chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: vomiting; nausea; diarrhea; This is a spontaneous report received from contactable consumer. A consumer (patient) reported for a herself that the 47-year-old female patient received first dose of bnt162b2 (BNT162B2), PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Deltoid Left on 20Apr2021 around 2:00-3:00PM (Batch/Lot Number: EK8733) as 1st dose, single for covid-19 immunization. The patient medical history was none. The patient's concomitant medications were not reported.  The patient experienced vomiting (medically significant) on 21Apr2021 with outcome of recovered on 21Apr2021, nausea (medically significant) on 21Apr2021 with outcome of recovered , diarrhea on 21Apr2021 with outcome of recovered on 21Apr2021. Therapeutic measures were taken as a result of vomiting, nausea.  The clinical course was reported as follows: After my first dose I had one episode of nausea, vomiting, and diarrhea. I am going for my second dose today. Is this something that is common that other people experience after the second dose? Seriousness criteria was other medically important condition. She received the first dose of the covid vaccine, and within 24 hours, she experienced vomiting and nausea. She could not put her finger on anything that she ate or drank. She took antiemetics. She only had the one moment of vomiting and nausea. She is getting ready to take the second dose of the covid vaccine. She is asking if this is something common with other people.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 58-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:00AM (Batch/Lot Number: EM6208) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, lot number: EN6203) on 06Mar2021,10:00 AM in Right arm for covid-19 immunisation. The patient experienced bells palsy (medically significant) on 12Apr2021 23:00 with outcome of recovering. Therapeutic measures were taken as a result of bells palsy included Steroids and antibiotic.  The clinical course was reported as follows: Im not sure it was the shot. But they said to report it. After 2 weeks and 1 day I came down with Bells Palsy.Ae resulted in [Emergency room/department or urgent care]. No covid prior vaccination. No covid tested post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: Thrush; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient that has received both dose of the Pfizer COVID vaccine and after both doses he has experienced thrush as a side effect on an unspecified date. Patient wanted to know if antibiotics will affect the vaccines efficacy. The outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Heart rate, Heart rate decreased, Hypotension
Clinical narrative: someone was on the floor; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is a consumer calling in regards to the Pfizer Covid-19 vaccine. Caller was self-reporting on adverse events when he reported that another person, the patient, had some kind of reaction while he was at the vaccination facility for his first dose of the Covid-19 vaccine. Caller reported that while he was waiting for the Covid-19 vaccine at the vaccination facility on 09Apr2021.  Caller reported that while he was waiting, he noticed that someone was on the floor and all the sudden, facility staff members put a rolling screen around the patient. Caller reported that he could tell the patient was male.  Caller reported that the event occurred between 2 PM and 3 PM on 09Apr2021. Caller reported that he didn't think that the patient was a senior citizen.  Caller reported that he thinks the patient was someone younger. Caller reported that he did not know what happened to the patient. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity, Therapeutic response unexpected
Clinical narrative: someone was on the floor; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is a consumer calling in regards to the Pfizer Covid-19 vaccine. Caller was self-reporting on adverse events when he reported that another person, the patient, had some kind of reaction while he was at the vaccination facility for his first dose of the Covid-19 vaccine. Caller reported that while he was waiting for the Covid-19 vaccine at the vaccination facility on 09Apr2021.  Caller reported that while he was waiting, he noticed that someone was on the floor and all the sudden, facility staff members put a rolling screen around the patient. Caller reported that he could tell the patient was male.  Caller reported that the event occurred between 2 PM and 3 PM on 09Apr2021. Caller reported that he didn't think that the patient was a senior citizen.  Caller reported that he thinks the patient was someone younger. Caller reported that he did not know what happened to the patient. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: someone was on the floor; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is a consumer calling in regards to the Pfizer Covid-19 vaccine. Caller was self-reporting on adverse events when he reported that another person, the patient, had some kind of reaction while he was at the vaccination facility for his first dose of the Covid-19 vaccine. Caller reported that while he was waiting for the Covid-19 vaccine at the vaccination facility on 09Apr2021.  Caller reported that while he was waiting, he noticed that someone was on the floor and all the sudden, facility staff members put a rolling screen around the patient. Caller reported that he could tell the patient was male.  Caller reported that the event occurred between 2 PM and 3 PM on 09Apr2021. Caller reported that he didn't think that the patient was a senior citizen.  Caller reported that he thinks the patient was someone younger. Caller reported that he did not know what happened to the patient. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Skin burning sensation, Urticaria
Clinical narrative: burning sensation all over/her skin felt like it was on fire; burning sensation all over/her skin felt like it was on fire; breaking out in hives; This is a spontaneous report from a contactable consumer, the patient's mother. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8735, second dose) solution for injection intramuscular in the right arm on 03May2021 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (first dose, Lot ER8731) for COVID-19 vaccination on 11Apr2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06May2021, the patient was breaking out in hives. On 09May2021, the patient had burning sensation all over/her skin felt like it was on fire. The patient was taken to the doctor (office visit). By Sunday (09May2021), the patient was completely covered and went to the ER (emergency room) where she was treated with IV diphenhydramine (BENADRYL) and steroids. The patient was not admitted to the hospital. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle tightness, Thrombosis
Clinical narrative: feels like a blood clot; My right calf has felt strange ever since the second dose and it feels like a blood clot/toes also felt strange/My toes also felt strange for a few weeks but that subsided; a tightness in the leg that doesn't want to go away; This is a spontaneous report received from a contactable consumer. This consumer reported for himself that the 35-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:00 (Batch/Lot Number: 6203) as 2nd dose, single for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer COVID 19, Lot number=9265) on 01Feb2021,01:00 PM,in Left arm for covid-19 immunisation. The patient experienced feels like a blood clot on 23Feb2021 with outcome of not recovered , my right calf has felt strange ever since the second dose and it feels like a blood clot/toes also felt strange/my toes also felt strange for a few weeks but that subsided on 23Feb2021 with outcome of not recovered , a tightness in the leg that doesn't want to go away on 23Feb2021 with outcome of not recovered. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination.   The clinical course was reported as follows: My right calf has felt strange ever since the second dose and it feels like a blood clot. There is a tightness in the leg that doesn't want to go away. My toes also felt strange for a few weeks but that subsided. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies.   Follow up letter has been generated for further information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: bleeding; This is a spontaneous report from a contactable consumer (patient). A 42-year-old not pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Apr2021 10:30 (Batch/Lot Number: ER8734) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergies to Penicillin, turkey, chicken. Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had vaccine on 06Apr2021 and that evening about 22:00 started bleeding very heavy. She bled for 2 1/2 weeks changing overnight pads ever 45-60 minutes. On 21Apr21 was bleeding so bad. Changing pads every 10 minutes. Patient went to the emergency room and was gave a very heavy dose of hormones to stop the bleeding. She went to see gynaecologist on 23Apr21 and was scheduled for a hysterectomy due to all the bleeding. The event outcome was not recovered. The patient was hospitalized for bleeding (haemorrhage) for 1 day. The patient underwent lab tests and procedures which included Nasal Swab covid test: negative on 10May2021.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis bullous, Pemphigoid
Clinical narrative: bullous type rash on bilateral lower extremities, which appeared as a large fluid-filled blister; pemphigoid-like reaction/ could be a bullous pemphigoid; This is a spontaneous report from a contactable nurse. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07May2021 08:10 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing morbidly obese, blood clot in one of legs that resolved. The patient's concomitant medications were not reported, patient was not currently on any medications. No prior vaccinations within 4 weeks. Patient had the first dose of bnt162b2 on 16Apr2021 with lot: EW0158. The patient received the second vaccine on 07May2021 and he noticed the rash starting that night and really noticed it progress on 08May2021. On 11May2021, patient with a bullous type rash on bilateral lower extremities, which appeared as a large fluid-filled blister, a pemphigoid-like reaction. Patient had had no new soap, clothing, or detergent. He has had nothing new. The reporting nurse say this is medically significant because she is concerned it could be a bullous pemphigoid which could be life threatening if that is the case. No emergency room or physician office visit. The events outcome was not recovered.; Sender's Comments: Based on the available information and known product profile, the potential causal relationship between the reported events and use of BNT162B2 is cannot be fully excluded. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contactable nurse reported for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Mar2021 (Batch/Lot Number: ER8727) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypertension, paroxysmal atrial tachycardia, stroke when she was 40, had COVID in Mar2020 (Her cardiologist believes she had COVID too but never did a test) and broke her ankle. Concomitant medication included warfarin sodium (COUMADIN) because she had a stroke and broke her ankle and got a clot from her ankle to her groin; ongoing diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE) taken for paroxysmal atrial tachycardia and hypertension; Chlorthalidone taken for polyuria and hypertension; verapamil hydrochloride (VERAPAMIL) taken for paroxysmal atrial tachycardia for years. Patient received first dose of bnt162b2 on 28Feb2021 in left upper arm. Patient was a retired nurse and stated about a month after the second dose of the vaccine she started getting lightheaded, she went to Urgent Care because her daughter who is a nurse insisted. Her blood pressure at Urgent Care was really, really high, she was having excessive hypertension. Before the vaccine she was on a blood pressure medication for several years and had no issues. She went to see her cardiologist and they moved her from one medication to 3 medications (then add Losartan, Diltiazem) to get this controlled. In the morning she was lightheaded and her blood pressure is high before her morning medication. Diltiazem is 24 hours. She gets up at 3AM and once she takes the medication it seems to be ok. Her blood pressure is reasonable now. It is not like it was initially when elevated. Initially it was 180/88 to 94 when she first went to see the cardiologist after second COVID19 Vaccine. Currently her blood pressure in the morning is usually 154/ 77. That was when she first takes it when she gets up. Later in the morning it is running 110/77. The event outcome was unknown. She was feeling that it had to do with the second injection. Patient considered it was medically significant for high blood pressure and lightheaded, and considered both events related to COVID19 Vaccine.; Sender's Comments: Based on the known drug profile, there is a reasonable possibility of casual relationship between the drug BNT162b2 and the events Dizziness and Hypertension. 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: Asymptomatic COVID-19, Body temperature, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: had her first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021; first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021/ Patient has no symptoms; This is a spontaneous report received from contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Apr2021 around 10:45 or 11 am (Batch/Lot Number: EN0169) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient had her first Pfizer Covid vaccine dose on 20Apr2021 and tested a nose swab test positive for Covid on 10May2021 using a Covid self test. She took the test twice. Patient has no symptoms, does not feel tired and has no temperature. Her temperature was 97.5F, which was checked when she came into work. Patient was scheduled another Covid test on 12May2021. She wants to know if she has tested positive for Covid, can she still get the second dose of the vaccine. No emergency room or physician office visit. The event outcome was unknown.  Follow-up attempts completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured, Loss of consciousness
Clinical narrative: she passed out; diarrhea; stools are black in color; This is a spontaneous report from a contactable consumer(patient).  A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 in Arm Left on 07May2021 (Lot Number: EVL8737) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  She had her first dose of Pfizer COVID vaccine on 07May2021, between 11 and noon, after receiving the vaccine, she experienced diarrhea, stools are black in color; as well as that same night she passed out and it's the first time this happens to her. The outcome of Diarrhea was recovered on 08May2021, of Black stools was not recovered, of Passed out was unknown. The Diarrhea started right after when she got home that evening. For the diarrhea, it started last Friday to early Saturday morning. Saturday 08May2021 morning she had about 2 bowel but its now checked itself (means it stopped). She had the Kaopectate. Then Sunday 09May2021and Monday 10May2021 she had no Diarrhea, no bowel movement but then today 11May2021, she had one bowel movement, there was no diarrhea but her stool was black. Her stools have been black in color since Friday 07May2021. She has never had black stools. The Kaopectate was started after the vaccine. Kaopectate is over the counter. She bought it for the diarrhea and upset stomach. Friday night she also passed out and that has never happened before.  She is concerned about Friday night because she went to the bathroom at 2-3 at night and she passed out in the bathroom, she didn't feel faint or anything, she just passed out, she woke up on the bathroom floor. It happened just the one time on Friday night. She was scheduled for the second dose on 01Jun2021.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Chest pain, Chills, Diaphragmalgia
Clinical narrative: "It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter.  She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flatulence, Headache, Malaise, Muscle spasms, Myocardial infarction
Clinical narrative: "It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter.  She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: "It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter.  She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: "It felt like I was having a heart attack"; severe stomach/diaphragm pain; evere stomach/diaphragm pain; spasms; Felt like gas and came on right after she ate bread and butter.  She felt like it was in her back and chest "100 times worse than what I'm used to."; she is "unwell in general" and it is around her chest/upper stomach; She thought it was chest pain or gas; fever; Chills; Headache; body ache; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10May2021 at the age of 30-years-old (Lot Number: EW0173) as single dose for COVID-19 immunisation. Patient received the first dose on 19Apr2021 at the age of 30-years-old, Lot: EW0161, administered in left arm. Concomitant medications included ongoing vitamins NOS (DAILY MULTIVITAMIN); ongoing drospirenone, ethinylestradiol (LORYNA). The patient received the second dose of the Pfizer Covid 19 vaccine 10May2021. She had a fever 102.6 or 102.8 degrees Fahrenheit. It went up to 103 degrees and was now down to 101 degrees. She had chills, headache, body ache and soreness at the injection site. These symptoms started around 9:00 or 9:30pm last night. Fever, chills, headache, body ache and soreness at the injection site were with onset date 10May2021. She was hit with the whole nine yards of symptoms. She ate bread and toast earlier 11May2021 and has been having severe stomach/diaphragm pain, spasms and contractions. She thought it was chest pain or gas. She was unsure if she should be worried or if this is a side effect. This pain started around noon 11May2021. An AE was being filed however she ate bread/toast early this morning and she began having stomach/diaphragm area pain, like spasms and contractions. Patient stated symptoms have resolved for the moment and the last "attack" she had was while she was calling Pfizer. She said it came and went. Felt like gas and came on right after she ate bread and butter. She felt like it was in her back and chest "100 times worse than what I'm used to." She said she was "unwell in general" and it was around her chest/upper stomach. "It felt like I was having a heart attack". "Is this a side effect of the vaccine? Should I seek medical attention if it gets worse?" The outcome of events (severe stomach/diaphragm pain, spasms, contractions, fever, chills, headache, body ache and soreness at the injection site) was not recovered, outcome of other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from program. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 at the age of 58-years-old (Batch/Lot number was unknown) as single dose for COVID-19 immunization. Lot Number reported as PW0153 or EW0153, administered either at 12:45PM or 2:45PM (first dose). The patient's medical history and concomitant medications were not reported. The caller said her next COVID-19 Vaccine dose was on 15May2021, but she had got COVID-19 after her first COVID-19 Vaccine dose. The caller wanted to know about getting her second COVID-19 Vaccine since she tested positive for the COVID-19 Virus on 27Apr2021. She tested positive 3 days after the first dose which was given on 24Apr2021. She still has the whooping cough now. The caller also mentioned her sister also tested positive and couldn't get her first dose. It was explained after the first dose she had a whooping cough, chills, loss of appetite, and high temperature that would go up and down, and she felt weak. This lasted two weeks. It started 3 days after getting the vaccine and she is fine right. She still has the whooping cough but not much now and it is fading. She got sick Tuesday afternoon, on 27Apr2021 and was sick through today, other than the cough. She explains at first for the high temperature she did not take any Tylenol at all because she didn't know she could. She did take Advil pm but it didn't work, Expiry: Feb2022, Lot: AW9333, and no UPC is known. It was explained she thinks it didn't work because she didn't continue it, she would stop then start a few days later with another dose. She didn't take it continuously or regularly and feels if she had it would have worked. After another week, because the fever didn't go down with the Advil, she then took Tylenol and her fever went down. Treatment included: She gargled warm salt water and used steam, through her nose and mouth to help her chest with the cough; she cured herself. She would drink lots of liquids, her mouth was dry a lot of time. It was reported whooping cough from 27Apr2021 to ongoing, recovering; chills was from 27Apr2021 to 11May2021; loss of appetite from 27Apr2021 to 11May2021; high temperature from 27Apr2021 to 11May2021; weakness from 27Apr2021 to 11May2021. The outcome of event positive COVID-19 test with symptoms was unknown.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Feeling of body temperature change, Finger deformity
Clinical narrative: Fevers; Chills; Felt like I was going to faint; Arm was hurting; Felt super bad; Felt super hot then very cold; Felt like I had to vomit but I didn't; Pale; When I tried to move my arm I couldn't move it at all it was like it completely fell asleep; Fingers twisted; Smelled alcohol; Back hurt; Head hurt/light headaches; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 30-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: EW0172) at 0.3 ml single for COVID-19 immunization.  The patient had no known allergies and other medical history. The patient did not have COVID-19 prior vaccination. The patient was not pregnant. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 15Apr2021 04:00 pm (Lot Number: EW0153) for COVID-19 immunization. The next day after she got the vaccine, when she woke up her arm was hurting and then out of nowhere she felt super bad that she had to sit on the floor because she felt like she was going to faint. Then she felt superhot then very cold and she felt like she had to vomit but she didn't, her mom said she was pale and then when she tried to move her arm she couldn't move it at all it was like it completely fell asleep and her fingers twisted. she smelled alcohol and she started feeling better, all this happened in a matter of 10-15 mins. Then she spent the whole day in bed with fevers and chills every once in a while. The next couple of days her back hurt and her head hurt. she still get light headaches and her back hurts sometimes. Event onset date was 07May2021 09:00. The patient did not receive treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient come of the events was recovering
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Musculoskeletal disorder, Nausea, Pain in extremity
Clinical narrative: Fevers; Chills; Felt like I was going to faint; Arm was hurting; Felt super bad; Felt super hot then very cold; Felt like I had to vomit but I didn't; Pale; When I tried to move my arm I couldn't move it at all it was like it completely fell asleep; Fingers twisted; Smelled alcohol; Back hurt; Head hurt/light headaches; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 30-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: EW0172) at 0.3 ml single for COVID-19 immunization.  The patient had no known allergies and other medical history. The patient did not have COVID-19 prior vaccination. The patient was not pregnant. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 15Apr2021 04:00 pm (Lot Number: EW0153) for COVID-19 immunization. The next day after she got the vaccine, when she woke up her arm was hurting and then out of nowhere she felt super bad that she had to sit on the floor because she felt like she was going to faint. Then she felt superhot then very cold and she felt like she had to vomit but she didn't, her mom said she was pale and then when she tried to move her arm she couldn't move it at all it was like it completely fell asleep and her fingers twisted. she smelled alcohol and she started feeling better, all this happened in a matter of 10-15 mins. Then she spent the whole day in bed with fevers and chills every once in a while. The next couple of days her back hurt and her head hurt. she still get light headaches and her back hurts sometimes. Event onset date was 07May2021 09:00. The patient did not receive treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient come of the events was recovering
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Parosmia, Pyrexia
Clinical narrative: Fevers; Chills; Felt like I was going to faint; Arm was hurting; Felt super bad; Felt super hot then very cold; Felt like I had to vomit but I didn't; Pale; When I tried to move my arm I couldn't move it at all it was like it completely fell asleep; Fingers twisted; Smelled alcohol; Back hurt; Head hurt/light headaches; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 30-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: EW0172) at 0.3 ml single for COVID-19 immunization.  The patient had no known allergies and other medical history. The patient did not have COVID-19 prior vaccination. The patient was not pregnant. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 15Apr2021 04:00 pm (Lot Number: EW0153) for COVID-19 immunization. The next day after she got the vaccine, when she woke up her arm was hurting and then out of nowhere she felt super bad that she had to sit on the floor because she felt like she was going to faint. Then she felt superhot then very cold and she felt like she had to vomit but she didn't, her mom said she was pale and then when she tried to move her arm she couldn't move it at all it was like it completely fell asleep and her fingers twisted. she smelled alcohol and she started feeling better, all this happened in a matter of 10-15 mins. Then she spent the whole day in bed with fevers and chills every once in a while. The next couple of days her back hurt and her head hurt. she still get light headaches and her back hurts sometimes. Event onset date was 07May2021 09:00. The patient did not receive treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient come of the events was recovering
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Thrombosis, Ultrasound scan
Clinical narrative: Patient was diagnosed with blood clots confirmed by Ultrasound; This is a spontaneous report received from a contactable physician. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0164), on 21Apr2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history included colon cancer (patient had a history of colon cancer 2 years removed) from unspecified date. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 30Mar2021 as 1st dose, single for COVID-19 immunization. It was reported that patient was diagnosed with blood clots confirmed by ultrasound during the emergency room visit on 03May2021. Patient was placed on apixaban (ELIQUIS) 5 mg, twice a day.  Patient had history of colon cancer 2 years removed, and recent colonoscopy on 13Apr2021 was clear. The event was reported as non-serious. The outcome of the event was unknown.; Sender's Comments: The event of blood clot is assessed as possibly related to the suspect BNT162B2 based on temporal association, but medical history of colon cancer was confounder. 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 Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Cough, Diabetes mellitus management, Drug ineffective
Clinical narrative: Got Pfizer 1st shot 22MAR though had the virus; Got Pfizer 1st shot 22MAR though had the virus; Had terrible cough; having heart palpitation; had fatigue cough slept for 2 days; loss of breath; saw fluid on her chest.; has swollen lymph nodes; 3 abnormal EKG; A1C at 10 which used to be at 8; Right side of her foot is tingling and swollen; Right side of her foot is tingling and swollen; has aching in right arm and from the clavicles to the chest . Left arm feels same way/having different type of pain other from her chronic pain from C7; Was also having protein in urine; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included the patient had neck surgery and several falls before.  The patient's concomitant medications were not reported. The patient got Pfizer 1st shot 22Mar2021 though had the virus and Doctor did not want her to have the antibody test. End up in hospital. Had terrible cough and Doctor ended giving antibiotic. Had heart check and Electrocardiogram (EKG) done. Was having heart palpitation. She saw a diabetes Doctor and nephrologist. Was ready to have back surgery 05May. Also had fatigue cough slept for 2 days and had loss of breath. Called CDC and told her it was normal and her body was building the immune system. Additionally Doctor saw fluid on her chest. Surgeon told her she had swollen lymph nodes. Now she felt better but still have the cough. She was having different type of pain other from her chronic pain from C7. She went to the ER had 3 abnormal EKG and glycemia was at 500 and A1C at 10 which used to be at 8, never saw this before. Did not have a heart attack. Right side of her foot is tingling and swollen. When legs swell has aching in right arm and from the clavicles to the chest. Left arm feels same way. Went for pre-op and surgery was cancelled due to all those bad results. Was also having protein in urine but now everything is good. Had genetic testing  but everything was negative. Also still having coughing and lost of breath. Doctor wanted her to take the 2nd dose. The outcome of the event coughing and lost of breath was not recovered, of other events was unknown.  Information on the lot/batch number has been requested.