chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: body aches; Fever, Low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A and 033F21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for an unknown indication.    The patient's past medical history included Pacemaker syndrome (Pacemaker Passed out and pulse got down to 32) on 12-Jun-2017, Sick sinus syndrome (had sick sinus syndrome, ultimate diagnosis.) on 12-Jun-2017 and Obesity (Obesity Confirmed weight loss of 80 pounds was before Paxlovid). Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) three tabs in the morning and three tabs at night. On an unknown date, the patient experienced PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 17-Jul-2022. At the time of the report, PAIN (body aches), PYREXIA (Fever, Low grade fever) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient clarified that first dose was not bad but experienced fever, body aches, low grade fever and tired.  No treatment drug details was reported.   This case was linked to MOD-2022-618147, MOD-2022-618142 (Patient Link).
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; administered 0.2 ml instead of 0.25 ml of the pediatric vaccine for 6 months to 5 years of age; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.2 ml instead of 0.25 ml of the pediatric vaccine for 6 months to 5 years of age) and NO ADVERSE EVENT (No adverse event) in a 16-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 02-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.2 ml instead of 0.25 ml of the pediatric vaccine for 6 months to 5 years of age). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.2 ml instead of 0.25 ml of the pediatric vaccine for 6 months to 5 years of age) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered 0.2 ml instead of 0.25 ml of the pediatric vaccine for 6 months to 5 years of age).    No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and MYALGIA (body aches) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Sick sinus syndrome. Concurrent medical conditions included Obesity (Obesity Confirmed. Started in high school, extra 15 pounds has been whole life.) and Pacemaker syndrome (Pacemaker Passed out and pulse got down to 32 and had sick sinus syndrome, ultimate diagnosis.) since 12-Jun-2017. Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.            No treatment medication reported by reporter.   This case was linked to MOD-2022-618147, MOD-2022-618090 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and MYALGIA (body aches) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Sick sinus syndrome. Concurrent medical conditions included Obesity (Obesity Confirmed. Started in high school, extra 15 pounds has been whole life.) and Pacemaker syndrome (Pacemaker Passed out and pulse got down to 32 and had sick sinus syndrome, ultimate diagnosis.) since 12-Jun-2017. Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.            No treatment medication reported by reporter.   This case was linked to MOD-2022-618147, MOD-2022-618090 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Gait disturbance, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING; Pain legs; Neck pain; Swelling of limbs/HANDS/FEET SWELLED; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING), PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING), PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain). At the time of the report, GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING) outcome was unknown and PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain) had not resolved.            The patient had other concomitant therapy of steroids. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial Humira formulation was Solution for injection in pre-filled pen No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Leg pain; Painful arm; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Leg pain) and PAIN IN EXTREMITY (Painful arm) 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 ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Ache). On 21-Jul-2022, the patient experienced PAIN IN EXTREMITY (Painful arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain). In July 2022, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, PAIN (Ache) had resolved and PAIN IN EXTREMITY (Leg pain) outcome was unknown.     No concomitant medications was reported. No treatment medications was reported.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Fatigue, Psoriasis, Skin disorder
Clinical narrative: Skin disorder; Psoriasis flare-up; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Skin disorder), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On 21-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Apr-2022, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced SKIN DISORDER (Skin disorder), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, SKIN DISORDER (Skin disorder) and PSORIASIS (Psoriasis flare-up) had not resolved and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  The reporter's causality for the events of dark spots, felt tired and broke out with plaque psoriasis with respect to the Humira was not provided.  The reporter's causality for the events of Dark spots, felt tired and broke out with plaque psoriasis with respect to the Pfizer Biontech was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Stress
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis. The patient's past medical history included Ulcerative colitis. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA). At the time of the report, SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event's of Skin disorder and Stress was not provided for Humira. No treatment drug details was reported. Reporter did not allow further contact.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Gastritis, Gastrooesophageal reflux disease, Influenza like illness, Muscle spasms
Clinical narrative: Flu like symptoms; Gastritis; GERD; NIGHT CRAMPS IN LEG; Constipation; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD), MUSCLE SPASMS (NIGHT CRAMPS IN LEG), INFLUENZA LIKE ILLNESS (Flu like symptoms), GASTRITIS (Gastritis) and CONSTIPATION (Constipation) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1st dose. In June 2022, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD), MUSCLE SPASMS (NIGHT CRAMPS IN LEG) and GASTRITIS (Gastritis). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and CONSTIPATION (Constipation). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had not resolved, MUSCLE SPASMS (NIGHT CRAMPS IN LEG) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and GASTRITIS (Gastritis) and CONSTIPATION (Constipation) had resolved.            Concomitant medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter causality was reported as probable for the event GERD and not reported for other events with respect to HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB).  Treatment information was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes).    No patient reported being pregnant. Patient did not report being immunocompromised.  Patient received the 2nd booster of the Moderna vaccine. Patient do not have any medication record. Date the vial initially stored in the refrigerator was on 29Jul2022. Date and time vial first punctured was on 01Aug2022 at 09:30 am. Date of administration of vaccine was on 1st 02Aug2022 at 10 am and administered every 15 minutes after 10 am until 11 am. The vial stored in room temperature post puncture. The vial did not undergone any temperature excursions. Patient did not report having side effects.  No treatment medications were reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 88-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "OSA" (unspecified if ongoing); "aortic stenosis" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; ASPIRIN [ACETYLSALICYLIC ACID]; ACETAMINOPHEN; VITAMIN D NOS. Past drug history included: Bactrim, reaction(s): "Drug Allergy", notes: Known allergies: Bactrim; Mesalamine, reaction(s): "Drug Allergy", notes: Known allergies: mesalamine; Leuprolide, reaction(s): "Drug Allergy", notes: Known allergies: leuprolide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: positive COVID RAT; (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Jul2022 to 23Jul2022.  Clinical Course: Reported as, Recurrence of COVID symptoms 3 days after completing Paxlovid with positive COVID RAT after negative test on day 5 of treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid 19 cannot be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Rebound COVID. After testing negative on Day 6; Positive, notes: tested positive on Day 10 of COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, the patient received antiviral COVID 19 treatment with Paxlovid orally from 20Jul2022 to 24Jul2022. It was reported that the patient has rebound COVID. After testing negative on Day 6 and sx had improved the patient began to have sx again and tested positive on Day 10 of COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies to Dogs/Cats" (unspecified if ongoing); "Allergies to Dustmites" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; SPIRONOLACTONE; ESCITALOPRAM; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (09Jul2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Jun2022) covid positive line faded to almost invisible; (01Jul2022) positive, notes: covid positive line faded to almost invisible by 29Jun2022 but strongly visible on 01Jul2022; (09Jul2022) slowly faded, notes: covid positive line faded to almost invisible by 29Jun2022 but strongly visible on 01Jul2022 and slowly faded until 09Jul2022 when it was no longer visible (tested every 2 days). Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti-viral medications of Paxlovid (Lot number: GC4027) for treatment of COVID-19 from 22Jun2022 to 27Jul2022. Additional information: Other medication within 2 weeks: Montelukast (Brand Camber), Spironolactone (Brand: Amneal), Escitalopram (Brand: Lupin), Omeprazole (Brand: Zydus), Zyrtec and Albuterol.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Petechiae, Rash macular, Vaccination site bruising, Vaccination site pain
Clinical narrative: 'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; The baby did try to pull her leg, but she may have some pain from the injection; 'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  An 11-week-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 28Jul2022 as dose 1, single (Lot number: FG5300, Expiration Date: Apr2024) at the age of 11 weeks, in left thigh for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pentacel, for Immunization; Hep b, for Immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 29Jul2022, outcome "unknown" and all described as "'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered"; VACCINATION SITE PAIN (non-serious) with onset 29Jul2022, outcome "unknown", described as "The baby did try to pull her leg, but she may have some pain from the injection". The events "'blotchy bruised rash' (petetchae like) in the lower leg from the knee to the bottom of the foot, scattered" and "the baby did try to pull her leg, but she may have some pain from the injection" required physician office visit.  Additional information: The physician said it was a blotchy bruised rash on leg from her knee down to the bottom of her foot. The presentation of the rash is scattered. She doesn't think it is serious. The child was acting herself. She was able to hold the baby's foot on the table. The baby did try to pull her leg, but she may have some pain from the injection. The baby has full range of movement. It doesn't look deep. The parents didn't mention anything on 28Jul2022. The parents noticed in the morning of 29Jul2022 and sent the doctor a picture. The event did not require an emergency room visit. The doctor had the patient come in. This was her 2 months shots, and first time getting this vaccine. The doctor spaces her vaccines out, so the infant received Pentacel and Hep B two weeks ago. Causality: it is hard to tell if the vaccine caused the rash. It is likely related because it is in the same leg, and the same lower part of leg. There is no other explanation. The parents denied the leg getting caught on anything or something like that. The bruise was very local. It wasn't scattered bruising or she would have done blood work. There were no other rashes.  Follow-up attempts are completed. No further information is expected.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site rash
Clinical narrative: 'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; The baby did try to pull her leg, but she may have some pain from the injection; 'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  An 11-week-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 28Jul2022 as dose 1, single (Lot number: FG5300, Expiration Date: Apr2024) at the age of 11 weeks, in left thigh for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pentacel, for Immunization; Hep b, for Immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 29Jul2022, outcome "unknown" and all described as "'blotchy bruised rash' (Petetchae like) in the lower leg from the knee to the bottom of the foot, scattered"; VACCINATION SITE PAIN (non-serious) with onset 29Jul2022, outcome "unknown", described as "The baby did try to pull her leg, but she may have some pain from the injection". The events "'blotchy bruised rash' (petetchae like) in the lower leg from the knee to the bottom of the foot, scattered" and "the baby did try to pull her leg, but she may have some pain from the injection" required physician office visit.  Additional information: The physician said it was a blotchy bruised rash on leg from her knee down to the bottom of her foot. The presentation of the rash is scattered. She doesn't think it is serious. The child was acting herself. She was able to hold the baby's foot on the table. The baby did try to pull her leg, but she may have some pain from the injection. The baby has full range of movement. It doesn't look deep. The parents didn't mention anything on 28Jul2022. The parents noticed in the morning of 29Jul2022 and sent the doctor a picture. The event did not require an emergency room visit. The doctor had the patient come in. This was her 2 months shots, and first time getting this vaccine. The doctor spaces her vaccines out, so the infant received Pentacel and Hep B two weeks ago. Causality: it is hard to tell if the vaccine caused the rash. It is likely related because it is in the same leg, and the same lower part of leg. There is no other explanation. The parents denied the leg getting caught on anything or something like that. The bruise was very local. It wasn't scattered bruising or she would have done blood work. There were no other rashes.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuralgia, Pain, SARS-CoV-2 test
Clinical narrative: Severe body aches; Fatigue; Nerve pain that went on for about 8 months. Has recently diminished to tolerable levels.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6200, Location of injection: Arm Left), administration date: 04Mar2022, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: En6200, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 12Nov2021, outcome "recovering"; NEURALGIA (non-serious) with onset 12Nov2021, outcome "recovering", described as "Nerve pain that went on for about 8 months. Has recently diminished to tolerable levels."; PAIN (non-serious) with onset 12Nov2021, outcome "recovering", described as "Severe body aches". The events "severe body aches", "fatigue" and "nerve pain that went on for about 8 months. has recently diminished to tolerable levels." required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue, neuralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Patient did not receive any other vaccine in four weeks. Patient received Multi vitamin in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, patient has not been tested for COVID-19. It was reported that patient experienced severe body aches, fatigue, nerve pain that went on for about 8 months. Has recently diminished to tolerable levels.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling in arms; Extreme fatigue; sleeping 18 or more hrs a day.; Loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 15:45 as dose 1, single (Lot number: FK9893) at the age of 69 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: FATIGUE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Loss of appetite"; CHILLS (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered"; SLEEP DISORDER (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "sleeping 18 or more hrs a day."; PARAESTHESIA (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "tingling in arms". The events "tingling in arms", "extreme fatigue", "sleeping 18 or more hrs a day.", "loss of appetite" and "chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, fatigue, sleep disorder, decreased appetite, chills.  Additional information: Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: No. No other medications in two weeks. No other vaccine in four weeks. Extreme fatigue for over 3 months, sleeping 18 or more hours a day. Loss of appetite, chills, tingling in arms. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. No treatment for AE. No COVID prior to vaccination.  No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: tingling in arms; Extreme fatigue; sleeping 18 or more hrs a day.; Loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 15:45 as dose 1, single (Lot number: FK9893) at the age of 69 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: FATIGUE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "Loss of appetite"; CHILLS (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered"; SLEEP DISORDER (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "sleeping 18 or more hrs a day."; PARAESTHESIA (non-serious) with onset 18Apr2022 at 13:00, outcome "not recovered", described as "tingling in arms". The events "tingling in arms", "extreme fatigue", "sleeping 18 or more hrs a day.", "loss of appetite" and "chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, fatigue, sleep disorder, decreased appetite, chills.  Additional information: Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: No. No other medications in two weeks. No other vaccine in four weeks. Extreme fatigue for over 3 months, sleeping 18 or more hours a day. Loss of appetite, chills, tingling in arms. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. No treatment for AE. No COVID prior to vaccination.  No follow-up attempts possible. No further information expected.
Age: 62.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 62 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: "Lupus" (unspecified if ongoing); "Long QT syndrome" (unspecified if ongoing); "Cardiomyopathy" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BENADRYL. Past drug history included: Sulfasoxizole, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received vaccine. Had other medications in 2 weeks with Levothyroxine and Benadryl. On an unknown date patient received COVID-19 treatment started on 22Jul2022 and ended on 27Jul2022 having lot number 2815213.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2 .
Age: 78.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown), on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks brand=Lyrica 75mg tid, Citalopram 40mg and Finasteride 5mg. Treatment Paxlovid, Treatment start date=19Jul2022 , Treatment stop date=24Jul2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: ENS318), in left arm, on 22Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 6SK21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing), notes: name of drug as reported: no. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient received Paxlovid as COVID-19 treatment from 22Jul2022 to 27Jul2022. The patient was not taking any other medications within 2 weeks of starting COVID-19 treatment. COVID relapsed (on 28Jul2022) 2 days after completion of 5 days Paxlovid treatment. No symptoms. Feeling fine, but COVID positive after COVID negative. Relevant past drug history: name of drug as reported: no, reaction: allergy.
Age: 53.0
Sex: M
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 54-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Prostate cancer (prostatectomy)" (unspecified if ongoing), notes: Prostate cancer (prostatectomy); "Ulcerative colitis" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative; (27Jul2022) Positive; (30Jul2022) Positive; (unspecified date) Negative; (18Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient was did not reported any Seriousness criteria. The Paxlovid treatment start date 18Jul2022 and stop date 22Jul2022 was received. The patient received other medication details was in 2weeks product Spironolactone/Hydrochlorothiazide 25mg/25mg tablet and Mesalamine 1000 mg suppository and Other was used OTC Medications. The started experiencing COVID-19 symptoms on 17Jul while traveling out of state. He went to an urgent care clinic on 18Jul to be tested using PCR, and the doctor prescribed Paxlovid and initial infection resolved within 5 days by the end of the Paxlovid treatment. He tested negative on 22Jul using a home rapid test. He felt fine for the next 4 days and tested negative on 26Jul using a PCR test. On 27Jul I started experiencing symptoms again and took a home rapid test which showed positive. He then had a second "rebound" infection starting on 27Jul. I tested positive today (30Jul) using a home rapid test, and am still feeling sick but my health was improving on adverse event start date 27Jul2022. The AE resulted in None of the above. The patient recovered Recovering and no treatment for AE. The other medical history High blood pressure, Prostate cancer (prostatectomy), Ulcerative colitis and Device Date: 30Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  Additional information: Known allergies was none; Anti-viral details included Product COVID 19 Treatment with Brand Paxlovid which treatment start date was 14Jul2022 & treatment stop date was 18Jul2022 for indication treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 at 13:00 as dose 2, single (Lot number: EN6199), in left arm and on 22Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Feb2022 at 13:00 as dose 4 (booster), single (Lot number: 007J21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of Vaccine products" (unspecified if ongoing). The patient had no known allergies. 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Jul2022) Negative, notes: Tested negative 21Jul2022; (27Jul2022) Positive, notes: Tested positive again 27Jul2022 with a return of symptoms; (30Jul2022) Positive, notes: Still symptomatic and testing positive on 30Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: The patient tested negative on 21Jul2022 with cessation of all symptoms by 23Jul2022. The patient received treatment with Paxlovid from 15Jul2022 to 19Jul2022 for COVID-19.