chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pulmonary congestion, SARS-CoV-2 test
Clinical narrative: I had lung congestion; I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID; I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Mar2022, outcome "recovered" (2022) and all described as "I had 3 Pfizer shots in 2021 / On 31Mar I tested first positive for COVID"; PULMONARY CONGESTION (medically significant) with onset Apr2022, outcome "recovered" (2022), described as "I had lung congestion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Saturday I had a positive antigen test again; (05Apr2022) Positive, notes: still testing positive in an antigen test; (unspecified date) Negative, notes: Thursday evening was the first time I tested negative; (31Mar2022) Positive, notes: I tested first positive for COVID; (17Apr2022) negative, notes: I finally tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, pulmonary congestion.  Clinical course: Paxlovid Rebound: On 31Mar Patient tested first positive for COVID. Patient started Paxlovid same evening. On Tuesday morning 05Apr patient completed my Paxlovid but was still testing positive in an antigen test. Thursday evening was the first time patient tested negative. Saturday patient had a positive antigen test again. Monday patient had lung congestion. Tuesday patient started second course of Paxlovid that finally cleared the infection. Sunday 17Apr patient finally tested negative and it has remained that way. Patient had 3 Pfizer shots in 2021.  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: Cough, Food allergy, Hypersensitivity, Immune system disorder, Milk allergy
Clinical narrative: serious allergic reaction; tightening of throat; cough; over excited immune system; had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk; had allergy from eating frost flakes and milk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 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: HYPERSENSITIVITY (medically significant) with onset 22Feb2022, outcome "unknown", described as "serious allergic reaction"; COUGH (non-serious) with onset 2022, outcome "unknown"; MILK ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy from eating frost flakes and milk"; FOOD ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "over excited immune system"; THROAT TIGHTNESS (non-serious) with onset 2022, outcome "unknown", described as "tightening of throat". Therapeutic measures were taken as a result of hypersensitivity, food allergy, milk allergy.  Clinical course: Patient injected Epipen for the event allergy reactions to a homemade burger with no additives, took Benadryl for the event allergy from eating frost flakes and milk as well . Reporter stated that, wonder if you have seen more cases of people developing serious food allergies after their booster shots. My kid (15) had her booster in Jan2022. Lately, patient had more and more episodes of allergic reactions to food (many of the food items she has had since birth, nothing really new). To a point whatever patient eats, her throat closes up and patient starts to cough. I wonder if it is because of the reaction for an over excited immune system from the vaccine.  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: Throat tightness
Clinical narrative: serious allergic reaction; tightening of throat; cough; over excited immune system; had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk; had allergy from eating frost flakes and milk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 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: HYPERSENSITIVITY (medically significant) with onset 22Feb2022, outcome "unknown", described as "serious allergic reaction"; COUGH (non-serious) with onset 2022, outcome "unknown"; MILK ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy from eating frost flakes and milk"; FOOD ALLERGY (non-serious) with onset 2022, outcome "unknown", described as "had allergy reactions to a homemade burger\had allergy from eating frost flakes and milk"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "over excited immune system"; THROAT TIGHTNESS (non-serious) with onset 2022, outcome "unknown", described as "tightening of throat". Therapeutic measures were taken as a result of hypersensitivity, food allergy, milk allergy.  Clinical course: Patient injected Epipen for the event allergy reactions to a homemade burger with no additives, took Benadryl for the event allergy from eating frost flakes and milk as well . Reporter stated that, wonder if you have seen more cases of people developing serious food allergies after their booster shots. My kid (15) had her booster in Jan2022. Lately, patient had more and more episodes of allergic reactions to food (many of the food items she has had since birth, nothing really new). To a point whatever patient eats, her throat closes up and patient starts to cough. I wonder if it is because of the reaction for an over excited immune system from the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Feeling abnormal, Headache, Suspected COVID-19
Clinical narrative: she got covid virus; she got covid virus; headaches,Kind of achy headaches; experienced weird sensation in right arm , right foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9261), on 21Feb2021 as dose 2, single (Lot number: EM9810) and on 04Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she got covid virus"; HEADACHE (non-serious), outcome "unknown", described as "headaches,Kind of achy headaches"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "experienced weird sensation in right arm , right foot".Patient reports that she had all of the vaccines, first two primary and one of booster doses. The sensation happened after the booster, not distinctly after, it's just happened, not immediate, not right away. All this is registered with my Doctors office. It's been in the last couple of months, happening about once a month for the last 3 months. It's a dragging of her right foot and dragging of her right arm. She is calling it like a gorilla thing. the foot is kind of like flapping, and arm is feeling like dragging. Foot and arm, it goes away and comes back. Patient had experiencing headaches, kind of achy headaches, never had that before either, she was not a headache kind of person. Just wants to report she was experiencing some weird symptoms. Was highly disappointed. She went to withheld and got COVID after 2.5 years of being protected. On three different occasions she has had a weird sensation in her right arm and right foot.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Missed my period after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 31 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: MENSTRUAL DISORDER (disability) with onset Sep2021, outcome "not recovered", described as "Missed my period after the first dose". The event "missed my period after the first dose" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of menstrual disorder. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient in her 80's received BNT162b2 (BNT162B2), 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 (Series of primary immunization completed), for Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02May2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive.  Clinical course: Reporter scheduled for second booster of pfizer Covid 19 today however they spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today. Reporter would like to know if they should receive the second booster dose today given the fact that they have been in close proximity with a person who tested positive for Covid. The reporter and his wife have not yet tested for Covid infection. Patient tested positive today, 02May2022 and has appointment for the second booster of Pfizer Covid-19 later today. Clarification of what patient tested positive for not provided as caller unwilling to provide any further information for this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. 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-202200649519 same reporter/drug/AE with different patient
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I contracted Covid on 20Apr2022; I contracted Covid on 20Apr2022; 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 04Mar2021 at 12:00 as dose 3 (booster), single (Lot number: EN6198) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 20Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I contracted Covid on 20Apr2022". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19..  Clinical course: Patient received COVID treatment as Pfizer Paxlovid on 21Apr2022 to 25Apr2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028) in left arm, on 05May2021 as dose 2, single (Lot number: ER8737), in left arm and on 08Mar2021 as dose 1, single (Lot number: ENG199), in left arm at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Apr2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  clinical course was reported as: The patient did not receive any other medication in 2weeks. adverse event: Symptoms went away two days after treatment and came back a few days, with the same intensity as at the beginning of the infection, after treatment was over. Still testing positive with an antigen test two weeks after the original infection date. The patient did not have any known allergies. Treatment used was Pfizer Paxlovid, treatment start date=19Apr2022, treatment stop date=24Apr2022, indication=Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Thrombosis
Clinical narrative: blood clots on legs, arms/blood clots on fingers; palpitation racing heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "blood clots on legs, arms/blood clots on fingers"; PALPITATIONS (non-serious), outcome "not recovered", described as "palpitation racing heart". The event "blood clots on legs, arms/blood clots on fingers" required physician office visit. The patient underwent the following laboratory tests and procedures: Palpitations: palpitation racing heart, notes: palpitation racing heart. Therapeutic measures were not taken as a result of thrombosis, palpitations.  Clinical course: Batch/lot was Unknown because Unable to locate or read the details. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event was palpitation, racing heart, blood clots on legs, arms. Blood clots on fingers. These continue to appear every time he take NSAIDs even after one year of vaccine shots. The patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Device Date : 02May2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 12:30 as dose 1, single (Lot number: EN5318), in right arm, on 24Feb2021 at 03:00 as dose 2, single (Lot number: El9269), in right arm, on 29Sep2021 at 12:00 as dose 3 (booster), single (Lot number: PC3183), in right arm and on 01Apr2022 at 12:00 as dose 4 (booster), single (Lot number: Fj4991) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: SYNTHROID, start date: 01Jan2002; SERTRALINE, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Anti-viral Paxlovid started on 21Apr2022 and stopped on 25Apr2022. Reported as, On 28Apr2022 at 10:00, 3 to 4 days after 5th day of Paxlovid, achy and not feeling well, fatigue, next day awoke with sore throat and laryngitis, on following days heavy URI, the feelings of bronchitis with harsh non productive cough, no fever, tired and weak. S/S mild with starting Paxlovid on day 2 of onset of symptoms. Patient was not recovered from symptoms and no treatment received for symptoms.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immune system disorder
Clinical narrative: weakened immune system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US141088_NS.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown). 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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "weakened immune system". The action taken for ofatumumab was unknown.  Additional information included: Product: COVID-19 BOOSTER. Relationship to patient: Self. Event: Patient reports weakened immune system using kesimpta and Covid boosters.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID,Fatique,Cough,Rhinorrhoea; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 1, single (Lot number: FK5618, Expiration Date: 28Feb2022) and on 15Dec2021 as dose 2, single (Lot number: FK5618, Expiration Date: 28Feb2022) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "tested positive for COVID,Fatique,Cough,Rhinorrhoea"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Periorbital swelling
Clinical narrative: swelling underneath eyes; Covid vaccine side-effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-042822-11107 (Company).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ADVERSE EVENT (non-serious) with onset Jul2021, outcome "unknown", described as "Covid vaccine side-effects"; PERIORBITAL SWELLING (non-serious) with onset 29Apr2022, outcome "unknown", described as "swelling underneath eyes".  Additional information: Patient had injection under eyes 26Oct2021 and had swelling the same day that lasted four months, starting from the date of injection. The swelling improved after four months; but today 29Apr2022, woke up with a little swelling underneath eyes again. Patient received Pfizer Covid vaccine on an unknown date for first vaccination, Jul2021 for 2nd vaccination. Patient also stated she had Covid vaccine side-effects in July, Aug and Sep2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer; Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 02Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 67 years, in right 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: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: tree nuts" (unspecified if ongoing), notes: Known allergies: tree nuts; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts; "Known allergies: coconut" (unspecified if ongoing), notes: Known allergies: coconut. Concomitant medication(s) included: AMITRIPTYLINE; ARMOUR THYROID; ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; Fatigue; Soreness; 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 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (primary series immunization completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu-like symptoms"; FATIGUE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "Soreness".  Additional information: Symptoms went away after a few hours. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebral congestion, Cough, Lower respiratory tract congestion, Pain
Clinical narrative: COVID-19; COVID-19; Moderate head and chest congestion; Moderate head and chest congestion; dry cough; core body aches to present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 16:00 as dose 1, single (Lot number: ER8729), in left arm, on 12Apr2021 at 16:00 as dose 2, single (Lot number: ER8729), in left arm and on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: adult ADHD. Concomitant medication(s) included: LISINOPRIL, start date: 10Feb2020; FEBUXOSTAT, start date: 15Jan2016; DULOXETINE, start date: 01Jun2016; VYVANSE, start date: 01Jun2016. Past drug history included: Allopurinol, reaction(s): "Known allergies: Allopurinol". The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered", COVID-19 (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "COVID-19"; LOWER RESPIRATORY TRACT CONGESTION (non-serious), CEREBRAL CONGESTION (non-serious) all with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "Moderate head and chest congestion"; PAIN (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "core body aches to present"; COUGH (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "dry cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (20Apr2022) Positive; (27Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of lower respiratory tract congestion, cerebral congestion, cough, pain.  Clinical course: Patient received Paxlovid for the treatment of COVID-19 from 20Apr2022 to 25Apr2022 and also received other medication in 2 weeks.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Moderate head and chest congestion; Moderate head and chest congestion; dry cough; core body aches to present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 16:00 as dose 1, single (Lot number: ER8729), in left arm, on 12Apr2021 at 16:00 as dose 2, single (Lot number: ER8729), in left arm and on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: adult ADHD. Concomitant medication(s) included: LISINOPRIL, start date: 10Feb2020; FEBUXOSTAT, start date: 15Jan2016; DULOXETINE, start date: 01Jun2016; VYVANSE, start date: 01Jun2016. Past drug history included: Allopurinol, reaction(s): "Known allergies: Allopurinol". The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered", COVID-19 (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "COVID-19"; LOWER RESPIRATORY TRACT CONGESTION (non-serious), CEREBRAL CONGESTION (non-serious) all with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "Moderate head and chest congestion"; PAIN (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "core body aches to present"; COUGH (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "dry cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (20Apr2022) Positive; (27Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of lower respiratory tract congestion, cerebral congestion, cough, pain.  Clinical course: Patient received Paxlovid for the treatment of COVID-19 from 20Apr2022 to 25Apr2022 and also received other medication in 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 1, single (Lot number: ER8735), in left arm, on 05May2021 at 12:00 as dose 2, single (Lot number: ER8735), in right arm and on 01Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 301358A) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 17Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: Covid symptoms and positive rapid antigen test on 17Apr2022; (24Apr2022) Negative, notes: Negative rapid antigen test on 24Apr2022 (Day 8); (29Apr2022) Negative, notes: Symptoms returned on 29Apr202 (Day 13) along with positive rapid antigen test; (01May2022) Positive, notes: Still testing positive as of 01May2022 (Day 15). Therapeutic measures were taken as a result of covid-19.   Clinical course: Covid symptoms and positive rapid antigen test on 17Apr2022. Symptoms quickly improved and resolved. Negative rapid antigen test on 24Apr2022 (Day 8). Symptoms returned on 29Apr2022 (Day 13) along with positive rapid antigen test. Still testing positive as of 01May2022 (Day 15). Patient did not have known allergies. Patient did not received other medication in 2weeks. For treatment of covid-19 patient also received Paxlovid (from 17-Apr-2022 to 21-Apr-2022).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: Bad diarrhea; Not feeling too hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV Positive" (unspecified if ongoing), notes: He usually has diarrhea on a regular basis as part of being HIV positive; "Melanoma cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 01May2022, outcome "unknown", described as "Bad diarrhea"; FEELING ABNORMAL (non-serious) with onset 01May2022, outcome "unknown", described as "Not feeling too hot".  Additional information: He got the first dose, second dose, and first booster at a Cancer hospital. Saturday he just went to the regular. What they gave him looks like Pfizer COVID-19 Vaccine A12 plus Gray Cap but was not mentioning RDMA or whatever. The first thing he wants to know was, was the first and second dose and the first and second booster, are they the exact same thing? Because when he got his first and second dose, the lot number started with two letters and four numbers. The first COVID booster had five numbers and one letter, and then when he got the second booster, it was same form as the first and second shot with two letters and four numbers. It made him think for a second to check on if it was related. That was when he got to the lot number. He had bad diarrhea yesterday and was not feeling too hot, but it could be something he ate. Caller declines report. He usually has diarrhea on a regular basis as part of being HIV positive. It was not something to report, it just made him think when he had it. He was unsure of the way processes the shots. Did not answer his questions. He had to ask them for the expiration date, and if they are keeping it in the freezer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 at 16:00 as dose 1, single (Lot number: ER8730), in left arm, on 18Apr2021 at 16:00 as dose 2, single (Lot number: EW0162), in left arm and on 06Dec2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 12:00, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had not received any other medication in 2weeks. Patient had received anti-viral Paxlovid as a treatment medication for the event COVID-19 from 16Apr2022 to 21Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Infertility, Menstrual disorder, Premature menopause, SARS-CoV-2 test
Clinical narrative: Second dose missed another period; random premature ovarian failure; infertility; Dose number=2; administration date=22Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 16Sep2021, when the patient was 31-year-old, for Covid-19 Immunization, reaction(s): "Missed my period after the first dose". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Dose number=2; administration date=22Nov2021"; MENSTRUAL DISORDER (disability), outcome "not recovered", described as "Second dose missed another period"; PREMATURE MENOPAUSE (disability), outcome "not recovered", described as "random premature ovarian failure"; INFERTILITY (disability), outcome "not recovered". The events "second dose missed another period", "random premature ovarian failure" and "infertility" required physician office visit. Clinical course: The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of menstrual disorder, premature menopause, infertility.   Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, 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). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster),  single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "borderline high blood pressure" (unspecified if ongoing); "Ductal carcinoma in situ" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; runny nose; Congestion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure; "Atrial fibrillation" (unspecified if ongoing); "Season allergies" (unspecified if ongoing), notes: Other medical history: season allergies. Concomitant medication(s) included: DILTIAZEM CRISTERS. The following information was reported: NASAL CONGESTION (non-serious) with onset 27Apr2022, outcome "not recovered", described as "Congestion"; RHINORRHOEA (non-serious) with onset 27Apr2022, outcome "not recovered", described as "runny nose"; DRUG INEFFECTIVE (medically significant), outcome "unknown", 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; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of rhinorrhoea, nasal congestion. Clinical course included Antiviral Paxlovid for treatment for COVID-19. Patient stated that Recurrence of viral load of covid-19. Unsure if runny nose and congestion is from covid-19 or seasonal allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have had a rebound in testing positive (no symptoms), 6 days after completing paxlovid. In the time between completing my course and testing positive again, I received 3 negative at home rapids; I have had a rebound in testing positive (no symptoms), 6 days after completing paxlovid. In the time between completing my course and testing positive again, I received 3 negative at home rapids; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "I have had a rebound in testing positive (no symptoms), 6 days after completing paxlovid. In the time between completing my course and testing positive again, I received 3 negative at home rapids".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Positive, notes: In the time between completing my course and testing positive again, I received 3 negative at home rapids and a negative PCR test; (Apr2022) Negative, notes: In the time between completing my course and testing positive again, I received 3 negative at home rapids and a negative PCR test; (01May2022) Positive; (Apr2022) Negative, notes: In the time between completing my course and testing positive again, I received 3 negative at home rapids and a negative PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 20Apr2022 to 25Apr2022. No other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; 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 received BNT162b2 (BNT162B2), on 04Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown, Manufacturer: Pfizer), administration date: 14May2021, when the patient was 40-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 01Dec2021, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Other vaccine in four weeks reported as no. Other medications in two weeks reported as no. Treatment received for AE reported as no. Covid prior vaccination reported as no. Covid tested post vaccination reported as no. No Known allergies was reported. Other medical history reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
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(s) (Consumer or other non HCP).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Post-concussion syndrome" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing); "peanuts" (unspecified if ongoing); "coconut, peaches" (unspecified if ongoing). Concomitant medication(s) and other medication in 2 weeks included: ALLEGRA. Past drug history included: Compazine, reaction(s): "Known Allergies:Compazine". 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 which included Paxlovid from 09Apr2022 to 14Apr2022. On 19Apr2022, the patient had a rebound infection on day 12 after feeling well for two days, five days after her last dose of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.