chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Feeling abnormal, Hypersensitivity, Lethargy
Clinical narrative: afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information.   A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation.   The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported.  on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The  outcome of events was unknown.   The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart.  She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Tachycardia
Clinical narrative: afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information.   A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation.   The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported.  on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The  outcome of events was unknown.   The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart.  She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: A little swelling or redness; Only left and lower, feel like "I am being blown by a blow to torch; The pain is horrible; A little swelling or redness; 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), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported a little swelling or redness, only left and lower, feel like "i am being blown by a blow to torch and the pain is horrible on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Somnolence
Clinical narrative: the patient is experiencing an ear ache; patient being sleepy; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW0170) as single dose vaccinated at the age of 88 years old for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the patient is experiencing an ear ache and sleepy on 21Apr2021. Caller reported that the lot number on her Covid-19 vaccine was EW0170 and that the patient probably had the same lot number for her Covid-19 vaccine since the caller and the patient got the vaccines at the same location on the same day, 20Apr2021. The patient does not take any medications at all and is a very healthy woman. Caller reported that the patient does not take a single pill. Caller reported that because the patient does not take any medications, it is probably the reason why the patient's body acted the way it did. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Headache, Loss of consciousness
Clinical narrative: was going to blackout; Body aches; headache; chills; nausea; Chest pain; This is a spontaneous report from a contactable consumer reported for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 20:30 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Heart murmur. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as 1st dose, single for COVID-19 immunization. On 25Apr2021 16:00, the patient experienced body aches, headache, chills, nausea and chest pain, chest pain was severe with chills, felt like she was going to blackout, her husband propped her up in bed, gave Advil and a cool rag for her head, temp was 98.3 Fahrenheit. Outcome of the events were unknown.  Follow up attempts needed. Further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: was going to blackout; Body aches; headache; chills; nausea; Chest pain; This is a spontaneous report from a contactable consumer reported for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 20:30 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Heart murmur. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as 1st dose, single for COVID-19 immunization. On 25Apr2021 16:00, the patient experienced body aches, headache, chills, nausea and chest pain, chest pain was severe with chills, felt like she was going to blackout, her husband propped her up in bed, gave Advil and a cool rag for her head, temp was 98.3 Fahrenheit. Outcome of the events were unknown.  Follow up attempts needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Pain, Vaccination site mass
Clinical narrative: These side effects include pain in the left armpit where the vaccine was administered; Tiredness; Bodyache; Headache; Development of tennis ball size lump on left armpit (same side where he got the vaccine); This is a spontaneous report from a contactable consumer.  A 26-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 24Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on on an unspecified date as a single dose for covid-19 immunization. On an unspecified date, the patient experienced several side effects included pain in the left armpit where the vaccine was administered, the development of tennis ball size lump on left armpit (same side where he got the vaccine), tiredness, bodyache and headache after receiving the 2nd dose of the COVID-19 vaccine. Caller would like to know if this is a normally experienced side effect post vaccination and how long does it go away. The outcome of the event development of tennis ball size lump on left armpit, pain in the left armpit was unknown and others were resolved. It was reported that patient referred to HCP for further clinical recommendations and side effect management.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Vertigo
Clinical narrative: vertiginous; Light headedness; it has progressed to when she is walking and she feels like she will pass out.; This is a spontaneous report from a contactable Physician (patients father) via medical information team. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unknown route of administration on 09Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer Covid 19 vaccine 3 weeks ago on 09Apr2021. Patient began experiencing vertiginous symptoms of light headedness and dizziness nocturnally when trying to lay down however it has progressed to when she is walking and she feels like she will pass out. The symptoms are persisting and she has not gotten significantly better. Reported stated that a search of her resources contain no information regarding his daughters symptoms being reported and that the PI for the vaccine contains no information about his daughters symptoms being reported. LAB-1457-7.0Revised: 06April2021. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report was received from a contactable consumer or other non hcp via a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 20 Apr 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient called in and stated that she got the 1st dose yesterday 20Apr2021 and stated that she had a fever today on 21Apr2021, she asked what recommendations we had. The outcome of fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A lot of injection site pain and it continues now; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included flu shot for painful arm. The patient experienced a lot of injection site pain and it continues now on an unspecified date. The mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extreme arm pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unknown age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 08Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Pfizer COVID vaccine first dose on 08Apr2021 and had experienced "extreme arm pain every day since. Patient did not remember if it was that evening or in the morning, some days are worse than others, it was sad what had been going through had been affecting my activities. Patient was supposed to get second dose on Thursday. Patient wanted to know the efficacy percentage from Pfizer after a single dose of this vaccine, stated she has "heard all over, everywhere that some people took 1 dose and may be fine with it being 50% or something and second 95%. Response received as alternative dosing regimens of Pfizer-BioNTech COVID-19 Vaccine have not been evaluated. The decision to implement alternative dosing regimens resides with health authorities; however, we at Pfizer believe that it was critical for health authorities to conduct surveillance on implemented alternative dosing schedules to ensure that vaccines provide the maximum possible protection. The outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in right calf; This is a spontaneous report received from contactable consumer for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:15 (Batch/Lot Number: EW0151) as 2nd dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history allergy to penicillin.  The patient's concomitant medications were not reported.  Historical Vaccine included the first dose of BNT162B2 on 21Mar2021 05:15 PM in Left Arm (Batch/lot number: Ep6955) as 1st dose, single for COVID-19 Immunization. The patient experienced blood clot in right calf on 15Apr2021 03:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clot in right calf included Blood thinners. No Hospitalization Prolonged. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: eye pain; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer. This contactable consumer reported same event for both her son and herself. This is the report for patient herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient and her son both got their 1st dose yesterday(20Apr2021) of the Covid vac-cine and now today (21Apr2021) they are experiencing eye pain. She wanted to know if this was a normal side effect. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: This is a spontaneous report from Pfizer-sponsored program.  This contactable consumer reported same event for both her son and herself. This is the report for her son. The consumer (patient's mother) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced eye pain on 21Apr2021. The outcome of event was unknown.  No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s)
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: nausea; dizziness; headache; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 20Dec2020 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that about 2 weeks after the vaccine the patient experienced nausea, dizziness and headache.The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia
Clinical narrative: muscle pain; bone pain but only in the right side of her body; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 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 medical history and concomitant medications were not reported. The patient experienced muscle pain and bone pain but only in the right side of her body on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: She started her menstrual cycle 10 days earlier; This is a spontaneous report from a contactable pharmacist. A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown Expiry date: unknown) via an unspecified route of administration on 21Apr2021 as single dose for COVID-19immunization. Patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown Expiry date: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient's medical history was not reported. The concomitant medication includes antidepressants; however, unspecified. On 23Apr2021 Patient started menstrual cycle 10 days earlier than normal. pharmacist reports that patient states her menstrual cycle was always regular. Also, mentioned that she was healthy, has no children. The reporter wants to know if Pfizer has any information on this as a reported side effect. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Developed a rash on both of legs; Rash showed up on her arm at the "location that I got the vaccine as well"; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient (at 40 years ) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration, administered on arm on 12Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Apr2021, at night, the patient developed a rash on both of legs. She also stated that the rash showed up on her arm at the location that she got the vaccine as well, but she stated that the rash has already gone away. she did take pictures of it. The patient was due for her second dose on 03May2021 and would like to know if she was still okay to get it despite the side effects she experienced. Response was the patient knows the contraindications to receiving a dose of the vaccine. Also let her know that rash had been reported as a non-severe allergic reaction to the vaccine. The outcome of the events was reported as recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Hypoaesthesia, Pain
Clinical narrative: I had numbness in both legs. It started from my left thigh and it's now radiating to the right side.; body aches; dizziness; joint pain; cough; My skin blotches; Eyesight are weak; This is a spontaneous reported from a contactable consumer (patient). An 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Jan21 for COVID-19 immunization. In Feb2021, the patient had numbness in both legs. It started from left thigh and it's now radiating to the right side, body aches, dizziness, joint pain, cough, my skin blotches, eyesight are weak. He took Tylenol maximum strength. He stopped because on the label it's said not to take it for extended time. His doctor recommended Aleve. After taking it for few days he was saw no change at all. He was took Tylenol again. He been taking Tylenol for 2 weeks. He was noticed a change and improvement. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Visual impairment
Clinical narrative: I had numbness in both legs. It started from my left thigh and it's now radiating to the right side.; body aches; dizziness; joint pain; cough; My skin blotches; Eyesight are weak; This is a spontaneous reported from a contactable consumer (patient). An 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Jan21 for COVID-19 immunization. In Feb2021, the patient had numbness in both legs. It started from left thigh and it's now radiating to the right side, body aches, dizziness, joint pain, cough, my skin blotches, eyesight are weak. He took Tylenol maximum strength. He stopped because on the label it's said not to take it for extended time. His doctor recommended Aleve. After taking it for few days he was saw no change at all. He was took Tylenol again. He been taking Tylenol for 2 weeks. He was noticed a change and improvement. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Colitis, Condition aggravated, Inflammation, SARS-CoV-2 test
Clinical narrative: Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; Severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 27Mar2021 13:30 (Batch/Lot Number: Er8737) as 1st dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis reactive. The patient's concomitant medications were not reported. The patient experienced severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints on 16Apr2021 09:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of severe flare up of inflammatory condition, reactive arthritis, mainly in colon (colitis) and joints included Anti-inflammatory prescriptions. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had been tested for COVID-19, Nasal Swab on 24Apr2021 with result of negative. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: She experienced dizziness; Headache; Fatigue; Body ache; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: UNKNOWN) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, headache, fatigue, body ache, muscle pains on her neck to her shoulder. Patient asked if this was normal and for how long would these side effects last. Outcome was unknown for all the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: She experienced dizziness; Headache; Fatigue; Body ache; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; Muscle pains on her neck to her shoulder; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number: UNKNOWN) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, headache, fatigue, body ache, muscle pains on her neck to her shoulder. Patient asked if this was normal and for how long would these side effects last. Outcome was unknown for all the events.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Urine odour abnormal
Clinical narrative: slight fever; fatigue for a day; aches; my urine has a strong smell, smells like bad deli meat; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, patient had a slight fever, aches, fatigue for a day and noticed that urine has a strong smell, smells like bad deli meat. Outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a contactable Physician reporting for a patient (reporter's son.) A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 04Apr2021 14:45 (Lot Number: ER8732) as a single dose (at the age of 46-years-old) for COVID-19 immunisation.  Medical history included ongoing gout (controlled), and Bell's palsy from an unknown date (patient had Bell's palsy 13 years before). Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included allopurinol (300 mg) at 300 mg from an unknown date for gout.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 12Apr2021 the patient experienced Bell's palsy.  The patient started symptoms on 12Apr2021 and progressed to facial paralysis on 23Apr2021 which was finally diagnosed as Bell's Palsy. The Bell's Palsy is stable and has not improved much yet. Clinical course is as follows: on Monday, 12Apr2021 one and a half weeks after the vaccine the patient's symptoms began, he had minimal symptoms on 10Apr2021 and on 23Apr2021 he had facial paralysis and on that day he started treatment. On Friday (date not specified) the patient had facial weakness. The reporter considered the event non-serious. The reporter would like to know the post-marketing incidence of Bell's palsy and the reporter was trying to decide whether the patient (reporter's son) gets second dose of Pfizer Covid BioNTech Vaccine or forgoes it. Therapeutic measures were taken as a result Bell's palsy included treatment with high-dose prednisone and valicyclovir (VALTREX). The clinical outcome of the Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The reporter stated that this (Bell's palsy) may be a random event or a related event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA 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: Dyspnoea, Platelet count decreased
Clinical narrative: drop in platelets after pfizer vaccination; shortness of breath at rest; This is a spontaneous report from a contactable consumer reporting same events under the same suspect products for 13 patients. This reporter reported for one of the 13 patients that a patient of an unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient medical history included cough from Feb2020 to Feb2020. Patient concomitant medications were not reported. The patient experienced drop in platelets after pfizer vaccination, shortness of breath at rest. The events were assessed as non-serious. The outcome of the event drop in platelets after Pfizer vaccination was unknown whereas the outcome of the event shortness of breath at rest was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Rash pruritic, Tinea infection, Vaccination site rash
Clinical narrative: I have a rash on my arm at the site of the first vaccination,; Itchy rash; Like a round circle on my arm; looks like a big ringworm; This is a spontaneous report received from a contactable consumer (patient). A 68-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 15Feb2021 (at 68-years age) as single dose, and dose 2 via an unspecified route of administration, administered in right arm on 09Mar2021 as single dose for covid-19 immunisation. Medical history included diabetes from 2000 and ongoing, blood pressure high from 1976, that was 45 years ago potassium low, thyroid for 15 years, cholesterol from 15 years. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes, losartan (LOSARTAN) taken for blood pressure high; levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, atorvastatin (ATORVASTATIN) taken for cholesterol; metoprolol (METOPROLOL) taken for blood pressure. Patient was taking Losartan before and also taking a HCTZ, two individual tablets but the doctor combined it to about 6 months ago. Patient took a 20 mEq. Patient took a lab test at her Doctor's office because she was diabetic. She took one every 6 months; I took it in February. It was 6.4. After receiving the Pfizer covid vaccine and patient experienced rash on her arm at the site of the first vaccination, an itchy rash and a round circle on arm; looks like a big ringworm. Patient thought it was after the first shot and before the second shot. Patient did not notice it until about a month ago. It was itchy for a while, then the rash became more dominant, and patient was able to notice it. It looked like a big ringworm. It was a like over a month ago. Patient had itch and she put Cortisone cream (treatment) on it. It was a triple antibiotic ointment, once or twice a day, depends on when it starts to itch, it was a cream. The outcome of event itchy rash was not recovered and unknown for other events.  Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Follow-up (21Apr2021): This is follow-up spontaneous report from contactable consumer. A 68-Years-old female consumer (patient) reported vaccination date, concomitant medication, relevant medical history and treatment information.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: she had problems with her gallbladder; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient has a scheduled second dose due on 22Apr2021. She found out that she had problems with her gallbladder, and asked if she can still get the second dose tomorrow. Outcome of event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: cannot walk right now; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she had her first dose over 3 weeks ago on an unspecified date in 2021. She was supposed to get her second dose which was due last Friday. She had a surgery on her foot and could not walk right now (from an unspecified date in 2021). She wanted to know how long she must wait to get second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizziness; This is a spontaneous report received from a contactable consumer (patient's parent). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); via an unspecified route of administration on 08Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); vaccine on 18Mar2021 for Covid-19 immunization. On an unspecified date patient experienced headache and dizziness. Reporter wanted to know if this is normal and how long should this last. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: nausea; her skin felt as if she had a sunburn/ described feeling of skin as a "prickly feeling"; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Apr2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Per caller her granddaughter received her first PFIZER COVID-19 vaccine two weeks ago. Caller reported that night after receiving the vaccine (on 13Apr2021) her granddaughter had nausea and her skin felt as if she had a sunburn, no redness noted. Caller described feeling of skin as a prickly feeling. The symptoms lasted for about eight days. Caller was asking if her granddaughter should receive the second Pfizer Covid 19 vaccine. No PQC was present. Outcome of the events was unknown..  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Malaise, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: lungs were still hurting; not feeling well; pneumonia/pneumonia from COVID; COVID Positive; This is a spontaneous report received from Medical Information Team and from a Pfizer-sponsored program  from a contactable consumer (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient received her 1st dose of the Pfizer COVID Vaccine on 06Apr2021 but came back COVID Positive on 09Apr2021. She mentioned that she was diagnosed with pneumonia on 19Apr2021 in the hospital and was sent home with antibiotics. She mentioned that she was a healthy person, but her lungs were still hurting and she was still not feeling well. She is due for her 2nd dose tomorrow (27Apr2021) and was asking if she should proceed with it as she had pneumonia from COVID. Outcome of the events was unknown.  Information for lot number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Decreased immune responsiveness, Immune system disorder
Clinical narrative: No immune response from his testing.; immune disorder; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 76-year-old male patient received the second dose of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot number: EM9810) via an unspecified route of administration on 11Feb2021, as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT62B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Lot number: EL9262) via an unspecified route of administration on 21Jan2021, as a single dose for COVID-19 immunization. On an unspecified date (reported as 2 days ago), the patient had no immune response, his doctor told that he has immune disorder. The patient underwent lab test for blood work: No immune response, on an unknown date. Patient was wondering about what should he do now. Patient wanted to get a third booster shot. However, he was informed that the vaccine was not approved for use other than a 2 dose series. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
Clinical narrative: Patient contracted COVID-19 disease on 4-20-21; Patient contracted COVID-19 disease on 4-20-21; This is a spontaneous report from a contactable other HCP. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730) via intramuscular route administration at arm left on 24Mar2021 16:15 as single dose for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient had no relevant medical history. Concomitant medication was not reported. It is unknown if patient receive any other medications within 2 weeks of vaccination or any other vaccines within 4 weeks prior to the COVID vaccine. It is unknow if patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested positive for COVID-19 since the vaccination. Patient contracted COVID-19 disease on 20Apr2021. The patient did not received treatment for the event. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 20Apr2021 Nasal Swab. The clinical outcome of the event was not recovered.   Follow-up (27Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of awareness of the date: 23Apr2021.  Additional information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 1 week after the second dose.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue, Headache, Hypoaesthesia
Clinical narrative: On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported.  The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.