chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in my arm where I received the vaccine; Cannot raise my arm ; like my shoulder; Fatigue; I thought maybe I dislocated the shoulder; Starting to feel like pretty bad joint pain like I sub-located the joint; Feels like strain; Muscle pain; This is a spontaneous report from a contactable nurse, the patient.  A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/lot number: EK9231; Expiry Date: 30Apr2021), via an unspecified route of administration in an unspecified site on 26Dec2020 around 12:40 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient has no relevant medical history. The patient's concomitant medications were not reported. I received the Covid vaccine today and I am a Nurse and I am having pretty significant pain in my arm where I received the vaccine. Consumer (Nurse) stated, "I had the vaccine at around 12:40. I came back to my unit and around 3:00PM, I moved a patient. I was holding a patient and so I thought maybe some of that was just fatigue from holding a patient in the procedure but and then I started to move it and I thought maybe I dislocated the shoulder. I was starting to feel like pretty bad joint pain like I sub-located the joint and then it started to be in you know, then I was like really trying to concern like what the sensation was that I was feeling .Knowing all while I got the vaccine and I am feeling the muscle sort of feels like strain. I was told that I cannot say for sure if it just the vaccine. It could also be the handling the patient. But it is both types of pain like looking at the side effects it says joint pain, muscle pain. Injection site pain I do not have. Tiredness and headache no. So it is Muscle pain and joint pain I have. I took a Tylenol (not further clarified) as the pain really started to bother me at around 4. I took Tylenol at about 5 and I started putting an ice pack at around 5:30. It is still pretty significant I would say with those interventions this calmed down to about at 6 and I cannot raise my arm like to my shoulder. I am scheduled to get the second shot on the 17th." It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient took Tylenol for pain. The clinical outcome of vaccination site pain, vaccination site movement impairment, fatigue, joint pain, myalgia, was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Throat started hurting; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was seeking information on the Covid-19 vaccine side effects and mentioned that her throat started hurting for 8-12 hours (h) after receiving the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on the right arm on 28Dec2020 16:00 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced arm tenderness on 28Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash over her ear; The rash then spread on her elbow, hips, legs, stomach and back; The rash then spread on her elbow, hips, legs, stomach and back; This is a spontaneous report from a non-contactable nurse reporting for herself. A 55-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 19Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash over her ear on 21Dec2020 with outcome of unknown, the rash then spread on her elbow, hips, legs, stomach and back on 21Dec2020 with outcome of unknown. The events were considered non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received the first dose of the vaccine; Have now tested positive; Received the first dose of the vaccine; Have now tested positive; This is a spontaneous report from a  pharmacist. It was reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history  and concomitant medications were not reported.  The patient  received the first dose of the vaccine; and have now tested positive.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the reported events and vaccination with BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: rash on the administration site; it is localized on the administration site (which also is sore); This is a spontaneous report from a contactable Nurse reporting for herself.  A 34-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, 1 day after vaccination, the patient experienced rash on the administration site. The rash has not extended all over her body, it was localized on the administration site (which also is sore). The outcome of events was unknown. She has not experienced similar reactions with other vaccines. Patient queried if she should receive the 2nd dose.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; This is a spontaneous report from a contactable physician.   A 66-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EH9899) intramuscular at single dose on28Dec2020 18:00 for Covid-19 immunisation, administered at hospital.  Medical history included Covid-19: he tested positive for COVID and received the monoclonal antibody, bamlanivimab on 13Dec2020; other unspecified health conditions which might make him high risk. The patient previously received monoclonal antibody 17-1a, bamlanivimab on 13Dec2020. For Covid-19. The patient received other unspecified medications in two weeks. On 28Dec2020 21:00, 3 hours after vaccination, he was feeling bad with flu-like symptoms, nausea, headache, dizziness, fatigue and diarrhea. No treatment received. Covid was not tested post vaccination. The outcome of events was not recovered.  His colleague now knows he should have waited 90 days after the antibody but reporter was wondering if there was information. Since there probably is no information, this is a unique situation and reporter wondered if Pfizer wants him to run any particular tests or send in some blood to Pfizer for testing to further medical knowledge on giving the vaccine within 90 days of the antibodies.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; This is a spontaneous report from a contactable physician.   A 66-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EH9899) intramuscular at single dose on28Dec2020 18:00 for Covid-19 immunisation, administered at hospital.  Medical history included Covid-19: he tested positive for COVID and received the monoclonal antibody, bamlanivimab on 13Dec2020; other unspecified health conditions which might make him high risk. The patient previously received monoclonal antibody 17-1a, bamlanivimab on 13Dec2020. For Covid-19. The patient received other unspecified medications in two weeks. On 28Dec2020 21:00, 3 hours after vaccination, he was feeling bad with flu-like symptoms, nausea, headache, dizziness, fatigue and diarrhea. No treatment received. Covid was not tested post vaccination. The outcome of events was not recovered.  His colleague now knows he should have waited 90 days after the antibody but reporter was wondering if there was information. Since there probably is no information, this is a unique situation and reporter wondered if Pfizer wants him to run any particular tests or send in some blood to Pfizer for testing to further medical knowledge on giving the vaccine within 90 days of the antibodies.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain, Peripheral swelling
Clinical narrative: Having a fast heartbeat; Swelling in arm; Its just a little bit achy; This is a spontaneous report from a contactable consumer  reporting for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 27Dec2020 10:00 at single dose for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included metformin (METFORMIN), atorvastatin (ATORVASTATIN), ezetimibe (ZETIA), fenofibrate (FENOFIBRATE).  The patient experienced swelling in arm  on 27Dec2020 with outcome of unknown , having a fast heartbeat  on 28Dec2020 with outcome of unknown , its just a little bit achy on Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included heart rate: fast   on 28Dec2020  .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Headache, Hot flush
Clinical narrative: burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination.  The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain of skin, Pyrexia, Vaccination site pain
Clinical narrative: burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination.  The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Muscular weakness, Paraesthesia, Tachycardia
Clinical narrative: I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient).  This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism.  Physician stated, "I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: pain/tenderness underneath the arm, "like a band, swollen and tender"; pain/tenderness underneath the arm, "like a band, swollen and tender"; pain/tenderness underneath the arm, "like a band, swollen and tender"; This is a spontaneous report from a contactable nurse.  A 41-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient experienced pain/tenderness underneath the arm, "like a band, swollen and tender" (non-serious).  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed a case of herpes zoster on my left flank area; This is a spontaneous report from a contactable physician. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 01:15 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, coronary artery disease, asthma, hypertension, and gastrooesophageal reflux disease (GERD). Concomitant medications included irbesartan, sulfasalazine, and hydroxychloroquine. The patient previously took lansoprazole (PREVACID) and experienced drug allergies. On 28Dec2020, the patient developed a case of herpes zoster on his left flank area. Therapeutic measure was taken as a result of herpes zoster that included valaciclovir (Valtrex). Clinical outcome of event was recovering.  Information on lot/Batch Number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced tachycardia on an unspecified date. The outcome of event was unknown.  The physician wanted to know the side effect of tachycardia resolves on it's own or if intervention is needed, if side effects would increase at the 2nd dose, should Md pre-medicate for second dose or avoid 2nd dose.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Lymphadenopathy
Clinical narrative: Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself).  This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation.  Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself).  This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation.  Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; diarrhea; This is a spontaneous report from a contactable consumer reporting for herself.   A 44-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek5730) at single dose to right arm on 22Dec2020 for Covid-19 immunisation.   Medical history and concomitant medications were none.  The patient experienced severe reaction of vomiting and diarrhea on 24Dec2020, about 48 hours after vaccination, lasted about 7 hours, it went away on 24Dec2020, and she has recovered completely, but it took days to get back to normal. The outcome of events was recovered on 24Dec2020. She queried if it is safe to get the 2nd dose, if it makes her feel like the 1st one, she doesn't want it.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: chills; achy joints; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and achy joints on Dec2020 with outcome of recovering. Patient was still experiencing the symptoms but was feeling better. The patient wanted to know how long symptoms typically last after vaccination.  Information about Lot/batch no has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: chills; achy joints; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and achy joints on Dec2020 with outcome of recovering. Patient was still experiencing the symptoms but was feeling better. The patient wanted to know how long symptoms typically last after vaccination.  Information about Lot/batch no has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: achy joints; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection, lot number: EK5730, intramuscular in the left shoulder on 23Dec2020 12:00 at a single dose for covid-19 prophylaxis. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included Shingrix and experienced weak, tired and achy that lasted for 24 hours, he received this 6 months ago (2020). The patient experienced achy joints and fatigue, both on 24Dec2020 at 10:00 with outcome of recovering. The patient called about the Covid-19 vaccine and reported that he received it last Wednesday on 23Dec2020. He said that since then he has had achy joints and fatigue that started on Thursday 24Dec2020 that has been going on through today. He received the vaccine at the hospital where he works at. His symptoms are persisting, but stated that he does feel a little bit better today. He said that it does not seem to be getting worse. He read achy joints and tiredness were some of the reactions to be expected with the medication, and now he was thinking it was a little more long term than what it should be.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: achy joints; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection, lot number: EK5730, intramuscular in the left shoulder on 23Dec2020 12:00 at a single dose for covid-19 prophylaxis. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included Shingrix and experienced weak, tired and achy that lasted for 24 hours, he received this 6 months ago (2020). The patient experienced achy joints and fatigue, both on 24Dec2020 at 10:00 with outcome of recovering. The patient called about the Covid-19 vaccine and reported that he received it last Wednesday on 23Dec2020. He said that since then he has had achy joints and fatigue that started on Thursday 24Dec2020 that has been going on through today. He received the vaccine at the hospital where he works at. His symptoms are persisting, but stated that he does feel a little bit better today. He said that it does not seem to be getting worse. He read achy joints and tiredness were some of the reactions to be expected with the medication, and now he was thinking it was a little more long term than what it should be.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Computerised tomogram abnormal, Cough, Dyspnoea
Clinical narrative: had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2 reports.   A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80% (hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and positive COVID test was reported as medically significant; and other events were reported as non-serious.  Outcome of O2 saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other events were unknown.    Information about lot/batch number has been requested. ; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Intensive care, Lung infiltration, Myalgia, Pain
Clinical narrative: had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2 reports.   A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80% (hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and positive COVID test was reported as medically significant; and other events were reported as non-serious.  Outcome of O2 saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other events were unknown.    Information about lot/batch number has been requested. ; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2 reports.   A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80% (hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and positive COVID test was reported as medically significant; and other events were reported as non-serious.  Outcome of O2 saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other events were unknown.    Information about lot/batch number has been requested. ; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Viral test negative
Clinical narrative: Anaphylactic reaction requiring two doses of Epinephren to control. Still having issues; other vaccine same date product received; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 12:30 PM on 18Dec2020 at single dose for COVID-19 immunization, and first dose of other Pfizer vaccine same date product (other vaccine same date lot number: elt9899) on right deltoid on 18Dec2020 for unknown indication. Medical history reported as none. Concomitant medication included vitamin C and colecalciferol (VITAMIN D). The patient experienced anaphylactic reaction at 12:30 PM on 18Dec2020 requiring two doses of epinephren to control. still having issues, resulted in: Doctor or other healthcare professional office/clinic visit, Hospitalization in Dec2020. days hospitalization: 1. The patient received treatment: 2 doses of epinephrine, solumedrol, benadryl, IV and O2 for event anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was not recovered. Lot/Batch and Expiration date has been requested.; Sender's Comments: The information available in this report is limited and anecdotal and does not allow a medically meaningful assessment of the case. There is a plausible temporal association between vaccines administration and onset of the reported event. It is unclear what is the nature of the vaccine co-administered with BNT162b2. Currently no information is available on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: fever; headache; increased heart rate; increased blood pressure; congestion; back hurting; joint pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history breast cancer with surgical treatment in Nov2019 and radiation treatment in Feb2020.  The patient previously took zinc oxide and experienced headache. Concomitant medication included anastrozole (unknown manufacturer), calcium (unknown manufacturer), colecalciferol (VITAMIN D), ascorbic acid, bioflavonoids nos (unknown manufacturer). On 21Dec2020 the patient experienced fever, headache, increased heart rate, increased blood pressure, congestion, joint pain with outcome of not recovered and back hurting between the shoulder blades with outcome of recovering. She took paracetamol (TYLENOL) as treatment for the fever. The consumer states she was still having all of these side effects but the back pain was a little better now. The patient wanted to know if she should get the second dose of the Pfizer-Biontech Covid-19 vaccine since she was experiencing side effects after the first injection.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nasal congestion, Pyrexia
Clinical narrative: fever; headache; increased heart rate; increased blood pressure; congestion; back hurting; joint pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history breast cancer with surgical treatment in Nov2019 and radiation treatment in Feb2020.  The patient previously took zinc oxide and experienced headache. Concomitant medication included anastrozole (unknown manufacturer), calcium (unknown manufacturer), colecalciferol (VITAMIN D), ascorbic acid, bioflavonoids nos (unknown manufacturer). On 21Dec2020 the patient experienced fever, headache, increased heart rate, increased blood pressure, congestion, joint pain with outcome of not recovered and back hurting between the shoulder blades with outcome of recovering. She took paracetamol (TYLENOL) as treatment for the fever. The consumer states she was still having all of these side effects but the back pain was a little better now. The patient wanted to know if she should get the second dose of the Pfizer-Biontech Covid-19 vaccine since she was experiencing side effects after the first injection.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; nausea; This is a spontaneous report from a contactable other hcp.   A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular from 28Dec2020 09:00 to 28Dec2020 09:00 single dose for COVID-19 immunisation.  Medical history included haemochromatosis from an unknown date, rubber sensitivity from an unknown date. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC), trazodone, quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT). Vaccine location was arm left. The patient experienced diarrhea on 29Dec2020 10:00, nausea on 29Dec2020 10:00.  The action taken in response to the events for BNT162B2 was not applicable. Events outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: ears are on fire; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL, strength: 25 mg) at 75 mg for unspecified indication. It was reported that on 23Dec2020 the patient took BENADRYL 25 mg pre-vaccination and was given BENADRYL 50 mg post vaccination, the patient experienced ears are on fire on an unspecified date. The patient outcome of the event was unknown.    Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Limb discomfort, Pain
Clinical narrative: chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, Urticaria
Clinical narrative: hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Hypertension
Clinical narrative: arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation.  Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Muscular weakness, Nausea, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation.  Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.