chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Muscle and joint pain; Muscle and joint pain; Achy all day; This is a spontaneous report received from a contactable nurse (patient herself). An unspecified aged female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. . Patient stated that, "she doesn't see any expiration date on it. LOT# is PF1 (incomplete sentence) it just says Pfizer. It just says Covid-19 Pfizer and the date on it Jan2021. On 03Feb2021 patient was reported as she had the Covid Vaccine on Saturday and she had been experienced a lot of muscle and joint pain today." She was just wondering, she guess it is okay to get her second shot which would be like in 3 weeks." She further stated about causality that, she was not 100 percent sure. She thinks it was because you know she was achy all day today". The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: developed a rash on the same arm that she received the vaccine/ located in the crease of the elbow and about 5 inches in diameter/ red and hot; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 25Jan2021 at 09:00 (24-year-old at time of vaccination) at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. The patient had no COVID prior to vaccination. Concomitant medications were not reported. The patient did not received other medications in two weeks. The patient did not received any other vaccine in four weeks. On 01Feb2021 at 08:00, the patient developed a rash on the same arm that she received the first dose of the vaccine. Developed rash around a week after the first shot. Rash is located in the crease of the elbow and about 5 inches in diameter. Rash is red and hot. Put cortisone on the rash and it got better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not test COVID post vaccination. Therapeutic measures were taken as a result of the event and included cortisone. The outcome of the event was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Exercise tolerance decreased, Fatigue, Headache
Clinical narrative: Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021.  Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Neck pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Exercise intolerance; Chest pain; Lymphadenopathy; Fever; Severe neck pain; Fatigue.; Myalgia; Headache; Dizziness; This is a spontaneous report from a contactable physician. A 45-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL9262 ,expiration date not reported), via an unspecified route of administration, administered on the right arm on 23Jan2021 14:00 (at the age of 45-years-old) at single dose for COVID-19 immunization. Medical history included asthma and known allergies: latex. Concomitant medications included melatonin (manufacturer unknown), ubidecarenone (COQ10 [UBIDECARENONE]), ergocalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA), and birth control all taken for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Ek9321, expiration date not reported), via an unspecified route of administration, administered on the left arm on 02Jan2021 18:00 at the age of 45 years-old at single dose for COVID-19 immunization and experienced headache, myalgia, chills, lymphadenopathy and brain fog on 03Jan2021. On 24Jan2021 08:00, the patient experienced fever, severe neck pain, fatigue, myalgia, headache, and dizziness. On 25Jan2021, the patient experienced fever, lymphadenopathy, fatigue, myalgia and dizziness. On 26Jan2021 and 27Jan2021, the patient continued to experience the events previously stated with headache. On 28Jan2021, the patient continued to experience the events previously stated with chest pain. On 29Jan2021 to 31Jan2021, the patient continued to experience the events previously stated. On 01Feb2021, the patient experienced continued fever, fatigue, lymphadenopathy, chest pain, and exercise intolerance. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jan2021.  Events resulted in physician office visit and was treated by steroid. Outcome for events reported were not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: he didn't get it because he tested positive for Covid; he didn't get it because he tested positive for Covid; Tickle in his throat; This is a spontaneous report from contactable consumers (one was patient's wife) via medical information team and via a Pfizer-sponsored program. A 68-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809), via an unspecified route of administration, in the left arm on 05Feb2021 10:00 at a single dose for COVID-19 immunisation. Medical history included high blood pressure and thyroid. There were no concomitant medications. No additional vaccines were administered on the same date as the BNT162B2 vaccine. The patient had no prior vaccinations within 4 weeks. The patient got his first vaccine on 05Feb2021 and was supposed to get the second one last Friday (25Feb2021) but he didn't get it because he tested positive for Covid. The patient's wife wanted to know if he can still get his second dose; does the second dose have to be within 21 days; and do they have to make another appointment for the second dose or would they just walk in. They called the doctor on Thursday (Feb2021) because the patient was having a tickle in his throat (unspecified date in 2021) and the patient's wife did not like the way the patient was looking. The doctor advised him to go for the COVID-19 test because the patient was in direct contact with someone at work. The patient tested positive for COVID-19 virus (positive PCR and rapid COVID-19 test) on 26Feb2021 and was told not to get the second COVID-19 vaccine. It was clarified that the patient only has a tickle in his throat and no other symptoms. In addition, a lot of people at the patient's work have the virus, more than 50%. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Cerebral disorder, Discomfort, Hyperhidrosis
Clinical narrative: Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse sweating; Never had low blood sugar before/Blood sugar crashed; Left side got tight; This is a spontaneous report from a contactable other hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:45 am (Batch/Lot Number: EN6203) at age of 61-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes. No pregnant. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication included semaglutide (OZEMPIC), metformin (METFORMIN), lisinopril (LISINOPRIL), all empagliflozin, linagliptin (GLYXAMBI) taken for an unspecified indication, start and stop date were not reported. The patient experienced left side got tight including brain/ brain was not cooperating with the eyes/ brain shaking, profuse sweating, never had low blood sugar before/ blood sugar crashed on 03Mar2021 09:30. Adverse event: Left side got tight including brain. After maybe 20 minutes while she was driving back. Blood sugar crashed and brain was not cooperating with the eyes. Brain shaking. Profuse sweating. Ate something when she got to work and started improving. Never had low blood sugar before. No treatment for events. The patient underwent lab tests and procedures which included blood glucose: low/crashed on 03Mar2021 09:30. The event outcome recovered in Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: She was tested for antibodies and the result was negative; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose, via an unspecified route of administration, on unspecified date (lot number not reported) at a single dose; then the second dose, via an unspecified route of administration, on 25Jan2021 (lot number not reported) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received both doses of the Pfizer-BioNTech Covid-19 vaccine (second dose 25Jan2021). She was tested for antibodies and the result was negative (SARS-CoV-2 serology covid-19). She would like to know if we have any information on this topic, why her test was negative. The patient did the covid antibody test on 01Mar2021 with result of negative. Her doctor recommended her to receive a booster, she would like to know if there are any recommendations on receiving a booster shot. As of 25Jan2021 she had received 2 doses of the Covid 19 vaccine. On Monday of this week 01Mar2021, her regular doctor did blood tests. She got results on Tuesday, 02Mar2021. She had the Covid antibody test and she doesn't understand, she had thought that the blood test would show positive for Covid antibodies. The antibody test was negative. Now she is worried, and asked "did the vaccine not work?" She had called her doctor and she was told to get a booster and she doesn't even know if that's a thing or where you can get a booster. She doesn't understand what this antibody test is supposed to show.  She had a Covid antibody test done in May2020 and it showed negative and that was what she expected. She didn't have the Covid 19 vaccine and she didn't have Covid. She asked, "How can it show the same thing after receiving the Covid Vaccine?" Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: a little bit "headachy"; a little bit of soreness in the muscle of his arm; This is a spontaneous report from a Sponsored Program, from a contactable consumer, the patient. A male patient of unspecified age (reported as 70 without units) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201, expiration date Jun2021), via an unspecified route of administration 21Feb2021 at as a single dose for COVID-19 vaccination.  Medical history was unknown. The patient's concomitant medications included hyaluronate sodium (SUPARTZ) as injection on patient's knees, the patient is scheduled to start another series of 5 sets of this medication.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  On an unknown date the patient experienced a little bit of soreness in the muscle of his arm as well as feeling a little bit headachy, but the patient stated he has this normally and would describe it as very, very mild. The patient was also inquiring for information regarding Supartz gel injections and the Pfizer BioNTech COVID-19 vaccine. The patient explained that these shots are 'some version of hyaluronan acid' and states he is set to receive them once every week for 5 weeks starting today. The patient is concerned because these doses will fall around the same time he is scheduled to receive his second dose of the vaccine on 14Mar2021. The patient also mentioned that in his research of the injections online, he read that when these injections are given for dermatology purposes, they can cause some swelling after use. The patient further stated  he had absolutely no response to the vaccine whatsoever, there is nothing out of the ordinary, other than the other injection (Supartz).The patient was inquiring if he should consult his orthopedics doctor to postpone this until after he had his second dose of vaccine. The patient further stated he does not have "any allergies or any history of those kind of things, and he does not expect that, but he does not want to in any way affect the efficacy of the vaccine, so he thought it would be prudent to make a call before he did this" (started next series of Supartz). The clinical outcome of the little bit of soreness in the muscle of his arm as well as feeling a little bit headachy was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable physician reporting for his sister. An 80-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, in 2021, as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. Concomitant medications were not reported. The patient experienced COVID-19 in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in 2021.   The information on the lot/batch number has been requested.; Sender's Comments: The information provided is limited and does not allow for a complete medical assessment.   It is unlikely  that the  reported COVID-19  was causally  related to BNT162B2.   This was probably an intercurrent  condition.  Case will be reassessed if additional information is  received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Pain in extremity
Clinical narrative: has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Lower respiratory tract infection, Respiratory tract irritation
Clinical narrative: Feeling like I am developing a chest cold during the night and right in the morning when I wake up.; Irritated airways, feels as if I am coming down with bronchitis.; Irritated airways, feels as if I am coming down with bronchitis.; This is a spontaneous report from a contactable consumer, who reported for herself. A 30-years-old female consumer received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 11Mar2021 1400 (at the age of 30-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a School or Student Health Clinic. She has had no other vaccines or medications in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no other relevant medical history and concomitant medications were not reported. On 12Mar2021 at 10:00pm, the patient had Feeling like I am developing a chest cold during the night and right in the morning when I wake up. Irritated airways, feels as if I am coming down with bronchitis. The patient went to see a doctor or other healthcare professional office/clinic visit. Treatment was not received. The clinical outcome of the events chest cold /Irritated airways, feels as if I am coming down with bronchitis was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood triglycerides, Blood triglycerides increased, Lipids, Lipids increased
Clinical narrative: lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Feb2021 as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunization. The patient mentioned that he received the 2nd dose on 11Feb2021 and about 2 or 3 weeks after, on 04Mar2021, he went in with his doctor for his semi-annual check up and had laboratory work done. He got his results just last weekend and it was noted that all of his lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448. The patient's triglyceride and all of his lipids were elevated and he wondered if the vaccine might have affected his triglycerides and his other lipids. He was feeling well as of calling and was scheduled for a revisit with his doctor in 3 months. He was asking if that was a side effect of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood triglycerides increased, Lipids
Clinical narrative: lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Feb2021 as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunization. The patient mentioned that he received the 2nd dose on 11Feb2021 and about 2 or 3 weeks after, on 04Mar2021, he went in with his doctor for his semi-annual check up and had laboratory work done. He got his results just last weekend and it was noted that all of his lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448. The patient's triglyceride and all of his lipids were elevated and he wondered if the vaccine might have affected his triglycerides and his other lipids. He was feeling well as of calling and was scheduled for a revisit with his doctor in 3 months. He was asking if that was a side effect of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Fluid retention
Clinical narrative: fluid retention required a visit to the emergency room; shortness of breath; fluid retention; This is a spontaneous report from contactable consumer, the patient.  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN9581), via an unspecified route of administration on 04Feb2021 at 09:00 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family history was denied. However, the patient did say that he had fluid retention prior to the vaccination (duration not specified). The patient further reported that he had illness at vaccination; he specified that he was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine  Concomitant medications were not provided. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that he had fluid retention and shortness of breath and was admitted to the hospital "the week of 20Feb2021."  He was discharged that weekend, on Friday. He knows it was that week because on 25Feb2021 he was supposed to get the second shot and he missed it because he was in the hospital. He has fully recovered now from the fluid retention and shortness of breath. Adds he had the fluid retention prior to receiving the first dose of the Pfizer COVID 19 vaccine and was experiencing fluid retention when he got the first dose of the Pfizer COVID 19 vaccine. The received unspecified treatment for the events. The clinical outcomes of the events fluid retention and shortness of breath were reported as recovered on 27Feb2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Gastric disorder, Hallucination, Hypoaesthesia
Clinical narrative: hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope
Clinical narrative: hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Dizziness, Eye swelling, Loss of consciousness
Clinical narrative: When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Cerebrovascular accident, Computerised tomogram, Condition aggravated
Clinical narrative: loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dysarthria, Electrocardiogram, Eyelid function disorder, Facial paralysis
Clinical narrative: loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paresis, Full blood count, Headache, Heart rate, Hypoaesthesia oral
Clinical narrative: loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased
Clinical narrative: loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Bell's palsy, Drug ineffective, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid/ she has not experienced any Covid 19 symptoms; Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) at the age of 32-years-old, via an unspecified route of administration in right arm on 23Feb2021 at 12:00 at single dose for COVID-19 immunization. Medical history was not reported as none. She has no known allergies, was not pregnant, and has no COVID prior to vaccination. Concomitant medications included birth control and allergy medication. The patient has no other vaccine in four weeks. The vaccine was administered in a hospital. The patient experienced Bell's palsy on 13Mar2021 at 18:30 and tested positive for COVID on 14Mar2021. She is scheduled for the second dose on 16Mar2021, but she is not taking it as she was COVID19 positive and had Bell's palsy. She has not experienced any COVID-19 symptoms. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of Bell's palsy and included treatment with prednisone. The patient underwent lab tests and procedures which included nasal swab PCR which was positive and MRI which was clear, all fine on 14Mar2021.The outcome of the events was recovering.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Varicose vein
Clinical narrative: Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in right arm on 10Mar2021 14:30 (at the age of 62-years-old) as single dose for covid-19 immunisation. The vaccine facility type was a pharmacy or drug store. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Medical history included macular. Concomitant medication included amitriptyline. The patient previously took erythromycin and statins and experienced drug allergies from these. The reported adverse events were superficial blood clot on left calf at the lower end of some varicose veins two days after injection (on 12Mar2021 at 10:00). It may be unrelated, but the patient wanted to let know. The events resulted in emergency room/department or urgent care. AE treatment included hot compress, support stockings and ibuprofen (MOTRIN). The outcome of the events was recovering.; Sender's Comments: Varicose veins most probably was a preexisting condition, unrelated to BNT162B2 vaccine. The reported superficial blood clots are considered a complication of varicose vein and unlikely related to BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Rash, SARS-CoV-2 test
Clinical narrative: Rash; Severe reaction of Erythema Multiforme; This is a spontaneous report from a contactable physician. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was in urgent care, had a severe reaction of Erythema Multiforme on Mar2021 from the Pfizer covid vaccine, after the first dose. Patient was negative for covid infection, reporter believes his reaction is due to covid vaccine. Patient visited urgent care on 12Mar2021 with a rash. He was prescribed Prednisone. He returned the following day with was described as erythema multiforme, which doctor believes was due to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, VIth nerve paralysis
Clinical narrative: Suspect 6th Nerve Palsy; Double Vision; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 AM (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunization. Medical history included High Blood Pressure (controlled by medication) from an unknown date and unknown if ongoing. The patient had no known allergies. The patient has no COVID prior to vaccination, and not COVID tested post vaccination. No other vaccine in four weeks. Other medication in two weeks was noted (reported as yes) but it was unspecified. The patient previously vaccinated of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EN6200 on 17Feb2021 12:30 PM at the left arm single dose for COVID-19 immunization. It was reported that the patient experienced Double Vision and Suspect 6th Nerve Palsy on 11Mar2021 at 08:00 AM. The outcome of the events was recovering. There was no treatment for the event.