chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Limb discomfort, Mobility decreased
Clinical narrative: 4 days after the second vaccine in injection I had the same overall feeling once; next week I am having an increasingly "heavy" feeling to my right arm and leg; right side feel heavy or almost numb; I am still able to use the arm and leg but it feels difficult to move.; This has progressed to a periodic numbness to the right hand and bottom of right foot; numbness in both hands off and on; This is a spontaneous report from a contactable nurse (patient herself). A 38-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261), via intramuscular route of administration in Arm Left on 25Jan2021 at 09:00 (38-years-old at the time of vaccination) as single dose for covid-19 immunisation. Medical history included migraines, PFO with closure, stroke, PNA 2002, headaches, covid-19 (patient had covid prior vaccination). No known allergies were reported. Patient did not receive other vaccine in four weeks. Concomitant medication(s) included ASA taken for an unspecified indication, start and stop date were not reported; ibuprofen taken for headache, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (lot number: EK4176) via intramuscular route of administration in Arm Left on 04Jan2021 at 12:00 (38-years-old at the time of vaccination) as single dose for covid-19 immunisation and had an episode of right leg numbness and an overall odd' feeling throughout her entire body that subsided in about 5 minutes. On an unspecified date in Jan2021, 4 days after the second vaccine, the patient had the same overall feeling (like first dose) once, while at work, that made right side feel heavy or almost numb. It persisted for a few hours and subsided. The next week patient had an increasingly heavy' feeling to right arm and leg. It was periodic but seems to be progressing to a constant heavy feeling. Patient was still able to use the arm and leg, but it feels difficult to move. This has progressed to a periodic numbness to the right hand and bottom of right foot. Also, when sleeping patient was getting numbness in both hands off and on. Events resulted in visit doctor or other healthcare professional office/clinic visit for events. It was unknown if patient received treatment for the events. Patient was not tested covid post vaccination. The outcome of events was not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient (reporter's mother) experienced dizziness 1 week after the first dose on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her right arm to her elbow was hurting; Swelling; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 05Feb2021 02:55 (Age at Vaccination: 76 years) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included PRESERVISION (reported as eyes) for AREDS 2, 1 twice daily from Feb2021 to ongoing started a week ago; hair skin and nails (reported as stye) as 2 gummies daily on an unknown date in 2020 (reported as 3 to 4 months ago). On 06Feb2021, the patient experienced swelling. On 07Feb2021, the patient has trouble moving her arm/ received vaccine in left arm, but right arm was hurting. The patient reported that when she woke up on Saturday her right arm was hurting. She received the vaccine in her left arm. The muscles in her right arm to her elbow was hurting. She also has swelling in her arm. She used Hemp Pain Cream. She is asking if she can take any type of pain killers. She is also having trouble moving her arm. She confirms that this started after receiving the vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. There were no prior vaccines administered within 4 weeks. The patient still had pain even after using Hemp Vana Pain Cream. Patient received treatment as Hemp Vana Pain Cream (Lot number: 37455C, expiration date: Dec2021). The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy
Clinical narrative: Shoulder pain; Swollen Lymph Node under Arm; Headache; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL9264; Expiration date was not reported), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 at 10:30 (at the age of 59-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Patient received no other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination and the patient was not tested for COVID, post vaccination. The patient medical history and concomitant medications were not reported. The patient previously took Penicillin and experienced drug hypersensitivity (allergies). The patient had experienced shoulder pain, swollen lymph node under arm, headache on an unspecified date. Patient did not received treatment for the events. The outcome of the events was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 40 year-old non-pregnant female patient second received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as Dose 2, single for COVID-19 immunization (40 years at the time of vaccination). It was unknown if patient had other medical history and known allergies. It was unknown if the patient had received any other medications with two weeks after Covid-19 vaccination. The patient was not Covid-19 infected prior vaccination. The vaccination facility was reported as hospital. The patient had not received any other vaccine four weeks prior to Covid-19 vaccine. The patient previously received first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. On Jan2021, the patient experienced chills which lasted only a few hours after receiving his 2nd dose. The patient was not tested for Covid-19 post vaccination. The patient had not received treatment medication for the resulted event. The outcome of the event was recovered on an unknown date in 2021.  Information on Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Rash, Somnolence
Clinical narrative: Tired; Could not keep my eyes open; Rash; Allergy; This is a spontaneous report from a contactable consumer (Patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was tired, could not keep my eyes open, rash and allergy. It was reported that, patient had a reaction to the Covid Vaccination. Patient had the vaccination, Wednesday the 3rd (unspecified) at 1:30. And patient was fine, just very tired. About 8 O'clock, patient could not keep eyes open. So, patient said now was just going to go to bed. Patient went to bed, slept till at around a little, past 10 O'clock, and woke up and patient was covered with a rash and so had allergies to dust and stuff like that. So, patient took an allergy pill that has the Benadryl (treatment) in it and went back to bed and then in the morning 3 quarters of the rash was gone, just had a little bit, a few on patient's face and little bit on neck. Patient inquired and was concerning about second vaccination coming up the 24th, is it okay to have the vaccination. Therapeutic measures were taken as a result of allergy. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pruritus, Rash, Vaccination site pain
Clinical narrative: her husband said he got itchy immediately after receiving his first COVID-19 Vaccine; She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins; a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad; her husband said he felt run down a week after he received his first COVID-19 Vaccine dose; Injection site pain; This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiration date: Not reported) via an intramuscular route of administration, administered in Arm Left on 12Jan2021 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included ongoing psoriasis, Allergic to penicillin. The patient's concomitant medications were not reported. It was reported that her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. She said her husband doesn't have any allergies, except for Penicillin. She said her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. She clarified her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. She said a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. The outcome of the events was recovered on Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Fatigue, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: arm pain; a little uncomfortable; fatigue; tired; breathing issues; The initial case was missing the following minimum criteria: Adverse event NOS. Upon receipt of follow-up information on (20Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.     A female patient of (Age: 79; Unit: Unknown) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization.  Medical history included ongoing asthma and reflux; patient had Covid virus from Mar2020 to an unknown date, Patient was tested for antibodies over the summer and had antibodies, patient had no idea how much, the test indicated presence of antibodies. The patient's concomitant medications were not reported. After about an hour of vaccination, patient had arm pain, a little uncomfortable. Patient reported she iced arm, and kept icing arm, at night was uncomfortable, the next day, had a little problem but it was okay, she could raise arm. And she states that she was told, and read that she should just keep exercising arm, back and forth up and down, it seemed to help and went away and by the day after it was gone. I was a little usa and had to lie down. Patient had a little fatigue for 2 days or so and was having some breathing issues, but wasn't sure because she have asthma and reflux. Patient had a sensation when breathing, couldn't really tell you if she was short of breath or not, and was a little concerned, took antacids and it went away. that is why patient didn't think it had to do with the shot. It went away the next day, and didn't bother her at all, Patient feel her response was quite mild. Patient reported her left arm hurt a little bit, that was the arm she had the shot, and was tired. Patient reported she will be getting her 2nd dose on 23Feb2021. Patient had a sars-cov 2 antibody test recently and had no antibodies. Therapeutic measures were taken with antacids and ice (iced the arm).  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: extreme hives on body; first night hard woke up with a hard time breathing; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 17-years-old) as single dose for covid-19 immunisation at workplace clinic. Medical history included anxiety. Patient had known allergies as she got a rash from Sulfa drugs. Concomitant medication included (other medication in two weeks) fluoxetine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Solution for injection) on an unknown date (at the age of 17-years-old) for COVID-19 immunisation. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient did not have COVID-19 and the patient not been tested for COVID-19 post vaccination. On 16Feb2021, patient experienced first night hard woke up with a hard time breathing and extreme hives on body on 20Feb2021. Therapeutic measures were taken as a result of the events included Benadryl. The outcome of events was recovered on an unknown date in 2021.  Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Body Aches; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 09Feb2021 (at the age of 24-years-old) at dose 2, single for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunization. The vaccine was administered at a workplace clinic. On 10Feb2021 at 01:00, the patient experienced chills, body aches, and low-grade fever. No treatment was received in response to the events. She was no tested for COVID post vaccination. The outcome of the events was recovered on 10Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Culture throat, Dyspnoea, Feeling abnormal, Gait disturbance
Clinical narrative: She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported.  A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown.  Follow-up: Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities
Clinical narrative: She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported.  A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown.  Follow-up: Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Diarrhoea, Fatigue
Clinical narrative: progressively got worse over the next day; feeling bad; heart rate that hit 175; My oxygen saturation was 90-91%; spasms; body aches / sore; diarrhea; fever; muscle pain; headache; severe chills; tired / exhausted; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiration Date: 31May2021), via an unspecified route of administration on 03Feb2021 as 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient started feeling bad on 04Feb2021 and progressively got worse over the next day. The patient had severe diarrhea, fever of 102.8, heartrate that hit 175 at one point and then settle down to 130's for 16 hours. The patient had severe muscle pain with spasm, headache and body aches along with severe chills. The oxygen saturation was 90-91% during that time. The patient was a registered nurse and did not go to the ER but the patient would admit it was a frightening 48 hours. The patient was left so tired, sore and exhausted. Needless to say the patient would not be taking the second vaccine and would truly be scared for the life if things were to be any worse than the first one. The outcome of all the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event : heart rate increased and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate, Heart rate increased, Muscle spasms
Clinical narrative: progressively got worse over the next day; feeling bad; heart rate that hit 175; My oxygen saturation was 90-91%; spasms; body aches / sore; diarrhea; fever; muscle pain; headache; severe chills; tired / exhausted; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiration Date: 31May2021), via an unspecified route of administration on 03Feb2021 as 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient started feeling bad on 04Feb2021 and progressively got worse over the next day. The patient had severe diarrhea, fever of 102.8, heartrate that hit 175 at one point and then settle down to 130's for 16 hours. The patient had severe muscle pain with spasm, headache and body aches along with severe chills. The oxygen saturation was 90-91% during that time. The patient was a registered nurse and did not go to the ER but the patient would admit it was a frightening 48 hours. The patient was left so tired, sore and exhausted. Needless to say the patient would not be taking the second vaccine and would truly be scared for the life if things were to be any worse than the first one. The outcome of all the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event : heart rate increased and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Oxygen saturation, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: progressively got worse over the next day; feeling bad; heart rate that hit 175; My oxygen saturation was 90-91%; spasms; body aches / sore; diarrhea; fever; muscle pain; headache; severe chills; tired / exhausted; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiration Date: 31May2021), via an unspecified route of administration on 03Feb2021 as 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient started feeling bad on 04Feb2021 and progressively got worse over the next day. The patient had severe diarrhea, fever of 102.8, heartrate that hit 175 at one point and then settle down to 130's for 16 hours. The patient had severe muscle pain with spasm, headache and body aches along with severe chills. The oxygen saturation was 90-91% during that time. The patient was a registered nurse and did not go to the ER but the patient would admit it was a frightening 48 hours. The patient was left so tired, sore and exhausted. Needless to say the patient would not be taking the second vaccine and would truly be scared for the life if things were to be any worse than the first one. The outcome of all the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event : heart rate increased and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Raised rash B/L Forearms; This is a spontaneous report from a contactable Physician. This 52-year-old female physician reported in response to HCP letter sent in a cross reference case which included that: A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Deltoid Left on 14Jan2021 (at the age of 52-year-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 23Dec2020 as dose1, single for covid-19 immunisation and experienced diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted, one episode of chills. The patient concomitant medications were not reported. On 25Jan2021 10:00, the patient had raised rash on B/L forearms, not itchy surgical gown touches-and they did not change our gowns. Very strange. It was mostly gone now. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as 1st dose single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, got her first dose of Covid-19 vaccine last January 29. The next dose will be tomorrow; however, she was diagnosed with Urinary Tract Infection and prescribed by her doctor with Cefuroxime 250mg, she took 1 tab today. She was asked  if it is okay for her to get the vaccine tomorrow. On an unspecified date Patient had urinary tract infection with outcome of unknown. Therapeutic measures were taken Cefuroxime 250mg as a result of urinary tract infection (urinary tract infection).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site pain
Clinical narrative: Injection site pain; urinary tract infection (UTI); This is a spontaneous report from a contactable consumer or other non health care professional.  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, in Left Arm on 23Feb2021 at 15:45 (at the age of 65-years-old) as 1st dose, single for Covid-19 immunisation. The patient medical history included depression, arthritis, post-traumatic stress disorder (PTSD). The patient was diagnosed with all the medical history in her twenties. The patient concomitant medications were not reported. The patient had no other recent vaccinations or started any new medications. On 24Feb2021, the patient had experienced urinary tract infection and injection site pain on an unspecified date. The patient reported that the first symptoms she had only a very small pain where she got the shot. She informed that her main concern is that last night she had a UTI, so she wondered if it could be because of that, clarified to being a side effect. She reported that she got her first dose late in the afternoon, about 03:45PM. She took over the counter AZO yesterday for the UTI since it was horrible yesterday. No further details provided about the AZO. The patient received treatment for the event urinary tract infection. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Impaired healing, Inflammation
Clinical narrative: Re-injured my back; Increased inflammation in my body overall due to the recent vaccination; He thinks that adding an injury on top of an already stressed system, is causing; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 3249), dose 2 via an unspecified route of administration, administered on 17Feb2021 10:30 as single Dose in left arm for COVID-19 immunization. The patient medical history included attention deficit hyperactivity disorder from an unknown date, asthma from an unknown date, and have a lower back injury from Jul2015 and ongoing. Historical vaccination included the patient received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 26Jan2021 as single dose  for COVID-19 immunization. The patient concomitant medications included loratadine (CLARITINE), amfetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL, bupropion hydrochloride (WELLBUTRIN). The patient experienced re-injured my back, increased inflammation in my body overall due to the recent vaccination, he thinks that adding an injury on top of an already stressed system, is causing on 20Feb2021. The patient aware that it should be reported late in the day of 25Feb2021 after an appointment with her physician. Since it was an injury and not an illness, or even expected potential side effect, she didn't attribute it as a possible link to the vaccine until she saw her doctor. She reported it as soon as she accessed her laptop following that appointment. The patient treating physician was not sure if her slower than normal healing was related to the vaccine or not, but he hypothesized that since she had recently been vaccinated, her body had an increase in inflammation. The patient treating physician thinks that adding an injury on top of an already stressed system, is causing the slower healing.The patient had taken flexeril and ibuprofen for reported events. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ligament sprain
Clinical narrative: twisted his knee on 23Feb and received a cortisone shot; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated her husband received the first dose of the Covid 19 vaccine on 17Feb2021 and he experienced twisted his knee on 23Feb2021. Therapeutic measures were taken as a result of twisted his knee which included a cortisone shot. His second dose was scheduled for 11Mar2021 and wanted to know if it was wrong that he received the cortisone. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Itchiness on chest; rash on chest; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in Arm Right on 24Feb2021 13:30 (at the age of 77 years old) (Batch/Lot Number: ERV6200) as single dose for COVID-19 immunization. Previously the patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, in Arm Right on 04Feb2021 14:00 (at the age of 77 years old) (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history included trigeminal neuralgia. Concomitant medications included gabapentin; oxcarbazepine taken for an unspecified indication. The patient has no known allergies. On 24Feb2021 at 09:00 the patient experienced itchiness and rash on chest, Shortness of breath and self-administered Cortisone cream only on chest. No other vaccines were received in four weeks. The patient had no covid prior vaccination and was has not been tested for Covid-19 post vaccination. Therapeutic measures were taken as a result of itchiness and rash on chest, shortness of breath. The clinical outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: tooth swelled and got messed up; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patent had first dose of the Pfizer COVID-19 vaccine on Monday (22Feb2021) and on Tuesday (23Feb2021), her tooth swelled and got messed up. She went to the dentist on (26Feb2021) and got prescribed with amoxicillin. She wanted to know if there would be an interaction with the Pfizer COVId-19 vaccine and antibiotics. Therapeutic measures were taken as a result of event: treatment included amoxicillin. Outcome for the event was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer. This 50-year-old female consumer reported. A 50-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 25Feb2021 at 11:45 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation at clinic. Medical history included asthma from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing. Patient had no known allergies. The concomitant medications were not reported. patient received other medication prior two weeks of vaccination. Patient was not received any other vaccine prior four weeks of vaccination. On 25Feb2021 at 12:15 AM, 30 minutes after vaccination, the patient experienced trouble breathing and felt dizzy. Patient visited to Emergency room/department or urgent care for the events. Since vaccination patient not tested for covid-19. Therapeutic measures were taken as a result of the events with Albuterol, Epi pen, Benadryl, Pepcid and Prednisone. The outcome of the events were resolving. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Nervousness, Restlessness
Clinical narrative: within 10 minutes of vaccination very rapid heart rate; shortness of breath; restlessness; incredible nervousness; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting).  A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: PfuzerEN6203 and expiration date was not reported), via an unspecified route of administration in arm right on 23Feb2021 at 09:30 as 1st dose, single for COVID-19 immunization, (age at the time of vaccination was 73-year-old). Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient previously took epinephrine, some antibiotics, sofa and experienced drug hypersensitivity. Concomitant medications included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported and immunitone Plus mushroom extracts bo. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 23Feb2021 at 09:45, within 10 minutes of vaccination the patient experienced very rapid heart rate, incredible nervousness, shortness of breath, restlessness. The patient received treatment for all the events and nurse remained with me until 10:45. Outcome of the events are reported as recovered.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Malaise, Oxygen saturation
Clinical narrative: difficulty breathing; chest tightness; feeling itchy with some chest tightness; O2 sat 70%; not feeling well; This is a spontaneous report from a contactable Nurse. A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6202), via intramuscular route of administration at arm right on 27Feb2021 14:45 (02:45 PM) (at the age of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included allergies to penicillin, iodine contrast, cephalosporins. The patient concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. It was unknown whether the patient was tested for covid post vaccination. Patient did not receive other medications in two weeks. The patient experienced difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well on 27Feb2021 14:45 (02:45 PM). Adverse event: after vaccine administration patient ambulated to the 15 minute hold location, during that time patient began to close eyes and reported not feeling well, patient husband was with her and notified staff, patient taken to private location and evaluated by nursing staff, patient barely able to state name, reported chest tightness, difficulty breathing, heart rate was 88, O2 sat 70%, administered one dose of epinephrine and administered 10L of O2 vis facemask, vital signs obtained and EMS services contacted, patient able to state name and location, reported feeling itchy with some chest tightness, continued to montior vitals until EMS services arrived. AE resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate was 88, O2 sat was 70% on 27Feb2021. The patient received epinephrine as a treatment medication and patient taken to ER (emergency room) for further evaluation for the events difficulty breathing, chest tightness, feeling itchy with some chest tightness, O2 sat 70%, not feeling well. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of dyspnea and other. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate