chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control
Clinical narrative: blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK9231/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 08:00 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM)ongoing since an unknown date and thyroid cancer excised. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced her blood sugars have been out of control in the range of 400-500's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that on both occasions after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. The outcome of the event blood blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event "blood sugars have been out of control in the range of 400-500's" in this insulin-dependent diabetes mellitus patient 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
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain at injection site, sore arm.  Especially not able after second injection (soreness was much worse) but stated no numbness from the injection as would be very concerned if this occurred.; Pain at injection site, sore arm.  Especially not able after second injection (soreness was much worse) but stated no numbness from the injection as would be very concerned if this occurred.; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 05Jan2021 as a single dose for COVID-19 IMMUNIZATION. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 26Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced pain at injection site, sore arm with the first dose. On 26Jan2021, the patient experienced pain at injection site, sore arm with the second dose. The patient reported that it was especially notable after second injection (soreness was much worse) but stated no numbness from the injection. The patient believed the individual who administered the second dose may have administered too quickly causing the additional soreness. The events did not require hospitalization. The patient did not receive treatment for the events. The outcome of the events pain at injection site, sore arm was recovering. 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.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar is higher; This is a spontaneous report from a contactable consumer (patient's wife). This 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 25Jan2021 (at the age of 76 years-old) for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. On an unknown date, his blood sugar was higher. Sometimes he received testosterone injections and it stays high for a couple of days. The clinical outcome of blood sugar was higher was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Heart rate, Heart rate increased, Malaise
Clinical narrative: cough; heart rate went up; not feeling well; chills; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, NDC number and expiration date were unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported. The vaccine was not administered at the military facility. The patient had no medical history. She had no family medical history. There were no concomitant medications; the patient had no other products. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient did not require any visit to a physician or emergency room (ER) for the adverse events (AEs). The patient had no prior vaccinations within 4 weeks. The reporter provided information on the side effects of the patient. The patient had the vaccine on 24Jan2021 and she had "basic" not feeling well that evening, chills that night; and had developed a cough on Monday evening, on 25Jan2021. She was still coughing and didn't feel well. The reporter didn't know if it was due to the vaccine. The patient was still with coughing and just not feeling good. The reporter was asking if the coughing was related to the vaccine, was it normal for the vaccine, or should she get the test. The reporter further stated that in the afternoon of 24Jan2021, the patient was not feeling well and had chills that evening. The reporter added that the patient's heart rate went up with the chills on 24Jan2021 in the evening, but then went back down when the chills went away on 25Jan2021. The reporter mentioned that the patient's husband had it (vaccine) at the same time and had no problem. The patient was scheduled for the second dose of the vaccine, but the reporter did not have the paper to provide the date. The reporter assessed the events as non-serious. The patient recovered from the events "chills and heart rate went up" on 25Jan2021, while she was not recovered from the events "not feeling well and cough."
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fall, Influenza like illness
Clinical narrative: bruising above the knees and on his lower legs; fall; Pain as if he had the flu; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unknown route of administration on 13Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After his second dose the patient reported bruising above the knees and on his lower legs; the patient also mentioned a fall. He stated he had pain as if he had the flu. The patient was most worried about the pain and bruising in his legs; he inquired if that was normal/reported nearly two weeks after a dose, and what he should do. He reported that he called his physician and if it's not better by "this." The patient was also looking for information that he could be sent. The clinical outcomes of bruising above the knees and on his lower legs, fall, and pain as if he had the flu were unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Fatigue, Headache
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old)  at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old)  at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old)  at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: hardly got sore; Chills; Nausea/Nauseated; This is a spontaneous report from a contactable consumer, the patient. A 88-years-old female received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EL1283), via an unspecified route of administration  in left arm on 11Jan2021 at 14:00 (at the age of 88-years-old) as a single dose for Covid-19 immunisation. Medical history included Covid-19 from Dec2020 to an unknown date ('quarantine was over a few days before Christmas'.), Heart attack, Had four stents placed, ongoing Blood pressure high , ongoing blood cholesterol , drug hypersensitivity ('allergic to lots of medications'). Concomitant Medication include 'blood thinners, blood pressure, cholesterol, that sort of thing'. No additional details provided. No other vaccines were given within 4 weeks. On 12Jan2021, The patient experienced chills all day long.  She never ran a temperature. She got nauseated around 9:00 PM-9:30 PM and on an unspecified date reported she hardly got sore, no additional details provided. She drank ginger ale, went to bed. She got up the following morning and was fine. By 13Jan2021 she felt fine and no longer had chills or nauseated. The adverse events did not require a visit to the emergency room or physicians office. Consumer inquired if she can use antipyretics before or after vaccination of the covid-19 vaccine. The patient is scheduled to get the second dose on 01Feb2021. The clinical outcome of the event is chills and nausea were recovered on 13Jan20201 while hardly got sore was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little sore; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose 20Jan2021 and was scheduled for 2nd dose 10Feb2021. She has heard other people get very sick after getting 2nd dose but does not know of anyone that has gotten sick after getting vaccine and stated she has heard that somewhere and wanted to know if that's true. Also said after her 1st dose she did not get sick, but she was a little sore but that's it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: she was exposed to COVID and then started getting symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. The patient's concomitant medications were not reported. Last Wednesday (20Jan2021), the patient got the first dose of Pfizer COVID19 vaccine. On Thursday (21Jan2021), the patient was notified that she was exposed to COVID on unspecified date and then started getting symptoms on Sunday (24Jan2021). She did not provide details on the "symptoms". The patient underwent swab test (COVID-19 virus test) on unspecified date with pending result (unknow result). Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Upper-airway cough syndrome
Clinical narrative: Sinus drainage; Dizziness and tiredness that comes and goes; Dizziness and tiredness that comes and goes; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, after receiving vaccine the patient then developed dizziness and tiredness that comes and goes. He also states he has sinus drainage which he says may have started before vaccine. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it.  The outcome of the event sore throat was not recovered, while for the other event, it was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Muscle fatigue
Clinical narrative: Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Gait inability, Inappropriate schedule of product administration, Nausea
Clinical narrative: Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: little chills; fatigue; right arm pain, left arm pain; light fever (99.7); This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient experienced little chills, light fever 99.7 (unknown unit), right arm pain and then her left arm was painful, and fatigue. The patient wanted to know if this was normal. The clinical outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Off label use, Product use issue
Clinical narrative: Lupus and Idiopathic pulmonary fibrosis; Lupus and Idiopathic pulmonary fibrosis; patient had fever, had short of breath, had terrible dry cough; like when having flares; Was short of breath; terrible dry cough; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization.  Medical history included Lupus and Idiopathic pulmonary fibrosis. She takes Hydroxychloroquine and Mycophenolate 50 mg for it. The patient's concomitant medications were not reported. On Jan2021, 3 days after vaccine administration, patient had fever, had short of breath, had terrible dry cough; like when having flares. She wanted to know should she take the second dose or not. She also asked the protection percentage after the first dose. Outcome of the events was unknown.   Information about lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lupus and Idiopathic pulmonary fibrosis; Lupus and Idiopathic pulmonary fibrosis; patient had fever, had short of breath, had terrible dry cough; like when having flares; Was short of breath; terrible dry cough; Fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization.  Medical history included Lupus and Idiopathic pulmonary fibrosis. She takes Hydroxychloroquine and Mycophenolate 50 mg for it. The patient's concomitant medications were not reported. On Jan2021, 3 days after vaccine administration, patient had fever, had short of breath, had terrible dry cough; like when having flares. She wanted to know should she take the second dose or not. She also asked the protection percentage after the first dose. Outcome of the events was unknown.   Information about lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Dyspnoea, Nausea
Clinical narrative: shortness of breath; throat felt really tight; joint pain; body aches; nausea; fever/higher fever up until 100.2 Degree F; injection site hurting, swelling; injection site hurting, swelling; coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration on 19Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, the patient had the "normal" adverse effects: joint pain, body aches, nausea, fever. On the 21Jan2021, she developed shortness of breath since her throat felt really tight and was prescribed with steroids, but she still feels tightness in her throat. On the 25Jan2021 she got higher fever up until 100.2 Degree F. On 26Jan2021, she went to urgent care and they did a COVID test on her and prescribed an inhaler for her. Today the test result came back negative but she still got nausea, injection site hurting, swelling and coughing in Jan2021. The event nausea, throat felt really tight, injection site hurting, swelling and coughing was not recovered while for other events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Throat tightness, Vaccination site pain
Clinical narrative: shortness of breath; throat felt really tight; joint pain; body aches; nausea; fever/higher fever up until 100.2 Degree F; injection site hurting, swelling; injection site hurting, swelling; coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration on 19Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, the patient had the "normal" adverse effects: joint pain, body aches, nausea, fever. On the 21Jan2021, she developed shortness of breath since her throat felt really tight and was prescribed with steroids, but she still feels tightness in her throat. On the 25Jan2021 she got higher fever up until 100.2 Degree F. On 26Jan2021, she went to urgent care and they did a COVID test on her and prescribed an inhaler for her. Today the test result came back negative but she still got nausea, injection site hurting, swelling and coughing in Jan2021. The event nausea, throat felt really tight, injection site hurting, swelling and coughing was not recovered while for other events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: shortness of breath; throat felt really tight; joint pain; body aches; nausea; fever/higher fever up until 100.2 Degree F; injection site hurting, swelling; injection site hurting, swelling; coughing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, via an unspecified route of administration on 19Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, the patient had the "normal" adverse effects: joint pain, body aches, nausea, fever. On the 21Jan2021, she developed shortness of breath since her throat felt really tight and was prescribed with steroids, but she still feels tightness in her throat. On the 25Jan2021 she got higher fever up until 100.2 Degree F. On 26Jan2021, she went to urgent care and they did a COVID test on her and prescribed an inhaler for her. Today the test result came back negative but she still got nausea, injection site hurting, swelling and coughing in Jan2021. The event nausea, throat felt really tight, injection site hurting, swelling and coughing was not recovered while for other events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hemiparesis, Malaise
Clinical narrative: her whole left side went weak and she fell down 3 times; her whole left side went weak and she fell down 3 times; not doing so well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021 11:30, at single dose, for covid-19 immunization and; methylprednisolone (MEDROL, tablet), via an unspecified route of administration, from an unspecified date, at unknown dosage, for inflammation in the cartilage in the ribs. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer Covid vaccine yesterday 26Jan2021 at around 11:30; and later that night she had a really bad reaction where her whole left side went weak and she fell down 3 times also, she was not doing so well. She then talked to her doctor who instructed her to call in the adverse event to find out if the Medrol dose pack that was prescribed for her inflammation in the cartilage in the ribs may have caused a reaction or if there was a correlation. The action taken in response to the events for BNT162B2 was not applicable while for methylprednisolone was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash appeared in both upper arms/the rash had extended to the rest of the arms/ both legs also displayed the rash; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration in left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. The patient has no medical history. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Jan2021 21:00, a few hours after receiving the vaccine, a rash appeared in both upper arms. By the end of the day, the rash had extended to the rest of the arms. After 36 hours of receiving the vaccine, both legs also displayed the rash. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known  allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. 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 25Jan2021, The patient experienced fatigue,  swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021.  No treatment was given for the events. The clinical outcome of the events fatigue,  swollen lymph nodes above the left clavicle that sore was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Just a little pain at the injection site and is kind of tired today; Just a little pain at the injection site and is kind of tired today; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age (reported as 89, unit unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021 10:55, at single dose, for covid-19 immunization, at the hospital. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO) from 2020. The patient reported that she had no reaction, just a little pain at the injection site in Jan2021 and was kind of tired on 27Jan2021 (today). The patient also reported that after she got the vaccine, they gave her a fact sheet. She just read it in the morning of 27Jan2021 (this morning). It said that you should mention if you have any allergies, fever, bleeding disorders, or are on a blood thinner. The patient stated she is on XARELTO for over a year now. The patient was wondering what complications would arise from this. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Sciatica
Clinical narrative: sciatic problem/ sciatic nerve going down my leg; feel pain that goes down his right leg/ bum down to his foot; I have a tough time walking; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL92U3) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. Concomitant medications included different pills. The patient called and would like to know if his sciatic problem in his left side was related to the Covid vaccine he received. After he got his shot he went down and parked for 15 minutes and then he went to ride home, and when he got out of the car he had sciatic nerve going down his leg on 21Jan2021. He can't seem to get rid of it and now he was just wondering what would have done that. He felt the pain that goes down his right leg/bum down to his foot, he had a tough time walking on 21Jan2021. Patient was taking different pills and stated, "nothing real serious but this is little bit serious". Treatment for the events: patient tried different saps and stuffs to put on his leg and he had also taken Tylenol arthritis pill. Outcome of the events was unknown.    No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El9261) via an unspecified route of administration, on the left arm, on 22Jan2021 at 15:30 PM (at the age of 46 years) at a single dose for COVID-19 immunization. Medical history included Hashimoto's disease. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liothyronine (LIOTHYRONINE), thyroid (ARMOUR THYROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 16:30 PM, the patient experienced increased heart rate, over 100 when resting. The event was reported as non-serious. The patient had lab tests which included heart rate: over 100 on 22Jan2021. No treatment was given. The clinical outcome of the increased heart rate, over 100 when resting was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Investigation, Pain, Painful respiration, Respiratory rate
Clinical narrative: Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This is a spontaneous report from a contactable pharmacist.  A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), intramuscular from 25Jan2021 16:00 at SINGLE DOSE in left arm for COVID-19 immunization.  Medical history included allergic rhinitis, depression, hypertension, and lupus. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), bupropion, hydroxychloroquine, olmesartan, colecalciferol, folate sodium, magnesium, omega-3 fatty acids, pyridoxine hydrochloride, vitamin b12 nos, vitamin e nos (SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS]), curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]).  The patient previously took codeine and experienced Known allergies, hives, itching, throat swells. The patient had first dose of BNT162B2 on 04Jan2021 15:15 at 52-years-old. It was reported that the patient experienced usual chest pressure related to lupus condition but after getting Covid vaccine it is now a on 25Jan2021 16:00, sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED (Emergency department) with RR. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included investigation: 6/10 on 25Jan2021, respiratory rate: unknown results on 25Jan2021. The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: side effect of a metallic taste in her mouth, back of throat, and nose; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced side effect of a metallic taste in her mouth, back of throat, and nose on 27Jan2021. The patient wants more information on this. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on her left arm, via an unspecified route of administration on 25Jan2021 at a single dose for covid-19 immunization. Medical history included Open heart surgery in 2006. There were no concomitant medications. It was reported that the patient had the COVID shot on the 25Jan2021, she and her husband, and she sat for 20 minutes, everything was fine, she got in the car, and was going down the road, she had chest pains, then it eased up and it stopped then probably another 25 to 30 minutes later is started again. The chest pains started probably a half hour after the shot. They went away, then she had it three times that day, and once today, and once yesterday, so they are ongoing. The outcome of the event was not recovered.