chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination.  Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age.  Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Viral rash
Clinical narrative: Post-viral rash on day 10-13 after vaccine administration; Extreme fatigue; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old female patient received BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 at 16:00 at single dose for COVID-19 immunization.  Medical history included migraine, PCOS from an unknown date and unknown if ongoing and known allergy to kiwi. Concomitant medication included naproxen and methocarbamol (ROBAXIN).  The patient experienced extreme fatigue and post-viral rash on day 10-13 after vaccine administration on 27Dec2020. Therapeutic measures were taken as a result of post-viral rash which included treatment with Benadryl (in case of allergic reaction). The patient did not recover from the events.  Information about Lot/Batch has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Contusion, Incorrect route of product administration, Weight
Clinical narrative: I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles; administered via sub cutaneous with a half inch needle; This is a spontaneous report from a contactable Pharmacist reporting for himself. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730 and expiry date: 31Mar2021), Subcutaneously on 29Dec2020 at 16:40 at single dose at Left Deltoid at Hospital for Prevention. There were no medical history or concomitant medications. There were no prior vaccinations within 4 weeks, no family medical history, and no additional vaccines administered on same date of Pfizer suspect. The patient wanted to know what the recommendations are if the COVID Vaccine was administered subcutaneously. He clarified he received the COVID Vaccine, but he believed it was administered via sub cutaneous with a half inch needle on 29Dec2020 at 16:40. He knew with other vaccines such as the Flu Vaccine, if it is not given intramuscularly, a patient is subject to revaccination. The patient wanted to know if he needs to be revaccinated with the COVID Vaccine since it wasn't an intramuscular injection. Relevant Tests were None. On 01Jan2021, the patient stated that he had started developing a red bruise like the bubbles on his arm; it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient reported that the shot was given with the half inch of needle because it was only recommended with the one inch or larger; so actually, he was trying to find it on the mail. The question he wanted to ask was if it went to the deep muscle enough or possibly into the tissue. But over the last, like 24 hours, he has started developing a red bruise like the bubbles on his arm. It didn't feel like he ever had any muscle pain or anything and it seemed more like under the skin there was a bubble and not like inflammatory muscles. The patient's weight was reported as 104.33 kg or 230 pounds. The patient did not receive any treatment for the events. Outcome of the events was unknown. Causality between the event "I have start developing a red bruise like the bubbles on my arm; it seems more like under skin there is a bubble and not like inflammatory muscles" and BNT162B2 was reported as related.  Follow-up (01Jan2021): New information received from a contactable pharmacist includes additional events (contusion, blister), an additional laboratory data, and the clinical course of the events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Gastritis, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test; gastritis; diarrhea; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685; expiry date was not reported), via an unspecified route of administration on the upper right arm on 21Dec2020 at single dose for COVID-19 immunization.  Medical history included blood pressure high, attention deficit hyperactivity disorder (ADHD), hypertension all from an unknown date and unknown if ongoing, and was a former smoker. Concomitant medication included lisinopril and methylphenidate. The patient reported that after he received the vaccine, he tested positive for Covid on 30Dec2020. The patient further reported that he ended up getting significant gastritis on Christmas Eve, which he didn't think about acquiring COVID, he had had the vaccine, he ate a bunch of holiday fare, so he thought he had got a stomach bug or something like that. He says he had considerable diarrhea on Christmas morning, but no fever or chills, then those symptoms resolved by Saturday, and he didn't think about it, he didn't have any issues. He says that he went to get tested, which they do frequently, and his temperature was checked frequently at the places he goes and he had no fever, and is still not febrile now. He says that he gets a weekly COVID test which allows for him to enter different facilities, and this was the first time in 9 months that he tested positive since this all came out. He says he has worked in some heavy duty places, but he wears his PPE, his respirator, his shield, and still did this stuff after he got the vaccine, he didn't let his guard down since it might take a while for immunity to kick in, but he still didn't think that it could be possible to have COVID on Christmas Eve, he was rather surprised he was positive. The patient confirms that he hasn't had the second dose of the vaccine yet. He says that his diarrhea improved on day or two starting after he had been having bloating on Christmas Eve and Christmas morning. He says his diarrhea resolved, he took no medication for it, and had no change in his heart rate or breathing, no problems anywhere else, he didn't feel that bad, except for the going to the bathroom. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Dec2020. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this subject cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; This is a spontaneous report from a contactable other HCP received from a Pfizer-sponsored program.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported to get the vaccine, and within a couple of hours or days, test positive for covid. The outcome of the event was unknown  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2020520145 different patients, same drug and event
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Cough; Fever; body aches; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; Tested positive for COVID after the first dose of the vaccine/tested positive for COVID-19; This is a spontaneous report from a contactable physician reporting for himself from a Pfizer sponsored program, IBCC (Inbound Call Center for HCPs). A 31-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular Deltoid Left, on 17Dec2020 9:00, single dose for COVID-19 immunisation. Relevant medical history included seasonal allergies and asthma. Concomitant medications were reported as none. The patient took the first dose of the COVID-19 Vaccine and he is schedule on 07Jan2021 for his second dose. After the first dose he tested positive for COVID on 30Dec2020. The patient got tested for COVID-19 around 10:30 a.m. The patient hasn't seen a physician and he doesn't don't plan on it. The patient had a cough on an unspecified. Early on he had a fever and body aches but that passed after the first day. Caller clarifies the fever and body aches started Sunday and were gone by Tuesday morning. The cough started on Monday and is still ongoing and persisting. The patient was not hospitalized in response to the events. Outcome of the event cough was not recovered, the events fever and body aches recovered on an unspecified date, while it was unknown for tested positive for COVID after the first dose of the vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the SARS-CoV-2 test positive, LOE and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Test positive for COVID after the first vaccine dose; Test positive for COVID after the first vaccine dose; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is the 2nd of 2 reports. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 vaccination. The patient's relevant medical history and concomitant medications was not reported. The patient was tested positive after the first dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2020520651 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Test positive for COVID after the first vaccine dose; Test positive for COVID after the first vaccine dose; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is the 1st of 2 reports. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left deltoid on 16Dec2020 at a single dose for COVID-19 vaccination. There were no relevant medical history and concomitant medications. The patient was test positive for covid after the first vaccine dose on 27Dec2020 with outcome of not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID 19 test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2020520645 same reporter/product/event, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 30Dec2020 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced numbness to face around nose area. The clinical outcome of numbness to face around nose area was unknown. 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 number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Fatigue, Headache, Nausea
Clinical narrative: Cold sweats; Fever of 102; Headache; Fatigue; Nausea; Pain in arm; This is a spontaneous report from a contactable nurse.  A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=Ec0142, via an unspecified route of administration, in right arm on 30Dec2020 at 19:30 (at the age of 25 years-old) as a single dose for COVID-19 immunization. The patient did not receive any vaccinations 4 weeks prior to vaccination with COVID-19 and also had not taken any other medications in 2 weeks. The vaccine was administered at a hospital. Prior to the vaccination, the patient had not been tested for COVID-19. Medical history included an allergy to Kiwi fruit.  There were no concomitant medications.  On 30Dec2020, the patient experienced cold sweats, fever of 102, headache, fatigue, nausea and pain in arm. The patient was not hospitalized for the events and no treatment was administered. The clinical outcome of the events of cold sweats, fever of 102, headache, fatigue, nausea was recovering. After vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Cold sweats; Fever of 102; Headache; Fatigue; Nausea; Pain in arm; This is a spontaneous report from a contactable nurse.  A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=Ec0142, via an unspecified route of administration, in right arm on 30Dec2020 at 19:30 (at the age of 25 years-old) as a single dose for COVID-19 immunization. The patient did not receive any vaccinations 4 weeks prior to vaccination with COVID-19 and also had not taken any other medications in 2 weeks. The vaccine was administered at a hospital. Prior to the vaccination, the patient had not been tested for COVID-19. Medical history included an allergy to Kiwi fruit.  There were no concomitant medications.  On 30Dec2020, the patient experienced cold sweats, fever of 102, headache, fatigue, nausea and pain in arm. The patient was not hospitalized for the events and no treatment was administered. The clinical outcome of the events of cold sweats, fever of 102, headache, fatigue, nausea was recovering. After vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive for COVID-19 after 1st dose; positive for COVID-19 after 1st dose; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse was inquiring about receiving the second dose of vaccine after testing positive for COVID-19 after 1st dose. Outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: came out positive for Covid-19; came out positive for Covid-19; This is a spontaneous report from a contactable pharmacist.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient came out positive for covid-19 on 30Dec2020 and inquired if he should still get the 2nd dose.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got her first dose of the Covid vaccine, tested positive afterward; This is a spontaneous report from a contactable Health Care Professional (the patient).  A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK5730, expiration date unknown) intramuscularly, on an unspecified date (at the age of 38-years-old) at an unspecified dose in the right arm for COVID-19 immunization. Medical history included asthma from an unknown date. The patient's concomitant medications were reported as "supplements." The patient stated that she got her first dose of the COVID vaccine, tested positive afterward (COVID-19). The patient states that she is "still going to be in her 10 day window to get that second dose. She is wondering if she can still get it or if she has to start over." When probed for any laboratory test, the reporter stated  "I had a COVID test before the vaccine so I guess that's a lab test" (CONFIRMATION PENDING with regard to timing COVID test in relation to vaccine administration).The clnical outcome of COVID-19 was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; testing positive for covid/ they have had a patient have a positive COVID test after vaccine was given; This is a spontaneous report from a contactable pharmacist via medical information team and a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs).  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiration date 31Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history included ongoing asthma.  The reporter was not aware of any allergies, adverse reactions to previous vaccines, significant medical history or any relevant family medical history of the patients. Concomitant medications were reported as none. It was reported that that they had a patient who had a positive COVID test after vaccine was given. The patient who received the vaccine on 18Dec2020 now testing positive for COVID. The patient received the first vaccine dose on 18Dec2020. She tested positive 30Dec2020. They wanted to give her monoclonal antibodies (Bamlanivimab) but they don't know how that would interact with the vaccine. Also, they didn't know how the product and the positive test would play into her already having the first dose and getting the second dose. The second shot would be due on 08Jan2020. The patient was not at the facility at the point of reporting, they had been talking to her by phone. The type of test done was unknown. No treatments known. The outcome of the event "positive COVID test after vaccine was given" was not recovered. The event was assessed as medically significant, and unrelated to vaccine by reporter. The seriousness assessment option was made due to her history of asthma.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive COVID test after vaccine was given".
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration at left arm on 21Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient received the unspecified concomitant medications within 2 weeks of vaccination; patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was contracted COVID on 29Dec2020 20:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient received the treatment Monochrome antibiotic for event. The patient received the COVID test post vaccination on 29Dec2020. The COVID test type post vaccination was Nasal Swab, COVID test name post vaccination was RNA, COVID test result was Positive. The patient was not COVID prior vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the vaccination with BNT162B2 in this patient cannot be completely excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Myalgia, Oxygen saturation
Clinical narrative: extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: PO2 decreased
Clinical narrative: extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck and chest; Rash on my face across my nose and cheeks; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on 28Dec2020 at 15:00 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization.  Medical history included arthritis, hypothyroidism and chronic back pain and arthritis in back; all from unspecified dates and unspecified if ongoing. It was reported that the patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications (taken in two weeks) included duloxetine hydrochloride, levothyroxine, nortriptyline and methocarbamol (ROBAXIN); all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020 at 19:00 the patient experienced a "rash on my face across my nose and cheeks" and on 30Dec2020 the patient experienced "rash on neck and chest". It was reported that "the evening after my vaccine I developed a rash on my face across my nose and cheeks. The next day I developed a rash on my neck and chest and the rash on my face was gone. I still have a rash on my neck and chest. No fever or other symptoms." It was reported that the adverse events were non-serious and did not require treatment nor hospitalization. The clinical outcome of the event "rash on my face across my nose and cheeks" was recovered/resolved on an unspecified date and the outcome of the event "rash on neck and chest" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test positive
Clinical narrative: He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; He lost the sense of smell on 28Dec2020 and later tested positive; This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient (respiratory therapist) of an unspecified age received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 16Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. He lost the sense of smell on 28Dec2020 and later tested positive in Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I came down with a COVID infection; I came down with a COVID infection; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not reported) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient came down with a COVID infection on 23Dec2020 with outcome of unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event "came down with a COVID infection" based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash occurred approx 48 hrs after receiving vaccine.  Both arms, lower legs, feet, neck.; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular at first dose on 17Dec2020 at single dose for covid-19 immunisation in left arm in hospital.  Medical history was not reported and no known allergy, no allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), atorvastatin, fish oil and 'women's 50+ MV'. The patient experienced rash occurred approximately 48 hours after receiving vaccine, both arms, lower legs, feet, neck on 19Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of event was resolving.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Nausea, Rash
Clinical narrative: Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip exfoliation, Lymphadenopathy, Stomatitis
Clinical narrative: Stomatitis; lips completely peeled off; submandibular lymph nodes; headache; This is a spontaneous report from a contactable physician. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular in left arm on 17Dec2020 11:00 at first single dose for COVID-19 immunization. Medical history reported as none. No other concomitant medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient experienced stomatitis on day 11 post vaccine (lips completely peeled off) Day 14- submandibular lymph nodes and headache. Adverse event start date: 27Dec2020 16:00. Events were considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Numbness to right arm; This is a spontaneous report from a contactable nurse (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerBiontech; lot number: 4c9231) intramuscularly at right arm on 30Dec2020 at 09:45 AM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was nursing Home/Senior Living Facility. No relevant medical history and concurrent conditions. No known allergies (no allergies to medications, food, or other products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numbness to right arm on 30Dec2020 at 03:30 PM. The event was reported as non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of event was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 included COVID test post vaccination (COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Color) on 29Dec2020 was negative.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Return of redness, itching, swelling at injection site one week after injection.; Return of redness, itching, swelling at injection site one week after injection; Return of redness, itching, swelling at injection site one week after injection; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 at 07:30 (at the age of 57-years-old) as a single dose for Covid-19 vaccination. Medical history included Multiple Chemical Sensitivity (affecting my respiratory tract) from an unknown date. 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. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 20:30, the patient experienced a return of redness, itching, swelling at injection site one week after injection. Therapeutic measures were not taken for the redness, itching, swelling at injection site. The clinical outcome of the events redness, itching, swelling at injection site was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I shoulder pain in the joint.; This is a spontaneous report from a contactable other HCP, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:15 (at the age of 52-years-old) as a single dose, via intramuscular route of administration in the left arm for COVID-19 vaccination. Medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 18:00, the patient experienced l shoulder pain in the joint. The patient did not receive any treatment for the event. The clinical outcome of the l shoulder pain in the joint was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Warmth of injection site; nausea; body aches; splitting headache; dizziness; Low grade fever; extreme tiredness; This is a spontaneous report from a contactable nurse, the patient. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:00 (at the age of 25-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included diphenhydramine hydrochloride (BENADRYL), ibuprofen, paracetamol (TYLENOL), and fexofenadine, all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and famotidine, both from unknown dates to unknown dates for unknown indications, and experienced allergy. On 31Dec2020 at 17:00, the patient experienced warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea. The patient did not receive any treatment for the events. The clinical outcome of the events warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea was recovering. 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site warmth
Clinical narrative: Warmth of injection site; nausea; body aches; splitting headache; dizziness; Low grade fever; extreme tiredness; This is a spontaneous report from a contactable nurse, the patient. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 31Dec2020 at 10:00 (at the age of 25-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included diphenhydramine hydrochloride (BENADRYL), ibuprofen, paracetamol (TYLENOL), and fexofenadine, all from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin and famotidine, both from unknown dates to unknown dates for unknown indications, and experienced allergy. On 31Dec2020 at 17:00, the patient experienced warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea. The patient did not receive any treatment for the events. The clinical outcome of the events warmth of injection site, body aches, splitting headache, dizziness, low grade fever, extreme tiredness, and nausea was recovering. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vaccination site swelling
Clinical narrative: Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Quarantine, SARS-CoV-2 test positive
Clinical narrative: She tested positive PCR; She tested positive PCR; This is a spontaneous report from a contactable Nurse. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. Resident inoculated on 17Dec. She tested positive PCR on 29Dec2020. Currently in quarantine and asymptomatic. She was scheduled for dose 2 on 06Jan2021. This still fell in quarantine period. The nurse wanted to know if the patient could get the second dose on 06Jan, if not when should she get second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported event "test positive PCR".