chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I am having hives; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0150) on 31-Mar-2021 at single dose for COVID-19 immunization. The patient had second vaccine about two weeks ago from the day of report and on the day of report, on an unspecified date in 2021, in the morning, the patient developed hives. The patient reported to have hives and then the patient called the doctor's office and they told to probably call someone connected with vaccine to see if it was caused by that and what should be done about it. The patient wanted to know whether to guess if it was connected to the vaccine or not. The patient reported that she was not sure if she called the right number because the sheet she received, it was confusing to her. She was trying to get a hold of a nurse or someone who could may be tell me if the symptoms she was having could be related to the COVID vaccine. In response to further probing, the patient stated that the patient would rather not do that right now. Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call. Event seriousness was not specified. The clinical outcome of events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: severe sore throat; I was experiencing fever; I am in pain and after the vaccine shot; This is a spontaneous report from a contactable consumer. A 29 years male consumer (patient) re-ported.  A 29-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0175, Expiry date: not reported) via an unspecified route of administration, on 01May2021 (29-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05May2021, the patient experienced severe sore throat, i was experiencing fever and i am in pain and after the vaccine shot. It was reported that patient stated that he just recently got the Pfizer (Covid-19 Vaccine) first shot on Saturday and he was experiencing fever, and he would say severe sore throat. He don't know its good bad, is that supposed to happen, or he don't know he was in pain and after the vaccine shot, he don't know what steps to take. The patient stated not received treatment as , he is experiencing the symptoms today." The patient did not receive any treatment for the event. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Arm and shoulder pain was mild/sore arm and whole shoulder after first dose; Headache after first dose; Arm and shoulder pain was mild/sore arm and whole shoulder after first dose; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 38-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 12Mar2021 (at the age of 38-year-old) as dose 1, single for covid-19 immunization. Medical history reported as No. The patient's concomitant medications were not reported. Additional vaccines was not administered on same date of the Pfizer suspect. On 12Mar2021 the patient experienced arm and shoulder pain was mild/sore arm and whole shoulder after first dose, headache after first dose. Caller lost his father 2 weeks before he received his vaccine. It was motivation, for himself and his family to get the vaccine. Emergency room, physician office visit reported as no. Relevant Tests reported as no. Outcome of the event Arm and shoulder pain was mild/sore arm and whole shoulder after first dose resolved on 16Mar2021 and outcome of the event Headache after first dose was resolved on 13Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a non-contactable other hcp (Nurse). A patient of unspecified age and gender received BNT162B2 (BNT162B2), Formulation solution for injection, Batch/Lot number was not reported via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Sneezing
Clinical narrative: Feeling sick; Sneezing a lot; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer was calling for her husband he had his first shot on Saturday, but he was feeling very sick and he was sneezing a lot on unspecified date. The outcome of events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Headache
Clinical narrative: I start feeling really bad headache; now I have difficult to breath; I start feeling really bad headache; now I have difficult to breath; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Not Reported, Expiry Date: Unknown) via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the patient took the 1st dose on 14Apr2021, and the patient had the appointment for 2nd dose on Friday but that last Friday (28Apr2021) the patient started feeling really bad headache, then the patient had difficult to breath. Patient stated, ok so I take the 1st dose on 14Apr2021and I have the appointment for my 2nd dose on Friday but this last Friday I start feeling really bad headache, now I have difficult to breath. I took the Covid test that was negative but now I have difficult to breath, so it's okay to do the second dose on Friday or should I wait. The patient underwent lab tests and procedures which included covid-19 that was negative on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 at 09:30 (at the age of 59-years-old) as DOSE 1, SINGLE for covid-19 immunisation (to not catch Covid. He works with the public. To not infect anyone else). Medical history included ongoing hypertension from an unspecified date (high blood pressure) reported as He takes medication for high blood pressure. Concomitant medication included unspecified medication for high blood pressure. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No prior vaccinations within 4 weeks. Patient Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AEs was none. On 11Mar2021, the next day after vaccination patient experienced sore shoulder. While reporting on friend, the patient added that he received both doses of the Pfizer vaccine. He did not have any problems except for a sore shoulder. It lasted for about 12 hours. He gets weekly texts to see if he has a reaction. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 31Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Event did not require a visit to Emergency Room or Physician Office. Relevant Tests done were none. Reporter seriousness for sore shoulder was Unspecified. The outcome of sore shoulder was resolved on 12Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: soreness only on my arm where the vaccination was done; I broke out in a rash on my torso; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: unknown, expiry date was unknown) on an unspecified date via an unspecified route of administration as DOSE 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date via an unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date the patient experienced that after taking second dose patient reported soreness on arm where the vaccination was done and about a week later patient broke out in a rash, on the torso which lasted for about 3 or 4 days. The patient did not change soaps or anything. The outcome of the event soreness on arm where the vaccination was done was unknown. The outcome of the event broke out in a rash, on the torso was resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: A little swelling; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EW0173) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. She had her covid vaccine about 30 minutes ago she had  a question because her pharmacist gave her soluble thereafter because she was experiencing little swelling on an unspecified date. The outcome of event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pyrexia, Somnolence, Tremor
Clinical narrative: cold; chills; shaking; a fever 100.1; She dozed and went to sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: ER8737), via an unspecified route of administration in Arm on 05May2021 (Age at vaccination 76-years-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included bad back which have been for 15 years or longer, high blood pressure which had for 20-something years, gastro stomach problems which had for 15 years, probably 10 to 15 years, blood clot, blood thinner, covid-19 from unspecified date in Jan2021 to an unknown date. Concomitant medications included cetirizine taken for hypersensitivity, apixaban (ELIQUIS) taken for anticoagulant therapy, lisinopril taken for blood pressure measurement, amlodipine (AMLODIPINE) taken for blood pressure measurement, famotidine, ergocalciferol (VIT D), ascorbic acid (VITAMIN-C). Patient did not receive any other vaccinations within four weeks prior to the Covid1-19 vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: ER8727), via an unspecified route of administration in Arm left on 16Apr2021 as DOSE 1, SINGLE for covid-19 immunization and experienced fever and chills. Patient reported that she took her first vaccine and then she had chills so bad she could not stop shaking. Patient had a fever 100 and cold which was last night. She does not feel bad, she does not feel sick or anything. She guesses it is because of the blood thinners she is taking because she had COVID but had a clot in her lung. Her doctor said the clot is gone but the doctor wanted her to finish taking the blood thinner. Patient added there was nothing else, just she was so cold she could not take her blood pressure. She dozed and went to sleep. She stated that thank God this morning she was not cold. Patient stated that she did some lab work but that was last week. The only thing the doctor did was give her a chest, nuclear. Patient confirms as chest, nuclear. She thinks that is how it is spelled, like a nuclear bomb. The doctor said the clot was gone. The doctor did not see it, that is why they did a nuclear test and they injected nuclear fluid into her arm so it could go to her lungs to let them know if anything was still there. She developed the blood clot when she got COVID. The outcome of all the events was unknown  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb mass, Lymph node pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: I had a swollen lump at the back of my arm; Pain and swollen area in my Lymph nodes/swollen lymph nodes; Swelling and soreness to the back of the arm that was injected; Swelling and soreness to the back of the arm that was injected; Pain and swollen area in my Lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 26Apr2021 (at the age of 71-years-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid vaccine on 26Apr2021, was complaining of swelling and soreness to the back of the arm that was injected, which began a week after the vaccine (May2021). Had been taking Advil and used Hydrocortisone, as well as applying ice. Patient also experienced swollen lymph nodes (May2021) (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. She wanted to ask if, she should proceed with her second vaccine shot on 16May2021. Patient further stated, she got her first Pfizer shot (COVID Vaccine) on April26 and about 10days later (May2021) she had a swollen lump at the back of her arm where the shot was given up at the top of arm in the back swollen lump and she had been putting ice on it for a few days and taking Advil and she did not know what that was. She needed to know if she could still get her second shot. Patient took Tylenol 500 mg once a day for the pain and swollen area in her lymph nodes and she took 2 Advil may be in 3 days and the Advil then she knew was 200 mg each. She had not taken anything in 24 hours. Therapeutic measures were taken as a result of i had a swollen lump at the back of my arm (limb mass), swelling and soreness to the back of the arm that was injected (vaccination site swelling), swelling, Pain and swollen area in my Lymph nodes (lymph node pain), Pain and swollen area in my Lymph nodes/swollen lymph nodes (swollen lymph nodes) and soreness to the back of the arm that was injected (vaccination site pain). The clinical outcome for the events was unknown except recovered for pain and swollen area in my Lymph nodes/swollen lymph nodes on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site pain
Clinical narrative: I had a swollen lump at the back of my arm; Pain and swollen area in my Lymph nodes/swollen lymph nodes; Swelling and soreness to the back of the arm that was injected; Swelling and soreness to the back of the arm that was injected; Pain and swollen area in my Lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 26Apr2021 (at the age of 71-years-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid vaccine on 26Apr2021, was complaining of swelling and soreness to the back of the arm that was injected, which began a week after the vaccine (May2021). Had been taking Advil and used Hydrocortisone, as well as applying ice. Patient also experienced swollen lymph nodes (May2021) (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. She wanted to ask if, she should proceed with her second vaccine shot on 16May2021. Patient further stated, she got her first Pfizer shot (COVID Vaccine) on April26 and about 10days later (May2021) she had a swollen lump at the back of her arm where the shot was given up at the top of arm in the back swollen lump and she had been putting ice on it for a few days and taking Advil and she did not know what that was. She needed to know if she could still get her second shot. Patient took Tylenol 500 mg once a day for the pain and swollen area in her lymph nodes and she took 2 Advil may be in 3 days and the Advil then she knew was 200 mg each. She had not taken anything in 24 hours. Therapeutic measures were taken as a result of i had a swollen lump at the back of my arm (limb mass), swelling and soreness to the back of the arm that was injected (vaccination site swelling), swelling, Pain and swollen area in my Lymph nodes (lymph node pain), Pain and swollen area in my Lymph nodes/swollen lymph nodes (swollen lymph nodes) and soreness to the back of the arm that was injected (vaccination site pain). The clinical outcome for the events was unknown except recovered for pain and swollen area in my Lymph nodes/swollen lymph nodes on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes all over her body; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EWN0171), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroid. The patients concomitant medications were not reported.  The patient experienced rashes all over her body on an unspecified date.She called the hospital and they said that her rashes may be an allergy to one of the ingredients of the vaccine or it's her immune system reacting with the vaccine. She took Zyrtec medication for this side effect. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache for 2 days and today she is fine; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received 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 single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and headache for 2 days on an unspecified date and today she was fine. The outcome of the events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had rashes on both arms but not on the injection site; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07May2021, the patient received the second dose of Pfizer Covid-19 vaccine and had rashes on both arms but not on the injection site. They enquired how long the rashes will last. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Sinusitis
Clinical narrative: Have a stuffy nose and a cough; Have a stuffy nose and a cough; I have been dealing with my sinusitis; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history included ongoing sinusitis (this happens with her every year). The patient concomitant medications were not reported. On an unspecified date in 2021, the patent experienced have a stuffy nose and a cough, I have been dealing with my sinusitis. Patient stated, I received my first dose of Pfizer (Unspecified Medication) on April 15, and I am scheduled to receive my second dose this evening but for the past week I have been dealing with my sinusitis. I have a stuffy nose and a cough So; I didn't know if I can still get the vaccine today. Patient stated, yes but this happened due to my sinusitis, this happens with me every year around this time (Further clarification was unknown). At the time of this report, outcome of all the events was unknown.  No follow-up attempts were needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: reddess, rash, hot to touch right side of face; reddess, rash, hot to touch right side of face; scalp is itchy; This is a spontaneous report from a contactable consumer or other non hcp.  A 57-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 as 2nd dose, single for covid-19 immunisation. Medical history included cerebrovascular accident from 2010, Stroke in 2010, peripheral sensory neuropathy from 2009, Sensory neuropathy as a result of car accident in 2009. The patient's concomitant medications were not reported. It was reported that, on 06May2021, the patient experienced redness, rash, hot to touch right side of face with outcome of not recovered. Therapeutic measures were taken as a result of redness, rash, hot to touch right side of face (rash)  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Loss of personal independence in daily activities, Nausea, Speech disorder, Tremor
Clinical narrative: am unable to go to work, so I am on short-term disability as a result; was at work when I suddenly was unable to stand. I dropped to my knees and started vomiting. I couldn't open my eyes because everything was shaking or moving. I was admitted to emergency room; was at work when I suddenly was unable to stand. I dropped to my knees and started vomiting. I couldn't open my eyes because everything was shaking or moving. I was admitted to emergency room; nauseous.; My vision is still off; could not stand; difficulty talking; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (at the age of 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. Patient did not have known allergies. Concomitant medication(s) included pantoprazole sodium sesquihydrate (PANTOPRAZOL A) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151), administered in Arm Right on 08Apr2021 15:00 (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. The patient stated that on 29Apr2021, he was at work when he suddenly was unable to stand. He dropped to his knees and started vomiting. He could not open his eyes because everything was shaking or moving. He was admitted to emergency room. He could not stand or open his eyes without being nauseous. Everything was still shaking. He had severe vomiting. He was released and sent home. He was unable to stand or open eyes for 48 hours. He had difficulty talking without vomiting. On day 3, he was able to sit up and walk with assistance. He was also slowly able to hold down food. It was day 11 and he was still unsteady on his feet. His vision was still off. It was still very hard to focus. He was unable to go to work, so was on short-term disability as a result. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient did not receive any treatment. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: am unable to go to work, so I am on short-term disability as a result; was at work when I suddenly was unable to stand. I dropped to my knees and started vomiting. I couldn't open my eyes because everything was shaking or moving. I was admitted to emergency room; was at work when I suddenly was unable to stand. I dropped to my knees and started vomiting. I couldn't open my eyes because everything was shaking or moving. I was admitted to emergency room; nauseous.; My vision is still off; could not stand; difficulty talking; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (at the age of 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. Patient did not have known allergies. Concomitant medication(s) included pantoprazole sodium sesquihydrate (PANTOPRAZOL A) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151), administered in Arm Right on 08Apr2021 15:00 (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. The patient stated that on 29Apr2021, he was at work when he suddenly was unable to stand. He dropped to his knees and started vomiting. He could not open his eyes because everything was shaking or moving. He was admitted to emergency room. He could not stand or open his eyes without being nauseous. Everything was still shaking. He had severe vomiting. He was released and sent home. He was unable to stand or open eyes for 48 hours. He had difficulty talking without vomiting. On day 3, he was able to sit up and walk with assistance. He was also slowly able to hold down food. It was day 11 and he was still unsteady on his feet. His vision was still off. It was still very hard to focus. He was unable to go to work, so was on short-term disability as a result. Patient did not have covid prior vaccination and covid was not tested post vaccination. Patient did not receive any treatment. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Hypoaesthesia
Clinical narrative: they put something in her gums for numbness; Can't Taste; This is a spontaneous report from a contactable consumer (Patient). A 19-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0167, Expiration Date: 31Aug2021, NDC number: Unknown), via an unspecified route of administration, administered in left arm on 06May2021 (at the age of 19-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. There were no investigation assessment and no other products. On an unspecified date patient experienced if something they put in her gums for numbness and on 06May2021, patient experienced can't taste. The clinical course reported as follows, Caller states when she got the vaccine today they asked about any other vaccines she had recently. Caller states the only thing that slipped her mind was they put something in her gums for numbness the other day at the dentist. Caller asks if that will have an effect on the vaccine or not.   Caller states since she has gotten the shot, she can't taste. Clarifies her taste was not gone completely. States if it was on her tongue, she can't taste it but if swallows it, then she can taste it. Caller states she tested it by candy, once she swallowed, she could taste it, but when it was directly on her tongue, she couldn't taste anything. Caller states if she licks ice cream, she can't taste it at all. Caller states she read the entire fact sheet and she doesn't see anything about that and was asking was this a normal side effect from the vaccine. Caller confirms today was her first dose of the vaccine. The outcome of event can't taste was not recovered and for other it was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: rash on her right arm; arm was a little itchy; Rash is red; This is a spontaneous report from a contactable consumer. This contactable female consumer (reported for herself). An 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737, expiry date: unspecified date in Jul2021) via unknown route of administration in right arm on 19Apr2021 (at the age of 89 Years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she got her first dose on 19April2021, about 12:00 because she got the shot and then had to wait and go into another room where she waited 15 minutes and maybe it was 13:00 when she got the vaccine. Caller stated so she had to wait 15 minutes and it was like 13:05 when she could leave so she had to have got the first dose of the vaccine sometime between 12:00 and 12:45 and had no problems everything was fine until this week on 05May2021, Wednesday she broke out with a rash on her right arm which was the arm she got the shot in, and also her arm was a little itchy but not worse than a regular rash but it was a rash. It was stated that she had not been ill or feverish she just developed a rash. Reporter stated she is due to get the second dose on Monday 10May2021 and was wondering if she should get the vaccine or not. Caller stated her rash was not as red but it had not disappeared but the itching was bad yesterday and it was not itchy now. Caller stated the thing that bothered her is that she is due for the second shot on Monday and it started to get more itchy last night and if it was not for the itching she would probably would not be calling now. Caller stated the itching stopped this morning and was not experience it currently. Caller stated she was not sure if she had recovered completely from the itching since it was still early in the day as it was 11:00 am where she was at and she was not sure what it will feel like at say 6:00pm. Caller stated she had not seen her doctor for a year, ever since the pandemic she had a telephone call and her doctor works in the afternoon Monday through Thursday and she had not been able to reach him. Patient did not have other vaccines Prior Vaccinations (within 4 weeks). Patient did not visit Emergency Room or Physician Office due to events. Patient did not receive treatment. The outcome of the event arm was a little itchy was recovered on 07May2021 and other events were recovering.  No follow-up attempts were needed. No further information was expected.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on her right arm; arm was a little itchy; Rash is red; This is a spontaneous report from a contactable consumer. This contactable female consumer (reported for herself). An 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737, expiry date: unspecified date in Jul2021) via unknown route of administration in right arm on 19Apr2021 (at the age of 89 Years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she got her first dose on 19April2021, about 12:00 because she got the shot and then had to wait and go into another room where she waited 15 minutes and maybe it was 13:00 when she got the vaccine. Caller stated so she had to wait 15 minutes and it was like 13:05 when she could leave so she had to have got the first dose of the vaccine sometime between 12:00 and 12:45 and had no problems everything was fine until this week on 05May2021, Wednesday she broke out with a rash on her right arm which was the arm she got the shot in, and also her arm was a little itchy but not worse than a regular rash but it was a rash. It was stated that she had not been ill or feverish she just developed a rash. Reporter stated she is due to get the second dose on Monday 10May2021 and was wondering if she should get the vaccine or not. Caller stated her rash was not as red but it had not disappeared but the itching was bad yesterday and it was not itchy now. Caller stated the thing that bothered her is that she is due for the second shot on Monday and it started to get more itchy last night and if it was not for the itching she would probably would not be calling now. Caller stated the itching stopped this morning and was not experience it currently. Caller stated she was not sure if she had recovered completely from the itching since it was still early in the day as it was 11:00 am where she was at and she was not sure what it will feel like at say 6:00pm. Caller stated she had not seen her doctor for a year, ever since the pandemic she had a telephone call and her doctor works in the afternoon Monday through Thursday and she had not been able to reach him. Patient did not have other vaccines Prior Vaccinations (within 4 weeks). Patient did not visit Emergency Room or Physician Office due to events. Patient did not receive treatment. The outcome of the event arm was a little itchy was recovered on 07May2021 and other events were recovering.  No follow-up attempts were needed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Nasopharyngitis, Sinusitis
Clinical narrative: sinus infections; I just got over a bronchitis, cold like a slight bronchitis; I just got over a bronchitis, cold like a slight bronchitis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 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. OOn an unspecified date, the patient experienced sinus infections, i just got over a bronchitis, cold like a slight bronchitis. Reporter was asked if elderly parents can get vaccine because little congested, coughing.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: He is been running a fever about 100 degree, 101 degree; My son has headache for almost 2-4 days; This is a spontaneous report from a contactable consumer (Patient father).  A male patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose (Dose number unknown) for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient has headache for almost 2-4 days. He has been running a fever about 100-degree, 101-degree. Outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information was expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed; Fever; Left Arm Soreness; the pain was at the injection site; it was through out, and today it hurts from her armpit to the back of the shoulder; it was through out, and today it hurts from her armpit to the back of the shoulder; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0171, Expire Date: Unknown), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:30 (at the age of 21-Year-old) as a single dose for covid-19 immunization. The patient received vaccination through drive Thru. The patient's medical history and concomitant medications were not reported. The patient received flu vaccines, possibly tetanus vaccines in the past. Family Medical History Relevant to event was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0161, Expire Date: Unknown), via an unspecified route of administration, on 14Apr2021 (at the age of 21-Year-old) as a single dose for covid-19 immunisation. On 05May2021 at 15:40, patient experienced left arm soreness. On 06May2021 at 10:00, patient experienced fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed, fever. On an unknown date in 2021, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The patient received Tylenol as a treatment drug and was advised to lay in bed. Therapeutic measures were taken as a result of fever, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The clinical outcome of left arm soreness was recovering, fever recovered on 06May2021, fatigue, was recovered on 07May2021 and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed; Fever; Left Arm Soreness; the pain was at the injection site; it was through out, and today it hurts from her armpit to the back of the shoulder; it was through out, and today it hurts from her armpit to the back of the shoulder; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0171, Expire Date: Unknown), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:30 (at the age of 21-Year-old) as a single dose for covid-19 immunization. The patient received vaccination through drive Thru. The patient's medical history and concomitant medications were not reported. The patient received flu vaccines, possibly tetanus vaccines in the past. Family Medical History Relevant to event was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection, Batch/Lot Number: EW0161, Expire Date: Unknown), via an unspecified route of administration, on 14Apr2021 (at the age of 21-Year-old) as a single dose for covid-19 immunisation. On 05May2021 at 15:40, patient experienced left arm soreness. On 06May2021 at 10:00, patient experienced fatigue, all she wanted to do was lay down, tried to get up multiple times and got back in bed, fever. On an unknown date in 2021, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The patient received Tylenol as a treatment drug and was advised to lay in bed. Therapeutic measures were taken as a result of fever, the pain was at the injection site, it was throughout, and today it hurts from her armpit to the back of the shoulder. The clinical outcome of left arm soreness was recovering, fever recovered on 06May2021, fatigue, was recovered on 07May2021 and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Illness, Migraine
Clinical narrative: sick; splitting headache; chills; fever wasn't too high; foggy head; migraine; This is a spontaneous report from a contactable consumer. This consumer (patient mother) reported for her 50-year-old male patient (reporter's son) that:  A 50-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm on 02May2021 09:00 as DOSE 1, SINGLE for covid-19 immunisation. Second dose was scheduled for 30May2021. The patient medical history included lyme disease. The patient concomitant medications were not reported. On an unspecified date, the patient was real sick for a week, splitting headache, chills; he went to a doctor, fever wasn't too high, but wasn't well enough to go to work; told her his head was killing him, had migraine headaches for couple days, foggy head. Caller almost thought he had COVID, the extreme reaction almost crossed with symptoms to COVID but it was not COVID, they told him it was just a reaction to the Pfizer Covid-19 Vaccine. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sick; splitting headache; chills; fever wasn't too high; foggy head; migraine; This is a spontaneous report from a contactable consumer. This consumer (patient mother) reported for her 50-year-old male patient (reporter's son) that:  A 50-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm on 02May2021 09:00 as DOSE 1, SINGLE for covid-19 immunisation. Second dose was scheduled for 30May2021. The patient medical history included lyme disease. The patient concomitant medications were not reported. On an unspecified date, the patient was real sick for a week, splitting headache, chills; he went to a doctor, fever wasn't too high, but wasn't well enough to go to work; told her his head was killing him, had migraine headaches for couple days, foggy head. Caller almost thought he had COVID, the extreme reaction almost crossed with symptoms to COVID but it was not COVID, they told him it was just a reaction to the Pfizer Covid-19 Vaccine. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Little trouble breathing and using a humidifier at night; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Not Provided) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was handicapped and on a cane. Unable to confirm if patient was handicapped and using a cane prior to taking the vaccine. Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date the patient experienced little trouble breathing and using a humidifier at night. Treatment received for the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.