chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; Rash; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 (Batch/Lot Number: EW0182) as single dose for covid-19 immunisation at the age of 71-year-old. Medical history included ongoing blood cholesterol abnormal. Concomitant medications included atorvastatin taken for blood cholesterol abnormal; metoprolol; caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]); alprazolam (XANAX) taken for sleep disorder; xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) taken for sinus disorder. The patient reported it's the second shot and it was 15May2021 of this year. On 17May2021, its delayed by 3 days but I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts not so bad that I can little bit but itself hurts no so bad that I can live with it but it still hurts. Now its second day of it and I still have it. I used ice according to the pharmacist told me do. I am taking Benadryl since yesterday. I guess you could call it a rash. It started yesterday and it is continuing today. I only took one tablet Benadryl one time 25 mg. The reporter stated may be a few months ago. Everything was good all my labs were good. The outcome of events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts; Rash; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 (Batch/Lot Number: EW0182) as single dose for covid-19 immunisation at the age of 71-year-old. Medical history included ongoing blood cholesterol abnormal. Concomitant medications included atorvastatin taken for blood cholesterol abnormal; metoprolol; caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]); alprazolam (XANAX) taken for sleep disorder; xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) taken for sinus disorder. The patient reported it's the second shot and it was 15May2021 of this year. On 17May2021, its delayed by 3 days but I got a large cutaneous erythema at the site of the injection which was still very warm and is swollen and itchy and it hurts not so bad that I can little bit but itself hurts no so bad that I can live with it but it still hurts. Now its second day of it and I still have it. I used ice according to the pharmacist told me do. I am taking Benadryl since yesterday. I guess you could call it a rash. It started yesterday and it is continuing today. I only took one tablet Benadryl one time 25 mg. The reporter stated may be a few months ago. Everything was good all my labs were good. The outcome of events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood fibrinogen, Blood fibrinogen increased, Body temperature, C-reactive protein
Clinical narrative: Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac resynchronisation therapy, Chest pain, Chills, Computerised tomogram
Clinical narrative: Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Fluid wave test, Headache, Hot flush
Clinical narrative: Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Paraesthesia, Pneumonia, Polymerase chain reaction, Pyrexia
Clinical narrative: Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, TRPV4 gene mutation, Vaccination failure
Clinical narrative: Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus, Thyroid function test, Urticaria
Clinical narrative: allergy reaction; Itching on my back and my stomach; Hives on my arms, my back, my torso, my stomach and near my collar bone, my chest area; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 15May2021 (Batch/Lot Number: EW0186) as 1ST DOSE,SINGLE for covid-19 immunization. The patient's medical history includes Grave's disease. The patient's concomitant medications were not reported. The patient experienced allergy reaction, itching on my back and my stomach and hives on my arms, my back, my torso, my stomach and near my collar bone, my chest area on unspecified date. Consumer stated, "I had an adverse reaction, allergy reaction from the Pfizer shot. I received first Pfizer BioNTech Covid vaccine on the 15th of May which is Saturday 2 days ago and as Sunday morning, Saturday night I started itching on my back and my stomach and I woke up Sunday morning with hives and they went away Sunday after Sunday evening but when I went back to bed Sunday night I started itching again and this morning I woke up with more hives on my arms, my back, my torso, my stomach and near my collar bone, my chest area. So I called my doctor and they put me on steroids and asked me to call to let you all know." Probed for recent lab work, consumer: "Yes, I did. It was. So, I do not have, it was a physical that I had I know one of the blood work was, it was a physical. I used to have Grave's disease so one of the test was to check my thyroid but I don't know what you call that. Only today I was given a steroid shot. Nothing else, I didn't do any other treatment." The patient underwent lab tests and procedures which included thyroid function test: grave's disease on an unspecified date (I had I know one of the blood work was, it was a physical. I used to have Grave's disease so one of the test was to check my thyroid). Therapeutic measures were taken as a result of allergy reaction, itching on my back and my stomach and hives on my arms, my back, my torso, my stomach and near my collar bone, my chest area. Outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Feeling abnormal, Headache, Mycotic allergy
Clinical narrative: felt like crap /allergies; sore body; dehydrated; Headache; runny itchy nose; sore arm; very weak; felt like walking on clouds; This is a spontaneous report from a contactable consumer (patient).  A 39 years old female patient received the first dose of BNT162B2 (Lot number either EW0170 or EWO170) at single dose for COVID-19 immunization on 26Apr2021. Relevant history included stroke in 2019. Relevant concomitant drug was unknown.  The patient experienced runny itchy nose and Headache since 15May2021 with outcome of resolving.  She experienced sore body since 16May2021 with resolved outcome.   The patient also experienced sore arm, very weak and felt like walking on clouds on 27Apr2021.  The outcome of event sore arm, very weak was resolved on 28Apr2021. The outcome of felt like walking on clouds was resolved on 30Apr2021. The patient stated her runny nose and sore body were due to picking up heavy boxes and lifting heaving stuff and that she worked for amazon.  The patient stated began on 16May2021, in the morning. When she really noticed her nose was irritating her, sore body, and runny nose, this was what made her go in the afternoon to get tested. She had recovered, did not feel a sore body like she did, it had improved. She did not have a sore body at the reporting time.  Refer to the headaches, she stated she went to urgent care and was told she was dehydrated and they checked her urine and was put on an IV. As treatment, she was taking Fioricet, also provides name as but/acetaminophen for headache. She felt like crap this morning but thought it was allergies as she had carpet in her house. She was wet in the rain Saturday, was sweating hot in the beginning then the rain came out of nowhere and she got in the air conditioning and thought that's how she got the cold. She was self medicating and last night was the worst.  She went to an urgent care as felt like walking on clouds and had got an IV again, and was hydrated.   Her arm was sore, and for 2-3 days she felt very weak. She was warned that did that.  The patient stated she was going to get the second dose, she thought she may have COVID but did not. She had a COVID-19 PCR test on 16May2021 with negative result. She went to urgent care and was prescribed hydrochloroquine and doxycycline. She wanted to get her second dose out of the way. Urgent care prescribed her the hydrochloroquine and doxycycline to be on the safe side. She was upset because she wanted to get the second vaccine but was told that she needed to contact Pfizer to see if it is ok because they may interact with the covid vaccine and would not give her the second dose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Urine analysis
Clinical narrative: felt like crap /allergies; sore body; dehydrated; Headache; runny itchy nose; sore arm; very weak; felt like walking on clouds; This is a spontaneous report from a contactable consumer (patient).  A 39 years old female patient received the first dose of BNT162B2 (Lot number either EW0170 or EWO170) at single dose for COVID-19 immunization on 26Apr2021. Relevant history included stroke in 2019. Relevant concomitant drug was unknown.  The patient experienced runny itchy nose and Headache since 15May2021 with outcome of resolving.  She experienced sore body since 16May2021 with resolved outcome.   The patient also experienced sore arm, very weak and felt like walking on clouds on 27Apr2021.  The outcome of event sore arm, very weak was resolved on 28Apr2021. The outcome of felt like walking on clouds was resolved on 30Apr2021. The patient stated her runny nose and sore body were due to picking up heavy boxes and lifting heaving stuff and that she worked for amazon.  The patient stated began on 16May2021, in the morning. When she really noticed her nose was irritating her, sore body, and runny nose, this was what made her go in the afternoon to get tested. She had recovered, did not feel a sore body like she did, it had improved. She did not have a sore body at the reporting time.  Refer to the headaches, she stated she went to urgent care and was told she was dehydrated and they checked her urine and was put on an IV. As treatment, she was taking Fioricet, also provides name as but/acetaminophen for headache. She felt like crap this morning but thought it was allergies as she had carpet in her house. She was wet in the rain Saturday, was sweating hot in the beginning then the rain came out of nowhere and she got in the air conditioning and thought that's how she got the cold. She was self medicating and last night was the worst.  She went to an urgent care as felt like walking on clouds and had got an IV again, and was hydrated.   Her arm was sore, and for 2-3 days she felt very weak. She was warned that did that.  The patient stated she was going to get the second dose, she thought she may have COVID but did not. She had a COVID-19 PCR test on 16May2021 with negative result. She went to urgent care and was prescribed hydrochloroquine and doxycycline. She wanted to get her second dose out of the way. Urgent care prescribed her the hydrochloroquine and doxycycline to be on the safe side. She was upset because she wanted to get the second vaccine but was told that she needed to contact Pfizer to see if it is ok because they may interact with the covid vaccine and would not give her the second dose.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Fatigue, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare-ups; Fatigue; Off-balance/equilibrium is off; This is a spontaneous report from a  Program received from a contactable healthcare professional and consumer. A 49-year-old male patient received bnt162b2 (BNT162B2), dose 2 at vaccination age of 49-year-old via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; and tofacitinib citrate (XELJANZ XR; strength: 11 mg), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE) at vaccination age of 49-year-old on an unspecified date for Covid-19 immunization. The patient's concomitant medication was not reported. The patient reported that after he completed the second dose of covid 19 vaccine weeks ago on 31Mar2021, he experienced fatigue and rheumatoid arthritis flare-ups (swelling and joint pain) with no missed doses while receiving the vaccine on an unspecified date in 2021. MD was aware & prescribed him with prednisone 5 mg. The patient also reported his feeling off-balance from laying down too much because of "equilibrium is off" (2021) which was unknown if MD was aware. He mentioned that his left knee has "no cartilage & bone in bone," and swollen improved when using cbd oil (cannabinoid oil). The patient has a scheduled appointment with a rheumatologist next month. The patient was encouraged to call MD. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on a temporal association , a causal relationship between the reported events and suspect drug is assessed as possible.  The underlying medical conditions could have contributed.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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Neck pain, Vaccination site pain
Clinical narrative: Visibly and palpable enlargement of the left supraclavicular lymph node (Virchow's node), accompanied with pain; Neck pain on posterior and left lateral aspect; Lethargy; Mild soreness of the left arm at the site of vaccination; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration in left arm, on 16May2021 at 10:00 AM (at the age of 33 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history included attention deficit hyperactivity disorder (ADHD). There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: ER8736) on 25Apr2021 at 12:00 PM (at the age of 33 years) for COVID-19 immunization (left arm). The patient had no known drug allergies (NKDA). The patient was not diagnosed with COVID-19 prior vaccination. The most recent vaccine was administered in a pharmacy or drug store facility. Two days after the second dose (as reported) (administered on 16May2021), the patient noted a visibly and palpable enlargement of the left supraclavicular lymph node (Virchow's node), accompanied with pain, locally and neck pain on posterior and left lateral aspect starting on 17May2021. Other symptoms past the 24 hours of second dose administration (17May2021) were lethargy that lasted 2 days and mild soreness of the left arm at the site of vaccination. It was unknown if treatment was given for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from "Lethargy" on 19May2021. The patient had not recovered from the other events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in hands and now feet; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Ew0179), via an unspecified route in the left arm on 06May2021 at 09:00 (at the age of 65 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included high cholesterol, acid reflux, familial tremors, weak bladder. The patient's had unspecified concomitant medications within 2 weeks of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Ew0169) via an unspecified route in the arm left on 15Apr2021 at 09:15 as 1st dose, single for COVID-19 immunisation. On 15May2021 at 09:00, the patient experienced tingling in hands and now feet. Started about 9 days after 2nd dose in hands and now was affecting feet. Patient received no treatment for the events. Since vaccination patient was not tested for COVID 19. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cold and cough; cold and cough; This is a spontaneous report from a contactable consumer or other non hcp consumer). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient had covid prior vaccination. It was unknown whether the patient was tested Covid post vaccination. It was unknown whether the patient received other vaccine in four weeks, or he had received any other medications in two weeks. On an unspecified date, after vaccination the patient experienced cold, and cough and his second dose were due today. Consumer stated he did not have a fever. Consumer asked that it was ok for him to proceed with getting the second dose today. It was unknown if patient received any treatment for event. The outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: started period couple days early after first vaccine,second period since the vaccine and is on Day 16 of period; heavy bleeding along with clots and things; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 01Mar2021as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. On Mar2021 the patient experienced heavy bleeding along with clots and things and started period couple days early after first vaccine, second period since the vaccine and was on Day 16 of period. It had gotten worse but did subside. States she had another small period in between the first and second vaccine, but that only lasted for a day. She had the second dose 3 weeks after the first dose on 22Mar2021 and a couple days after that her period started early on 03May2021 and she is now on her period and on Day 16 and it's gotten worse.  She had issues with both doses and enquired if prolonged bleeding with periods was a side effect of the vaccine and how long these periods last and if they ever end. She stated she knew there were other women with these things. She got the first Pfizer BioNTech vaccine in 01Mar2021 and shortly a day or two afterwards her period started, which was a couple days early and did not stop for 10 days. It was really, really heavy bleeding along with clots and things. She was tested for anemia in Apr2021 and her iron was low and was found to be anemic. She went to a specialist and was suggested a biopsy to rule out that there was nothing else going on. They suggested for doing an ablation to stop the bleeding or a partial hysterectomy if nothing else worked. She did not had any energy and it was hard to breath with no oxygen in blood. The outcome of the event heavy bleeding along with clots and things and started period couple days early after first vaccine, second period since the vaccine and is on Day 16 of period was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Nausea; Didn't feel well; This is a spontaneous report received from a contactable consumer or other non hcp via pharmaceutical corporation. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had nausea and didn't feel well. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Flat affect, Hypoaesthesia, Nausea
Clinical narrative: felt numb and emotionless; felt numb and emotionless; felt sick to my stomach; Food does not take good anymore and I have to force myself to eat; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 16:30 (Batch/Lot Number: EW0173) (at the age of 27-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included known allergies nickel. Concomitant medications included none (did not receive other medications the patient received within 2 weeks of vaccination). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Right on 20Apr2021 17:30 (Batch/Lot Number: EW0170) for covid-19 immunisation and had no adverse event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021 09:30, the patient experienced felt numb and emotionless, felt sick to my stomach and food does not take good anymore and i have to force myself to eat. Seriousness criteria reported as non-serious. No treatment was given for the events. The outcome of the events was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain oedema, Lethargy, Somnolence
Clinical narrative: Dr wonders if she has brain edema; felt lethargic; had balance issues; wants to sleep all the time; This is a spontaneous report from a contactable physician.  A 7-decade-old (in her 60s) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient received her first dose of PFIZER BIONTECH COVID-19 VACCINE on an unknown date (Batch/Lot number was not reported) as COVID-19 immunization. Then, received the 2nd dose on 22Mar2021. In 2021, she felt lethargic, had balance issues and wanted to sleep all the time. She continued to struggle with all mentioned symptoms. The physician wondered if she has brain edema. The physician wanted to know if other healthcare professional discussed these issues around COVID vaccines. Outcome of the events were not recovered  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, the Company considered serious Brain edema and the reported non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. 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