chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days 12 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment (Paxlovid), treatment start date was 23Sep2022, treatment stop date was 05Oct2022 and indication was treatment of COVID-19. Other medication in 2weeks reported as yes.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, FLUC3
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: 6h9694) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L20A), on 11Feb2021 as dose 2, single (Lot number: 030620A) and on 02Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medications included: ROSUVASTATIN; FIBERCON; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022 (also reported as 01Oct2022), outcome "recovering" and all described as "Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, FLUC3
Symptoms: Abdominal pain, Diarrhoea, Interchange of vaccine products, Off label use, Product use issue
Clinical narrative: Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: 6h9694) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L20A), on 11Feb2021 as dose 2, single (Lot number: 030620A) and on 02Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medications included: ROSUVASTATIN; FIBERCON; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022 (also reported as 01Oct2022), outcome "recovering" and all described as "Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, FLUC3
Symptoms: SARS-CoV-2 test
Clinical narrative: Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: 6h9694) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L20A), on 11Feb2021 as dose 2, single (Lot number: 030620A) and on 02Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medications included: ROSUVASTATIN; FIBERCON; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022 (also reported as 01Oct2022), outcome "recovering" and all described as "Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. Concomitant medication included: PANTOPRAZOLE.. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received the paxlovid on 31Aug2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201205965 Same reporter/patient, different drug, different event.;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 09:00 as dose 1, single (batch/lot number: Er26132) at the age of 40 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Parsonage Turner syndrome" (unspecified if ongoing); "walnuts allergies" (unspecified if ongoing); "shellfish allergies" (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: Covid-19 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: rash on her elbow; swelling is going to the lymph nodes; itching; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 37-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 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: RASH (non-serious), outcome "unknown", described as "rash on her elbow"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling is going to the lymph nodes"; PRURITUS (non-serious), outcome "unknown", described as "itching".  Additional information: the patient got the COVID-19 vaccine on a Wednesday (unspecified what date) as a booster and she had a non severe rash on her elbow and itching but there was nothing at the injection site. The rash and swelling was going to the lymph nodes. She wanted to know if this has been reported with this vaccine and if she needed medical attention. The pharmacist wanted to know if those were normal side effects of the new one.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Body temperature, Body temperature increased, Fatigue, Headache
Clinical narrative: Very sore arm in area of injection; sore underarm area; body aches; muscle aches; headache; lingering fatigue; slightly elevated temperature; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 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. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "Very sore arm in area of injection"; PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 04Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Oct2022, outcome "unknown", described as "lingering fatigue"; MYALGIA (non-serious) with onset 04Oct2022, outcome "unknown", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 04Oct2022, outcome "unknown", described as "slightly elevated temperature"; AXILLARY PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "sore underarm area". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, pain, myalgia, headache, fatigue, body temperature increased. Additional information included: Very sore arm in area of injection including sore underarm area, body/muscle aches and headache within 12 hours of vaccination, with lingering fatigue, body aches, slightly elevated temperature and headache 24 hours after injection. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: Very sore arm in area of injection; sore underarm area; body aches; muscle aches; headache; lingering fatigue; slightly elevated temperature; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 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. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "Very sore arm in area of injection"; PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 04Oct2022, outcome "unknown"; FATIGUE (non-serious) with onset 04Oct2022, outcome "unknown", described as "lingering fatigue"; MYALGIA (non-serious) with onset 04Oct2022, outcome "unknown", described as "muscle aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 04Oct2022, outcome "unknown", described as "slightly elevated temperature"; AXILLARY PAIN (non-serious) with onset 04Oct2022, outcome "unknown", described as "sore underarm area". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, pain, myalgia, headache, fatigue, body temperature increased. Additional information included: Very sore arm in area of injection including sore underarm area, body/muscle aches and headache within 12 hours of vaccination, with lingering fatigue, body aches, slightly elevated temperature and headache 24 hours after injection. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; ESTRADIOL; MELOXICAN; MONTELUKAST; ACYCLOVIR [ACICLOVIR]; DEXAMETHASON [DEXAMETHASONE], start date: 08Sep2022, stop date: 17Sep2022; WELLBUTRIN; OMEPRAZOLE; XANAX. The following information was reported: VACCINATION FAILURE (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: Treatment of COVID-19; (12Sep2022) Negative, notes: 1st covid tested negative on day 5; (25Sep2022) Positive, notes: tested positive 13 days after testing negative from 1st covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was given Paxlovid as treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She described to be already very sick from COVID; She described to be already very sick from COVID; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "celiac disease" (unspecified if ongoing), notes: caller mentioned that she has the celiac disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She described to be already very sick from COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: very sick from COVID.  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 in the case, an association between the reported events and 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-202201206645 Same patient/drug/event, different dose;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 08:00 as dose 1, single (Lot number: EL1283), in left arm, on 12Feb2021 at 08:00 as dose 2, single (Lot number: EN5318), in left arm and on 11Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergy. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (19Sep2022) Negative, notes: tested negative 19Sep2022; (21Sep2022) Positive, notes: On 21Sep started to have congestion again and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (Treatment start date: 17Sep2022; Treatment stop date: 21Sep2022).
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Pain in extremity, Product preparation error, Vaccination site pain
Clinical narrative: Little soreness at the site; sore arm; Caller stated a COVID 19 bivalent booster shot was mixed in the same syringe with a flu vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Little soreness at the site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "Caller stated a COVID 19 bivalent booster shot was mixed in the same syringe with a flu vaccine".  Additional information: Caller stated a COVID-19 bivalent booster shot was mixed in the same syringe with a flu vaccine and administered to one family member. She stated her family member was "not concerned, guessing it would work, but she became aware today and she just wanted to make sure this was okay. They were not having adverse reactions, just a little soreness at the site, which was expected but she concerned about the efficacy, and side effects. Dose/dosage form: Gray cap, original/Omicron BA.4/BA.5 (bivalent), greater than or equal to 12 years - 15/15 mcg per dos. She was a nurse, and she knew that they were not doing this when they were administering the vaccines. She wanted to know if that was an acceptable practice, and if not, what concerns they should have as far as efficacy and monitoring for adverse reactions. Her family member was having no adverse reactions, just a sore arm, nothing else or anything that would be unexpected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 at 10:00 as dose 4 (booster), single (Lot number: fj4991) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Known allergies and other medication in 2weeks reported as No. 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: Treatment of COVID-19; (unspecified date) Negative, notes: negative test from first infection; (02Oct2022) Positive, notes: positive covid test result 7 days after negative test from first infection. (8 days after end of Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral Paxlovid COVID 19 Treatment started on 20Sep2022 and stopped on 24Sep2022 with Lot number 2815071.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: white patches and stuff in cheeks of mouth; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0217) at the age of 48 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL DISORDER (non-serious) with onset Jun2021, outcome "not recovered", described as "white patches and stuff in cheeks of mouth". The events "white patches and stuff in cheeks of mouth" required physician office visit.  Additional information: When received the first dose Pfizer COVID vaccine, white patches and stuff in cheeks of mouth came out. The doctors were having trouble figuring out what was going on. Patient reported it still hadn't gone away. The doctor was going to try to treat it. Patient read up online and is something that was people who took Pfizer Vaccine caught, called Lichen planus. Patient received second dose of BNT162b2 (BNT162B2, lot: EW0181), left arm on 02Jul2021; first booster of BNT162b2 (BNT162B2, lot: FK9896), left arm on 25Jan2022 and second booster of BNT162b2 (BNT162B2, lot: FT7139), left arm on 26Aug2022. Patient also received Hepatitis A and Hepatitis B Vaccine (manufacturer unknown) on 02Jul2021.
Age: 62.0
Sex: U
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 16:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (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 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 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, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: every dose made her sick; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her sick".  Additional information: The patient reported that every dose of the Pfizer COVID-19 vaccine (original primary series and two booster doses) made her sick. She suspected that this reaction was caused by gluten or an egg-derived ingredient. She took a third booster dose from Moderna and that vaccine didn't make her sick at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210013 Same patient/drug/event, different dose;US-PFIZER INC-202201210014 Same patient/drug/event, different dose;US-PFIZER INC-202201210015 Same patient/drug/event, different dose;US-PFIZER INC-202201206422 Same patient/drug/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; 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), on 30Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 31Mar2022, outcome "unknown".  Clinical course: Caller mentioned "latest booster" and "booster" only but was not able to specify which formulation of the vaccine he received. After checking PI and providing response, caller stated that he had his booster last "30Mar", had atrial fibrillation the next day, and had regular rhythm the next day. Caller also stated he received "another booster morning of 30Sep" and had arterial fibrillation at 4 in the afternoon. Caller said Pfizer booster and the last one put out for type omicron when asked to read name product. Unable to clarify formulation of Pfizer booster. He was needed information and asking has there been any indication that the booster can cause an atrial fibrillation event and it was said as Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and smell; Loss of taste and smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2022 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "known allergies: Ceftin". The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 22Sep2022, outcome "not recovered" and all described as "Loss of taste and smell". Therapeutic measures were not taken as a result of anosmia, ageusia.  Additional information: Facility type Vaccine was reported as Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. Patient did not have covid prior to vaccination.   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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive with the rapid test/not feeling well; he tested positive with the rapid test/not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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) all with onset 02Oct2022, outcome "recovering" and all described as "he tested positive with the rapid test/not feeling well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: The patient reported not feeling well on 02Oct2022, and it was getting worse so he went for a COVID-19 test on 04Oct2022. He tested positive with the rapid test and his doctor prescribed him PAXLOVID. The patient stated he was doing okay now except he got a cough and fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: initial positive Covid test; initial positive Covid test; He had 3 Moderna + last one was Pfizer; He had 3 Moderna + last one was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 2), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 3), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 2022, outcome "unknown" and all described as "He had 3 Moderna + last one was Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "initial positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Mar2011. 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: Positive, notes: COVID 19 Treatment,; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of covid-19.  Clinical course: Antiviral treatment included Paxlovid from 21Sep2022 to 26Sep2022 for treatment of Covid-19. No known allergies were reported.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dysgeusia, Fatigue, Myalgia
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Mar2011. 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: Positive, notes: COVID 19 Treatment,; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of covid-19.  Clinical course: Antiviral treatment included Paxlovid from 21Sep2022 to 26Sep2022 for treatment of Covid-19. No known allergies were reported.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Mar2011. 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: Positive, notes: COVID 19 Treatment,; Positive, notes: COVID rebound. Therapeutic measures were taken as a result of covid-19.  Clinical course: Antiviral treatment included Paxlovid from 21Sep2022 to 26Sep2022 for treatment of Covid-19. No known allergies were reported.
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: using improper technique and administered in tendon; using improper technique and administered in tendon; frozen shoulder; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose brand name unknown=COVID19 Vaccine, is bivalent=False, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose number=1), for COVID-19 immunization; Bnt162b2 (prev dose brand name unknown=COVID19 Vaccine, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2), for COVID-19 immunization. The following information was reported: PERIARTHRITIS (non-serious) with onset Dec2021, outcome "recovered", described as "frozen shoulder"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown" and all described as "using improper technique and administered in tendon". Therapeutic measures were not taken as a result of periarthritis.  Additional information: MD reports that vaccine was administered by pharmacist in grocery store using improper technique and administered in tendon. MD also states that primary care has seen in an increase in frozen shoulder d/t improper administration technique of covid vaccines. Other vaccine received in four weeks and other medications in two weeks reported as unknown. Covid prior to vaccination and covid tested post vaccination reported as unknown. Known allergies and other medical history reported as unknown.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Dose4 Pfizer /Dose 1,2,3 Moderna; This is a spontaneous report received from 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 06May2022 at 12:45 as dose 4 (booster), single (Lot number: FK9894) at the age of 69 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN. Past drug history included: Iodine, reaction(s): "known allergies: iodine"; Betadine, reaction(s): "known allergies: betadine". Vaccination history included: moderna (Dose Number: 3, Batch/Lot No. : OSIE 21A, Location of Injection: Arm Left), administration date: 28Oct2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Itching from my head to my torso", "rash on my wrists", "pinpoint numbness on lip"; moderna (Dose Number: 2, Batch/Lot No. : 023m20a, Location of Injection: Arm Left), administration date: 21Feb2022, for COVID-19 Immunization; moderna (Dose Number: 1, Batch/Lot No. : 032L20a, Location of Injection: Arm Left), administration date: 24Jan2021, when the patient was 68-year-old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06May2022, outcome "unknown", described as "Dose4 Pfizer /Dose 1,2,3 Moderna".  Additional information: Patient did not receive any other vaccines within 4 weeks. Other medical history was reported as healthy. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19. Booster dose 5, Pfizer as bivalent (5H 9702) was admninistered on 28Sep2022 at 16:30 pm in left arm.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: felt achy; chills; fever (100.8); dose number: 5; dose number: 5; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "OA in several joints" (unspecified if ongoing), notes: OA in several joints; "known allergies: Sulfonamides" (unspecified if ongoing). The patient took concomitant medications. 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; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "dose number: 5"; CHILLS (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022); PAIN (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022), described as "felt achy"; PYREXIA (non-serious) with onset 03Oct2022, outcome "recovered" (04Oct2022), described as "fever (100.8)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia.  Additional information: On 03Oct2022, the patient felt achy and had chills and fever (100.8). the next morning (04Oct2022), the patient felt fine.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 10Apr2021 as dose 2, single (Lot number: EW0153) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm and on 22May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "elevated cholesterol (normal after statins)" (unspecified if ongoing); "enlarged liver" (unspecified if ongoing); "Year round outside and inside allergies" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. 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: Positive; Negative, notes: on home Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient had no known allergies.