chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times; tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 14:00 as dose 1, single (Lot number: FF2589), in arm and on 25Oct2021 at 14:00 as dose 2, single (Lot number: FH8020) at the age of 36 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to PCN" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "tested positive for COVID-19 directly 3 weeks after 2nd dose/got COVID-19 on record 2 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient wanted to report experience with Pfizer vaccine shot. After got vaccinated, he got COVID-19 several times. Ever since taking vaccination keeps getting sick. He was never sick and didn't get COVID-19 before. Got them 1.5-2 years after pandemic because of jobs forcing into vaccination shot. He was worried about losing job. Now aftermath, he wasn't in danger of losing his job. Was completely abused by work making him get vaccination shot. Continues to be sick. His level of power is not all the way there since he was vaccinated. Anything he can do or paperwork to fill out to make this on report. Got COVID-19 he thinks 3 weeks after vaccinated like 2-3 times. Went to get tested and tested positive for COVID-19 directly 3 weeks after 2nd dose. Very sick after that. Has got COVID-19 on record 2 times. Keeps getting sick. Hasn't gotten power back, no strength after vaccinated. Power level low and limited. Noted after COVID-19 twice. Severely sick since 2nd dose. Didn't go back for booster. Scared of getting more shots or boosters. Worked through pandemic and never got vaccinated for couple years or 1-1.5 years, right after he got vaccinated has been ill since. He is very healthy might take Tylenol or Robitussin if sick but very healthy. The patient did not get vaccinated or did not have medication before any of this.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), on 05Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromicin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from  06Aug2023 to 11Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: other medical history: Fibromyalgia; "history of anxiety/depression" (unspecified if ongoing), notes: other medical history: history of anxiety/depression. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2023) Negative; (11Aug2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid Rebound after completing 5 day (10 dose) series. I began the treatment in the evening of 01Aug and finished the morning of 06Aug. I had negative tests on Wed. 09Aug and Friday 11Aug. Rebound symptoms started in the afternoon on Sunday 13Aug and included headache congestion, runny nose, sore throat, and fatigue. Paxlovid was taken as treatment from 01Aug2023-06Aug2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 21Apr2021 as dose 2, single (Lot number: ER8732), in right arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "collapsed trachea" (ongoing), notes: 90% collapsed trachea post CPR- tracheostomy fully recovered, still have unable to insert stent; "post CPR- tracheostomy" (unspecified if ongoing); "unable to insert stent" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: felt drained, tired & yucky; felt drained, tired & yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Aug2023 at 11:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in Fingers/Toes" (unspecified if ongoing); "Osteoarthritis in Fingers/Toes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 13Sep2022, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Jun2022, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2589, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 30Sep2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 14Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions". The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 10Aug2023, outcome "recovered" (12Aug2023) and all described as "felt drained, tired & yucky". Therapeutic measures were not taken as a result of fatigue, feeling abnormal. The next day and the day after, patient felt drained, tired & yucky. The 2nd day was a bit better. Full energy returned on 3rd day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276406 same patient/drug, different dose/event;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: felt drained, tired & yucky; felt drained, tired & yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Aug2023 at 11:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in Fingers/Toes" (unspecified if ongoing); "Osteoarthritis in Fingers/Toes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 13Sep2022, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Jun2022, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2589, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 30Sep2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 14Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions". The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 10Aug2023, outcome "recovered" (12Aug2023) and all described as "felt drained, tired & yucky". Therapeutic measures were not taken as a result of fatigue, feeling abnormal. The next day and the day after, patient felt drained, tired & yucky. The 2nd day was a bit better. Full energy returned on 3rd day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276406 same patient/drug, different dose/event;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 09Aug2023 at 11:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 12:00 as dose 1, single (Lot number: EM9809), in left arm, on 18Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in left arm, on 30Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 02Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in Fingers/Toes" (unspecified if ongoing), notes: other medical history: Osteoarthritis in Fingers/Toes. The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid", notes: known allergies: Macrobid. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID-19 treatment.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 09Aug2023 at 11:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 12:00 as dose 1, single (Lot number: EM9809), in left arm, on 18Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in left arm, on 30Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 02Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in Fingers/Toes" (unspecified if ongoing), notes: other medical history: Osteoarthritis in Fingers/Toes. The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid", notes: known allergies: Macrobid. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID-19 treatment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID and her doctor prescribed PAXLOVID; tested positive for COVID and her doctor prescribed PAXLOVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (had all the flu shots.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID and her doctor prescribed PAXLOVID". The events "tested positive for covid and her doctor prescribed paxlovid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient had received all the Pfizer 1st, 2nd shot and 2 booster doses of COVID. She received last dose of vaccine in 2022. She was tested positive for COVID and her doctor prescribed PAXLOVID it because of her result. Patient received every shot and never been sick. She wears a mask and live alone. She went to the office, and she saw someone closing the door. It was a small room. She thought she must have gotten COVID from her. That was Friday (unknown date), patient had fever, she didn't have a lot of loss of appetite or headache. Patient felt like she had a strep throat and she waited to see her doctor until the next morning. They told patient if she had a sore throat, she could test positive for COVID. The doctor didn't even send a throat culture. Patient was not sure if she had strep or not. Her doctor prescribed the medication PAXLOVID without ruling her strep throat. The patient thought they should send the strep throat culture before giving her the medication. Patient was dripping wet this morning (14Aug2023). She had hoarseness in her throat. Most symptoms are over. Her fever is going down. Her son who had COVID had to go to the hospital. But her COVID was not that bad that's because she had the shots. It did not affect her breathing. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Patient asked should she take Paxlovid prescribed by her doctor even after her symptoms have subsided. She did not want to take it because she might experience the side effects associated with it. The reporter considered event as non-serious.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276322 same reporter/patient/product, different event.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) Negative; (14Aug2023) Positive, notes: Experienced symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used from 05Aug2023 to 09Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received 5 Covid-19 vaccinations/contracting Covid; Received 5 Covid-19 vaccinations/contracting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received 5 Covid-19 vaccinations/contracting Covid". He has received 5 Covid-19 vaccinations in which the last one was in Nov. He stated the vaccines were a mixture; however they, were "mostly from Pfizer and the other one started with a S. Therapeutic measures were taken as a result of drug ineffective, covid-19: he was prescribed Paxlovid two days ago due to contracting Covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 10:00 as dose 5 (booster), single (Lot number: Gh9694) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 as dose 4 (booster), single (Lot number: 056m21a), in left arm for covid-19 immunisation; COVID-19 VACCINE (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 03Aug2023 to 07Aug2023.
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: Pfizer's vaccine caused several friends of mine suicidal thoughts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "Pfizer's vaccine caused several friends of mine suicidal thoughts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 7 people had  died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had  died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276245 Same reporter/event/drug, different patient;US-PFIZER INC-202300276246 Same reporter/event/drug, different patient;US-PFIZER INC-202300276247 Same reporter/event/drug, different patient;US-PFIZER INC-202300276248 Same reporter/event/drug, different patient;US-PFIZER INC-202300276249 Same reporter/event/drug, different patient;US-PFIZER INC-202300276250 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had  died from Pfizer
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Already got vaccinated. but tested positive for Covid today; Already got vaccinated. but tested positive for Covid today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2023, outcome "unknown" and all described as "Already got vaccinated. but tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) positive, notes: tested positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: double sided Bells Palsy; Gullian Barre Syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), 7 days after the suspect product(s) administration, outcome "recovering", described as "double sided Bells Palsy"; GUILLAIN-BARRE SYNDROME (medically significant), 7 days after the suspect product(s) administration, outcome "recovering", described as "Gullian Barre Syndrome". The patient underwent the following laboratory tests and procedures: Lumbar puncture: double sided Bells Palsy and Gullian Barre Syndrome. Therapeutic measures were taken as a result of bell's palsy, guillain-barre syndrome. 2 and half years later the patient was still recovering and going to the cancer center every other week to receive IVIG treatment. This is going to be for the rest of patient's life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 14Jun2023, outcome "unknown", described as "a heart attack". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: received Pentacel but not the Hib portion, patient is being recalled to receive Hib separate (with no reported adverse event); Initial information received on 11-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not the HIB portion, patient is being recalled to receive HIB separate (with no reported adverse event).  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 10-Aug-2023, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but not the HIB portion suspension for injection with unknown batch number, strength & expiry date via unknown route in unknown administration site for Routine immunization with no reported adverse event (single component of a two-component product administered) (latency: same day).  Information on the batch number was requested.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: dry component was administered to patients by reconstitution with sterile water with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 4 months old female patient who was given dry portion (ACTHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event while receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.  On 01-Aug-2023, the patient received standard 0.5 ml (total) dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ791AA, expiry date: 10-Oct-2023) via intramuscular route in the right thigh for Immunization.  On 01-Aug-2023, the patients had dry portion (ACTHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event (product preparation error) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  Reportedly, Medical assistant asked if it is okay to administer only the liquid portion of the vaccine because the dry component was administered to 2 patients by reconstitution with sterile water  Action taken-not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 14 y/o patient was administered a Menactra in January and accidentally received another one in August with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 14 years old who experienced was administered Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] in january and accidentally received another one in august with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Aug-2023, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date in Aug-2023, the 14 y/o patient was administered a Meningococcal A-C-Y-W135 (D Conj) Vaccine in january and accidentally received another one in august with no reported adverse event (extra dose administered) (latency: same day).  It was reported, If a 14 y/o patient was administered a Menactra in January and accidentally received another one in August is there anything that needs to be done? Do they still need the booster at 16 y/o.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: administration of Pentacel to a patient with only the liquid part containing the DTaP-IPV component, leaving the Hib component, with no reported adverse event; Initial information was received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who had administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with only the liquid part containing the dtap-ipv component, leaving the hib component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a 0.5 ml, once dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ868AA, expiry date: 30-Mar-2024, strength: standard) via intramuscular route in the left deltoid for Immunisation.  On 05-Aug-2023 the patient had administration of pentacel to a patient with only the liquid part containing the dtap-ipv component, leaving the hib component, with no reported adverse event (single component of a two-component product administered) (Latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: injection site after the injection is done is not sore like when after she gets a flu shot; Initial information received on 11-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 77-year-old female patient who stated injection site after the injection is done is not sore like when after she gets a flu shot after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had an event of injection site after the injection is done is not sore like when after she gets a flu shot (vaccination site pain) (unknown latency) following the administration of influenza vaccine.  It was reported: The caller states that she just started with Dupixent about a month ago and her first two injections were given in the office, with the nurse, in her arm which she said about sent her through the floor. She states that she was waiting a while, and everything was fine, and she didn't have a reaction. She states that she gave it in her thigh which was a lot less painful than the injections in the arm. The caller states that when she gave it at home in her thigh, the injection stung and burned towards the end of the injection and it wasn't something she can't deal with, but she would like to know if it is normal and if it is because she should not be pushing as hard or if there is a trick to making the injections less painful. She states that she thought she did that in terms of letting the alcohol completely dry, but she states that she will wait a little longer. She states that she did let her pen warm up for 45 minutes, but she will let it warm up longer next time. She states that her injection site after the injection is done is not sore like when after she gets a flu shot. She states that she never had that happen, but it is just the last two seconds when she is slowing injecting itself towards the end that it stings and burns. She states that the nurse who taught her how to inject Dupixent wasn't all that informative and told her "oh well that happens sometimes" in terms of the burning and stinging and the nurse watched her do it and told her she was doing "it fine". She states that she will be going back to the doctor in a month or so and she will address that then  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown; Sender's Comments:  US-SA-2023SA248545:01724942
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bipolar I disorder, COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt in house  Date of Admission: 7/28/2023   Medical Diagnosis: Bipolar 1 Disorder   Date of Surgery/Procedure: not applicable this admission    Precautions: Fall risk, right hemi-paresis, impulsive at times,   Per MD note 8/5 "COVID-found to be positive; asymptomatic; completed paxlovid here; isolation already complete for community at 5 days" - isolation precautions lifted at bedside.    PPE Worn:  Provider: N95 Patient masked? No   Covid-19 Testing:  Lab Results
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Areflexia, Chills, Choking, Computerised tomogram, Cyanosis
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Disability, Discomfort, Dyspnoea, Gait disturbance, Headache
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hiccups, Hyperhidrosis, Impaired driving ability, Impaired work ability, Injection site pain
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Laboratory test, Loss of personal independence in daily activities, Loss of proprioception, Magnetic resonance imaging
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Neck pain, Pain, Sitting disability
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Spinal pain, Tremor, Vision blurred, Vomiting
Clinical narrative: Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse effects were reported. Patient was given MMR vaccine that was incorrectly prepared
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Paraesthesia
Clinical narrative: Patient started with a fever 7-8 hours after vaccination on Monday Aug 7, 2023. Maximum temperature was 103.7 3 days after the vaccination, with associated tingling of the arms and headache. The tingling went away with ibuprofen. Fever lasted for 6+ days. He also has been fatigue despite more than adequate sleep. On Friday , the patient started to have diarrhea/loose stool (>6 times a day, maximum 10+), associated with lower belly discomfort.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient started with a fever 7-8 hours after vaccination on Monday Aug 7, 2023. Maximum temperature was 103.7 3 days after the vaccination, with associated tingling of the arms and headache. The tingling went away with ibuprofen. Fever lasted for 6+ days. He also has been fatigue despite more than adequate sleep. On Friday , the patient started to have diarrhea/loose stool (>6 times a day, maximum 10+), associated with lower belly discomfort.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFER BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFER BUD
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINED RECEIVED AFTER BUD
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINED RECEIVED AFTER BUD
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received vaccine at 16 and was given again when patient is 18
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD