chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Hyperthyroidism, Thyroid function test, Thyroid stimulating immunoglobulin
Clinical narrative: seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid; My TSH is low; TSI high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A 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 included: "Hypothyroid" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs; "Hashimotos disease" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious), outcome "unknown", described as "My TSH is low"; THYROID STIMULATING IMMUNOGLOBULIN INCREASED (non-serious), outcome "unknown", described as "TSI high". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (unspecified date) Low, notes: My TSH is low; (Apr2021) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Jun2022) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Sep2022) Low; Thyroid function test: (unspecified date) Normal, notes: I had 3 Covid vaccines in the time between when my Thyroid tests came back Normal; Thyroid stimulating immunoglobulin: (unspecified date) High; Thyroxine: (unspecified date) Normal; Tri-iodothyronine: (unspecified date) Normal. Clinical course:After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. - It seems after receiving 3 Pfizer Covid Vaccines patient have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid. Her TSH was low - T3 and T4 normal- and TSI high. Nothing had changed for Me except that patient had 3 Covid vaccines in the time between when her Thyroid tests came back Normal. In Apr2021 and then in Jun2022 and Sep22 when TSH was low. Patient inquired would this resolve on it's own.  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: Thyroid stimulating immunoglobulin increased, Thyroxine, Tri-iodothyronine
Clinical narrative: seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid; My TSH is low; TSI high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A 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 included: "Hypothyroid" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs; "Hashimotos disease" (ongoing), notes: After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "seems after receiving 3 Pfizer Covid Vaccines I have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious), outcome "unknown", described as "My TSH is low"; THYROID STIMULATING IMMUNOGLOBULIN INCREASED (non-serious), outcome "unknown", described as "TSI high". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (unspecified date) Low, notes: My TSH is low; (Apr2021) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Jun2022) Low, notes: In Apr2021 and then in Jun2022 and Sep22 when TSH was low; (Sep2022) Low; Thyroid function test: (unspecified date) Normal, notes: I had 3 Covid vaccines in the time between when my Thyroid tests came back Normal; Thyroid stimulating immunoglobulin: (unspecified date) High; Thyroxine: (unspecified date) Normal; Tri-iodothyronine: (unspecified date) Normal. Clinical course:After being diagnosed as Hypothroid with Hashimotos disease for over 4yrs. - It seems after receiving 3 Pfizer Covid Vaccines patient have now been diagnosed as Hyperthroid- or Subclinical Hyperthyroid. Her TSH was low - T3 and T4 normal- and TSI high. Nothing had changed for Me except that patient had 3 Covid vaccines in the time between when her Thyroid tests came back Normal. In Apr2021 and then in Jun2022 and Sep22 when TSH was low. Patient inquired would this resolve on it's own.  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Cataract
Clinical narrative: Cataract surgery; hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery", start date: Aug2021 (unspecified if ongoing), notes: had cataract surgery in Mar2022 and before that in Aug2021.; "high blood pressure" (unspecified if ongoing), notes: She has high blood pressure. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9269, Expiry date: Unknown, Site: Unknown), administration date: 04Mar2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EP7534, Expiry date: Unknown, Site: Unknown, Event onset: Aug2021), administration date: 25Mar2021, when the patient was 81-year-old, for Covid-19 Immunization, reaction(s): "Cataract surgery". The following information was reported: CATARACT (medically significant) with onset Mar2022, outcome "unknown", described as "Cataract surgery"; ALOPECIA (non-serious) with onset 2022, outcome "not recovered", described as "hair loss".  Clinical course: It was reported that that her hair loss, "Started this at the end of February early March. The beauticians said lots of women are losing their hair at various ages. She has lost all her hair, and if she has to live with it, she has to live with it. We were scheduled to get our next booster, and she found the paper with your number on it. She just wanted to ask. satisfy my curiosity." Her hair loss started in the spring 2022 like late Feb2022 or Mar2022. She is curious as to why this happened. It may have nothing to do with it, but this was strange. She has had 4 doses of the Covid-19 Vaccine. 2 primary doses and 2 booster doses. Her last dose before she lost her hair was on 12Oct2021. Her last dose she had in May2022 after she had already lost most of her hair. Prior Vaccinations (within 4 weeks): Cataract surgery in Mar2022 and before that in Aug2021.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Laziness, Somnolence
Clinical narrative: Just felt lazy for a day; little sleepy; 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 77-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 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 (Received two Pfizer COVID Vaccines , Dose 1, Single), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Received two Pfizer COVID Vaccines , Dose 2, single), administration date: Jan2021, for COVID-19 immunization. The following information was reported: LAZINESS (non-serious) with onset 2022, outcome "recovered", described as "Just felt lazy for a day"; SOMNOLENCE (non-serious) with onset 2022, outcome "recovered", described as "little sleepy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that she was tested for bloodwork which appeared that she has high antibodies and so her doctor does not recommend her getting another booster dose. When received first Booster Pfizer COVID Vaccine, just felt lazy for a day or so, you know a little sleepy. Then bounced right back after a day or two. Has been no problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Tremor
Clinical narrative: Severe tremors; fell out of bed; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 13:30 as dose 4 (booster), single (Lot number: J 32777) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin's lymphoma in remission" (unspecified if ongoing), notes: Non Hodgkin's lymphoma in remission; "sjogrens" (unspecified if ongoing); "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "hypothyroidism" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "lymphocytic colitis" (unspecified if ongoing); "capillary leak syndrome remission" (unspecified if ongoing), notes: capillary leak syndrome remission. Concomitant medication(s) included: LOMOTIL [LOPERAMIDE HYDROCHLORIDE]; LISINOPRIL; HYDROCORTISONE; TIROSINT. Past drug history included: Plaquenil, reaction(s): "Known allergies: Plaquenil"; Flagyl, reaction(s): "Known allergies: Flagyl". Vaccination history included: Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number=FC3181,, Other vaccine same date dose number=3,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization; Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number= EL9266,, Other vaccine same date dose number=2,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization; Bnt162b2 (Other vaccine same date product=Pfizer,, Other vaccine same date lot number= EL 3249,, Other vaccine same date dose number=1,, Other vaccine same date vaccine location=Left arm.), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 17Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "Severe tremors"; FALL (non-serious) with onset 17Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "fell out of bed". Therapeutic measures were not taken as a result of tremor, fall.  Additional information: Patient reported severe tremors for 1 hour, found on floor in am fell out of bed and don't remember falling or my son picking me up to put back in bed. Facility type vaccine include Pharmacy or Drug Store. No other vaccine in four weeks. No Covid Prior Vaccination. No Covid Tested Post Vaccination. Other medications in two weeks included Lomotil, lisinopril, hydrocortisone, tirosint and verspam.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 1, single (Lot number: 30135BA) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm".  Additional information: The patient got her original vaccines back in 2021. With the original series, she had pain in her arm. No investigations were done.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 2, single (Lot number: FH8020) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: 30135BA), administration date: 13Oct2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Pain in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in her arm".  Additional information: COVID vaccine history: All Pfizer First vaccine: given: 13Oct2021 Lot: 30135BA, second vaccine: given 03Nov2021 lot: FH8020.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Pyrexia
Clinical narrative: bedridden for 3 days with a fever; bedridden for 3 days with a fever; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Says after dose 1 of Covid vaccine had a bad headache and brain fog, for 3 days.), for COVID-19 immunization, reaction(s): "brain fog", "bad headache". The following information was reported: BEDRIDDEN (non-serious), PYREXIA (non-serious), outcome "recovered" and all described as "bedridden for 3 days with a fever".  Additional Information: Patient stated that, same thing happened when Moderna vaccine for a booster was taken and lasted for 5 days. Also, confirmed that, event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: both arms slightly sore; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose number unknown (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 25Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for 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: PRODUCT USE ISSUE (non-serious) with onset 25Oct2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 25Oct2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both arms slightly sore".  Additional information: Patient received Covid booster Bivalent. He and his wife both got the Covid vaccine 2 days ago and got the flu shot. It was the Covid booster, the new booster. Reporter and wife went to (PRIVACY) pharmacy 2 days ago and got the flu shot in the right arm and Covid booster in the left arm. The following day, both of reporter arms were slightly sore but he had no problems. Reporter clarified that Reporter and wife had the flu shot and Covid booster at same time. Reporter states that he had no rash like his wife but his arms are a little sore, slightly but, there was nothing red. Reporter declined to complete report on this experience. He states to document that he had both vaccines from the same batch number and he does not have any red rash. Reason for no lot number: of Flu shot: Complainant does not have the product with them at the time of call.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 02Apr2021 at 12:00 as dose 2, single (Lot number: GR8737), in left arm, on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 20Apr2022 at 12:00 as dose 4 (booster), single (Lot number: Fj4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: GERD" (unspecified if ongoing); "Other medical history: High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2020, stop date: 13Oct2022; FAMOTIDINE, start date: 01Dec2021, stop date: 13Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Oct2022) Negative, notes: after completing first Paxlovid course and testing negative; (27Oct2022) Positive, notes: Positive COVID home test nine days after completing first Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Positive COVID home test nine days after completing first Paxlovid course and testing negative and Known allergies reported as No
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2022, stop date: Oct2022; BUPROPION, start date: Jan2022, stop date: Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Negative, notes: Tested negative with little to no symptoms 2 days after complete treatment; (21Oct2022) Positive, notes: then 6 days after  completing treatment have fever, aches and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received other medication in 2 weeks. Tested negative with little to no symptoms 2 days after complete treatment, then 6 days after completing treatment have fever, aches and tested positive. Patient had not known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Dose 2: Moderna/Dose 3: Pfizer; headache; sore throat and lymph nodes along jaw line swell and hurt; sore throat and lymph nodes along jaw line swell and hurt; sore throat and lymph nodes along jaw line swell and hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Fatigue Syndrome" (unspecified if ongoing); "chronic myofascial pain" (unspecified if ongoing); "POTS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 1, is bivalent: False, Batch/Lot No: 002B21A, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 50-year-old, for COVID-19 immunization; moderna (Dose Number: 2, is bivalent: False, Batch/Lot No: OUDB21A, Location of injection: Arm Left), administration date: 10Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021, outcome "unknown", described as "Dose 2: Moderna/Dose 3: Pfizer"; HEADACHE (non-serious) with onset 29Nov2021, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 29Nov2021, outcome "unknown" and all described as "sore throat and lymph nodes along jaw line swell and hurt". Additional information: headache 9 minutes after shot (has happened with every mRNA vaccine), 25 minutes after shot - sore throat and lymph nodes along jaw line swell and hurt has happened 30 min after 3rd. The patient did not receive any other vaccines in four weeks. covid prior vaccination and covid tested post vaccination was reported as no.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Fatigue, Laziness
Clinical narrative: her antibodies are high; after getting the vaccines, she is feeling tired and lazy; after getting the vaccines, she is feeling tired and lazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 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, SINGLE), administration date: Jan2022, for COVID-19 Immunization, reaction(s): "she is feeling tired and lazy", "she is feeling tired and lazy". The following information was reported: LAZINESS (non-serious), FATIGUE (non-serious) all with onset 2022, outcome "unknown" and all described as "after getting the vaccines, she is feeling tired and lazy"; ANTIBODY TEST ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "her antibodies are high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller already had the 2 primary vaccines in Jan, she had not gotten the booster yet since then as her antibodies were high, they were now in Oct and her antibodies were still high. She was asking when she could get the booster, after getting the vaccines, she was feeling tired and lazy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; EFFEXOR SR; MICROGESTIN FE. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Tree nuts, nuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: 2 weeks after initial positive result; (23Oct2022) Positive, notes: positive result occurred on 23Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication within 2 weeks of vaccination. Patient received Paxlovid for Treatment of COVID-19 from 09Oct2022 to 13Oct2022. COVID Rebound symptoms and positive result occurred on 23Oct, 2 weeks after initial positive result, and 10 days after completing 1 course of Paxlovid. Symptoms more severe during rebound.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested covid positive; tested covid positive; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 17May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2022, outcome "unknown" and all described as "tested covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive, notes: She also found to have positive COVID-19 test. 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.; Sender's Comments: Based on the known safety profile of vaccine and the information available the Causal relation between the events VACCINATION FAILURE, COVID-19 and suspect drug are assessed as related
Sex: F
Vaccine: COVID19
Symptoms: Body height, Dizziness, Interchange of vaccine products, Nausea, Vertigo
Clinical narrative: This was the second booster (not bivalent) so her 4th dose total and first three were Moderna; This was the second booster (not bivalent) so her 4th dose total and first three were Moderna; Vertigo; nausea; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1), for COVID-19 immunization; Moderna (DOSE 2), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER)), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "This was the second booster (not bivalent) so her 4th dose total and first three were Moderna"; VERTIGO (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patent weight 157.4 and height was 5.41/2. Patient had Vertigo/nausea/ lightheaded for 3 months. Events took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Weight, Wrong product administered
Clinical narrative: This was the second booster (not bivalent) so her 4th dose total and first three were Moderna; This was the second booster (not bivalent) so her 4th dose total and first three were Moderna; Vertigo; nausea; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1), for COVID-19 immunization; Moderna (DOSE 2), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER)), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "This was the second booster (not bivalent) so her 4th dose total and first three were Moderna"; VERTIGO (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patent weight 157.4 and height was 5.41/2. Patient had Vertigo/nausea/ lightheaded for 3 months. Events took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: patient got Covid vaccine shot 5 and flu shot same day; patient got Covid vaccine shot 5 and flu shot same day; received terrible pain that is described 15Oct and still in same pain after 7 days; This is a spontaneous report received from 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 5 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2022, outcome "not recovered", described as "received terrible pain that is described 15Oct and still in same pain after 7 days"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "patient got Covid vaccine shot 5 and flu shot same day".  Additional information: Patient got Covid vaccine shot #5 and flu shot same day/same arm and received terrible pain that was described 15Oct and still in same pain after 7 days. Event took place after use of product.  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: Amnesia, Disturbance in attention, Dizziness, Feeling abnormal, Headache
Clinical narrative: forgetting things; my head is cloudy; I can't concentrate and unaware of what is real and what is not; my brain hurts; I feel dizzy a lot; I feel like I am dying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is patient.  A 41-year-old male 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. Past drug history included: Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.; Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.  The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "forgetting things"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my head is cloudy"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't concentrate and unaware of what is real and what is not"; HEADACHE (non-serious), outcome "unknown", described as "my brain hurts"; DIZZINESS (non-serious), outcome "unknown", described as "I feel dizzy a lot"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "I feel like I am dying". Additional information: After taking the 1st covid shot patient started forgetting things. he had a breakdown and was in facility and his head was cloudy. he can't concentrate and unaware of what is real and what is not. he feel like he was dying, his brain hurts and he feel dizzy a lot. He hardly ever had unclouded thoughts.  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: Ill-defined disorder
Clinical narrative: forgetting things; my head is cloudy; I can't concentrate and unaware of what is real and what is not; my brain hurts; I feel dizzy a lot; I feel like I am dying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is patient.  A 41-year-old male 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. Past drug history included: Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.; Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.  The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "forgetting things"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my head is cloudy"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't concentrate and unaware of what is real and what is not"; HEADACHE (non-serious), outcome "unknown", described as "my brain hurts"; DIZZINESS (non-serious), outcome "unknown", described as "I feel dizzy a lot"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "I feel like I am dying". Additional information: After taking the 1st covid shot patient started forgetting things. he had a breakdown and was in facility and his head was cloudy. he can't concentrate and unaware of what is real and what is not. he feel like he was dying, his brain hurts and he feel dizzy a lot. He hardly ever had unclouded thoughts.  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: Fatigue, Influenza like illness
Clinical narrative: flu-like symptoms; feeling a bit tired; 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary Immunization series complete; , Dose 1, Single), for COVID-19 Immunization; Comirnaty (Dose 2, Single), for COVID-19 Immunization; Comirnaty (Dose 3 (Booster), Single), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "feeling a bit tired".  Additional information: Description of Event: After approx. 10 hours from a covid vaccine booster shot experienced flu-like symptoms. 24h after still feeling a bit tired.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: elevated ongoing heart rate; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 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: HEART RATE INCREASED (non-serious) with onset Oct2022, outcome "unknown", described as "elevated ongoing heart rate"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Report of elevated ongoing heart rate and fatigue. Took vaccine two days ago. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200091591 same drug/ae/reporter, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: had a bad headache and brain fog for 3 days; had a bad headache and brain fog for 3 days; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. 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: HEADACHE (non-serious), FEELING ABNORMAL (non-serious), outcome "recovered" and all described as "had a bad headache and brain fog for 3 days". Additional information: Patient was the physician. Says after dose 1 of COVID vaccine had a bad headache and brain fog for 3 days.  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: Rash
Clinical narrative: Rash all over the body; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003862).  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 completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash all over the body". Additional information: On 13Oct2022, it was reported that the patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine booster shot dose for an unknown indication. It was reported the patient had rash all over the body after receiving the Pfizer COVID-19 booster shot. No further follow-up is anticipated.  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: Atrial fibrillation, Cardiac failure congestive
Clinical narrative: Afib (Atrial fibrillation); (Congestive Heart Failure) CHF; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US210550_OS .  A 74-year-old male 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. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib (Atrial fibrillation)"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "(Congestive Heart Failure) CHF".  Clinical course: It was reported that patient had the 2 Pfizer COVID vaccines then had atrial fibrillation and congestive heart failure.  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: Headache
Clinical narrative: Mild headache that started 1 hour post injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL; PROZAC. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache that started 1 hour post injection".  Additional Information: Mild headache that started 1 hour post injection. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Magnetic resonance imaging, Sensory loss
Clinical narrative: Almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. Then eventually her feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), in Jul2021 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: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: SENSORY LOSS (non-serious) with onset Jul2021, outcome "unknown", described as "Almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. Then eventually her feet". The events "almost immediately after the 2nd shot she lost feeling in her fingers/traveled both hands and arms. then eventually her feet" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her daughter had a severe side effect from the Pfizer BioNTech Covid 19 Vaccine. It was administered in Jul2021. Almost immediately after the 2nd shot, she lost feeling in her fingers. It then traveled both hands and arms. Then eventually her feet. They had seen 3 Neurologists, psychiatrists, multiple primary care physicians and no one could or was willing to help them. MRI's clean. EMG, clean etc. The reporter needed to know what to do and provided all details to Pfizer months ago  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.