chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19 infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 1, single (Lot number: FK5618), in right arm and on 08Dec2021 as dose 2, single (Lot number: FK5618) at the age of 11 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14Aug2022, outcome "recovering", described as "COVID-19 infection"; VACCINATION FAILURE (medically significant) with onset 14Aug2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. 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 and included Paxlovid. Clinical course: Anti-viral details: COVID-19 Treatment (Paxlovid) was started from 10Aug2022 and stopped on 14Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Migraine
Clinical narrative: 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 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 31Aug2022) at the age of 28 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 26Jul2022, outcome "not recovered", described as "constant migraine on left side of head"; EYE PAIN (non-serious) with onset 26Jul2022, outcome "not recovered", described as "reoccurring pain in left eye". Therapeutic measures were taken as a result of eye pain, migraine. Additional information: Patient states that he received his first dose of the Pfizer Covid19 vaccine primary series 3 weeks ago. Caller states he is scheduled for his 2nd dose tomorrow. Caller states that since he received his first dose of the vaccine, he has had "reoccurring pain in left eye and constant migraine on left side of head." Caller is asking "are these normal side effects of the vaccine and should I still have my 2nd dose tomorrow". Calling to see if this is something that has been reported as an issue that has been happening with other people or, if it is just something else. Everything started happening after the shot. Pain in eye: Started later that same day, that he got the shot, 26Jul2022. Outcome: Stayed pretty consistent. Would have a few days with no irritation at all. Then, all of a sudden, it would come right back. Migraines a lot more: Started same day as the eye pain. Outcome: Has stayed the same and hasn't gotten any worse. Is occurring more often than before. Treatment: No, just Advil. For  Only: Vaccination Facility Type: Pharmacy/Drug Store. History of all previous immunization with the Pfizer vaccine considered as suspect was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was No. No AE(s) require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was No.  AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): No. Relevant Tests: None. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID again; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "Bees allergy" (unspecified if ongoing), notes: Bees and insect bites; "prostate cancer" (unspecified if ongoing); "hearing loss" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "sinusitis" (unspecified if ongoing); "erectile dysfunction" (unspecified if ongoing); "Insect bite allergy" (unspecified if ongoing), notes: Bees and insect bites; "Barretts Esophagus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "recovering" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 13Aug2022, outcome "recovering", described as "positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive; (10Aug2022) Negative; (13Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included oral Paxlovid from 05Aug2022 to 10Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: 05Aug patient started with symptoms and had a positive test Placed on Paxlovid 05Aug (with renal dosing). Patient then tested negative and symptom free on 10Aug2022. Symptoms started again on 13Aug2022 was positive for COVID again. Patient is feeling worse today sneezing, congestion, coughing, muscle/body aches. Rebound symptoms started from 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events drug ineffective, covid-19 , disease recurrence and the suspect drug cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 at 18:00 as dose 2 (booster), single (Lot number: 133026801) at the age of 37 years, in left arm for COVID-19 immunisation; JANSSEN COVID-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Apr2021 at 14:30 as dose 1, single (Lot number: 1808980), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "generalized anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: banana, some citrus" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 29Jul2022. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included PAXLOVID. Clinical course: Anti-viral details: COVID 19 Treatment (PAXLOVID) was started from 10Aug2022 and stopped on 15Aug2022.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 at 18:00 as dose 2 (booster), single (Lot number: 133026801) at the age of 37 years, in left arm for COVID-19 immunisation; JANSSEN COVID-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Apr2021 at 14:30 as dose 1, single (Lot number: 1808980), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "generalized anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: banana, some citrus" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 29Jul2022. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included PAXLOVID. Clinical course: Anti-viral details: COVID 19 Treatment (PAXLOVID) was started from 10Aug2022 and stopped on 15Aug2022.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Nausea, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 at 18:00 as dose 2 (booster), single (Lot number: 133026801) at the age of 37 years, in left arm for COVID-19 immunisation; JANSSEN COVID-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Apr2021 at 14:30 as dose 1, single (Lot number: 1808980), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "generalized anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: banana, some citrus" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 29Jul2022. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "JANSSEN dose 1 on 03Apr2021, COMIRNATY dose 2 (booster) on 15Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included PAXLOVID. Clinical course: Anti-viral details: COVID 19 Treatment (PAXLOVID) was started from 10Aug2022 and stopped on 15Aug2022.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: vaccine brand other: Covishield; vaccine brand other: Covishield; Treatment of COVID-19; Treatment of COVID-19; Rebound symptoms with repeat positive COVID test after testing negative previously; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVISHIELD), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latent TB" (unspecified if ongoing), notes: Other medical history= Latent TB; "leukocytoclastic vasculitis" (unspecified if ongoing), notes: Other medical history= leukocytoclastic vasculitis; "Lupus anticoagulant with prior clot" (unspecified if ongoing), notes: Other medical history= Lupus anticoagulant with prior clot. Concomitant medication(s) included: AZATHIOPRINE, start date: 04May2022, stop date: 04Aug2022; ISONIAZID; WARFARIN; PYRIDOXINE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 13Aug2022, outcome "recovered" (14Aug2022), described as "Rebound symptoms with repeat positive COVID test after testing negative previously"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "vaccine brand other: Covishield"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative previously; Positive, notes: Rebound symptoms with repeat positive COVID test. 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.; Sender's Comments: The reported disease recurrence described as "rebound symptoms with repeat positive COVID test after testing negative previously" was considered as drug ineffective of vaccine BNT162B2, which was likely associated with off label use and interchange of vaccine products.
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: vaccine brand other: Covishield; vaccine brand other: Covishield; Treatment of COVID-19; Treatment of COVID-19; Rebound symptoms with repeat positive COVID test after testing negative previously; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVISHIELD), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latent TB" (unspecified if ongoing), notes: Other medical history= Latent TB; "leukocytoclastic vasculitis" (unspecified if ongoing), notes: Other medical history= leukocytoclastic vasculitis; "Lupus anticoagulant with prior clot" (unspecified if ongoing), notes: Other medical history= Lupus anticoagulant with prior clot. Concomitant medication(s) included: AZATHIOPRINE, start date: 04May2022, stop date: 04Aug2022; ISONIAZID; WARFARIN; PYRIDOXINE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 13Aug2022, outcome "recovered" (14Aug2022), described as "Rebound symptoms with repeat positive COVID test after testing negative previously"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "vaccine brand other: Covishield"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative previously; Positive, notes: Rebound symptoms with repeat positive COVID test. 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.; Sender's Comments: The reported disease recurrence described as "rebound symptoms with repeat positive COVID test after testing negative previously" was considered as drug ineffective of vaccine BNT162B2, which was likely associated with off label use and interchange of vaccine products.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from contactable consumer. The reporter is the patient. An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: 004m20a), in left arm, on 26Feb2021 as dose 2, single (Lot number: 023m20a), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: 026d21a), in left arm and on 11Mar2022 as dose 4 (booster), single (Lot number: 466k21a) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient had no known allergies. No adverse events from vaccines. The following information was reported: vaccination failure (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: anti-viral, from 02Aug2022 to 06Aug2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 027L20A), in left arm, on 04Feb2021 as dose 2, single (Lot number: 010mzoa), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 06sf21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Giant cell arteritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: 11 days after starting Paxlovid I had a bounce back experience; positive, notes: Five days later I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment start date was 01Aug2022, treatment stop date was 06Aug2022, for treatment of COVID-19. 11 days after started treatment with Paxlovid the patient had bounce back experienced and started testing positive again. Five days later the patient tested positive and not feeling great. The patient does not think the dose is sufficient to knock out the virus.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 14:30 as dose 1, single (Lot number: EN6201), in right arm, on 01Mar2021 at 14:00 as dose 2, single (Lot number: EN6198), in right arm, on 07Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FK9896), in right arm and on 21Apr2022 at 10:45 as dose 4 (booster), single (Lot number: KPSSF) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive other medication in 2 weeks. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Aug2022) Negative, notes: on day 8 after the start date, I tested negative; (16Aug2022) Positive, notes: I tested positive and had some symptoms reappear. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took a treatment of Paxlovid and on day 8 after the start date, she tested negative. On day 10, she tested positive and had some symptoms reappear, particularly the sore throat and hoarseness.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: got both Pfizer boosters; got both Pfizer boosters; SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron; SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "unknown" and all described as "SARS-COVID RNA U01.7, she got the delta [variant]/diagnosed with Omicron"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "got both Pfizer boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive, notes: diagnosed with Omicron.  Additional information: The patient was diagnosed with Omicron yesterday and was told Paxlovid could help her. However, she can't swallow pills. She needed to crush it in applesauce. She just went this morning for monoclonal antibodies [instead of PAXLOVID] because she did find out she cannot crush or open [PAXLOVID] in any way. She was hoping the antibodies work. She got vaccines, the first to get them in Jan and then she got 3 months later or a month later whatever, the second vaccine and then they got both Pfizer boosters and they were happy they didn't have any side effects from it at all. They felt really good and they felt very safe. She got SARS-COVID RNA U01.7, she got the delta [variant] and when she came down with this she was really surprised because they thought they were protected and they were also happy that labs such as Pfizer were coming out with ways to help them. She had a car accident because of that she had a concussion and it left her with a problem swallowing pills so she had to opt for the monoclonal antibodies. Stated the scientists that have done so much, labs that have done so much to help the whole world to survive this horrible pandemic.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 15Aug2021 as dose 1, single (Batch/Lot number: unknown), on 05Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; TYLENOL; FLONASE [MOMETASONE FUROATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Paxlovid treatment; (11Aug2022) Positive, notes: My COVID came back four days after I completed the Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took other medication on 2 weeks, other medications citalopram, Tylenol, Flonase products. Patient Covid came back four days after patient completed the Paxlovid treatment. Adverse event start date 11Aug2022 and recovering. Patient treated Paxlovid start date 02Aug2022 and stop date 07Aug2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.  This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 limited information in the case , a possible causal association between   the reported events drug ineffective, covid 19 and the suspect drug cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "seasonal and indoor allergies" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "trigeminal neuralgia" (unspecified if ongoing); "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures including Paxlovid 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.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Biopsy, Colonoscopy
Clinical narrative: Chronic diarrhea; weight loss; stomach cramps; bloating; debilitating; depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim"; Metropolal, reaction(s): "known allergies Metropolal"; Injectafer, reaction(s): "known allergies Injectafer". The following information was reported: DIARRHOEA (disability) with onset 29Jan2021, outcome "unknown", described as "Chronic diarrhea"; ABDOMINAL DISTENSION (disability) with onset 29Jan2021, outcome "unknown", described as "bloating"; ASTHENIA (disability) with onset 29Jan2021, outcome "unknown", described as "debilitating"; DEPRESSION (disability) with onset 29Jan2021, outcome "unknown"; ABDOMINAL PAIN UPPER (disability) with onset 29Jan2021, outcome "unknown", described as "stomach cramps"; WEIGHT DECREASED (disability) with onset 29Jan2021, outcome "unknown", described as "weight loss". The events "chronic diarrhea", "weight loss", "stomach cramps", "bloating", "debilitating" and "depression" required physician office visit. Therapeutic measures were taken as a result of diarrhoea, weight decreased, abdominal pain upper, abdominal distension, asthenia, depression. The patient had second dose of BNT162b2 (lot number EN6200) on 17Feb2021 in left arm and third dose (lot number 30155BA) on 01Oct2021 in left arm.  The patient had chronic diarrhea, weight loss, stomach cramps, bloating. She went to a doctor and tried several different things. She ended up going to two different gastroenterologists and was put on several different diets. She had at least a dozen lab tests done. Upper and lower GI, colonoscopy with biopsy, 3 CT scans, Ultrasound and X-rays and cause could not be found. The only thing that changed was that she had the vaccines. This was debilitating as she could not leave the house for more than 20 minutes at a time. She have had to see a counselor because of depression related to this.  The patient did not had Covid-19 prior to vaccination and the she did not test Covid post vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Depression, Diarrhoea, Laboratory test, Ultrasound scan
Clinical narrative: Chronic diarrhea; weight loss; stomach cramps; bloating; debilitating; depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim"; Metropolal, reaction(s): "known allergies Metropolal"; Injectafer, reaction(s): "known allergies Injectafer". The following information was reported: DIARRHOEA (disability) with onset 29Jan2021, outcome "unknown", described as "Chronic diarrhea"; ABDOMINAL DISTENSION (disability) with onset 29Jan2021, outcome "unknown", described as "bloating"; ASTHENIA (disability) with onset 29Jan2021, outcome "unknown", described as "debilitating"; DEPRESSION (disability) with onset 29Jan2021, outcome "unknown"; ABDOMINAL PAIN UPPER (disability) with onset 29Jan2021, outcome "unknown", described as "stomach cramps"; WEIGHT DECREASED (disability) with onset 29Jan2021, outcome "unknown", described as "weight loss". The events "chronic diarrhea", "weight loss", "stomach cramps", "bloating", "debilitating" and "depression" required physician office visit. Therapeutic measures were taken as a result of diarrhoea, weight decreased, abdominal pain upper, abdominal distension, asthenia, depression. The patient had second dose of BNT162b2 (lot number EN6200) on 17Feb2021 in left arm and third dose (lot number 30155BA) on 01Oct2021 in left arm.  The patient had chronic diarrhea, weight loss, stomach cramps, bloating. She went to a doctor and tried several different things. She ended up going to two different gastroenterologists and was put on several different diets. She had at least a dozen lab tests done. Upper and lower GI, colonoscopy with biopsy, 3 CT scans, Ultrasound and X-rays and cause could not be found. The only thing that changed was that she had the vaccines. This was debilitating as she could not leave the house for more than 20 minutes at a time. She have had to see a counselor because of depression related to this.  The patient did not had Covid-19 prior to vaccination and the she did not test Covid post vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: Chronic diarrhea; weight loss; stomach cramps; bloating; debilitating; depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim"; Metropolal, reaction(s): "known allergies Metropolal"; Injectafer, reaction(s): "known allergies Injectafer". The following information was reported: DIARRHOEA (disability) with onset 29Jan2021, outcome "unknown", described as "Chronic diarrhea"; ABDOMINAL DISTENSION (disability) with onset 29Jan2021, outcome "unknown", described as "bloating"; ASTHENIA (disability) with onset 29Jan2021, outcome "unknown", described as "debilitating"; DEPRESSION (disability) with onset 29Jan2021, outcome "unknown"; ABDOMINAL PAIN UPPER (disability) with onset 29Jan2021, outcome "unknown", described as "stomach cramps"; WEIGHT DECREASED (disability) with onset 29Jan2021, outcome "unknown", described as "weight loss". The events "chronic diarrhea", "weight loss", "stomach cramps", "bloating", "debilitating" and "depression" required physician office visit. Therapeutic measures were taken as a result of diarrhoea, weight decreased, abdominal pain upper, abdominal distension, asthenia, depression. The patient had second dose of BNT162b2 (lot number EN6200) on 17Feb2021 in left arm and third dose (lot number 30155BA) on 01Oct2021 in left arm.  The patient had chronic diarrhea, weight loss, stomach cramps, bloating. She went to a doctor and tried several different things. She ended up going to two different gastroenterologists and was put on several different diets. She had at least a dozen lab tests done. Upper and lower GI, colonoscopy with biopsy, 3 CT scans, Ultrasound and X-rays and cause could not be found. The only thing that changed was that she had the vaccines. This was debilitating as she could not leave the house for more than 20 minutes at a time. She have had to see a counselor because of depression related to this.  The patient did not had Covid-19 prior to vaccination and the she did not test Covid post vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Lethargy, Lymphadenopathy
Clinical narrative: feeling bad/she is still "feeling crappy"; has swollen lymph nodes; is lethargic; has a low-grade fever; feels like she doesn't have the energy to take a shower.; 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 female patient received BNT162b2 (BNT162B2), on 11Aug2022 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 (DOSE 1, DOSE 2, Primary Immunization series completed, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Aug2022, outcome "not recovered", described as "feeling bad/she is still "feeling crappy""; ASTHENIA (non-serious) with onset Aug2022, outcome "unknown", described as "feels like she doesn't have the energy to take a shower."; PYREXIA (non-serious) with onset Aug2022, outcome "unknown", described as "has a low-grade fever"; LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "has swollen lymph nodes"; LETHARGY (non-serious) with onset Aug2022, outcome "unknown", described as "is lethargic". 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling bad/she is still "feeling crappy"; has swollen lymph nodes; is lethargic; has a low-grade fever; feels like she doesn't have the energy to take a shower.; 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 female patient received BNT162b2 (BNT162B2), on 11Aug2022 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 (DOSE 1, DOSE 2, Primary Immunization series completed, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Aug2022, outcome "not recovered", described as "feeling bad/she is still "feeling crappy""; ASTHENIA (non-serious) with onset Aug2022, outcome "unknown", described as "feels like she doesn't have the energy to take a shower."; PYREXIA (non-serious) with onset Aug2022, outcome "unknown", described as "has a low-grade fever"; LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "has swollen lymph nodes"; LETHARGY (non-serious) with onset Aug2022, outcome "unknown", described as "is lethargic". 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: once I stop testing positive for the antibodies of the vaccine, will my symptoms improve; once I stop testing positive for the antibodies of the vaccine, will my symptoms improve; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "once I stop testing positive for the antibodies of the vaccine, will my symptoms improve".  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: Computerised tomogram, Pain in extremity
Clinical narrative: sore arm; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Lot number: EW0196), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing), notes: Comments: Anxiety; "Depression" (ongoing), notes: Comments: Depression. Concomitant medication(s) included: FAMOTIDINE; SEROQUEL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She has had 2 doses. The first was on 14Jul2021 (Lot EW0196), and the second was of 04Aug2021 (Lot FA7485) at (Name withheld). She stated that a nurse told her over the weekend that she should have gotten, Moderna because it has no side effects. She was told that Pfizer had side effects of myocarditis, then mentioned that she has a family history of heart disease, but that she never had issues with heart disease or blood pressure. It was unclear if she was implying that she was experiencing those issues. She was also asking if 1P36 deletion syndrome was related to the vaccine, as well as neuropathy and bowel issues. She stated that after the first shot, all she had was a sore arm, then stated that she got it in her left arm, where there was also a nicotine patch. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Sciatica
Clinical narrative: sciatica; excruciating pain; her mobility is at 20%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 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. Vaccination history included: Bnt162b2 (Dose Number: Unknown), for COVID-19 Immunization, reaction(s): "she contracted covid in December". The following information was reported: SCIATICA (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "excruciating pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "her mobility is at 20%".  Additional information: Please see below note Withheld received this morning. Passing along. To whom it may concern. Hi my name was Withheld and hoping you can point me in the right direction. Me and my wife got vaccinated last year with the Pfizer vaccine in the Withheld. She has been experiencing either both extreme or rare case of sciatica after she contracted COVID in December. She was 35 5'5 and 120 pounds she was by no means overweight and her diet was primarily gluten free products and balanced diet with supplements. She has been seeing a doctor at the Withheld location about 8 min away. They dont have any answers for her. Everyday she was in excruciating pain and her mobility was at 20%. was there any assistance or case studies that you provide that can point us down the right avenue. Any help would be greatly appreciated. Thanks and have a good day! Sincerely Withheld.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she is vaccinated, just got Covid; she is vaccinated, just got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK4176), on 04Feb2021 as dose 2, single (Lot number: EL3302) and on 03Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she is vaccinated, just got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measure included Paxlovid, which was taken on 11Aug2022 as a result of vaccination failure, covid-19.
Age: 45.0
Sex: M
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 46-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.