chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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: "Asthma" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing), notes: Known allergies- Shellfish. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Now testing positive again with symptoms within 60 days of having Covid paxlovid treatment; (May2022) Negative, notes: Completed full series and tested negative after 7 days in Early May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included no other medication in 2weeks. Treatment of COVID-19 included Paxlovid.   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: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HNT" (unspecified if ongoing); "HLP" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "OSA on CPAP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient received Paxlovid for COVID 19 treatment. Treatment start date is 16Jun2022 and treatment stop date is 21Jun2022, indication for treatment of COVID 19.route of administration Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 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's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 31Dec2012. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and other medication with in 2weeks: Yes, known allergies: Amoxicillin and other medical history: Obesity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose number unknown, single (Lot number: FL3197) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 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), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Contracted COVID". Clinical course: Patient already received 2 shots of the Pfizer COVID-19 vaccine but not yet received the booster dose. He contracted COVID a few weeks ago and was asking how long does he need to wait before he can get the booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Photophobia
Clinical narrative: The neuropathy on his feet also intensified up his legs; The photophobia was so bad/ it got worse with the second vaccine; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: May2021) at the age of 69 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Pfizer, Lot: EL9262, Time given: Believes something like mid day early afternoon, Dose given: Unknown; Asking what were the choices?, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Photophobia".  The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "The neuropathy on his feet also intensified up his legs"; PHOTOPHOBIA (non-serious) with onset 2021, outcome "not recovered", described as "The photophobia was so bad/ it got worse with the second vaccine". The events "the neuropathy on his feet also intensified up his legs" and "the photophobia was so bad/ it got worse with the second vaccine" required physician office visit.  Clinical course: Patient received his 1st dose of the vaccine on 21Jan2021 and developed photophobia shortly after receiving the vaccine as patient was not able to look at his computer without getting a headache. Patient received his 2nd Pfizer COVID-19 vaccine on 11Feb2021 and the photophobia was so bad that he could no longer look at his cellphone or TV without getting a headache and also had some trouble with sunlight when outdoors. After 2nd vaccine, the neuropathy on his feet also intensified up his legs. Prior Vaccinations(within 4 weeks) reported as no.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The neuropathy on his feet also intensified up his legs; The photophobia was so bad/ it got worse with the second vaccine; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: May2021) at the age of 69 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Pfizer, Lot: EL9262, Time given: Believes something like mid day early afternoon, Dose given: Unknown; Asking what were the choices?, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Photophobia".  The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "The neuropathy on his feet also intensified up his legs"; PHOTOPHOBIA (non-serious) with onset 2021, outcome "not recovered", described as "The photophobia was so bad/ it got worse with the second vaccine". The events "the neuropathy on his feet also intensified up his legs" and "the photophobia was so bad/ it got worse with the second vaccine" required physician office visit.  Clinical course: Patient received his 1st dose of the vaccine on 21Jan2021 and developed photophobia shortly after receiving the vaccine as patient was not able to look at his computer without getting a headache. Patient received his 2nd Pfizer COVID-19 vaccine on 11Feb2021 and the photophobia was so bad that he could no longer look at his cellphone or TV without getting a headache and also had some trouble with sunlight when outdoors. After 2nd vaccine, the neuropathy on his feet also intensified up his legs. Prior Vaccinations(within 4 weeks) reported as no.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Photophobia
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), mid day early afternoon in arm and on 11Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: May2021), early afternoon at the age of 69 years, in arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Clinical course was reported as patient (Pt) received his 1st dose of the vaccine on 21Jan2021 and developed photophobia shortly after receiving the vaccine as he wasn't able to look at his computer without getting a headache. Pt states that he received his 2nd Pfizer Covid19 vaccine on 11Feb2021 and the photophobia was so bad that he could no longer look at his cellphone or TV without getting a headache and also had some trouble with sunlight when outdoors. Pt states that after the 2nd vaccine, the neuropathy on his feet also intensified up his legs. Pt states that on 07May2022 he got Covid and his side effects from the vaccine have ongoing. There were no additional vaccines administered on same date of the Suspect. Adverse events did not require a visit to Emergency Room. There were no prior vaccinations(within 4 weeks) of Covid-19 vaccination. There were no predisposing factors.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), mid day early afternoon in arm and on 11Feb2021 as dose 2, single (Lot number: EL9266, Expiration Date: May2021), early afternoon at the age of 69 years, in arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Clinical course was reported as patient (Pt) received his 1st dose of the vaccine on 21Jan2021 and developed photophobia shortly after receiving the vaccine as he wasn't able to look at his computer without getting a headache. Pt states that he received his 2nd Pfizer Covid19 vaccine on 11Feb2021 and the photophobia was so bad that he could no longer look at his cellphone or TV without getting a headache and also had some trouble with sunlight when outdoors. Pt states that after the 2nd vaccine, the neuropathy on his feet also intensified up his legs. Pt states that on 07May2022 he got Covid and his side effects from the vaccine have ongoing. There were no additional vaccines administered on same date of the Suspect. Adverse events did not require a visit to Emergency Room. There were no prior vaccinations(within 4 weeks) of Covid-19 vaccination. There were no predisposing factors.
Age: 77.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm 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), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not receive any other medications within two weeks of vaccination. COVID 19 treatment from 16Jun2022 to 20Jun2022. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Muscle disorder
Clinical narrative: Muscle twitches and tics, mostly in stomach; Muscle twitches and tics, mostly in stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 1, single (Batch/Lot number: unknown) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MUSCLE DISORDER (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Oct2021, outcome "recovered" and all described as "Muscle twitches and tics, mostly in stomach". The events "muscle twitches and tics, mostly in stomach" required physician office visit. Therapeutic measures were not taken as a result of muscle disorder, abdominal discomfort.  Clinical information: No known allergies. No covid prior vaccination and covid tested post vaccination. Facility type vaccine was pharmacy or drug store. BNT162b2 was administered on an unknown date in Oct2021 at 3:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=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 70-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability
Clinical narrative: has a hard time driving around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose number unknown (booster), single (Lot number: EP7534) 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: IMPAIRED DRIVING ABILITY (non-serious), outcome "unknown", described as "has a hard time driving around".  Additional information: The patient got her first booster dose on 22Nov2021 and still up until now did not get the second booster dose of Pfizer COVID Vaccine. She had a medical inquiry regarding any recommendations for her. No one had been talking about it and she thought she had better check to see what's the matter. One of her lady friends from church said she better go have that checked, and then they told her it was too late to get the second booster dose of Pfizer COVID Vaccine. She called to ask if that was right, what the recommended duration between the first and second booster dose was. She mentioned that she was 87 and had a hard time driving around.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), utcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She had two vaccines and one booster, and she feels it protected her from having severe Covid.; She had two vaccines and one booster, and she feels it protected her from having severe Covid.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had two vaccines and one booster, and she feels it protected her from having severe Covid.". 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (004756).  A female patient received BNT162b2 (BNT162B2), as unk, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (hospitalization), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 57, notes: Increased. The action taken for levothyroxine sodium was unknown. Clinical course: Caller wanted to know about reports of elevated TSH levels after covid vaccine. How long it takes to resolve, is there any inflammation going on. She had seen this with herself and with other members of her family, her Sister, daughter and brother- in-law, they all took Synthroid and had elevated TSH levels in the more recent labs, they all had gotten the Pfizer covid vaccine also. She stated other people were also experiencing it post covid injection they were having thyroid problems. Members were not having any symptoms but their TSH level were very elevated, her was 57 and she was in the hospital due to it. Her doctors were also not aware of this side effect. Her brother- in law stated that this could be reaction from covid vaccine /reagents as he did the research internationally. Their doctor thought that they were not taking Synthroid. The TSH level is markedly increased when taking Synthroid and after receiving the Covid vaccine: TSH 57. Caller stated she would like to report a concern and obtain some information regarding the Pfizer Covid vaccine, adult. Caller stated she was a nurse practitioner. Caller stated that she had noticed with herself, and some of her family members, that the TSH level was markedly increased when taking Synthroid and after receiving the Covid vaccine. Caller did not provide any specific identifiers for her family members. Caller stated she had read information about the Covid vaccine, and it could cause autoimmune difficulties, including thyroid problems  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 known drug safety profile, there is reasonable possibility of causal association between the event TSH increase and the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (004756).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for levothyroxine sodium was unknown.  Additional information: Caller wanted to know about reports of elevated TSH levels after covid vaccine. How long it takes to resolve, was there any inflammation going on. She has seen this with herself and with other members of her family, her Sister, daughter and brother- in-law, they all take Synthroid and have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also. She stated other people were also experiencing it post covid injection they are having thyroid problems. Members were not having any symptoms, but their TSH level were very elevated, her was 57 and she was in the hospital due to it. Her doctors were also not aware of this side effect.  Her brother- in law stated that this could be reaction from covid vaccine /reagents as he does the research internationally. Their doctor thinks that they were not taking Synthroid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was Covid + 2 weeks ago; was Covid + 2 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "was Covid + 2 weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (19Jun2022) Negative; (28Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" 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 (3 times); Negative; Negative. 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.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ovarian cysts" (unspecified if ongoing), notes: Other medical history: ovarian cysts; "Known allergies: raisins" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics; "Birth Control" (unspecified if ongoing). Concomitant medication(s) and other medications in 2 weeks included: ESCITALOPRAM; VITAMIN D NOS; APRI taken for contraception; ALLEGRA. Past drug history included: Omnicef, reaction(s): "Known allergies: omnicef", notes: Known allergies: omnicef. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 Treatment with Paxlovid, started on 26Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 16:30 as dose 1, single (Lot number: 026L20A), in left arm, on 15Feb2021 as dose 2, single (Lot number: 026L20A), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 076C21A) at the age of 55 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). The patient took concomitant medications, also reported as other medication in two weeks. Past drug history included: Ceclor, reaction(s): "Known allergies : Celcor". 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 08Jun2022 and stopped on 12Jun2022. Clinical course was reported as Took Paxlovid for 5 days, mild symptoms Covid. Fast recovery. Chest heaviness residual. Rebound Covid Positive 2.5 weeks later, mild symptoms (reported as on 25Jun2022). Notified Doctor. Patient received no treatment for symptoms and not recovering from symptoms.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Frustration tolerance decreased, Hallucination, auditory, Headache
Clinical narrative: Auditory hallucination; Hot flashes; Headache; Confusion; Lethargy; Frustrated; It's very frustrating but I just keep calm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 39-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 was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: HALLUCINATION, AUDITORY (medically significant), outcome "unknown", described as "Auditory hallucination"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; HEADACHE (non-serious), outcome "unknown"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion"; LETHARGY (non-serious), outcome "unknown"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Frustrated; It's very frustrating but I just keep calm". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were not taken as a result of hallucination, auditory, hot flush, headache, confusional state, lethargy, frustration tolerance decreased. Clinical course: The reporter was calling because he had a patient for his second dose but it seemed like he had some serious concerns about this vaccine. The patient had auditory hallucination or something from, since he got the COVID shot. Also the patient had hot flashes, headache, confusion, lethargy. The patient wanted to visit a Neurologist.  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: Hot flush, Lethargy
Clinical narrative: Auditory hallucination; Hot flashes; Headache; Confusion; Lethargy; Frustrated; It's very frustrating but I just keep calm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist). The reporter is the patient.  A 39-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 was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: HALLUCINATION, AUDITORY (medically significant), outcome "unknown", described as "Auditory hallucination"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; HEADACHE (non-serious), outcome "unknown"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion"; LETHARGY (non-serious), outcome "unknown"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Frustrated; It's very frustrating but I just keep calm". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were not taken as a result of hallucination, auditory, hot flush, headache, confusional state, lethargy, frustration tolerance decreased. Clinical course: The reporter was calling because he had a patient for his second dose but it seemed like he had some serious concerns about this vaccine. The patient had auditory hallucination or something from, since he got the COVID shot. Also the patient had hot flashes, headache, confusion, lethargy. The patient wanted to visit a Neurologist.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid-19 on 16Jun2022; I tested positive for Covid-19 on 16Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 17Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "I tested positive for Covid-19 on 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: My positive result was confirmed by multiple rapid tests over the next few days; (16Jun2022) positive, notes: I tested positive for Covid-19 on 16Jun2022 on a rapid antigen test; (21Jun2022) negative, notes: I tested negative on a rapid antigen test on 21Jun; (28Jun2022) positive, notes: on the morning of 28Jun I again tested positive on a rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated this as a 'rebound' case. He tested positive for Covid-19 on 16Jun2022 on a rapid antigen test and began treatment with Paxlovid the same day. COVID 19 Treatment Paxlovid started from 15Jun2022 to 20Jun2022. His positive result was confirmed by multiple rapid tests over the next few days. His symptoms improved steadily and tested negative on a rapid antigen test on 21Jun, the same day he completed his final dose of Paxlovid. On the evening of 27Jun, some symptoms returned and on the morning of 28Jun he again tested positive on a rapid antigen test. Other medication within 2 weeks was reported as Nyquil, with start date on 15Jun2022 and stop date on 23Jun2022. No known allergies were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Dec2020 as dose 1, single (Lot number: 025J20-2A), in left arm, on 17Jan2021 as dose 2, single (Lot number: 025J20-2A), in right arm and on 20Aug2021 as dose 3 (booster), single (Lot number: 088D21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune cholangitis" (unspecified if ongoing); "Probable autoimmune disease of liver" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) negative, notes: On day 5 when Paxlovid finished patient felt good and tested negative; (07Jun2022) negative, notes: Retested negative on days 7 and 9; (09Jun2022) negative, notes: Retested negative on days 7 and 9; (01Jun2022) positive, notes: Patient began Paxlovid on first day of symptoms and positive home antigen test; (11Jun2022) positive, notes: on day 11 felt sick and home antigen test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Rebound Covid on day 11 of infection. Patient began Paxlovid on first day of symptoms and positive home antigen test. On day 5 when Paxlovid finished patient felt good and tested negative. Retested negative on days 7 and 9 but on day 11 felt sick and home antigen test positive. Was sick/symptomatic 4 days. Also developed and treated for sinus infection at this time with Augmentin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid 19; positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:45 as dose 3 (booster), single (Lot number: FK9894) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 at 15:00 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 04Apr2021 at 09:30 as dose 1, single (Lot number: 043A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "comorbidity: obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (25Jun2022) Negative, notes: Day 9; (27Jun2022) Positive, notes: Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After testing positive for Covid 19, the patient started Paxlovid within hours of the positive test (Day 0 of symptoms). The patient took the full dosage as prescribed (3 pills, 2x a day, for 5 days.) The patient symptoms (sore throat, stuffy head, digestive issues, and fatigue) disappeared by Day 6 and the patient tested negative on Day 9. A few symptoms (sore throat, stuffy head, and fatigue) returned on Day 10 (26Jun2022 17:00) and the patient was tested positive again on Day 11. The adverse event was not resulted in emergency room or physician office visit.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid 19; positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 16:45 as dose 3 (booster), single (Lot number: FK9894) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 at 15:00 as dose 2, single (Lot number: 012F21A), in left arm for covid-19 immunisation; jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 04Apr2021 at 09:30 as dose 1, single (Lot number: 043A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "comorbidity: obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (25Jun2022) Negative, notes: Day 9; (27Jun2022) Positive, notes: Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After testing positive for Covid 19, the patient started Paxlovid within hours of the positive test (Day 0 of symptoms). The patient took the full dosage as prescribed (3 pills, 2x a day, for 5 days.) The patient symptoms (sore throat, stuffy head, digestive issues, and fatigue) disappeared by Day 6 and the patient tested negative on Day 9. A few symptoms (sore throat, stuffy head, and fatigue) returned on Day 10 (26Jun2022 17:00) and the patient was tested positive again on Day 11. The adverse event was not resulted in emergency room or physician office visit.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right 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's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "allergies: NSAIDS" (unspecified if ongoing). 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details included COVID 19 Treatment, Pfizer Paxlovid, treatment start date was 26Jun2022 (lot number=1914705A).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.