chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Malaise, Product preparation issue
Clinical narrative: malaise; only received Adjuvant portion; only received Adjuvant portion; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2022, the patient received the 2nd dose of Shingrix. On 3rd January 2021, less than a day after receiving Shingrix, the patient experienced malaise, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the malaise was not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: This reporter was the concerned patient. The patient received a dose of Shingrix and since the date of injection patient was feeling malaise which had not gone away at the time of reporting. Upon health care professional preparing the injection, the patient noted that they only withdrew liquid from one vital and did not reconstituted into the powder vital. After receiving the shot, the patient received a call from the office stating there was a mistake and he only received the liquid (adjuvant) portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient's health care professional recommended to come in for an additional full dose.  The patient wanted to know what to look out for in this case.  The reporter provided health care professional's information but did not remember the name of his physician.  The patient provided permission to contact health care professional. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Haematochezia, Nausea, Pain in extremity
Clinical narrative: STOMACH IS HURTING; NAUSEA; DIARRHEA; BLOOD IN STOOL/BLEEDING WITH DEFECATION/POOPING BLOOD FOR THE PAST FEW DAYS; ARM IS HURTING; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. The patient claimed that his arm hurt after taking the vaccine (29-Dec-2021). Patient experienced some nausea and diarrhea afterwards. On 09-JAN-2022, the patient experienced blood in stool/bleeding with defecation/ pooping blood for the past few days. This prompted him to go to the emergency room. The patient was in perfect health before the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in stool/bleeding with defecation/pooping blood for the past few days, and the outcome of nausea, diarrhea, stomach is hurting and arm is hurting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220113776-COVID-19 VACCINE AD26.COV2.S-blood in stool/bleeding with defecation/pooping blood for the past few days. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Hypotension, Loss of consciousness
Clinical narrative: This spontaneous report received from a patient concerned a 65-year-old white female of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, 1 total administered on 02-SEP-2021 to left arm as prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-SEP-2021 (day 2 after vaccination), the patient experienced low blood pressure. Laboratory data included: Blood pressure (NR: not provided) low. On an unspecified date, the patient was passed out and landed on floor, and reporter stated that it could be due to dehydration. The action taken with covid-19 vaccine was not applicable. The patient recovered from passed out and landed on floor, and low blood pressure, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220115924- Covid-19 vaccine Passed out and landed on the floor. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients of unspecified sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy dates were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, multiple patient developed blood clots.  As per the reporter "consumer states that she knows that people have had blood clots after the Janssen COVID-19 vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220115938-Covid-19 vaccine ad26.cov2.s- Blood Clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia, Paraesthesia, Vaccination site paraesthesia
Clinical narrative: felt tingling in my left arm at the injection site; I slept a lot.; felt tingling in my right arm, too; tired; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills). At the time of the report, VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case is concerning a male patient of unknown age with no medical history reported, experienced the unexpected, AESI of Hypersomnia and other nonserious events. The event occurred 28 days after the third dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2021-403276, MOD-2021-403277 (Patient Link).; Sender's Comments: This spontaneous case is concerning a male patient of unknown age with no medical history reported, experienced the unexpected, AESI of Hypersomnia and other nonserious events. The event occurred  28 days after the third dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: recently tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (recently tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. In 2021, the patient experienced SARS-COV-2 TEST POSITIVE (recently tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (recently tested positive for covid) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced non-serious event of special interest SARS-CoV-2 test positive. The event occurred following the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. Furthermore, information regarding vaccination schedule and first and second dose was not provided. Also, no information about patient's accompanying symptoms has been provided at this time. The rechallenge is not applicable considering that the event occurred following the third dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-CoV-2 test positive is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced non-serious event of special interest SARS-CoV-2 test positive. The event occurred following the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. Furthermore, information regarding vaccination schedule and first and second dose was not provided. Also, no information about patient's accompanying symptoms has been provided at this time. The rechallenge is not applicable considering that the event occurred following the third dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-CoV-2 test positive is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID/started with symptoms, fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID/started with symptoms, fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID/started with symptoms, fever). At the time of the report, COVID-19 (tested positive for COVID/started with symptoms, fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, SARS-CoV-2 test: positive (Positive) Result turned positive on 15-Dec-2021.         No concomitant medications were reported. No treatment medications were reported.  The patient recently made a trip.  On around 06-Dec or 07-Dec, the patient developed symptoms of COVID like fever. The patient wanted to know for how long do the patient have to wait to get the booster dose.  Company comment: This is a spontaneous case concerning a patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19. The event Covid-19 occurred approximately 286 days after the second dose of mRNA-1273 vaccine administration with positive Covid-19 test result. No reported treatment information. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19. The event Covid-19 occurred approximately 286 days after the second dose of mRNA-1273 vaccine administration with positive Covid-19 test result. No reported treatment information. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pain in extremity, Sleep disorder
Clinical narrative: He was shaking; He got chills, He is freezing, Absolutely freezing; Headache, Splitting headache; He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing; He could not sleep because he was so cold even with the heater in the same room; It does not matter if my arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore) and CHILLS (He got chills, He is freezing, Absolutely freezing) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Patient got his first and second dose from Pfizer and that those left his arm useless for a few days and he could not lift up weight. He was someone that can lift 150 pounds and after the vaccines he could not lift 20 pounds.). Past adverse reactions to the above products included Arm discomfort with Pfizer. Concomitant products included GELATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room) and PAIN IN EXTREMITY (It does not matter if my arm is sore). On 07-Jan-2022 at 2:00 AM, the patient experienced TREMOR (He was shaking), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache). At the time of the report, TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache) outcome was unknown.            Patient stated that with 7 blankets over him, he was not getting warm. Patient stated that he hates to be cold and had never been cold before. He also explained how he was able to go outside in the cold with his thermal and was not getting cold and how he was using an axe to chop wood and how he was lifting up weight in his normal life.  No treatment medications were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: He was shaking; He got chills, He is freezing, Absolutely freezing; Headache, Splitting headache; He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing; He could not sleep because he was so cold even with the heater in the same room; It does not matter if my arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore) and CHILLS (He got chills, He is freezing, Absolutely freezing) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (Patient got his first and second dose from Pfizer and that those left his arm useless for a few days and he could not lift up weight. He was someone that can lift 150 pounds and after the vaccines he could not lift 20 pounds.). Past adverse reactions to the above products included Arm discomfort with Pfizer. Concomitant products included GELATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room) and PAIN IN EXTREMITY (It does not matter if my arm is sore). On 07-Jan-2022 at 2:00 AM, the patient experienced TREMOR (He was shaking), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache). At the time of the report, TREMOR (He was shaking), FEELING COLD (He is cold inside (the house) with a thermal/ freezing right now, absolutely freezing), SLEEP DISORDER (He could not sleep because he was so cold even with the heater in the same room), PAIN IN EXTREMITY (It does not matter if my arm is sore), CHILLS (He got chills, He is freezing, Absolutely freezing) and HEADACHE (Headache, Splitting headache) outcome was unknown.            Patient stated that with 7 blankets over him, he was not getting warm. Patient stated that he hates to be cold and had never been cold before. He also explained how he was able to go outside in the cold with his thermal and was not getting cold and how he was using an axe to chop wood and how he was lifting up weight in his normal life.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine was administered to a minor; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was administered to a minor) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was administered to a minor). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was administered to a minor) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided.  No  Concomitant medications were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: Nasal congestion; common cold like symptoms; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), NASOPHARYNGITIS (common cold like symptoms), HEADACHE (Headache) and CHILLS (Chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis, Allergy, Immunocompromised and HIV infection. Concomitant products included LORATADINE for Allergy NOS, OMEPRAZOLE for Gastritis, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for HIV disease, CETIRIZINE for Itching, CENTRUM VITAMINTS and FISH OIL for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion), NASOPHARYNGITIS (common cold like symptoms), HEADACHE (Headache) and CHILLS (Chills). On 10-Feb-2021, NASAL CONGESTION (Nasal congestion), NASOPHARYNGITIS (common cold like symptoms), HEADACHE (Headache) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.  Patient stated that since her symptoms she had stopped taking conmed   This case was linked to MOD-2022-438834, MOD-2022-438940 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Oropharyngeal pain
Clinical narrative: very bad sore throat; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (very bad sore throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced DIARRHOEA (Diarrhea). On 10-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (very bad sore throat). At the time of the report, DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (very bad sore throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; Tested positive for covid-19; Booster; Location of injection for vaccine received same date: Flu Vaccine; Location of injection for vaccine received same date: Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 09:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 15Feb2021 09:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 25Jan2021 09:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 27Oct2021, outcome "unknown" and all described as "Location of injection for vaccine received same date: Flu Vaccine"; IMMUNISATION (medically significant) with onset 27Oct2021 09:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 07:00, outcome "unknown" and all described as "Tested positive for covid-19". The event "tested positive for covid-19" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive; (29Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course:  Reported Event: Tested positive for covid-19 on 29Dec2021.  Woke up with a sore throat, took a at home rapid antigen test and it was positive. Later that day took a pcr test and it was also positive. Had mild symptoms for 4 days including headache, sore throat, and cough.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination failure
Clinical narrative: Tested positive for covid-19; Tested positive for covid-19; Booster; Location of injection for vaccine received same date: Flu Vaccine; Location of injection for vaccine received same date: Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 09:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 15Feb2021 09:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 25Jan2021 09:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 27Oct2021, outcome "unknown" and all described as "Location of injection for vaccine received same date: Flu Vaccine"; IMMUNISATION (medically significant) with onset 27Oct2021 09:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 07:00, outcome "unknown" and all described as "Tested positive for covid-19". The event "tested positive for covid-19" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive; (29Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course:  Reported Event: Tested positive for covid-19 on 29Dec2021.  Woke up with a sore throat, took a at home rapid antigen test and it was positive. Later that day took a pcr test and it was also positive. Had mild symptoms for 4 days including headache, sore throat, and cough.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID after 3 vaccine doses; Tested positive for COVID after 3 vaccine doses; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Tested positive for COVID after 3 vaccine doses". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive; (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Nasal congestion
Clinical narrative: Tested positive for covid; Tested positive for covid; Wet cough; diarrhea; chills; stuffy nose; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 22 years as dose 2, single and administered in arm left, administration date 03Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Penicillin products" (unspecified if ongoing), notes: known allergies: Penicillin products. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive for covid"; COUGH (non-serious) with onset 26Dec2021, outcome "recovering", described as "Wet cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "recovering", described as "stuffy nose"; DIARRHOEA (non-serious) with onset 26Dec2021, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, nasal congestion, diarrhoea, chills, pain.  Additional information : patient did not receive any other vaccine in four weeks, Patient did not receive any treatment for AE. prior vaccination patient not tested covid positive , post vaccination Patient tested covid positive . patient have Penicillin products allergies
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; Wet cough; diarrhea; chills; stuffy nose; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 22 years as dose 2, single and administered in arm left, administration date 03Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Penicillin products" (unspecified if ongoing), notes: known allergies: Penicillin products. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive for covid"; COUGH (non-serious) with onset 26Dec2021, outcome "recovering", described as "Wet cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "recovering", described as "stuffy nose"; DIARRHOEA (non-serious) with onset 26Dec2021, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, nasal congestion, diarrhoea, chills, pain.  Additional information : patient did not receive any other vaccine in four weeks, Patient did not receive any treatment for AE. prior vaccination patient not tested covid positive , post vaccination Patient tested covid positive . patient have Penicillin products allergies
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 13Sep2021 (Batch/Lot number: unknown) as dose 3, (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 13Jan2021, for Covid-19 Immunization; Comirnaty (Dose 2), administration date: 03Feb2021, for Covid-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 04Jan2022, outcome "unknown", described as "tested positive COVID". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.; Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: covid 3 times -, once in 2020, once in 2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: booster; diagnosed with covid-19 infection; diagnosed with covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid-19 infection". Therapeutic measures were taken as a result of covid-19. Clinical course: HCP states she has a 42 yr old female patient diagnosed with covid-19 infection and has been prescribed Paxlovid - states this patient has taken one days dose so far.  The lot number for bnt162b2 was not provided and will be requested during follow; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and Immunization
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid 19/ positive antigen test; Contracted Covid 19/ positive antigen test; Booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single, administered in arm left, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes 2" (unspecified if ongoing); "Known allergies: mango, papaya" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIPIZIDE. The following information was reported: IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Booster shot"; VACCINATION FAILURE (medically significant) with onset 04Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 04Jan2022, outcome "not recovered" and all described as "Contracted Covid 19/ positive antigen test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: Nasal Swab; (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: covid prior vaccination was reported as no.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: off label use; Interchange of vaccine products; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose: 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive.  Additional information: The symptoms were minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. The patient was isolating and wearing mask and thankfully neither wife nor daughter was positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: off label use; Interchange of vaccine products; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose: 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Despite 2 shots of Moderna +Pfizer booster-last Wednesday I tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive.  Additional information: The symptoms were minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. The patient was isolating and wearing mask and thankfully neither wife nor daughter was positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested Covid-19 positive; tested Covid-19 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested Covid-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information information provided a causal association between reported events Drug ineffective, covid-19 and suspect BNT162B2 cannot be excluded. case will be assessed once new information becomes available.