chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain on left shoulder and arm; Pain on left shoulder and arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's family history included: "blood clotting" (unspecified if ongoing), notes: in the family; "diabetic" (unspecified if ongoing), notes: Mother is diabetic and history of arthritis; "arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Warfarin for blood clotting; Alopurinol for Gout. Vaccination history included: Tetanus shot (Tetanus arm soreness but it went away and it did not last. Unknown manufacturer, lot and expiration), for Immunization, reaction(s): "soreness". The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset May2021, outcome "not recovered" and all described as "Pain on left shoulder and arm". The events "pain on left shoulder and arm" required emergency room visit. Therapeutic measures were not taken as a result of arthralgia, pain in extremity.  Additional information: The patient was experiencing the pain ever since she got the injection. She thought it was like when you get a tetanus shot, that pain, only it never went away. Patient thought it was another issue with her shoulder than the injection. When she did go back to Urgent Care last week, they looked it up and told her there were other people with similar issues as her and she should notify Pfizer about it. Patient believes 1st dose was in May2021 at 13:30 and 2nd was Jun2021. This pain occurred after the first dose. This would have been the first shot, and then she got the booster like a month afterwards, a month between the two. Patient received a flu and shingles shot but they were way later. No further details provided. Patient did the waiting period they recommend and there was no reaction or soreness which she said was like a Tetanus. Patient stated the previous soreness to the Tetanus shot was nothing like this. She did not have a manufacturer, lot or expiration for the previous Tetanus. It went away, but this pain had not. The patient was normally took Warfarin for blood clotting and Alopurinol for Gout, both prior to getting the vaccine. Patient did not have prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine.  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) :PFIZER INC-202200724940 Same product and event, different patients
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Ag 16May and sx 14May; positive Ag 16May and sx 14May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "unknown" and all described as "positive Ag 16May and sx 14May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Paranasal sinus discomfort, SARS-CoV-2 test, Vaccination failure
Clinical narrative: no booster and sz mild ST cough sinus pressure 5/13 and then Ag positive 5/14; no booster and sz mild ST cough sinus pressure 13May and then Ag positive 14May; Cough; sinus pressure; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 30-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 2, single (Lot number: EL3247) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, prev dose brand: Pfizer), administration date: 26Jan2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 13May2022, outcome "unknown"; COVID-19 (medically significant) with onset 13May2022, outcome "unknown", described as "no booster and sz mild ST cough sinus pressure 13May and then Ag positive 14May"; VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", described as "no booster and sz mild ST cough sinus pressure 5/13 and then Ag positive 5/14"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 13May2022, outcome "unknown", described as "sinus pressure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, paranasal sinus discomfort. Clinical course: Facility type vaccine other: Workplace clinic. Post vaccination patient was tested for COVID.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Positive On Antigen Test; COVID Positive On Antigen Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID Positive On Antigen Test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: COVID Positive On Antigen Test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: If other vaccine in four weeks was reported as unknown. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Positivity on Antigen Test; COVID Positivity on Antigen Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID Positivity on Antigen Test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of COVID-19. Clinical course: Patient had not COVID-19 prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 05Apr2022 at 01:45 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Known allergies: probable penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: Jan2010, stop date: 05May2022; SYNTHROID, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details product=COVID 19 Treatment, brand Pfizer Paxlovid, treatment start date=05May2022, treatment stop date 09May2022, For Treatment of COVID-19.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Caller relays she is 83 years old and had many other vaccines and had no reaction besides her arm would hurt and that was it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in arm, on 04Feb2021 as dose 2, single (Lot number: EM9810), in arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 82 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis", start date: Feb2022 (unspecified if ongoing); "High blood pressure diagnosed years ago" (unspecified if ongoing); "Diabetes" (unspecified if ongoing), notes: Patient was prediabetic for a long time and now on medication for this for the last 6 months. Concomitant medication(s) included: TYLENOL. Vaccination history included: Flu vaccine (Normal flu vaccine, patient has a sore arm.). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Caller relays she is 83 years old and had many other vaccines and had no reaction besides her arm would hurt and that was it.". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Concomitant medications: Patient stated that she had just her daily medications. Declines to list.; Sender's Comments: Linked Report(s) : PFIZER INC-202200712728 similar report from same reporter
Age: 46.0
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) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 46 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). The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: amoxycillin, reaction(s): "Known allergies: amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The clinical course reported as COVID symptoms return, positive antigen test on day 13 after original infection - congestion, headache. The patient received other medications in two weeks. The patient received other medications in 2 weeks product was Macrobid, start date= 01May2022, stop date= 05May2022. The patient receive treatment with Brand=Paxlovid, start date/ stop date 04May2022. The patient known allergies Sulfa, amoxycillin.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. The following information was reported: 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: Positive; Positive; Negative. Therapeutic measures were taken as a result of covid-19.  Additional information: Report about covid treatment was Yes. If vaccine received reported as Yes. Other medication in 2weeks reported as Yes. Anti viral details: Product: COVID 19 Treatment, Brand: pfizer paxlovid, Treatment start date: 05May2022, Treatment stop date: 09May2022. Other medication details: Other medication in 2weeks product: Station, other medication in 2weeks product: Zoloft. Rebound of symptoms at day 12. Rapid antigen test, positive again after being negative a week ago. Known allergies reported as No.  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: Ageusia
Clinical narrative: lost her sense of taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste".  Additional information: Caller mentioned that they keep on sending her paperwork to fill out. She stated that, she lost her sense of taste after getting the booster shot. Stated that, while reading the opening spiel caller disconnected the call. No other information was mentioned after she stated that she lost her sense of taste. Created Manual AE form. Any medical questions addressed by this program forwarded/referred to Medical Information (Live Operators Only) was reported as no: Customer and/or medical inquiry was not forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Papule, Rash
Clinical narrative: Rash and bumps on chest under pectoral muscle on both sides on 1st day after vaccine. Same around neck 2nd day.; Rash and bumps on chest under pectoral muscle on both sides on 1st day after vaccine. Same around neck 2nd day.; 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 male patient received BNT162b2 (BNT162B2), on 13May2022 at 08:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: REMERON; ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 01Apr2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 11Mar2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: RASH (non-serious), PAPULE (non-serious) all with onset 14May2022 at 22:00, outcome "recovered" (May2022) and all described as "Rash and bumps on chest under pectoral muscle on both sides on 1st day after vaccine. Same around neck 2nd day.". Therapeutic measures were taken as a result of rash, papule.  Additional information:No other vaccine in four weeks. Other medications in two weeks were Remeron and Atorvastatin. Antihistamine  was as treatment for adverse events until gone. There was no known allergies. Covid tested post vaccination was no. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: Severe diarrhea the next day after the first dose, continuing up to this day.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 at 15:00 as dose 1, single (Lot number: EN6206) at the age of 83 years, in left arm and on 27Mar2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CVD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bladder cancer" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; HYDROCHLOROTHIAZIDE; ATENOLOL; ISOSORBIDE. Past drug history included: Statins, reaction(s): "Known allergies: statins". The following information was reported: DIARRHOEA (non-serious) with onset 08Mar2021 at 08:00, outcome "not recovered", described as "Severe diarrhea the next day after the first dose, continuing up to this day.". The event "severe diarrhea the next day after the first dose, continuing up to this day." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Administration facility. Ae treatment was RX Dicyclomine 10mg. 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: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "breast cancer diagnosis Feb2022, stage 1a", start date: Feb2022 (unspecified if ongoing), notes: breast cancer diagnosis Feb2022, stage 1a. The patient's concomitant medications were not reported. Past drug history included: Statins, reaction(s): "Known allergies: statins", notes: Known allergies: statins. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "not recovered" and all described as "tested positive for Covid on 28Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (09May2022) Negative, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (14May2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022; (16May2022) Positive, notes: tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. I developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022. Therapeutic measures were taken as a result of drug ineffective, Covid-19. It was unknown whether patient received other medication in two weeks. Vaccine lot number were also not available. Patient tested positive for Covid on 28Apr2022. I then tested negative after taking Paxlovid on 09May2022. Patient developed Covid symptoms on 13May2022 and had a positive test for Covid on 14May2022 and again on 16May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Enuresis, Myalgia, Pain, SARS-CoV-2 test, Sleep disorder
Clinical narrative: woke up wetting the bed in the middle of the night.; Body aches; muscle soreness; woke up wetting the bed in the middle of the night.; This is a spontaneous report received from a non-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 16May2022 at 18:00 as dose 1, single (Lot number: Fm9992) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "ocd" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SERTRALINE; COLLAGEN; FIBER. The following information was reported: ENURESIS (non-serious), outcome "recovering", PAIN (non-serious), outcome "recovering" and all described as "Body aches"; MYALGIA (non-serious), outcome "recovering", described as "muscle soreness"; SLEEP DISORDER (non-serious), outcome "unknown", described as "woke up wetting the bed in the middle of the night.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of enuresis, pain, myalgia, sleep disorder.  Additional information: Patient had no known allergies and was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 3 (booster), single (Lot number: EW0161) at the age of 45 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. Past drug history included: No. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Virus return on day 13 tested negative on day 10 then symptoms returned on day 13 and tested positive; Positive, notes: Virus return on day 13 tested negative on day 10 then symptoms returned on day 13 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : Paxlovid is given to the patient for COVID 19. Treatment start date: 04May2022, Treatment stop date: 08May2022, Lot number: 0069108530, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Aug2016, stop date: 02May2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2021, 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: (01May2021) Positive, notes: Began Paxlovid 1 day after positive test. Therapeutic measures were taken as a result of covid-19. Clinical course: Began Paxlovid 1 day after positive test. Finished course in 5 days as recommended. Complete reversal of symptoms. Felt fine for 8 days. Day 9 symptoms reoccurred, exactly as they had previously. Currently on day 2 of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 1, single (Lot number: 320308), in left arm and on 20Nov2021 as dose 2, single (Lot number: FJ8757) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2010, stop date: 15May2022; FLUTICASONE PROPIONATE (GLUCOCORTICOID) nasal, start date: 01Jan2010; VITAMIN D3, start date: 01Jan2010; CETIRIZINE, start date: 01Jan2010; MAGNESIUM, start date: 01Jan2010; GLUCOSAMINE & CHONDROITIN COMPLEX, start date: 01Jan2010. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient' other medication in 2weeks included product Fluticasone propionate nasal spray lot number TH8980, Vitamin D3, lot number VS210874, Cetirizine lot number=1LE1998C, Glucosamine & Chondroitin lot number 300012, Magnesium lot number 2451963. Antiviral details: Product COVID 19 Treatment, Brand Pfizer. Treatment start date was 16May2022 and treatment stop date was 17May2022. Lot number FY8927. Indication was treatment of COVID-19. Adverse event: Constant TERRIBLE stomach cramping and diarrhea. Way worse than the Covid symptoms. Adverse events start date was 16May2022, at 08:00 PM. The patient did not receive treatment and not recovered
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headaches every other day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2022 at 17:00 as dose 2, single (Lot number: Cvs3118) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Rmm , Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 28Dec2021, when the patient was 28-year-old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Persistent headaches every other day". Therapeutic measures were not taken as a result of headache.  Additional information: The patient not received any other vaccine in four week. The patient not tested covid 19 positive post and prior to vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea, Carbon dioxide, Chills, Erythema, Metabolic function test
Clinical narrative: minor redness& chills; minor redness& chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2020 at 10:00 as dose 1, single (Lot number: EJ1685) at the age of 79 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia", start date: 1944, stop date: 1944, notes: Treated with sulfa (Later developed allergy); "Pneumonia", start date: 1963, stop date: 1963, notes: Treated with penicillin; "Pneumonia", start date: 1996, stop date: 1996, notes: Treated with penicillin (Latter developed allergy); "Treated with penicillin (Latter developed allergy)" (unspecified if ongoing); "High blood Pressure" (unspecified if ongoing); "Treated with sulfa (Later developed allergy)" (unspecified if ongoing). The patient's family history included: "smokers" (unspecified if ongoing), notes: I started at age18 and smoked for 20 yrs) but besically since birth. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for hypertension, start date: 1996 (ongoing); BENAZEPRIL oral taken for hypertension, start date: 2006 (ongoing). The following information was reported: ERYTHEMA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "minor redness& chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Family medical History Relevant to AE(S): Father died after many stroke (Over years) in his 80's and Mother had maligant hypertension and COPD -Died at 90. Both parents were heavy smokers most adult lives.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 62-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 at 11:00 as dose 2, single (Lot number: EN6203) at the age of 61 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: Patient did not receive any other medication in 2weeks. Patient had no allergies. Patient received Paxlovid for the treatment of COVID-19 from 01May2022 to 06May2022. After taking paxlovid, patient seem to have a recurrence of Covid about 10 days after completing the dosage. He have much milder symptoms the second time.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EN6204), in right arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 13May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical information: The patient had no known allergies and no other medical history. . No follow-up attempts are possible. 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 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), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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: 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: Unknown results. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient 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 (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". She had a heart attack just a few days after getting a Pfizer booster. She had no heart issues. She was a healthy lady. They would never know for sure what took her from them would she have a heart attack during her sleep anyway? She thought it's very suspicious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: severe allergic reaction to the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Polyethylene glycol, reaction(s): "allergic to Polyethylene glycol", notes: Consumer is allergic to Polyethylene glycol had severe allergic, reaction to the Pfizer vaccine. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "severe allergic reaction to the Pfizer vaccine".  Additional Information: Caller (name withheld) a consumer was allergic to Polyethylene glycol had severe allergic reaction to the Pfizer vaccine, she would like to know if she can ask someone from the Pfizer if the powder of the Paxlovid tablet can be manufactured near her place so that if ever they tested positive from Covid-19 they can take medication without the Polyethylene glycol in the ingredients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergies; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: EL3247,, Prev dose dose number: 1), administration date: 01Feb2021, when the patient was 26-year-old, for COVID-19 Immunization, reaction(s): "PCR Positive", "Cough", "Congestion"; BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: EL3247,, Prev dose dose number: 2), administration date: 22Feb2021, when the patient was 26-year-old, for COVID-19 Immunization, reaction(s): "PCR Positive", "Cough", "Congestion". The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2022, outcome "unknown", described as "Allergies". It was unknown if therapeutic measures were taken as a result of hypersensitivity.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: Bumps and itching on back, belly, and both arms from elbows to shoulders; Bumps and itching on back, belly, and both arms from elbows to shoulders; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID:.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "Bumps and itching on back, belly, and both arms from elbows to shoulders".  Additional information: Caller said he and his wife had reactions to the Pfizer COVID vaccine. Caller stated that it may be like getting a flu shot wherein sometimes it works right sometimes it doesn't to the point that you can still get a flu. Caller says that COVID mutates from one strain to a different one so he wanted to know how the vaccine is still the same, composition-wise, given that there have been a lot of new strains compared to the original strain and he doesn't know if the Pfizer COVID vaccine has the new strain of virus. Response: Spoke as per attached, provided disclaimer. Told caller that the Pfizer COVID vaccine does not actually contain a virus strain from COVID and that the main active ingredient of the vaccine is an mRNA. Explained to caller how this can still neutralize various strains of COVID, which is why it remains the same even though there have been a lot of different COVID strains. New AE added: Bumps and itching on back, belly, and both arms from elbows to shoulders Information has been updated for reporter and patient. Expiry Date of COVID-19 vaccine: Jul2021.Patient is caller's wife. Patient age: Just turned 68 years old, 2 years before that patient would have been 66 years old. Bumps and itching on back, belly, and both arms from elbows to shoulders. Start date of adverse event: Patient's 1st injection was 18Mar2021, so this started 20Mar2021. 1st dose: Date: 18Mar2021, received at withheld, Asthma and Allergies Building. Lot number: DN6207. Expiration date: Jul2021. Dose, route: Left deltoid, injection, doesn't know actual dose, looks like half cc, was a little TB syringe. 2nd dose: Date: 08Apr2021. Lot number: ER5727. Expiration date: Mar2021, really weird, just noticing that. Caller corrects himself and states that the 3, indicating March is a 7, indicating July. Corrects expiration date to Jul2021. 3rd dose, 1st booster dose: Date: 20Oct2021, Lot number: FF5790. Expiration date: Unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Stridor
Clinical narrative: minor stridor that is slowly resolving; I was vaccinated while pregnant with him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-month-old male patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The mother's relevant medical history was not reported. The mother's concomitant medications were not reported. The following information was reported: STRIDOR (non-serious), outcome "recovering", described as "minor stridor that is slowly resolving"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "I was vaccinated while pregnant with him".  Additional information: A potential AE has been reported to the Pfizer Clinical Trials Contact Center. It was reported that she had a 12 month old son and I would love for him to be a part of this trial. He had no health conditions, aside from minor stridor that is slowly resolving. He hasn't had COVID (that we know of) but she was vaccinated while pregnant with him.   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) : PFIZER INC-202200732536 Maternal case
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot/sinus thrombosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 14:00 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 19 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 19-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 02Feb2021, when the patient was 18-year-old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant, life threatening) with onset 02May2022 at 12:00, outcome "not recovered", described as "Blood clot/sinus thrombosis". The patient was hospitalized for thrombosis (hospitalization duration: 4 day(s)). The event "blood clot/sinus thrombosis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of thrombosis with Blood thinners.  Clinical information: Blood thinners given as a treatment. The patient did not have covid prior vaccination. She tested for covid post vaccination (result: Negative). She did not have known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200735242 Same patient and drug, different event separated in time