chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: flare up of her Lyme disease/Possibly flared up her Lyme disease; flare up of her Lyme disease/Possibly flared up her Lyme disease; Back pain; Headache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 19Jul2021 (Batch/lot number not reported), at age 28 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included Lyme disease from an unknown date and ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received on an unspecified date, as dose 1, single for COVID-19 immunsation with no reaction reported. On 19Jul2021 (Monday), the patient received her second dose of the Pfizer COVID-19 vaccine. The patient was fine during the first couple of days. On 22Jul2021 (Thursday), the patient had a bad headache, dizziness, fatigue and back pain. She stated that she was trying to call her doctor in case the vaccine flared up her Lyme disease to see if the doctor wanted to do a round of antibiotics. Her doctor advised her to call Pfizer to see if there is any information about the vaccine causing a flare up of her Lyme disease. She stated that the doctor will not do anything until he knows if it flared up her Lyme disease. She stated that she had Lyme disease before she started getting the shot. She wanted to know if the vaccine flared up her Lyme disease. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal swelling, Rash, Swelling
Clinical narrative: difficulty breathing; throat swelling; rash; swelling; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on 18Jul2021 (Batch/Lot Number: df1307; Expiration Date: 30Aug2022) (at the age of 66-year-old) as single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 18Jul2021 and 30 minutes after she experienced a rash, swelling and throat swelling with difficulty breathing and after 1 or 2 hours it went away, no epinephrine needed. The patient is a doctor. The outcome of the events was recovered on 18Jul2021. The pharmacist asked how long pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) is good once the needle is attached, and the pharmacist also asked of what other vaccines are contraindicated if a patient had an anaphylactic reaction to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The pharmacist also asked for stability information for Pneumovax 23.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the events difficulty breathing and throat swelling with PREVNAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hordeolum, Palpitations
Clinical narrative: Dizziness for about a week.; Heart palpitations for about a week; "stiles while sleeping"; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included Wolf Parkinson white diagnosed in 2014, after giving birth to her second child (pregnancy). Concomitant medications included loratadine (CLARITIN), calcium carbonate (TUMS), vitamin d nos (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received sulfa drugs, sulfamethoxazole; trimethoprim (BACTRIM) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 21Apr2021 at 09:00, the patient experienced dizziness and heart palpitations for about a week. The patient reported heart palpitations mostly happened at night when laying down and when woke up in the morning and some stiles while sleeping on 21Apr2021. It had not been detectable though since the patient was 6 weeks postpartum and had virtually no palpitations since 6 weeks, post partum until she received the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness for about a week, heart palpitations for about a week and "stiles while sleeping" were unknown at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site vesicles
Clinical narrative: arm hurt so bad; arm seemed to have swollen a bit; water blister had formed over the injection site; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 24Jul2021 at 15:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, morbid obese and COVID-19. The patient has known allergy to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metformin HCL (MANUFACTURER UNKNOWN) and ethinylestradiol, norgestimate (SPRINTEC) both taken for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 the second day of shot at 13:15 the patient experienced her arm hurt so bad and it seemed to have swollen a bit so the patient took off the band aid and went to put another band aid on. She observed a water blister had formed over the injection site and did not want to pop it so had put another band aid over it. It had not gone down or away but it was only been a few days and the patient just wanted to know if it is normal cause as she did not see it in the paperwork as a side effect. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm hurt so bad, it seemed to have swollen a bit and water blister had formed over the injection site were not recovered at the time of the report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Hiccups
Clinical narrative: I experienced terrible acid reflux overnight; I started having intractable hiccups; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 23Jul2021 at 19:00, 3 hours after the vaccine, the patient started having intractable hiccups that lasted over 48 hours. These hiccups lasted sometimes longer than an hour and provided may be a 30 minutes break before starting again. On 24Jul2021, the second night of sleep, the patient experienced terrible acid reflux overnight. The patient ate a healthy diet and could not remember the last time when he experienced acid reflux. The patient took digestive enzymes and went to sleep, the acid reflux was gone in the morning and so were the hiccups. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of acid reflux which included treatment with digestive enzymes, however no therapeutic measures were taken as a result of intractable hiccups. The clinical outcomes of event intractable hiccups and terrible acid reflux were recovered on 25Jul2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Flushing, Hypersensitivity, Influenza
Clinical narrative: rash at the base of her neck to her shoulder; turned red; thermometer registered a fever; felt like she had the flu and all this mess; allergic reaction; had muscle aches; felt flushed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, covid-19 from Jan2021 and was hospitalized. The patient's concomitant medications were not reported. On Jul2021, patient turned red and the thermometer registered a fever when placed near the redness. She felt flushed. She had a rash at the base of her neck to her shoulder on Jul2021. She did take Benadryl for symptoms. She stayed there for a while and then she was starting to feel okay. She took it last Friday (from date of report) and Friday wasn't too bad but Saturday was horrible. She felt like she had the flu and all this mess. She never ran a fever but then on Saturday evening she had looked in the mirror and her face was like on fire, and she knew that's an allergic reaction. She has an EpiPen and she has been using Benadryl. She had muscle aches that she was taking Aleve for and Tylenol for a fever. She has a temperature scanner that you can just hold up to your forehead but not touch it and when she did it against her forehead she had no temperature, no fever, but if she did it on her cheek it was a fever. It was just really weird. She really felt more scared of the delta variant than of COVID that had put her in the hospital. Patient was asking if taking antihistamines before the COVID vaccine and all during it make it ineffective because she really would like to be vaccinated. She was just hoping that maybe she can take antihistamines before she gets the COVID vaccine and during the time while she was feeling symptoms because she was not a typical person who typically reacts to severely. But in 15 minutes she was sitting in the store and she did react fairly quickly by the flushing and she had to take Benadryl and they took her blood pressure and then finally let her go. She was there longer than most people but she just doesn't know if antihistamines will render it ineffective, like if she takes Benadryl on the day she gets her 2nd COVID vaccine, before she even shows up, and then Benadryl all the way through the time she was having symptoms. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: rash at the base of her neck to her shoulder; turned red; thermometer registered a fever; felt like she had the flu and all this mess; allergic reaction; had muscle aches; felt flushed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, covid-19 from Jan2021 and was hospitalized. The patient's concomitant medications were not reported. On Jul2021, patient turned red and the thermometer registered a fever when placed near the redness. She felt flushed. She had a rash at the base of her neck to her shoulder on Jul2021. She did take Benadryl for symptoms. She stayed there for a while and then she was starting to feel okay. She took it last Friday (from date of report) and Friday wasn't too bad but Saturday was horrible. She felt like she had the flu and all this mess. She never ran a fever but then on Saturday evening she had looked in the mirror and her face was like on fire, and she knew that's an allergic reaction. She has an EpiPen and she has been using Benadryl. She had muscle aches that she was taking Aleve for and Tylenol for a fever. She has a temperature scanner that you can just hold up to your forehead but not touch it and when she did it against her forehead she had no temperature, no fever, but if she did it on her cheek it was a fever. It was just really weird. She really felt more scared of the delta variant than of COVID that had put her in the hospital. Patient was asking if taking antihistamines before the COVID vaccine and all during it make it ineffective because she really would like to be vaccinated. She was just hoping that maybe she can take antihistamines before she gets the COVID vaccine and during the time while she was feeling symptoms because she was not a typical person who typically reacts to severely. But in 15 minutes she was sitting in the store and she did react fairly quickly by the flushing and she had to take Benadryl and they took her blood pressure and then finally let her go. She was there longer than most people but she just doesn't know if antihistamines will render it ineffective, like if she takes Benadryl on the day she gets her 2nd COVID vaccine, before she even shows up, and then Benadryl all the way through the time she was having symptoms. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Inflammation, Swelling
Clinical narrative: and in the morning he developed some swelling in the same area (near the armpit); a day after he began to have pain under his armpit; The next day he presented with some inflammation around the armpit area; This is a spontaneous report from a contactable consumer. This consumer (wife) reporting for a 43-year-old male patient (husband) reported that: A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in right arm on 23Jul2021 (at the age of 43-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173, Expiration date: 31Aug2021), via an unspecified route of administration in right arm on 30Jun2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunisation. It was reported that on behalf of her husband who received the second dose of Pfizer's COVID-19 vaccine on last Friday, a day after he began to have pain under his armpit and in the morning, he developed some swelling in the same area (near the armpit), this reaction occurred in the same arm where he received the vaccine. She wants to know if these are side effects reported with the vaccine. The next day of vaccination (24Jul2021), he presented with some inflammation around the armpit area and some pain in that area as well and she gave him ibuprofen. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Chills, Dizziness, Dysstasia
Clinical narrative: Tunnel vision; Dizziness/he got so dizzy that he could not stand up or see clearly; stated that he got so dizzy that he could not stand up; stated that he got so dizzy that he could not see clearly; Nausea; he did not feel so good; Felt unwell/Felt sick; Vomiting/throwing up; Low blood pressure; Profusely sweaty; Chills; has anxiety but had never had a reaction to that degree; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tunnel vision, dizziness/he got so dizzy that he could not stand up or see clearly, nausea, he did not feel so good, felt unwell/felt sick, vomiting/throwing up, low blood pressure, profusely sweaty, chills, has anxiety but had never had a reaction to that degree; all on unspecified dates. Patient had his first Pfizer shot. Stated that he had a very bad reaction. Stated that he is trying to get a better understanding of what happened. Stated that he had a fear of getting it but got for his mom and family because he is trying to protect them. Stated that a few minutes after the shot that he got so dizzy that he could not stand up or see clearly. Stated that he started to feel very nauseous. Stated that he tried to get up and told the woman at the counter the he did not feel so good. Stated that he went and sat down and it got worst. Stated that he had tunnel vision, felt unwell/felt sick and was throwing up on the floor. Stated that they brought over the trashcan and he was still throwing up. Stated that someone calmed him down little bit and called the EMT. Stated that they checked his blood pressure and it was low and asked questions. Stated that if he continued to feel dizzy or broke out in hives to go to the hospital. Stated that he has anxiety but had never had a reaction to that degree. Wanted to know what happened. Stated that he does not feel like getting the second shot if that was his first response. Stated that he had anxiety before the vaccine. Is for Pfizer Covid 19 shot. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: low on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypotension, Malaise, Nausea
Clinical narrative: Tunnel vision; Dizziness/he got so dizzy that he could not stand up or see clearly; stated that he got so dizzy that he could not stand up; stated that he got so dizzy that he could not see clearly; Nausea; he did not feel so good; Felt unwell/Felt sick; Vomiting/throwing up; Low blood pressure; Profusely sweaty; Chills; has anxiety but had never had a reaction to that degree; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tunnel vision, dizziness/he got so dizzy that he could not stand up or see clearly, nausea, he did not feel so good, felt unwell/felt sick, vomiting/throwing up, low blood pressure, profusely sweaty, chills, has anxiety but had never had a reaction to that degree; all on unspecified dates. Patient had his first Pfizer shot. Stated that he had a very bad reaction. Stated that he is trying to get a better understanding of what happened. Stated that he had a fear of getting it but got for his mom and family because he is trying to protect them. Stated that a few minutes after the shot that he got so dizzy that he could not stand up or see clearly. Stated that he started to feel very nauseous. Stated that he tried to get up and told the woman at the counter the he did not feel so good. Stated that he went and sat down and it got worst. Stated that he had tunnel vision, felt unwell/felt sick and was throwing up on the floor. Stated that they brought over the trashcan and he was still throwing up. Stated that someone calmed him down little bit and called the EMT. Stated that they checked his blood pressure and it was low and asked questions. Stated that if he continued to feel dizzy or broke out in hives to go to the hospital. Stated that he has anxiety but had never had a reaction to that degree. Wanted to know what happened. Stated that he does not feel like getting the second shot if that was his first response. Stated that he had anxiety before the vaccine. Is for Pfizer Covid 19 shot. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: low on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tunnel vision, Visual impairment, Vomiting
Clinical narrative: Tunnel vision; Dizziness/he got so dizzy that he could not stand up or see clearly; stated that he got so dizzy that he could not stand up; stated that he got so dizzy that he could not see clearly; Nausea; he did not feel so good; Felt unwell/Felt sick; Vomiting/throwing up; Low blood pressure; Profusely sweaty; Chills; has anxiety but had never had a reaction to that degree; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tunnel vision, dizziness/he got so dizzy that he could not stand up or see clearly, nausea, he did not feel so good, felt unwell/felt sick, vomiting/throwing up, low blood pressure, profusely sweaty, chills, has anxiety but had never had a reaction to that degree; all on unspecified dates. Patient had his first Pfizer shot. Stated that he had a very bad reaction. Stated that he is trying to get a better understanding of what happened. Stated that he had a fear of getting it but got for his mom and family because he is trying to protect them. Stated that a few minutes after the shot that he got so dizzy that he could not stand up or see clearly. Stated that he started to feel very nauseous. Stated that he tried to get up and told the woman at the counter the he did not feel so good. Stated that he went and sat down and it got worst. Stated that he had tunnel vision, felt unwell/felt sick and was throwing up on the floor. Stated that they brought over the trashcan and he was still throwing up. Stated that someone calmed him down little bit and called the EMT. Stated that they checked his blood pressure and it was low and asked questions. Stated that if he continued to feel dizzy or broke out in hives to go to the hospital. Stated that he has anxiety but had never had a reaction to that degree. Wanted to know what happened. Stated that he does not feel like getting the second shot if that was his first response. Stated that he had anxiety before the vaccine. Is for Pfizer Covid 19 shot. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: low on unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Feeling hot, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: my stomach was burning on the inside; I was hot and cold with sweats; I was hot and cold with sweats; chills; I would get hot; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 21Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included disability, sensitization, central nervous system is more sensitive from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received fist dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date caller is a consumer inquiring about additional information regarding the side effects of the Pfizer Covid-19 vaccine. Caller reports after I got the first one, I didn't feel too bad, but after the second one my stomach was burning on the inside and then I was hot and cold with sweats, chills, then I would get hot. Me and my girlfriend got it at the same 21Jul2021, and my girlfriend is going through the same thing. We got at the same time. May be that's why, because I'm disabled, and my central nervous system is more sensitive. I have sensitization which makes me more sensitive. My girlfriend is also feeling like her stomach is burning, but it could be from having to poop all the time. The outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This is a spontaneous report from a contactable nurse or other health care professional (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient reported she is a licensed practical nurse and she had her first shot last Thursday. She has been experiencing nausea and diarrhea since. Asking how long is going to last as she needs to go back to work. She had to call off work today and it is not looking good for going to work tomorrow. She also wants to know if this may happen again when she will get her second dose. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection, Eye infection, Eye swelling, Osteitis, Urticaria
Clinical narrative: eyes, ears, and jaws had an infection.; eyes, ears, and jaws had an infection.; eyes, ears, and jaws had an infection.; broke out in hives on my face; eyes started to swell shut; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient) communicated to Pfizer-sponsored program Pfizer.com-General Company Information. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 04Mar2021, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the 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 for covid-19 immunisation. On 10Mar2021, the patient experienced broke out in hives on face exactly where a mask was located, and eyes started to swell shut. Initially, the patient did not think the hives were caused from the vaccine. The patient took an antihistamine which stopped this action. On an unspecified date in Jun2021, after three months, the patient had an infection of eyes, ears, and jaws for which the patient had to get an antibiotic. It was reported that the patient was fine now and just thought to inform about this delayed reaction and was thankful for the vaccine. The patient outcome of the events was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Heavy exposure to ultraviolet light, Oedema peripheral, Pain in extremity
Clinical narrative: got exposed to the sun a lot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and is now moving down her arms along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; soreness is going out. It is just a little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration administered in Arm on 22Jul2021 as dose 2, single dose for covid-19 immunization (at the age of 70-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization and had no issues. It was reported that on 22Jul2021 (on Thursday) the patient received the second dose of vaccine and stated that on Sunday 25Jul2021, patient got exposed to the sun a lot and her arm where she got the shot was getting red and hot and was now moving down her arms along with the heat. Patient was trying to know if it was normal. The patient further stated that she set in the sun and she didn't know that the heat was goanna bother her arm. Right now on an unspecified date in Jul2021 her arm was puffy, swelling, hot, and the redness was moving down the arm along with the heat. She wanted to know if this was normal. She stated that she had first shot and had no issues. She then said it started Saturday night when she put ice on it. It just seems like the red and hot was moving down her arm. She was just trying to find out if it was normal. On an unspecified date in Jul2021 the soreness was going out and It was just a little sore. The outcome of the event pain in arm was recovering and outcome was unknown for rest of the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: got exposed to the sun a lot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and is now moving down her arms along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; soreness is going out. It is just a little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration administered in Arm on 22Jul2021 as dose 2, single dose for covid-19 immunization (at the age of 70-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization and had no issues. It was reported that on 22Jul2021 (on Thursday) the patient received the second dose of vaccine and stated that on Sunday 25Jul2021, patient got exposed to the sun a lot and her arm where she got the shot was getting red and hot and was now moving down her arms along with the heat. Patient was trying to know if it was normal. The patient further stated that she set in the sun and she didn't know that the heat was goanna bother her arm. Right now on an unspecified date in Jul2021 her arm was puffy, swelling, hot, and the redness was moving down the arm along with the heat. She wanted to know if this was normal. She stated that she had first shot and had no issues. She then said it started Saturday night when she put ice on it. It just seems like the red and hot was moving down her arm. She was just trying to find out if it was normal. On an unspecified date in Jul2021 the soreness was going out and It was just a little sore. The outcome of the event pain in arm was recovering and outcome was unknown for rest of the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Influenza like illness, Neck mass, Pain
Clinical narrative: still feeling a little flu-ish; mass in the right portion of her neck; really really sick; severe weakness and aching; severe weakness and aching; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunisation. On Jul2021, patient had been really really sick and flu-ish and it had been 12 days since her second shot. Patient asked that does it take that long to cause the problem. Patient also had severe weakness, aching and mass in the right portion of her neck. She feels too sick and weak to be on the phone for long. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout attack in left foot/ gout flare; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0175) via an unspecified route of administration in the left arm on 30Apr2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0185) via an unspecified route of administration in the left arm on 21May2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included gout. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and cherry extract (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 the patient experienced gout attack in left foot. The first attack was 17 days after the 1st Pfizer shot and 2nd gout flare started on 21Jun2021, 31days after 2nd dose. On Doctor advice the patient postponed steroid treatment until 48hours after 2nd COVID shot was received. Therapeutic measures were as a result of the event and included treatment with colchicine (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event of gout attack was recovered on an unknown date in 2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; headache; nausea; chills; fever as high as 101.6; feeling exhausted; Swollen lymph nodes; assumes her body was developing a strong immune response and it was "really bad"; sick; This is a spontaneous report from a contactable Physician. This Physician (patient) reported for herself.  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: 31Jul2021), via unspecified route, administered on 09Apr2021 (at the age of 63-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: 13Jul2021), via unspecified route, administered on 19Mar2021 (at the age of 63-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient experienced shingles, arm pain at the injection site and feeling abnormal after first dose of vaccination. The patient medical history and concomitant medications were not reported. On an 09Apr2021, after the vaccination, the patient experienced side effects and was too sick at the night of vaccination. And on an unspecified date after vaccination, Patient went through heck for 24 hours and assumes her body was developing a strong immune response which was bad. Patient also experienced diarrhoea, headache, Nausea, Swollen lymph nodes, chills and fever as high as 101.6 Fahrenheit and patient was feeling exhausted. fever and chills were observed with the first 1 to 2 days after vaccination. Patient asked about the severity of the second dose and how does that correlate to the third potential booster dose. This is based on assumption that there will be a 3rd dose. She was enquiring about any data that correlated to the severity of symptoms and is there any data that correlates it with a robust immune response. The patient also asked about a booster dose. The patient lab data include body temperature monitoring on an unspecified date with a reading of 101.6 Fahrenheit. The outcome of the event illness was recovered on Apr2021, and outcome other events was unknown.  No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immune system disorder, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: diarrhea; headache; nausea; chills; fever as high as 101.6; feeling exhausted; Swollen lymph nodes; assumes her body was developing a strong immune response and it was "really bad"; sick; This is a spontaneous report from a contactable Physician. This Physician (patient) reported for herself.  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: 31Jul2021), via unspecified route, administered on 09Apr2021 (at the age of 63-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: 13Jul2021), via unspecified route, administered on 19Mar2021 (at the age of 63-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient experienced shingles, arm pain at the injection site and feeling abnormal after first dose of vaccination. The patient medical history and concomitant medications were not reported. On an 09Apr2021, after the vaccination, the patient experienced side effects and was too sick at the night of vaccination. And on an unspecified date after vaccination, Patient went through heck for 24 hours and assumes her body was developing a strong immune response which was bad. Patient also experienced diarrhoea, headache, Nausea, Swollen lymph nodes, chills and fever as high as 101.6 Fahrenheit and patient was feeling exhausted. fever and chills were observed with the first 1 to 2 days after vaccination. Patient asked about the severity of the second dose and how does that correlate to the third potential booster dose. This is based on assumption that there will be a 3rd dose. She was enquiring about any data that correlated to the severity of symptoms and is there any data that correlates it with a robust immune response. The patient also asked about a booster dose. The patient lab data include body temperature monitoring on an unspecified date with a reading of 101.6 Fahrenheit. The outcome of the event illness was recovered on Apr2021, and outcome other events was unknown.  No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Computerised tomogram coronary artery, Dyspnoea, Echocardiogram, Ejection fraction decreased
Clinical narrative: Myocarditis; pt developed Sx of HF; leg edema; SOB; EF 40%; This is a spontaneous report from a contactable physician. A 51-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Apr2021 (at the age of 51-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) on an unspecified date (at the age of 51-years-old) for COVID-19 immunization. It was reported that on Jun2021, the patient developed Sx (symptom) of HF (heart failure) with sob (shortness of breath) and leg edema; had echo done showing EF 40%. The physician sent the patient for cardiac MRI (magnetic resonance imaging) which showed findings c/w (consistent with) myocarditis; she had CCTA (coronary computed tomography angiography) done showing normal coronaries. She denied any history of cold or URI (upper respiratory infection) Sx. Second dose of vaccine was received on Apr2021 and symptoms started 6-8 weeks after. Therapeutic measures were received as a result of the adverse events. Corrective treatment included: Lasix, toprol, lisinopril, echo, venous duplex, cardiac MRI, labs, CCTA. Outcome of the events was recovering. The events resulted into a Doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient has not been tested for COVID-19.   Information on batch number has been requested.; Sender's Comments: Based on the available information in the case, the causal association between the events myocarditis, cardiac failure and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging heart, Myocarditis, Oedema peripheral, Ultrasound Doppler
Clinical narrative: Myocarditis; pt developed Sx of HF; leg edema; SOB; EF 40%; This is a spontaneous report from a contactable physician. A 51-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Apr2021 (at the age of 51-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) on an unspecified date (at the age of 51-years-old) for COVID-19 immunization. It was reported that on Jun2021, the patient developed Sx (symptom) of HF (heart failure) with sob (shortness of breath) and leg edema; had echo done showing EF 40%. The physician sent the patient for cardiac MRI (magnetic resonance imaging) which showed findings c/w (consistent with) myocarditis; she had CCTA (coronary computed tomography angiography) done showing normal coronaries. She denied any history of cold or URI (upper respiratory infection) Sx. Second dose of vaccine was received on Apr2021 and symptoms started 6-8 weeks after. Therapeutic measures were received as a result of the adverse events. Corrective treatment included: Lasix, toprol, lisinopril, echo, venous duplex, cardiac MRI, labs, CCTA. Outcome of the events was recovering. The events resulted into a Doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient has not been tested for COVID-19.   Information on batch number has been requested.; Sender's Comments: Based on the available information in the case, the causal association between the events myocarditis, cardiac failure and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.