chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial pain, Headache, Lymphadenopathy, Toothache
Clinical narrative: headache; painful swollen glands; face and tooth pain; face and tooth pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH6963) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ulcer" (unspecified if ongoing); "I have allergic dermatitis to numerous chemicals" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: ACIDOPHILUS; D3; MELATONIN. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FJ4989, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 28Apr2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 21Oct2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 14Feb2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: FACIAL PAIN (non-serious), TOOTHACHE (non-serious) all with onset 24Sep2022 at 08:00, outcome "not recovered" and all described as "face and tooth pain"; HEADACHE (non-serious) with onset 24Sep2022 at 08:00, outcome "not recovered"; LYMPHADENOPATHY (non-serious) with onset 24Sep2022 at 08:00, outcome "not recovered", described as "painful swollen glands". The events "headache", "painful swollen glands" and "face and tooth pain" required physician office visit. Therapeutic measures were taken as a result of headache, lymphadenopathy, facial pain, toothache.  Additional information: If other vaccine in four weeks: No. Other medication in two weeks: Acidophilus, 2,000iu D3; B complex; Melatonin 1. If covid Prior vaccination: No. If covid tested post vaccination: No. she developed headache the day after the vaccine and still have a headache 5 days later. I also developed painful swollen glands the day after the vaccine and face and tooth pain. saw dentist for the toothache.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Anisocoria, Aphasia, Haemorrhage, Hypotonia
Clinical narrative: spontaneous Intraparenchymal hemorrhage; flaccid on right side; aphasic; anisocoria; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Gray Cap-PFIZER BIONTECH 0.3ML IM, Without Preservative), on 03Jun2022 at 16:15 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history included: "a.fib." (unspecified if ongoing). Concomitant medication(s) in two weeks included: ASPIRIN [ACETYLSALICYLIC ACID]. No other vaccine in four weeks.  No COVID prior vaccination. COVID not tested post vaccination. No known allergies. The following information was reported: ANISOCORIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal"; APHASIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "aphasic"; HYPOTONIA (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "flaccid on right side"; HAEMORRHAGE (death, medically significant) with onset 09Jun2022 at 16:00, outcome "fatal", described as "spontaneous Intraparenchymal hemorrhage". The events "spontaneous intraparenchymal hemorrhage", "flaccid on right side", "aphasic" and "anisocoria" required emergency room visit. AE resulted in: Emergency room/department or urgent care. The patient date of death was 10Jun2022. Reported cause of death: "Intraparenchymal hemorrhage". It was not reported if an autopsy was performed.  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, the causal association between the events spontaneous intraparenchymal hemorrhage", "hypotonia", "aphasia" and "anisocoria" and the suspect drug BNT162B2 cannot be excluded.  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.; Reported Cause(s) of Death: Intraparenchymal hemorrhage
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Tinnitus
Clinical narrative: loud tinnitus; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:00 as dose 5 (booster), single (Lot number: 5342) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid." (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Azithromycin, reaction(s): "Known allergies: azithromycin"; Protonix, reaction(s): "Known allergies: protonix". Vaccination history included: BNT162b2 (Dose 4, single, Batch/Lot No: 9896, location of injection: Arm Left), administration date: 02Apr2022, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "Loud tinnitus/noise in ears", "difficult to concentrate"; BNT162b2 (Dose 3, single, Batch/Lot No: 8028, location of injection: Arm Left), administration date: 04Nov2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "Loud tinnitus/noise in ears", "difficult to concentrate"; BNT162b2 (Dose 2, single, Batch/Lot No: EN6208, location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose 1, single, Batch/Lot No: EL9266, location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Sep2022, outcome "not recovered", described as "difficult to concentrate"; TINNITUS (non-serious) with onset Sep2022, outcome "not recovered", described as "loud tinnitus". Therapeutic measures were not taken as a result of tinnitus, disturbance in attention. Additional information: The patient experienced prolonged (lasting several weeks) episodes of loud tinnitus after each booster and her recent omicron booster. The noise in both her ears was intrusive and annoying, making it very difficult to concentrate. The patient had no COVID prior vaccination and did not have COVID test post vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Tinnitus
Clinical narrative: loud tinnitus/The noise in both my ears is intrusive and annoying; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 3 (booster), single (Lot number: 8028) at the age of 61 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid. Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin", notes: Known allergies: azithromycin; Cipro, reaction(s): "Known allergies: Cipro", notes: Known aller-gies: Cipro; Protonix, reaction(s): "Known allergies: protonix", notes: Known allergies: protonix. Vac-cination history included: BNT162b2 (Pfizer second primary, Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Pfizer first primary dose, Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 04Nov2021, outcome "not recovered", described as "difficult to concentrate"; TINNITUS (non-serious) with onset 04Nov2021, outcome "not recovered", described as "loud tinnitus/The noise in both my ears is intrusive and annoying". Therapeutic measures were not taken as a result of tinnitus, disturb-ance in attention.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not had COVID prior vaccination and also not tested positive post the vaccination. It was reported that, patient had prolonged (lasting several weeks) episodes of loud tinnitus after each booster and she had recent omicron booster. The noise in both ears was intrusive and annoying, making it very difficult to concentrate. Patient did not received any treatment for AEs.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Tinnitus
Clinical narrative: loud tinnitus/The noise in both my ears is intrusive and annoying; difficult to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: 9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALSARTAN. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: Cipro"; Known allergies: azithromycin, reaction(s): "Known allergies: azithromycin"; Known allergies: protonix, reaction(s): "Known allergies: protonix". Vaccination history included: BNT162b2 (dose 3 single, Batch/Lot No: 8028, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 61-year-old, for Covid-19 Immunization, reaction(s): "Prolonged (lasting several weeks) episodes of loud tinnitus after each booster"; BNT162b2 (dose 3 single, Batch/Lot No: 8028, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Difficult to concentrate", "The noise in both my ears is intrusive and annoying, making it very difficult to concentrate."; BNT162b2 (dose 2 single, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (dose 1 single, Batch/Lot No: EL9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 60-year-old, for COVID-19 immunization.  The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "loud tinnitus/The noise in both my ears is intrusive and annoying"; DISTURBANCE IN ATTENTION (non-serious), outcome "not recovered", described as "difficult to concentrate". Therapeutic measures were not taken as a result of tinnitus, disturbance in attention.  Follow-up attempts are completed. No further information is expected.  Additional information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior to vaccination. The patient did not tested post vaccination. Prolonged (lasting several weeks) episodes of loud tinnitus after each booster and patient's recent omicron booster. The noise in both ears was intrusive and annoying, making it very difficult to concentrate.  Follow-up attempts are completed. No further information is expected.
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) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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 "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment, Rebound covid. 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer); not feeling well; not feeling normal; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024693 (Moderna), 149362 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "morphine allergy" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "cipro antibiotics" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient; "Sulfa" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "not feeling well", "not feeling normal", "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours", "feeling tired"; BNT162b2 (DOSE 2, SINGLE), administration date: 13Feb2021, for COVID-19 immunization, reaction(s): "not feeling well", "not feeling normal", "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours", "feeling tired". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer)"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling normal"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, feeling abnormal, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200073355 same patient, different vaccine dose/event;US-PFIZER INC-202201194741 same patient, different vaccine dose/event;US-PFIZER INC-202201194743 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female 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. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "body chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache". Additional information: The reporter stated that she did work for Pfizer from 2001-2014. Caller states that Hopefully she had now experienced all the symptoms of all the shots and next time she won't have them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201193681 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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 immunization, reaction(s): "body chills", "bad headache", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "body chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201193681 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "Body chills", "Bad headache", "Fever"; Bnt162b2 (dose 2), for COVID-19 Immunization, reaction(s): "Body chills", "Bad headache", "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "body chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201193681 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:01), administration date: 26Mar2021, when the patient was 60-year-old, for Covid-19 Immunization; BNT162b2 (Dose:02), administration date: 16Apr2021, when the patient was 60-year-old, for Covid-19 Immunization; BNT162b2 (Dose:03), administration date: 23Mar2022, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "fever"; CHILLS (non-serious), outcome "not recovered", described as "body chills"; HEADACHE (non-serious), outcome "not recovered", described as "bad headache".  Additional information: Do the other shots have vomiting. I didn't get it with the other shots, I didn't get it with the other ones. Is vomiting directly related to the new variant vaccine? Pt had 4 previous PFizer covid vaccines and boosters. She states that she did work for Pfizer from 2001-2014. Patient is a 62 year old female. Per caller: 'I got kinda crappy for day or two fever, body chills, bad headache. Caller states, "Hopefully I have now experienced all the symptoms of all the shots and next time I wont have them".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201193681 same patient, different dose/event;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOPAMAX; LYRICA. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002191).  A male patient received BNT162b2 (BNT162B2), 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 complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "Blood clot". Clinical course: reporter knows someone whose husband died from blood clots after received the Pfizer covid 19 vaccine booster shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195450 same product and event, different patients;; Reported Cause(s) of Death: Blood clot
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clots". The patient date of death was unknown. Reported cause of death: "blood clots".  Clinical course: The reporter was calling for Xeljanz refill. She mentioned she knows someone who's husband died from blood clots after received the Pfizer covid 19 vaccine booster shot. Another friend in (Withheld) also died from blood clots after receiving the covid vaccine. Agent does not have address to provide. Agent provided Xelsource number to caller.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195438 same product and event, different patients;; Reported Cause(s) of Death: blood clots
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid infection after four dats; Rebound Covid infection after four dats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 09:00 as dose 4(booster), single (Batch/Lot number: unknown) at the age of 77 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 was not reported. Concomitant medication(s) included: PRALUENT, start date: 18Sep2022; ATORVASTATIN CALCIUM, start date: 19Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Sep2022 at 06:15, outcome "not recovered" and all described as "Rebound Covid infection after four dats". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female patient received BNT162b2 (BNT162B2), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. MANUFACTUERER UNKNOWN.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN.), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tired". Additional information: The reporter reported girlfriend received the 2nd Pfizer booster last Friday and was still very tired today which was Wednesday. She works in a nursing home and since she recently started working they are requesting a Tdap and MMR Titer. Reporter feel this was too soon to get these with her recent booster. Could you please let me know your thoughts about all these shots just a week or so apart from each other.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose 5 (booster); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (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), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), outcome "unknown", described as "dose 5 (booster)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative test obtained after 4 days; Positive, notes: In daily testing tested again faintly positive after Paxlovid final dose taken. Symptoms fully re-occurred, with strongly positive rapid test 4 days after final Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date: 18Sep2022, Treatment Stop Date: 23Sep2022.  Paxlovid rebound. Symptoms improved within 3 days and negative test obtained after 4 days. In daily testing tested again faintly positive after Paxlovid final dose taken. Symptoms fully re occurred, with strongly positive rapid test 4 days after final Paxlovid dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: I have developed psoriasis above my eyelids, eyebrows, and right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "I have developed psoriasis above my eyelids, eyebrows, and right ear".   Additional information: It was reported that patient had taken all the Covid-19 vaccines including boosters and had developed psoriasis above eyelids, eyebrows and right ear. The patient inquired it was a side effect of the vaccine because he never had a skin condition 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: Chills, Pyrexia
Clinical narrative: chills; mild fever; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 (Dose 2, Single), for Covid-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 (Dose 3 (Booster), Single), for Covid-19 immunization, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "mild fever". Additional information: Description of Event: Patient reports mild fever and chills for less than 24 hours after bivalent. States symptoms were less than with initial Covid-19 vaccine and previous booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cutaneous lymphoma, Neoplasm recurrence
Clinical narrative: rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously; rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CUTANEOUS LYMPHOMA (medically significant), NEOPLASM RECURRENCE (medically significant), outcome "unknown" and all described as "rare skin lymphoma recurred/The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously". Clinical course: The (Name Withheld) paper follows earlier isolated reports suggesting a possible link between COVID-19 vaccination and lymphoma. (Name Withheld), who heads the division of clinical dermatology at the (Clinic name withheld) in (State name withheld), co-authored a paper published in May2021 about a patient whose rare skin lymphoma recurred after his initial Pfizer shot. The tumorous ulcer appeared in the armpit of the same arm in which the man had received the injection, and then regressed spontaneously. A second shot of the vaccine, delivered three weeks later, produced no further lesions,   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: Pericarditis
Clinical narrative: Mild pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 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 complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Mild pericarditis". Clinical course: The patient experienced Mild pericarditis following Covid booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) and 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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "tested positive for COVID". The event "tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Description of Event: Patiennt presented to the emergency department with transaminitis and tested positive for COVID and was admitted to the hospital one day after COVID 19 booster vaccine was administered. Provider is unsure if this was a Pfizer product or not. Event took place after use of product.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Auditory disorder, Headache, Loss of personal independence in daily activities, Vertigo, Visual impairment
Clinical narrative: vertigo; hearing and vision issues; hearing and vision issues; significant headaches; This has affected my ability to work from the often; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown"; AUDITORY DISORDER (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "hearing and vision issues"; HEADACHE (non-serious), outcome "unknown", described as "significant headaches"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "This has affected my ability to work from the often".  Additional information: Patient received the first and second Pfizer vaccines for COVID and have been having vertigo, hearing and vision issues as well as significant headaches over the past several months. This has affected my ability to work from the often and I would like to know if others have reported.  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: Asthenia
Clinical narrative: mostly debilitated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ASTHENIA (non-serious), outcome "unknown", described as "mostly debilitated".  Additional information: It was reported that in Apr2021, the patient supported in a mission advocated by getting the covid vaccine. Since then the patient had been mostly debilitated.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Chills; fever; with the bivalent I had a little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 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 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (Dose 1, Dose 2), for COVID-19 immunization, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "with the bivalent I had a little sore arm".  Additional information: It was reported that, patient got the new omicron booster, patient had all regular and all boosters Most had chills fever But with the bivalent, patient had a little sore arm Maybe tired Did it work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Chills; fever; sore arm; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "chills", "fever"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "chills", "fever"; Bnt162b2 (Dose 3), for Covid-19 immunization, reaction(s): "chills", "fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional Information: It was reported that the patient got the new omicron booster. The patient had all regular and all boosters. The patient mostly had chills and fever, but with the bivalent the patient had a little sore arm, and maybe tired.   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: 12.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patients; 12 years with reported no adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases CLUSTER: 2022SA402396, 2022SA402704, 2022SA402436, 2022SA402443, 2022SA402500, 2022SA402505, 2022SA402514, 2022SA402525, 2022SA402530, 2022SA402619, 2022SA402662, 2022SA402707, 2022SA402718 and 2022SA402964.  This case involves a 12 years old female patient who was reported with flublok being administered to pediatric patients; 12 years with reported no adverse event while receiving vaccine influenza quadrivalent recombinant vaccine[Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 9V (yeast) (Gardasil 9) for Immunisation.  On 16-Sep-2022, the patient received a 1 dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml once with standard strength (lot UJ887AA, expiry date- 09-Jun-2023) (with unknown formulation) via intramuscular route in the left deltoid for Immunisation.  On 16-Sep-2022 the flublok being administered to pediatric patients; 12 years with reported no adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient under the age of 65 who was given fluzone high dose vaccine (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]) with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if there were lab data/results available. The company suspect product was inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (fluzone high dose vaccine was given to a patient under the age of 65 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.