chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID test; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (positive COVID test) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus syndrome.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive COVID test). At the time of the report, COVID-19 (positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication was reported. It was reported that the patient needed a monoclonal antibody treatment. It was reported that the patient needed infusion No treatment medication was provided.  Company comment- This spontaneous concerns a female patient of unknown age with relevant medical history of Lupus, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a third dose of mRNA-1273 vaccination. Outcome of the events was unknown at the time of this report. The relevant medical history of Lupus can be a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous concerns a female patient of unknown age with relevant medical history of Lupus, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a third dose of mRNA-1273 vaccination. Outcome of the events was unknown at the time of this report. The relevant medical history of Lupus can be a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: It was reported that patient had soreness after getting COVID booster shot.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (It was reported that patient had soreness after getting COVID booster shot.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 20-Nov-2020, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) .07 microgram/kilogram. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN (It was reported that patient had soreness after getting COVID booster shot.). At the time of the report, PAIN (It was reported that patient had soreness after getting COVID booster shot.) outcome was unknown.            The concentration of co-suspect reported as 2.5 mg/ml The current dose 0.070 µg/kg  of co-suspect was reported as continuous, IV route. No treatment drugs were reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The vial was initially stored in the refrigerator was on 22-Jun-2022, the vial was first punctured on 29-Jun-2022 around 11 am, the vaccine was administered on 30-Jun-2022 at approximately 3 pm, the vial was stored at room temperature post puncture, the vial did not undergo any temperature excursions and the total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was 28 hours.  The reporter reported that the patient had not reported any adverse event.  No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: flu-like symptoms with primary doses after 2nd dose; mild achiness; site was a letter red and a little tender; site was a letter red and a little tender; feverish; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID.  Concurrent medical conditions included Acid reflux (oesophageal), Restless leg syndrome, Hashimoto's thyroiditis (Hashimoto's thyroiditis), Blood pressure high (High Blood pressure), Drug allergy (Sulfa drugs), Iodine contrast media allergy (Iodine contrast) and Seasonal allergy (Seasonal allergies). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Hashimoto's thyroiditis, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Restless leg syndrome.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness) outcome was unknown.            Patient's height was reported as 5'5.  Patient did not receive any other vaccines prior within 1 month to Moderna vaccination.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-598147, MOD-2022-598106 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: flu-like symptoms with primary doses after 2nd dose; mild achiness; site was a letter red and a little tender; site was a letter red and a little tender; feverish; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID.  Concurrent medical conditions included Acid reflux (oesophageal), Restless leg syndrome, Hashimoto's thyroiditis (Hashimoto's thyroiditis), Blood pressure high (High Blood pressure), Drug allergy (Sulfa drugs), Iodine contrast media allergy (Iodine contrast) and Seasonal allergy (Seasonal allergies). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Hashimoto's thyroiditis, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Restless leg syndrome.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms with primary doses after 2nd dose), VACCINATION SITE ERYTHEMA (site was a letter red and a little tender), VACCINATION SITE PAIN (site was a letter red and a little tender), PYREXIA (feverish) and PAIN (mild achiness) outcome was unknown.            Patient's height was reported as 5'5.  Patient did not receive any other vaccines prior within 1 month to Moderna vaccination.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-598147, MOD-2022-598106 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was first punctured on 29-Jun-2022 around 1 PM and administered to patient on 30-Jun-2022 around 3 PM; Vaccine was administered past the 12 hour puncture period; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the 12 hour puncture period) and PRODUCT STORAGE ERROR (The vial was first punctured on 29-Jun-2022 around 1 PM and administered to patient on 30-Jun-2022 around 3 PM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the 12 hour puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 29-Jun-2022 around 1 PM and administered to patient on 30-Jun-2022 around 3 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the 12 hour puncture period) and PRODUCT STORAGE ERROR (The vial was first punctured on 29-Jun-2022 around 1 PM and administered to patient on 30-Jun-2022 around 3 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose for suspect product was reported as second booster dose. It was reported that patient was on a few maintenance medications.  It was reported that the vial (1 dose from 1 vial) was initially stored in refrigerator on 28-Jun-2022 and was punctured first on 29-Jun-2022 around 1PM. The vial was stored at room temperature post puncture for  around 26 hours and was administered to patient on 30-Jun-2022 around 3 PM. The vial did not undergo any temperature excursion. It was also reported that patient was not experiencing any symptoms and no treatment was given.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Lot number: FH8028), in left arm and on 11Apr2022 as dose 2, single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: LEVOTHYROXINE, start date: Oct2017. 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: (unspecified date) unknown results, notes: Treatment of COVID-19; (25Jun2022) Negative, notes: COVID symptoms returned 2 days after initial 10-day course of quarantine and testing negative; (27Jun2022) Positive, notes: Retesting 2 days later was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: COVID symptoms returned 2 days after initial 10-day course of quarantine and testing negative. Retesting 2 days later was positive.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for levothyroxine sodium was unknown.   Additional information: Additional Information: Patient took Synthroid and had elevated TSH levels in the more recent labs. Patient was not having any symptoms but TSH level were very elevated. As per patient, it could be reaction from covid vaccine /reagents as he did the research internationally. His doctor thought he was not taking Synthroid. It was reported that patient was well.  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: came out positive; came out positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "came out positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Because I was tested positive for COVID I have been vaccinated (Unspecified Vaccine) twice with Pfizer; Negative, notes: I took a test for the one in the little box and it came out negative; Positive, notes: I did again the test. It came out positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Because patient was tested positive for COVID she had been vaccinated, twice with Pfizer. She got a mild cold and she was thinking it was just a flu and that was on Thursday and then she thought it was just a flu and Friday she took a test for the one in the little box and it came out negative. So she was thinking it is only the flu and then she became more sick and Friday, Saturday, Sunday  she did again the test. It came out positive. Then she was very, very sick from COVID. But yesterday her cough had diminished a little a lot and her body ache had diminished too. But her Doctor called her concerned that she had COVID and he said to her, they were going to send you something that was going to make you feel a lot better. They send her Paxlovid but she thought that was like poison.  It almost killed me. Consumer stated, no medication. She was only taking the medication for her thyroid but she told her doctor she was not going to take her thyroid medication while she was taking these Pfizer thing because she did not know if it was going to do a bad reaction so he say it was you can choose take not a problem. But she still did not take the medication. Treatment she mentioned she just took Pedialyte.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: extremely tired; site of the injection was a bit sore/lift my arm up there is a heaviness/tightness in the area of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TART CHERRY; OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE]. Past drug history included: Demerol, reaction(s): "known allergies:Demerol"; Erythromycin for Known allergies: Erythromycin. Vaccination history included: BNT162b2 (DOSE: 1, SINGLE; Lot No: EP7533; Anatomical location: Arm Left), administration date: 13Apr2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, SINGLE; Lot No: ER8733; Anatomical location: Arm Right; Vaccine Administration Time: 02:15 PM), administration date: 06Jul2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Feb2022, outcome "not recovered", described as "extremely tired"; VACCINATION SITE DISCOMFORT (non-serious) with onset 24Feb2022, outcome "not recovered", described as "site of the injection was a bit sore/lift my arm up there is a heaviness/tightness in the area of the injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, vaccination site discomfort.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 09:00 as dose number unknown, single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (28Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment from 16Jun2022 to 20Jun2022.  On 28Jun2022, a rebound infection occurred including sore throat, dry cough and fatigue. Positive Covid test.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-month-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 28Jun2022 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 15 months intramuscular, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 28Jun2022 at 15:30, outcome "recovered", described as "Fever of 101". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: It was reported that facility type vaccine was Doctor's office/urgent care. No other vaccine in four weeks. No covid tested post vaccination. No Known allergies. It was reported that patient had no other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, Headache
Clinical narrative: My head hurts; My bones hurt all over; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer), Program ID: (133943).  A 53-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 22Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; palbociclib (IBRANCE), since 22Jun2022 (ongoing) at 125 mg cyclic (125 mg, cyclic (daily on days 1 through 21 of each 28 day cycle)), oral for breast cancer. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: BONE PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "My bones hurt all over"; HEADACHE (non-serious) with onset Jun2022, outcome "unknown", described as "My head hurts". The action taken for palbociclib was dosage not changed. Additional information: Reporter seriousness for bones and head hurt: Unspecified. Patient had her first covid booster and started Ibrance the same time. Her bones hurt all over and her head hurts. Patient wasn't sure what caused it. The adverse event was non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye; Age at Vaccination: 2 yo; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 2-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 29Jun2022 at 13:45 as dose 1, single (Lot number: FT9142) at the age of 2 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included(in two weeks): FLUORIDE [SODIUM FLUORIDE]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 29Jun2022 at 13:45, outcome "unknown", described as "Age at Vaccination: 2 yo"; RASH (non-serious) with onset 29Jun2022 at 15:45, outcome "not recovered", described as "generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye". Therapeutic measures were not taken as a result of rash. Additional information: Within 2 hours of receiving vaccine, developed generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye. Didn't seem to be itchy or bothersome. No fever. Patient had no known allergies. The patient had not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin G decreased, Fatigue, Impaired work ability, Inflammatory pain
Clinical narrative: severe inflammatory pain in my hands, wrists, forearms; debilitating nausea; muscle spasms in my right arm; extreme fatigue; IGG level is critically low; I am desperate i cannot work; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Avascular necrosis" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "Severe nausea", "headache", "sweating with chills", "sweating with chills", "chest pain", "injection site soreness", "shaking hands"; BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "sore throat". The following information was reported: IMPAIRED WORK ABILITY (non-serious) with onset 28Feb2021, outcome "not recovered", described as "I am desperate i cannot work"; BLOOD IMMUNOGLOBULIN G DECREASED (non-serious) with onset 28Feb2021, outcome "not recovered", described as "IGG level is critically low"; NAUSEA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "debilitating nausea"; FATIGUE (non-serious) with onset 28Feb2021, outcome "not recovered", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "muscle spasms in my right arm"; INFLAMMATORY PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "severe inflammatory pain in my hands, wrists, forearms". The events "severe inflammatory pain in my hands, wrists, forearms", "debilitating nausea", "muscle spasms in my right arm", "extreme fatigue", "igg level is critically low" and "i am desperate i cannot work" 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 inflammatory pain, nausea, muscle spasms, fatigue, blood immunoglobulin g decreased, impaired work ability.  Additional information: Patient had no COVID prior vaccination. Patient had no other vaccine in four weeks. Patient had no known allergies. Orthopaedist, Rheumatologist, Neurologist, Immunologist no one can account for patient's debilitating symptoms that started right after my 2nd vaccine.  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: Muscle spasms, Nausea, SARS-CoV-2 test
Clinical narrative: severe inflammatory pain in my hands, wrists, forearms; debilitating nausea; muscle spasms in my right arm; extreme fatigue; IGG level is critically low; I am desperate i cannot work; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Avascular necrosis" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, for Covid-19 immunization, reaction(s): "Severe nausea", "headache", "sweating with chills", "sweating with chills", "chest pain", "injection site soreness", "shaking hands"; BNT162b2 (Dose 1, single, Lot number: EJ1686 , Administration time: 09:30 AM, Vaccine location: Left arm), administration date: 04Jan2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "sore throat". The following information was reported: IMPAIRED WORK ABILITY (non-serious) with onset 28Feb2021, outcome "not recovered", described as "I am desperate i cannot work"; BLOOD IMMUNOGLOBULIN G DECREASED (non-serious) with onset 28Feb2021, outcome "not recovered", described as "IGG level is critically low"; NAUSEA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "debilitating nausea"; FATIGUE (non-serious) with onset 28Feb2021, outcome "not recovered", described as "extreme fatigue"; MUSCLE SPASMS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "muscle spasms in my right arm"; INFLAMMATORY PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "severe inflammatory pain in my hands, wrists, forearms". The events "severe inflammatory pain in my hands, wrists, forearms", "debilitating nausea", "muscle spasms in my right arm", "extreme fatigue", "igg level is critically low" and "i am desperate i cannot work" 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 inflammatory pain, nausea, muscle spasms, fatigue, blood immunoglobulin g decreased, impaired work ability.  Additional information: Patient had no COVID prior vaccination. Patient had no other vaccine in four weeks. Patient had no known allergies. Orthopaedist, Rheumatologist, Neurologist, Immunologist no one can account for patient's debilitating symptoms that started right after my 2nd vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing), notes: heart disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid as Covid-19 treatment from 16Jun2022 to 21Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3(booster), single (Lot number: FC3183) at the age of 73 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot: EN6202 , Expiry: Jun2021), administration date: 04Mar2021, when the patient was 72-year-old, for Covid-19 immunization; Bnt162b2 (Second dose: Date administered: Mar2021, she can't read the second digit in the day of the month-the first digit is 2, but the second digit she can't tell, it might be 24Mar2021, but she can't be sure of that; this was from the vaccine record card. , Lot: She was trying to read what they wrote on the vaccine record card, thinks it may be EP6955. NDC/Expiry: Unknown, not on the vaccine record card.), administration date: Mar2021, when the patient was 72 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient also received fourth dose on 28Jun2022 (Lot number: FM0173) at the age of 73 years for covid-19 immunization. And the patient is in excellent health. The patient age at vaccine was retained as 73 Years as per DOB. Event COVID-19 was deleted with DOSE 1 and 2 as it was reported that the patient has never had COVID. She mentioned separately that her blood pressure can get a little high, so she takes the lowest dose of Lisinopril when it gets a little high which is 1 pill a day. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). An 89 old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, Unknown manufacturer), for covid-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "patient has had sore throat after receiving COVID booster shot". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Platelet transfusion
Clinical narrative: Platelet transfusion; 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-163-4445836-00.  An 81-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; venetoclax (VENCLEXTA), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET TRANSFUSION (hospitalization), outcome "unknown". The action taken for venetoclax was unknown.  The reporter considered "platelet transfusion" related to BNT162b2.  Additional information:  Patient was hospitalized and needed platelet blood transfusion. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of platelet blood transfusion with VENCLEXTA (VENETOCLAX) was no reasonable possibility.  Company's opinion is that there is no reasonable possibility that the event of platelet blood transfusion is related to VENCLEXTA (VENETOCLAX).  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 information in the case report, a possible causal relationship between the reported event: "Platelet transfusion" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing). Concomitant medication(s) included: VALTREX. Vaccination history included: BNT162b2 (Dose 1, Site of injection: Left Deltoid, Route: IM, Batch/Lot number: EH9899), administration date: 29Dec2020, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, Site of injection: Right Arm, Route: IM, Batch/Lot number: EL1283), administration date: 15Jan2021, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 3, Site of injection: Right Arm, Route: IM, Batch/Lot number: FD0809), administration date: 05Sep2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset Apr2022, outcome "unknown", described as "Muscle aches/pains"; CHILLS (non-serious) with onset Apr2022, outcome "unknown", described as "Sever chills with rigors".
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Oral herpes
Clinical narrative: not eating and drinking fluids as much as she usually does; herpetic gingivostomatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL HERPES (non-serious) with onset Jun2022, outcome "unknown", described as "herpetic gingivostomatitis"; DECREASED APPETITE (non-serious) with onset 26Jun2022, outcome "unknown", described as "not eating and drinking fluids as much as she usually does".  Additional information: It was reported that patient (reporters daughter) who was two got vaccinated with her first dosage of Pfizer. Two days later she started not eating and drinking fluids as much as she usually does. The patient later started pointing non-stop to her mouth due to something bothering her. The before day of report, she was taken to the dentist to see if they saw something the reporter didn't see and dentist confirmed that she had herpetic gingivostomatitis. The patient was 100 % healthy before getting her vaccine. They believe that she was having a side effect.   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: Crohn's disease, Drug level, Inflammatory marker increased, Investigation, Nasopharyngitis
Clinical narrative: Common cold; Crohn's disease aggravated; Inflammatory marker increased; 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-163-4443121-00.  A 16-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from Dec2021 (Lot number: 1160679) to Mar2022 at 40 mg 2x/week (citrate free 40 mg, 2x/week), second regimen from Mar2022 (Lot number: 1160679) to Jun2022 at 40 mg weekly and third regimen since Jun2022 (ongoing) (Lot number: 1160679) at 40 mg weekly, all subcutaneous. The patient's relevant medical history included: "Non Tobaco user" (unspecified if ongoing); "Abstains From Alcohol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration: Intramuscular), administration date: 2021, for Covid-19 Vaccination; Bnt162b2 (Dose:2, Route of administration: Intramuscular), administration date: 2021, for Covid-19 Vaccination. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jun2022, outcome "recovered" (17Jun2022), described as "Common cold"; CROHN'S DISEASE (medically significant) with onset 2022, outcome "not recovered", described as "Crohn's disease aggravated"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Drug level: (2022) High; Inflammation level: (2022) High. The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "crohn's disease aggravated" related to BNT162b2. The reporter's assessment of the causal relationship of "inflammatory marker increased" and "common cold" 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.  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 information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; body aches; 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-163-4448417-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160838), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Solicited report by a consumer of an adult female with events of non-serious COVID-19 and BODY ACHES with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced COVID-19 and BODY ACHES. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB) for the event(s) of COVID-19 and BODY ACHES was not provided. The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE UP ON ARMS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The reporter considered "covid-19" and "body aches" related to BNT162b2.  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 known drug safety profile, there is reasonable possibility of causal association between the events "covid-19" and "body aches"  and the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s):  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; treprostinil sodium (TREPROSTINIL SODIUM), since 20Nov2020 (ongoing) (Lot number: 939656, Expiration Date: 31Jan2023) at 0.07 ug/kg (0.070 ug/kg), iv drip for pulmonary arterial hypertension. The patient's relevant medical history included: "pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: OPSUMIT. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Soreness". The action taken for treprostinil sodium was unknown.  Addition information: This is a 56 years old, 112 lb female patient began therapy with Remodulin (treprostinil sodium, concentration 2.5 mg/ml), on 20Nov2020 for primary pulmonary arterial hypertension. The current dose was reported as 0.070 µg/kg, continuous via intravenous (IV) route. On an unreported date in 2022, the patient experienced the event of soreness (pain). It was reported that patient had soreness after getting COVID booster shot. The reporter did not provide causality for the event of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.