chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: Really bad case of cellulitis; The lymph nodes in her legs blew up really bad; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in arm right on 03Feb2021 (at the age of 73-years-old) at mid day (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility type was hospital and vaccine was not administered at other facility. Medical history included ongoing lymphoedema and cellulitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccines included Flu vaccine years ago, and last Flu vaccine on 15Dec2020 taken for immunization and had a cold (she tried to get good sleep, 8 hours of sleep at night and to eat well and take care of herself when was getting her vaccines), Shingrix vaccine in Aug2020 and Oct2020 taken for immunization and reaction was not reported, if any. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: Vaccine Name: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: None. She's calling about the Covid 19 vaccine. She reports she does have multiple medical problems. Patient reported after she received her Covid 19 vaccines she had a really bad case of cellulitis and the lymph nodes in her legs blew up really bad. The problem started with the first Covid 19 vaccine. She did get an antibiotic from her doctor but she doesn't remember what the name of it is and she did not remember what day she went to see the doctor. Maybe sometime in Mar2021 or Apr2021. She didn't make the connection with the Covid 19 vaccine until she saw that other people were reporting it. She did have a history of Lymphedema and cellulitis but her legs have never blown up like that. Her legs did get better but the swelling came and go. She was using Ace bandages on her legs. The events resulted in Physician Office Visit and not resulted in Emergency Room visit. Therapeutic measures were taken in response to the events. Investigation assessment/ relevant tests were none. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Condition aggravated, Lymphadenopathy, Peripheral swelling, Skin discolouration
Clinical narrative: cellulitis; the lymph nodes in her legs blew up really bad; Her problems got worse after the second dose.; a pink color showed up on her legs at her ankles; legs blew up; This is a spontaneous report from a contactable consumer who is reported for herself that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EM6198 and Expiry date was not reported) dose 2 via an unspecified route of administration in Right Arm on 24Feb2021 as dose 2, single for covid-19 immunisation. and the patient also received BNT162B2 (Solution for injection, Lot number: EM9810 and Expiry date: 30Jun2021) via an unspecified route of administration in right arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history included ongoing lymphoedema, cellulitis from an unknown date and unknown if ongoing. When probing if she ever had an adverse reaction to any other vaccine, she reported that she is susceptible to getting a cold virus with the flu vaccine, years ago she received a flu vaccine. She had her last flu vaccine on 15Dec2020, and she spaces her vaccines out. She had the Shingrix vaccines in Aug2020 and Oct2020. The patient's concomitant medications were not reported. On an unspecified date she reports she does have multiple medical problems. After she received her Covid 19 vaccines she had a really bad case of cellulitis and the lymph nodes in her legs blew up really bad. The problem started with the first Covid 19 vaccine but after the second Covid 19 vaccine it blew up really bad. Meaning, the cellulitis in her legs and the lymph nodes swelling in her legs got worse. She started to notice that a pink color showed up on her legs at her ankles then her legs blew up with the second Covid 19 vaccine. She did get an antibiotic from her doctor, but she does not remember what the name of it is and she does not remember what day she went to see the doctor, maybe sometime in Mar2021 or Apr2021. She did not make the connection with the Covid 19 vaccine until she saw that other people were reporting it. She does have a history of Lymphedema and cellulitis, but her legs have never blown up like that. Her legs did get better, but the swelling comes and goes now. She is using Ace bandages on her legs. The patient visited physician office for the events, and she did not visit emergency room. The patient received treatment for the events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (06Jul2021): Follow-up attempts are completed. No further information is expected
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Golf ball to baseball size lump under his left armpit; Soreness underneath his left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196), dose 1 via unspecified route of administration, administered in left arm (left shoulder) on 30Jun2021 (at 10:45AM) as single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 01Jul2021, the patient experienced soreness underneath his left arm. On 02Jul2021 (late afternoon the day after the first injection), the patient experienced golf ball to baseball size lump under his left armpit. When he just got into the shower a little bit ago he discovered the source of the soreness. There is a golf ball to baseball size lump under his left armpit, the same arm he received the Covid 19 vaccine. Patient has not seen his primary care doctor or gone to the emergency room. He noticed the soreness in his left armpit late yesterday afternoon, 01Jul2021. When he got into the shower today, 02Jul2021 and lifted his arm, he thought holy cow, there's a lump. When probing for reason why he decided to get the Covid 19 vaccine he reports it was work related. He either had to wear a mask or get the Covid 19 vaccine. He adds if this persists for another day or two he was going to see his primary care doctor. He had a Covid 19 test done on the 23Jun2021 that came back negative. When probing adverse events with any other vaccine he reports soreness or stiffness. He has served in the military and has had multiple vaccinations. He doesn't recall any vaccine specifically that caused stiffness or soreness. He was asking if there are any other recommendations on how to get rid of the lump under his armpit. The outcome of all the events was not recovered.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Gout, Pain, Pain in extremity
Clinical narrative: Arthritis; I was still in some pain; The pain then went to my big toe (very severe); I still have some pain in my ankle; I think it was gout; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Jun2021 (at the age of 38 years-old) as dose 2, single for covid-19 immunisation. 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. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), on unspecified date in 2021 (at the age of 38-yesr-old) via unknown route for COVID-19 immunisation and experienced arthralgia. Reporter stated between vaccine 1st and 2nd, On 27Jun2021, patient started feeling pain in his right ankle, which turned into severe pain. Patient went to urgent care 2 days after his second vaccine. First, they told him it was arthritis. He went back 12 days later because he was still in some pain. They ran no further tests. The pain then went to his big toe (very severe) which lasted about 2 weeks, but he still have some pain in his ankle. Patinet think it was gout, possible brought on by the vaccine. Patient visited Emergency room/department or urgent care. Treatment was received for the events as Steroids. The outcome of the events was reported as recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unknown date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced bronchitis when patient received COVID-19 vaccine. The patient was prescribed xeljanz 5mg. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Chills; he started throwing up; wants to receive the Johnson and Johnson vaccine instead; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter (patient's wife) reported for a male patient (reporter's husband) that:  Is the Reporter a Healthcare Professional (HCP)? Unknown Is the reporter's contact information available to you or a sub-contracted party? Yes Is the reporter the prescribing HCP? Unknown  Suspect Product(s): Covid-19 Vaccine  Verbatim and Event Description:  No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Swapped from program. Caller husband received first dose from Pfizer and had lots of side effects some which are Chills, he started throwing up and she stated that he almost got all the side effects that were listed on the Fact Sheet. He was too concerned to receive the second dose from Pfizer and wants to receive the Johnson and Johnson vaccine instead. They wanted to know what are our recommendations on that. Read ISI and transferred to PMI.   Medical Information (MI): Where any medical questions adressed by this program forwarded/referred to medical information? Yes: Customer and/or medical inquiry forwarded or referred to MI  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Dyspnoea, Oxygen saturation increased, SARS-CoV-2 test
Clinical narrative: Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); This is a spontaneous report from a contactable nurse. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route, administered in right arm on 17Jun2021 16:00 (age at vaccination: 65 years) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included muscular sclerosis, myasthenia gravis, diabetes mellitus, multiple sclerosis and covid-19. The patient had covid prior vaccination. There were no known allergies. On 18Jun2021, the patient went into unexpected and sudden cardiac arrest and died, on 18Jun2021 22:00, prior to cardiac arrest patient was short of breath and was using increased oxygen (5l to maintain at 92%). The patient was attempted for resuscitation via CPR and EMS. On an unknown date, the patient underwent sars-cov-2 test which was positive. The patient received other medications received within 2 weeks of vaccination. The patient has not been tested for covid-19 since the vaccination. The patient died on 18Jun2021 due to cardiac arrest. An autopsy was not performed. The device timestamp was 04Jul2021.  Information on Lot/Batch information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, cardiac arrest, Dyspnea, Death cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: "I came down with shingles after I  took my COVID-19 vaccine."; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had received tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient came down with shingles after she took Covid-19 vaccine. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: non-aural vertigo; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. On an unspecified date, approximately 2 months after receiving the second dose of Pfizer COVID 19 vaccine, the patient experienced non-aural vertigo. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: Granuloma annulare; I just had rash; This is a spontaneous report from a contactable consumer (patient). An unspecified age female patient received an unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Expiration date: Unknown) as single dose for COVID-19 immunization. Medication history and concomitant medication were not reported. On an unspecified date, the patient experienced granuloma annulare and rash. Caller was asked if there have been any reports with the Pfizer-BioNTech COVID-19 Vaccine of a rash called Granuloma annulare. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Emotional disorder, Feeling abnormal
Clinical narrative: vomitted / threw up; felt weak; couldn't really walk; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; clammy; This is very abnormal for him; ill; rash; hives; sore throat; little bumps, like pustules on the one side of his body/water bubbles; looks like shingles; upset and stressed out; This is a spontaneous report form a contactable consumer (patient's mother). A 17-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on 03Jul2021 at 22:00 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and the reporter stated her received his first dose of the Pfizer vaccine in a different country. On 04Jul2021, after four hours, the patient woke at 2:00 am and vomitted, felt weak, couldn't really walk, had severe muscle pain with nausea and dizziness, he threw up and clammy. When he woke up in the morning he noticed little bumps, like pustules on the one side of his body, they looked at pictures in the internet and it looks like shingles. The patient got rash, hives, water bubbles over his chest and sore throat. The patient was very upset and stressed out over this, which the reporter knows was probably not helping and the reporter was not with him. The reporter stated that this was very abnormal for him because he was an athlete. The reporter was familiar territory for him, he had never been that ill and he just want to know if this was a common side effect or if it was the side effect from Pfizer that can expect. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Herpes zoster, Illness, Myalgia, Nausea
Clinical narrative: vomitted / threw up; felt weak; couldn't really walk; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; clammy; This is very abnormal for him; ill; rash; hives; sore throat; little bumps, like pustules on the one side of his body/water bubbles; looks like shingles; upset and stressed out; This is a spontaneous report form a contactable consumer (patient's mother). A 17-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on 03Jul2021 at 22:00 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and the reporter stated her received his first dose of the Pfizer vaccine in a different country. On 04Jul2021, after four hours, the patient woke at 2:00 am and vomitted, felt weak, couldn't really walk, had severe muscle pain with nausea and dizziness, he threw up and clammy. When he woke up in the morning he noticed little bumps, like pustules on the one side of his body, they looked at pictures in the internet and it looks like shingles. The patient got rash, hives, water bubbles over his chest and sore throat. The patient was very upset and stressed out over this, which the reporter knows was probably not helping and the reporter was not with him. The reporter stated that this was very abnormal for him because he was an athlete. The reporter was familiar territory for him, he had never been that ill and he just want to know if this was a common side effect or if it was the side effect from Pfizer that can expect. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pustule, Rash, Urticaria, Vomiting
Clinical narrative: vomitted / threw up; felt weak; couldn't really walk; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; clammy; This is very abnormal for him; ill; rash; hives; sore throat; little bumps, like pustules on the one side of his body/water bubbles; looks like shingles; upset and stressed out; This is a spontaneous report form a contactable consumer (patient's mother). A 17-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on 03Jul2021 at 22:00 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and the reporter stated her received his first dose of the Pfizer vaccine in a different country. On 04Jul2021, after four hours, the patient woke at 2:00 am and vomitted, felt weak, couldn't really walk, had severe muscle pain with nausea and dizziness, he threw up and clammy. When he woke up in the morning he noticed little bumps, like pustules on the one side of his body, they looked at pictures in the internet and it looks like shingles. The patient got rash, hives, water bubbles over his chest and sore throat. The patient was very upset and stressed out over this, which the reporter knows was probably not helping and the reporter was not with him. The reporter stated that this was very abnormal for him because he was an athlete. The reporter was familiar territory for him, he had never been that ill and he just want to know if this was a common side effect or if it was the side effect from Pfizer that can expect. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematoma, Haemorrhage subcutaneous, Limb discomfort, Rash macular
Clinical narrative: got tired; On 01Jul I got one the size of a silver dollar (hematoma).  It does not hurt and I did not bump ag; have been getting these like blood bleed under my skin on my arm; blood bleeds under his skin on his arm; began getting red spots (like a blood spot) on my arm.  On July 1st I got one the size of a silver dollar (hematoma).  It does not hurt and I did not bump ag; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 (at the age of 64 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EW0153) as single dose for COVID-19 immunisation. It was reported that after receiving the Pfizer Covid vaccine the patient on 13May2021, the patient began getting red spots (like a blood spot) on arm. On 01Jul2021 he got one the size of a silver dollar (hematoma). It did not hurt and did not bump against anything. He would like to know if this a side effect of the Covid vaccine. Have others reported this symptom, How many? The patient was not on any blood thinners and a very healthy adult male. He has become large, blood bleeds under his skin on his arm; this has happened 4 times now. It was reported that last Thursday he couldn't go to his work, got tired. The patient was a very healthy old man and ever since he got the vaccine, he started to have this, under the skin bleed and spots, red spots and bleed on arms. The adverse event resulted in Doctor or other healthcare professional office or clinic visit on 12Jul2021 and received treatment. The outcome of the events was not recovered and fatigue was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: he experienced tinnitus or ringing in his ears; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for her son.  A 32-year-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration, on an unspecified date (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported that after taking the vaccine, the patient experienced tinnitus or ringing in his ears. After that, he refused to take the 2nd dose. 65 days have passed already. The reporter wanted to know if her son can still take the 2nd dose or does he have to repeat all over. The outcome of the event was reported as unknown.  Information regarding the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: after her first dose of the Pfizer covid vaccine about 30 min later she felt nauseas and felt like she was going to pass out; after her first dose of the Pfizer covid vaccine about 30 min later she felt nauseas and felt like she was going to pass out; This is a spontaneous report from a contactable consumer (patient) from a Regulatory Authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patients's medical history and concomitant medications were not reported. The patient experienced after her first dose of the pfizer covid vaccine about 30 min later she felt nauseas and felt like she was going to pass out on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Migraine with aura, Mucosal hypertrophy
Clinical narrative: Migraine w/ Aura; mucosal thickening; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for 72-year-old female consumer patient that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265, Expiry Date: Unknown) via intramuscular on 01Feb2021 (at the 72 years of age) as dose 1, single for COVID-19 immunization. Medical history included hypercholesterolaemia from 03Dec2010 and ongoing. Concomitant medications included oral ezetimibe, simvastatin (10-4mg) taken for hypercholesterolaemia from 18Nov2010 and ongoing; oral eicosapentaenoic acid ethyl ester (VASCEPA) 1g taken for hypercholesterolaemia from 03Dec2020 and ongoing; oral nadolol (NADOLOL) 80mg taken for arrhythmia from 29Feb2012 and ongoing; oral sertraline hydrochloride (ZOLOFT P) 50mg taken for anxiety from 19Apr2021 and ongoing; oral escitalopram oxalate (LEXAPRO) 10mg taken for anxiety from 22Mar2021 to 19Apr2021 (Discontinued Lexapro due to he felt sick to his stomach). The vaccination facility type was community event center and not military facility. Patient had loud Pfizer vaccines back in Feb2021. 1st dose was 01Feb2021 and 2nd was 22Feb2021. Patient did have an MRI Brain u1 and u10 contrast 3 days prior to first shot due to Migraine w/aura and also experienced mucosal thickening In Feb2021. MRI was normal except for some white spots and mucosal thickening. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer-sponsored program.   A male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 30Jun2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had his 1st dose of Pfizer Covid 19 Vaccine (30Jun2021) and 2nd dose will be on (21Jul2021) it's just that after having the 1st dose (withheld) was admitted at the hospital and experienced AFib - Atrial Fibrillation so (Withheld) wanted to get information about the reactions of the Vaccine. Outcome of the events was unknown. Information on Lot/Batch information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Orthostatic hypotension, Pain in extremity
Clinical narrative: Chronic Orthostatic Hypotension; Chronic Pain in the  Arm that got the shot still; Dizziness; Cannot walk without support and fall to my knees to prevent falling; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 12:00 (at the age of 79-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included seizure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included midodrine; levetiracetam; doxazosin; finasteride, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right in Feb2021 at 12.00 (at the age of 79-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Since 15Apr2021, 12:00 PM, the patient experienced chronic orthostatic hypotension, chronic pain in the arm that got the shot still, dizziness, cannot walk without support and fall to my knees to prevent falling. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hosp, Disability or permanent damage. The patient was hospitalized for 10 days. The patient received treatment for AE, adjusted medications. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I had a terrible experience w/the pharmacist who didn't make vaccinating a teenager very comforting; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose for Covid-19 immunization. The patient had a terrible experience w/the pharmacist who didn't make vaccinating a teenager very comforting on an unspecified date. So, I question the entire thing. The outcome of event was unknown.  Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lost lot of hair; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179), via an unspecified route of administration on arm right on 24May2021 10:15 (age at vaccination: 71 years) at single dose for COVID-19 immunisation. The patient medical history included ongoing CPRD since May1972. Family medical history was reported as unrelated vintage. The patient Concomitant medications included JANSSEN COVID-19 VACCINE taken for virus from an unspecified date and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) taken for virus from an unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179), via an unspecified route of administration on arm right on 03May2021 10:15 at single dose for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced lost lot of hair (not life threatning). Therapeutic measures were taken and treatment included antibiotics. The outcome of the events was not recovered.  The reporter considered the events as not serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Headache, Menopause
Clinical narrative: menopause symptoms; A throbbing headache; her brain is not working properly; This is a spontaneous report from a Pfizer sponsored program, via a Non-contactable consumer (patient, self-reported).  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included estrogen replacement therapy. Concomitant medications were not reported. The patient reported that she received the Covid-19 vaccine 9 days ago. It had completely interfered with her estrogen replacement therapy and she was experienced menopause symptoms, a throbbing headache and her brain was not working properly on an unspecified date. The patient wanted to know how long did this last and why weren't we telling people about this. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for himself that a 47-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in left arm on 20Jan2021 (at the age of 47 year sold) as single dose for COVID-19 immunisation. Medical history included High cholesterol. No known allergies reported. Concomitant medication included rosuvastatin calcium (CRESTOR) at 40 mg, the patient received within 2 weeks of vaccination. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. On 05Jul2021 at 11:00 AM, the patient tested positive to COVID-19. The patient reported that he knows that the vaccine is not 100%, but research at this time is very important. The adverse event result in visit to emergency room or department or urgent care. Treatment was received for the adverse event include 2 bags of fluids, vitamin b, c, d, in injection. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: positive on 05Jul2021. Therapeutic measures were taken as a result of the events. The report was assessed as serious. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives. Patient treated with zyrtec and benadryl; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 06Jun2021 (at the age of 12-years-old) as second dose, single for COVID-19 immunization. Medical history was reported as none. There were no known allergies reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 16May2021 (at the age of 12-years-old) for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021, the patient experienced hives. Patient was treated with Zyrtec and Benadryl. The outcome of the event was recovered on an unspecified date in Jun2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alcoholic psychosis
Clinical narrative: Alcoholic hallucinations; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for a male patient (reporter's husband).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and Expiry Date were unknown), via an unspecified route of administration, on an unknown date in 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient experienced Alcoholic hallucinations and hospitalised. The reporter stated that her husband got hospitalized in up until now, no idea yet when he will be released from the hospital. Now, the main concern here is that 07Jul2021 would be the second dose (later clarified as Covid19 vaccine) of her husband. Her husband might not get the second dose on time." The seriousness of event alcoholic hallucination was reported as hospitalization. The outcome of the event was not resolved.  Further probing was not done. Hence, limited information available.  Information related to batch/Lot no. was requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, a contactable female consumer (patient) reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, Apr2021 exactly 1 week after the day of vaccination, she tested positive from COVID-19 virus and asked how long she could wait to take the 2nd dose, is it 60 days or 90 days. The clinical outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Back pain, Chest pain, Feeling hot
Clinical narrative: pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of the vaccine reddened an area of my arm; it got hot; back ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 28Jun2021 16:30 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on 07Jun2021 10:30 (at the age of 24-year-old) at dose 1, single for covid-19 immunisation and experienced pain in the arm that was bearable. 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported events: 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. second dose that patient received on 28Jun2021 at 4:30 pm patient started a pain in patient left arm around 2 hours after the vaccine, after 12 hours after the vaccine patient felt weak, patient left arm hurt. patient left armpit started to hurt and patient took analgesic which helped patient for 8 hours. After this, patient back and both armpits began to ache, but being stronger on the right, but that pain moved to the chest subjecting pressure for about 2-3 min. This on the night of 29Jun2021 to whatever it takes patient another analgesic. Early on 30Jun2021, patient left arm and armpit continued to hurt but patient back and left armpit no longer that night (8:00 pm) patient left arm 3cm below the application of the vaccine an area of patient arm became red for 2 nights and warmed up. Patient already fine. Patient received treatment with analgesic for adverse events. Outcome of the events was resolved on an unspecified date in 2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of the vaccine reddened an area of my arm; it got hot; back ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 28Jun2021 16:30 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on 07Jun2021 10:30 (at the age of 24-year-old) at dose 1, single for covid-19 immunisation and experienced pain in the arm that was bearable. 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported events: 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. second dose that patient received on 28Jun2021 at 4:30 pm patient started a pain in patient left arm around 2 hours after the vaccine, after 12 hours after the vaccine patient felt weak, patient left arm hurt. patient left armpit started to hurt and patient took analgesic which helped patient for 8 hours. After this, patient back and both armpits began to ache, but being stronger on the right, but that pain moved to the chest subjecting pressure for about 2-3 min. This on the night of 29Jun2021 to whatever it takes patient another analgesic. Early on 30Jun2021, patient left arm and armpit continued to hurt but patient back and left armpit no longer that night (8:00 pm) patient left arm 3cm below the application of the vaccine an area of patient arm became red for 2 nights and warmed up. Patient already fine. Patient received treatment with analgesic for adverse events. Outcome of the events was resolved on an unspecified date in 2021.