chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown) and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2022) positive, notes: still positive per home antigen test today 29Oct2022; (17Oct2022) positive, notes: Patient diagnosed with Covid 19 on 17Oct2022; (27Oct2022) positive, notes: She tested positive for covid on 27Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was diagnosed with Covid 19 on 17Oct2022, took paxlovid standard dosing 18Oct2022 through 23Oct2022 and felt recovered. Then on 27Oct2022 developed covid symptoms with significant congestion, symptoms more significant than initial illness episode per pt. She tested positive for covid on 27Oct2022 and is still positive per home antigen test today 29Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for covid cannot be excluded based on temporal association and available information.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Nervousness, Toothache, Trigeminal neuralgia
Clinical narrative: so the first two time that I had the tooth problem; so the first two time that I had the tooth problem; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History); "diabetes" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Patient got the Pfizer vaccine from the beginning /the first two time that patient had the tooth problem, patient thought it was dental related.), for Covid-19 immunization, reaction(s): "I had the tooth problem", "Tooth ache". The following information was reported: TOOTHACHE (non-serious), TOOTH DISORDER (non-serious), outcome "unknown" and all described as "so the first two time that I had the tooth problem". The event "so the first two time that i had the tooth problem" required physician office visit. Therapeutic measures were taken as a result of toothache, tooth disorder.  Additional information: This report was not related to a study or programme. The first two time that patient had the tooth problem, patient thought it was dental related. Patient went to the dentist, they gave the pain medicine blah-blah. Patient received second booster on 26Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tooth disorder, Toothache
Clinical narrative: so the first two time that I had the tooth problem; so the first two time that I had the tooth problem; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History); "diabetes" (ongoing), notes: Patient was on high risk, Patient have diabetes and hypertension (Intent : History). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Patient got the Pfizer vaccine from the beginning /the first two time that patient had the tooth problem, patient thought it was dental related.), for Covid-19 immunization, reaction(s): "I had the tooth problem", "Tooth ache". The following information was reported: TOOTHACHE (non-serious), TOOTH DISORDER (non-serious), outcome "unknown" and all described as "so the first two time that I had the tooth problem". The event "so the first two time that i had the tooth problem" required physician office visit. Therapeutic measures were taken as a result of toothache, tooth disorder.  Additional information: This report was not related to a study or programme. The first two time that patient had the tooth problem, patient thought it was dental related. Patient went to the dentist, they gave the pain medicine blah-blah. Patient received second booster on 26Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; Interchange of vaccine products; 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 17:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: ENG201), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 12Oct2021 as dose 3 (booster), single (Lot number: 31045B4) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2022, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive, notes: Positive test for covid on 21Oct22; (28Oct2022) Negative, notes: Tested negative for covid on 28Oct22; (30Oct2022) Positive, notes: Tested positive for covid on 30Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2022 at 14:00 as dose number unknown, single (Lot number: gh9720) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart - with stent" (unspecified if ongoing); "heart - with stent" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "known allergies cipro", notes: known allergies cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Negative, notes: completed doses of paxlovid 23Oct, took antigen test - negative; (28Oct2022) Positive, notes: symptom free - symptom returned on 28Oct - antigent test positive; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: my teeth are hurting so bad; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have diabetes and hypertension" (unspecified if ongoing); "I have diabetes and hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "my teeth are hurting so bad". The event "my teeth are hurting so bad" required physician office visit. Therapeutic measures were taken as a result of toothache. Additional information: patients teeth were hurting so bad on the left side and that's the side that patient got the shot on it; lasting longer than expected; more severe because now it's numbing the side of the face all the way up to eye .       No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "High BP" (unspecified if ongoing), notes: Other medical history: High BP; "hashimoto thyroiditis" (unspecified if ongoing); "renal cell carcinoma (kidney removed)" (unspecified if ongoing), notes: Other medical history: renal cell carcinoma (kidney removed); "renal cell carcinoma (kidney removed)" (unspecified if ongoing), notes: Other medical history: renal cell carcinoma (kidney removed). Concomitant medication(s) included: NORVASC, start date: 08May2013; BENICAR, start date: 08May2013; SYNTHROID, start date: 08May2013; ZINC, start date: 08May2013. The following information was reported: DRUG INEFFECTIVE (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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Penicillin allergy" (unspecified if ongoing); "Graves' disease" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE, start date: 01Feb2022, stop date: 29Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: COVID 19 Treatment, Brand: Paxlovid; (29Oct2022) Positive, notes: Rebound covid. Positive antigen test in 29Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 19Oct2022; Treatment stop date: 23Oct2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation;  BNT162b2 (BNT162B2), on 28Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 07Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 13Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
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) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665), 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 had no relevant medical history. Concomitant medication(s) included: ONE-A-DAY [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE], start date: Jan2022. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 18Oct2022 to 22Oct2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid rebound, non symptomatic; Covid rebound, non symptomatic; 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0161), in right arm, on 10Dec2021 as dose 3 (booster), single (Lot number: FJ16111), in left arm and on 28May2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "Neurological" (unspecified if ongoing); "Musc" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT; LIOTHYRONINE; TRIPLE MAGNESIUM COMPLEX. The following information was reported: VACCINATION FAILURE (medically significant), 1 year 6 months 18 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "Covid rebound, non symptomatic". 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 vaccination failure, covid-19: paxlovid from 03Oct2022 to 08Oct2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: she feels really achy and uncomfortable; she feels really achy and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (ORANGE CAP), SINGLE), administration date: 07Nov2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "she feels really achy and uncomfortable".  Additional information: Pediatrician is calling about two patients: 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech Covid 19 vaccine at their (Withheld) instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He is not worried so much about repercussions of the vaccines, he is more concerned as to whether or not this will affect the series going forward. Physician states that five-year-old is getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain. Seriousness was reported as no.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Jun2022 at 09:00 as dose 4 (booster), single (Lot number: o56M21A) 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 was not reported. Concomitant medication(s) included: ATORVASTATIN, stop date: 18Oct2022; OMEPRAZOLE; ASPIRIN LOW; MUCINEX; TUMS [CALCIUM CARBONATE]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Jun2022 at 09:00, outcome "unknown"; DRUG INEFFECTIVE (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: negative, notes: had two negative covid self-tests; negative, notes: had two negative covid self-tests; positive (very faint line), notes: I had a positive (very faint line) self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 15:30 as dose 1, single (Lot number: EN6201), in right arm, on 10Mar2021 at 15:30 as dose 2, single (Lot number: EN6199), in right arm, on 07Oct2021 at 17:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 15Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension (under successful treatment)" (unspecified if ongoing), notes: Other medical history: Hypertension (under successful treatment). Concomitant medication(s) included: ATORVASTATIN, start date: 01Oct2015, stop date: 20Oct2022; TRIAMTERENE/HCTZ, start date: 01Oct2015, stop date: 20Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid as Covid-19 treatment from 20Oct2022 to 25Oct2022. Patient has no known allergies.
Age: 70.0
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 (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:45 as dose 5 (booster), single (Lot number: 6H9693) at the age of 70 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 06Jun2022 at 15:15 as dose 4 (booster), single (Lot number: FP4554), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: (26Oct2022) Negative; (30Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 21Oct2022 to 25Oct2022.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09Apr2021 at 15:30 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2021 at 13:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 26Dec2021 at 13:30, outcome "unknown", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Rebound within a week of completing paxlovid course of treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 (Dose: 2, after you have your two main shot, its the third booster, correct." (Clarified as Pfizer COVID-19 Vaccine).), for COVID-19 Immunization; Bnt162b2 (Dose: 1, after you have your two main shot, its the third booster, correct." (Clarified as Pfizer COVID-19 Vaccine).), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "feeling bad".  Additional information: Reporter was calling on behalf of a family member, extended family member who got the shot a week ago Saturday meaning not yesterday, a week ago Saturday and she went to develop side effect that was listed on your website like almost a week later she started feeling bad about Wednesday. Reporter stated it is the third booster after you have your two main shot, its the third booster, correct (Clarified as Pfizer COVID-19 Vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I started feeling Wonky about 4 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "I started feeling Wonky about 4 days later".  Additional information: It was reported that they were calling on behalf of a family member, extended family member who got the shot a week ago Saturday meaning not yesterday, a week ago Saturday and she went to develop side effect that was listed on your website like almost a week later she started feeling bad about Wednesday. Is it possible to just have side effects that late? And the patient got shot (Pfizer COVID-19 Vaccine) 2 weeks ago and then the patient started feeling Wonky (Not clarified further hence event captured as per verbatim) about 4 days later the patient was asking a yes and no question here was it possible to have side effect after days?. Consumer stated, It is the third booster after the patient had two main shot, its the third booster, correct.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: About 26 hours after vaccination, patient had a generalized tonic clonic seizure which spontaneously resolved. He was subsequently taken to the emergency room, treated with normal saline and acetaminophen.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node base of neck on side the shot was given on. Currently waiting to see if the swelling goes down on its own. Follow-up with my primary care doctor again in 2 weeks.
Age: 42.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Anxiety, Blood creatine phosphokinase normal, Blood magnesium normal, Electric shock sensation, Electrocardiogram normal
Clinical narrative: Severe fatigue in legs and some fatigue in arms/head  began the day after vaccines were administered (10/27).  Over the next few days, I began to feel tingling all over the body and muscle twitches all over the body.  This is accompanied by feelings of electric currents running under the skin, strange sensations in the stomach, and high anxiety.  All symptoms continue.
Age: 42.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Fatigue, Human chorionic gonadotropin normal, Metabolic function test normal, Muscle twitching, Paraesthesia
Clinical narrative: Severe fatigue in legs and some fatigue in arms/head  began the day after vaccines were administered (10/27).  Over the next few days, I began to feel tingling all over the body and muscle twitches all over the body.  This is accompanied by feelings of electric currents running under the skin, strange sensations in the stomach, and high anxiety.  All symptoms continue.
Age: 42.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Sensory disturbance
Clinical narrative: Severe fatigue in legs and some fatigue in arms/head  began the day after vaccines were administered (10/27).  Over the next few days, I began to feel tingling all over the body and muscle twitches all over the body.  This is accompanied by feelings of electric currents running under the skin, strange sensations in the stomach, and high anxiety.  All symptoms continue.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound foetal abnormal
Clinical narrative: Estimated due date 6/9/22. Received COVID booster 9 days before beginning of miscarriage.  Reporting just in case it could be related. Miscarriage began at 7 weeks.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT, start date: 06Mar2021. Patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Interchange of vaccine product"; 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, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID from 21Oct2022 to 25Oct2022.  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: Contusion, Nervousness, Vasodilatation
Clinical narrative: bruise; upper part is like the veins are popping out; It kind of scared me the way it looked, my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset Oct2022, outcome "unknown", described as "It kind of scared me the way it looked, my arm"; CONTUSION (non-serious) with onset Oct2022, outcome "unknown", described as "bruise"; VASODILATATION (non-serious) with onset Oct2022, outcome "unknown", described as "upper part is like the veins are popping out". The events "bruise", "upper part is like the veins are popping out" and "it kind of scared me the way it looked, my arm" required physician office visit.  Additional information: Patient reported that he did not want to go through all that and had a question. Patient got a shot for the new booster, for it was the new one that just came out that they have. It didn't hurt, Reported to get 3 or 4 of them (Further could not be clarified over the call) but this time this one did not hurt, it had same procedure. This is the first time that reported with side effects. The other ones, it didn't happen or maybe it was not noticed or because patient wasn't checking, it wasn't seen. But patient looked in the mirror and noticed, while shower, washing arm, patient was noticing that there was kind of a bruise and by the upper part was like the veins are popping out or whatever. Inquired if natural. When probed for clarifying the suspect name: Patient reported that , went to the doctor yesterday. Had an appointment with one doctor but then patient went to the usual one. Patient was talking about the new one that just came out, the booster, the bivalent. Reported to wonder if there was anything to worry about. or should just wait, As it had been since yesterday. Could wait another day, Patient thought should wait a day or 2." Patient reported to inquire if that is normal. as it was weird currently, It kind of scared the patient the way it looked, the arm. Patient did not understand the bruise part as it was something new. Patient thought should wait a day or 2. Patient stated to know what he was doing, being crazy. There was no big deal. There was no big problem. Patient felt should give the body a chance to accept it as if any reaction hospital could be visited and medical information could be contacted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza, Myalgia
Clinical narrative: Flu symptoms; headache; muscle pain; sore throat; sinusitis; weakness/loss of energy; tiredness; Pfizer Bivalent - Dose Number: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Oct2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 1"; INFLUENZA (non-serious) with onset 28Oct2022, outcome "unknown", described as "Flu symptoms"; HEADACHE (non-serious) with onset 28Oct2022, outcome "unknown"; MYALGIA (non-serious) with onset 28Oct2022, outcome "unknown", described as "muscle pain"; SINUSITIS (non-serious) with onset 28Oct2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 28Oct2022, outcome "unknown", described as "sore throat"; FATIGUE (non-serious) with onset 28Oct2022, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset 28Oct2022, outcome "unknown", described as "weakness/loss of energy".  Additional information: There was no other vaccine in four weeks or Other medications in two weeks and there was no covid prior vaccination or covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinusitis, Wrong product administered
Clinical narrative: Flu symptoms; headache; muscle pain; sore throat; sinusitis; weakness/loss of energy; tiredness; Pfizer Bivalent - Dose Number: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Oct2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 1"; INFLUENZA (non-serious) with onset 28Oct2022, outcome "unknown", described as "Flu symptoms"; HEADACHE (non-serious) with onset 28Oct2022, outcome "unknown"; MYALGIA (non-serious) with onset 28Oct2022, outcome "unknown", described as "muscle pain"; SINUSITIS (non-serious) with onset 28Oct2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 28Oct2022, outcome "unknown", described as "sore throat"; FATIGUE (non-serious) with onset 28Oct2022, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset 28Oct2022, outcome "unknown", described as "weakness/loss of energy".  Additional information: There was no other vaccine in four weeks or Other medications in two weeks and there was no covid prior vaccination or covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Had cataract surgery in Mar2022 and before that in Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP7534) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: She had high blood pressure and stuff like that. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number- EL9269, Expiration Date- UNKNOWN), administration date: 04Mar2021, when the patient was 81-year-old, for COVID-19 Immunization. The following information was reported: CATARACT (medically significant) with onset Aug2021, outcome "unknown", described as "Had cataract surgery in Mar2022 and before that in Aug2021". Therapeutic measures were taken as a result of cataract. Patient called about the Pfizer BioNTech COVID-19 vaccine. She has had 4 doses of the COVID-19 Vaccine. 2 primary doses and 2 booster doses. She had high blood pressure and stuff like that, but nothing that was out of the ordinary for someone that was 82 years old. The information was captured as provided. She was told to get a booster dose. Vaccination Facility Type was reported as Satellite Clinic for the hospital. Prior Vaccinations within 4 weeks was reported as none. Patient had cataract surgery in Mar2022 and before that in Aug2021. Family Medical History Relevant to Adverse Events and relevant tests was reported as none. Other Conditions and investigations were reported as No.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Red blood cell sedimentation rate increased, Vaccination site mass
Clinical narrative: With the first 3 doses she usually gets a bump on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 1, single (Lot number: FF8839) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hard to walk" (unspecified if ongoing); "hands go numb" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "inflammation disease". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "With the first 3 doses she usually gets a bump on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, the patient had attacks where it was hard to walk and use her hands because they go numb. The patient Sed rate and C-reactive proteins were high. The patient was told it was inflammation disease. She was on prednisone for 2 years. Had test after test. Does not know the name of her disease. The patient was not on Prednisone anymore. Does not know if the prednisone helped whatever it was as she was able to walk and use her hands now. The patient did not receive other vaccines within four weeks prior to COVID vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Red blood cell sedimentation rate increased, Vaccination site mass
Clinical narrative: With the first 3 doses she usually gets a bump on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 2, single (Lot number: FF2593) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hard to walk" (unspecified if ongoing); "her hands because they go numb" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "inflammation disease". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: FF8839, Anatomical location: Left arm), administration date: 29Sep2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "With the first 3 doses she usually gets a bump on the injection site". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "With the first 3 doses she usually gets a bump on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Information: It was reported that, the patient had attacks where it was hard to walk and use her hands because they go numb. The patient Sed rate and C-reactive proteins were high. The patient was told it was inflammation disease. She was on prednisone for 2 years. Had test after test. Does not know the name of her disease. The patient was not on Prednisone anymore. Does not know if the prednisone helped whatever it was as she was able to walk and use her hands now. The patient did not receive other vaccines within four weeks prior to COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201268928 same patient, different dose, similar report from same reporter;
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, Red blood cell sedimentation rate, Vaccination site mass
Clinical narrative: With the first 3 doses she usually gets a bump on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "hard to walk" (unspecified if ongoing); "hands go numb" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "inflammation disease". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: FF8839; Anatomical location: Left arm), administration date: 29Sep2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "With the first 3 doses she usually gets a bump on the injection site"; BNT162b2 (DOSE 2, SINGLE; Lot: FF2593; Anatomical location: Left arm), administration date: 21Oct2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "With the first 3 doses she usually gets a bump on the injection site". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "With the first 3 doses she usually gets a bump on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, the patient had attacks where it was hard to walk and use her hands because they go numb. The patient Sed. rate and C-reactive proteins were high. The patient was told it was inflammation disease. She was on prednisone for 2 years. Had test after test. Does not know the name of her disease. The patient was not on Prednisone anymore. Does not know if the prednisone helped whatever it was as she was able to walk and use her hands now. The patient did not receive other vaccines within four weeks prior to COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201268928 same reporter, patient. Different dose and events.;