2021 as dose 2, single (Lot number: 012A21A), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm COVID-19 immunisation. The patient's relevant medical history included: "Treated for moderately high blood pressure (under control)" (unspecified if ongoing). Concomitant medication included: LOSARTAN, start date: 15Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Oct2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Oct2022) Negative, notes: Recovered from COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Additional information: The patient has no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 at 12:00 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Received Paxlovid treatment from 22Sep2022 to 26Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "oral allergy syndrome" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "known allergies: Soy and nickel" (unspecified if ongoing); "known allergies: Soy and nickel" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Gluten (celiac dx)" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID; LIOTHYRONINE; LATANOPROST; PROGESTERONE. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet"; Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: indication=Treatment of COVID-19. Therapeutic measures(paxlovid) were taken from 18Sep2022 to 23Sep2022 as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: had a metallic taste in my mouth, like I did after the initial two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: E*6198), in left arm and on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "Celiac" (unspecified if ongoing), notes: Other medical history: Celiac; "Known allergies: Gluten (celiac dx)" (unspecified if ongoing), notes: Known allergies: Gluten (celiac dx). Concomitant medication(s) included: NP THYROID; LIOTHYRONINE; LATANOPROST; PROGESTERONE. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. The following information was reported: DYSGEUSIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "had a metallic taste in my mouth, like I did after the initial two vaccines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: had a metallic taste in my mouth, like I did after the initial two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: E*6198), in left arm and on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "Celiac" (unspecified if ongoing), notes: Other medical history: Celiac; "Known allergies: Gluten (celiac dx)" (unspecified if ongoing), notes: Known allergies: Gluten (celiac dx). Concomitant medication(s) included: NP THYROID; LIOTHYRONINE; LATANOPROST; PROGESTERONE. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. The following information was reported: DYSGEUSIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "had a metallic taste in my mouth, like I did after the initial two vaccines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: had a metallic taste in my mouth, like I did after the initial two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune thrombocytopenia" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: LIOTHYRONINE; PROGESTERONE; LATANOPROST; NP THYROID. Past drug history included: Cipro, reaction(s): "known allergies: Cipro"; Percocet, reaction(s): "known allergies: Percocet". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: E*6198, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 48-year-old, for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "had a metallic taste in my mouth, like I did after the initial two vaccines".
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: had a metallic taste in my mouth, like I did after the initial two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune thrombocytopenia" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: LIOTHYRONINE; PROGESTERONE; LATANOPROST; NP THYROID. Past drug history included: Cipro, reaction(s): "known allergies: Cipro"; Percocet, reaction(s): "known allergies: Percocet". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: E*6198, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 48-year-old, for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "had a metallic taste in my mouth, like I did after the initial two vaccines".
Age: 34.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood test, Off label use, Seizure, Vital signs measurement, X-ray
Clinical narrative: seizure; He also had a flu shot on the same day; He also had a flu shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5,Gray cap), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing), notes: Had been seizure free for a couple of weeks; "Sinus Tachycardia" (ongoing). Family Medical History included father has high sugar, bypass surgery in 2007, and high cholesterol and Mother High Blood Pressure. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 04Oct2022, outcome "unknown" and all described as "He also had a flu shot on the same day"; SEIZURE (medically significant) with onset 05Oct2022, outcome "recovered" (05Oct2022). The event "seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Vital signs measurement: Unknown results; X-ray: Unknown results, notes: Blood work, they did a X-Ray of his Right Shoulder because he wasn't sure if it was injured, and monitored his vital signs. Therapeutic measures were taken as a result of seizure.It was reported that patient received the Pfizer-BioNTech Covid-19 Vaccine, Bivalent, on Tuesday 04Oct2022. One day after that, on 05Oct2022, he had a seizure evening time and went to the ER on 05Oct2022 after 7pm ,he was not admitted to the hospital, he was treated in the ER and discharged early this morning. He also had a flu shot on the same day. He has a history of seizures, but he had been seizure-free for a couple of weeks. He wanted to know if the seizure could be related to vaccination.  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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 15:00 as dose 1, single (Lot number: EN6205), in right arm, on 30Mar2021 at 14:00 as dose 2, single (Lot number: ER8732), in right arm and on 12Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Malaise, Nausea, Tinnitus
Clinical narrative: i am going to get sick; tinnitus; it is getting better however it is still there and annoying; felt like my ears was blocked like, I could not even hear clearly; nauseous very quickly but it went away it did not last that long; 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), as dose number unknown, single (Lot number: FP7150), in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 21Sep2022, outcome "recovered" (21Sep2022), described as "nauseous very quickly but it went away it did not last that long"; EAR DISCOMFORT (non-serious) with onset 22Sep2022, outcome "unknown", described as "felt like my ears was blocked like, I could not even hear clearly"; TINNITUS (non-serious) with onset 22Sep2022, outcome "recovering", described as "tinnitus; it is getting better however it is still there and annoying"; MALAISE (non-serious), outcome "unknown", described as "i am going to get sick".  Additional information: patient just want to report the side effect of the Covid. Patient got the COVID Vaccine with Pfizer on the 21Sep2022 and the day when had vaccine patient just got nauseous very quickly but it went away it did not last that long. However the next day patient woke up and had tinnitus and did not realize that patient felt it but was so busy, so the next day it came and go, it came and go, the next day was very annoying. Patient just thought was going to get sick or you know was going to get a Flu (Further clarifications unknown). Patient felt like ears was blocked like, could not even hear clearly but then was not feeling sick or anything but ears so then patient realized that must be because of vaccine because patient did not had anything else. Patient was not getting sick anything like that, so was still experiencing but it was not bad as a few days after got the vaccine. Patient just want to let you know that and hopefully it will go away. The nausea went away after 15 minutes because patient was in the office from 30 minutes and it went away. Patient thought it just went away. It did not bother that much nausea but that tinnitus yes. Patient considered the COVID-19 Vaccine caused me the adverse event because patient did not had anything prior and was healthy individual, patient usually eat healthy food. Patient exercise did everything possible to keep immunity system healthy and all of a sudden patient had tinnitus which never had. Patient thought it was and thought because it happened the next day and that was why patient was like okay and it is getting better however it was still there and annoying patient thought it is related to that.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 43 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's relevant medical history included: "Lymphoma" (unspecified if ongoing); "in remission" (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". 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.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years 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: "Hypergammaglobulinaemia benign monoclonal" (unspecified if ongoing), notes: Other medical history: Mgus; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After testing negative on Paxloivid, tested positive on day 3 after my last dose; (unspecified date) Positive, notes: Treatment of COVID-19; (05Oct2022) Positive, notes: After testing negative on Paxloivid, tested positive on day 3 after my last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association  the causal role of suspect  BNT162B2 cannot be excluded for reported events. Case will be reviewed on receipt of FU information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Off label use, Product use issue, Pyrexia
Clinical narrative: dry mouth; feverish; fatigue; Flu also received on 02Oct2022; Flu also received on 02Oct2022; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5, on 02Oct2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 02Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Vaccination history included: BNT162b2 (Dose 1, single, in arm left, at 12:00 PM), administration date: 17Mar2021, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, in arm left, at 04:00 PM), administration date: 07Apr2021, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (booster), single, at 01:00), administration date: 02Dec2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 02Oct2022, outcome "unknown" and all described as "Flu also received on 02Oct2022"; DRY MOUTH (non-serious) with onset 03Oct2022, outcome "recovered"; FATIGUE (non-serious) with onset 03Oct2022, outcome "recovered"; PYREXIA (non-serious) with onset 03Oct2022, outcome "recovered", described as "feverish". Therapeutic measures were not taken as a result of dry mouth, pyrexia, fatigue.  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-202101720607 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Diabetes mellitus, Myocardial infarction
Clinical narrative: diabetic; had a heart attack; takes a blood thinner; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), in 2021 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. Vaccination history included: Covid-19 vaccine (Dose 1, Manyfacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manyfacturer: Unknown), for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack"; BLOOD DISORDER (non-serious), outcome "unknown", described as "takes a blood thinner". She received a 1st dose and never got second dose. She is now scheduled to get booster tomorrow. She got both vaccines and one booster already. Patient took a blood thinner, had a heart attack and diabetic. Patient also stated it had been over a year since her 1st booster dose. She did not get the second booster shot of Pfizer COVID 19 vaccine. But she is scheduled for the booster dose or what should be the third dose tomorrow. Therapeutic measures were taken as a result of blood disorder with blood thinner.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.