chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Speech disorder, Vision blurred, Water pollution
Clinical narrative: Loss of taste and partial smell; Loss of taste and partial smell; Hard to talk or eat or drink; Hard to talk or eat or drink; Hard to talk or eat or drink; Bells Palsy; Blurry vision; Fever; Felt achy; This is a spontaneous report from a contactable consumer (patient).  This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261), via an unknown route, on 29Jan2021 (at 10:00 AM) at a single dose in the left arm for COVID-19 immunisation. Relevant medical history includes diabetes, arteriolosclerosis, blocked carotid artery, gastrooesophageal reflux disease (GERD) and chronic prostatitis. Past drug history included allergy to penicillin and cefixime (FLEXERIL). Relevant concomitant medications included doxazosin mesylate (CARDURA), lisinopril, metformin, omeprazole, repaglinide (PRANDIN) and other unspecified medications. He had fever and felt achy for a couple of day. On 03Feb2021 (at 08:00), the patient had total paralyzed on right side of his face, right eye will not close, mouth paralyzed on right side. Hard to talk or eat or drink. Blurry vision in right eye due to not closing. On 04Feb2021, the patient has loss of taste and partial smell. The patient performed physician office visit. Then, he went to the emergency room (ER) and Bells Palsy was confirmed on 06Feb2021. He stated that his blood work is currently fine. He was given prednisone and acyclovir for Bells Palsy and for hard to talk or eat or drink. The patient was not treated for the remaining events. Pre and post vaccination COVID test were not performed. All events were considered serious for disability except of fever and felt achy. The outcome of the events fever and felt achy was unknown while the outcome of the remaining events was not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (consumer).  A female patient of an unspecified age received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it is okay to receive as scheduled on 20Feb2021 her second dose of Pfizer-BioNTech COVID-19 Vaccine if she has shingles. She stated that she went to the hospital because of it and it started 2 and a half weeks ago. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Malaise
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (consumer).  A female patient of an unspecified age received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if it is okay to receive as scheduled on 20Feb2021 her second dose of Pfizer-BioNTech COVID-19 Vaccine if she has shingles. She stated that she went to the hospital because of it and it started 2 and a half weeks ago. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable Pharmacist, the patient's daughter-in-law.  An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 vaccination. Medical history included stroke and atrial fibrillation from unknown dates. Concomitant medications were not reported. On 12Feb2021, the patient experienced a stroke. The clinical outcome of the event stoke was unknown. No additional information was reported.   Information about lot/ batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Body temperature, Pyrexia, Respiratory arrest
Clinical narrative: Anaphylactic response to Covid vaccine; stopped breathing; fever; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative.  An adult female patient of unspecified age (reported as mid-twenties) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included allergy to steroids. The patient's concomitant medications were not reported. The patient previously took propylene glycol and the patient was allergic to propylene glycol. On an unspecified date, the patient had an anaphylactic response to Covid vaccine. The patient stopped breathing. She was treated with epinephrine and transported to the hospital. The patient received other fluids and was and was released a day later when her fever was below 100F. The patient had similar allergy to steroids and did not connect that she was allergic to propylene glycol. It was reported that the events took place after use of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vitreous detachment
Clinical narrative: posterior vitreous detachment of left eye; This is a spontaneous report from a contactable pharmacist.   A 44-year-old female pharmacist reported for herself that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261), via an unspecified route of administration left arm single dose on an unspecified date for covid-19 immunisation. Medical history included Crohn's disease, drug hypersensitivity to NSAIDs. Concomitant medication included certolizumab pegol (CIMZIA). The patient experienced posterior vitreous detachment of left eye on 11Feb2021. Laser treatment was used to repair. The outcome was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain lower, Arterial rupture, Body height, Body height decreased
Clinical narrative: artery had been nicked and they went in and fixed that; lower right abdominal area was swollen and he was in a lot of pain; lower right abdominal area was swollen and he was in a lot of pain; he had a hernia removed; his hemoglobin has been going up and down; He shrunk, he is 5'11.75; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just recently had surgery he had a hernia removed and a week after that; he had the operation done arthroscopically and a week after that; the lower right abdominal area was swollen and he was in a lot of pain and he ended up going to the hospital and they admitted him in the ER and they gave him some Morphine and hooked up to all kinds of stuff and eventually they found out that an artery had been nicked and they went in and fixed that and his hemoglobin has been going up and down. At any rate he had surgery again and they cleaned out all of that blood and they didn't find any more leaks but the patient's wife was wondering if it would be okay to have the booster for the COVID vaccine on 18Feb2021 (Thursday). The patient's wife confirmed that all of this happened since him having the first dose of the vaccine, but it was not related. The patient's wife also reported that the patient's height shrunk, and he was 5'11.75". The outcome of artery had been nicked was recovered, and unknown for the rest of the events.   Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the reported events were related to BNT162b2. These are more likely associated with the surgical condition and post surgical complications.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin abnormal, Hernia
Clinical narrative: artery had been nicked and they went in and fixed that; lower right abdominal area was swollen and he was in a lot of pain; lower right abdominal area was swollen and he was in a lot of pain; he had a hernia removed; his hemoglobin has been going up and down; He shrunk, he is 5'11.75; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just recently had surgery he had a hernia removed and a week after that; he had the operation done arthroscopically and a week after that; the lower right abdominal area was swollen and he was in a lot of pain and he ended up going to the hospital and they admitted him in the ER and they gave him some Morphine and hooked up to all kinds of stuff and eventually they found out that an artery had been nicked and they went in and fixed that and his hemoglobin has been going up and down. At any rate he had surgery again and they cleaned out all of that blood and they didn't find any more leaks but the patient's wife was wondering if it would be okay to have the booster for the COVID vaccine on 18Feb2021 (Thursday). The patient's wife confirmed that all of this happened since him having the first dose of the vaccine, but it was not related. The patient's wife also reported that the patient's height shrunk, and he was 5'11.75". The outcome of artery had been nicked was recovered, and unknown for the rest of the events.   Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the reported events were related to BNT162b2. These are more likely associated with the surgical condition and post surgical complications.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Peripheral swelling
Clinical narrative: face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date.  The patient, on 16Feb2021  had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date.  The patient, on 16Feb2021  had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated "it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Headache, Hypokinesia
Clinical narrative: I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Malaise, Pain, Pyrexia
Clinical narrative: I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; I got fever, I got diarrhea. I got body ache, headache.; Unable to eat, loss of appetite.; Not feeling too well; very sick; can hardly move; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9069), via an unspecified route of administration at single dose on 10Feb2021 for covid-19 immunisation. Medical history included diabetes, thyroid removed. Concomitant medication included influenza vaccine, metformin, levothyroxine, ferrous sulfate, atorvastatin. The patient stated that experienced: I got fever, I got diarrhea. I got body ache, headache, unable to eat, loss of appetite, not feeling too well, very sick, can hardly move , all on an unspecified date in Feb2021 with outcome of unknown. The patient was hospitalized for these events from Feb2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: unknown results in Feb2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry mouth, Dysgeusia, Eye pain, Fatigue
Clinical narrative: Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient).  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue".  The patient also reported that she had a herpes simplex virus that was dormant unless she  get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She  stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Hypoaesthesia, Intraocular pressure test abnormal, Palpitations, Paraesthesia
Clinical narrative: Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient).  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue".  The patient also reported that she had a herpes simplex virus that was dormant unless she  get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She  stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient).  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue".  The patient also reported that she had a herpes simplex virus that was dormant unless she  get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She  stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Immediate brain fog and continued for 2 days; This is a spontaneous report from a contactable consumer (patient). The 83-year-old female patient receive second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 15Feb2021 on Right arm at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 25Jan2021on Right arm at single dose for covid-19 immunization. The patient experienced immediate brain fog and continued for 2 days on 15Feb2021 12:00 PM with outcome of recovered. No treatment received. She is not pregnant. Facility type vaccine was other.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain and swelling for 48 hours; Injection site pain and swelling for 48 hours; headache 24 hour; feeling unwell for 24 hours; tiredness for 24 hours; This is a spontaneous report from a contactable consumer. The consumer reported for himself that the 69-years-old male patient received second dose of bnt162b2 (BNT162B2,COVID 19, brand: pfizer, lot number: GM9810), via an unspecified route of administration on 17Feb2021 10:00AM on Right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, brand: pfizer, lot number: EL9261), via an unspecified route of administration on 27Jan2021 on Right arm at single dose for covid-19 immunisation. The patient experienced injection site pain and swelling for 48 hours, headache 24 hour, feeling unwell for 24 hours, tiredness for 24 hours all on 18Feb2021 06:00AM with outcome of recovered. Facility where the most recent COVID-19 vaccine was administered was other. The patient received other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The case was assessed non-serious.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for other vaccines within 4 weeks PRIOR.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills primarily 12-24 hours after shot; fever 24-30 hours after shot; This is a spontaneous report from a contactable consumer. The consumer reported for himself that the 68-years-old male patient received second dose of bnt162b2 (BNT162B2, PfizerBiontech, lot number: EM9810,) via an unspecified route of administration on 16Feb2021 11:15AM  on left arm at single dose for covid-19 immunisation. Medical history included heart stents from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin 40 mg, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) 325 mg. The patient previously took first dose of bnt162b2 (COVID 19 PfizerBionTech, lot number: L3247) on 26Jan2021 09:30 AM on Left arm for covid-19 immunisation The patient experienced chills primarily 12-24 hours after shot on 16Feb2021 23:30 with outcome of recovered , fever 24-30 hours after shot on 16Feb2021 23:30 with outcome of recovered. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Investigation, Pneumonia, X-ray
Clinical narrative: pneumonia; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers reported that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL1284, via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol (abnormal) and asthma. Concomitant medication included budesonide, simvastatin for cholesterol and benralizumab (FASENRA) for asthma. She has got a lot of other medications (at least 15 medications). The patient was hospitalized this week due to a pneumonia on 13Feb2021 (in between 1st dose and 2nd dose). The patient was in a hospital for 7 hours in and out. She was hospitalized in 13Feb2021. She missed the 2nd appointment today (16Feb2021) 11:30AM and they were informed that they need to call. The healthcare professional advised not to as she was on antibiotics (levofloxacin 750 mg) for pneumonia which was contracted after the first dose. She then wanted to reschedule her second dose. The patient underwent lab tests and procedures which included blood, x-rays, CAT scan and tested for virus, influenza. The tests were done in the hospital and she way okay.
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Streptococcus test positive
Clinical narrative: positive for strep; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient was positive for strep (in 2021) and put on antibiotics. The patient was on antibiotics for 24 hours and second dose was due today and wanted to know if it was okay to be on the antibiotics with vaccination. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event "patient was positive for strep" is attributed to an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state, Facial discomfort, Headache, Investigation
Clinical narrative: she could have had a mild stroke; Headache; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a headache after covax last week Wednesday. On Thursday (unknown date), she had stroke type symptoms of confusion, difficulty talking and right side of face felt funny. The patient was taken to the emergency room on Friday and they said she could have had a mild stroke even though her tests were all negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: she could have had a mild stroke; Headache; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a headache after covax last week Wednesday. On Thursday (unknown date), she had stroke type symptoms of confusion, difficulty talking and right side of face felt funny. The patient was taken to the emergency room on Friday and they said she could have had a mild stroke even though her tests were all negative. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diverticulitis
Clinical narrative: Callers dr developed Diverticulitis after first dose/she is having a recurrence of her diverticulitis; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer Sponsored Program.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization.  Medical history included diverticulitis from an unknown date and unknown if ongoing (she mentioned she is now having similar symptoms to when she first had diverticulitis).  The patient's concomitant medications were not reported.  The patient experienced diverticulitis after first dose/she is having a recurrence of her diverticulitis on an unspecified date.  The patient underwent lab tests and procedures which included abdominal cat scan: diagnosed with diverticulitis on 24Dec2020. Therapeutic measures were taken as a result of the event and included treatment with AUGMENTIN. The patient outcome of the event was unknown.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has an appointment tomorrow for the 2nd dose but she tested positive on  08Feb; has an appointment tomorrow for the 2nd dose but she tested positive on  08Feb; This is a spontaneous report from Pfizer-sponsored program received from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had an appointment tomorrow (17Feb2021) for the 2nd dose but she tested positive on 08Feb2021. The outcome of the events was unknown. The information on the lot/batch number had been requested.
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration
Clinical narrative: will be having a Wet or Dry macular degeneration procedure; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program.  A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 22Feb2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 03Feb2021 for Covid-19 immunisation.  The patient experienced macular degeneration on an unknown date and she will be having a wet or dry macular degeneration procedure on 23Feb2021 with outcome of unknown. Patient was kind of worried because they're asking her questions about if she took vaccination these past few weeks before going to hospital.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hip fracture
Clinical narrative: his mother was hospitalized due to hip fracture; This is a spontaneous report from a contactable consumer Pfizer-sponsored program. A female patient of an unspecified age received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was asking if he could reschedule his mother's second dose appointment which should've been the day of reporting because his mother was hospitalized due to hip fracture (onset date and hospitalization date not reported). The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; very sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Feb2021 at 14:30 at a single dose, for COVID 19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility where vaccine was administered was reported as "other". On 12Feb2021, the patient had a very sore arm. The patient was tired the next day (13Feb2021). The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Cough, Dysentery
Clinical narrative: congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown.   Information on the lot/batch number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown.   Information on the lot/batch number has been requested.