chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My Sugar level have shot up very high. It is not going below 250 and goes to 390 after eating!; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered at the left arm on 17Feb2021 16:15 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus (diabetic). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, the patient's sugar level had shot up very high. It was not going below 250 and went to 390 after eating. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: sciatic nerve pain; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9261; Expiration Date: May2021) at single dose, second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9267; Expiration Date: May2021) at single dose for COVID-19 immunization. There was no medical history reported. There were no concomitant medications. Patient is calling about the second vaccination he had for the virus and he developed sciatic nerve pain and he wanted to know if it was safe to take Ibuprofen with having gotten the vaccine or if that would hurt his protection from the virus. He confirmed it is the Pfizer COVID 19 vaccine. He also said with the sciatic nerve pain he actually got the first vaccination and then he was messing around putting in light bulbs and stuff and that is when he got the sciatic nerve pain from an unspecified date so it had been a couple weeks or so. He didn't think it was from the vaccination. He kept hearing it on TV about taking Tylenol and everything with the vaccine. No further information provided. He clarified he was retired from company and he is no longer an employee there. The outcome of the event was unknown.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event sciatic nerve pain cannot be totally excluded. The concurrent condition reported as  "he was messing around putting in light bulbs and stuff and that is when he got the sciatic nerve pain from an unspecified date " may be major cofounder.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer or other health professional. A 28-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EN5318) via an unspecified route of administration on 11Feb2021 in Arm Right at single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy (seasonal allergies) from an unknown date and unknown if ongoing. Historical vaccination included at age of 28 years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Manufacturer: Pfizer/BioNTech; Lot: EL3247) on 21Jan2021 in Left arm at single dose for COVID-19 immunisation. Concomitant medications included cetirizine and fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported. On 14Feb2021, The patient experienced shingles. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of shingles. The outcome of event was recovering.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: Sore arm at injection site; Joint pain in my knees; Tiredness and fatigue.; This is a spontaneous report from a non-contactable consumer, the patient. A 28-years-old male patient received the second  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247)  via an unspecified route of administration, administered in Arm Left on 12Feb2021  at 11:30 (at the age of 28-years-old) as SINGLE DOSE for covid-19 immunization. Facility in which vaccine was administered was a Workplace clinic Medical history included Known allergies: Penicillin. Concomitant medication included paracetamol (TYLENOL). Historical Data includes  BNT162B2 Dose 1,  Lot number: EL3247,  Administered on 22Jan2021 at 12:00, in the Left arm for covid-19 immunization. No other vaccines were given within 4 weeks.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 12Feb2021 at 16:00 The patient experienced sore arm at injection site,  joint pain in my knees,  tiredness and fatigue. The events were considered non serious. No treatment was given for the events.  The clinical outcome of the events sore arm at injection site,  joint pain in my knees,  tiredness and fatigue were recovering.     No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: severe itching and a red rash across a large area in my mid back area; severe itching and a red rash across a large area in my mid back area; This is a spontaneous report from a non-contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; lot number El9265) via an unspecified route on 05Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL1283) on 15Jan2021 at 19:15 in the left arm for COVID-19 immunization. The patient previously received sulfa drugs from an unknown date for an unknown indication and experienced allergy. On 12Feb2021, the patient experienced severe itching and a red rash across a large area in her mid back area. The patient did not receive any treatment for the events. The outcome of severe itching and red rash across a large area in her mid back area was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dysphagia, Fatigue, Gait disturbance
Clinical narrative: Prolonged tiredness; increased weakness; dragging right foot when walks; little more trouble swallowing pills than before; little more trouble swallowing pills than before; This is a spontaneous report from a contactable consumer (the patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: aortic stenosis, COPD (chronic obstructive pulmonary disease), blood pressure medications, and trouble swallowing pills. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021, the patient experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before. No treatment was received for the events. The clinical outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Been feeling unwell for more than 24 hours. Very fatigued and this is day 3; Been feeling unwell for more than 24 hours. Very fatigued and this is day 3; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration in the right arm on 24Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 the patient experienced "been feeling unwell for more than 24 hours. Very fatigued and this is day 3." The patient did not receive treatment for the adverse events. The clinical outcome of the events "been feeling unwell for more than 24 hours. Very fatigued and this is day 3" were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On her right inner wrist area she developed a hive; This is a spontaneous report from a contactable consumer (patient's husband). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 (batch/lot number: EL8982) at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The first experience was with the first dose. On her right inner wrist area, she developed a hive, just one. The hive appeared a couple hours after the first vaccine. The hive stayed there for 3 to 4 hours and then dissipated. Outcome of the event was recovered on 14Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose fluctuation, Body temperature, Fatigue
Clinical narrative: completely lethargic; couldn't move; headache; pain in her joints; fatigued; slightly elevated fever like over 99 less than 100; sugar has been elevated and it's spiking up and down; This is a spontaneous report from a contactable consumer (daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL8982, second dose) solution for injection on 06Feb2021 at 16:00 (at an unknown age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot EL8982, first dose) for COVID-19 immunisation on 16Jan2021 and experienced shaking and pain in your arm. The patient had the second shot on Saturday, 06Feb2021, and at 8pm she had a headache, pain in her joints, was fatigued, had a slightly elevated fever like over 99 less than 100. Then on 07Feb2021, she could not get out of bed, completely lethargic, fatigued, couldn't move really was in bed for almost a full day and a half. Now the concern was her sugar has been elevated and it's spiking up and down this entire week in Feb2021. The outcome of the events headache, pain in her joints, fatigued, fever, completely lethargic, couldn't move and blood sugar level fluctuation was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Movement disorder, Pyrexia
Clinical narrative: completely lethargic; couldn't move; headache; pain in her joints; fatigued; slightly elevated fever like over 99 less than 100; sugar has been elevated and it's spiking up and down; This is a spontaneous report from a contactable consumer (daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL8982, second dose) solution for injection on 06Feb2021 at 16:00 (at an unknown age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Lot EL8982, first dose) for COVID-19 immunisation on 16Jan2021 and experienced shaking and pain in your arm. The patient had the second shot on Saturday, 06Feb2021, and at 8pm she had a headache, pain in her joints, was fatigued, had a slightly elevated fever like over 99 less than 100. Then on 07Feb2021, she could not get out of bed, completely lethargic, fatigued, couldn't move really was in bed for almost a full day and a half. Now the concern was her sugar has been elevated and it's spiking up and down this entire week in Feb2021. The outcome of the events headache, pain in her joints, fatigued, fever, completely lethargic, couldn't move and blood sugar level fluctuation was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Migraine, Pyrexia
Clinical narrative: No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration on 30Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation in hospital. The patient's medical history was unknown. It was unknown whether the patient had allergies to medications, food, or other products or not. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), on 09Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation and felt tired, lethargic all weekend. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination or not. On 30Jan2021, the patient experienced no taste, fever and migraine. The patient underwent lab tests and procedures included body temperature: Fever on an unspecified date. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal
Clinical narrative: side effect of blood sugar; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267, expiry date not reported), via an unspecified route of administration at the right arm on 17Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension (blood pressure high) from Jan2019 and diabetes mellitus (diabetic) from Apr2019. The patient experienced side effect of blood sugar on 17Feb2021. Patient said he tested his blood sugar before he got the vaccine in the morning before breakfast it was 95, which was normal for him, then his blood sugar was lower than normal after breakfast which he got at a restaurant he goes to regularly so he knew how it usually would be, by 30 points. He said that he keeps good enough records to tell that after lunch, which was a meal he eats regularly so he should know what his sugar usually is, and his sugar was 65 points higher, then after his evening meal it was 10 points higher. He clarified that he got his first dose of the vaccine before he ate breakfast. Clinical outcome of the event was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Nausea, Nerve compression, Pain in extremity, Plantar fasciitis
Clinical narrative: pinching all over body; mildly nauseated; Plantar fasciitis; The pain in my foot became excruciating; could barely walk; The pain in my foot became excruciating; could barely walk; This is a spontaneous report from a contactable Consumer (patient).   A 67-year-old female patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EL9263), via an unspecified route of administration in right arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization.  Medical history included known allergies to Sulfites, Iodine as contrast, Dairy, Gluten.  Concomitant medication included levothyroxine, liothyronine (NP THYROID), latanoprost (LATANOPROST) and Supplements (Other medications in two weeks). The patient was not pregnant. The patient did not have COVID prior vaccination. The patient did not have COVID tested post vaccination. The patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= COVID-19 immunization), via an unspecified route of administration in right arm on 29Jan2021 11:30 AM at single dose for COVID-19 immunization. The patient did not have other vaccine in four weeks. 19Feb2021 after 2nd shot: pinching all over body and mildly nauseated. Plantar fasciitis left foot had no pain for 24 hours. 24 hours later: no nausea. The pain in the foot became excruciating; could barely walk. Lasted 2 days. Milder now. Adverse event start date was 19Feb2021 10:30 AM. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Diarrhoea, Tinnitus
Clinical narrative: diarrhea worsened 2 hours after receiving the vaccine; Ringing in my ear; was already having a flare; Hearing loss was already there and the vaccine actually exacerbated the situation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6201, first dose) solution for injection intramuscular in the right arm on 24Feb2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing irritable bowel syndrome from Mar2020 and acid reflux (esophageal). Concomitant medication included ongoing lansoprazole (PREVACID) for acid reflux (esophageal) from Nov2020. The patient stated his diarrhea worsened 2 hours after receiving the vaccine (24Feb2021 at 19:00) and had diarrhea again around 10 pm. The patient stated hearing loss was already there and the vaccine actually exacerbated the situation in 2021. The patient also experienced ringing in my ear in 2021. The patient's nurse, primary care doctor, and gastroenterologist stated it was okay to receive the vaccine as the patient was in the middle of a flare up with his IBS (inflammatory bowel syndrome) in 2021. Treatment for the event hearing loss exacerbated included unspecified steroids and has been working. The outcome of the events diarrhea worsened and ringing in my ear was unknown. The outcome of the events hearing loss exacerbated and having a flare was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Body temperature, Dyspnoea, Eye disorder
Clinical narrative: experienced a lot of pain; had trouble trying to breathe; sweating; fever; couldn't move his arm it hurt so much; couldn't move his arm it hurt so much; I don't feel right/he is not himself at all; I feel sick; nauseous; horrible headache; both his eyes were black and blue; part of the shoulder she put it in was swollen; I have to give him something with sugar to get it back up; instead of going through the muscle that you supposed to,she went through his shoulder, she did it on his shoulder; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: unknown), via an unspecified route of administration in the shoulder (as reported), on 18Feb2021, as single dose, for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (reported as diabetic). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on an unspecified date, as single dose, for COVID-19 immunisation. On 18Feb2021, the patient received his second shot. It was reported that when the patient was given the injection, instead of going the muscle that you supposed to, the girl went through his shoulder, she did it on his shoulder. It did not bother the patient and when they got home, all of a sudden, on the same day (18Feb2021), the patient experienced a lot of pain, had trouble trying to breathe, was sweating, had a fever which went down after taking Tylenol, couldn't move his arm it hurt so much. During the night of 18Feb2021, it was reported that the patient said, "I don't feel right, I feel sick", he was nauseous, and he was not himself at all. On 18Feb2021, the patient also had a horrible headache, his eyes were black and blue (pending clarification), and the part of the shoulder she put it in was swollen. It was reported that the patient is diabetic, and the patient's wife stated "I have to give him something with sugar to get it back up". It was reported that the patient never had anything like this before. Treatment included Tylenol for fever. The patient was recovering from fever. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Hypokinesia, Malaise
Clinical narrative: experienced a lot of pain; had trouble trying to breathe; sweating; fever; couldn't move his arm it hurt so much; couldn't move his arm it hurt so much; I don't feel right/he is not himself at all; I feel sick; nauseous; horrible headache; both his eyes were black and blue; part of the shoulder she put it in was swollen; I have to give him something with sugar to get it back up; instead of going through the muscle that you supposed to,she went through his shoulder, she did it on his shoulder; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: unknown), via an unspecified route of administration in the shoulder (as reported), on 18Feb2021, as single dose, for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (reported as diabetic). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on an unspecified date, as single dose, for COVID-19 immunisation. On 18Feb2021, the patient received his second shot. It was reported that when the patient was given the injection, instead of going the muscle that you supposed to, the girl went through his shoulder, she did it on his shoulder. It did not bother the patient and when they got home, all of a sudden, on the same day (18Feb2021), the patient experienced a lot of pain, had trouble trying to breathe, was sweating, had a fever which went down after taking Tylenol, couldn't move his arm it hurt so much. During the night of 18Feb2021, it was reported that the patient said, "I don't feel right, I feel sick", he was nauseous, and he was not himself at all. On 18Feb2021, the patient also had a horrible headache, his eyes were black and blue (pending clarification), and the part of the shoulder she put it in was swollen. It was reported that the patient is diabetic, and the patient's wife stated "I have to give him something with sugar to get it back up". It was reported that the patient never had anything like this before. Treatment included Tylenol for fever. The patient was recovering from fever. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Product administered at inappropriate site, Pyrexia
Clinical narrative: experienced a lot of pain; had trouble trying to breathe; sweating; fever; couldn't move his arm it hurt so much; couldn't move his arm it hurt so much; I don't feel right/he is not himself at all; I feel sick; nauseous; horrible headache; both his eyes were black and blue; part of the shoulder she put it in was swollen; I have to give him something with sugar to get it back up; instead of going through the muscle that you supposed to,she went through his shoulder, she did it on his shoulder; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: unknown), via an unspecified route of administration in the shoulder (as reported), on 18Feb2021, as single dose, for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (reported as diabetic). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on an unspecified date, as single dose, for COVID-19 immunisation. On 18Feb2021, the patient received his second shot. It was reported that when the patient was given the injection, instead of going the muscle that you supposed to, the girl went through his shoulder, she did it on his shoulder. It did not bother the patient and when they got home, all of a sudden, on the same day (18Feb2021), the patient experienced a lot of pain, had trouble trying to breathe, was sweating, had a fever which went down after taking Tylenol, couldn't move his arm it hurt so much. During the night of 18Feb2021, it was reported that the patient said, "I don't feel right, I feel sick", he was nauseous, and he was not himself at all. On 18Feb2021, the patient also had a horrible headache, his eyes were black and blue (pending clarification), and the part of the shoulder she put it in was swollen. It was reported that the patient is diabetic, and the patient's wife stated "I have to give him something with sugar to get it back up". It was reported that the patient never had anything like this before. Treatment included Tylenol for fever. The patient was recovering from fever. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: experienced a lot of pain; had trouble trying to breathe; sweating; fever; couldn't move his arm it hurt so much; couldn't move his arm it hurt so much; I don't feel right/he is not himself at all; I feel sick; nauseous; horrible headache; both his eyes were black and blue; part of the shoulder she put it in was swollen; I have to give him something with sugar to get it back up; instead of going through the muscle that you supposed to,she went through his shoulder, she did it on his shoulder; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: unknown), via an unspecified route of administration in the shoulder (as reported), on 18Feb2021, as single dose, for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (reported as diabetic). The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on an unspecified date, as single dose, for COVID-19 immunisation. On 18Feb2021, the patient received his second shot. It was reported that when the patient was given the injection, instead of going the muscle that you supposed to, the girl went through his shoulder, she did it on his shoulder. It did not bother the patient and when they got home, all of a sudden, on the same day (18Feb2021), the patient experienced a lot of pain, had trouble trying to breathe, was sweating, had a fever which went down after taking Tylenol, couldn't move his arm it hurt so much. During the night of 18Feb2021, it was reported that the patient said, "I don't feel right, I feel sick", he was nauseous, and he was not himself at all. On 18Feb2021, the patient also had a horrible headache, his eyes were black and blue (pending clarification), and the part of the shoulder she put it in was swollen. It was reported that the patient is diabetic, and the patient's wife stated "I have to give him something with sugar to get it back up". It was reported that the patient never had anything like this before. Treatment included Tylenol for fever. The patient was recovering from fever. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Cognitive disorder, Headache, Insomnia
Clinical narrative: nausea; violent headache; chills/shivering; vomiting; cannot sleep; having vivid dreams; trouble thinking; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. An 80 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 (at the age of 80, units not provided) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking. It was reported that the patient was hospitalized in the ER (emergency room) 45 minutes after receiving the dose. The clinical course was reported as follows: "The patient received her first COVID-19 vaccine and ended up in the ER with a violent headache, nausea, chills, shivering, trouble thinking and even sleep was an enemy because she had vivid dreams." The patient reported that due to these symptoms she was thinking to get the second dose later than 3 weeks. She wanted to know if she should get the second dose. She also wanted to know if she could pass these side effects along (as reported). The clinical outcomes of the events nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; violent headache; chills/shivering; vomiting; cannot sleep; having vivid dreams; trouble thinking; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. An 80 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 (at the age of 80, units not provided) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking. It was reported that the patient was hospitalized in the ER (emergency room) 45 minutes after receiving the dose. The clinical course was reported as follows: "The patient received her first COVID-19 vaccine and ended up in the ER with a violent headache, nausea, chills, shivering, trouble thinking and even sleep was an enemy because she had vivid dreams." The patient reported that due to these symptoms she was thinking to get the second dose later than 3 weeks. She wanted to know if she should get the second dose. She also wanted to know if she could pass these side effects along (as reported). The clinical outcomes of the events nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Ischaemic stroke, Magnetic resonance imaging head, Pain
Clinical narrative: small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, White blood cell count, White blood cell count increased
Clinical narrative: small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dysphonia, Heart rate
Clinical narrative: BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Throat tightness
Clinical narrative: BP 142/68; like my throat is closing up; Voice hoarse; chest feeling tight; This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265), via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and flu vaccine and experienced allergies. The patient was vaccinated on 05Feb2021. Patient was initially hesitant to get vaccine, reported prior bad reaction to flu vaccine. Patient spoke with the pharmacist and decided to proceed with vaccination. On 05Feb2021, approximately 2 minutes after being seated in the observation area, patient began to feel "like her throat was closing up". Another employee brought the attention of this RN who notified the pharmacist and other clinic staff. Initial assessment, patient seated, in apparent distress stating, "I feel like my throat is closing up". Voice hoarse. 25 mg diphenhydramine hcl (BENADRYL) administered. Patient declined additional 25 mg diphenhydramine hcl stating it made her too sleepy. Patient brought to private monitoring area. VS obtained. HR 78, BP 130/73, SpO2 99%. Reported feeling "some better". HR 76, SpO2 97%, BP 106/66; reported "chest feeling tight". Decision for epinephrine (Epi) administration. Epi Pen administered to L thigh. HR 89, BP 142/68, SpO2 99%. Patient taken to emergency department (ED). Care tx ED RN. Patient stable upon tx to ED. The patient required emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included diphenhydramine hcl and epinephrine. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported), via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunization; and apixaban (ELIQUIS), at an unspecified dose, frequency, route of administration and dates of use for blood thinner. Medical history included blood thinner therapy from an unknown date and unknown if ongoing; the patient had no allergies. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced a sore arm. The patient stated that he noted that the paperwork stated to tell the nurse if you were taking a blood thinner, he took apixaban, but no one asked him about that. The patient wondered if there was known information about apixaban with the vaccination. The action taken in response to the event for apixaban was unknown. The clinical outcome of sore arm was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (26Feb2021): This is a follow-up report based on information received by Pfizer from [manufacturer control number [COMPANY--2021-021398], license party for apixaban (ELIQUIS) and includes: License Partner Assessment.  Assessment: For Eliquis (Unknown), the reporter did not provide any causality assessments. Further company follow-up with the Consumer is not possible. Sore Arm was non-serious and related to apixaban
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Fatigue, Vaccination site pain
Clinical narrative: I had periods of dizziness like my atrial fibrillation was acting up every few minutes all day, both days; Left arm was sore for a day; I had periods of dizziness; I was fatigued and took 2 naps each day; This is a spontaneous report from a contactable consumer (patient herself).   An 84-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EN6200), via an unspecified route of administration on the left arm, first dose on 23Feb2021 12:15 at single dose for COVID-19 immunization.  Medical history included atrial fibrillation from an unknown date and allergies to penicillin. The patient is not pregnant. No other vaccine received in four weeks. Concomitant medication included cyanocobalamin (B12-VITAMIIN), vitamin b complex (B COMPLEX), calcium (CALCIUM), ascorbic acid (VIT C), and rivaroxaban (XARELTO) from unspecified dates in two weeks. On 24Feb2021, the patient experienced left arm was sore for a day however the day following the vaccination and the day after that (Wed and Thursday) patient had periods of dizziness like her atrial fibrillation was acting up every few minutes all day, both days. Patient was fatigued and took 2 naps each day. No treatment was received for the AEs. Patient did not have COVID prior vaccination and not tested with COVID post vaccination. The outcome of the event left arm was sore for a day was recovered on 25Feb2021, and for the other events, it was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Oromandibular dystonia, Pyrexia
Clinical narrative: fever; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; I have dystonia (OMD)/ my symptoms have been aggravated the last few days; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Feb2021 16:45 (batch/lot number: EN 6200) as a single dose for COVID-19 immunisation. Medical history included dystonia (OMD), multi nodular goiter, fatty liver, and uterine fibroids. The patient was not pregnant at the time of vaccination. Concomitant medications included omeprazole, colecalciferol (VITAMIN D), and tonic lemonade with thc; taken for unspecified indications, start and stop dates were not reported. The patient previously took amoxicillin clavulanate and experienced allergies. On 27Feb2021 16:00, the patient has just developed a fever and she really doesn't get fevers. She was normally low at 96.7 and today she was 98.7. She has dystonia (OMD) and her support group was reporting Covid vaccines were making dystonia symptoms worse. Her symptoms have been aggravated the last few days. She had no dystonia reaction until the last 2 days and symptoms might not have anything to do with the vaccine. She was just reporting this because her support group was saying they were worse since the vaccine. She was concerned she has a fever since she never gets them. She hasn't been out of the house since the vaccination. Facility type for the vaccine was a school or student health clinic. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. There was no treatment received for the events. The outcome of the events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss in left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), on 24Feb2021 (at the age of 82 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included known allergies: Keflex. Historical vaccine included: first dose of BNT162B2 lot number=en9581, administration date=03Feb2021 at 02:00 PM, Right arm.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin sodium (WARFIN), Spironolactone, Torsemide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021at 14:00 AM, the patient experienced Hearing loss in left ear, and tinnitus. No treatment was received for the events hearing loss in left ear and tinnitus. The outcome of the events hearing loss in left ear and tinnitus was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.