chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Increased upper airway secretion
Clinical narrative: Soreness on arm on the way home/arm hurt; pain increased yesterday, last night felt horrible, hurt from head to toe/ She hurt all over; pain increased yesterday, last night felt horrible, hurt from head to toe; Major chills; bad headache; feel mucous going down her throat/she is having drainage that is going down her throat; flu; fever; felt like she was going to give out; joint pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via medical information team.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown, Expiration date: unknown) via an intramuscular route of administration in left arm on 06Feb2021 at 13:00 (age at vaccination 70-year-old) at dose number unknown single for covid-19 immunisation. The patients relevant medical history included she has a slow metabolism She said that she has a lot of reactions to medications because her metabolism is so slow, Covid-19 in Mar2020 and was out for about 6 weeks. The patients concomitant medications were not reported. On an unspecified date in feb2021 patient experienced Soreness on arm on the way home arm hurt, pain increased yesterday, last night felt horrible, hurt from head to toe, Major chills, headache, feel mucous going down her throat she was having drainage that is going down her throat, flu, Fever, felt like she was going to give out, joint pain. She was hurting that she had like a major flu. She said that she had a lot of reactions to medications because her metabolism is so slow. She said that maybe a hour or so ago, she took a tramadol and reported that she did have a fever. her fever is now going down. patient was supposed to go back on the 27Feb2021 to get her second dose of the vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 antibody test: Negative on an unspecified date. The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness on arm on the way home/arm hurt; pain increased yesterday, last night felt horrible, hurt from head to toe/ She hurt all over; pain increased yesterday, last night felt horrible, hurt from head to toe; Major chills; bad headache; feel mucous going down her throat/she is having drainage that is going down her throat; flu; fever; felt like she was going to give out; joint pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via medical information team.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown, Expiration date: unknown) via an intramuscular route of administration in left arm on 06Feb2021 at 13:00 (age at vaccination 70-year-old) at dose number unknown single for covid-19 immunisation. The patients relevant medical history included she has a slow metabolism She said that she has a lot of reactions to medications because her metabolism is so slow, Covid-19 in Mar2020 and was out for about 6 weeks. The patients concomitant medications were not reported. On an unspecified date in feb2021 patient experienced Soreness on arm on the way home arm hurt, pain increased yesterday, last night felt horrible, hurt from head to toe, Major chills, headache, feel mucous going down her throat she was having drainage that is going down her throat, flu, Fever, felt like she was going to give out, joint pain. She was hurting that she had like a major flu. She said that she had a lot of reactions to medications because her metabolism is so slow. She said that maybe a hour or so ago, she took a tramadol and reported that she did have a fever. her fever is now going down. patient was supposed to go back on the 27Feb2021 to get her second dose of the vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 antibody test: Negative on an unspecified date. The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Soreness on arm on the way home/arm hurt; pain increased yesterday, last night felt horrible, hurt from head to toe/ She hurt all over; pain increased yesterday, last night felt horrible, hurt from head to toe; Major chills; bad headache; feel mucous going down her throat/she is having drainage that is going down her throat; flu; fever; felt like she was going to give out; joint pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via medical information team.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown, Expiration date: unknown) via an intramuscular route of administration in left arm on 06Feb2021 at 13:00 (age at vaccination 70-year-old) at dose number unknown single for covid-19 immunisation. The patients relevant medical history included she has a slow metabolism She said that she has a lot of reactions to medications because her metabolism is so slow, Covid-19 in Mar2020 and was out for about 6 weeks. The patients concomitant medications were not reported. On an unspecified date in feb2021 patient experienced Soreness on arm on the way home arm hurt, pain increased yesterday, last night felt horrible, hurt from head to toe, Major chills, headache, feel mucous going down her throat she was having drainage that is going down her throat, flu, Fever, felt like she was going to give out, joint pain. She was hurting that she had like a major flu. She said that she had a lot of reactions to medications because her metabolism is so slow. She said that maybe a hour or so ago, she took a tramadol and reported that she did have a fever. her fever is now going down. patient was supposed to go back on the 27Feb2021 to get her second dose of the vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 antibody test: Negative on an unspecified date. The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Euphoric mood, Fall, Feeling drunk, Feeling hot
Clinical narrative: quite dizzy and loopy; she was quite pale; feeling to being high or drunk; feeling to being high or drunk; almost fell over the coffee table; notes a warm sensation; slept for many hours; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.   On 02Feb2021, after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday patient experienced a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home on autopilot not sure how she made it home. Upon arriving at home, she noted she was quite dizzy and loopy, almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk. She stated that she went to bed, slept for many hours, and when she woke up, she felt a lot better and asked is this a severe reaction and what should she do about the second dose. The clinical outcome of all the events was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.         Question: Caller is a consumer reporting AE's after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday, 02Feb2021. She believes she had a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home "on autopilot" -not sure how she made it home.  Upon arriving at home she noted she was quite dizzy and "loopy", almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk.  She state she went to bed, slept for many hours, and when she woke up she felt a lot better.  Is this a severe reaction? What should she do about the second dose?   Call Details:  Callback to (phone number withheld); (name withheld) 43 y/o  Had the Pfizer first dose last Tuesday 02Feb2021 at a college in (place name withheld) Questions about the second dose-  Severe Reaction? Waited in the car 15 minutes -  warm sensation and then as I started driving away, I was on autopilot and felt stoned-ish- not right - dizzy/loopy almost fell over the coffee table. slept it off and had my husband check on me-  when I woke up I felt better  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pallor
Clinical narrative: quite dizzy and loopy; she was quite pale; feeling to being high or drunk; feeling to being high or drunk; almost fell over the coffee table; notes a warm sensation; slept for many hours; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.   On 02Feb2021, after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday patient experienced a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home on autopilot not sure how she made it home. Upon arriving at home, she noted she was quite dizzy and loopy, almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk. She stated that she went to bed, slept for many hours, and when she woke up, she felt a lot better and asked is this a severe reaction and what should she do about the second dose. The clinical outcome of all the events was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.         Question: Caller is a consumer reporting AE's after receiving her first dose of Pfizer-Biontech Covid19 vaccine last Tuesday, 02Feb2021. She believes she had a severe reaction. She waited in her car for 15 minutes after administration, then notes a warm sensation when she started driving away, states she drove home "on autopilot" -not sure how she made it home.  Upon arriving at home she noted she was quite dizzy and "loopy", almost fell over the coffee table, her husband told her she was quite pale, and she equates the feeling to being high or drunk.  She state she went to bed, slept for many hours, and when she woke up she felt a lot better.  Is this a severe reaction? What should she do about the second dose?   Call Details:  Callback to (phone number withheld); (name withheld) 43 y/o  Had the Pfizer first dose last Tuesday 02Feb2021 at a college in (place name withheld) Questions about the second dose-  Severe Reaction? Waited in the car 15 minutes -  warm sensation and then as I started driving away, I was on autopilot and felt stoned-ish- not right - dizzy/loopy almost fell over the coffee table. slept it off and had my husband check on me-  when I woke up I felt better  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Malaise, Stress
Clinical narrative: Not feeling well; Stressed; Checked her blood pressure and it was 150/80/blood pressure went up; Not feeling right; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN5318, Pfizer NTEC), via an unspecified route of administration on 04Feb2021 as 1st dose at unknown dose, single for covid-19 immunization. Medical history included blood pressure problems. Concomitant medication(s) included vitamin c [ascorbic acid], ibuprofen, zinc. The patient stated she took an Ibuprofen one hour before her first dose of the vaccine on 04Feb2021 before and she didn't know before but now it is everywhere that you are not supposed to take Ibuprofen or pain medication and she didn't know but she took. She stated she is worried it might lower the effectiveness of the vaccine. She stated she also took Vitamin C and a whole bunch of immune boosters like Zinc and supplements and asked will the vaccine be less effective. Patient further stated she has high blood pressure. She received the first dose of the vaccine on 04Feb2021, 30 minutes after the shot she was not feeling well and they checked her blood pressure and it was 150/80. When she left she was not feeling bad so she wanted to stop by the grocery store. When she was in the parking lot of the grocery store she was not feeling right (she stated this was a half an hour later) and her blood pressure went up in 04Feb2021. She stated she has blood pressure problems so she may have been stressed out because there were a lot of people there. She took her PRN blood pressure medication, Clonidine, and this usually makes her blood pressure go down in 20 minutes. She waited half an hour but it did not go down. She stated she may have been stressed because it went unusually high. It was better after going home and getting a warm drink. The outcome of the event Blood pressure high, Stress was recovering; other events was unknown.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling sensation around her lips and mouth; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 05Feb2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient experienced tingling sensation around her lips and mouth. The patient stated that she was calling about the Covid Vaccine. She got the vaccine on Friday 05Feb2021 and immediately after the injection she experienced tingling around the mouth, she did not tell anyone at the time, she then continued and waited the 15 minutes, she thought since she had no swelling, she figured to still not say anything. She continued into the next day. It didn't cause her any stress, but she would like to know if she should receive the second dose of the vaccine. The clinical outcome of the tingling sensation around her lips and mouth were not recovered.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling sensation around her lips and mouth; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on 05Feb2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient experienced tingling sensation around her lips and mouth. The patient stated that she was calling about the Covid Vaccine. She got the vaccine on Friday 05Feb2021 and immediately after the injection she experienced tingling around the mouth, she did not tell anyone at the time, she then continued and waited the 15 minutes, she thought since she had no swelling, she figured to still not say anything. She continued into the next day. It didn't cause her any stress, but she would like to know if she should receive the second dose of the vaccine. The clinical outcome of the tingling sensation around her lips and mouth were not recovered.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling of lips and chin immediately following injection.; Tingling of lips and chin immediately following injection.  Lasted approximately 24 hours; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021(at the age of 68 years) as single dose for covid-19 immunization. Medical history included High blood pressure and cholesterol, and osteoarthritis. The patient previously took neomycin and experienced drug hypersensitivity, metronidazole (FLAGYL) and experienced drug hypersensitivity. Concomitant medications included celecoxib 200mg, bupropion HCL 150mg and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient experienced tingling of lips and chin immediately following injection on 05Feb2021. lasted approximately 24 hours. Patient was not received any treatment for occurred events. On an unspecified date in Feb2021, the patient had resolved from the events.   Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling of lips and chin immediately following injection.; Tingling of lips and chin immediately following injection.  Lasted approximately 24 hours; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021(at the age of 68 years) as single dose for covid-19 immunization. Medical history included High blood pressure and cholesterol, and osteoarthritis. The patient previously took neomycin and experienced drug hypersensitivity, metronidazole (FLAGYL) and experienced drug hypersensitivity. Concomitant medications included celecoxib 200mg, bupropion HCL 150mg and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient experienced tingling of lips and chin immediately following injection on 05Feb2021. lasted approximately 24 hours. Patient was not received any treatment for occurred events. On an unspecified date in Feb2021, the patient had resolved from the events.   Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Full blood count, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: I'm freezing and all kinds of things on a daily basis; pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension, internal bleeding and take special medications to keep her CBC where it needed, thyroid cancer, cancer, cholesterol, rheumatoid and osteoarthritis from an unknown date, she bruise all the time, depression and PTSD since her husband has committed suicide. Concomitant medications included methotrexate taken for neoplasm malignant; folic acid taken for blood cholesterol, start and stop date were not reported. Patient took chemotherapy for rheumatoid arthritis. She was feeling like she had covid all her life because she was in pain, has chills and freezing and all kinds of things on a daily basis. She bruise all the time, but did not get bruise from the vaccine. The first dose of event was very uneventful. Patient had intramuscular injection before and the pain she had was just terrible. She don't want any more pain in her life. She wanted to ask what are the risk of bleeding with the vaccine and also wish to know the information about risks and blood thinners was in the fact sheet so she could read about that before getting the shot. She goes back on 21Feb2021 for the second dose. She made it clear that, she has a autoimmune disease of rheumatoid arthritis and did not want to take a shot in the muscle. She would have an adverse in next two weeks. She does not told anything about the second dose. The man that gave her the shot said that the side effects depended on her immune system. It could be nothing. She has a headache from holding the phone. She wanted to ask if she takes a blood thiner when she got the vaccine. She does not take a blood thinner. She has a internal bleeding and has to have routine CBC's. As long as her count is at a certain point she does not have to have an operation. The patient underwent lab tests and procedures which included full blood count: unknown results on an unknown date. Outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Rash papular
Clinical narrative: had 6 inches long raised area that is hot to touch, feels firm, red, painful and bumpy; right after her father received the vaccine he felt hot and flushed; This is a spontaneous report from a contactable Other HCP via medical information team. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included diabetic. Patients concomitant medication were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization and experienced heaviness in his chest and flutters. Caller stated her father received the second dose of the vaccine three days ago around noon and was experiencing a reaction on his arm. Caller stated her father had 6 inches long raised area that was hot to touch, feels firm, red, painful and bumpy. Caller stated he said it was not itchy. Caller stated he was sent to the emergency room and was checked out, but everything was fine. Caller stated it started 18 hours after receiving the vaccine and he took some Tylenol. Caller states she also remembers right after her father received the vaccine, he felt hot and flushed and took some Benadryl. The outcome of event was unknown.  Information on the lot/batch number has been requested.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: getting a cut on her foot; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of (age:90, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes. The patient's concomitant medications were not reported. The patient was a consumer who is due for her second Covid19 vaccine this Wednesday. But, she received a tetanus shot last Friday, 05Feb2021, after getting a cut on her foot on an unspecified date and because of her history of diabetes. She stated that her doctor told her she must reschedule her second dose of vaccine because of receiving the tetanus shot.  She also called the CDC to get more information, and they were unable to provide information to her. The caller inquired she should reschedule her and if  not reschedule, will it kill her. The patient was advised there are no data to assess the concomitant administration of the bnt162b2 vaccine with other vaccines and referred caller back to vaccination site, let them know when and why she received the tetanus shot, and what their guidance would be.The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Penile blister, Penile swelling
Clinical narrative: swelling on my penis along with a series of small bump; swelling on my penis along with a series of small bump; This is a spontaneous report from a contactable consumer (Patient). An elderly male patient (Age: 74 unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in left arm on 05Feb2021 11:30 as single for COVID-19 immunisation at Hospital. Patient had known medications, food and pollen allergies and hay fever. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications in two weeks, the list was approximately 30 items long. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 05Feb2021, later in evening, patient experienced a swelling on penis along with a series of small bump. The swelling was approximately 25-30mm in length and 5mm in width. The site ran parallel to the glands, were it complete, it would had been a ring around the shaft. The swelling lessening and the bumps are diminishing in size. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Coughing; runny nose; 100 fever; This is a spontaneous report from a contactable consumer (patient himself). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration, administered in left arm  on 06Feb2021 10:45 (at the age of 66-year-old) as single for covid-19 immunisation. Medical history included myeloma remission. Concomitant medications included lenalidomide (REVLIMID), ezetimibe (ZETIA), acyclovir, aspirin, amlodipine taken for an unspecified indication received within two weeks. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. On 08Feb2021 03:00, the patient experienced coughing, runny nose, 100 fever. The patient lab tests which included body temperature was 100 on 08Feb2021. The patient did not underwent COVID test post vaccination. No treatment medications was received for the adverse events. The outcome of the events was resolving.  Information about Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Red itchy swollen lump at injection site 9 days after injection; red itchy swollen lump at injection site 9 days after injection; red itchy swollen lump at injection site 9 days after injection; This is a spontaneous report from a contactable Other healthcare professional. A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 30Jan2021 at 14:15 as DOSE 1, SINGLE for covid-19 immunization. The patient was hypothyroid. The patient had no known allergies. The patient's concomitant medication included metformin (MANFCTURER UNKNOWN); thyroid (ARMOUR THYROID) received within 2 weeks of vaccination. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. On 08Feb2021 at 21:00, the patient experienced red itchy swollen lump at injection site 9 days after injection. The patient did not receive any treatment for the event. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: extreme fatigue; headache; arm ache at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 06Feb2021 14:45 as dose 1, single (at the age of 50-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any prior COVID-19 vaccination. Patient did not test for COVID-19 post vaccination. Patient did not have any known allergies. Facility type vaccine was reported as Other. Patient did not receive any other vaccine in 4 weeks. Patient medical history included mitral valve prolapse, depression. The concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) strength 300 mg, CITALOPRAM strength 30 mg. On 07Feb2021 at 09:00 patient experienced extreme fatigue, headache, arm ache at injection site. Patient did not receive any treatment for the adverse events. On an unspecified date in Feb2021, the outcome of the events was resolved.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: little nausea; This is a spontaneous report from a contactable Other HCP and contactable consumer (patient). A 77-year-old female reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 04Feb2021 (at the age of 77 years), as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experience little nausea. The outcome of the event was unknown. No additional information/details provided.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of two reports. This consumer reported for a male patient (husband) (unknown age) that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 04Feb2021 as a DOSE 1, SINGLE for COVID-19 immunisation. Patient also on EXCEDRIN [CAFFEINE; PARACETAMOL] for an unspecified indication. Patient medical history included migraines. Concomitant medications were not reported. On 05Feb2021 patient experienced diarrhea. Outcome of the event was unknown.   Follow-up attempts completed. No further information expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Swollen lump found under the right armpit 5 days post vaccination; sore and painful to touch; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration in arm right on 01Feb2021 13:00 (at the age of 32-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient has not had covid prior vaccination. The patient was not tested covid post vaccination. The patient's concomitant medications were not reported. The patient previously took ibuprofen for an unspecified indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swollen lump found under the right armpit 5 days post vaccination which is sore and painful to touch on 06Feb2021 18:30. At first discovery, the size of the lump was about the size of a quarter. The lump has decreased in size 2 days later, however still sore. The patient did not receive any treatment for the events. The outcome of event was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: This is a spontaneous report received from a contactable consumer (Patient). A 65-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9269 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 05Feb2021 at 13:00 (at the age of 65-year-old), as a single dose for COVID-19 immunization. The patient's medical history included Pre diabetic, high BP (blood pressure) and thyroid.The patient previously took Advil (ibuprofen) and experienced allergies, aspirin (acetylsalicylic acid) and experienced allergies. Other medications in 2 weeks included thyroid medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 05Feb2021 at 6:00 PM, patient had experienced very bad upper stomach pain for 3 days with diarrhoea. No treatment was received. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles.; 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), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was muscle relaxer and arthritis and concomitant medications METHOCARBAMOL muscle relaxer and acetylsalicylic acid (ASPIRIN) a bayer aspirin for arthritis. On an unspecified date, the patient experienced caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles. Caller reported that he received the first dose of the pfizer vaccine on 21Jan2021 and the vaccine felt like water going through his muscles. Caller stated that he takes methocarbamol and bayer aspirin and wanted to know if this caused this sensation. He was concerned since he took a low dose baby aspirin. He was asking if that was considered a blood thinner. He took the first shot three weeks ago. He was supposed to get the second dose this week. For his own piece of mind, he would just want to ask the question. He had the vaccine at his primary doctors office. He was curious about the comment on page 2 of the handout. It said to tell the vaccinator about all of your medical conditions. The outcome for event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear infection, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: dizziness; sore arm; mild cold with ear infection; mild cold with ear infection; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in in arm left on 20Jan2021 at 13:00 (at the age of 51-year-old) as single for COVID-19 immunization. Vaccine facility type was Hospital facility. The patient did not had medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not administered other vaccine in four weeks or other medications in two weeks. Prior to vaccination, the patient did not had COVID. The patient was healthy. On 20Jan2021, the patient experienced sore arm immediately and on 25Jan2021, about 5 days later, she experienced dizziness. After 2 days of dizziness and not going away, it scared her enough to think she might have COVID. On 28Jan2021, the patient underwent lab test and procedure which included nasal swab: negative. Dizziness tapered off and lasted approximately 6 days. Assumed it was a possible mild cold with ear infection. Therapeutic measures were not taken as a result of the events. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; Experiencing Chills, Headache, Nausea she feels the symptoms of having a fever; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 30Jan2021 as 1 ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had experienced chills, headache, nausea she felt the symptoms of having a fever, but her temperature was normal. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Caller asked if it is okay that he is taking amoxicillin after taking first dose of covid-19 vaccine; This is a spontaneous report from a contactable male consumer (patient) received from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication) included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. The patient reported caller asked if it is okay that he is taking amoxicillin after taking first dose of covid-19 on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: sneezing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sneezing (non-serious) on an unspecified date. Caller received first and second dose and mentioned she was sneezing every now and then but other than that she's fine. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Pain
Clinical narrative: back is injured after getting the covid vaccine/twisted her back; pain; This is a spontaneous report from a contactable consumer or other non hcp received from a Pfizer (Patient, reported for self). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as Dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got first covax 3 weeks ago and then twisted her back last night (on 07Feb2021) and patient was asking if she can take an advil for the pain. The patient was to get the second covax today. Outcome of the events were unknown  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a contactable female consumer (patient), of an unspecified age reported that she received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 06Feb2021 (reported as Saturday), as a single dose for COVID-19 immunization. The patient previously took first dose of BNT162B2 vaccine for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, her 2nd dose of Covid vaccine on Saturday and had chills on 06Feb2021 (Saturday) and Sunday. She wants to know if the chills mean the vaccine was working. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Is it normal to have her numbers (blood sugar) high 274 Saturday night; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients daughter) reported for a 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number& Expiry date not reported) via unspecified route of administration on 06Feb2021 (at age of 82-years-old) as single dose for COVID-19 Immunization. Patient medical history includes diabetes from unknown date. Patient concomitant medications not reported. On 07Feb2021, one day after vaccination, patient experienced blood sugar was high 274 on saturday night. Patient daughter reported that it was never that high then this morning sunday it was 176 and that is still high. She enquired, is that due to the vaccine, would you know. She takes her at night and then in the morning, the sugar, she is diabetic, the blood sugar was very high, so she checks got her injection for her diabetes not clarified. Reporter stated,  want to know is that due to the Covid-19 vaccine. Reporter was informed about the role of Pfizer Drug Safety. Reporter stated need answer to this question or is myself I can answer for her. Treatment received for the event. Patient underwent lab test and procedures include blood sugar test was 274 (high) on unspecified date. The Outcome of event was unknow.   Information on the lot/batch number has been requested.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: got backache; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient got backache got 1st vaccine shot and got backache and asking if naproxen is okay to take. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itching; small plum red; This is a spontaneous report from a contactable consumer (Patient) in response to Non-HCP letter sent in cross reference case. A 51-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, in Arm Left on an unspecified date (at the age of 51-years-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching and small plum red. It was reported that, patient took second vaccine he was ok so far (5 days already) only his arm left vaccine area have a small plum red and itching. Patient visited to emergency room for covid test (no results provided (as reported)). Reporting issues (side effects, complaints, etc.) with a Pfizer product. Reported issue occur after use of a Pfizer product. Outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts completed. No further information expected.