chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Fatigue, Pain, Pain in extremity, Sluggishness
Clinical narrative: Diverticulitis; Sore arm; Fatigued/ very tired; sluggish; pain with getting up and walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8731), via an unspecified route of administration on 24Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727) on 01Apr2021 (at the age of 55-years-old) for COVID-19 immunisation. On 24Apr2021, the patient experienced sore arm that lasted for about 3 days; felt fatigued and sluggish for the first couple of days post vaccination which started to taper off by 27Apr2021. It was in and out now. On an unspecified date in 2021, after the second vaccination, the patient was fatigued and very tired, had pain with getting up and walking. On 08May2021, the patient ended up in the hospital and was diagnosed with diverticulitis from eating a lot of nuts (as of an unspecified date in 2021). She was hospitalized from 08May2021 to 10May2021. The clinical outcome of sore arm was resolved on Apr2021 (reported as 27Apr2021 or 28Apr2021), of diverticulitis and pain with getting up and walking was unknown, of "Fatigued/ very tired" and sluggish was not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Oral pruritus, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Swelling, Throat tightness, Urticaria
Clinical narrative: swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cold sweat, Dyspnoea, Mobility decreased, Night sweats
Clinical narrative: Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing in his ears; Cold sweat; Severe fever and sweats that night; Could not get up from the chair or move to 40 minutes; Achy; Arm severely sore; This is a spontaneous report from a contactable consumer (parent of the patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09May2021 (Batch/Lot Number: ER8735, at the age of 30 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included allergies to antibiotics (penicillin and all cross over drugs). The patient has no prior no health issues. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included the patient received the first dose of the BNT162B2 vaccine (Batch/Lot Number: EW0151) on 09Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was reported as none. The patient was not taking any other medications within 2 weeks of receiving the vaccination. On 09May2021, the patient received the second dose of the BNT162B2 vaccine. On 09May2021, the patient had a immediate reaction to the vaccination where his breathing almost completely shut down. He experienced ringing in his ears, lost his vision and had cold sweats. He could not get up from the chair or move for 40 minutes. It was reported that the patient meditates, and he kept his breathing going on his own. The pharmacist assisted him. That night he was achy and had severe fever and sweats. He had to rest for many days. His arm was severely sore and took many days to recover. It was reported that the patient has a very high threshold for pain, but this was severe. The patient has not been tested for COVID-19 after receiving the vaccination. The consumer inquired if the patient should avoid all COVID booster shots next year. The consumer inquired if it possibly this was a polyethylene glycol reaction. No treatment was received for the events. The outcome of event arm was severely sore was recovered in May2021. The outcome of the events loss of vision, breathing almost completely shut down, severe fever, ringing in his ears, night sweats, cold sweats, could not get up from the chair or move and achey was reported as recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing in his ears; Cold sweat; Severe fever and sweats that night; Could not get up from the chair or move to 40 minutes; Achy; Arm severely sore; This is a spontaneous report from a contactable consumer (parent of the patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09May2021 (Batch/Lot Number: ER8735, at the age of 30 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included allergies to antibiotics (penicillin and all cross over drugs). The patient has no prior no health issues. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included the patient received the first dose of the BNT162B2 vaccine (Batch/Lot Number: EW0151) on 09Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was reported as none. The patient was not taking any other medications within 2 weeks of receiving the vaccination. On 09May2021, the patient received the second dose of the BNT162B2 vaccine. On 09May2021, the patient had a immediate reaction to the vaccination where his breathing almost completely shut down. He experienced ringing in his ears, lost his vision and had cold sweats. He could not get up from the chair or move for 40 minutes. It was reported that the patient meditates, and he kept his breathing going on his own. The pharmacist assisted him. That night he was achy and had severe fever and sweats. He had to rest for many days. His arm was severely sore and took many days to recover. It was reported that the patient has a very high threshold for pain, but this was severe. The patient has not been tested for COVID-19 after receiving the vaccination. The consumer inquired if the patient should avoid all COVID booster shots next year. The consumer inquired if it possibly this was a polyethylene glycol reaction. No treatment was received for the events. The outcome of event arm was severely sore was recovered in May2021. The outcome of the events loss of vision, breathing almost completely shut down, severe fever, ringing in his ears, night sweats, cold sweats, could not get up from the chair or move and achey was reported as recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Choking, Parosmia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received a dose (unspecified dose number) of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 27Apr2021 at 12:30 (at 55-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), and bupropion hydrochloride (WELLBUTRIN SR). The patient denied any COVID diagnosis prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 14May2021 the patient began to experience smelling cigarette smoke when none was there. The patient stated that sometimes it makes her choke a little. The patient also began to experience extremely painful and swollen breasts since 14May2021. The patient has not been tested for COVID since the vaccine. The outcome of the events smelling cigarette smoke when none was there, makes her choke a little, and extremely painful, swollen breasts was not recovered.   Information on the Batch/Lot number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Thrombosis
Clinical narrative: Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 21Apr2021 at 09:00 (at the age of 44-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FR2613), administered in arm left on 25Mar2021 at 09:30 AM, for COVID-19 immunisation. The patient experienced blood clotting on 16May2021 at 22:00. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date (prior to vaccination). There was no treatment received for the event. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Investigation, Pericarditis
Clinical narrative: Acute pericarditis; This is a spontaneous report received from a contactable consumer (patient).  A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0162), via an unknown route in the left arm, on 15Apr2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8730) administered in Mar2021 for COVID-19 immunisation. No relevant medical history was provided. The patient was not diagnosed with COVID-19 before vaccination. The patient did not have concomitant medications. No other vaccine was received in four weeks. On 13May2021 at 13:00, the patient was found to have acute pericarditis. The event was assessed serious because requiring hospitalization. An angiogram was done, and results were not provided. On 14May2021, a Nasal Swab was done and resulted negative. The patient was recovering from the event.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Headache, Heavy menstrual bleeding, Lethargy
Clinical narrative: fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days early; Heavy menstruation; Lethargic; fatigue for 4 days; Headache; dry throat; thirsty; This is a spontaneous report from a contactable consumer.   A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 09:45 (Batch/Lot Number: EW0161) at the age of 24 years old as a single dose for covid-19 immunisation and dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 09:45 (Batch/Lot Number: EP6955) at the age of 24 years old Medical history and concomitant medications were not reported.  The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 1500 the patient experienced Sore arm, body aches, low grade fever 99.1, menstruation 3 days early, Heavy menstruation, Lethargic, fainting from heavier menstruation, fatigue for 4 days, Headache, dry throat, thirsty. The patient was not hospitalized for the events. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pain, Pain in extremity, Pyrexia, Syncope
Clinical narrative: fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days early; Heavy menstruation; Lethargic; fatigue for 4 days; Headache; dry throat; thirsty; This is a spontaneous report from a contactable consumer.   A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 09:45 (Batch/Lot Number: EW0161) at the age of 24 years old as a single dose for covid-19 immunisation and dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 09:45 (Batch/Lot Number: EP6955) at the age of 24 years old Medical history and concomitant medications were not reported.  The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 1500 the patient experienced Sore arm, body aches, low grade fever 99.1, menstruation 3 days early, Heavy menstruation, Lethargic, fainting from heavier menstruation, fatigue for 4 days, Headache, dry throat, thirsty. The patient was not hospitalized for the events. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days early; Heavy menstruation; Lethargic; fatigue for 4 days; Headache; dry throat; thirsty; This is a spontaneous report from a contactable consumer.   A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 09:45 (Batch/Lot Number: EW0161) at the age of 24 years old as a single dose for covid-19 immunisation and dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 09:45 (Batch/Lot Number: EP6955) at the age of 24 years old Medical history and concomitant medications were not reported.  The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 1500 the patient experienced Sore arm, body aches, low grade fever 99.1, menstruation 3 days early, Heavy menstruation, Lethargic, fainting from heavier menstruation, fatigue for 4 days, Headache, dry throat, thirsty. The patient was not hospitalized for the events. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable nurse (parent of the patient).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 13May2021 at 11:00 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE (at the age of 27 years old) for covid-19 immunisation.  Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for depression at 150mg once a day from Apr2021 (reported as 2 weeks prior to vaccination date) to May2021 (stopped after she had the seizure).  The patient experienced seizure on 14May2021 at 13:00 with outcome of unknown.  She had no history of seizure activity. No family history of seizures. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date, computerised tomogram: normal on an unspecified date, electrocardiogram: normal on an unspecified date, and electroencephalogram: normal on an unspecified date. The event required emergency room visit and physician office visit.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head  MRI, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-2021605934 Same reporter/drug/event, different patient.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Inappropriate schedule of product administration, Off label use
Clinical narrative: Bell's palsy affecting right half of face; dose number 2 administered on 21Apr2021; dose number 2 administered on 21Apr2021; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunisation. Medical history included asthma, eczema and known allergies included beef. Patient was not pregnant at time of vaccination. Concomitant medications included epinephrine and melatonin. No other vaccine was given in four weeks. The patient previously took first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in right arm on 07Apr2021 10:00 (at age of 21-year-old) as single dose for COVID-19 immunisation. On 21Apr2021, the patient received dose number 2 and experienced bell's palsy affecting right half of face on 18May2021 12:00. The event bell's palsy resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy affecting right half of face with 60mg Prednisone daily for 7 days. No covid prior vaccination. No covid tested post vaccination. Outcome was not recovered for bell's palsy affecting right half of face and for remaining events was unknown.  No Follow-up attempts are Possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: my body developed an elevated inflamation event in my neck, shoulders and hands.  It has since been diagnosed as Polymyalgia Rhuematica.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot unknown), via an unspecified route of administration in the left arm on 26Mar2021 10:00 as second dose, single for Covid-19 immunisation. Medical history included osteoarthritis, allergic to penicillin and shrimp. She had her first dose of bnt162b2 on 05Mar2021 (lot unknown) at 10:00am in the left arm. The patient's concomitant medications were not reported. On 14Apr2021 (also reported as within a week of last dose), the patient informed her body developed an elevated inflammation event in her neck, shoulders and hands and diagnosed as Polymyalgia Rhuematica in which she had a clinic visit to a doctor or other healthcare professional office. This was treated with prednisone. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Fall, Multiple fractures, Vaccination site pain
Clinical narrative: after an accident, which she broke multiple bones; after an accident, which she broke multiple bones; she fell; has some soreness at the site of injection; This is a spontaneous report from a contactable consumer (reporting about sister, patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Pfizer 9810) as single dose for covid-19 immunisation at the age of 57-year-old. Medical history included ongoing diabetes. There were no concomitant medications. The patient experienced soreness at the site of the injection on unspecified date in 2021. In May2021, the patient had an accident, broke multiple bones, she fell, was in hospital. The outcome of events was unknown. The consumer reported the patient just has some soreness at the site of injection, but after she fell, she has described many indications, indications that are going to affect her, those indications are not related to COVID at all, they are related to her injury and diabetes.  Information about batch/ lot number has been requested.  Follow-up (27May2021): New information received from the same contactable consumer included: Lot number, medical history, new events (accident, broke multiple bones, fell, soreness at the site of the injection). The case was upgraded from non-serious to serious.  Follow-up attempts are needed. further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Contusion, Dyspnoea, Heart rate irregular, Myocarditis
Clinical narrative: Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at the age of 22-year-old. Medical history included covid-19 prior to the vaccination. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and levonorgestrel (KYLEENA) (reported as Kyleena IUD). No other vaccine received in four weeks. It was reported that I woke up with intense chest pain two days after the first dose. Thought I was having a heart attack. Now realizing it was Myocarditis. Intense pain when moving and lifting heavy objects. Apple watch detected an abnormal heartbeat which fixed itself later on in the day. I experienced shortness of breath. The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly. The events stated on 24Feb2021 08:00. No treatment received, and outcome of events was recovered with sequelae on unspecified date in 2021. The patient hasn't been tested post vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumothorax spontaneous, SARS-CoV-2 test
Clinical narrative: Spontaneous Pneumothorax; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12May2021 09:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Apr2021 at 17:15 (age: 30-years) in the right arm for COVID-19 immunization. On 15May2021 06:00, the patient experienced spontaneous pneumothorax. The patient was hospitalized for the event for 9 days. Therapeutic measure was taken as a result of the event which included chest drain. The patient underwent Nasal swab test with negative result on 18May2021. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Shortness of breath started getting severe/ diagnosed with CHF/ unable to breathe when laying back in a chair; This is a spontaneous report from a contactable consumer (patient himself). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization and experienced intermittent SOB 5 days after. He received the second dose on Saturday, 15May2021. Shortness of breath started getting severe on the following Monday (18May2021), worsened on Tuesday, and went to ED on Wednesday. He was diagnosed with CHF. He has experienced being unable to breathe when laying back in a chair and having to stop 5-6 times during a 1 mile walk due to the shortness of breath. He has been referred to a Cardiologist. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hot flush, Hyperhidrosis, Palpitations, Somnambulism
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 22:30 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old.  Medical history included allergies to Penicillin, Cipro. There were no concomitant medications. On 14May2021 18:00 (as reported), the patient experienced Sleepwalking for 6 hours straight. Hallucinations. Severe sweating, heart racing, hot flash. The events were recovered without treatment. The patient was not COVID prior vaccination and hasn't been tested post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Haematemesis, Illness
Clinical narrative: when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dysphagia, Headache
Clinical narrative: sever sore throat; difficult to swallow; headache; chills; sweats; light head/woozy; fever 100.7--101.0; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 16:30 at single dose in left arm (at the age of 68-year-old) for COVID-19 immunization. Medical history was none. He had no Known allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), simvastatin and metoprolol. The patient did not receive other vaccine in four weeks. On 27Apr2021 16:30, the patient experienced headache, fever 100.7-101.0, chills, sweats, light head, woozy, severe sore throat, difficult to swallow, lasted up to 6 days slowly got better each day. His primary is concerned about and so was he about the throat, he prescribed an epipen for him to have. He had many reservations about his 2nd shot. He had lived a very healthy life very rarely being sick. No treatment was received for the events. The outcome of all events was resolved on 03May2021.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pyrexia
Clinical narrative: sever sore throat; difficult to swallow; headache; chills; sweats; light head/woozy; fever 100.7--101.0; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 16:30 at single dose in left arm (at the age of 68-year-old) for COVID-19 immunization. Medical history was none. He had no Known allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), simvastatin and metoprolol. The patient did not receive other vaccine in four weeks. On 27Apr2021 16:30, the patient experienced headache, fever 100.7-101.0, chills, sweats, light head, woozy, severe sore throat, difficult to swallow, lasted up to 6 days slowly got better each day. His primary is concerned about and so was he about the throat, he prescribed an epipen for him to have. He had many reservations about his 2nd shot. He had lived a very healthy life very rarely being sick. No treatment was received for the events. The outcome of all events was resolved on 03May2021.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery dissection, Computerised tomogram neck, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: mini stroke (TIA); small carotid dissection in neck artery; This is a spontaneous report from a non-contactable consumer (patient).  A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 01May2021 10:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history included hypertension. The patient had no known allergies. Concomitant medications included lisinopril (LISINOPRIL), amlodipine besilate (AMLODIPINE BESILATE) and lactulose (LIS) all taken for an unspecified indications and therapy dates. On 21May2021 (also reported as 2 weeks after 1st vaccine), the patient went to the emergency room department with a mini stroke (TIA). CT of neck on that same day of 21May2021 showed a small carotid dissection in neck artery. The patient also had nasal swab COVID test on that day with unknown results. It was reported that TIA possibly caused by dissection being blocked for a short time. The patient went 3 days in hospital (since May2021) running test. It was stated that the events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had prescriptions (unspecified medications) and follow up care as treatment. The patient recovered from the events in May2021. The patient then received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 26May2021 16:45 ((Batch/Lot number was not reported) on the left arm.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Specialist consultation
Clinical narrative: swollen Lymph nodes in left neck/clavicle area; This is a spontaneous report from a contactable pharmacist. A 52-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via intramuscular route of administration in the right arm on 01Feb2021 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Medical history included breast cancer (CA) female "13 years post breast CA, chemotherapy and mastectomy". The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 01May2021, the patient developed swollen lymph nodes in left neck/clavicle area. CT scan done (unspecified date in May2021 with unknown results). When visited oncologist for evaluation (unspecified date in May2021), node was negative but the oncologist noted they were seeing this in post -CA patients. He acknowledged it was a bit farther out than usual, the vaccine was a possible reason. The clinical outcome of the swollen lymph nodes in left neck/clavicle area was resolving.  The lot number for the vaccine, 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 to the reported event "swollen Lymph nodes in left neck/clavicle area" cannot be completely excluded based on 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Systemic lupus erythematosus
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 36-year-old female patient received BNT162B2, via an unspecified route of administration in Mar2021 (Batch/Lot number and expiry date were not reported) as 2nd dose, single for COVID-19 immunization. Medical history included migraines (treated with Relpax and Botox) and not tolerating medication, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in Feb2021 for COVID-19 immunisation; eletriptan (RELPAX) and botox, both for migraine. The office manager told the physician about her daughter who got the Pfizer COVID vaccine shots in February and March. She did not have any immediate adverse events. However, in April she started having underlying chest pains for 13 days and her rheumatologist diagnosed her with lupus and said it was caused by the COVID vaccine. The patient has a history of not tolerating medication very well. She also has migraines treated with Relpax and Botox. The outcome of the other events was unknown.  The following information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of lupus and chest pains cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Mood swings, Pharyngeal swelling, Rash, Suicidal ideation
Clinical narrative: suicidal thoughts; allergic reaction; a rash; throat swelling; erratic moods; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 29-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium; bifidobacterium lactis (PROBIOTIC); magnesium, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The allergic reaction included a rash and throat swelling. Psychological/neurological effects included suicidal thoughts and erratic moods. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Doctor's office/urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient received the medication for events. The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Another employee that he works with got fully vaccinated in January, and then got covid a few months later.; Another employee that he works with got fully vaccinated in January, and then got covid a few months later; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another employee that he works with got fully vaccinated in January, and then got Covid a few months later on an unspecified date. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021614562 same drug, different patient/event
Sex: F
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: Pemphigus; This is a spontaneous report from a contactable pharmacist. This reporter reported for 9 patients. A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. The event was assessed as non-serious by the reporter.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of pemphigus cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.c,Linked Report(s) : US-PFIZER INC-2021615628 same reporter and drug, different patient and AE
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Pericarditis
Clinical narrative: episode of pericarditis; episode of pericarditis; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included pericarditis. The patient's concomitant medications were not reported. Patient who had medical history of pericarditis had another episode of pericarditis and was brought to the hospital after receiving the COVID vaccine. He received ketorolac (TORADOL) and was discharged. Outcome of the event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot be fully excluded.   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 RAs, Ethics Committees, and investigators, as appropriate.