chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Caller states she became sick and started getting sick; Booster; congestion; cough; sore throat; fever; diarrhea; she thinks no appetite.; 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 49 year-old female patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2588) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, lot number:  PF EN6207), administration date: 17Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 02, lot number: EW0162, Anatomical Location of Administration of Pfizer vaccine considered as suspect: left upper arm), administration date: 05Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot", "the 2nd dose she got was diluted too much and was recommended to get revaccinated for the 2nd shot". The following information was reported: IMMUNISATION (non-serious) with onset 19Oct2021, outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "she thinks no appetite."; ILLNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Caller states she became sick and started getting sick". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (21Dec2021): This is a spontaneous follow-up report from same contactable Consumer. This 49-year-old female patient reported for herself that:  Updated information: Reporter information, Patient information, Relevant Medical History, Historical Vaccine, Lab data, Suspect product information and Event information were added  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Penis disorder
Clinical narrative: the young man had received both doses of Comirnaty primary series as well as a booster dose; after a while his penis shrunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1), for COVID-19 immunization, reaction(s): "after a while his penis shrunk"; Comirnaty (Dose: 2), for COVID-19 immunization, reaction(s): "after a while his penis shrunk". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "the young man had received both doses of Comirnaty primary series as well as a booster dose"; PENIS DISORDER (non-serious), outcome "unknown", described as "after a while his penis shrunk".  Additional Information: A consumer reported for a male patient. Caller states he was calling regarding a side effect of the Covid-19 vaccine and stated he was not calling for him. He stated that he was calling for someone else that was really upset and bashful, stating that it seems his penis has shrunk. When caller was asked if he could complete report, he stated that the patient was not there, and he stated that he just found out about it about an hour ago. All he knew was that the young man had received both doses of Comirnaty primary series as well as a booster dose, and after a while his penis shrunk. The caller stated that the patient said he was really embarrassed and did not want to talk about it. Then, he finally did. Clarified that the caller had no further details to provide to complete the report.  Caller asked if there were other men that might have these problems with the vaccine. Investigation assessment was not provided. The event was reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: he had a sore arm but only for a couple of hours; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 06Feb2021, for COVID-19 immunization, reaction(s): "before he has asthma but after taking the second dose he is virtually asthma-free."; Bnt162b2 (Dose: 2), administration date: 27Feb2021, for COVID-19 immunization, reaction(s): "before he has asthma but after taking the second dose he is virtually asthma-free.". The following information was reported: IMMUNISATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "he had a sore arm but only for a couple of hours".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Investigation, Ventricular tachycardia
Clinical narrative: ventricular tachycardia, it actually hit her heart; never had heart trouble before; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 18Feb2021 (Lot number: EL9266) at the age of 70 years as dose 2, single for COVID-19 immunization. The patient had no relevant medical history. The patient took concomitant medications, which included unspecified multivitamins. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single, Batch/Lot number: EN5318), administration date: 28Jan2021, for COVID-19 immunization. The patient had no prior vaccinations (within 4 weeks). The following information was reported: VENTRICULAR TACHYCARDIA (medically significant) with onset 2021, outcome "not recovered," described as "ventricular tachycardia, it actually hit her heart; never had heart trouble before." The event was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram (Echo): (2021) unknown results; holter monitor: (2021) unknown results; and test: (2021) unknown results. It was further reported that the patient was just curious; she had a reaction to the shot, to the point where, it was not that she had a fever or anything like that; she ended up without maybe six weeks after the first two shots, okay; the second shot, she ended up with ventricular tachycardia, it actually hit her heart of course when she went to the cardiologist and had test taking and everything out, the only thing that doctors could say was "yes it was, no it was not," but she never had heart trouble before and after taking this shot, she got ventricular tachycardia. She was just curious about how many people had called and said that there was some sort of heart-related or other incidents, because she knew she was probably not the first. The patient did take the booster; they did tell everybody to take this booster and so far, she had tachycardia and that was something that was not going to go away unfortunately, but down it was what it was. But, she was just curious to find out why it hit certain people in certain spots. When asked regarding treatment for the event, the patient stated that except getting an echo and wearing a monitor, a holter, they did want to put her on a beta blocker, but she refused the beta blocker; she did not like medication and she was going to live with what she had.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Very swollen lymph nodes under left arm and on left neck; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 15:30 (Lot number: FL3197) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: LITHIUM; LEVOTHYROXINE; GABAPENTIN; MINOCYCLINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 16Apr2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 07May2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 15:30, outcome "unknown", described as "Dose number = 3"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 12:00, outcome "not recovered", described as "Very swollen lymph nodes under left arm and on left neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: No seriousness criteria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and reported Event Very swollen lymph nodes under left arm and on left neck. Their was no covid diagnosed prior to vaccination and patient  was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: fatigue; low-grade fever (101 F); chills; headache; booster; injection site soreness/warmth starting 20Dec2021; injection site soreness/warmth starting 20Dec2021; 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), intramuscular, administered in arm left, administration date 20Dec2021 14:15 (Lot number: FH8027) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: peanuts" (unspecified if ongoing); "known allergies: blueberries" (unspecified if ongoing), notes: known allergies: blueberries; "known allergies: CT scan dye" (unspecified if ongoing), notes: known allergies: CT scan dye. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CALCIUM CITRATE/VITAMIN D. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:15, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 20Dec2021, outcome "recovering" and all described as "injection site soreness/warmth starting 20Dec2021"; FATIGUE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "low-grade fever (101 F)"; CHILLS (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site warmth, fatigue, pyrexia, chills, headache.  Additional Information: The patient had no other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination and since the vaccination was not tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: fatigue; low-grade fever (101 F); chills; headache; booster; injection site soreness/warmth starting 20Dec2021; injection site soreness/warmth starting 20Dec2021; 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), intramuscular, administered in arm left, administration date 20Dec2021 14:15 (Lot number: FH8027) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: peanuts" (unspecified if ongoing); "known allergies: blueberries" (unspecified if ongoing), notes: known allergies: blueberries; "known allergies: CT scan dye" (unspecified if ongoing), notes: known allergies: CT scan dye. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CALCIUM CITRATE/VITAMIN D. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:15, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 20Dec2021, outcome "recovering" and all described as "injection site soreness/warmth starting 20Dec2021"; FATIGUE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "low-grade fever (101 F)"; CHILLS (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site warmth, fatigue, pyrexia, chills, headache.  Additional Information: The patient had no other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination and since the vaccination was not tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm; body aches; nausea; Dose number 3; 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 (COMIRNATY), intramuscular, administered in arm left, administration date 20Dec2021 14:30 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Apr2021, when the patient was 45 years old, for Covid-19 immunization; Comirnaty (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:30, outcome "unknown", described as "Dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "Sore arm"; PAIN (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "body aches"; NAUSEA (non-serious) with onset 21Dec2021 06:00, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, pain, nausea.  Additional information: Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. Other medications in two weeks: FLO PMS Gummy Vitamins;Hair Skin & nails 5,000 mcg Biotin.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chronic obstructive pulmonary disease, Disease recurrence, HIV infection, Visual impairment
Clinical narrative: HIV; heart condition; Chronic obstructive pulmonary disease (COPD); Chronic obstructive pulmonary disease (COPD)/heart condition; visually impaired; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HIV INFECTION (medically significant), outcome "unknown", described as "HIV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)/heart condition"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". Clinical details as follows: The patient had a heart condition and I have HIV. I'm visually impaired, I received my primary vaccination series and a booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). He asks: "Do you have any information on the effectiveness of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) booster dose 4 months after vaccination?" The patient mentioned that he has a heart condition and Chronic obstructive pulmonary disease (COPD) now. And he already had his first and second dose of the vaccine also he already had his Booster Shot. He is asking the effectiveness of the booster shot after 4 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle Soreness; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 13:00 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for influenza, administration date 09Dec2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, administration time=15:30, Lot number: unknown, vaccine location=Left arm), administration date: 09Mar2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, administration time=02:00, Lot number: unknown, vaccine location=Left arm), administration date: 30Mar2021, when the patient was 25 years old, for Covid-19 Immunization, reaction(s): "Chills", "Feeling hot", "Headache", "General body pain". The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 13:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 20Dec2021 01:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious) with onset 20Dec2021 01:00, outcome "recovering", described as "Muscle Soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, myalgia. Additional information: No other medications were taken in two weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID tested post vaccination. The patient did not have any known allergies or other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: AFib; Fast heart beating; Rash; Dizziness; Weakness; Shortness of breath; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "AFib"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Fast heart beating"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Shortness of breath". The reporter stated that he just wanted to know his wife had the first and second Pfizer vaccines and she had the very bad problems with some risks. The patient experienced afib, fast heart beating, rash, dizziness and weakness and shortness of breath. She had the first vaccine in Apr2021 and then she had the second shot in Apr2021 and then she started having the effects after that. Now, it's the time to get the booster and he was wondering if they would recommend her getting the booster or just skipping it because she had the bad effects with the second shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: AFib; Fast heart beating; Rash; Dizziness; Weakness; Shortness of breath; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "AFib"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Fast heart beating"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Shortness of breath". The reporter stated that he just wanted to know his wife had the first and second Pfizer vaccines and she had the very bad problems with some risks. The patient experienced afib, fast heart beating, rash, dizziness and weakness and shortness of breath. She had the first vaccine in Apr2021 and then she had the second shot in Apr2021 and then she started having the effects after that. Now, it's the time to get the booster and he was wondering if they would recommend her getting the booster or just skipping it because she had the bad effects with the second shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: She has blood clots from her feet all the way to her lungs; She has blood clots from her feet all the way to her lungs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) for a Pfizer sponsored program (159558). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization; BNT162B2 (DOSE 2), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization), PULMONARY THROMBOSIS (hospitalization), outcome "unknown" and all described as "She has blood clots from her feet all the way to her lungs".  Additional information: The reporter stated that the patient, after taking her shots, was in the hospital and has blood clots from her feet all the way to her lungs. The patient already took the vaccine with a booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin increased, Inappropriate schedule of product administration, Joint range of motion decreased, Magnetic resonance imaging, Pain
Clinical narrative: pain after the vaccine and then lost range of motion; pain after the vaccine and then lost range of motion; Inappropriate schedule of vaccine administered; 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), administered in arm left, administration date 29Jul2021 (Lot number: EW0202) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arrythmia" (unspecified if ongoing); "low IGG" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ZOLOFT. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: ER8733), administration date: 31Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "covid". The following information was reported: PAIN (disability), JOINT RANGE OF MOTION DECREASED (disability) all with onset 31Jul2021, outcome "not recovered" and all described as "pain after the vaccine and then lost range of motion"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Clinical course was reported as follows. She had pain after the vaccine and then lost range of motion. After it didn't go away and got worse. She went to a doctor and physical therapy. She had covid in Feb2021 and that is why she waited longer in between my 2 vaccines because she got very sick after her 1st vaccine and doctor told her to wait a bit for the 2nd. She has had a MRI, 2 cortisone injections and physical therapy and can't do things like put on a bra or jacket or do small things around my home or wash my hair. The event "pain after the vaccine and then lost range of motion" and "pain after the vaccine and then lost range of motion" resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment for events included physical therapy, 2 cortisone shots and MRI. The patient underwent the following laboratory tests and procedures: PRL Covid 19: (17Dec2021) negative, notes: Nasal Swab; MRI: (unspecified date) unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101841484 similar report from same reporter
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got very sick; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 15:30 (Lot number: ER8733) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arrythmia" (unspecified if ongoing); "Low IGG" (unspecified if ongoing); "covid", start date: Feb2021 (unspecified if ongoing), notes: I had covid in Feb 2021. Concomitant medication(s) included: ZOLOFT. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very sick". The event "got very sick" was evaluated at the physician office visit. Clinical course: She had covid in Feb2021 and that is why she waited longer in between her 2 vaccines because she got very sick after her 1st vaccine and doctor told her to wait a bit for the 2nd.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on both a rapid and PCR COVID test; tested positive on both a rapid and PCR COVID test; tested positive on both a rapid and PCR COVID test; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Lot number: 30145BA) at the age of 50 years as dose 3 (booster), single, intramuscular, administration date 05Apr2021 (Lot number: ER8733) as dose 2, single and intramuscular, administration date 08Mar2021 (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "not recovered", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "not recovered" and all described as "tested positive on both a rapid and PCR COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (21Dec2021) positive, notes: Rapid; sars-cov-2 test: (21Dec2021) positive, notes: PCR. Therapeutic measures were not taken as a result of vaccination failure, covid-19.Clinical comments: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered is Workplace clinic.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Seizure
Clinical narrative: he had also his booster shot summer or early fall. Caller mentioned that he's having seizures; booster; seizures got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 301458A, Expiration Date: 30Nov2021) at the age of 68 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "ryders syndrome" (unspecified if ongoing); "AVM (Arteriovenous malformation)" (unspecified if ongoing), notes: Diagnosed a couple of decades ago or at least 10 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 Immunization; Bnt162b2 (dose 2), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 Immunization. The patient received his first dose on 28Jan2021 and second dose on 26Feb2021. The patient also received the booster dose but the day indicated in his vaccination card is incorrect, but he received it in the late summer or early fall. The patient was asking if there are any side effects related to AVMs because he has been having seizures on 29Oct2021 since he had the booster dose. The seizures got worse and then he started medication and they have improved. Vaccination Facility Type was Grocery store. Vaccine Administered at Facility was No. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The AEs require a visit to Emergency Room twice but the caller was never admitted to the hospital. Prior Vaccinations (within 4 weeks) was None. The outcome of seizures and seizures got worse was recovering, of other event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "type II diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The event "tested positive for covid" and "tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient stated he was currently at the doctor's office waiting to be seen. The patient just tested positive for Covid. He had had the first two Pfizer vaccine back in Jan2021. The patient confirmed he was asking how to participate in clinical trials for SARS-Cov2 protease inhibitor, oral.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: heart attack; three strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "three strokes". Clinical course: Caller is a male patient. States that he has been trying to get the booster dose and he can not find anybody to give him the shot. Mentions that he had visited # and they do not have appointments until 14:00. Says that if we could send him the vaccine, as he is a diabetic, he could administer it to both his daughter and himself. He states that he has had a heart attack and three strokes and he is aware that he should give this information to the vaccine provider so they can vaccine them expeditely but no one wants to hear him. He asks for information on where can he get an appointment for the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Polymers allergy
Clinical narrative: anaphylactic reaction; PEG(polyethylene glycols) is the ingredient that the patient allergic to; PEG(polyethylene glycols) is the ingredient that the patient allergic to; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction"; POLYMERS ALLERGY (medically significant), ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "unknown" and all described as "PEG(polyethylene glycols) is the ingredient that the patient allergic to". The patient would like to get the second dose in the doctor's office, reporter would like to know what is the protocol and if that is allowed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: This is a spontaneous report received from a non-contactable reporter (Consumer). A female patient of an unspecified age received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "suffered a severe case of pericarditis". 3 days after the second dose, the reporter's wife suffered a severe case of pericarditis and Pfizer did not provide any information regarding this concerning the booster, so basically the reporter's question is, does Pfizer advice people who already suffered from pericarditis as a side effects from m-RNA vaccine, does Pfizer advice to those people to get the booster right now? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Ejection fraction decreased, Magnetic resonance imaging, Myocarditis
Clinical narrative: Myopericarditis/ myocarditis; a reduction in my LVEF to approximately 35%-40%; 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 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Apr2021 12:15 (Lot number: EW0176) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose 1; LOT# EP7533; Anatomical site of administration of vaccine: Left arm), administration date: 05Apr2021, for Covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 30Apr2021, outcome "recovering", described as "Myopericarditis/ myocarditis"; EJECTION FRACTION DECREASED (hospitalization, medically significant) with onset 30Apr2021, outcome "recovering", described as "a reduction in my LVEF to approximately 35%-40%". The patient was hospitalized for myocarditis, ejection fraction decreased (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: echocardiogram: 35%-40%, notes: reduction in my LVEF; 50%, notes: LVEF has returned to 50%; magnetic resonance imaging: 35%-40%, notes: reduction in my LVEF. Therapeutic measures were taken as a result of myocarditis, ejection fraction decreased. The patient stated that he had an adverse reaction to his second dose of the Pfizer covid vaccine, involving myo-pericarditis and a reduction in his LVEF to approximately 35%-40% (echocardiogram and MRI, respectively). After 8 months of recovery, the patient felt fine and his LVEF has returned to at least 50% (echocardiogram). The patient stated also that he would say that he was still recovering from the myocarditis. Although, he would say he was about 90% recovered. When he had a follow up appointment about three months prior to this report, his left ventricular ejection fraction have recovered from 35 to 50 percent which was still suboptimal. He will have a follow up appointment next month for when he would be able to say he would have recovered 100% but he would say that he had at least 90% recovered. The patient specified that the outcome of the events was "Certainly, improved". The patient had a two-day hospital stay where he was monitored and given cardiac drugs. So, he took both a beta-blocker and ACE-inhibitor on the direction of his cardiologist (not clarified further).  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Peripheral swelling, Vaccination site pain
Clinical narrative: Booster; Pain and swelling in armpit.; Pain and swelling in armpit; Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Dec2021 (Lot number: FD7218) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, brand=Pfizer , Batch/Lot No: EW0167, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03May2021, when the patient was 18 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, brand=Pfizer, Batch/Lot No: EW0153, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious) with onset 19Dec2021, outcome "recovering", described as "Pain and swelling in armpit."; PERIPHERAL SWELLING (non-serious) with onset 19Dec2021, outcome "recovering", described as "Pain and swelling in armpit"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2021, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of axillary pain, peripheral swelling, vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient of unspecified date received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administration date 2021 (Lot number: unknown) as dose 2, single and administration date 2021 (Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Weak immune system" (ongoing); "Arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: The patient was asking if she is protected against the new Omicron variant after having had the primary (2-dose) series of the Pfizer-BioNTech COVID-19 vaccine. She was concerned as she was supposed to be traveling on the week of the report. The patient noted that she had COVID-19 in Aug2021. The patient underwent the following laboratory tests and procedures: COVID-19 test: (Aug2021) positive. The outcome of the event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.