chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Depression, Erythema, Herpes zoster
Clinical narrative: after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen; after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen; started having increased redness; lower back pain; she responds "generally agree" with statement "generally it's been hard to cope with ra and sometimes i feeldiscouraged/depressed; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster) , single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "She had shingle", start date: Apr2021 (unspecified if ongoing), notes: she had shingle; "Rheumatoid arthritis" (unspecified if ongoing); "The left side of her head is still itchy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3 (1st booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "after she had her second covid booster 09Apr2022 her shingles symptoms started to worsen"; ERYTHEMA (non-serious), outcome "unknown", described as "started having increased redness"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain"; DEPRESSION (non-serious), outcome "unknown", described as "she responds "generally agree" with statement "generally it's been hard to cope with ra and sometimes i feeldiscouraged/depressed".  Additional Information: Date of Event: See event. Describe event, problem or product use error: Patient reports her md advised her that if she is feeling well, she only needs to take xeljanz 5 mg tab daily and not twice daily as prescribed by MD. She had shingles Apr2021 and feels that shingles never went away, the left side of her head is still itchy. After she had her second covid booster 09Apr2022 her shingles symptoms started to worsen and she started having increased redness. She has lower back pain that started last week, she is unsure if pain is related to arthritis or due to over exertion while exercising. She responds "generally agree" with statement "generally it's been hard to cope with RA and sometimes I feel discouraged/depressed." Improved since start of therapy. Advised to update MD with new/worse symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: Large and painful inflammation of left axillary lymph nodes; Large and painful inflammation of left axillary lymph nodes; Large and painful inflammation of left axillary lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 07:15 AM), administration date: 03Jun2021, when the patient was 14-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left), administration date: 13May2021, when the patient was 14-year-old, for COVID-19 immunization. The following information was reported: INFLAMMATION (non-serious), LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious) all with onset 29Apr2022 at 06:00, outcome "recovered" (2022) and all described as "Large and painful inflammation of left axillary lymph nodes". Therapeutic measures were taken as a result of inflammation, lymphadenopathy, lymphadenopathy. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient was treatment received was Motrin for events inflammation and lymphadenopathy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 2, single (Lot number: EN6202) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Penicillin, reaction(s): "Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 09Feb2021, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 04Mar2021, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Reported Event: Patient reported Tinitus in her left ear that had not gone away. It was so bad it deterred her from receiving a booster for fear of it becoming worse or even worse than that, in both ears. A CONSTANT ringing and chirping in her ear. She had tried different things to help cope with the nagging, sometimes debilitating irritation of the noise in her head (ear). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chest discomfort, Dizziness, Malaise
Clinical narrative: nausea; strange feeling on my chest/ Knot in chest; stomach cramping and nabbing; Light headedness and feeling faint; not feeling well; faint feeling; knot in her stomach and chest that is churning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 at 15:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high Has been normal for some time now. Does not feel like it is relevant. Concomitant medication(s) included: TURMERIC [CURCUMA LONGA], start date: 2022. Vaccination history included: BNT162b2 (Dose 1, LOT: EL9267, NDC, EXP, Dose: Unknown, Right arm), administration date: 22Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, LOT: EN6207, NDC, EXP, Dose: Unknown, Left arm), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, LOT: FF2589, NDC, EXP, Dose: Unknown, Given at withheld pharmacy store number: #, Left arm), administration date: 15Oct2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "Light headedness and feeling faint"; DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "faint feeling"; NAUSEA (non-serious) with onset 12May2022, outcome "not recovered", described as "knot in her stomach and chest that is churning"; MALAISE (non-serious) with onset 12May2022, outcome "unknown", described as "not feeling well"; ABDOMINAL PAIN UPPER (non-serious) with onset 12May2022, outcome "unknown", described as "stomach cramping and nabbing"; CHEST DISCOMFORT (non-serious) with onset 12May2022 at 05:00, outcome "not recovered", described as "strange feeling on my chest/ Knot in chest"; NAUSEA (non-serious) with onset 12May2022 at 13:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; strange feeling on my chest/ Knot in chest; stomach cramping and nabbing; Light headedness and feeling faint; not feeling well; faint feeling; knot in her stomach and chest that is churning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11May2022 at 15:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high Has been normal for some time now. Does not feel like it is relevant. Concomitant medication(s) included: TURMERIC [CURCUMA LONGA], start date: 2022. Vaccination history included: BNT162b2 (Dose 1, LOT: EL9267, NDC, EXP, Dose: Unknown, Right arm), administration date: 22Feb2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, LOT: EN6207, NDC, EXP, Dose: Unknown, Left arm), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, LOT: FF2589, NDC, EXP, Dose: Unknown, Given at withheld pharmacy store number: #, Left arm), administration date: 15Oct2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "Light headedness and feeling faint"; DIZZINESS (non-serious) with onset 12May2022, outcome "not recovered", described as "faint feeling"; NAUSEA (non-serious) with onset 12May2022, outcome "not recovered", described as "knot in her stomach and chest that is churning"; MALAISE (non-serious) with onset 12May2022, outcome "unknown", described as "not feeling well"; ABDOMINAL PAIN UPPER (non-serious) with onset 12May2022, outcome "unknown", described as "stomach cramping and nabbing"; CHEST DISCOMFORT (non-serious) with onset 12May2022 at 05:00, outcome "not recovered", described as "strange feeling on my chest/ Knot in chest"; NAUSEA (non-serious) with onset 12May2022 at 13:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "NSCLC of lower lobe" (unspecified if ongoing), notes: NSCLC of lower lobe; "osteopenia" (unspecified if ongoing); "hypothyroidism post-operative" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM oral; PANTOPRAZOLE SODIUM oral. Past drug history included: Demerol, reaction(s): "demerol: Drug Allergy"; Tylenol, reaction(s): "tylenol: Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible
Sex: U
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: she knows of two other people who had similar thyroid problems after receiving similar thyroid problems after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), outcome "unknown", described as "she knows of two other people who had similar thyroid problems after receiving similar thyroid problems after receiving the vaccine". Additional Information: The caller is a 47-year-old female patient who previously called to report an "armpit lump" that appeared on Monday on the same arm where she received the on Monday on the same arm where she received the vaccine, after having received a booster shot on Saturday of the COVID vaccine for the Saturday booster shot of Pfizer's COVID vaccine. She mentions that "the little ball she does not know whether to consult with her primary care physician or what to do about it.to do about it. She provided the report number of # from agent. She mentions that she had not spoken to anyone from Pfizer Medical Information. She also mentions that when the first vaccine was given to her she was given information about mild reactions, which included this lump as a secondary reaction, and asked if there would be a as a secondary reaction, and she asked if there would be any type of I additional information. During the call, the caller mentioned that her first dose was on 15Apr and the second on 06May ,And that in October she started 06May, and that in October she started to feel sick so she went to see her doctor who diagnosed her with She went to see her doctor who diagnosed her with hyperthyroidism, for which she received treatment for a month and a half (6 weeks) and that she has and has returned to normal values since then. Without However, she knows of two other people who had similar thyroid problems after receiving the vaccine. She mentions that she finds it curious that it is transient, that she knows others with a similar other people with a similar problem and that she presented with no family history of hyperthyroidism.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: two other people who had similar thyroid problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), outcome "unknown", described as "two other people who had similar thyroid problems".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: During the call, the caller mentioned that her first dose was on 15Apr and the second on 06May, and that in Oct she started to feel sick so she went to see her doctor who diagnosed her with hyperthyroidism, for which she received treatment for a month and a half (6 weeks) and that she had returned to normal values since then. The reporter stated that she knew of two other people who had similar thyroid problems after receiving the vaccine. She mentioned that she found it curious that it is transient, that she knows other people with a similar problem and that she presented with no family history of hyperthyroidism.
Age: 37.0
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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: en6205), on 30Mar2021 as dose 2, single (Lot number: er2613) and on 05Dec2021 as dose 3 (booster), single (Lot number: fj1621) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ADVAIR; ALBUTEROL [SALBUTAMOL]; NITROFURANTOIN. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: Tested negative on 07May2022 only to get sick with COVID again and test positive on 11May2022; (11May2022) positive, notes: Tested negative on 07May2022 only to get sick with COVID again and test positive on 11May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 01May2022 to 05May2022for the treatment of COVID-19. Other medication in 2 weeks included Advair, Albuterol, Nitrofurantoin and Vitamins.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 20-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7534) intramuscular, on 21Apr2021 as dose 2, single (Lot number: EP7534) and on 20Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 20 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: If covid prior vaccination: Yes; (10May2022) Positive, notes: Nasal Swab, QuickVue At-Home OTC COVID-19 Test (Lot F40656); (12May2022) Positive, notes: Nasal Swab, QuickVue At-Home OTC COVID-19 Test (Lot F40656). Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts were possible. No further information was expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 the first time on 16Apr2022; tested positive for COVID-19 the first time on 16Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11Mar2021 at 12:00 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: EN6204 301308A) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEXAPRO. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "tested positive for COVID-19 the first time on 16Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive; (unspecified date) Unknown results, notes: no results back yet; (26Apr2022) Negative, notes: Took a rapid test and tested negative to it 10 days later"; (11May2022) Positive, notes: I wanted to go out yesterday; (12May2022) Positive, notes: I tested again today this morning. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Rhinorrhoea
Clinical narrative: allergy; runny nose; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 22Apr2021, when the patient was 29-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EP7533, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 29-year-old, for Covid-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 11May2022, outcome "recovering", described as "allergy"; RHINORRHOEA (non-serious) with onset 11May2022, outcome "recovering", described as "runny nose". It was unknown if therapeutic measures were taken as a result of drug hypersensitivity, rhinorrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 14:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: 1F039A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 08Nov2021, when the patient was 35-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 1F039A, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 16Oct2021, when the patient was 35-year-old, for COVID-19 Immunization. The following information was reported: NASAL DISORDER (non-serious), FATIGUE (non-serious) all with onset 11May2022 at 14:45, outcome "unknown" and all described as "feel nasal and tired". Therapeutic measures were not taken as a result of nasal disorder, fatigue.  Additional information: No other vaccines were administered within 4 weeks. Patient was not diagnosed with COVID prior to vaccination. She had not tested positive for COVID since the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - Ringing in ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EP7534) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 35-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "Tinnitus - Ringing in ear". The event "tinnitus - ringing in ear" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, unknown if patient been tested for COVID-19. Patient had no known allergies and no other medical history.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Other medication in 2 weeks: No. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "not recovered", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: by day 5 of the treatment, I was still testing positive; (May2022) Positive, notes: Now day 12 I am still symptomatic and testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID treatment. Product: COVID 19 Treatment, Treatment start date=06May2022, Treatment stop date=10May2022. Patient started taking Paxlovid on the fifth day of symptoms (it was hard to get) so did not nip the outbreak in the bud. The drug appeared to work, by day 5 of the treatment patient was still testing positive, but the test was far slower to develop and was far paler than previous tests. Patients assume this is a very rough proxy of viral load. Symptoms were significantly reduced. Patient then ran out of Paxlovid, and symptoms resumed: sore throat, cough, headache, fatigue. New tests were far faster to react. Now day 12 patient still symptomatic and testing positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had her booster and then tested positive for Covid; had her booster and then tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 87 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 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 "had her booster and then tested positive for Covid". 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 patient was treated with PAXLOVID (lot number FY6859; Expiry Date: Jan2023). The patient reported she will be 88 next month and that she had her booster and then tested positive for COVID; she had the booster and the line on the test came up very faint. Follow-up received on 11May2022 from product quality group providing investigation results concluded the complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine Injectable lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause  were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient was again tested COVID positive; the patient was again tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Influenza B virus infection", start date: 03Mar2021 (unspecified if ongoing); "COVID-19", start date: 03Mar2021 (unspecified if ongoing). Concomitant medication(s) included: ENBREL unknown, start date: Mar2021, stop date: Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "unknown" and all described as "the patient was again tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Mar2021) positive; (21Dec2021) positive.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thyroid function test, Thyroiditis acute
Clinical narrative: Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Ist dose, single), for COVID-19 Immunisation. The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". The patient underwent the following laboratory tests and procedures: Thyroid function test: Unknown result, notes: hyperthyroidsm & hypothyroidism was evaluated. Duration of duration of the hyperthyroid phase was also evaluated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event thyroiditis acute and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200708586 Same article/ Event/drug and different patient
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Infectious thyroiditis
Clinical narrative: Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Ist done, single), for COVID-19 immunization.The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: hyperthyroidsm & hypothyroidism was evaluated. Duration of duration of the hyperthyroid phase was also evaluated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200708586 Same article/ Event/drug and different patient
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Got a blood clot in my right leg on 05Dec, 3 days after the booster shot which almost killed me.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162b2 (BNT162B2), on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 79 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Sulphur" (unspecified if ongoing), notes: Known allergies: Sulpher. and other medical history: was reported as none Concomitant medication(s) included: FINASTERIDE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 19Feb2021, when the patient was 78-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 27Jan2022, when the patient was 78-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (caused and prolonged hospitalization, medically significant, life threatening) with onset 05Dec2021 at 22:30, outcome "recovered with sequelae", described as "Got a blood clot in my right leg on 05Dec, 3 days after the booster shot which almost killed me.". The patient was hospitalized and prolonged hospitalization for thrombosis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of thrombosis. It was reported that the facility type where vaccine was given was Pharmacy or Drug Store and other medications  given in two weeks was Finasteride 5 mg. The treatment given for the event was blood thinners.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines being given post temperature excursion, with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional via Physician.  This case involves a 11 years old male patient for whom vaccines being given post temperature excursion, with no reported adverse event while receiving Influenza Quadrival A-B Vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV Vaccine (HPV Vaccine) for Immunisation.  On 02-May-2022, the patient received a dose of 0.5 ml TOTAL of suspect Influenza Quadrival A-B Vaccine (lot UT7376NA; expiry date 30-Jun-2022) via intramuscular route in the right deltoid for Immunization.  On 02-MAY-2022 the patient reported vaccines being given post temperature excursion, with no reported adverse event (product storage error) following the administration of Influenza Quadrival A-B Vaccine.  Action taken with Quadrivalent Influenza Vaccine (Fluzone QIV) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01090544: 01092803: 01092787: 01092741: 2022SA167374:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines given post excursion, with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 4-year-old male patient for whom vaccines were given post excursion, with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) for Immunisation.  On 03-May-2022, the patient received a dose of suspect diphtheria, tetanus, ac pertussis and ipv vaccine lot C5916AA with unknown dosage form, strength and expiration date via intramuscular route in the left deltoid for immunization.  On 03-MAY-2022 the patient developed a non-serious event of vaccines given post excursion, with no reported adverse event (product administration error) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with diphtheria, tetanus, ac pertussis and ipv vaccine (quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccines given post excursion, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event vaccines given post excursion, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01092869: 01092879: 01092814: 01092832: 01092891: 01092687: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: medication error due to vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who experienced medication error due to vaccines being given post temperature excursion with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 03-May-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7376NA(expiry date: 30-Jun-2022)  via intramuscular route in the left thigh for Immunization.  On 03-MAY-2022 the patient developed a non-serious medication error due to vaccines being given post temperature excursion with no reported adverse event (medication error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to vaccines being given post temperature excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medication error due to vaccines being given post temperature excursion with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Asthenia, Confusional state, Decreased appetite, Dizziness
Clinical narrative: She was diagnosed with PMR (polymyalgia rheumatica); Four hours later she started to have symptoms of: body and joint pain; Four hours later she started to have symptoms of: body and joint pain; patient had fever; weak; patient had confused; patient had no appetite; patient started to have light headedness; patient had symptom of fatigue; patient had malaise; patient had trigeminal neuralgia; Initial information received on 09-May-2022 regarding an unsolicited valid  serious case received from a patient via call center.   This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) and patient had trigeminal neuralgia while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2021, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine (lot UJ725AA) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in unknown administration site for Flu vaccination.   On 05-OCT-2021 the patient developed a serious she was diagnosed with pmr (polymyalgia rheumatica) with symptom [body and joint pain (pain and arthralgia), pyrexia, asthenia, confused (confusional state), no appetite (decreased appetite), light headedness (dizziness), fatigue asthenia and malaise] (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine.  On 05-OCT-2021 the patient developed a non-serious patient had trigeminal neuralgia (trigeminal neuralgia) (latency 4 hours) following the administration of influenza quadrivalent recombinant vaccine.   Seriousness- medically significant for polymyalgia rheumatic   trigeminal neuralgia (non- serious)  Action taken: not applicable.  The patient was treated with prednisone for Polymyalgia rheumatica and Trigeminal neuralgia.  Outcome- Recovered / Resolved for Polymyalgia rheumatica and Trigeminal neuralgia; Sender's Comments: Sanofi Company Comment dated 16-May-2022: This case involves a 59 years old female patient who experienced she was diagnosed with pmr (polymyalgia rheumatica) while receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV]. The causal role of the company suspect drug cannot be excluded based on the temporal relevance instead of the time to onset is compatible with the role of the vaccine. However, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of  vaccine cannot be assessed.