chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: she has a suspected exposure to a COVID19 patient/develops symptoms is unable to get the 2nd dose in time; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient herself). A female patient of an unspecified ag received bnt162b2 (BNT162B2 also reported as PFIZER COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications. The patient was asking if she can get her second shot if she had a suspected exposure to a COVID19 patient and if she developed symptoms and was unable to get the 2nd dose in time, when will the new schedule be. The outcome of event was unknown.   Lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Suspected COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu-like symptoms; feel sick; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was experiencing flu-like symptoms on an unspecified date. Patient feel sick for almost a week now as of this report. Outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: headache (with progression to migraine on 30Dec2020); headache (with progression to migraine on 30Dec2020); This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. Patient was told she was exposed to a Covid positive patient on the day prior to receiving her vaccine (28Dec2020). The patient's concomitant medications were not reported. Patient experienced a headache with progression to migraine on 30Dec2020, off and on since 30Dec2020. Outcome of the events was unknown. She was asking if she gets tested for Covid, will the test results be affected by the vaccine.  Information on the Lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection, Vaccination site pain
Clinical narrative: Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site mass
Clinical narrative: big bump/bigger than a dollar coin; soreness over 24 hours; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 48, unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 25Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had soreness over 24 hours on Dec2020. She was wondering if the person who administered it, administered it subcutaneous instead of intramuscularly. Since 25Dec2020 until 03Jan2021, there was a big bump. There was no pain when patient touched it but she felt like it's getting bigger. It wasn't as big. It's bigger than a dollar coin. It was like a raisin. Outcome of the event of big bump was not recovered while for the other event was unknown. Patient was not sure what size needle was used and went back to ask the nurse. When she drew the needle out, there was medication that.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: felt pain on injection site; headache; very achy; cold; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced drug allergy. Patient stated that she got the Covid vaccine last 24Dec2020 and felt fantastic for 12 hours and after that she felt pain on injection site, headache, very achy and cold for 2 days in Dec2020 and then it went away. Then last Friday, she experienced the same signs and symptoms and had herself swabbed yesterday and got a negative result. She wanted to know if this is a delayed reaction to the vaccine or if she could be having Covid since she is an HCP is usually exposed to patients. Patient also mentioned that she is allergic to Thimerosal. She mentioned that she is allergic to Thimerosal and wants to know if the Covid vaccine contains any derivatives which may be similar to it. Escalating to inquiry to Second line. Offered to provide list of ingredients which she could check with local pharmacist if it does contain Thimerosal derivatives but insisted that there may be scientists or pharmacists from Pfizer who can check on this information. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Nausea, Paraesthesia, Paranasal sinus discomfort
Clinical narrative: nasal congestion; sinus pressure; nausea; extreme fatigue; tingling in hands and feet; Patient reported not able to get out of bed and sleeping most of the day; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer (in her late 30's) reported for herself that she received BNT162B2 single dose in Dec2020 for COVID-19 immunisation. Medical history included autoimmune disease (not disclosed). Concomitant drugs were not provided. The patient received vaccine on Monday and by Thursday began experiencing nasal congestion, sinus pressure, nausea, extreme fatigue, tingling in hands and feet. Patient reported not able to get out of bed and sleeping most of the day in Dec2020. At report, these symptoms had not subsided. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: nasal congestion; sinus pressure; nausea; extreme fatigue; tingling in hands and feet; Patient reported not able to get out of bed and sleeping most of the day; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer (in her late 30's) reported for herself that she received BNT162B2 single dose in Dec2020 for COVID-19 immunisation. Medical history included autoimmune disease (not disclosed). Concomitant drugs were not provided. The patient received vaccine on Monday and by Thursday began experiencing nasal congestion, sinus pressure, nausea, extreme fatigue, tingling in hands and feet. Patient reported not able to get out of bed and sleeping most of the day in Dec2020. At report, these symptoms had not subsided. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer who reported for a patient. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EH9899) via an unspecified route of administration on 22Dec2020 at 06:45 (at an unspecified age) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to sulfa and nuts, from unspecified dates and unspecified if ongoing. Other medical history was reported as "none". Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was reported that it was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccination. On 22Dec2020 the patient experienced "arm soreness". It was reported that treatment was not received for the adverse event. The clinical outcome of the event "arm soreness" was recovered/resolved on an unspecified date.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight sore arm; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration from 02Jan2021 09:45 at single dose for Covid-19 immunization. The patient medical history included heart issues. Concomitant medications were not reported. The patient has received other unspecified medications in two weeks. The patient previously took Penecillon and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight sore arm on 02Jan2021 (15:45). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.  This case is non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine, and a few days later they took the Rapid Antigen Test, the COVID test. And it turned out positive. The person took other tests as well, PCR test which came out negative. The reporter didn't know if there was any research or data if that was done maybe during clinical trials of whether it is possible to come out positive on an antigen test which tests for bio-protein. The reporter believe that was what in the vaccine. The reporter guess the vaccine causes the reaction in the body to make that protein in the body. The reporter wonder if it was possible it could be false positive on one of those tests because of the vaccine, because of the way that rapid test works. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got tested positive; Got tested positive; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Transferring agent stated, "I have a nurse (reporter) on the other line. She is currently on hold. She is reporting an adverse event about COVID Vaccine because she is saying that their doctor (Incomplete sentence). I mean, the nurse on the other line is working at the vaccine clinic. One of their doctors in the clinic had COVID Vaccine on 17Dec2020. I mean, the Doctor got positive or tested positive on 23Dec2020. Should that mean that the COVID Vaccine or the first dose of COVID Vaccine did not take effect for the Doctor itself because the Doctor got positive? They would like to know if they should still need to take second dose of COVID Vaccine." When paraphrased the concern, reporter stated, "Correct. And the question is would he need to get his second dose. It is said that it's two doses." The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event test positive based on the known safety profile. However the short duration of 6 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pain
Clinical narrative: body aches; headache; mild discomfort; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect and Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her vaccine 02Jan2021 and was experiencing body aches and headache in Jan2021. The patient asked if she can  take Tylenol, ibuprofen or Excedrin or some version of a pain reliever. The patient was having mild discomfort in Jan2021. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Giant cell arteritis, Headache
Clinical narrative: Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Varicose vein, Vascular pain
Clinical narrative: Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dry throat, Feeling abnormal, Presyncope, Tremor
Clinical narrative: feeling like he was going to pass out; throat was really dry within 15 minutes; Was very shaky. He was not falling over but had to be very careful with his steps.; burning sensation like a really bad acid reflux in chest that went to his back; he felt off. It is hard to explain.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 31Dec2020 07:20 at single dose for covid-19 immunization. Medical history included ongoing acid reflux, gout, anxiety depression. Ongoing Concomitant medication included allopurinol from Dec2020 for Gout, fluoxetine hydrochloride (PROZAC) at 20mg daily from Dec2020 2 weeks ago for Anxiety depression, omeprazole from Dec2020 3 weeks ago for Acid reflux (esophageal), calcium carbonate (TUMS ANTACID) from 2019 as needed for acid reflux. He experienced some unusual side effects that were not listed on the web. His boss advised him to call. Within a few minutes on 31Dec2020 after getting the vaccine he was feeling like he was going to pass out but didn't. His throat was really dry within 10-15 minutes on 31Dec2020.  He was very shaky. He was not falling over but had to be careful with his steps. After getting the vaccine you have to sit and be monitored for 15 minutes. After that he was ok enough. He thought this was an expected reaction. He usually reacted to things though he didn't know why. He did fine with the flu shot. He had burning sensation like a really bad acid reflux in chest that went to his back on 31Dec2020. His throat was no different compared to like when you were going to get sick. He had drank a ton of water and his throat was still dry. He was not shaky but he felt off. It was hard to explain. Investigation assessment was no. The outcome of shaky and feeling like he was going to pass out was recovered on 31Dec2020, of dry throat was not recovered, of burning sensation was recovering, of others was unknown.   Information on Lot/batch number has been requested.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Increased appetite, Insomnia, Vomiting
Clinical narrative: ate more than usual; vomited; refused to take any daytime naps; Baby had 3 breast feeding sessions after patient received vaccine; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and baby. This case is the baby report. A 9-month-Old male patient received BNT162B2 (lot number EL0104), transmammary on 30Dec2020 18:45 at 9 Months at single dose for COVID-19 immunization. The medical history was not reported. The patient was not allergies to medications, food, or other products. The concomitant medications were levothyroxine sodium (SYNTHROID), calcitriol, calcium, fish oil and multivitamin. On the day following the vaccine, the baby refused to take any daytime naps, ate more than usual, and vomited on 31Dec2020 10:00 AM. None of these were typical behavior for the baby. Baby had 3 breast feeding sessions after patient received vaccine, and then was eating frozen reserves. We do not know at this point whether the baby will revert to his norm or whether the change in behavior will continue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not allergies to medications, food, or other products. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521814 same vaccine, different patient and AE.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is second of 2 reports.  A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiration date Mar2021), via an unspecified route of administration on 19Dec2020 at 0.3 mL, single in the left deltoid for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 30Dec2020, the patient tested positive for COVID after having received the vaccine. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. He seemed healthy. He was fit. He showed up for work everyday. He was vaccinated on 19Dec2020, then tested positive for COVID yesterday, on 30Dec2020. The reporter was wondering if the patient should still get the second dose in 3 weeks, or wait 90 days after tested positive. The reporter needed to know whether to stick with the 21 day time period for the second dose, or wait 90 days. They had been telling people who were already positive, or who had COVID in the past, to wait 90 days to get the vaccine. The reporter had read all of the literature and looked online and could not find any information on this. The outcome of the event "tested positive for COVID after having received the vaccine" was not recovered. The event was assessed as non-serious, and unrelated to vaccine by reporter. She did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine.; Sender's Comments: Based on the information currently available, the reported event "tested positive for COVID" which was further reported as getting COVID by the nurse, was likely related to patient's exposure to SARS-CoV-2 virus prior to vaccination, and unlikely causally related to BNT162B2 vaccine.  Further information like confirmative virus genome /nucleic acid detection needed for more meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021001215 Same drug and events, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Viral test
Clinical narrative: Got the vaccine and developed COVID; Got the vaccine and developed COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. This pharmacist reported similar events for two patients. This is the second of two reports for Infection Control Nurse's daughter. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine and 10 days later, got COVID, so, she got swabbed on unknown date. The patient was wondering if she needed to start over or if she was okay to get the second dose. The outcome of events was 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 "got COVID",  based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021001217 same reporter/product, similar events, different patients.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is 1st of 2 reports. A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EJ1685, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at left deltoid, at 0.3 mL, single for covid-19 immunization. Medical history included ongoing diabetic. Concomitant medication included insulin for diabetic; pioglitazone hydrochloride (ACTOS) for diabetic and all ongoing. The patient received the vaccine on 18Dec2020 and then less than a week later, on 23Dec2020 was positive for COVID. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. The reported stated that obviously this person was exposed prior to getting the vaccine and was not symptomatic. But she needed to know, should she stick with the 21 day time period for the second dose or wait 90 days. The patient described COVID as the flu with an attitude. He was staying home and resting. The reporter did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine. The event was assessed as non-serious, and unrelated to vaccine by reporter. The outcome of the events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "tested positive for COVID" is related to BNT162B2 vaccine.  Patient most likely was exposed to SARS-CoV-2 virus prior vaccination.,Linked Report(s) : US-PFIZER INC-2021001199 Same drug and events, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Paranasal sinus hypersecretion, Viral test
Clinical narrative: Patient got the vaccine and 10 days later got Covid; Patient got the vaccine and 10 days later got Covid; Sinus drainage; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. This pharmacist reported similar events for two patients. This is the first of two reports for Infection Control Nurse.  A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine and 10 days later, got COVID. So, the patient got swabbed because of the sinus draining but she was not ill. The patient was not sick she got some sinus drainage. The outcome of event was unknown. The patients were wondering if they need to start over or if they were okay to get the second dose.  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.  However, the duration of 10 days since the vaccine first dose is short, and it is unlikely patient would have fully developed immunity.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021001212 same reporter/product, similar events, different patients.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID 1 week after vaccination; patient tested positive for COVID 1 week after vaccination; This is a spontaneous report from a contactable physician (patient's wife). This physician reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 21Dec2020, single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient tested positive for COVID on 28Dec2020 (1 week after vaccination). Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: chills and not feeling very good; chills and not feeling very good; rapid COVID test positive; rapid COVID test positive; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This case is serious, the other one is non-serious.   A 22-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899) intramuscular at left deltoid on 22Dec2020 19:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccines given at the same time. The patient received a flu shot back between 27th or 28th Nov2020 in her left deltoid. Caller reported getting the COVID vaccine on the 22Dec2020 and feeling fine before that. On the 28Dec2020 she started feeling chills and not feeling very good and that hasn't gone away. The patient went and got a rapid COVID test and it came back positive, not sure if it was because of the vaccine having antigens in it or she came into contact with it or if she just weakened immune system from the shot. The patient wanted to know if that was true. Then stated she and her mom got the COVID vaccine and her mom received it on the 23Dec. On the 29Dec her whole family started to get sick and experiencing the same things she experienced. The patient was not feeling well at the time of the call. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : 2021001266 same reporter/ drug, different patient/event
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: PCR was positive last night; PCR was positive last night; This is a spontaneous report from a contactable Other Health Professional (Patient) reported that a 39-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899  and Expiration Date unknown) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history was unknown. The concomitant medications were reported as none. The patient experienced received the Pfizer's COVID Vaccine on 18Dec2020 (later clarified) at work, at (Institution name) and she just wanted to report that on 23Dec2020, her husband developed symptoms, he was positive on the 26Dec2020 and then she was just converted and her PCR was positive last night on 30Dec2020 (later clarified).  Patient think her husband exposed then she was exposed. Treatment included Advair is twice a day and albuterol is three times a day. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 PCR test positive  based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. Of note, the patient was exposure to COVID-19 (her husband developed COVID-19).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oedema peripheral, Palpitations, Peripheral swelling
Clinical narrative: Legs were swollen; had swollen legs like edema; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included patient had sort of allergic reaction not to a vaccine but 'a bad reaction'. There were no concomitant medications. The patient received COVID Vaccine on 18Dec2020 and ended up on Christmas she went to take a bath that was on 24Dec2020 or 25Dec2020 and noticed that her legs were all swollen and she was not used to that at all having swollen legs. She did work on her feet but she wasn't working on her feet for that week, so she just didn't know what was causing the swelling and within the last couple of days in Dec2020 she had a quick heart rate like her pulse, it's not that high but for she it was high it was like 112, 115 as her resting heart rate, so it's just been having like heart palpitations kind of, she just wanted to report that and kind of see if other people were getting that as a symptom possibly from vaccine. She had in her past had sort of allergic reaction not to a vaccine but 'a bad reaction'. She had swollen legs like edema, so she was just hoping. And then the patient stated that she wasn't tired at the starting, so she wasn't tired the same day' (could not be clarified further). No treatment was received for all events. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a weird little side effect where the left side of mouth, like the outer 10 percent of upper lower lip and the corner of my mouth went numb for about 45 minutes and then completely resolved. The patient asked when giving the second one should the patient expect a similar response.  The information on the batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient).  A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization.  Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil.  The patient previously took clindamycin and methimazole and experienced drug allergy.  On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative   on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020.  No treatment received for the adverse events.  The outcome of the events was resolved on an unspecified date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Headache, Investigation, Oropharyngeal pain, Pyrexia
Clinical narrative: chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient).  A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization.  Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil.  The patient previously took clindamycin and methimazole and experienced drug allergy.  On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative   on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020.  No treatment received for the adverse events.  The outcome of the events was resolved on an unspecified date.