chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness at the injection site; redness at the injection site; fever of 101.2 degrees Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-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 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and PYREXIA (fever of 101.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.2 (High) 101.2 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 14-Dec-2021, the patient received the booster dose of Moderna COVID-19 vaccine in the right arm.  The patient had experienced no side effects or adverse events to the booster dose.  Treatment information was not reported by the reporter.   This case was linked to MOD-2022-568117 (Patient Link).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sore injection site arm; Injection site arm  with swelling; Redness at injection site; Itching at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm), VACCINATION SITE SWELLING (Injection site arm  with swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm), VACCINATION SITE SWELLING (Injection site arm  with swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm), VACCINATION SITE SWELLING (Injection site arm  with swelling), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had injection site which looked like a mosquito or spider bite. No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   This case was linked to MOD-2022-568158 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: patient had a very high fever of 102.7 degrees Farenheight which lasted for 7 hours; The patient received his first Moderna Covid-19 vaccine in 25JAN2021, patient received his second dose 1MAR2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (patient had a very high fever of 102.7 degrees Farenheight which lasted for 7 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna Covid-19 vaccine in 25JAN2021, patient received his second dose 1MAR2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-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 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna Covid-19 vaccine in 25JAN2021, patient received his second dose 1MAR2021). On an unknown date, the patient experienced PYREXIA (patient had a very high fever of 102.7 degrees Farenheight which lasted for 7 hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (patient had a very high fever of 102.7 degrees Farenheight which lasted for 7 hours) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna Covid-19 vaccine in 25JAN2021, patient received his second dose 1MAR2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.7 (High) 102.7 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received booster dose of the Moderna covid-19 vaccine on 14-Dec-2021 on right arm, lot number 039D21A expiration date was 02-JAN-2022. The patient had no side effects or adverse events to booster. The patient's fever had to be treated aggressively with opening his bedroom window to let cold air in and with consuming cold drinks. Cold wash cloth on his forehead and took his heavy blankets away. The patient took Tylenol alternating with Ibuprofen. This course of action took away the fever after 7 hours.   This case was linked to MOD-2022-568154 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning); vaccine administered after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) and PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) and PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Refrigerator expiration date was  05-Jun-2022 and vaccine was removed from refrigerator on 06-May-2022.  Puncture expiration date was reported as 12-May-2022  at 11:00pm (first punctured on 12-May-2022 at 11:00 am-kept in refrigerator through following morning)  On 13-May-2022 vaccine was administered to patient in the morning.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Haemoglobin, Memory impairment, Vaccination site pain
Clinical narrative: The patient reports having a poor memory. Patient does not recall when the memory problems started; Patient had blood work done showing that he is anemic and has a low Hemoglobin count; The patient recalls having a sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Patient had blood work done showing that he is anemic and has a low Hemoglobin count), MEMORY IMPAIRMENT (The patient reports having a poor memory. Patient does not recall when the memory problems started) and VACCINATION SITE PAIN (The patient recalls having a sore injection site arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (The patient recalls having a sore injection site arm). On 08-Apr-2021, the patient experienced ANAEMIA (Patient had blood work done showing that he is anemic and has a low Hemoglobin count). On an unknown date, the patient experienced MEMORY IMPAIRMENT (The patient reports having a poor memory. Patient does not recall when the memory problems started). At the time of the report, ANAEMIA (Patient had blood work done showing that he is anemic and has a low Hemoglobin count), MEMORY IMPAIRMENT (The patient reports having a poor memory. Patient does not recall when the memory problems started) and VACCINATION SITE PAIN (The patient recalls having a sore injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Haemoglobin: 12.9 (Low) 12.9.         Concomitant drugs were not reported.  Patient did not experience any adverse reactions or side effects after receiving his first Moderna Covid-19 vaccine.  Treatment details were not given.   This case was linked to MOD-2021-368881 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Therapeutic response unexpected
Clinical narrative: patient reported a positive reaction, these past colonoscopies had no polyps; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022L21A, 026O24A, 028N21A and 036A21A) for COVID-19 vaccination.     The patient had no allergies and had never been tested positive or diagnosed with COVID-19.  The patient's past medical history included Polyps (patient had  polyps since the last 17 years). Concurrent medical conditions included Blood pressure high (patient is on Blood pressure medication) and High cholesterol (patient is on High cholesterol medication).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (patient reported a positive reaction, these past colonoscopies had no polyps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: polyp (abnormal) patient had undergone 8 colonoscopies in the last 17 years and each report always had detected polyps and no polyps (normal) recent past colonoscopies had shown no polyps.         Concomitant medications included blood pressure medication and high cholesterol medication. No treatment information was provided.  On 24-Oct-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 06-Apr-2022, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient reported that the vaccination was the only positive thing that changed the patient's condition.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product preparation error
Clinical narrative: Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration; administered with expired vaccine 15-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 15-Apr-2022) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses administered were 11 doses, probably 3 vials. The vials were not stored in the refrigerator, they were directly thawed from the freezer before administration. No temperature excursions were reported. No patient administered with the vaccine has reported any event at the time of the call.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow-up received includes patient details and dose details added.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered with expired vaccine on 29-Apr-2022- 5 doses; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with expired vaccine on 29-Apr-2022- 5 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  The vial was initially not stored in the refrigerator they directly thaw them from the freezer before administration.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains significant information included patient demographics.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site movement impairment
Clinical narrative: report a possible side effect of the Moderna Booster; I cant move the arm. Cannot put arm behind my back or neck and shoulder/Patient said I had Left arm modality,Patient said I took booster on the left arm in November 2021.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (report a possible side effect of the Moderna Booster) and VACCINATION SITE MOVEMENT IMPAIRMENT (I cant move the arm. Cannot put arm behind my back or neck and shoulder/Patient said I had Left arm modality,Patient said I took booster on the left arm in November 2021.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced IMMUNISATION REACTION (report a possible side effect of the Moderna Booster) and VACCINATION SITE MOVEMENT IMPAIRMENT (I cant move the arm. Cannot put arm behind my back or neck and shoulder/Patient said I had Left arm modality,Patient said I took booster on the left arm in November 2021.). The patient was treated with Rehabilitation therapy (Patient had rehab and physical therapy) for Immunisation reaction and Rehabilitation therapy (Patient had rehab and physical therapy) for Vaccination site movement impairment. At the time of the report, IMMUNISATION REACTION (report a possible side effect of the Moderna Booster) and VACCINATION SITE MOVEMENT IMPAIRMENT (I cant move the arm. Cannot put arm behind my back or neck and shoulder/Patient said I had Left arm modality,Patient said I took booster on the left arm in November 2021.) outcome was unknown.            No concomitant medications were reported. It was reported that Patient does not take any medication on daily basis. Patient had Left arm modality. Patient started experiencing side effects as soon as patient came home. Patient was not able to provide any details on the lot number or the dates of vaccination. Treatment was reported as patient went to orthopedic, did rehab and physical therapy. Patient also took anti- inflammatory.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Live follow-up-Significant information received: Patient details, events added, reporter name updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Illness, Vaccination site pain
Clinical narrative: get second booster shot and it made her sick; she was in bed; soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product OBETICHOLIC ACID (OCALIVA) tablet for Primary biliary cholangitis.    Concurrent medical conditions included Primary biliary cholangitis, Pruritus, Nausea (Since 2013) since 2013 and Headache (Since 2013) since 2013.   On 23-Dec-2016, the patient OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. In 2021, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. On 25-Jun-2021, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram three times per week. On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and OBETICHOLIC ACID (OCALIVA) (Oral) 5 milligram three times per week. On an unknown date, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram three times per week and OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram. On 19-Apr-2022, the patient experienced ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site). At the time of the report, ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site) outcome was unknown.            Concomitant medication information was not provided by the reporter.  The causal relation of the events with Ocaliva was not reported.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was exposed to room temperature for 73-74 hours; The vial was first punctured on 13-May-2022 and administered on 16-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022 at 9:15 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 13-May-2022. It was first punctured on 13-May-2022 at 8.00 am Pacific Time and was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range 8 degree Celsius to 25 degree Celsius was 73-74 hours.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received. Added reporter, expiry date and time of Spikevax administration and updated lot number.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects have been mild or nonexistent, Unlike the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported that patient had Pfizer vaccine and boosters and patient did not trust products developed by J and J. CEP name was reported as Comirnaty Consumer Ad Testing.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear discomfort, Fatigue, Taste disorder
Clinical narrative: Bad taste; Clogged ears; Diarrhoea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy.    On 04-Sep-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired). At the time of the report, TASTE DISORDER (Bad taste), EAR DISCOMFORT (Clogged ears), DIARRHOEA (Diarrhoea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Patient took Pfizer on 11-May-2022 for indication of Treatment of COVID-19.Device Date was reported as 12-May-2022 No treatment medications were reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported The vials were not stored in the refrigerator and directly thawed them from the freezer before administration. The vial did not undergo any temperature excursions. No treatment medications were reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Condition aggravated, Cough, Drug ineffective
Clinical narrative: tested positive again; tested positive again; Symptoms are worse; congestion; cough; body aches; chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 11:00 as dose 1, single (Lot number: ER8735), in left arm, on 22Apr2021 at 11:00 as dose 2, single (Lot number: Ew0170), in right arm and on 14Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 3303BD) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 25Apr2022. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 07May2022, outcome "not recovered", described as "Symptoms are worse"; PAIN (non-serious) with onset 07May2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 07May2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 07May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took Paxlovid for 5 days after 1st day of positive test; Negative, notes: tested negative, on day 7; Positive, notes: came down with symptoms of covid again on day 10 and tested positive again. Therapeutic measures were not taken as a result of drug ineffective, covid-19, condition aggravated, nasal congestion, cough, pain, chills. Clinical course: Patient was received other medications in two weeks.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, SARS-CoV-2 test
Clinical narrative: tested positive again; tested positive again; Symptoms are worse; congestion; cough; body aches; chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 11:00 as dose 1, single (Lot number: ER8735), in left arm, on 22Apr2021 at 11:00 as dose 2, single (Lot number: Ew0170), in right arm and on 14Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 3303BD) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 25Apr2022. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 07May2022, outcome "not recovered", described as "Symptoms are worse"; PAIN (non-serious) with onset 07May2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 07May2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 07May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took Paxlovid for 5 days after 1st day of positive test; Negative, notes: tested negative, on day 7; Positive, notes: came down with symptoms of covid again on day 10 and tested positive again. Therapeutic measures were not taken as a result of drug ineffective, covid-19, condition aggravated, nasal congestion, cough, pain, chills. Clinical course: Patient was received other medications in two weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: Lisinopril; Hydrochlorothiazide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 day after the suspect product(s) administration, outcome "unknown" and all described as "Paxlovid: 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 the available reported information, the causal association between the event drug ineffective and Covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4382442-00. A 58-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160186) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Moderate to severe rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PAIN (non-serious), outcome "unknown", described as "achiness following Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. The reporter considered "Covid-19" related to BNT162b2. The reporter's assessment of the causal relationship of "achiness following Covid vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event drug ineffective, suspected Covid-19, pain cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: the 2nd was flu-like symptoms for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "the 2nd was flu-like symptoms for a day".  Additional information: Patient received no prior vaccinations. Patient enquired about any insight from company about medical problems after getting the Pfizer booster back in Oct2021. Patient received both other vaccines as Pfizer also. Patient stated that, unlike other two shots (the 1st was no symptoms and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. Case was reported as non serious. Patient stated that patient doesn't have the lot number but can email. Expiry date of Covid vaccine was unknown. Patient wanted to report some possible side effects from the vaccine. Patient had been having a lot of problems since patient received the vaccine. Consumer stated that, it's actually from the booster. So the first shot and the second shot were fine. There are normal symptoms (further clarifications unknown hence not captured as an event). There was nothing with the first one, the second was just like feels right. Consumer stated, no, don't have any medical conditions either. Investigations: No, lab test: Consumer stated, no not in last two weeks. They did initially one in the starting. Consumer stated, route of administration and anatomical site as, it was injection on upper left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Post procedural complication, Post procedural fistula, Rash, Vaginal discharge, Vaginal fistula
Clinical narrative: Vaginal fistula; Vaginal discharge; Post procedural complication; Post procedural fistula; Skin rash; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4381812-00 (Company).  A 51-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at cf, subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL FISTULA (hospitalization), outcome "not recovered"; VAGINAL DISCHARGE (hospitalization), outcome "unknown"; POST PROCEDURAL COMPLICATION (non-serious), outcome "unknown"; POST PROCEDURAL FISTULA (non-serious), outcome "unknown"; RASH (non-serious), outcome "not recovered", described as "Skin rash". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaginal fistula. Clinical course: On unknown dates, the patient experienced Fistula She was hospitalized after developed a fistula. Surgery was preformed to remove the fistula. Then, she developed vaginal leaking and another fistula. She was scheduled to have the surgery done again. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had rashes on both elbows, that she and her physician hoped the Humira would clear up, but it had not.   The reporter considered "vaginal fistula", "vaginal discharge", "post procedural complication", "post procedural fistula" and "skin rash" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lichen planus
Clinical narrative: I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster; LP flare after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Primary Immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster"; LICHEN PLANUS (non-serious), outcome "unknown", described as "LP flare after the vaccine".  Additional information: As reported patient was diagnosed with Vulvar Lichen planus after his covid-19 vaccine and after the booster, and had oral Lichen Planus. patient want to report LP flare after the vaccine. Patient was due for his next booster but worried about another flare  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Biopsy vulva, Lichen planus
Clinical narrative: I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster; LP flare after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Primary Immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster"; LICHEN PLANUS (non-serious), outcome "unknown", described as "LP flare after the vaccine".  Additional information: As reported patient was diagnosed with Vulvar Lichen planus after his covid-19 vaccine and after the booster, and had oral Lichen Planus. patient want to report LP flare after the vaccine. Patient was due for his next booster but worried about another flare  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID -19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: FD0810) at the age of 44 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: "I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005." (unspecified if ongoing), notes: I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005.; "I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005.", start date: 2005 (unspecified if ongoing), notes: I had primary spontaneous pneumothorax in both lungs and surgeries to resolve them in 2005. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", described as "COVID -19"; DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Negative; (18Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral (Ibuprofen) treatment was given from 08Apr2022 and treatment stop date was 13Apr2022. She tested negative for COVID on Saturday, April 16 after feeling great for a couple days. She began to get congestion in her head and throat in the evening on April 17. The next day she felt like she had a head cold. That evening, April 18, I took an over-the-counter COVID test and tested positive. The afternoon of April 19, she began to get fatigue and body aches and a cough. she took my temperature and it was in the high 99s Farenheit. On April 20 my temperature normalized, but my cough worsened. Her head cold symptoms were much improved by April 25, but her cough continued and still lingers today, May 9.  No follow up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2012; BASAGLAR, start date: Jan2014; OZEMPIC, start date: Jan2018; JARDIANCE, start date: Jan2016; RAMIPRIL, start date: Jan2012; ROSUVASTATIN, start date: Jan2017.   The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Negative; (10May2022) Positive; (29Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.   Clinical information: The patient had no known allergies. The patient had Rebound Covid Infection. The patient tested positive with symptoms 29Apr2022. The patient started and complied with 5-day course of Paxlovid for treatment of COVID-19 through 03May2022. Symptoms resolved antigen test negative on 05May2022. Developed URI symptoms on 09May2022. Antigen test positive on 10May2022.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain, Peripheral swelling, Pityriasis rosea, Rash
Clinical narrative: non- occlusive dvt right leg; pain; rash; skin eruption in right leg; pityriasis rosea; swelling and rash with skin eruption in right leg; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0185), on 22Jul2021 as dose 2, single (Lot number: EW0186) and on 14Jan2022 as dose 3 (booster), single (Lot number: FJ582) for covid-19 immunisation. The patient's relevant medical history included: "patient has htn" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE; TRAMADOL; CLONAZEPAM; OLMESARTAN; FUROSEMIDE; AMITRIPTYLINE; PEPCID AC; TRIAMCINOLONE ACETONIDE; ABILIFY; HEMOCYTE PLUS; DISULFIRAM; XARELTO. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "non- occlusive dvt right leg"; PAIN (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "skin eruption in right leg"; PITYRIASIS ROSEA (non-serious), outcome "unknown"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling and rash with skin eruption in right leg". The clinical course reported as Patient experienced pain, swelling and rash with skin eruption in right leg and diagnosed with non- occlusive dvt right leg and pityriasis rosea 20Feb2022. Optional information: patient has htn (Hypertension), diabetes, obesity, hyperlipidemia. Pfizer covid vaccine 1st dose 30jun21 (EW0185), 2nd dose 22Jul2021(EW0186), Booster 14Jan2022 (FJ582). Event took place after use of product.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.