chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: Headache had not totally left at all, at the time of the report her headache was still severe on the right side over her eye; Fever; Chills; Aching all over/ soreness; mild symptoms of soreness and redness; she started a rash last night, it was like she had measles; a fine red rash all over legs, arms and trunk and on even on chest; had no appetite just feeling yucky; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: 31May2021), via unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The relevant medical history included compromised immune system. Concomitant medications were not reported. The patient received first Covid on the 15Jan2021 and had mild symptoms of soreness and redness two days and then on the third day she started getting the headache and running a 99.4 fever an then on the fourth day she was running a fever 101.8, chills, aching all over, that fever had continued in the evening since then, went up to 102 was the highest count but its mostly to 100.8 to 101.8 since then and the headache had not totally left at all, at the time of the report her headache was still severe on the right side over her eye, she started a rash last night, it was like she had measles, a fine red rash all over legs, arms and trunk and on even on chest, she had no appetite just feeling yucky. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash erythematous, Rash morbilliform
Clinical narrative: Headache had not totally left at all, at the time of the report her headache was still severe on the right side over her eye; Fever; Chills; Aching all over/ soreness; mild symptoms of soreness and redness; she started a rash last night, it was like she had measles; a fine red rash all over legs, arms and trunk and on even on chest; had no appetite just feeling yucky; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: 31May2021), via unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The relevant medical history included compromised immune system. Concomitant medications were not reported. The patient received first Covid on the 15Jan2021 and had mild symptoms of soreness and redness two days and then on the third day she started getting the headache and running a 99.4 fever an then on the fourth day she was running a fever 101.8, chills, aching all over, that fever had continued in the evening since then, went up to 102 was the highest count but its mostly to 100.8 to 101.8 since then and the headache had not totally left at all, at the time of the report her headache was still severe on the right side over her eye, she started a rash last night, it was like she had measles, a fine red rash all over legs, arms and trunk and on even on chest, she had no appetite just feeling yucky. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pharyngeal swelling, Swelling face
Clinical narrative: Light headache; her face was swollen; her throat was swollen little bit; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262 and expiration date May2021), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes. The patient has concomitant medications (unspecified), taking a lot of medications. The patient had light headache on 23Jan2021, and she noticed her neck, her throat was swollen little bit, and her face was swollen in Jan2021. She doesn't know what she should do. She doesn't have any pain or anything, she feels great. The patient took Tylenol one time and that's it, the headache went away. It was not a bad headache, it was a light headache. Outcome of the event headache was recovered in Jan2021 while unknown for other events.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: It was itching so bad; Swelling on my where I got the shot, redness; It was itching so bad; Swelling on my where I got the shot, redness; It was itching so bad; Swelling on my where I got the shot, redness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included high blood pressure and autism. Concomitant medication included atenolol. On an unspecified date, the patient experienced that it was itching so bad; swelling on where she got the shot, redness. The patient underwent lab tests and procedures which included investigation: unknown results on 06Jan2021. Clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: I started to feel like itching on my skin but it is on different parts of my skin; I don't know if it is something in vaccine or it is something in my food or something else, like that kind of allergy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was not reported. Concomitant medication included unspecified medications; patient reported that he takes a lot of medications. On 19Jan2021, five days prior to the report, the patient experienced itching on his skin but it is on different parts of his skin. He stated, "I don't know if it is something with vaccine or it is something else but I, like a 5 days ago, I started to feel like itching on my skin but it is on different parts of my skin and I felt this is not nice and now I am looking for information like if you have like allergy or something. I don't know if it is something in vaccine or it is something in my food or something else, like that kind of allergy. I don't know what we can do with it." The patient received corrective treatment. On 23Jan2021, he took some Benadryl and on the morning o 24Jan2021, he took his Zyrtec (name not clarified) from his regular allergist. He stated that he has been prescribed for that. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoaesthesia oral, Investigation, Lip swelling, Swollen tongue
Clinical narrative: Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; Lower right lip started getting swollen and numb, it went to the whole lip, and then on to my tongue; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 23Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypertension, acid reflux, asthma and hypersensitivity. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) for asthma, atorvastatin, amlodipine and unspecified vitamins. On 23Jan2021, 45 minutes after the vaccination, the patient's lower light lip had started getting swollen and numb; it went to the whole lip, and then on to the tongue. The reported events had resulted to an emergency room visit. The patient had received an unspecified steroid as treatment for the events. The patient's CAT scan (unknown results) and electrolytes were fine; both on an unspecified date. The outcome of the events, 'lower light lip had started getting swollen and numb; it went to the whole lip, and then on to the tongue', was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Vitreous floaters
Clinical narrative: Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; This is a spontaneous report from two consumers. A contactable consumer (patient) and a non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration from an unspecified date at single dose for covid-19 immunization. The patient medical history included floaters and headaches. The concomitant medications were not reported. The patient had some predestined conditions of floaters and headaches but they either coincidentally or otherwise seemed to have gotten worse. They seemed to be getting more frequent since the patient had that that vaccine (Later clarified as Covid 19 vaccine Pfizer). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Tired; Had a temperature of 99; Small cough, not a lot, kind of a loose cough, not dry hacky cough; a little bit of light swelling at the injection site; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER9231), via an unspecified route of administration on 22Jan2021, 11:00 at a single dose for covid-19 immunization. The patient's medical history included diabetes mellitus and heart  issues from an unknown date. On 22Jan2021, the patient had a little bit of light swelling at the injection site. The patient slept good and did hot get any other symptoms. On  23Jan2020, in the afternoon, the patient had small cough, not a lot, kind of a loose cough, not dry hacky cough. On 24Jan2021, patient was tired, had a temperature of 99 in the morning. The patient did not have treatment for the events. The outcome of the events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: some mild diarrhea; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; dry cough; This is a spontaneous report from a contactable consumer reported for himself.  A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot EL3249 via unspecified route on 13Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. On unknown date in Jan2021 the patient developed a dry cough and then some friends of him were tested positive for Covid-19 (further clarification unknown) and so on 22Jan2021 the patient got tested again and the result was positive. On 24Jan2021 the patient had some mild diarrhea and the temperature was normal. Consumer stated that he received as treatment some Zinc and Vitamin E and Vitamin C. The outcome of the events was unknown. The second dose was scheduled for 03Feb2021.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Lot of rash on body; Itching; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration  on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lot of rash on body and itching both on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: Wheezing; Cough; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number: EL1283, expiry date: not reported), via an unspecified route of administration, on 21Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on 21Jan2021 and had a lot of typical side effects that were listed (further not clarified) but the patient also developed wheezing and a cough on an unspecified date in Jan2021. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Back disorder, Fatigue
Clinical narrative: Tired; I woke up this morning, my back was killing me, I could hardly move; I do have arthritis and I do get slight arthritis in the morning but this was really bad; This is a spontaneous report from a contactable consumer (patient). An 87-year-old patient of unspecified gender received bnt162b2 (BNT162B2, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history included ongoing arthritis. Concomitant medications were not reported. The patient stated, "I had the vaccine on Friday, I had a shot and it was fine. I got a little tired after it, but I was alright the next 2 days till Sunday. I woke up this morning (24Jan2021), my back was killing me, I could hardly move. And I am 87 years old and I do have arthritis (further clarification unknown) and I do get slight arthritis in the morning, but this was really bad. And I have been walking around and trying to exercise and it seems to be getting better. But I was wondering why I got it so severe if it was from the vaccine or what?" Outcome of the event arthritis was recovering, while outcome of other events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: My toes were like in a lot of pain as if someone had like slammed a hammer on all of my toes and they were very itchy; My toes were like in a lot of pain as if someone had like slammed a hammer on all of my toes and they were very itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer -Biontech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 22Jan2021 at 3 o'clock (as reported) and starting that night (22Jan2021) and whole all of 23Jan2021 the patient's toes were like in a lot of pain as if someone had like slammed a hammer on all of the patient's toes and they were very itchy. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Rash erythematous
Clinical narrative: Chills; I have a little red rash on my left thigh area/ smooth red rash on my upper left thigh, down to the knee cap; it is just like redness and that does not hurt, it is not itchy or nothing; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Jan2021 07:30 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 22Jan2021, this past Friday morning and roughly between 7:30 and was doing fine with it except that the patient had a little bit of chills but nothing predominant on an unspecified date. The patient also experienced a little red rash on the left thigh area and it is not raised or anything, it is just like redness and that does not hurt, it is not itchy or nothing on an unspecified date. The rash was described as smooth red rash on the upper left thigh, down to the knee cap but it is not itchy or hurting or anything. The outcome of the events was unknown.  The information about the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included she gets sick from bad food. The patient's concomitant medications were not reported. The patient had taken the Pfizer vaccine 2 days ago, her first dose, and she was vomiting. She was not sure if it was related to the vaccine or if it was from something she ate last night. She also had diarrhea, and she wanted to take ondansetron (ZOFRAN) that she had been prescribed to her from the past, from other problems. She gets sick from bad food. She has had it in the past, but she cannot stop vomiting. The pharmacist wanted to know if there were any known interactions between ZOFRAN and the Pfizer vaccine, and also if it was a known side effect, or if people were calling about vomiting. The pharmacist asked, you do not have anything related to the Pfizer vaccine and then any interactions on your part? You do not have any information about that? The clinical outcome of vomiting and diarrhea was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: extremely dizzy like vertigo; everything was spinning; extremely dizzy like vertigo; everything was spinning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had first Covid Vaccine on 20Jan2021 and patient didn't have any problems, it was late in the day and then on 22Jan2021 like not even 48 hours later, patient became extremely dizzy like vertigo, everything was spinning and that went on for several days and patient was still dizzy but not as extreme as what patient was and patient read all the papers that if this could be a side effect but patient was just wondering they said if it was really bad then go to emergency and patient didn't think because it got a little bit better each day. Outcome of events was recovering.   information on the LOT/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Frustration tolerance decreased, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Little tingling in the front of my palm; Metal taste in my mouth; My whole arm on my left and stuff is whole sore; Little nauseous; Frustrating; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported he/she had the vaccine yesterday and wanted to know if the symptoms were of allergic reactions or if it's normal. Patient would like to know he/she should get the second shot. The patient experienced a little tingling in the front of his/her palm, metal taste in mouth, his/her whole arm on my left and stuff was whole sore, and little nauseous on an unspecified date. He/she asked if they got to hear the side effects as it was so frustrating. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: sweating a little; sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 24Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided.  Patient received first vaccine shot the day before the report (reported as yesterday) and had no problem, just sore arm, that was not unusual but the day of the report (reported as today, this morning), after patient got up and walked around a little bit he/she was sweating a little bit. Patient did not feel bad, there was no fever. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; Patient developed mild COVID (positive test) 20 days after receiving 2nd shot; This is a spontaneous report from a contactable consumer.   A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. No COVID prior vaccination. On unknown date patient developed mild COVID (positive test) 20 days after receiving 2nd shot. The outcome of the event was recovering.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a "shot"  (reported as "your shot") yesterday morning 23Jan2021. The patient thought better to report it and asked if the patient should do anything for this or it will go away by itself. The patient came down with diarrhea at the time of report on 24Jan2021. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: Injection site was little sore; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), via an unspecified route of administration on 09Jan2021at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the injection site was little sore on an unspecified date. The patient did not receive treatment for the event reported. The patient underwent lab tests and procedures which included blood test: everything was fine on an unspecified date. Outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasal congestion
Clinical narrative: Chills; Had some congestion; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient had some side effects, he took the shot, the first shot on Wednesday and he is having chills even last night and then of course he has had some congestion. The consumer asked if how long do this normally last. No treatment received for both events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Got like the burning sensation too; This is a spontaneous report from a contactable consumer. A 63-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3249) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, menthol, zinc oxide (CALMOSEPTINE [MENTHOL;ZINC OXIDE]), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included hiatus hernia from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient stated, "I just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that I used on it. But I kind of got like the burning sensation too." The outcome of the event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Somnolence
Clinical narrative: She was tired.Fatigue; she just could not get out of bed, she was sleepy; Did not feel good; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET3248, expiration date was not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included thyroid disorder and hypertension which the patient mentioned that she does not have really but she takes hypertension medicine. Concomitant medication included levothyroxine sodium (SYNTHROID) and amlodipine besilate, telmisartan (TELMISARTAN AND AMLODIPINE) which was a substitute of TWYNSTA with LOT# is 3108115, expiry date: Oct2021. The patient had her vaccine on 19Jan2021 which was a Tuesday, and on 20Jan2021 on a Wednesday, she had side effects and then she started feeling better like on the Friday. But just a while ago, she had another side effect episode. She queried how long these will last or what do she needed to do. She asked if she can take her vitamins and everything else. She mentioned that she had to go back to her second one on 09Feb2021. She was tired. She just could not get out of bed, she was sleepy. She just did not feel good and kind of fatigued. Events all on 20Jan2021 on a Wednesday with outcome of recovering.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the site of injection of my virus injection was hurting so bad; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis which she just take care of the pain when it gets too bad with over the counter. The patient's concomitant medications were not reported. The patient was about 5 feet 1 inches, and 150 pounds. The patient queried if it was okay, because she had already done it, for her to take an ALEVE PM tablet because the site of injection of her virus injection was hurting so bad on 23Jan2021 with outcome of unknown. She queried if ALEVE, would hurt in any way, the effects of the virus vaccine. Therapeutic measures was taken as a result of the event with ALEVE PM.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: I was like and off balance; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; Little bit light headed /The way I was laying down I got more dizzy; This is a spontaneous report from a contactable consumer (patient)  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included blood pressure problems and Blood sugar abnormal (a little bit of blood sugar). Concomitant medications included metoprolol tartrate for blood pressure management. On 22Jan2021 the patient experienced 'little bit light headed /the way I was laying down I got more dizzy' and 'was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish'. On an unspecified date the patient also complained 'I was like and off balance'. At the time of the reporting event outcome was unknown.   Information on Lot/Batch number has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Chills, Faeces soft, Heart rate, Heart rate increased
Clinical narrative: Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown.   Information on Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Lot of tightness under my breast; Heart rate is elevated; Felt I wanted to vomit and then I vomited; Felt I wanted to vomit and then I vomited; Chills; Had a bowel movement, it felt soft; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes, and acid reflux from an unknown date. Concomitant medication included hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) for hypertension, labetalol for hypertension, metformin for type 2 diabetes, and pantoprazole for acid reflux. It was reported that the patient took the shot on Friday, 22Jan2021 and everything was fine, felt fine. Today, 24Jan2021 the patient was requested to call because on Saturday, 23Jan2021, the patient woke up, and got herself something to eat. The patient took her medication as normal and may be about, after she ate a meal, took the medicine (unspecified medication), the patient felt she wanted to vomit and then she vomited, she felt chills. She immediately had a bowel movement, it was like soft. She just wanted to just lay down and she went on and she just went to work because she was thinking it is just a shot and it will subside but she did want to get to work and felt she cannot do it. She came home and this morning (24Jan2021) and just felt a lot of tightness under her breast. She did not know if it had anything to do with it? Her heart rate is elevated a little it is like 104 because she is hypertensive. The patient reported that she did not have treatment and was going to go and get an X-ray as to why she is feeling this tightness under her breast. The patient underwent lab tests and procedures which included heart rate: 104 (elevated) on 24Jan2021. The outcome of the events was unknown.   Information on Lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included amlodipine (AMLODIPINE), lansoprazole (LANSOPRAZOLE), metformin (METFORMIN) and propranolol (PROPRANOLOL). The consumer stated, "I had this number to call. After I took the vaccine, the Pfizer vaccine on 18Dec2020, with the first one I had was severe headache on 19Dec2020 and I had some diarrhea on an unspecified date too. So, the headache started like from Saturday night sometimes until Monday and then after that it goes away, it went slowly but it goes away, severely, it was for two days." The outcome of the event headache was recovered on 21Dec2020 while the other event was unknown.   Information about batch/lot number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pain in extremity, Pruritus, Rash
Clinical narrative: Sore arm; I had a little bit of a rash on my shoulder; Back is full of pimples, red pimples, like red marks; Back is full of pimples, red pimples, like red marks and they itch; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure, gout, and rash on the penis area. Concomitant medications included tacrolimus for rash on the penis area, allopurinol for gout, amlodipine for blood pressure, benazepril, hydrochlorothiazide, metoprolol, and unspecified vitamins. The patient has not had laboratory in the past two weeks but last month, and the everything was fine. On an unspecified date in Jan2021, the patient had sore arm. On an unspecified date in Jan2021, the patient noticed that he had a little bit of a rash on his shoulder but then he looked at his back and it is full of pimples, red pimples, like red marks and they itch. It is on the upper part of the back, around the middle. The patient did not take anything for said events. As they were on his back, he didn't notice them until last night (unspecified date in Jan2021), they started to itch a little bit. So, they could have been there for 2 or 3 days.  The patient stated that the only thing he can think of is that it might be from the vaccine. Due date for the next shot is on 08Feb2021. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Throat tightness
Clinical narrative: Anaphylactic reaction; I felt as if my throat was closing off; I have cramping feelings in my throat; felt as if my throat was closing off; I was very sick for 3 days; This is a spontaneous report from a contactable nurse.  A nurse of unknown age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The nurse reported that she had her COVID 19 shot the past week and she reported her symptoms and wondered should not take the second dose because she was very sick for 3 days but that did not bother her. The thing that bother her was that she felt as if her throat was closing off, she had cramping feelings in throat. She was afraid that it was beginning to be 'anaphylaxis' but it was not. She reported that it did not go any further than that but she was fearful that her throat was going to close completely off. At the time of reporting the outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The suspected anaphylaxis with throat tightness and throat spasm were probably causally related to the use of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Symptoms of COVID-19 all over again; Symptoms of COVID-19 all over again; Bad fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This consumer reported 2 cases for different patients. This is the 2nd of 2 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history included COVID-19 (not ongoing). Concomitant medications were not reported. The patient experienced symptoms of COVID-19 all over again and bad fever all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date, body temperature: fever on unknown date.  The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076695 Same reporter/product/event, different patient
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pharyngeal swelling, Taste disorder, Vaccination site erythema
Clinical narrative: Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Off label use, Product use issue
Clinical narrative: allergy; patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding; patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 44-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 31Dec2020 at a single dose just to protect myself (covid-19 immunization). Medical history included blood pressure high and lost weight because she was breastfeeding. Concomitant medications included labetalol for blood pressure high. The patient reported that she had an allergy like maybe after a day (01Jan2021). The patient received her first dose of Pfizer Covid-19 Vaccine and mentioned that she was breastfeeding. The patient mentioned that she did not taking any treatment for the adverse events. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092765 same reporter/drug, different event/patient (baby)