chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Inappropriate schedule of product administration, Laboratory test, Pyrexia
Clinical narrative: January 4th was the first shot and February 20 was the second shot; Bad headaches; My temperature is 101.2 and it is going to 100.4 and then goes up back; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9266) via an unspecified route of administration on 20Feb2021 as 2nd dose, single for covid-19 immunisation. Medical history included high blood pressure, pre diabetic. Concomitant medication included losartan taken for high blood pressure. Patient previously received first dose of BNT162B2 (Batch/lot number: EK9231) on 04Jan2021 at the age of 39 years for COVID-19 immunisation and got COVID two weeks after first shot, qualitative PCR positive after 1st dose. Patient reported that January 4th was the first shot and February 20th was the second shot. After the second dose of Pfizer vaccine, patient was having symptoms of bad headaches and her temperature was 101.2 and it was going to 100.4 and then went up back, all on an unspecified date in Feb2021. She took paracetamol (TYLENOL) every six hours as treatment. Patient did some lab work last week (Feb2021) and went to see the doctor for the results. Patient asked if there is anything else she can do to get rid of her symptoms other than drinking lots of fluids. Outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives; 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, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ixekizumab (TALTZ) for psoriasis and was allergic. Caller was allergic to psoriasis medication called Taltz injections. She broke out in hives, and went to emergency room. Caller asking if ingredients in vaccine are similar to ingredients in Taltz. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number could not be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; headache; fatigue; body aches; This is a spontaneous report from a non-contactable consumer or other non-Health Professional. A 45-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9288, Expiration date: unknown), dose 1 via an unspecified route of administration on 23Feb2021 as 1ST DOSE, SINGLE for covid-19 immunization. patient medical history included ulcerative colitis, type 2 diabetes mellitus (from an unknown date and unknown if ongoing). Concomitant medication included sulfasalazine (SULFASALAZINE); ergocalciferol (VIT D); folic acid taken for an unspecified indication, start and stop date were not reported. patient not had allergies. patient did not received any other vaccine in four weeks. Patient not had COVID-19 test post the vaccine. patient had not COVID-19 test prior to the vaccine. On 23Feb2021 the patient experienced nausea, headache, fatigue, body aches. The outcome of events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Muscle soreness around injection site; This is a spontaneous report from a non-contactable consumer (patient). A 39-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 06:00 PM as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included lamotrigine (LAMOTRIGINE). The patient was not pregnant at the time of vaccination. Patient had no other vaccine in last four weeks. Patient was not tested COVID prior and post vaccination. On 22Feb2021 at 08:30 PM, the patient experienced muscle soreness around injection site. The outcome of event was recovering.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pain in extremity
Clinical narrative: I think I may have had a cold or something in my system when I got the vaccine.; Chills; Sore arm; This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously administered first dose of BNT162b2 for COVID-19 immunisation. The consumer stated, Well I had the second dose of the vaccine last Friday, 19Feb2021 and what I had from that the sore arm, I had that for 2 days, 2 and a half days my arm was sore and then 24 hours later I think (20Feb2021) I had the chills but they only lasted, it was a few hours and then that was gone. But my question is, I think I may have had a cold or something in my system when I got the vaccine I think and then is that the case, does that affect the you anything does that, you know if you have a cold or even if you had the regular flu in your system and you get the vaccine does that cause any problem? and I just want to ask you know when you take that second vaccine and if you have a cold in your system or if you have the regular flu does that affect the vaccine in any way and I also wanted to ask maybe you can help me with this how long do people have any effects from the like the chills or achiness, how long are people experiencing that after the vaccine. And I just want to ask that when you take that second vaccine and if you have a cold in your system or if you have the regular flu does that affect the vaccine in any way and I also wanted to ask that how long do people have any effects like the chills or achiness, how long are people experiencing that after the vaccine?". The outcome of events sore arm and chills was recovered on an unspecified date in Feb2021 where as outcome of event cold is unknown.  Information about Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain at injection site.; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 14:45 (Batch/Lot Number: EL3247) as single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. On 24Feb2021 00:30, the patient experienced mild pain at injection site. No treatment received for AE. Outcome of the event was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 48-years-old) (Lot Number: EL3247) as 2nd DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no COVID prior vaccination and not tested to covid post vaccination. On 01Feb2021, the patient administered first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left (Lot Number: EL3247). On 24Feb2021, the patient experienced mild fever, headache. No treatment was received for the events caused. The patient underwent lab tests and procedures on 24Feb2021 which included body temperature as mild fever. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Headache
Clinical narrative: Headache which does not quit. It is still going on right now; I feel real week; My bones hurt like I am catching cold or something; 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 was not reported), via an unspecified route of administration on 23Feb2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. patient has been waiting for over an hour because of your machine and now you are telling me you do not understand me. Is this waste of my time or what. patient got his Covid-19 vaccine yesterday. An hour later, patient has been having a headache which did not quit. It is still going on right now. patient felt real weak and now patient bones hurt like patient was catching cold or something. Patient was wanted to know that it was normal. Outcome for the event headache was not resolved and for remaining events outcome was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Pain
Clinical narrative: Significant lymph node swelling under left arm (left arm was injection site)/less severe lymph node swelling in jaw and neck; pain and discomfort; pain and discomfort; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 at 13:00 (at the age of 26-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included migraine and no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL); spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); isotretinoin (CLARAVIS). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 25Jan2021 at 13:00 (Lot Number: EL3249) for COVID-19 immunisation. On 18Feb2021, the patient experienced significant lymph node swelling under left arm (left arm was injection site). The lymph node under the arm was about the size of a small lemon. She also experienced less severe lymph node swelling in jaw and neck that caused pain and discomfort while chewing and brushing teeth. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Soreness in the shoulder; This is a spontaneous report from contactable consumer via Pfizer sponsored program COVAX US Support.    A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 as 1st dose, single for covid-19 immunization. On 23Feb2021, the patient actually got the two doses for the COVID-19 vaccine shot. Probably about 3 to 5 hours after the shot he experienced soreness in the shoulder. The patient asked if he could take Acetaminophen or Aspirin for soreness or other something reliever to relieve that. The outcome of event was unknown.   Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Headache, Paraesthesia, Swelling of eyelid, Vaccination site pain
Clinical narrative: Light headache; Felt left eye is tiring; Injection site sore; Short period of tinkling in left side of the brain; eye lid is heavy; This is a spontaneous report from a non-contactable consumer or other non hcp.    A 53-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in arm left on 23Feb2021 09:00 as 1st dose, single dose for covid-19 immunisation. The patient's age at vaccination was 53 years. The patient was not pregnant. The patient's medical history and concomitant medications were not reported. On 23Feb2021 15:00, the patient experienced injection site sore, light headache, short period of tinkling in left side of the brain, feel left eye is tiring, eye lid is heavy. Vaccine facility type was other. The patient did not have any other vaccine in four weeks. No covid test was done post vaccination. The patient did not have any known allergies and other medical history. Therapeutic measures were taken as a result of injection site sore, light headache and short period of tinkling in left side of the brain with Tylenol. The outcome of the events was recovered on an unspecified date 2021.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Skin rash (Pityriasis Rosea); This is a spontaneous report from a non-contactable physician. A 31-years-old female patient received bnt162b2 (COVID-19, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 12:00 (Batch/Lot Number: EL8982) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced skin rash (pityriasis rosea) on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A little bit of headache; This is a spontaneous report received from a non-contactable consumer (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, the patient had the Pfizer's second shot yesterday and have a little bit of headache when woke up on an unspecified date in Feb2021. The outcome of event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Urticaria
Clinical narrative: Mild welts on face; sore arm; mild headache; This is a spontaneous report from a non-contactable consumer. A 41-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) via an unspecified route of administration on 26Feb2021 as 1st dose, single for COVID-19 immunization. Facility type vaccine was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient did not had known allergies. Medical history was reported as no and concomitant medications were not reported. The patient experienced mild welts on face on 3rd day after first shot In addition to sore arm and mild headache on 28Feb2021. The patient did not received treatment for the events. The outcome of the events was reported as recovered on an unspecified date. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscle twitching
Clinical narrative: Red face; Right inner cheek twitching; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 22Feb2021 10:30 AM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies to sulfa. The patient previously took levofloxacin and levaquin experienced allergy. Concomitant medications included zinc; krill oil; citalopram and multivitamin. No other vaccine in four weeks. The patient experienced right inner cheek twitching on 22Feb2021 and on 23Feb2021 10:30 patient had red face sun sensitivity which appeared after 24 hours and is warm to touch. There was no covid prior vaccination and covid not tested post vaccination. There was no treatment received. The outcome of event right inner cheek twitching was recovered on 23Feb2021 and outcome of event red face was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy
Clinical narrative: Lethargic ~5 hours post vaccination; Chills throughout the night; 18 Hours post vaccination consistent headache; This is a spontaneous report from a Non-contactable consumer (patient).   A 28-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number=EL3247) dose 2, via an unspecified route of administration in Left arm on 18Feb2021 at 13:45PM (at the age of 28- year-old) as 2nd dose, single for covid-19 immunisation. Medical history included Chronic knee pain. No known allergies. The patient received other medications in two weeks: Spironolactone 100 mg, Clindamycin topical lotion. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration, administered in Left arm on 28Jan2021 02:00 PM (Batch/Lot number=EL3247) as 1st dose, single for covid-19 immunisation. The patient had no COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient was not tested COVID-19 post vaccination. On 18Feb2021 at 20:15 PM, the patient experienced lethargic 5 hours post vaccination, chills throughout the night, 18 hours post vaccination consistent headache. The patient did not receive any treatment for the events. The outcome of the events was recovered.  No follow up attempts are possible. information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; body aches; chills; This is a spontaneous report from a non-contactable Consumer or other non-HCP. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EM9809; Expiration date: Unknown), via an unspecified route of administration in the left arm on 22Feb2021 (at the age of 26-years-old) as single dose for COVID-19 immunization. Patient's medical history was not reported. Patient had no known allergies. Patient's concomitant medications included birth control pills. The patient previously administrated with first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9262; Expiration date: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 at 10:45 AM as single dose for COVID-19 immunization. On 22Feb2021, after 22hrs:30min from vaccination, she experienced fever, pain, chills. She did not receive any treatment. She did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: Swollen Lymph nodes under right arm showed up in my mammogram 9 days after the vaccine; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional.   A 65-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: el3247) via an unspecified route of administration in right arm on 30Jan2021 at 09:00 as first dose single for covid-19 immunisation.  Medical history included sjogren's syndrome, autoimmune thyroiditis, hypersensitivity, seasonal allergy, allergy to plants and aloe allergy. Concomitant medications included estradiol, norethisterone acetate (COMBIPATCH), levothyroxine (LEVOTHYROXINE) and ciclosporin (RESTASIS). It was reported that the patient didn't take any vaccine within 4 weeks and did not have covid test positive prior to vaccination. The patient experienced swollen lymph nodes under right arm showed up in mammogram 9 days after the vaccine administration. Laboratory tests included mammogram which showed swollen lymph nodes under right arm. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I seem to be getting a feeling of being tired; This is a spontaneous report from a contactable consumer or other Non-health care professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. On an unspecified date it was reported that patient seems to be getting a feeling of being tired last week and this week. Outcome of event was reported as unknown.  Information for lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reactions; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had lot of allergies, about 15 different things already. The patient thought of having allergic reactions as his heart doctor have kept patient on different cholesterol (Unspecified medication). Reporter told them that my father was dead, but I did have to take some Benadryl (Taken as treatment) after the first shot. It's better tonight but somewhat, my question is someone had told me that if you're allergic to the shot it won't do any good you have to take it over again. Is that true. I have a lot of allergies to lot of things. At the time of this report event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity
Clinical narrative: when I had the first shot I was having I thought allergic reactions/They didnt ask me after the second shot but it was even worst; when I had the first shot I was having I thought allergic reactions/They didnt ask me after the second shot but it was even worst; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a lot of allergies to lot of things. Patient had shot its the Pfizer shot, patient allergic to about 15 different things already. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. It was reported that patient had the first shot and thought was having allergic reactions that patient heart doctor have kept patient on different cholesterol (Unspecified medication) and patient told them that my father was dead, but patient did have to take some Benadryl (Taken as treatment) after the first shot. They did not ask me after the second shot but it was even worst. Patient had to take about 3 Benadryl after that kept that on hand all the time. It was better tonight. The Outcome of event was unknown. No follow up attempts are needed. Lot/batch number can not be requested. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pruritus, Urticaria
Clinical narrative: Hives; Itching; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she recieved BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EM9809 and Expiration date ; not supplied) via an unspecified route of administration, on 01Feb2021 (at the age of 79 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that She got the first dose 10Feb2021. She developed hives the next day 11Feb2021 and they stayed until she went to the doctor at least a week after and got the Prednisone. She was itching so bad. She says they have recovered at this point but another reason she was calling is that her doctor doesn't want to give anymore Prednisone for the next dose, She said they do not want to keep suppressing it. She guesses she will just have to see what's going to happen or maybe she shouldn't have it. The doctor said Pfizer may tell her not to take it. She does not see any expiration date or NDC number, just reminder for the next appointment. Dose: unknown to the caller. She just knows it was dose number 1 and that they went and got it. She says she thinks she will just follow up with her doctor and she also said to let them know when she gets the shot to watch her longer than 15 minutes, she may call them maybe they will just come up with some other medication to give her if she needs it because they do not want to give her Prednisone anymore. She guesses she will go take it and see what happens. She is sorry she could not find her doctor's address. Oh she found the doctor's information. Just so happens she got a piece of mail from them today. Investigation assessment; no. the outcome of events was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: cough; minor sore throat; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 01Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient is due to get his 2nd dose tomorrow, but he's currently experiencing cough and a minor sore throat and wants to know if he can get his 2nd dose or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Transaminases increased
Clinical narrative: Transaminitis; This is a spontaneous report from a contactable healthcare professional received from a Pfizer-sponsored program . A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced transaminitis. It was reported that, the healthcare professional called and reported that they had a patient that after taking the Covid-19 Vaccine, was tested to have transaminitis now. The reporter had no information about the patient and was asked whether there are any reports regarding this. As the caller wanted to know more information. On an unspecified date, the patient underwent lab tests and procedures which included transaminitis. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Heart rate, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). 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 was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The Patient's medical history included anxiety and is also under doctor supervision for anti-anxiety meds. On an unspecified date, the patient experienced heart racing after first dose of COVID-19 vaccine, heart racing lasted for 3-4 days, slow at first and more at night that woke her up at night, feeling of almost fainting because she felt out of control and feeling out of breath. It was reported that, event took place after use of product. The patient underwent lab tests and procedures which included EKG (electrocardiogram): normal on 24Feb2021, heart rate: racing lasted for 3-4 days, slow at first and more on at night on an unspecified date. The outcome of the events was recovered on 24Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). 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 was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The Patient's medical history included anxiety and is also under doctor supervision for anti-anxiety meds. On an unspecified date, the patient experienced heart racing after first dose of COVID-19 vaccine, heart racing lasted for 3-4 days, slow at first and more at night that woke her up at night, feeling of almost fainting because she felt out of control and feeling out of breath. It was reported that, event took place after use of product. The patient underwent lab tests and procedures which included EKG (electrocardiogram): normal on 24Feb2021, heart rate: racing lasted for 3-4 days, slow at first and more on at night on an unspecified date. The outcome of the events was recovered on 24Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm; chilling; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. A patient of an unspecified age and gender received the 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 an unspecified date, as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. The patient had no ill effects after first dose. On an unspecified date, after the second dose of vaccination, the patient experienced sore arm and chilling for 1 day only. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had a sore arm after first vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced he had a sore arm after first vaccine. It was reported that caller would have his second dose of the covid-19 vaccine on 15Mar2021, inquiring when restrictions would be lifted after having the vaccine and could they still get the virus, read ISI, caller stated he had a sore arm after first vaccine, relayed PMI number, transferred to PSCC, relayed hold time, caller did not want to remain on hold, will fax AE. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: had sore arm; stomach ache; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunization. Medical history included IBS (Irritable bowel syndrome). Concomitant medications were not reported. It was reported that informed that had the second covid-19 vaccine and had sore arm and stomachache. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of COVID-19 vaccine on an unknown date for COVID-19 Immunization. On an unspecified date (after administration of the vaccine), the patient experienced pain. The outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: fogginess; fatigue; This is a spontaneous report received from contactable consumer (patient) via a Pfizer-sponsored program . A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date (3 days after the first dose), the patient experienced fogginess and fatigue. Patient enquired whether he could use Flonase. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Suspected COVID-19
Clinical narrative: diagnosed with Covid; cough; diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing dementia. The patient's concomitant medications were not reported. About two weeks ago, the patient's son came home and he had some coughing and fever for a day and shortly after, the patient husband starting having symptoms. The patient had diarrhea and a cough and because he had dementia, his wife called the ambulance and they put him in the hospital and he was diagnosed with COVID. He had been there since last Sunday and they want to release him on 01Mar2021. The patient was supposed to get his second vaccine on 05Mar2021. The outcome of events was unknown.                 She had a cough but no fever. She has had a test but no results yet but she is in quarantine until the 7th and they are supposed to get their second vaccine on March 5.  She needs to reschedule her appointment.  They gave her a card with the time but she doesn't have a phone number of the place she got it. How does she reschedule?  DSU: filing AE/PC  age  69 for (name).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; 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, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm soreness and fatigue after use of vaccination. The outcome of all the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Got headaches and tinnitus from first shot. After the second dose it got worst.; Got headaches and tinnitus from first shot. After the second dose it got worst.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (Son) that: A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Unknown) and first dose both via an unspecified route of administration in unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per verbatim and event description, patient received both vaccines. Got headaches and tinnitus from first shot. After the second dose it got worst. The outcome of both events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Sneezing, Suspected COVID-19
Clinical narrative: started experiencing covid symptoms; loss of taste; loss of taste & smell; sneezing; This is a spontaneous report from a contactable consumer (patient) from a   female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: unknown, expiration date: unknown), via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that on 23Feb2021 she had her first dose of the covid-19 vaccine and on an unspecified date in 2021, she had some adverse events and started experiencing Covid symptoms like sneezing, and loss of taste and smell. She reported that something she was experiencing were known side effects of Pfizer vaccine and she was experiencing a symptom and was trying to figure out if it was a side effect of the vaccine or if she needs to get a COVID test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other HCP. This 28-year-old female other HCP reported for herself that she received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 19Feb2021 09:45 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunization. Medical history included, hashimoto's, mitral valve prolapse, known allergy, gluten. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunization (dose number 1, Lot number: EL3247), erythromycin and experienced known allergy: erythromycin. It was reported that, the 11 days (02Mar2021) after she received her second vaccine, she broke out in a full body rash/hives starting around 2:30pm. The rash was around my eyes, chin, ears, arms, armpits, hands, torso, shoulders, back, legs, and thighs. She took benadryl immediately (took one dose at 2:30pm and another dose at 6:30pm). The rash lasted the rest of the day and when she woke up the next morning it was gone. Later that day (03Mar2021), the rash/raised hives came back around 10:30am on my legs, back, right arm, neck, and buttocks. She took Benadryl and prescription steroids again and the rash lasted the rest of the day. The following morning (04Mar201) the rash was gone and has not come back as of today (05Mar2021). The outcome of the events was unknown.No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Urticaria, Vaccination site rash
Clinical narrative: Covid arm. Raised red welt on day 11 with pain; Covid arm. Raised red welt on day 11 with pain; very painful into shoulder blade; still painful into neck as well; Red circle around injection site; This is a spontaneous report from a contactable consumer. This 59-years-old non-pregnant female consumer (Patient) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Feb2021 02:45 PM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Penicillin. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced covid arm, raised red welt on day 11 with pain, very painful into shoulder blade, still painful into neck as well and red circle around injection site; all on 02Mar2021 at 04:00 PM. It was reported that Covid arm. Raised red welt on day 11 with pain. Better day 2, 3 day very painful into shoulder blade. Day 4 still painful into neck as well. Red circle around injection site. No treatment was received. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Urticaria
Clinical narrative: hives on my right arm (not same arm as shot)/hives on right leg; This is a spontaneous report from a contactable consumer (patient). This 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: 1), as single dose via an unspecified route of administration, administered in left arm on 28Feb2021 16:30 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 01Mar2021 15:00, patient developed hives on right arm (not same arm as shot) one day later.  Patient had covid test post vaccination as nasal Swab, on 01Mar2021 and result was negative. The clinical outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Red blotchy hives on upper abdomen; This is a spontaneous report from a non-contactable consumer. A 29-year-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in Arm Right on 14Feb2021 18:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; doxycycline (DOXYCYCLINE) taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 20:00 patient experienced red blotchy hives on upper abdomen. No treatment was provided for the event. The outcome for the event was recovered on unknown date.  No follow-up attempts are possible. No further information is expected.