chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This genocide this bioweapon; My father and my cousin had died so far; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A male patient 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 "This genocide this bioweapon; My father and my cousin had died so far". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter (Registered Nurse) stated, "I am not worrying about getting disconnected. Are you involved in this genocide this bioweapon COVID 19 jab (COVID-19 Vaccine)? Do you know it is a withheld violation? You are a pharmacist you know what is going on. Yes, I am a registered nurse and I know what is going on to Nuremberg violation. I have known for two years why you knew 6 months after Pfizer did, that is what going to happen to Pfizer. Where you located are you in (country)?" Reporter further stated, "I hope you are not involved in this Genocide because you know what they did with other people (not clarified) and knowingly or just say I was doing my job getting proud of it either then people also bring violation. You know about (withheld) do you not? You are educated you are a Pharmacist. What about this fake protein mRNA's that's making people 'creates' by protein? Did you have any family members died yet? My father and my cousin had died so far. Did you have anyone died in (country) or do they ban it in (country)?" Reporter also stated, "Can you have false information? Who the hell would believe Pfizer. You are part of that plan. (withheld) 2.0 study up on that, you know they hung people (further clarifications unknown)." The Reporter hung up the call abruptly. Thus, further probing was not done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events DEATH and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300043075 Same reporter/drug/event, different patient;; Reported Cause(s) of Death: This genocide this bioweapon; My father and my cousin had died so far
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He has Herpes for 40 years; the herpes that he had was gone after he took the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER8727) for covid-19 immunisation. The patient's relevant medical history included: "herpes" (unspecified if ongoing), notes: has Herpes for 40 years; the herpes that he had was gone after he took the vaccine. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "He has Herpes for 40 years; the herpes that he had was gone after he took the vaccine".  Additional information: The patient found the COVID cards where he took his shots. The first said the Pfizer BioNTech and its lot number is ER8727, expiration date is 22Mar2021 (Not clarified appropriately hence, not captured in tab). Then, got his next vaccine on 12Apr2021, with lot number: ER8729 (Clarified and captured in tab), expiration date is 12Apr2021 (Not clarified hence, not captured in tab). Third vaccine details were reported as took another dose, Lot number is FG3590, (20Oct2021). It was reported that the patient got more number which is on 26Apr2022. The patient was looking the lot number and it could be a 9. It did not on the top and its looks like a 9 and it's a Pfizer. F it might kind of look like a J. It could be FJ or FT4989 with expiration date reported as 26Sep2022 which was present on the card. The patient had one more shot which says a booster with lot number provided is GH9694, expiration date: 29Sep2022. He reported that he provided all the information which he had with him and reported that might be trouble in understanding the give details.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My neighbor took this/they're getting sick from COVID; My neighbor took this/they're getting sick from COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My neighbor took this/they're getting sick from COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azithromyacine, reaction(s): "Known allergies: Azithromyacine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years 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: "Asthma (allergy+chest infection induced)" (unspecified if ongoing); "Chest infection induced" (unspecified if ongoing); "Allergy" (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 "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the treatment Paxlovid from 18Jan2023 to 22Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 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 dsoe 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. 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". 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. Additional information: Anti viral details included COVID 19 Treatment from 17Jan2023 to 21Jan2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Lot number: EK9231), on 16Jan2021 as dose 2, single (Lot number: EL3802) and on 25Sep2021 as dose 3 (booster), single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (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 "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 included Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW061), on 10May2021 as dose 2, single (Lot number: EW0168) and on 20Dec2021 as dose 3 (booster), single (Lot number: 331308A) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: Tested negative for 4 days; (Jan2023) Negative, notes: Tested negative for 4 days; (Jan2023) Negative, notes: Tested negative for 4 days; (Jan2023) Negative, notes: Tested negative for 4 days; (17Jan2023) Positive, notes: Tested positive and started Paxlovid; (21Jan2023) Positive, notes: By day 5 I was very much improved but still tested positive; (24Jan2023) Negative; (25Jan2023) Positive, notes: Positive COVID test (no noticeable symptoms); (26Jan2023) Positive, notes: Positive COVID test (noticing return of congestion); (28Jan2023) Positive, notes: Positive COVID test (more noticeable but mild symptoms with congestion, soar throat, fatigue); (29Jan2023) Positive, notes: Positive COVID test (same symptoms as the day before)-Day 13. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "reflux" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "sphincter of Oddi dysfunction" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OMEPRAZOLE. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 3), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 01Aug2022, outcome "not recovered". The event "bell's palsy" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy.   Additional information: There was no other vaccine in four weeks. Antiviral medication, steroids were treatment for event. Patient did not have covid prior vaccination.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test date=28Dec2022; covid test result=Positive; covid test date=28Dec2022; covid test result=Positive; 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.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 at 12:30 as dose 1, single (Lot number: 330268D), in left arm and on 14Jul2022 at 14:00 as dose 2, single (Lot number: FN2903) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing); "right bundle block of heart" (unspecified if ongoing), notes: right bundle block of heart; "mild hypertension" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Black Pepper" (unspecified if ongoing); "known allergies: shrimp" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; ASPIRIN (E.C.); BISOPROLOL. Past drug history included: Cortisone, reaction(s): "known allergies Cortisone", notes: known allergies Cortisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2022, outcome "unknown" and all described as "covid test date=28Dec2022; covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300042104 same patient/drug, different dose/event;
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: covid test date=28Dec2022; covid test result=Positive; covid test date=28Dec2022; covid test result=Positive; 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.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 at 12:30 as dose 1, single (Lot number: 330268D), in left arm and on 14Jul2022 at 14:00 as dose 2, single (Lot number: FN2903) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetes" (unspecified if ongoing); "right bundle block of heart" (unspecified if ongoing), notes: right bundle block of heart; "mild hypertension" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Black Pepper" (unspecified if ongoing); "known allergies: shrimp" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; ASPIRIN (E.C.); BISOPROLOL. Past drug history included: Cortisone, reaction(s): "known allergies Cortisone", notes: known allergies Cortisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2022, outcome "unknown" and all described as "covid test date=28Dec2022; covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300042104 same patient/drug, different dose/event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Graves'" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (18Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (28Jan2023) Positive, notes: Tested positive 28Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19; The patient received Paxlovid from 13Jan2023 to 17Jan2023. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: Gj3277), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 11Apr2021 as dose 2, single (Lot number: Er8729), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: Fh8027), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: Fo9989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Unspecified anxiety" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 including Paxlovid from 20Jan2023 to 25Jan2023.
Sex: M
Vaccine: COVID19
Symptoms: Skin cancer
Clinical narrative: skin cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient 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: SKIN CANCER (medically significant), outcome "unknown". The husband of the reporter's sister-in-law developed skin cancer after receiving Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, 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: "POTS (pre covid)" (unspecified if ongoing); "hypermobile spectrum disorder" (unspecified if ongoing); "cervical dystonia" (unspecified if ongoing); "essential tremor" (unspecified if ongoing); "panic disorder" (unspecified if ongoing); "adhd" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Macrobid, reaction(s): "known allergies: macrobid"; Clindamycine, reaction(s): "known allergies: clindamycine"; Tetracycline, reaction(s): "known allergies: tetracycline"; Bactrim, reaction(s): "known allergies: bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment Paxlovid from 18Jan2023 to 22Jan2023.   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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years 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: "Acid reflux" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (23Jan2023) Negative; (26Jan2023) Negative; (27Jan2023) Positive, notes: after symptoms returned, tested again and tested positive; (29Jan2023) Positive, notes: tested again today (29Jan2023) and it was again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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: 67.0
Sex: F
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) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient had no allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 16Jan2023 to 20Jan2023.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; 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 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 74 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 51.0
Sex: F
Vaccine: 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).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EK5730), in left arm, on 23Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FE3502) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient had no allergy. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid form 11Jan2023 to 15Jan2023.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 60 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: "Migraines" (unspecified if ongoing); "Known allergies: Crab anaphylaxis" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE oral; EXCEDRIN MIGRAINE oral. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan rash". 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: (25Jan2023) Negative; (unspecified date) Positive, notes: Treatment of COVID-19; (27Jan2023) Positive, notes: Symptoms began 1:00 am 27Jan2023. Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 74.0
Sex: F
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 (consumer). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 13:00 as dose 5 (booster), single (lot number GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 18Feb2021 as dose 1, single (lot number EL9262), in left arm, on 20Mar2021 as dose 2, single (lot number ER2613), in left arm, as dose 3 (booster), single (lot number 30145BA), in left arm, and on 26Apr2022 as dose 4 (booster), single (lot number FK9896), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received the third booster dose on "01Oct2022" (as reported).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Ageusia, Chest pain, SARS-CoV-2 test
Clinical narrative: chest pain; lower abdominal pain; lost his taste, a part of it has come back but not completely; 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.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Bnt162b2 (Primary immunization complete; , Dose number unknown), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; ABDOMINAL PAIN LOWER (non-serious), outcome "unknown", described as "lower abdominal pain"; AGEUSIA (non-serious), outcome "recovering", described as "lost his taste, a part of it has come back but not completely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking any advice on how to help with pain, mentioned he is experiencing chest pain and lower abdominal pain. Patient was made aware by agent that will not be able to do medical advice. While the call is being transferred, patient mentioned that he has taken test for COVID Sunday it came back negative. He also mentioned that he lost his taste, a part of it has come back but not completely; and he experienced this "a week after". After providing response, patient stated that his next appointment will be in Jun and the emergency room is packed with COVID patients, which makes him afraid of going. Patient mentioned that it was the "Pfizer plus BioNTech vaccine, the updated booster" he got. He only experienced this with the "Pfizer plus BioNTech booster" and not with previous "Pfizer vaccines" he had, stating maybe because the booster has "BioNTech" combination. The patient was advised to seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Chest pain.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in and under left shoulder/blade; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date/time: 09Apr2021, Time(24 hr): 21:00, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EW0150), administration date: 09Apr2021, when the patient was 51-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Date/time: 30Apr2021, Time(24 hr): 20:45, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EW0169), administration date: 30Apr2021, when the patient was 51-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 3(BOOSTER), SINGLE, Date/time: 21Nov2021, Time(24 hr): 14:30, Site and route of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: FH8030), administration date: 21Nov2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "pain in and under left shoulder/blade".  Additional information: Pain in and under left shoulder/blade, was sudden onset. Made me concerned it could be something else. Can't remember how long it lasted.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201349553 same patient, different dose and event;
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolisms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient 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: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolisms".  Clinical course: Reporter stated that covid vaccine almost killed reporter, her son and her daughter. All 3 of them developed blood clots (pulmonary embolisms) in the same time frame after getting the vaccine. They have all suffered life changing effects and had been ongoing medical issues as well as dollar of medical bills. And no they were not old and fat and out of shape. In fact, if it hadn't been for being somewhat in shape none of them would have lived through it.  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: Balance disorder, Cerebrovascular accident, Facial pain, Hemiplegia, Thrombosis
Clinical narrative: Almost completely over stroke; affecting left side; blood clot in lower left leg; after shots balance worsened; pressure on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: Bnt162b2 (dose 1), for covid-19 immunisation, reaction(s): "pressure on left side of face", "blood clot in lower left leg"; Bnt162b2 (dose 2), for covid-19 immunisation, reaction(s): "pressure on left side of face", "blood clot in lower left leg". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke"; HEMIPLEGIA (medically significant), outcome "unknown", described as "affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "after shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "pressure on left side of face". The events "almost completely over stroke", "affecting left side", "blood clot in lower left leg", "after shots balance worsened" and "pressure on left side of face" required emergency room visit. Clinical course: Having reaction to shots (2 + 1 booster). Almost completely over stroke on "10Dec2", affecting left side, & after shots balance worsened (98% now 80%) & now need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring After shots. ER many times from COVID shot.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days; I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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; BNT162b2 (BNT162B2), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: After having 3 Pfizer COVID vaccines, I tested positive showing I had contracted the COVID virus recently with fever and sickness for 3 days which I am now over. My question is, how is this possible after getting these vaccines.  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.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got COVID twice/ vaccine that didn't work; Got COVID twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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 included: "overweight smoker" (unspecified if ongoing); "overweight smoker" (unspecified if ongoing); "had about 12 surgeries in the past 10 years" (unspecified if ongoing), notes: about 12 surgeries in the past 10 years because of back, knee, and shoulder problems. The patient's family history included: "asthma" (unspecified if ongoing), notes: The patient was an overweight smoker with asthma/ patient's children had asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Got COVID twice/ vaccine that didn't work"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Got COVID twice".  Additional information: The patient was an overweight smoker with asthma and had about 12 surgeries in the past 10 years because of back, knee, and shoulder problems and got COVID twice and thought it was just allergies - patient's family had the same mild symptoms and patient's husband was a cancer survivor and patient's children had asthma and autism. Stop spreading fake information and pushing vaccine that didn't work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual disorders; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual disorders". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A 33-year-old patient 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. Vaccination history included: Flu vaccine, for Immunization. The following information was reported: SYNCOPE (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "fainted". The patient had a faint one week after the vaccination and never had it before.  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: Death
Clinical narrative: I have family members who are injured or dead due to your company's potential unethical experiments and negligence; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. 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 "I have family members who are injured or dead due to your company's potential unethical experiments and negligence." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter asked, "Why is Pfizer doing gain of function research to mutate Covid viruses as (Withheld) talked to the Project reporter last week? I have family members who are injured or dead due to your company's potential unethical experiments and negligence."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: I have family members who are injured or dead due to your companies potential unethical experiments and negligence.
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Sore arm; feeling tired/ fatigued saying the booster shot knocked her out.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:   A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired/ fatigued saying the booster shot knocked her out.".  Additional information: The patient described feeling a sore arm in the hours following the administration. She also described feeling tired/fatigued saying the booster shot "knocked her out". 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: FLUX
Symptoms: Influenza
Clinical narrative: I did and still got it; Initial information received on 26-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who did it and still got it after receiving vaccine influenza vaccine.  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 an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient did and still got it (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.