chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Sluggishness, Somnolence
Clinical narrative: a little temperature / fever probably; chills; Confused; Caller states she took the Johnson and Johnson originally; Caller states she took the Johnson and Johnson originally; Booster; seizure; got lightheaded/ dizzy; sleepy / Fell asleep; tired; got sick; lethargic; When I got sick fell into fall; Sluggish; This is a spontaneous report from a contactable consumer.  A 52-year-old female consumer reported that she received third dose (booster) of bnt162b2 (COMIRNATY; Batch/Lot Number: FD0818) into left arm on 04Nov2021 at at 2:15  PM (at the age of 52-year-old) as single dose  for covid-19 immunisation. Medical history included  epilepsy diagnosed over 15 years. Concomitant drugs were none. The patient had received Johnson and Johnson vaccine on 15Mar2021 for covid-19 immunisation before the booster dose. The consumer reported that about 20 minutes after the booster vaccine on 04Nov2021, she went down the street to the chiropractor to work on her shoulder that was out of place from a fall previously, so she got vaccine in opposite arm, clarifies in the left arm, when she got there she walked in the door and she got really really lightheaded and so the nurse came and got her and took her to the room and fell against the wall, asked for an ice pack and laid down.  At this time she was very sleepy really quickly and tired, stated she laid down and went straight to sleep. The patient stated that this often happened when she had epileptic episodes, stated she was still aware and very confused at the time. She has been seizure free for 2 years, stated her mom took her home after the appointment on 04Nov2021, stated she was trying to figure out it if this was a breakthrough seizure or if it has anything to do with the shot. Haven't had a seizure in two years. Epilepsy for fifteen years, Focal seizure, she did not have gran mal, Simple complex. She had nocturnal seizures and got regularly monitored. Focal monitoring device. Slide the magnet over the device brewing or anything. Confused, sluggish and lethargic. When she got sick fell into fall. Put some ice and heat on other arm. Nurse just set her there for twenty minutes. Something was going on. Fell asleep.  Called her neurologist and they told her there have not been side effects of seizures with the vaccine.  On 05Nov2021 she felt fine, had a little bit of a temperature and chills, stated she has improved.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Purpura, Rash, SARS-CoV-2 test, Skin discolouration
Clinical narrative: Bleeding form rash site; black and blues; rash over various parts of her body- back, arms, legs, stomach, head, and it has gotten worse; Uncontrollable itching; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ENG6198, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 12Apr2021 at 15:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications received within two weeks were not reported. The patient didn't receive any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8727, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 22Mar2021 at 15:00 (at the age of 57-years-old) for COVID-19 immunisation and experienced rash over various parts of her body- back, arms, legs, stomach, head. On an unspecified date in Apr2021, the patient experienced bleeding form rash site, black and blues, rash over various parts of her body- back, arms, legs, stomach, head and it has gotten worse, and uncontrollable itching. It was reported that it has been 8 months and she still have the rash. She have never had any skin issues in her life. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included cream. The patient has been tested for COVID-19 since the vaccination on 01Sep2021 which included SARS-CoV-2 test via nasal swab with negative result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report based on information received by Pfizer. Contactable other healthcare professionals and a consumer reported that a female patient of an unspecified age 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 immunisation; escitalopram oxalate (LEXAPRO), route of administration, start and stop date, batch/lot number and dose were not reported for major depressive disorder.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient experienced heart palpitations after the Pfizer vaccine. The action taken in response to the event(s) for escitalopram oxalate was unknown. Outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: COVID breakthrough; COVID breakthrough; headache; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at age of 44-years-old as DOSE 2, SINGLE; dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) at age of 44-years-old as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID breakthrough-fevers, chills, headache, loss of smell and taste on 03Nov2021 with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test: Positive on 03Nov2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Dizziness, Fatigue, Metamorphopsia, Migraine
Clinical narrative: Could not see anything in the right-hand side of her vision. That area was concealed by washed out blur.; Ocular Migraine occurred approximately 24 hours after vaccine was administered.; her vision became distorted in both eyes; Migraine; Fatigue; Muscle aches; Dizziness; More trouble than usual focusing her vision; This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 administered in Left Upper Arm on 03Nov2021 (Batch/Lot number was not reported) at 28-year-old as DOSE 1, SINGLE for covid-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the Pregnant at Time of Vaccination. Medical history included Known allergies: Amoxicillin, Dairy Sensitivity, Artificial Fragrance Sensitivity, Many Skincare and Makeup Products. There were no concomitant medications. Ocular Migraine occurred approximately 24 hours after vaccine was administered. Zero history of this, or migraines. While folding laundry, after intimacy and a shower, her vision became distorted in both eyes. She could not see anything in the right-hand side of her vision. That area was concealed by washed out blur. Vision restored itself approximately 20-25 minutes later. Then a migraine set in. Awoke the next day (today) with fatigue, muscle aches and dizziness, with more trouble than usual focusing her vision. Events onset on 04Nov2021 15:00. No Treatment Received. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of event "Could not see anything in the right-hand side of my vision. That area was concealed by washed out blur" was recovered in Nov2021, of "her vision became distorted in both eyes" was recovered in 2021, of other events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ophthalmic migraine, Vision blurred
Clinical narrative: Could not see anything in the right-hand side of her vision. That area was concealed by washed out blur.; Ocular Migraine occurred approximately 24 hours after vaccine was administered.; her vision became distorted in both eyes; Migraine; Fatigue; Muscle aches; Dizziness; More trouble than usual focusing her vision; This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 administered in Left Upper Arm on 03Nov2021 (Batch/Lot number was not reported) at 28-year-old as DOSE 1, SINGLE for covid-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the Pregnant at Time of Vaccination. Medical history included Known allergies: Amoxicillin, Dairy Sensitivity, Artificial Fragrance Sensitivity, Many Skincare and Makeup Products. There were no concomitant medications. Ocular Migraine occurred approximately 24 hours after vaccine was administered. Zero history of this, or migraines. While folding laundry, after intimacy and a shower, her vision became distorted in both eyes. She could not see anything in the right-hand side of her vision. That area was concealed by washed out blur. Vision restored itself approximately 20-25 minutes later. Then a migraine set in. Awoke the next day (today) with fatigue, muscle aches and dizziness, with more trouble than usual focusing her vision. Events onset on 04Nov2021 15:00. No Treatment Received. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of event "Could not see anything in the right-hand side of my vision. That area was concealed by washed out blur" was recovered in Nov2021, of "her vision became distorted in both eyes" was recovered in 2021, of other events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Somnolence
Clinical narrative: Constant fatigue; joint pain; shortness of breath when I try to excersise; Sleeping a minimum of 12-14 hours a day; dose number 1, 25Mar2021, dose number 2, 11Apr2021; This is a spontaneous report from a contactable consumer (patient) reported for himself that:  A 57 years old male patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm right on 11Apr2021 10:00 (Batch/Lot Number: EW0162) as DOSE 2, SINGLE for covid-19 immunisation .Age at vaccination 57 years. Hitorical vaccine included: first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered on 25Mar2021 at 09:00 AM on left arm Lot# ER8730.Medical history included Abdominal aortic aneurysm (AAA)  from 2015 to an unknown date Concomitant medication(s) included labetalol taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; benazepril (BENAZEPRIL) taken for an unspecified indication, start and stop date were not reported; duloxetine (DULOXETINE) taken for an unspecified indication, start and stop date were not reported.  On 01Jul2021 the  patient reported Constant fatigue and joint pain, shortness of breath when I try to exercise. Sleeping a minimum of 12-14 hours a day.The outcome of the event dose number 1, 25Mar2021, dose number 2, 11Apr2021 was unknown. The outcome of the other events was not recovered.Additional information:Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic,No other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, no diagnosis with COVID-19.Since the vaccination, the patient hasn't  been tested for COVID-19  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: increase in the noise level of tinnitus and additional hearing loss; increase in the noise level of tinnitus and additional hearing loss; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 64-years, dose 3 via an unspecified route of administration, administered in arm right on an unspecified date (batch/lot number: EJ1685) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation, in hospital. Medical history included asthma. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at time of vaccination. Concomitant medications included budesonide (PULMICORT); triamcinolone acetonide (NASACORT). The patient historically received BNT162B2 for COVID-19 immunization (at the age of 63-years), first single dose (lot number: FF2587) in right arm on 23Dec2020 and second single dose (lot number: EL1289) in right arm on 13Jan2021. On 04Nov2021, the patient experienced increase in the noise level of tinnitus and additional hearing loss. No treatment received. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Rash, Wheezing
Clinical narrative: swelling of eyes lips; swelling of eyes lips; Rash; itching; Wheezing in lungs; This is a spontaneous report from a contactable other hcp (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: Ff3590, Expiration Date was not reported), via an unspecified route of administration, administered in the left deltoid on 06Nov2021 12:00 (at the age of 47-years-old), as dose 1, single for COVID-19 immunisation. Medical history included chronic dvt and known allergies: Sulfa. Concomitant medication included influenza vaccine taken for immunization on 15Oct2021 as dose number unknown, single. The patient previously took erythromycin and experienced hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced swelling of eyes lips and rash, itching with wheezing in lungs on 06Nov2021 12:45, 45 minutes after vaccination. Events resulted to Doctor or other healthcare professional office/clinic visit and treatment with Diphenhydramine (BENADRYL), steroids, and script for epinephrine (EPIPEN). The outcome of events as recovered with sequalae on an unspecified date (reported as with lasting effects).; Sender's Comments: Based on temporal association and known safety profile, a causal association between BNT162B2 and the reported events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events under same suspect product for 10 patients this is 7th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low oestrogen, can't concentrate/can't focus, can't sleep, depressed, and has anxiety. It was reported that the reporter who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in April, she had low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proved that she has low estrogen. She went on to state that she was aware of 10 people who experienced the similar reactions. When she was requested the date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called  the wrong number because she had received both doses of the Pfizer vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Estrogen: low. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Low estrogen; can't concentrate/can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events under same suspect product for 10 patients this is 7th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low oestrogen, can't concentrate/can't focus, can't sleep, depressed, and has anxiety. It was reported that the reporter who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in April, she had low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proved that she has low estrogen. She went on to state that she was aware of 10 people who experienced the similar reactions. When she was requested the date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called  the wrong number because she had received both doses of the Pfizer vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Estrogen: low. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: F
Vaccine: COVID19, UNK
Symptoms: Emphysema, Immunisation, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Booster; chronic emphysema; oxygen level went low; This is a spontaneous report based on information received by Pfizer from a non-contactable consumer (patient).  The 57-year-old non-pregnant female patient received bnt162b2(Pfizer Covid-19 medication), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA, Expiry Date: Feb2023), via an unspecified route of administration from 2020 and ongoing, at unspecified dose for an unspecified indication.  The patient medical history and concomitant medications were not reported. Historical vaccine included dose 1 and dose 2 both BNT162B2 on an unspecified date for COVID-19 immunization.  The patient experienced chronic emphysema and oxygen level went low on 01Oct2021 which led to hospitalization. Patient was on a BIPAP machine in the hospital. Patient went in 01Oct2021 and was released 08Oct2021.Patient has been on fluticasone furoate, umeclidinium bromide, vilanterol trifenatate for a year. Patient received the pfizer booster shot and she felt like that had something to do with it. The action taken in response to the events for fluticasone furoate, umeclidinium bromide, vilanterol trifenatate was unknown. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration on 13Apr2021 (at the age of 50-year-old) as a dose 2, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration on 23Mar2021 (at the age of 50-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not pregnant at the time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 07Nov2021, the patient was tested positive for COVID-19. Hospitalization prolonged was reported as no. Treatment was not received for the events. On 07Nov2021, the patient underwent lab tests and procedures which included Bionix Now (SARS-CoV-2 test), resulted as positive, Nasal swab. The device date was on 08Nov2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report from a contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EL3247, Expiry date: unknown) (age at the time of vaccination was 44 years), via intramuscular administered in Arm Left on 15Feb2021 at 13:00 as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EL3247, Expiry date: unknown) (age at the time of vaccination was 44 years), via intramuscular administered in Arm Left on 27Jan2021 at 09:30 as dose 1, single for COVID-19 immunization. The patient's medical history included asthma. No known allergies.The patient's concomitant medication included Lexapro (escitalopram oxalate). The patient received vaccine at workplace clinic. The patient did not take any other vaccine in four weeks prior COVID-19 vaccine. She was not diagnosed with COVID prior vaccination and tested positive with COVID post vaccination. On 02Nov2021 at 07:00, the patient experienced extreme body aches, mild fever (101.5), extreme headache, congestion, tired, cough, loss of taste, loss of smell and dizziness. The patient underwent lab tests and procedures, which included RT-PCR nasal swab: positive on 06Nov2021 and body temperature: 101.5 on 02Nov2021. No covid prior vaccination.  Treatment received no for the events. The outcome of the event was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypersensitivity, Musculoskeletal chest pain, Urticaria
Clinical narrative: covered in hives; having an allergic reaction; my chest is hurting; my rib are hurting; This is a spontaneous report from a contactable consumer (patient)   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Nov2021 (Batch/Lot number was not reported) as (dose # unknown) single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced covered in hives on Nov2021, my chest is hurting on Nov2021, having an allergic reaction on Nov2021, my rib are hurting on Nov2021. The events outcome was unknown.   Additional Context: Concern: Consumer stated, "I got the Pfizer vaccine two days ago and I didn't recognize any of the ingredients as in allergy but to be honest with you I don't know those big words. So and now I am covered in hives and as long as I take Benadryl (treatment) they seem to go away but I am not really sure if maybe I should go to a doctor if this is normal like this is a common symptoms maybe I am having an allergic reaction and my chest is hurting and my rib are hurting but I know that can be a side effect. I just want to make sure if I need to go to the hospital like if I should go or this is this can be normal a side effect with the vaccine." When requested to probe further: Consumer stated, "I am okay. I am trying to figure out if I should go to the emergency room. So, I am kind of in a rush." Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited Information available over the call.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Erythema, Pain, Pyrexia
Clinical narrative: there is still a large, light purplish discolored patch at injection site; there is still a large, light purplish discolored patch at injection site; raised temperature; Pain radiated into underarm and left side of chest; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; vaccine with 2" x 2" large hard lump in center; Pain radiated into underarm and left side of chest; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in the left arm on 25Oct2021 13:30 (at the age of 65 years old) as dose 3 (booster), single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. Medical history included gallstones from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 11:00 (at the age of 65 years old) as dose 1, single and bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 11:00 (at the age of 65 years old) as dose 2, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Oct2021 08:00, the patient experienced developed 6 by 4 painful, raised, hot, red welt at site of vaccine, vaccine with 2" x 2" large hard lump in centre, pain radiated into underarm and left side of chest. On Nov2021, patient had there is still a large, light purplish discoloured patch at injection site, there is still a large, light purplish discoloured patch at injection site, raised temperature. The patient underwent lab tests and procedures which included body temperature resulted slightly raised temperature on 26Oct2021. No treatment was received. All the events resulted in physician room visit. The clinical outcome of the events was reported as not recovered.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site discolouration, Vaccination site mass, Vaccination site pain, Vaccination site reaction
Clinical narrative: there is still a large, light purplish discolored patch at injection site; there is still a large, light purplish discolored patch at injection site; raised temperature; Pain radiated into underarm and left side of chest; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; vaccine with 2" x 2" large hard lump in center; Pain radiated into underarm and left side of chest; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in the left arm on 25Oct2021 13:30 (at the age of 65 years old) as dose 3 (booster), single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. Medical history included gallstones from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 11:00 (at the age of 65 years old) as dose 1, single and bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 11:00 (at the age of 65 years old) as dose 2, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Oct2021 08:00, the patient experienced developed 6 by 4 painful, raised, hot, red welt at site of vaccine, vaccine with 2" x 2" large hard lump in centre, pain radiated into underarm and left side of chest. On Nov2021, patient had there is still a large, light purplish discoloured patch at injection site, there is still a large, light purplish discoloured patch at injection site, raised temperature. The patient underwent lab tests and procedures which included body temperature resulted slightly raised temperature on 26Oct2021. No treatment was received. All the events resulted in physician room visit. The clinical outcome of the events was reported as not recovered.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: there is still a large, light purplish discolored patch at injection site; there is still a large, light purplish discolored patch at injection site; raised temperature; Pain radiated into underarm and left side of chest; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; developed 6" by 4" painful, raised, hot, red welt at site of vaccine; vaccine with 2" x 2" large hard lump in center; Pain radiated into underarm and left side of chest; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration, administered in the left arm on 25Oct2021 13:30 (at the age of 65 years old) as dose 3 (booster), single for COVID-19 immunisation at pharmacy or drug store. The patient was not pregnant at the time of vaccination. Medical history included gallstones from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 11:00 (at the age of 65 years old) as dose 1, single and bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 11:00 (at the age of 65 years old) as dose 2, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Oct2021 08:00, the patient experienced developed 6 by 4 painful, raised, hot, red welt at site of vaccine, vaccine with 2" x 2" large hard lump in centre, pain radiated into underarm and left side of chest. On Nov2021, patient had there is still a large, light purplish discoloured patch at injection site, there is still a large, light purplish discoloured patch at injection site, raised temperature. The patient underwent lab tests and procedures which included body temperature resulted slightly raised temperature on 26Oct2021. No treatment was received. All the events resulted in physician room visit. The clinical outcome of the events was reported as not recovered.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, Vaccination failure
Clinical narrative: Breakthrough case.  Postivie for COVID on 09Nov2021; Breakthrough case.  Postivie for COVID on 09Nov2021; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0217) via an unspecified route of administration, administered in arm left on 03Nov2021 (age at vaccination: 49-year-old) as dose 3 (booster), single and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number:EL3247) via an unspecified route of administration, administered in arm left on 16Feb2021 as dose 2, single and first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 26Jan2021 as dose 2, single all three doses taken for COVID-19 immunisation. Facility type vaccine was Workplace clinic. The patient took no other vaccine in four weeks, had no covid prior vaccination, was covid tested post vaccination, had no known allergies. There was no other medical history. The patient concomitant medications were not reported and no other medications in two weeks. On 08Nov2021, the patient experienced "Breakthrough case. Postivie for COVID on 09Nov2021". Adverse event resulted in Doctor or other healthcare Professional office/clinic visit. The patient underwent lab test and procedure which included PCR/ Nasal swab: Positive on 08Nov2021. No treatment was taken for adverse event. Outcome of event "Breakthrough case. Postivie for COVID on 09Nov2021" was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Cerebrovascular accident, Loss of consciousness, Muscular weakness, Speech disorder
Clinical narrative: Passed out; stroke; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 37-year-old female patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 (at the age of 37-year-old) as dose 2, single for covid-19 immunization. Patient's relevant medical history included ongoing endometriosis, diagnosed since she was about 21 years old. Historical vaccine included, patient previously received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 37-year-old) as dose 1, single for covid-19 immunization. On 27May2021 patient experienced Passed out, On unspecified date in Jun2021 stroke, her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected. It was reported that patient had a stroke and states she did not have anything wrong with her, states she was good prior to the vaccination. Caller states 5 months ago (captured as Jun2021) had the stroke, still recovering. Caller states her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected, states it is coming along but it was a bad stroke. Caller has difficulty coming up with some words and dates and numbers during the call. Reporter clarified that she was admitted to the hospital on 27May2021, stated she was in her house and she passed out. Stated her boss called her and she did not answer so her boss called her mom and her sister and when her sister called her and she did not answer, she came over to the callers house. Stated when they kicked the door in, they realized she was passed out and they found her that way and called the ambulance. Caller stated she was in the hospital for 16 days (till 12Jun2021), exact dates unknown, stated she went to rehab for 5 weeks after that, states she was home at the time of this report (reported as now) and she was continuing to recover and improve. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 PCR test; Positive COVID-19 PCR test; This is a spontaneous report from a contactable consumer or other non-health care professional. A 78-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6202) via intramuscularly, administered in arm left (reported as left arm) on 03Mar2021 (at the age of 77-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EM9809) via intramuscularly, administered in arm left (reported as left arm) on 10Feb2021 (at the age of 77-year-old) as dose 1, single both for covid-19 immunization administered in public health clinic/facility. Patient's relevant medical history included lung disorder (reported as ling) from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was tested for covid-19. Patient's concomitant medications included inhaler (unspecified) for an unspecified indication. The patient did not receive any other vaccine in four weeks. On 08Nov2021, patient had positive COVID-19 PCR test (captured as vaccination failure and asymptomatic covid-19) (medically significant). The patient underwent lab tests and procedures which included COVID-19 PCR test (sars-cov-2 test) resulted as positive (nasal swab) on 08Nov2021. It was unknown if patient received any treatment for adverse event. Outcome of the event COVID-19 PCR test (asymptomatic covid-19) was not recovered and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dry eye, Eye discharge, Feeling abnormal, Impaired driving ability
Clinical narrative: vaccine 1- got COVID; eyes are extremely dry; crackling noise in the ears; extreme brain fog; sleeping 12 hours+ per day; eye sight is blurry; There are days that I cannot drive; mucus or something in them every day; I cannot see well; can barely wake up; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EJ1686, age at the time of vaccination: 47-year-old), via an unspecified route of administration, in arm right on 05Jan2021 as dose 1, single for covid-19 immunisation. Medical history celiac, migraines, GERD, mixed connective tissue disease. Concomitant medications included omeprazole (PRILOSEC); fluticasone propionate (FLONASE); norgestimate; ethinyl estradiol all for unknown indication since an unknown date. 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. On 05Jan2021 at 20:00 the patient got COVID after the first vaccine, nothing ever went back to normal but had body aches, headaches, fever, fatigue, joint pain, no smell or taste, shortness of breath, extreme fatigue, sleeping 12 hours+ per day, eye sight was blurry, eyes were extremely dry, with mucus or something in them every day. Also have crackling noise in the ears all the time super annoying. There were days that she cannot drive because she cannot see well. She can sleep and do sleep during all hours when she was not at work, can barely wake up for work in the morning with extreme brain fog all day. Therapeutic measures were taken as a result the events with Tylenol, ointment for rash, xiidra and steroid eye. No Hospitalization Prolongation was present. The adverse event resulted doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid test as positive on an unknown date in 2021. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sleep disorder, Somnolence, Tinnitus, Vision blurred
Clinical narrative: vaccine 1- got COVID; eyes are extremely dry; crackling noise in the ears; extreme brain fog; sleeping 12 hours+ per day; eye sight is blurry; There are days that I cannot drive; mucus or something in them every day; I cannot see well; can barely wake up; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EJ1686, age at the time of vaccination: 47-year-old), via an unspecified route of administration, in arm right on 05Jan2021 as dose 1, single for covid-19 immunisation. Medical history celiac, migraines, GERD, mixed connective tissue disease. Concomitant medications included omeprazole (PRILOSEC); fluticasone propionate (FLONASE); norgestimate; ethinyl estradiol all for unknown indication since an unknown date. 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. On 05Jan2021 at 20:00 the patient got COVID after the first vaccine, nothing ever went back to normal but had body aches, headaches, fever, fatigue, joint pain, no smell or taste, shortness of breath, extreme fatigue, sleeping 12 hours+ per day, eye sight was blurry, eyes were extremely dry, with mucus or something in them every day. Also have crackling noise in the ears all the time super annoying. There were days that she cannot drive because she cannot see well. She can sleep and do sleep during all hours when she was not at work, can barely wake up for work in the morning with extreme brain fog all day. Therapeutic measures were taken as a result the events with Tylenol, ointment for rash, xiidra and steroid eye. No Hospitalization Prolongation was present. The adverse event resulted doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid test as positive on an unknown date in 2021. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: vaccine 1- got COVID; eyes are extremely dry; crackling noise in the ears; extreme brain fog; sleeping 12 hours+ per day; eye sight is blurry; There are days that I cannot drive; mucus or something in them every day; I cannot see well; can barely wake up; This is a spontaneous report from a contactable Other HCP (patient).  A 48-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EJ1686, age at the time of vaccination: 47-year-old), via an unspecified route of administration, in arm right on 05Jan2021 as dose 1, single for covid-19 immunisation. Medical history celiac, migraines, GERD, mixed connective tissue disease. Concomitant medications included omeprazole (PRILOSEC); fluticasone propionate (FLONASE); norgestimate; ethinyl estradiol all for unknown indication since an unknown date. 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. On 05Jan2021 at 20:00 the patient got COVID after the first vaccine, nothing ever went back to normal but had body aches, headaches, fever, fatigue, joint pain, no smell or taste, shortness of breath, extreme fatigue, sleeping 12 hours+ per day, eye sight was blurry, eyes were extremely dry, with mucus or something in them every day. Also have crackling noise in the ears all the time super annoying. There were days that she cannot drive because she cannot see well. She can sleep and do sleep during all hours when she was not at work, can barely wake up for work in the morning with extreme brain fog all day. Therapeutic measures were taken as a result the events with Tylenol, ointment for rash, xiidra and steroid eye. No Hospitalization Prolongation was present. The adverse event resulted doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid test as positive on an unknown date in 2021. The outcome of the events was not recovered.