chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: felt unusual; tiredness; soreness of the arm and hip; soreness of the arm and hip; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 as Dose 1, single for Covid-19 immunization. The patient's medical history included asthma (she had asthma but did not feel shortness of breath). The patient's concomitant medications were not reported. She received her first dose yesterday. According to her, she has asthma but did not feel shortness of breath. However, she felt unusual, nothing severe. She felt tiredness, soreness of the arm and hip after the 1st dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Pyrexia, Vaccination site erythema
Clinical narrative: Rash on the right side where I had the Pfizer vaccination, rash on both arms; Seem like it has fever in because that area is warm, to the touch is warm and a little sore; Pain towards my ear, to my head; pain in my left ear and head; Itching; Headache; Swelling like almost that part of the arm where the injection site is; still was a little redness; where the injection site is, still was a little redness and still a little sore; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021(at the age of 82-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Rash on the right side where I had the Pfizer vaccination, rash on both arms , Seem like it has fever in because that area is warm, to the touch is warm and a little sore, Pain towards my ear, to my head; pain in my left ear and head, When I lean down I got like pump bump, but when I raise up it wouldn't be there it wasn't a continuous thing, Itching , Headache, Swelling like almost that part of the arm where the injection site is, still was a little redness and still a little sore. Consumer stated, It look like EN and then it look like X2O3, that's what it looks like I am not sure about that, I think it's ENX2O3. It might not be that, it might be 62O3, it might be that. All I know that last number is 62O3, it's EN something. Consumer stated, With the Itching I still have the little rashes on my arm and my arm is still a little sore, not as sore as it was yesterday but still a little sore with my head when I stoop down is not as bad. The event was not worsened. Patient did not take anything for that because that happened during the night while she was asleep. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash on the right side where I had the Pfizer vaccination, rash on both arms; Seem like it has fever in because that area is warm, to the touch is warm and a little sore; Pain towards my ear, to my head; pain in my left ear and head; Itching; Headache; Swelling like almost that part of the arm where the injection site is; still was a little redness; where the injection site is, still was a little redness and still a little sore; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021(at the age of 82-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Rash on the right side where I had the Pfizer vaccination, rash on both arms , Seem like it has fever in because that area is warm, to the touch is warm and a little sore, Pain towards my ear, to my head; pain in my left ear and head, When I lean down I got like pump bump, but when I raise up it wouldn't be there it wasn't a continuous thing, Itching , Headache, Swelling like almost that part of the arm where the injection site is, still was a little redness and still a little sore. Consumer stated, It look like EN and then it look like X2O3, that's what it looks like I am not sure about that, I think it's ENX2O3. It might not be that, it might be 62O3, it might be that. All I know that last number is 62O3, it's EN something. Consumer stated, With the Itching I still have the little rashes on my arm and my arm is still a little sore, not as sore as it was yesterday but still a little sore with my head when I stoop down is not as bad. The event was not worsened. Patient did not take anything for that because that happened during the night while she was asleep. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Diarrhoea, Feeling abnormal, Flatulence
Clinical narrative: inflammation of hands and feet after 48 hours such that I couldnot get one shoe on; body aches from hours 12-48; sweats without fever from hours 8-48; chills at 6 hours; headache within 15 minutes; overall malaise; intestinal issues (gas, cramps, diarrhea then constipation); as if my system has been in shock; intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); excessive sleepiness for last 10 days; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 26Feb2021 09:00 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve prolapse, osteoarthritis, skin cancer from an unknown date. Patient has known allergies to penicillin and erythromycin. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks. Patient was not pregnant at the time of vaccination. On 26Feb2021, within 15 minutes, patient experienced headache, chills at 6 hours, sweats without fever from hours 8-48, body aches from hours 12-48, intestinal issues (gas, cramps, diarrhea then constipation), excessive sleepiness for last 10 days, and overall malaise, as if her system has been in shock.. After 48 hours, on 28Feb2021, patient had inflammation of hands and feet, so she removed rings and could not get one shoe on. Since the vaccination, patient had not been tested for COVID. No treatment was received in response to the events.  The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Inflammation, Malaise, Muscle spasms
Clinical narrative: inflammation of hands and feet after 48 hours such that I couldnot get one shoe on; body aches from hours 12-48; sweats without fever from hours 8-48; chills at 6 hours; headache within 15 minutes; overall malaise; intestinal issues (gas, cramps, diarrhea then constipation); as if my system has been in shock; intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); excessive sleepiness for last 10 days; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 26Feb2021 09:00 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve prolapse, osteoarthritis, skin cancer from an unknown date. Patient has known allergies to penicillin and erythromycin. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks. Patient was not pregnant at the time of vaccination. On 26Feb2021, within 15 minutes, patient experienced headache, chills at 6 hours, sweats without fever from hours 8-48, body aches from hours 12-48, intestinal issues (gas, cramps, diarrhea then constipation), excessive sleepiness for last 10 days, and overall malaise, as if her system has been in shock.. After 48 hours, on 28Feb2021, patient had inflammation of hands and feet, so she removed rings and could not get one shoe on. Since the vaccination, patient had not been tested for COVID. No treatment was received in response to the events.  The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: inflammation of hands and feet after 48 hours such that I couldnot get one shoe on; body aches from hours 12-48; sweats without fever from hours 8-48; chills at 6 hours; headache within 15 minutes; overall malaise; intestinal issues (gas, cramps, diarrhea then constipation); as if my system has been in shock; intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); intestinal issues (gas, cramps, diarrhea then constipation); excessive sleepiness for last 10 days; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Left arm on 26Feb2021 09:00 (at the age of 60 year old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve prolapse, osteoarthritis, skin cancer from an unknown date. Patient has known allergies to penicillin and erythromycin. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks. Patient was not pregnant at the time of vaccination. On 26Feb2021, within 15 minutes, patient experienced headache, chills at 6 hours, sweats without fever from hours 8-48, body aches from hours 12-48, intestinal issues (gas, cramps, diarrhea then constipation), excessive sleepiness for last 10 days, and overall malaise, as if her system has been in shock.. After 48 hours, on 28Feb2021, patient had inflammation of hands and feet, so she removed rings and could not get one shoe on. Since the vaccination, patient had not been tested for COVID. No treatment was received in response to the events.  The outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph nodes swollen under her neck, arm pits, and the back of arms; problems breathing; a lot of headaches; tenderness around the shot site; A lot of joint pains especially in the hips; The first one from January has not healed. It makes a scab and it comes off. It is not healing.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN5318, expiration date not reported) via an unspecified route of administration, in left arm, on 30Jan2021 16:00 (at the age of 71-years-old), at dose 1, single for covid-19 immunization from convention center. Medical history included asthma, arthritis, diabetes, cholesterol, reflux (as reported), allergies, vitamin d (as reported). Concomitant medications included glipizide for diabetes; liraglutide (VICTOZA); lisinopril taken for diabetes to keep her kidneys healthy; rosuvastatin calcium (ROSUVASTIN) taken for cholesterol; fenofibric acid taken for reflux; montelukast sodium (MONTELUKAST) taken for allergy; cyanocobalamin (VITAMIN B12) taken for vitamin d; meloxicam taken for arthritis, mometasone furoate (NASONEX); ergocalciferol (VITAMIN D) taken for unspecific indication. Historical vaccine included flu shot (FLU) administered on 11Sep2020 (Fluad quad 2020 2021 syringe. HARX: 120345300 (as reported), lot number, expiry date: unknown) from pharmacy. No additional vaccines administered on the same date of vaccination. On an unspecified date after vaccination in 2021, the patient experienced lymph nodes swollen under her neck, arm pits, and the back of arms, a lot of headaches, a lot of joint pains especially in the hips, tenderness around the shot site and the vaccination site has not healed. It made a scab and came off. After 2 to 2.5 hours of vaccination, the patient also had problems of breathing. The patient had her second dose of vaccination on 05Mar2021 for COVID-19 immunization. The patient had no investigation assessments. Therapeutic measures were taken for problems breathing included nebulizer and albuterol emergency inhaler. The outcome of the event vaccination site has not healed/ a scab was not recovered and outcome of other events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site scab
Clinical narrative: lymph nodes swollen under her neck, arm pits, and the back of arms; problems breathing; a lot of headaches; tenderness around the shot site; A lot of joint pains especially in the hips; The first one from January has not healed. It makes a scab and it comes off. It is not healing.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN5318, expiration date not reported) via an unspecified route of administration, in left arm, on 30Jan2021 16:00 (at the age of 71-years-old), at dose 1, single for covid-19 immunization from convention center. Medical history included asthma, arthritis, diabetes, cholesterol, reflux (as reported), allergies, vitamin d (as reported). Concomitant medications included glipizide for diabetes; liraglutide (VICTOZA); lisinopril taken for diabetes to keep her kidneys healthy; rosuvastatin calcium (ROSUVASTIN) taken for cholesterol; fenofibric acid taken for reflux; montelukast sodium (MONTELUKAST) taken for allergy; cyanocobalamin (VITAMIN B12) taken for vitamin d; meloxicam taken for arthritis, mometasone furoate (NASONEX); ergocalciferol (VITAMIN D) taken for unspecific indication. Historical vaccine included flu shot (FLU) administered on 11Sep2020 (Fluad quad 2020 2021 syringe. HARX: 120345300 (as reported), lot number, expiry date: unknown) from pharmacy. No additional vaccines administered on the same date of vaccination. On an unspecified date after vaccination in 2021, the patient experienced lymph nodes swollen under her neck, arm pits, and the back of arms, a lot of headaches, a lot of joint pains especially in the hips, tenderness around the shot site and the vaccination site has not healed. It made a scab and came off. After 2 to 2.5 hours of vaccination, the patient also had problems of breathing. The patient had her second dose of vaccination on 05Mar2021 for COVID-19 immunization. The patient had no investigation assessments. Therapeutic measures were taken for problems breathing included nebulizer and albuterol emergency inhaler. The outcome of the event vaccination site has not healed/ a scab was not recovered and outcome of other events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: she woke up and couldn't taste anything; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 03Feb2021 at 10:30 (at the age of 75-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure, diabetes type II, restless legs, fibromyalgia, and anticoagulant therapy all from an unknown date. Concomitant medications included pantoprazole, atorvastatin, pramipexole taken for restless legs, acetylsalicylic acid (BAYER ASPIRIN), clopidogrel taken for blood thinner, gabapentin taken for fibromyalgia, fluoxetine, valsartan taken for blood pressure, metformin taken for diabetes, ubidecarenone (COQ-10), fish oil, vitamin d3, and ascorbic acid (VITAMIN C); start and stop date were not reported. On 04Feb2021 between 5:00 AM and 6:00AM, the patient noticed she couldn't taste anything. The patient further reported that she lost her sense of taste. The patient then received second dose of BNT162B2 on 23Feb2021 and stated that she still does not have her sense of taste. The patient wanted to know when she will get her taste back and how long will this last. After her second dose, the patient went to the doctor for UT infection and asked the doctor about not being able to taste. The patient has not recovered from the event.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash all over the body; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on Saturday (unspecified date). The patient experienced red rash all over the body on unspecified date. The reporter asked if the patient should go to the hospital. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Rash. Started under armpit and has spread over body. It is spotted and not a continuous rash. I thought it resembled psoriasis spots; Administration date= 04Feb2021/Other vaccine same date vaccine date=18Feb2021; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Feb2021 as dose 2, single for covid-19 immunisation from workplace clinic. Medical history included hashimoto's and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 25Feb2021, patient experienced rash started under armpit and has spread over body. it is spotted and not a continuous rash. Patient thought it resembled psoriasis spots and never had anything like it until vaccination. Patient see the doctor next week. The patient administration date dose on 04feb2021 and other vaccine same date vaccine date on 18Feb2021. The outcome of event rash was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: just been feeling off; headache; tightness in lungs; loose stool; This is a spontaneous report from a contactable health care professional (patient). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 03Mar2021 at 15:00 (Lot Number: EN6202) as dose 1, single for COVID-19 immunization.  Medical history Hashimotos, Polyarthritis (most likely psoriatic) and allergies to sulfa antibiotics, penicillin (reported as PCN), scallops and gluten all from unknown dates. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); trazodone (manufacturer unknown); etanercept (ENBREL) and semaglutide (OZEMPIC), all taken for an unspecified indication, start and stop date were not reported. The patient experienced headache, tightness in lungs, loose stool and has just been feeling off on 04Mar2021 at 07:15. The patient did not receive treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pyrexia
Clinical narrative: blisters; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (spouse) reported that a male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient developed blisters and fever after having his first dose. He took Valacyclovir for the events. His next supposed dose will be on 26Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash from head to toe; This is a spontaneous report. A non-contactable other healthcare professional reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported, Expiration Date: 22Feb2021), via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash from head to toe with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Bone pain, Chills, Cough
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6208), at the age of 59, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient stated that she took the COVID-19 vaccine on Monday. She had been sick since that Monday until the day of report. The patient stated the symptoms they go and come back and same again. On Monday, patient's arm was sore (that was expected). On Tuesday morning she woke up with a cough. On Wednesday, she had fever, and had been shivering. The patient had fever and a cough. On Thursday, the cough stopped, and she had diarrhea. On Friday, patient had a headache and lost her taste. She lost taste since that Friday until the day of report. The patient was coughing and shivering no matter what she took. Nothing really helped. The patient took Tylenol. It helped for a while, then after that she went back to the same point again. The patient stated the cough was back where it was before. The patient could not even go to work, she felt so weak. She had muscle aches all over her body; her bone all over. She was wondering if she had to go for the second dose. The patient underwent lab tests and procedures, which included COVID test: result unknown on Mar 7, 2021. The outcome of cough, shivering, lost taste: not recovered; and outcome of other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6208), at the age of 59, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient stated that she took the COVID-19 vaccine on Monday. She had been sick since that Monday until the day of report. The patient stated the symptoms they go and come back and same again. On Monday, patient's arm was sore (that was expected). On Tuesday morning she woke up with a cough. On Wednesday, she had fever, and had been shivering. The patient had fever and a cough. On Thursday, the cough stopped, and she had diarrhea. On Friday, patient had a headache and lost her taste. She lost taste since that Friday until the day of report. The patient was coughing and shivering no matter what she took. Nothing really helped. The patient took Tylenol. It helped for a while, then after that she went back to the same point again. The patient stated the cough was back where it was before. The patient could not even go to work, she felt so weak. She had muscle aches all over her body; her bone all over. She was wondering if she had to go for the second dose. The patient underwent lab tests and procedures, which included COVID test: result unknown on Mar 7, 2021. The outcome of cough, shivering, lost taste: not recovered; and outcome of other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6208), at the age of 59, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient stated that she took the COVID-19 vaccine on Monday. She had been sick since that Monday until the day of report. The patient stated the symptoms they go and come back and same again. On Monday, patient's arm was sore (that was expected). On Tuesday morning she woke up with a cough. On Wednesday, she had fever, and had been shivering. The patient had fever and a cough. On Thursday, the cough stopped, and she had diarrhea. On Friday, patient had a headache and lost her taste. She lost taste since that Friday until the day of report. The patient was coughing and shivering no matter what she took. Nothing really helped. The patient took Tylenol. It helped for a while, then after that she went back to the same point again. The patient stated the cough was back where it was before. The patient could not even go to work, she felt so weak. She had muscle aches all over her body; her bone all over. She was wondering if she had to go for the second dose. The patient underwent lab tests and procedures, which included COVID test: result unknown on Mar 7, 2021. The outcome of cough, shivering, lost taste: not recovered; and outcome of other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Dizziness; left arm was numb; fingers moved by themselves; felt like his tongue was swollen; lips were numb; slight headache; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 13:00 (Lot Number: EN6206) (a the age of 76-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes and when his sugar dropped, he got dizzy and weak. Concomitant medications included metformin; rivaroxaban (XARELTO); metoprolol succinate; simvastatin; borago officinalis oil, fish oil, linum usitatissimum oil (TRIPLE OMEGA 3 6 9); cyanocobalamin (VITAMIN B12); colecalciferol (VITAMIN D3); all taken for an unspecified indication from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks. The patient was fine on 06Mar2021, day of vaccination. Towards the morning on 07Mar2021, he was feeling a little dizzy. His left arm was numb, and his fingers moved by themselves, his tongue felt like it was swollen, his lips were numb. He also had a slight headache. He slept until 4:30pm and took a nap for 5 hours. The reporter gave him a Tylenol as treatment. When the patient started seeing the doctor, he took blood work. He received a lab report, but reporter was unable to provide results. The event did not require emergency room visit but required physician office visit. The reporter was unsure if these are side effects. The outcome of dizziness, twitching and headache was unknown, and outcome of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Swollen tongue
Clinical narrative: Dizziness; left arm was numb; fingers moved by themselves; felt like his tongue was swollen; lips were numb; slight headache; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 13:00 (Lot Number: EN6206) (a the age of 76-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes and when his sugar dropped, he got dizzy and weak. Concomitant medications included metformin; rivaroxaban (XARELTO); metoprolol succinate; simvastatin; borago officinalis oil, fish oil, linum usitatissimum oil (TRIPLE OMEGA 3 6 9); cyanocobalamin (VITAMIN B12); colecalciferol (VITAMIN D3); all taken for an unspecified indication from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks. The patient was fine on 06Mar2021, day of vaccination. Towards the morning on 07Mar2021, he was feeling a little dizzy. His left arm was numb, and his fingers moved by themselves, his tongue felt like it was swollen, his lips were numb. He also had a slight headache. He slept until 4:30pm and took a nap for 5 hours. The reporter gave him a Tylenol as treatment. When the patient started seeing the doctor, he took blood work. He received a lab report, but reporter was unable to provide results. The event did not require emergency room visit but required physician office visit. The reporter was unsure if these are side effects. The outcome of dizziness, twitching and headache was unknown, and outcome of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: shoulder got very sore; the arm that they gave the shot in, my shoulder got very sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included 'arthritis in my shoulder.' The patient's concomitant medications were not reported. The patient was not reporting a severe reaction. Patient sated that "I have arthritis in my shoulder, the arm that they gave the shot in, my shoulder got very sore" on an unspecified date. The patient wanted to know if it was okay to take something for it like Acetaminophen or something. Somebody told the patient that Ibuprofen or Aspirin should not be taken. Patient did not know how many days it was not supposed to be taken for. Patient wanted to know if something could be taken for it or not. The patient still wanted to get the second shot. Outcome of the events was unknown.     No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia, Vomiting
Clinical narrative: body sweats; muscle pain; vomiting; fever; This is a spontaneous report from a Regulatory Authority. A contactable consumer (patient) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 70 years, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she was currently out of Genotropin medication. She also stated that on an unspecified date, she was not feeling well post COVID vaccination as she has had body sweats, muscle pain, vomiting and a fever and she was not able to get out of the bed. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Palpitations, Paraesthesia
Clinical narrative: had tingling in my ring and pinky fingers that felt like it was falling asleep; dizziness; elevated heart rate/heart pounding; elevated heart rate/heart pounding; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP 6955), (at the age of 40- years-old) via an unspecified route of administration, administered in Arm Right on 16Mar2021 13:45 as dose 1, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ofloxacin (OFLOXACIN) taken for an unspecified indication, start and stop date were not reported. It was reported that she was not a pregnant at the time of vaccination.  She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient had no known allergies. About 10 min after receipt of vaccine in right arm (16Mar2021 14:00), she had tingling in her ring and pinky fingers that felt like it was falling asleep. That was followed by dizziness and elevated heart rate/heart pounding. she had tinging. In her lips on the right side and her tongue. There was a funny taste in her mouth as well. She sat for a while but her heart was still pounding so requested to lay down. The tingling in her arm was not fully subsided 2 hours later and on 23Mar2021 seven days following first dose, the tingling recurred in the same area of her right arm, affecting the forearm and ring, pinky fingers. patient did not received treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity
Clinical narrative: she had bad allergies and was like a water faucet.; Felt really tired; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 51-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6200) via an unspecified route of administration in left arm on 19Feb2021 08:15 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization. Patient medical history was not reported. The concomitant medications were reported as none. Family Medical History Relevant to adverse events included Nephew with Covid, Niece that had Covid.  States she was not around them. She had a flu shot on an unspecified date in Oct2020 (reported as October) at, no issues voiced. Vaccination facility type was reported as School/Student Health Clinic. Patient did not receive the vaccine at a  facility. On 19Feb2021, the patient felt really tired, starting around 13:00 to 14:00 the day of the vaccine. Felt done, tired, and went to bed early. Was tired from that Friday 19Feb2021 until that Sunday 21Feb2021. Felt better on Monday 22Feb2021. Patient stated that on 11Mar2021 she had bad allergies and was like a water faucet.  She took children Benadryl 12.5mg 2 tablets and some eye drops.  Stated that it helped. Thought she was allergic to something in the building. Patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6204) via an unspecified route of administration in left arm on 12Mar2021 as dose 2, single for COVID-19 immunization. After receiving her second dose of the vaccine she thought she did not feel to bad at all, not tired like with the first one; until she woke up with this today. Patient experienced sore arm, Bells Palsy and she woke up her left eye felt weird after the second dose of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient mentioned she had no AEs prior to vaccination. Stated she was not the only one feeling tired, quite a few others were also. No further information or identifiers provided. The outcome of the event tiredness was resolved on 21Feb2021 while that of allergic reaction was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenitis
Clinical narrative: Diagnosed she has a lymph node in her neck that is filled, probably from infection; This is a spontaneous report from a non-contactable consumer (patient) via a REGULATORY authority. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was diagnosed, she had a lymph node in her neck that was filled, probably from infection. The patient underwent lab tests and procedures which included investigation: resulted as she had a lymph node in her neck that was filled, probably from infection. Therapeutic measure was taken as a result of the event and patient was prescribed Amoxicillin for that. Inquiring if that would affect her Covid vaccine shot that she was scheduled to receive on Wednesday. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: was put on 2 medications for a sinus infection; This is a spontaneous report received from a sponsored program Support. A contactable consumer (patient) reported that:   A male patient of an unspecified age received of first dose bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient received 1st dose of Covid vacine and then was put on 2 medications for a sinus infection. The patient wondering if he can take medication and still take 2nd dose of Covid vaccine. Therapeutic measures were taken as a result of was put on 2 medications for a sinus infection (sinusitis). Outcome of event was reported as unknown.  Information on the lot/batch number was requested.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Pyrexia, Renal disorder
Clinical narrative: Dizzy/Lightheaded; Stumbling; Vomiting; Headache; I have damage to my kidneys; Fever; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old male patient received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient reported that his hands are a mess they're like a ball. Patient took Pfizer Vaccine and when he got up in the middle of the night he felt dizzy, stumbling and vomiting all night. Patient was vomiting with a headache for three days. He damaged his kidney and had lightheaded and fever. Patient was prescribed with Xeljanz 5 MG. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizzy/Lightheaded; Stumbling; Vomiting; Headache; I have damage to my kidneys; Fever; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old male patient received unknown dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient reported that his hands are a mess they're like a ball. Patient took Pfizer Vaccine and when he got up in the middle of the night he felt dizzy, stumbling and vomiting all night. Patient was vomiting with a headache for three days. He damaged his kidney and had lightheaded and fever. Patient was prescribed with Xeljanz 5 MG. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Heart rate increased, Nausea, Supraventricular tachycardia
Clinical narrative: During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated; During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated; She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen.; Upon arrival to bay, HR 180-190; This is a spontaneous report from a non-contactable other health care professional. A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 70-years), on 24Mar2021 as dose 2, single for COVID-19 immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included dementia Alzheimer's type, Patient husband stated supraventricular tachy-cardia usually in high 200's or low 300's if it comes on, heart rate in the 150s at times from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, the patient experienced during her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated, she felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen, upon arrival to bay, hr 180-190. The treatment was received for the events with water and Trendelenburg position. The patient underwent lab tests and procedures which included heart rate increased: 180-190, heart rate increased: hr in the 150s at times HR in the 150s at times , supraventricular tachycardia: usually in high 200's or low 300's if it comes Usually in high 200's or low 300's if it comes on all on an unspecified date. Usually resolves on its own with elevation of feet above patient head per patient husband. Patient husband was main caregiver. He was not worried about it but wanted to know what her pressures were doing. Differential Diagnosis: Red flag symptoms. Follow up response to treatment: fair. Patient discharge. The clinical outcome of the events during her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated, she felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen, upon arrival to bay, hr 180-190 was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; fever; muscle aches; nausea; headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old non-pregnancy female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 26Mar2021 at 15:00 (age at vaccination 54years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing autoimmune disorders/allergies run in the family, drug hypersensitivity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing , mycotic allergy from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing , dairy intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19 reported as unknown. The patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 26Mar2021 at 20:00 the patient experienced chills, fever, muscle aches, nausea, headache. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered on unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.