chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I find I have been given Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I find I have been given Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I find I have been given Covid). At the time of the report, COVID-19 (I find I have been given Covid) outcome was unknown.            No concomitant drug information was given.  No treatment drug information was provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 after receiving the 3rd dose of mRNA-1273 vaccine. The onset date of the event was not reported. Clinical course, laboratory and treatment details were not reported. The outcome of event was unknown. Patient received first 2 doses of mRNA-1273 vaccine (date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 after receiving the 3rd dose of mRNA-1273 vaccine. The onset date of the event was not reported. Clinical course, laboratory and treatment details were not reported. The outcome of event was unknown. Patient received first 2 doses of mRNA-1273 vaccine (date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Vomiting
Clinical narrative: was in bed; chills; puked; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (was in bed), CHILLS (chills) and VOMITING (puked) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     It was reported that patient had no allergies. It was reported that patient has never been diagnosed or tested positive for COVID-19. No other vaccine was received by the patient within 1 month prior to Moderna COVID-19 vaccine.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced BEDRIDDEN (was in bed), CHILLS (chills) and VOMITING (puked). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (was in bed), CHILLS (chills) and VOMITING (puked) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Symptoms lasted for one day.   This case was linked to US-MODERNATX, INC.-MOD-2022-598091 (E2B Linked Report). This case was linked to MOD-2022-598089, MOD-2022-598068 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-598091:same reporter
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Myalgia, Skin burning sensation
Clinical narrative: weak; redness in the cheek and face; skin burning; muscle became sore; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2 and 029L20A) for COVID-19 prophylaxis.     The patient had never tested positive or diagnosed with COVID-19. The patient had no allergies. The patient was not given any other vaccine within 1 month prior to receiving the Moderna COVID-19 vaccine.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  After receiving the second dose of the vaccine, the patient thought that it was normal to feel weak.  The batch number of the second dose of the vaccine was mentioned as 026A2 and the rest is unknown, or ripped off.  The patient was currently not continuing any treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2022-598091 (E2B Linked Report). This case was linked to MOD-2022-598087, MOD-2022-598068 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-598091:same reporter
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lupus-like syndrome
Clinical narrative: a 54 year old reported the same (Drug-induced Lupus/Lupus)/after their 2nd dose of the Moderna vaccine(Lupus); This spontaneous case was reported by a nurse and describes the occurrence of LUPUS-LIKE SYNDROME (a 54 year old reported the same (Drug-induced Lupus/Lupus)/after their 2nd dose of the Moderna vaccine(Lupus)) in a 54-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUPUS-LIKE SYNDROME (a 54 year old reported the same (Drug-induced Lupus/Lupus)/after their 2nd dose of the Moderna vaccine(Lupus)) (seriousness criterion medically significant). At the time of the report, LUPUS-LIKE SYNDROME (a 54 year old reported the same (Drug-induced Lupus/Lupus)/after their 2nd dose of the Moderna vaccine(Lupus)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Lupus-like syndrome, after receiving the second dose of mRNA-1273 vaccine. Dates of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-598087, MOD-2022-598068.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Lupus-like syndrome, after receiving the second dose of mRNA-1273 vaccine. Dates of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-598089:same reporter
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm after 2nd dose; received 2nd dose 24 days after first dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm after 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 24 days after first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Bee sting (Allergic to Bees), Arthritis (has arthritis in knees, hip, back, and shoulders), Shellfish allergy (get a rash or get nauseated when eat fish), Drug allergy (Patient was allergic Sulfa.), Drug allergy (Allergic to demerol) and Drug allergy (Allergic to omega XL.). Concomitant products included ATENOLOL and AMLODIPINE BESYLATE for Hypertension, PRAVASTATIN, LOSARTAN POTASSIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 24 days after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after 2nd dose) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 24 days after first dose) outcome was unknown. It was reported that Recent change in status of patient historical condition was worsened. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No treatment details were reported. This case was linked to MOD-2022-598096 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Moderna booster dose to a patient under the age of 18 years old; Moderna booster dose to a patient under the age of 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (dose-1) and Pfizer vaccine (dose-2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 27-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna booster dose to a patient under the age of 18 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna booster dose to a patient under the age of 18 years old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported. No adverse events have been reported to the HCP.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Reacted with tachycardia to first Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (Reacted with tachycardia to first Moderna shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Altitude sickness (suffers from symptoms of altitude sickness with changes in elevation less than 1850).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Reacted with tachycardia to first Moderna shot). At the time of the report, TACHYCARDIA (Reacted with tachycardia to first Moderna shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's race was reported as (withheld).  No concomitant medications were reported.  The patient developed tachycardia within 5 minutes of taking the first shot of Moderna vaccine.  No treatment information was reported.   This case was linked to MOD-2022-598342 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: My leg muscles and joints hurt all the time; My leg muscles and joints hurt all the time; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time). At the time of the report, MYALGIA (My leg muscles and joints hurt all the time) and ARTHRALGIA (My leg muscles and joints hurt all the time) had not resolved.            No Concomitant medication was reported. No Treatment medication was reported.   This case was linked to MOD-2022-598674 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Physical disability
Clinical narrative: Crippled by the vaccine; Can't do job no longer; This spontaneous case was reported by a nurse and describes the occurrence of PHYSICAL DISABILITY (Crippled by the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHYSICAL DISABILITY (Crippled by the vaccine) (seriousness criterion disability) and IMPAIRED WORK ABILITY (Can't do job no longer). At the time of the report, PHYSICAL DISABILITY (Crippled by the vaccine) outcome was unknown and IMPAIRED WORK ABILITY (Can't do job no longer) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (disability) event of Physical disability and non-serious event of Impaired work ability unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was crippled after the vaccination and can't do her job. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with no medical history reported, who experienced the unexpected serious (disability) event of Physical disability and non-serious event of Impaired work ability unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was crippled after the vaccination and can't do her job. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to the Moderna COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (Allergic to the Moderna COVID vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic to the Moderna COVID vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic to the Moderna COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient doctor had prescribed Paxlovid which the patient had not taken yet. The patient stated that she was allergic to the Moderna COVID vaccine and wanted to know if the ingredients in Paxlovid were similar to the ones in the Moderna COVID vaccine No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Received the booster while breastfeeding.; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 28-May-2021 and Pfizer (Second dose) on 18-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.). On 28-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Received the booster while breastfeeding.) had resolved.            Concomitant and treatment medications was not reported. Patient's baby was 9 months old and eligible for vaccination. Patient did not had COVID test or diagnosis.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a mild arm ache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Just a mild arm ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Pain in arm with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a mild arm ache). At the time of the report, PAIN IN EXTREMITY (Just a mild arm ache) outcome was unknown. No concomitant medication was reported.  It was reported, on Tuesday patient decided to mix- and match and took Moderna after 3 Pfizer's vaccine. It was reported that some folks had worse.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Interchange of vaccine products, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Positive 4 months after booster 1; I had 2 Biontech (Pfizer)/ 1 Moderna; Mild cold and headache from the sinuses for 3 days; Mild cold and headache from the sinuses for 3 days; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Mild cold and headache from the sinuses for 3 days), HEADACHE (Mild cold and headache from the sinuses for 3 days), COVID-19 (Positive 4 months after booster 1) and INTERCHANGE OF VACCINE PRODUCTS (I had 2 Biontech (Pfizer)/ 1 Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Biontech (Pfizer) (Had 2 Biontech (Pfizer)) and Biontech (Pfizer) (Had 2 Biontech (Pfizer)). Past adverse reactions to the above products included No adverse event with Biontech (Pfizer) and Biontech (Pfizer). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Mild cold and headache from the sinuses for 3 days), HEADACHE (Mild cold and headache from the sinuses for 3 days), COVID-19 (Positive 4 months after booster 1) and INTERCHANGE OF VACCINE PRODUCTS (I had 2 Biontech (Pfizer)/ 1 Moderna). At the time of the report, NASOPHARYNGITIS (Mild cold and headache from the sinuses for 3 days) and HEADACHE (Mild cold and headache from the sinuses for 3 days) had resolved and COVID-19 (Positive 4 months after booster 1) and INTERCHANGE OF VACCINE PRODUCTS (I had 2 Biontech (Pfizer)/ 1 Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive 4 months after booster 1. Concomitant medication list was not provided. Treatment information was not provided. Company comment: This spontaneous case concerns an unknown-year-old patient, with no reported medical history, who experienced the unexpected events of Covid-19 (AESI), nasopharyngitis and headache approximately 4 months after 3rd. dose of mRNA-1273 Moderna COVID-19 Vaccine. Primary series for COVID-19 schedule was with 2 doses of Pfizer vaccine. On an unknown date, SARS-CoV-2 test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an unknown-year-old patient, with no reported medical history, who experienced the unexpected events of Covid-19 (AESI), nasopharyngitis and headache approximately 4 months after 3rd. dose of mRNA-1273 Moderna COVID-19 Vaccine. Primary series for COVID-19 schedule was with 2 doses of Pfizer vaccine.  On an unknown date, SARS-CoV-2 test positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Pruritus
Clinical narrative: Itching with the Moderna covid vaccine/ she had itching. had itching on her head, hands, and body; She used to drink some wine and now she cant drink after the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching with the Moderna covid vaccine/ she had itching. had itching on her head ,hands, and body) and ILL-DEFINED DISORDER (She used to drink some wine and now she cant drink after the Moderna vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Patients family all had good eyes. Her mom died at 87 with no sickness.  Family history included Alzheimer's disease (Patient's husband has Alzheimer's) since an unknown date. Concurrent medical conditions included Rheumatoid arthritis (A long time ago patient had a rheumatoid arthritis medicine.) and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching with the Moderna covid vaccine/ she had itching. had itching on her head,hands, and body) and ILL-DEFINED DISORDER (She used to drink some wine and now she cant drink after the Moderna vaccine). At the time of the report, PRURITUS (Itching with the Moderna covid vaccine/ she had itching. had itching on her head,hands, and body) was resolving and ILL-DEFINED DISORDER (She used to drink some wine and now she cant drink after the Moderna vaccine) had not resolved. It was reported that, the patient still had a little itching from vaccine. Just a little bit of itching left. She cannot put color on her hair right now. In Las Vegas reaction was not that bad. It got a little better. It took 9 months to get over it. It was reported that patient had no eye problems with Moderna vaccine. No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SULFASALAZINE; LISINOPRIL; VITAMIN D NOS; COQ10 [UBIDECARENONE]; NORETHINDRONE [NORETHISTERONE]. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". 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.   Clinical course: Patient took other medications in two weeks. Patient received Paxlovid for Covid-19 treatment. Treatment was started on 22Jun2022 stop date on 23Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Mar2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: foods: pineapple, carrots, apples; "vegetable allergy" (unspecified if ongoing), notes: foods: pineapple, carrots, apples. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: Feb2018; RED YEAST RICE, start date: Feb2019; KIRKLAND SIGNATURE FISH OIL, start date: Feb2019; NIACIN, start date: Feb2019; D3 50, start date: Feb2019. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient was treated with anti viral drugs (Lot number# GC9461) as a treatment for Covid-19 from 24Jun2022 to an unknown date in May2022. It was reported that the patient received other medications in two weeks of vaccine administration. Patient was taking Natures bounty (Zinc- 50mg) (Lot # 523179-03) from 24Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 14:00 as dose 1, single (Lot number: en6208), in left arm, on 05Apr2021 at 13:00 as dose 2, single (Lot number: er8737), in left arm, on 13Nov2021 at 14:00 as dose 3 (booster), single (Lot number: fh8020), in left arm and on 03May2022 at 14:00 as dose 4 (booster), single (Lot number: fk9894) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "known allergies arugula" (unspecified if ongoing), notes: known allergies arugula; "known allergies walnuts" (unspecified if ongoing), notes: known allergies walnuts; "known allergies eggplant" (unspecified if ongoing), notes: known allergies eggplant; "known allergies peppers" (unspecified if ongoing), notes: known allergies peppers; "Meniere's disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, 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) Unknown Results, notes: Experiencing rebound Covid after taking Paxlovid; (unspecified date) Negative, notes: Texted positive after testing negative; (23Jun2022) Positive, notes: Texted positive after testing negative; (Jun2022) Positive, notes: Still testing positive on day 8 after treatment ended. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: The patient was treated with Paxlovid from 15Jun2022 to 19Jun2022. Experiencing rebound Covid after taking Paxlovid, fours days (23Jun2022) after ending the 5 day treatment. Texted positive after testing negative. Still testing positive on day 8 after treatment ended. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient asked can she take Tylenol with it PAXLOVID as she can not find the answer in the paper that was in the PAXLOVID box, the print was tiny on the paper. Her fever was up again, and she can't find the answer. She has been 3 times vaccinated by Pfizer and she could not get the 4th dose. The patient had COVID-19. Report: 2GKIZXSP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 12:00 as dose 3 (booster) , single (Lot number: FH8020), in right arm and on 31Mar2022 at 18:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 77 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: "Lung cancer" (unspecified if ongoing), notes: Lung cancer; "Chemo/radiation summer of 2020", start date: 2020, stop date: 2020, notes: Chemo/radiation summer of 2020.; "immunotherapy" (ongoing), notes: Currently monthly immunotherapy. 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: (22Jun2022) negative, notes: Home Covid test on 22Jun2022-negative; (23Jun2022) positive, notes: Home Covid test 23Jun2022-positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient didn't taken any other medication in 2weeks. Home Covid test on 22Jun2022-negative. Sore throat, slight headache 25Jun2022. Home Covid test 23Jun2022-positive. Symptoms now include some loss of smell, taste, mild fever, itchy throat. No symptoms during first Covid.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 12:00 as dose number unknown (booster), single (Lot number: FH8027) at the age of 47 years for Covid-19 immunisation; CoviD-19 vaccine Janssen (COVID-19 VACCINE JANSSEN), on 30Mar2021 at 12:00 as dose 1, single (Lot number: 1802068) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer (Paxlovid), Treatment start date: 12Jun2022, Treatment stop date: 16Jun2022, lot number: G00470, Indication: Treatment of COVID-19. Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Drug ineffective, Covid 19 and the suspect drug cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 12:00 as dose number unknown (booster), single (Lot number: FH8027) at the age of 47 years for Covid-19 immunisation; CoviD-19 vaccine Janssen (COVID-19 VACCINE JANSSEN), on 30Mar2021 at 12:00 as dose 1, single (Lot number: 1802068) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer (Paxlovid), Treatment start date: 12Jun2022, Treatment stop date: 16Jun2022, lot number: G00470, Indication: Treatment of COVID-19. Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Drug ineffective, Covid 19 and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Jan2021 as dose 2, single (Lot number: EN6205) and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2559), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Heart issues" (unspecified if ongoing). Concomitant medication(s) included: Eliquis; Torsemide; Olmesartan; Metoprolol. 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, notes: on 11th day after testing positive and taken the Paxlovid woke up with severe cold symptoms. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: patient age group was elderly (65+ years), and current age was 74, current age units was months. She was vaccinated with other medication in 2 weeks anti viral drug like Paxlovid for COVID-19 treatment, with start date 11Jun2022 and stop date 16Jun2022. other medication details are she took Eliquis, Torsemide, Olmesartan, Metoprolol. on 11th day after testing positive and taken the Paxlovid woke up with severe cold symptoms. Have persisted since then. Cough, congestion, lost taste and smell, fatigue, no energy, with adverse event start date 21Jun2022 patient was not recovered, and treatment was received for the AE's methylprednisolone and Azithromycin. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) positive, notes: on day 8; (Jun2022) Negative, notes: on the day after treatment completion; (unspecified date) Unknown results, notes: Treatment of COVID-19. 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.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded.
Age: 45.0
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). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 14:00 as dose 2, single (Lot number: EN6205), in left arm and on 02Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative twice; Negative, notes: tested negative twice; Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: The patient has not taken any medications in 2 weeks. The patient took Paxlovid as a treatment drug for COVID-19. Treatment start date- 14Jun2022 and Treatment stop date- 19Jun2022. There were no known allergies and there was no other medical history reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6204), in left arm and on 14Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of DVT" (unspecified if ongoing); "May-Thurner's" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF, start date: 11Mar2022, stop date: 13Jun2022; ZYRTEC ALLERGY, start date: 08Jun2022, stop date: 08Jun2022; ZARBEE'S ALL NATURAL COUGH SYRUP NIGHTTIME, start date: 20Feb2020, stop date: 13Jun2022; RAINBOW [LEVODROPROPIZINE], start date: 31Aug2020. Past drug history included: Ct contrast, reaction(s): "Allergy"; Demerol for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Information: Other medications were given in 2 weeks were Fluticasone Propionate, Cetirizine, Elderberry Immune Support, Calcium Supplement with Magnesium and Vitamin D3 and Flonase. Paxlovid was prescribed as treatment for Covid-19. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Covid-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: The patient got Covid-19 infection. Clinical Course: The nurse calling for the Pfizer Covid-19 vaccine 5-11 years old.  She states that the patient received their first dose in Dec2021 and did not comeback. The patient got Covid-19 infection and was just never scheduled. The nurse would like to know if there is a deadline or should the patient need to restart the primary series. 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 limited information in the case, a possible causal association between the reported events Drug ineffective, Covid 19 and the suspect drug cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 as dose 2, single (Lot number: FW0151), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 45 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) positive; (unspecified date) Unknown result; (unspecified date) Negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: Adverse event-  Return of Covid-19 symptoms 7 days after finishing Paxlovid and a positive antigen test on day 8. I'd previously tested negative after finishing treatment. No follow-up attempts are possible. No further information is expected.