chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation.  Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years).  The patient's concomitant medications were not reported.  Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, Fall
Clinical narrative: She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; She is reporting that her parents both received their first dose of the Pfizer-Biontech Covid19 vaccine on 06Apr2021 and contracted Covid illness shortly after; a fall that resulted in a stroke; a fall that resulted in a stroke; This is a spontaneous report from a contactable consumer (patient's daughter).   A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 06Apr2021 and contracted COVID illness shortly after (unspecified date in Apr2021). The patient was due for his second dose tomorrow, but their quarantine will not be over by then. The patient suffered a fall that resulted in a stroke during this same time period (unspecified date in Apr2021). The reporter indicated that she did not think the stroke was due to the vaccine, but rather due to the fall. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient's father). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid 19 shot about 2 weeks ago (Apr2021), his first shot. About 4-5 days after the covid vaccine shot, he developed shortness of breath that is almost debilitating. He can barely move; he always lays down. His shortness of breath has lasted 4-5 days, and the patient can barely breathe. The reporter knows the answer is to have him see his doctor or an ER (emergency room), but he is in federal prison. The reporter inquired if he could get a letter stating the patient needs to be seen by a physician. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle strain, Pain in extremity
Clinical narrative: The patient medical history and concomitant medications were not reported. On 12Mar2021 same day after vaccination of first dose, the patient started experiencing his arm feels painful, felt strain when he lifts this arm, felt like there is something inside the arm, but cannot describe it further. The patient asked if these lingering symptoms were reported as side effect to the vaccine and if he should consult a doctor for them. The patient received both the doses of vaccine. The outcome of the events was reported as unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer (patient), reported a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration on 01Apr2021 as 1st DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as "this weekend"), the patient tested positive for covid. The patient was scheduled to receive the 2nd dose on 29Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Apr2021): positive. Clinical outcome of the events tested positive for covid was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mental impairment, Nausea
Clinical narrative: Brain dead and she can't think straight; Headache; Felt tiredness; Nausea; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX support. A female patient of an unspecified age (age 45, unit not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient was scheduled for her 2nd dose 18 days later which was on 01May2021. After her first dose had a reaction. She had headache couldn't think straight, felt tiredness. She had side effects which were headache, nausea, tired, brain dead and she can't think straight in Apr2021. She would like to know if she could take the 2nd dose 18 days later instead of 21 days later. She shared her side effects after the first dose because if she got the 2nd dose on Saturday she would have help with childcare and would have no work. And she would have side effects after she got the 2nd one too. She would like to get the second dose on 04May2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Feeling abnormal
Clinical narrative: blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself.   A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history.  The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021,  Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out.  Her tongue also began to swell.  She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive.  The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Loss of consciousness, Swollen tongue
Clinical narrative: blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself.   A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history.  The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021,  Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out.  Her tongue also began to swell.  She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive.  The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Malaise, Panic attack
Clinical narrative: didn't know who her fiancee was and didn't recognize the house; panic attack; wasn't feeling well; confused; This is a spontaneous report from a contactable consumer (reporters fiancee).   A 42 years old female patient received the second dose  bnt162b2 (PFIZER-BIONTECH COVID 19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 17:32 (at the age of 42 years old)  (Batch/Lot number was not reported) as SINGLE DOSE for covid 19 immunization. Medical history included hypertension( high blood pressure; had it for more than 10 years).  The patient concomitant medications includes blood pressure medication taken daily (details not provided). Historical Vaccine BNT162B2 was received on 07Apr2021 Dose 1, first dose was received 21 days before second dose.  The patient experienced panic attack, wasnt feeling well, confused on 29Apr2021, didnt know who her fiance was and didnt recognize the house on 29Apr2021 at 10:30. The clinical outcome of the events was unknown. The clinical course was as follows His fiancee went to get second vaccine shot yesterday. Today she woke up and said she wasn't feeling well. She had a bad reaction. She didn't know who her fiancee was and didnt recognize the house. The ambulance came and she had a panic attack. She did not  want to be touched by anyone. Patient didn't recognize caller or her daughter. The ambulance only checked her vitals. They did not take her to the hospital. The adverse events did not require an emergency room visit or physician office visit. She is home right now and is laying down, so reporter is not sure if she is still confused. He states that she didn't have any memory issues prior to the application of the vaccines second dose. He would like to know if this reaction was caused by the product. The clinical outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: like I could pass out of; Felt very dizzy/Feel very light headed; This is spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown) at left arm on 22Mar2021 12:00 at first dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included Blood cholesterol increased and Allergy to drug (Penicillin). Patient is not pregnant. Concomitant medication received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient felt very dizzy about a week after (01Apr2021) and has continued into the second vaccine. Feel very light headed like she could pass out of and on throughout the day for over a month now. the adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Outcome of the events was not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Throat tightness
Clinical narrative: Upon administering the vaccine , patient. Became very dizzy , and we had her lie down . She then complained of chest tightness , throat tightness , and difficulty breathing . An epipen was administered and paramedics were called . She was taken to the hospital where she was monitored and released . I spoke with her husband when they were home , and he indicated that she was fine
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Woke up in the middle of the night with diarrhea and vomiting.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Headache, Insomnia, Pyrexia, Vomiting
Clinical narrative: Vomiting headaches fever confusion insomnia.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthritis, Back pain, Bone pain, Chills
Clinical narrative: About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than  feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning).  It has been  about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hyperaesthesia, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than  feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning).  It has been  about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain of skin
Clinical narrative: About 10 hours after my second dose, I began to have muscle pain. The muscle pain is different than body aches that I?ve gotten with a cold. My muscles hurt and my skin is sensitive to the touch. It feels like the pain goes from the skin to the bone. I don?t know how else to describe it other than  feeling like a bad a sinus infection inside of my muscles. I know that?s a weird way to describe it but the pain is kind of indescribable and unique. The pain is worst in my neck and back. My joints also feel inflamed, it?s hard to close my hands into a fist. I spent most of the night freezing cold and shivering (I live without air conditioning).  It has been  about 35 hours since I received the vaccine. Cold and shivering has subsided but I have have the sweats for the past 8 or so hours. A bit of nausea and stomach pain started about 15 hours after the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Illness, Malaise, Nausea
Clinical narrative: felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started hemorrhaging female wise; she started hemorrhaging female wise; This is a spontaneous report from a contactable consumer, the patient, and other contactable consumers. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8735), via an unspecified route of administration in the left arm on 27Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Dec2020 and was sick for 4 months, neutropenia, allergy to latex; until the virus in Dec2020, the patient would hemorrhage no less than 3 weeks and spotted always for 4 months since COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR) and ethinylestradiol/levonorgestrel (PORTIA 21). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8732) on 31Mar2021 at 10:00 (at the age of 48-years-old) in the left arm for COVID-19 immunization and felt a little yucky. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO) and venlafaxine hydrochloride (EFFEXOR) and experienced allergies. On 29Apr2021 at 10:00 (also reported as 48 hours after the 2nd vaccination), the patient started gushing hemorrhaging female-wise. She described this as bleeding through her pads. Within a week in May2021, (also reported as a few days later), the patient experienced malaise, extreme nausea, throbbing of her arms and legs, and dizziness laying down. She said she felt really bad. She said she was rushed to the emergency room on 03May2021, and then again on 06May2021. The patient also reported feeling sick with fevers as of 04May2021 (also reported that she doesn't know when it started or ended) after the hospital, she was not able to make sense now. The patient was hospitalized for 3 days as of 06May2021 and was considering going back as she was feeling worse. At the hospital, the patient received fluids and antibiotics. The patient was treated with a supplement to slow the blood flow. She did not know if it was improving, persistent or worsening. For 3 days she could not take the supplement but started to bleed more yesterday (probably because she didn't take the supplement). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "she started hemorrhaging female wise", malaise, extreme nausea, throbbing of her arms and legs, dizziness, feeling sick and fever was not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaginal haemorrhage
Clinical narrative: felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started hemorrhaging female wise; she started hemorrhaging female wise; This is a spontaneous report from a contactable consumer, the patient, and other contactable consumers. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8735), via an unspecified route of administration in the left arm on 27Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Dec2020 and was sick for 4 months, neutropenia, allergy to latex; until the virus in Dec2020, the patient would hemorrhage no less than 3 weeks and spotted always for 4 months since COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR) and ethinylestradiol/levonorgestrel (PORTIA 21). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8732) on 31Mar2021 at 10:00 (at the age of 48-years-old) in the left arm for COVID-19 immunization and felt a little yucky. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO) and venlafaxine hydrochloride (EFFEXOR) and experienced allergies. On 29Apr2021 at 10:00 (also reported as 48 hours after the 2nd vaccination), the patient started gushing hemorrhaging female-wise. She described this as bleeding through her pads. Within a week in May2021, (also reported as a few days later), the patient experienced malaise, extreme nausea, throbbing of her arms and legs, and dizziness laying down. She said she felt really bad. She said she was rushed to the emergency room on 03May2021, and then again on 06May2021. The patient also reported feeling sick with fevers as of 04May2021 (also reported that she doesn't know when it started or ended) after the hospital, she was not able to make sense now. The patient was hospitalized for 3 days as of 06May2021 and was considering going back as she was feeling worse. At the hospital, the patient received fluids and antibiotics. The patient was treated with a supplement to slow the blood flow. She did not know if it was improving, persistent or worsening. For 3 days she could not take the supplement but started to bleed more yesterday (probably because she didn't take the supplement). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "she started hemorrhaging female wise", malaise, extreme nausea, throbbing of her arms and legs, dizziness, feeling sick and fever was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: in between these times she has been diagnosed with COVID-19/started to feel sick and had symptoms like cough and colds; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 10Apr2021 and stated her second dose is scheduled for Saturday (01May2021), however in between these times she has been diagnosed with COVID-19. On 18Apr2021, the patient started to feel sick and had symptoms like cough and colds. She tested positive for Covid- 19 on the 20Apr2021. The patient is asking if she can still go for her second dose or need to wait for a couple of weeks to take it. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia eye, Lacrimation increased, SARS-CoV-2 test
Clinical narrative: eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping; Right side of my face is numb; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: Er8733), via an unspecified route of administration at age of 39-year-old at arm right on 14Apr2021 12:15 at single dose for COVID-19 immunization. Medical history included high blood pressure. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, clomifene citrate (CLOMID), men's multivitamin, gluco, received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 10:00, right side of his face was numb, eyes are watery, more on the right, top to bottom feels numb/paralyzed type feeling. Seems to be a Bell's palsy type symptom but no drooping. The adverse events result in doctor or other healthcare professional office/clinic visit. The adverse events result in Emergency room/department or urgent care. The patient underwent lab tests included Curative testing (covid tested): negative on 19Apr2021. The patient was given allergy steroids for events. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was at the pharmacy to receive her second dose of the COVID-19 vaccine. She had received her first dose of the vaccine in Mar2021 at a different pharmacy, contracted COVID-19 after (date unspecified), and received antibody therapy for it on 02Apr2021. The clinical outcome of 'contracted COVID-19' after was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Muscular weakness
Clinical narrative: Partial loss of vision in left eye after vaccine; muscle weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose (also reported as second dose, pending clarification) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was reported as "ER8730.3ML/M" or "EW0170%ubt2016", pending clarification) via an unspecified route of administration at left arm on 27Mar2021 15:15 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included hypertension, arthritis, pneumonia, and allergies to rosemary, day lollies (day lillies). Concomitant medications in two weeks included verapamil HCl, losartan potassium (COZAAR), chlorthalidone, ubidecarenone (COQ10), and vitamin (unspecified). There was no other vaccine in four weeks. The patient experienced partial loss of vision in left eye after vaccine, muscle weakness on 27Mar2021 16:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of the event "partial loss of vision in left eye after vaccine" and included "Optomoligist and referral to retina specialist". The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: patient reported having a metal taste in her mouth after taking the first dose of the pfizer covid vaccine while on; This is a spontaneous report from a Pfizer-sponsored program from a contactable other health care professional (HCP) and a contactable consumer (patient). A 58-year-old female patient received first dose of  bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) 11 mg, oral from Feb2021 (Lot number was not reported) and ongoing at 11 mg daily for rheumatoid arthritis. Medical history included right total knee replaced 7 years before the time of the report and left total knee replacement on 21Apr2021 as outpatient. Concomitant medications were not reported. Patient reported having a metal taste in her mouth after taking the first dose of the pfizer covid vaccine while on tofacitinib citrate. No exact dates, further details reported, and md is aware. Patient reported (per md order) she had been off of tofacitinib citrate since 25Apr2021 due to having taken the second dose of the pfizer covid vaccine. Action taken in response to the event for tofacitinib citrate was dose not changed. Outcome of the event was unknown.  The information on the batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Computerised tomogram, Cough, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 at 34 years old (Lot Number: ER8734) as single dose, for covid-19 immunisation. Medical history included Anemia, Depression, Chronic Dry Eye, penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported; lifitegrast (XIIDRA) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took pseudoephedrine hydrochloride (SUDAFED) and experienced drug allergy. An hour after the vaccine on 03Apr2021, patient's fingers were red and swollen (like after exercise on a hot day) and she was itchy all over her body. No symptoms for almost 4 days--then she started feeling intermittently dizzy/lightheaded, feverish every night (chills and hot flashes) for the next 4 nights. She got a wracking cough and was short of breath (couldn't climb a single flight of stairs without needing to lie down for several minutes). She was also extremely exhausted-- slept 20 hours in a single day. After multiple telemedicine and in-person appointments, a trip to urgent care, and a chest x-ray and CT, she was diagnosed with pneumonia and treated with antibiotics, vitamin D, and two inhalers. She missed her period, had an elevated d-dimer, and her white blood cell count dropped from 7.0 Thousand u/L to 3.6. She was incapacitated for 2 weeks-- the sickest she had ever been in her life. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient performed Nasal Swab, negative on 11Apr2021. Therapeutic measures were taken for pneumonia. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Fatigue, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 at 34 years old (Lot Number: ER8734) as single dose, for covid-19 immunisation. Medical history included Anemia, Depression, Chronic Dry Eye, penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported; lifitegrast (XIIDRA) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took pseudoephedrine hydrochloride (SUDAFED) and experienced drug allergy. An hour after the vaccine on 03Apr2021, patient's fingers were red and swollen (like after exercise on a hot day) and she was itchy all over her body. No symptoms for almost 4 days--then she started feeling intermittently dizzy/lightheaded, feverish every night (chills and hot flashes) for the next 4 nights. She got a wracking cough and was short of breath (couldn't climb a single flight of stairs without needing to lie down for several minutes). She was also extremely exhausted-- slept 20 hours in a single day. After multiple telemedicine and in-person appointments, a trip to urgent care, and a chest x-ray and CT, she was diagnosed with pneumonia and treated with antibiotics, vitamin D, and two inhalers. She missed her period, had an elevated d-dimer, and her white blood cell count dropped from 7.0 Thousand u/L to 3.6. She was incapacitated for 2 weeks-- the sickest she had ever been in her life. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient performed Nasal Swab, negative on 11Apr2021. Therapeutic measures were taken for pneumonia. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Illness, Menstruation delayed, Peripheral swelling, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 at 34 years old (Lot Number: ER8734) as single dose, for covid-19 immunisation. Medical history included Anemia, Depression, Chronic Dry Eye, penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported; lifitegrast (XIIDRA) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took pseudoephedrine hydrochloride (SUDAFED) and experienced drug allergy. An hour after the vaccine on 03Apr2021, patient's fingers were red and swollen (like after exercise on a hot day) and she was itchy all over her body. No symptoms for almost 4 days--then she started feeling intermittently dizzy/lightheaded, feverish every night (chills and hot flashes) for the next 4 nights. She got a wracking cough and was short of breath (couldn't climb a single flight of stairs without needing to lie down for several minutes). She was also extremely exhausted-- slept 20 hours in a single day. After multiple telemedicine and in-person appointments, a trip to urgent care, and a chest x-ray and CT, she was diagnosed with pneumonia and treated with antibiotics, vitamin D, and two inhalers. She missed her period, had an elevated d-dimer, and her white blood cell count dropped from 7.0 Thousand u/L to 3.6. She was incapacitated for 2 weeks-- the sickest she had ever been in her life. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient performed Nasal Swab, negative on 11Apr2021. Therapeutic measures were taken for pneumonia. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test, White blood cell count, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Apr2021 12:00 at 34 years old (Lot Number: ER8734) as single dose, for covid-19 immunisation. Medical history included Anemia, Depression, Chronic Dry Eye, penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported; lifitegrast (XIIDRA) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took pseudoephedrine hydrochloride (SUDAFED) and experienced drug allergy. An hour after the vaccine on 03Apr2021, patient's fingers were red and swollen (like after exercise on a hot day) and she was itchy all over her body. No symptoms for almost 4 days--then she started feeling intermittently dizzy/lightheaded, feverish every night (chills and hot flashes) for the next 4 nights. She got a wracking cough and was short of breath (couldn't climb a single flight of stairs without needing to lie down for several minutes). She was also extremely exhausted-- slept 20 hours in a single day. After multiple telemedicine and in-person appointments, a trip to urgent care, and a chest x-ray and CT, she was diagnosed with pneumonia and treated with antibiotics, vitamin D, and two inhalers. She missed her period, had an elevated d-dimer, and her white blood cell count dropped from 7.0 Thousand u/L to 3.6. She was incapacitated for 2 weeks-- the sickest she had ever been in her life. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient performed Nasal Swab, negative on 11Apr2021. Therapeutic measures were taken for pneumonia. The outcome of the events was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Mental impairment, Myalgia
Clinical narrative: mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021.  Batch/Lot number has been obtained. further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Body height, Decreased appetite, Dizziness, Influenza like illness
Clinical narrative: AFib; has no appetite; all he wanted to do was sleep; felt like he was getting the flu; felt faint; lethargy; This is a spontaneous report from a contactable consumer.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955 or GP6955), via an unspecified route of administration on 24Apr2021 as single dose for covid-19 immunization.  Medical history included atrial fibrillation from an unknown date for 20 years. Concomitant medication included warfarin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported. No prior vaccinations within 4 weeks were noted. The patient experienced AFib on an unspecified date with outcome of unknown; felt faint on 25Apr2021 with outcome of recovered on 25Apr2021 (elaborated as felt faint when his head was down by his knees, in which he had to quickly jerk himself up and go sit down), lethargy on 25Apr2021 with outcome of recovering (elaborated as lethargy/he was so lethargic, he could hardly keep his eyes open);  has no appetite on an unspecified date with outcome of not recovered; all he wanted to do was sleep (elaborated as that he laid down and his eyes were so heavy in which all he wanted to do was sleep) on an unspecified date with outcome of unknown; felt like he was getting the flu on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body height: 180  (180 cm /5'11"), weight: 72.57 kg (160 lbs) on an unspecified date.   Details were as follows: Details were as follows: patient got his first COVID-19 vaccine shot on 24Apr2021. He said he was fine on Saturday. He said on 25Apr2021, he was so lethargic, he could hardly keep his eyes open. He said he got faint, and had to lay down. He said on Sunday, he thought the lethargy and faintness were a side effect of the COVID-19 vaccine, but the lethargy was continuing through to 29Apr2021. He said he also had no appetite, saying his appetite was waning. He said he did not feel like eating anything on 29Apr2021.  No emergency room or physician office visit was required.  He had AFIB, and that was why he had to worry about blood clots, and the reason he took Warfarin. Lethargic treatment was declined. The lethargy had improved some. He first felt faint around 10:00 an on Sunday.  Faint Treatment included cat naps during the day on Sunday, and didn't move around much. The patient noted that the faint feeling was better by Sunday night.  Reported for the last year his appetite had not been good, but he made it a habit to eat every day as a matter of his health. He said he kept asking himself what was he going to eat, and he said nothing appealed to him; he declined appetite suppressed treatment, but had taken Centrum every day for 10 years to supplement his diet, no further details provided.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Somnolence, Weight
Clinical narrative: AFib; has no appetite; all he wanted to do was sleep; felt like he was getting the flu; felt faint; lethargy; This is a spontaneous report from a contactable consumer.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955 or GP6955), via an unspecified route of administration on 24Apr2021 as single dose for covid-19 immunization.  Medical history included atrial fibrillation from an unknown date for 20 years. Concomitant medication included warfarin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported. No prior vaccinations within 4 weeks were noted. The patient experienced AFib on an unspecified date with outcome of unknown; felt faint on 25Apr2021 with outcome of recovered on 25Apr2021 (elaborated as felt faint when his head was down by his knees, in which he had to quickly jerk himself up and go sit down), lethargy on 25Apr2021 with outcome of recovering (elaborated as lethargy/he was so lethargic, he could hardly keep his eyes open);  has no appetite on an unspecified date with outcome of not recovered; all he wanted to do was sleep (elaborated as that he laid down and his eyes were so heavy in which all he wanted to do was sleep) on an unspecified date with outcome of unknown; felt like he was getting the flu on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body height: 180  (180 cm /5'11"), weight: 72.57 kg (160 lbs) on an unspecified date.   Details were as follows: Details were as follows: patient got his first COVID-19 vaccine shot on 24Apr2021. He said he was fine on Saturday. He said on 25Apr2021, he was so lethargic, he could hardly keep his eyes open. He said he got faint, and had to lay down. He said on Sunday, he thought the lethargy and faintness were a side effect of the COVID-19 vaccine, but the lethargy was continuing through to 29Apr2021. He said he also had no appetite, saying his appetite was waning. He said he did not feel like eating anything on 29Apr2021.  No emergency room or physician office visit was required.  He had AFIB, and that was why he had to worry about blood clots, and the reason he took Warfarin. Lethargic treatment was declined. The lethargy had improved some. He first felt faint around 10:00 an on Sunday.  Faint Treatment included cat naps during the day on Sunday, and didn't move around much. The patient noted that the faint feeling was better by Sunday night.  Reported for the last year his appetite had not been good, but he made it a habit to eat every day as a matter of his health. He said he kept asking himself what was he going to eat, and he said nothing appealed to him; he declined appetite suppressed treatment, but had taken Centrum every day for 10 years to supplement his diet, no further details provided.