chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nerve injury, Pain in extremity
Clinical narrative: Nerve damage; Still have severe pain in both legs; Extreme numbness and weakness in both legs; Extreme numbness and weakness in both legs; Could hardly walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 at 12:00 as dose 2, single (Lot number: Ep7533) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6205, Vaccine Administration Time: 01:15 AM), administration date: 19Mar2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Numbness in left leg", "Numbness in left leg and foot". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 19Apr2021 at 12:00, outcome "unknown", described as "Could hardly walk"; HYPOAESTHESIA (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 19Apr2021 at 12:00, outcome "not recovered" and all described as "Extreme numbness and weakness in both legs"; NERVE INJURY (non-serious), outcome "unknown", described as "Nerve damage"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Still have severe pain in both legs". The events "extreme numbness and weakness in both legs", "could hardly walk", "nerve damage" and "still have severe pain in both legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, muscular weakness, gait disturbance, nerve injury, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Patient had no known allergies. About 3 Days after Dose 1 had numbness in left leg and foot About 10 Days after dose 2 had extreme numbness and weakness in both legs and could hardly walk Was about to go to ER but made appointment Dr. Patient had nerve damage from COVID 19 vaccination and reff. to Dr neurologist did tests. Treatment for condition nerve Damage will take about 1to1.5 years to recover from nerve damage 01Nov2022 Still have severe pain in both legs and for the past 3 weeks must use a Cane to walk 31Oct2022 Dr started treatment with for condition.
Sex: U
Vaccine: COVID19, 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 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was tested positive for COVID, I had my boosters (Pfizer COVID-19 Vaccine). Therapeutic measures were taken as a result of drug ineffective, covid-19.Paxlovid was used as a treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, SARS-CoV-2 test, Urticaria
Clinical narrative: Days 1-3 headachy; tired/Days 4-9 fatigue; loss of appetite; hives/By end of day 10, hives have moved up and down body, particularly arms and legs. Day 11 hives spread to fully cover arms and legs, down to feet/toes and hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GH9697) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Previous dose details, Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=331308A,, Prev dose lot unknown=False,, Prev dose administration date=08Dec2021,, Prev dose dose number=3,, Prev dose vaccine location=Left arm), administration date: 08Dec2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)"; BNT162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False, Prev dose lot number=EW0172, Prev dose lot unknown=False,, Prev dose administration date=26Apr2021,, Prev dose dose number=2,, Prev dose vaccine location=Left arm,), administration date: 26Apr2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)"; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False, Prev dose lot number=EW0172, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for COVID-19 immunization, reaction(s): "tired (same as prev 3 doses)". The following information was reported: HEADACHE (non-serious) with onset Oct2022, outcome "recovering", described as "Days 1-3 headachy"; URTICARIA (non-serious) with onset Oct2022, outcome "recovering", described as "hives/By end of day 10, hives have moved up and down body, particularly arms and legs. Day 11 hives spread to fully cover arms and legs, down to feet/toes and hands"; DECREASED APPETITE (non-serious) with onset Oct2022, outcome "recovering", described as "loss of appetite"; FATIGUE (non-serious) with onset Oct2022, outcome "recovering", described as "tired/Days 4-9 fatigue". The events "days 1-3 headachy", "tired/days 4-9 fatigue", "loss of appetite" and "hives/by end of day 10, hives have moved up and down body, particularly arms and legs. day 11 hives spread to fully cover arms and legs, down to feet/toes and hands" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, fatigue, decreased appetite, urticaria.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0172) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "tired". The event "tired" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: ; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0172) at the age of 41 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin - one time skin reaction in 2003", start date: 2003 (unspecified if ongoing), notes: penicillin - one time skin reaction in 2003; "penicillin - one time skin reaction in 2003", start date: 2003 (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1 SINGLE, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 03Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "tired (same as prev 3 doses)". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired (same as prev 3 doses)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that No other vaccine in four weeks. No other medications in two weeks. Other medical history was none.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: headachy, tired (same as prev 3 doses); headachy, tired (same as prev 3 doses); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: penicillin", start date: 2003 (unspecified if ongoing), notes: Known allergies: penicillin- one time skin reaction in 2003. There were no concomitant medications. Vaccination history included: BNT162b2 (lot_number=EW0172, dose number=1, Left arm.), administration date: 03Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "tired"; BNT162b2 (lot_number=EW0172, dose number=1, Left arm.), administration date: 03Apr2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "headachy"; BNT162b2 (lot_number=EW0172,dose_number=2, Left arm.), administration date: 26Apr2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "tired"; BNT162b2 (lot_number=EW0172,dose_number=2, Left arm.), administration date: 26Apr2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "headachy". The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "headachy, tired (same as prev 3 doses)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient did not take other vaccine in four weeks and no other medications in two weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocarditis, Nasopharyngeal swab
Clinical narrative: Heart disease myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 3330 BA) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid Prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew 0175, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 38-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Er 8733, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 38-year-old, for Covid-19 Immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 22Dec2021, outcome "not recovered", described as "Heart disease myocarditis". The event "heart disease myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Dec2021) Heart disease myocarditis; Nasopharyngeal swab: (14Apr2022) Negative. Therapeutic measures were taken as a result of myocarditis.  Clinical course: The patient has not taken any vaccines in four weeks. The patient has not taken any other medication in two weeks. The patient was not tested covid post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I suffer from vertigo pre covid and it got worse during early 2020" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020. The patient's concomitant medications were not reported. Past drug history included: Meclizine for Vertigo, reaction(s): "no impact anymore it feels like", notes: Meclizine 25mg has had no impact anymore it feels like. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: Unknown), for COVID-19 Immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: patient reported that, had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there any links to case studies or general information about it. I suffer from vertigo pre covid and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I suffer from vertigo pre covid and it got worse during early 2020", start date: 2020 (unspecified if ongoing); "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meclizine, reaction(s): "no impact anymore it feels like", notes: Meclizine 25mg. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose: 3), for COVID-19 immunization, reaction(s): "Vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: Patient has a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there's any links to case studies or general information about it. Patient suffer from vertigo pre COVID and it got worse during early 2020. patient noticed every time patient have gotten the vaccine patient finally feel clear headed and not having a serious case of vertigo as patient previously had. Meclizine 25mg has had no impact anymore it feels like, patient had 5 shots already of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vertigo" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020; "It got worse" (unspecified if ongoing), notes: it got worse during early 2020. Concomitant medication(s) included: MECLIZINE [MECLOZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 Booster), for COVID-19 immunization; Bnt162b2 (DOSE 4 Booster), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: Hi ,  I had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if theres any links to case studies or general information about it. I suffer from vertigo pre covid and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of Callback attempt #1 01Nov2022 2:46PM: to leave voice message with callback number and INT. Sent "further discussion" letter. Hi , I had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there's any links to case studies or general information about it. I suffer from vertigo pre COVID and it got worse during early 2020. I noticed every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had. Meclizine 25mg has had no impact anymore it feels like, I had 5 shots already of.  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: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Headache, Neck pain
Clinical narrative: pain/Achy all over/Stabbing pain like a knife throughout her body; low grade fever but went up to 100.6 degrees; Chills; Couldn't walk, loss of balance; Headache; Neck pain; Tremors; 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), 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: PAIN (non-serious), outcome "unknown", described as "pain/Achy all over/Stabbing pain like a knife throughout her body"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever but went up to 100.6 degrees"; CHILLS (non-serious), outcome "unknown"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Couldn't walk, loss of balance"; HEADACHE (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "Tremors". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was not sure she has the right department. Product was Pfizer Covid vaccine booster, latest vaccine She got it Tuesday morning. She states that she was recommended to take this vaccine by a family member who was a doctor, also had these reactions with the previous Pfizer Covid vaccines, but this time they are more severe. Patient reclarify some details as she was speaking very quickly, clarified information as So much pain, so sick she was crying and had a low-grade fever but went up to 100.6 degrees Fahrenheit Chills Tremors Stabbing pain like a knife throughout her body Couldn't walk, loss of balance Achy all over Headache Neck pain. Patient states hat her husband had some of these bad reactions from the Pfizer Covid vaccines, she did not specify which reactions, patient states her husband has not gotten any booster yet. Patient states she did not see information anywhere that showed any severity, she will talk to her physician to see if maybe her husband should take the Moderna vaccine next time instead of the Pfizer vaccine. Patient declines to complete a report. She just wants to find out if these effects are the usual reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201264913 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: pain/Achy all over/Stabbing pain like a knife throughout her body; low grade fever but went up to 100.6 degrees; Chills; Couldn't walk, loss of balance; Headache; Neck pain; Tremors; 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), 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: PAIN (non-serious), outcome "unknown", described as "pain/Achy all over/Stabbing pain like a knife throughout her body"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever but went up to 100.6 degrees"; CHILLS (non-serious), outcome "unknown"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Couldn't walk, loss of balance"; HEADACHE (non-serious), outcome "unknown"; NECK PAIN (non-serious), outcome "unknown"; TREMOR (non-serious), outcome "unknown", described as "Tremors". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient states she was not sure she has the right department. Product was Pfizer Covid vaccine booster, latest vaccine She got it Tuesday morning. She states that she was recommended to take this vaccine by a family member who was a doctor, also had these reactions with the previous Pfizer Covid vaccines, but this time they are more severe. Patient reclarify some details as she was speaking very quickly, clarified information as So much pain, so sick she was crying and had a low-grade fever but went up to 100.6 degrees Fahrenheit Chills Tremors Stabbing pain like a knife throughout her body Couldn't walk, loss of balance Achy all over Headache Neck pain. Patient states hat her husband had some of these bad reactions from the Pfizer Covid vaccines, she did not specify which reactions, patient states her husband has not gotten any booster yet. Patient states she did not see information anywhere that showed any severity, she will talk to her physician to see if maybe her husband should take the Moderna vaccine next time instead of the Pfizer vaccine. Patient declines to complete a report. She just wants to find out if these effects are the usual reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201264913 similar report from same reporter;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone, Blood culture, No adverse event
Clinical narrative: Patient received Pfizer Covid-19 vaccine on the following dates: 26Apr2021, 30Apr2021, and 17May2021; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Apr2021, described as "Patient received Pfizer Covid-19 vaccine on the following dates: 26Apr2021, 30Apr2021, and 17May2021". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Follow-up (25Oct2022): Upon follow-up this case has been considered as invalid.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Eye discharge, Hypersensitivity, Rhinorrhoea, Throat tightness
Clinical narrative: allergic reaction; my throat closes up; I have to take a puff to be able to breathe; I have secretions coming out my nose and eyes; I have secretions coming out my nose and eyes; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; ibuprofen (IBUPROFEN); acetylsalicylic acid (ASPIRIN (E.C.)), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "recovered", described as "allergic reaction"; THROAT TIGHTNESS (non-serious), outcome "recovered", described as "my throat closes up"; DYSPNOEA (non-serious), outcome "recovered", described as "I have to take a puff to be able to breathe"; EYE DISCHARGE (non-serious), RHINORRHOEA (non-serious), outcome "recovered" and all described as "I have secretions coming out my nose and eyes". The action taken for ibuprofen and acetylsalicylic acid was unknown. Therapeutic measures were taken as a result of hypersensitivity, throat tightness, dyspnoea, eye discharge, rhinorrhoea. Additional information: Patient got the 4th dose of the Pfizer covid vaccine (2 doses and 2 boosters) that last one in Apr2021. The query is because after the second application when patient took ibuprofen or aspirin, patient get an allergic reaction. It never happened to the patient before but now patient's throat closes up, had to take a puff to be able to breathe and had to take an antihistamine or corticoid because patient had secretions coming out of the nose and eyes. The effect only lasts for a few hours and then its gone. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy, Investigation, Thyroid stimulating immunoglobulin
Clinical narrative: Thyroid eye disease (TED); This is a literature report for the following literature source(s):   A 53-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Non smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ENDOCRINE OPHTHALMOPATHY (medically significant), 24 hrs after the suspect product(s) administration, outcome "recovering", described as "Thyroid eye disease (TED)". The patient underwent the following laboratory tests and procedures: CAS: 2/7; Thyroid stimulating immunoglobulin: 3.21 IU/l. Therapeutic measures were taken as a result of endocrine ophthalmopathy.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Thyroid eye disease and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Suddenly got COVID just 3 months after having it in Jun2022; Suddenly got COVID just 3 months after having it in Jun2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EL0140), in left arm and on 12Jan2021 as dose 2, single (Lot number: EL0140) at the age of 46 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Smoker: No" (unspecified if ongoing), notes: smoker/former smoker: No. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Suddenly got COVID just 3 months after having it in Jun2022". Clinical course: The patient believed that she got the illness from the vaccine and/or it was a strange coincidence that she had vaccine reaction and suddenly got COVID just 3months after having it in Jun2022. The patient consider the Pfizer product had a casual effect to the adverse event.; Sender's Comments: Vaccination failure depends on many factors including pharmacokinetics, the epidemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient experience: COVID-19; Patient experience: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4409043.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (ongoing); "Balance Issues" (ongoing); "High Cholesterol" (ongoing); "High Blood Pressure" (ongoing). Concomitant medication(s) included: OCREVUS; LISINOPRIL; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Patient experience: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Unknown results.  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: Allergy to vaccine
Clinical narrative: allergy to mRNA vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003888 (Novavax).  A 75-year-old female patient 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergy to mRNA vaccines".  Additional information: On 17Oct2022, it was reported that a patient started treatment on an unspecified date with mRNA vaccines (COVID-19 Vaccine mRNA) at unspecified dose for an unspecified indication. It was reported the patient had allergy to mRNA vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Immunisation reaction
Clinical narrative: Ankylosing Spondylitis got worse in colder weather; after booster vaccine injection patient got teniduious; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4142709.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), on 08May2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Ankylosing Spondylitis got worse in colder weather"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "after booster vaccine injection patient got teniduious". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis got worse in colder weather" and "after booster vaccine injection patient got teniduious" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of after booster vaccine injection patient got teniduious with Adalimumab Solution for Injection was no reasonable possibility. The reporter's causality for the event(s) of after booster vaccine injection patient got teniduious and condition got worse in colder weather with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine, cannot be excluded for the reported events, based on temporal relationship. However, the reported event of spondylitis ankylosing aggravated  may possibly represent intercurrent medical condition in this patient . There is  limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; 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), in Nov2021 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Caller called and inquired about Pfizer Covid 19 vaccine booster shot. She wanted to get the new vaccine, the booster shot she only had was in Nov, but she kept on getting some cold. She was wondering for how long should she wait before getting the Pfizer booster bivalent shot. Caller was calling and inquiring about Pfizer Covid 19 vaccine booster shot. She wanted to get the new vaccine, the booster shot she only had was in Nov, but she kept on getting some cold. She was wondering for how long should she wait before getting the Pfizer booster bivalent shot. Created an AE form because caller mentioned that she kept getting a cold after the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: ILLNESS (non-serious), outcome "unknown", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing their hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "losing their hair".  Additional information: Caller called in and said her sister and several inmates and other inmate women got the Pfizer covid-19 booster and they started losing their hair.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Biopsy, Blood creatinine, Blood immunoglobulin G, Histology
Clinical narrative: Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine; This is a literature report for the following literature source(s):  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "prostate Cancer" (unspecified if ongoing), notes: In remission; "renal cancer" (unspecified if ongoing), notes: In remission; "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlodipine for hypertension; Naproxen for arthritis. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PEMPHIGOID (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovering", described as "Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Antibody test: within normal Limits; Biopsy: revealed a subepidermal, notes: split with numerous eosinophils linear lgG and C3 staining along the basement  membrane zone; revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Blood creatinine: Raising; Blood immunoglobulin G (normal high range 20): 169, notes: Unit: Units; Histology: revealed a subepidermal split with numerous, notes: eosinophils and linear lgG and C3 staining along the basement membrane zone; Immunology test: revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Positive, notes: For IgG BP 180 antibodies; Physical examination: brightly erythematous, indurated plaques were, notes: present on the trunk, arms, and legs with intact and denuded bullae on the bilateral palms. Therapeutic measures were taken as a result of pemphigoid.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the reported event and the suspect drug BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Immunology test, Pemphigoid, Physical examination
Clinical narrative: Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine; This is a literature report for the following literature source(s):  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "prostate Cancer" (unspecified if ongoing), notes: In remission; "renal cancer" (unspecified if ongoing), notes: In remission; "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlodipine for hypertension; Naproxen for arthritis. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PEMPHIGOID (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovering", described as "Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Antibody test: within normal Limits; Biopsy: revealed a subepidermal, notes: split with numerous eosinophils linear lgG and C3 staining along the basement  membrane zone; revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Blood creatinine: Raising; Blood immunoglobulin G (normal high range 20): 169, notes: Unit: Units; Histology: revealed a subepidermal split with numerous, notes: eosinophils and linear lgG and C3 staining along the basement membrane zone; Immunology test: revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Positive, notes: For IgG BP 180 antibodies; Physical examination: brightly erythematous, indurated plaques were, notes: present on the trunk, arms, and legs with intact and denuded bullae on the bilateral palms. Therapeutic measures were taken as a result of pemphigoid.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the reported event and the suspect drug BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: experiencing excessive ringing in my ears; 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), on 14Oct2022 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: TINNITUS (non-serious) with onset Oct2022, outcome "unknown", described as "experiencing excessive ringing in my ears".  Additional information: It was also reported that patient had been experiencing excessive ringing in ears every day ever since he/she received bivalent booster 14Oct2022. He/she was in the process of seeing specialist. 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: F
Vaccine: COVID19
Symptoms: Contusion, Urinary tract infection
Clinical narrative: urinary issues with urinary tract infection; her arm is bruised up from it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2022US217671_NS.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed with unknown manufacturer), for Covid-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary issues with urinary tract infection"; CONTUSION (non-serious), outcome "unknown", described as "her arm is bruised up from it". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: Patient was the reporter. The patient reported that she developed urinary issues with urinary tract infection towards the end of Aug2022, she took an antibiotic treatment for this but was still having issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.