chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine).    No concomitant medication were reported.  The patient received a Moderna Bivalent Vaccine for his first Primary Series dose of the Moderna Covid-19 vaccine on January 2, 2023 lot number AS7165B Expiration date May 31, 2023 No other adverse reactions were observed. The error was discovered when the patient came back for the second dose of his Moderna Covid-19 Primary Series.  No treatment medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 on 12Sep2022 as dose 1, single (Lot number: GH9694) at the age of 63 years, in left arm for Covid-19 immunisation. The patient didn't receive BNT162b2. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Sep2022, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and including Paxlovid treatment from 15Nov2022 to 19Nov2022.  Product investigation summary conclusion on 24Jan2023 included the complaint for ''Pfizer BioNTech COVID-19 Vaccine'' was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Withheld concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up attempts completed. No further information expected.  Follow-up (24Jan2023): This is a follow-up report from product quality group providing investigation results.  Updated information included: Product investigation summary conclusion, new suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 added based on lot number and it confirmed previously suspect vaccine BNT162B2 was not administered, new non-serious event "BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1" added and considered as wrong vaccine administered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; TAMSULOSIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 01May2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Rapid heart beat". The event "rapid heart beat" required physician office visit. Therapeutic measures were not taken as a result of heart rate increased.  Additional information: Facility type was vaccine pharmacy or drug store. The patient did not received other vaccine in four weeks. The patient had COVID prior vaccination and COVID tested post vaccination was reported as no. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient also received Dose 4 vaccine on 09Jan2023 at 07:00 PM, lot number was GJ6796 and vaccine location was left arm.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fall, Head injury, Loss of consciousness, Mobility decreased
Clinical narrative: Patient presents to pharmacy and reports loss of consciousness immediately after arriving home following vaccination administration. Patient also reports head injury as a result of LOC and inability to leave bed until today 2/3/2023.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Endotracheal intubation, Generalised tonic-clonic seizure
Clinical narrative: I experience chronic grand mal seizures where my lungs collapse and I need intubated in order to breath and also sedated in order for the seizure to stop. They do not stop in seconds or moments or when the ambulance arrives.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumothorax, Seizure, Urine analysis
Clinical narrative: I experience chronic grand mal seizures where my lungs collapse and I need intubated in order to breath and also sedated in order for the seizure to stop. They do not stop in seconds or moments or when the ambulance arrives.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Pyrexia, Vertigo
Clinical narrative: Vertigo, Vomitting, diarhea, headache, fever, sweats,
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vertigo, Vomitting, diarhea, headache, fever, sweats,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Mechanical urticaria
Clinical narrative: Chronic spontaneous urticaria and dermatographia starting about two weeks after my Moderna booster. I must take Zyrtec daily, and it?s been an entire year of this. If I stop taking Zyrtec, the urticaria and dermatographia return within two days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Chest discomfort, Chest pain, Coronary arterial stent insertion, Exercise tolerance decreased
Clinical narrative: A dull pain and tight feeling in the chest occurred after the vaccine when physical activities were engaged in, such as fast walking and dancing. These were common exercise activities that began to result in pain in the chest. Blockages were discovered in the heart and two stints were placed in two arteries.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A dull pain and tight feeling in the chest occurred after the vaccine when physical activities were engaged in, such as fast walking and dancing. These were common exercise activities that began to result in pain in the chest. Blockages were discovered in the heart and two stints were placed in two arteries.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test normal, Brain scan normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: 75 yr old patient got sudden onset head pain, sweating, dizzyness while seated for dinner 11/3/2022. This event was 9 days after getting the Pfizer shot (4th one). No action taken but patient felt like he would collapse if he got up.  The next morning patient was dizzy getting out of bed and wife drove him to the ER.  ER did numerous tests but did not find cause & he was discharged 6 hours later. "unremarkable"   Patient saw Dr his GP, on 11/08/2022. who reviewed ER report. Nothing more found. Dr. and the ER suspect a Transient Ischemic Attack (stroke).TIA
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Magnetic resonance imaging normal, Scan with contrast normal, Transient ischaemic attack
Clinical narrative: 75 yr old patient got sudden onset head pain, sweating, dizzyness while seated for dinner 11/3/2022. This event was 9 days after getting the Pfizer shot (4th one). No action taken but patient felt like he would collapse if he got up.  The next morning patient was dizzy getting out of bed and wife drove him to the ER.  ER did numerous tests but did not find cause & he was discharged 6 hours later. "unremarkable"   Patient saw Dr his GP, on 11/08/2022. who reviewed ER report. Nothing more found. Dr. and the ER suspect a Transient Ischemic Attack (stroke).TIA
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin normal
Clinical narrative: 75 yr old patient got sudden onset head pain, sweating, dizzyness while seated for dinner 11/3/2022. This event was 9 days after getting the Pfizer shot (4th one). No action taken but patient felt like he would collapse if he got up.  The next morning patient was dizzy getting out of bed and wife drove him to the ER.  ER did numerous tests but did not find cause & he was discharged 6 hours later. "unremarkable"   Patient saw Dr his GP, on 11/08/2022. who reviewed ER report. Nothing more found. Dr. and the ER suspect a Transient Ischemic Attack (stroke).TIA
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID treatment: Yes. Patient Adult (18-64 Years) with Current age: 48 Years, male. Vaccine received and no other medication in 2weeks. Anti viral details: product: COVID 19 Treatment, Paxlovid (Treatment start date: 18Jan2023, Treatment stop date: 23Jan2023). Vaccine dose number= 4 and adverse event: Covid rebound after Paxlovid on start date: 28Jan2023 with treatment AE: No. No known allergies, No other medical history.   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: 38.0
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 contactable reporter(s) (Other 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), on 16Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3247) and on 05Feb2021 as dose 2, single (Lot number: EL3247) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety disorder" (unspecified if ongoing); "sensitive to stimulants" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient received Anti-viral as COVID-19 treatment from 29Jan2023.  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.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Palpitations
Clinical narrative: heart racing; fluttering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19-year-old female patient received BNT162b2 (BNT162B2), in May2021 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: PALPITATIONS (non-serious), outcome "unknown", described as "heart racing"; ATRIAL FLUTTER (non-serious), outcome "unknown", described as "fluttering".  Additional information: The caller states her 19-year-old daughter got the Pfizer BioNTech COVID-19 vaccine in May2021 and had some heart racing and fluttering issues that were not immediate after the administration of the vaccine. These symptoms, that happened when the callers daughter was 17 years old, were attributed by the cardiologist to stress, anxiety and dehydration however, caller states that upon checking the VAERS reports, the lot numbers that her daughter was administered (EW0170 and FK9729) counted more that 3000 reports of side effects while her mother-in-law three lot numbers had only 124 reports. She now has learned to manage the anxiety a lot better, she was drinking the water she should, and she is still having these problems. Caller also states, Your fact sheet should be more factual.  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-202300046233 same patient/vaccine/event, different doses;US-PFIZER INC-202300046234 same patient/vaccine/event, different doses;
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Atrial flutter, Dehydration, Palpitations, Stress
Clinical narrative: Heart racing; Fluttering; Stress; Anxiety; Dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0170) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; ATRIAL FLUTTER (non-serious), outcome "unknown", described as "Fluttering"; STRESS (non-serious), outcome "unknown"; ANXIETY (non-serious), outcome "unknown"; DEHYDRATION (non-serious), outcome "unknown".  Clinical course: The caller states her 19-year-old daughter got the Pfizer BioNTech COVID-19 vaccine in May2021 and had some heart racing and fluttering issues that were not immediate after the administration of the vaccine. These symptoms, that happened when the caller's daughter was 17-year-old, were attributed by the cardiologist to stress, anxiety and dehydration however, caller states that upon checking the VAERS reports, the lot numbers that her daughter was administered (EW0170 and FK9729) counted more that 3000 reports of side effects while her mother-in-law three lot numbers had only 124 reports. She now has learned to manage the anxiety a lot better, she's drinking the water she should, and she is still having these problems. Caller also states, "Your fact sheet should be more factual." After providing Pfizer MI and Customer Service do not have information on the production number for each lot of the vaccine: I've called multiple people from Pfizer, nobody has been able to give me this information. Patient was thinking something was a little shady. So, this study says that one month after dose 2 none of the people had contracted or tested positive for COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046062 same patient/vaccine/event, different doses;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 05Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right 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: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM, start date: 01Jan2009, stop date: 30Jan2023. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Keflex, reaction(s): "Known allergies: keflex"; Tamiflu, reaction(s): "Known allergies: tamiflu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Antiviral Product Brand Paxlovid for  COVID 19 Treatment started on 09Jan2023 stopped on 11Jan2023.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination...she has been diagnosed with Lichen planus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EN6204) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LICHEN PLANUS (non-serious) with onset May2021, outcome "not recovered", described as "Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination...she has been diagnosed with Lichen planus".  Additional information: Has come to her attention when she had the Pfizer vaccination for COVID in 2021, she had some effects with this. She did not think anything about it. Went to her dermatologist with the issue. Now with all her research, she was going back to her dermatologist. Her outbreak of what she had going on was right after her first Pfizer COVID-19 vaccination and then continued to get worse after the second vaccination. The ailment was caused by Pfizer. Clarified she has been diagnosed with Lichen planus, a rash type of situation and this all came about. She had Lichen planus before but not in this area and not to the extent of the breakout.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046916 same product, patient, different AEs, different dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GL2524) at the age of 75 years, in right 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left Supravascular lymph node swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2153) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Cherries" (unspecified if ongoing), notes: known allergies: Cherries, Pollen and Dust mites; "Known allergies: Pollen" (unspecified if ongoing), notes: known allergies: Cherries, Pollen and Dust mites.; "Known allergies: Dust mites" (unspecified if ongoing), notes: known allergies: Cherries, Pollen and Dust mites. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "not recovered", described as "Left Supravascular lymph node swollen". The event "left supravascular lymph node swollen" required physician office visit and emergency room visit.  Additional information: The patient did not receive other vaccine in four weeks or other medications in two weeks. The patient did not have Covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047420 same patient different dose/drug/event;US-PFIZER INC-202300047486 same patient different dose/drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 Same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 as same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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 "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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-PV202300020087 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died since taking your covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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 "died since taking your covid vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Added: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-PV202300020087 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died since taking your covid vaccine
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab; (17Dec2022) Positive; covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL0140), on 19Jan2021 as dose 2, single (Lot number: EL3247) and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. ThThe following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "covid test result=Positive"; DISEASE RECURRENCE (medically significant) with onset 17Dec2022, outcome "unknown", described as "Nasal Swab; (17Dec2022) Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Nasal Swab; (17Dec2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Hospital. No other vaccine in four weeks. None medications in two weeks. No covid prior vaccination. No Known allergies. No Other medical history.; Sender's Comments: The reported COVID-19 positive twice after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202300047540 same patient, different vaccine dose/event;
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Seronegative arthritis, Swelling
Clinical narrative: Nasal Swab; (17Dec2022) Positive; covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EL0140), on 19Jan2021 as dose 2, single (Lot number: EL3247) and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. ThThe following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "covid test result=Positive"; DISEASE RECURRENCE (medically significant) with onset 17Dec2022, outcome "unknown", described as "Nasal Swab; (17Dec2022) Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Nasal Swab; (17Dec2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Hospital. No other vaccine in four weeks. None medications in two weeks. No covid prior vaccination. No Known allergies. No Other medical history.; Sender's Comments: The reported COVID-19 positive twice after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202300047540 same patient, different vaccine dose/event;
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Magnetic resonance imaging, Magnetic resonance imaging abdominal, Mass, Rectal haemorrhage
Clinical narrative: I was diagnosed with covid; I was diagnosed with covid; debilitating pain; debilitating pain; 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 28-year-old patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 15May2021 as dose 2, single (Lot number: EV0179) at the age of 28 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis", start date: Mar2020 (ongoing), notes: Illness/AE: Endometriosis, Onset date: Mar2020, Stop date (Pertinent details: Surgery 08Oct2021, laparoscopic excision stage 2); "Sleep" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE taken for sleep disorder, anxiety (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with covid"; ASTHENIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "debilitating pain". The events "i was diagnosed with covid" and "debilitating pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results; Magnetic resonance imaging: (08Apr2022) Normal; (unspecified date) Scar tissue or endo; (06May2022) inflammation under skin; Ultrasound abdomen: (19Mar2022) Normal; X-ray: (03Mar2022) Normal; (21Jan2023) Normal. Therapeutic measures were taken as a result of asthenia, pain which included naltrexone.  Additional information: The patient reported, "I received surgery Er endometriosis 10Aug2021, on 23Aug2021, my mom passes away in my apt due to covid + cirrhosis of the liver. I had to move her, which I shouldn't have been pulling during that time after surgery. I was diagnosed with covid that and was in debilitating pain until starting low dose naltrexone with wholistic doctor. In January, I had rectal bleeding so bad I had to wear a diaper. The lump on my back showed up, disappeared with super laxative before colonoscopy and has been there since the following day. I got the x-ray, us plus MRI done with no findings. Then, I got my Booster. I was in terrible pain for a week and then bruising on my pelvic floor has appeared. Both the lump plus bruising change in size and appearance. No doctor has been able to help or known what this is. I also have a bad muscle spasms in right qupvag. I moved back home so my doctor couldn't fill this out and is no longer at (facility name Withheld)."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375163 same patient and suspect vaccine; different dose and events;US-PFIZER INC-202300048571 same patient and suspect vaccine; different dose and events;
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Spinal X-ray, Ultrasound scan
Clinical narrative: I was diagnosed with covid; I was diagnosed with covid; debilitating pain; debilitating pain; 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 28-year-old patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 15May2021 as dose 2, single (Lot number: EV0179) at the age of 28 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis", start date: Mar2020 (ongoing), notes: Illness/AE: Endometriosis, Onset date: Mar2020, Stop date (Pertinent details: Surgery 08Oct2021, laparoscopic excision stage 2); "Sleep" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE taken for sleep disorder, anxiety (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with covid"; ASTHENIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "debilitating pain". The events "i was diagnosed with covid" and "debilitating pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results; Magnetic resonance imaging: (08Apr2022) Normal; (unspecified date) Scar tissue or endo; (06May2022) inflammation under skin; Ultrasound abdomen: (19Mar2022) Normal; X-ray: (03Mar2022) Normal; (21Jan2023) Normal. Therapeutic measures were taken as a result of asthenia, pain which included naltrexone.  Additional information: The patient reported, "I received surgery Er endometriosis 10Aug2021, on 23Aug2021, my mom passes away in my apt due to covid + cirrhosis of the liver. I had to move her, which I shouldn't have been pulling during that time after surgery. I was diagnosed with covid that and was in debilitating pain until starting low dose naltrexone with wholistic doctor. In January, I had rectal bleeding so bad I had to wear a diaper. The lump on my back showed up, disappeared with super laxative before colonoscopy and has been there since the following day. I got the x-ray, us plus MRI done with no findings. Then, I got my Booster. I was in terrible pain for a week and then bruising on my pelvic floor has appeared. Both the lump plus bruising change in size and appearance. No doctor has been able to help or known what this is. I also have a bad muscle spasms in right qupvag. I moved back home so my doctor couldn't fill this out and is no longer at (facility name Withheld)."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375163 same patient and suspect vaccine; different dose and events;US-PFIZER INC-202300048571 same patient and suspect vaccine; different dose and events;
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Colonoscopy, Drug ineffective, Magnetic resonance imaging
Clinical narrative: I was diagnosed with covid; I was diagnosed with covid; debilitating pain; debilitating pain; 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 28-year-old patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 15May2021 as dose 2, single (Lot number: EV0179) at the age of 28 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis", start date: Mar2020 (ongoing), notes: Illness/AE: Endometriosis, Onset date: Mar2020, Stop date (Pertinent details: Surgery 08Oct2021, laparoscopic excision stage 2); "Sleep" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE taken for sleep disorder, anxiety (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with covid"; ASTHENIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "debilitating pain". The events "i was diagnosed with covid" and "debilitating pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results; Magnetic resonance imaging: (08Apr2022) Normal; (unspecified date) Scar tissue or endo; (06May2022) inflammation under skin; Ultrasound abdomen: (19Mar2022) Normal; X-ray: (03Mar2022) Normal; (21Jan2023) Normal. Therapeutic measures were taken as a result of asthenia, pain which included naltrexone.  Additional information: The patient reported, "I received surgery Er endometriosis 10Aug2021, on 23Aug2021, my mom passes away in my apt due to covid + cirrhosis of the liver. I had to move her, which I shouldn't have been pulling during that time after surgery. I was diagnosed with covid that and was in debilitating pain until starting low dose naltrexone with wholistic doctor. In January, I had rectal bleeding so bad I had to wear a diaper. The lump on my back showed up, disappeared with super laxative before colonoscopy and has been there since the following day. I got the x-ray, us plus MRI done with no findings. Then, I got my Booster. I was in terrible pain for a week and then bruising on my pelvic floor has appeared. Both the lump plus bruising change in size and appearance. No doctor has been able to help or known what this is. I also have a bad muscle spasms in right qupvag. I moved back home so my doctor couldn't fill this out and is no longer at (facility name Withheld)."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375163 same patient and suspect vaccine; different dose and events;US-PFIZER INC-202300048571 same patient and suspect vaccine; different dose and events;
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Ultrasound abdomen, X-ray
Clinical narrative: I was diagnosed with covid; I was diagnosed with covid; debilitating pain; debilitating pain; 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 28-year-old patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 15May2021 as dose 2, single (Lot number: EV0179) at the age of 28 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis", start date: Mar2020 (ongoing), notes: Illness/AE: Endometriosis, Onset date: Mar2020, Stop date (Pertinent details: Surgery 08Oct2021, laparoscopic excision stage 2); "Sleep" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYZINE taken for sleep disorder, anxiety (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with covid"; ASTHENIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "debilitating pain". The events "i was diagnosed with covid" and "debilitating pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results; Magnetic resonance imaging: (08Apr2022) Normal; (unspecified date) Scar tissue or endo; (06May2022) inflammation under skin; Ultrasound abdomen: (19Mar2022) Normal; X-ray: (03Mar2022) Normal; (21Jan2023) Normal. Therapeutic measures were taken as a result of asthenia, pain which included naltrexone.  Additional information: The patient reported, "I received surgery Er endometriosis 10Aug2021, on 23Aug2021, my mom passes away in my apt due to covid + cirrhosis of the liver. I had to move her, which I shouldn't have been pulling during that time after surgery. I was diagnosed with covid that and was in debilitating pain until starting low dose naltrexone with wholistic doctor. In January, I had rectal bleeding so bad I had to wear a diaper. The lump on my back showed up, disappeared with super laxative before colonoscopy and has been there since the following day. I got the x-ray, us plus MRI done with no findings. Then, I got my Booster. I was in terrible pain for a week and then bruising on my pelvic floor has appeared. Both the lump plus bruising change in size and appearance. No doctor has been able to help or known what this is. I also have a bad muscle spasms in right qupvag. I moved back home so my doctor couldn't fill this out and is no longer at (facility name Withheld)."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375163 same patient and suspect vaccine; different dose and events;US-PFIZER INC-202300048571 same patient and suspect vaccine; different dose and events;