chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pancreatic carcinoma, Pancreatitis, Ulcer, Weight
Clinical narrative: she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin D3, multivitamins, and some other supplements. It was reported that the patient was in a delicate health situation that was discovered, she was losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021, they saw something like an ulcer on the pancreas head, with cancer cells, it was localized, it was serious, and she received chemo after the first dose. This came up from an accident she had in Jan, the airbag opened and hit her stomach. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; they saw something like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin D3, multivitamins, and some other supplements. It was reported that the patient was in a delicate health situation that was discovered, she was losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021, they saw something like an ulcer on the pancreas head, with cancer cells, it was localized, it was serious, and she received chemo after the first dose. This came up from an accident she had in Jan, the airbag opened and hit her stomach. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Inflammation
Clinical narrative: had digestive problems and before she got the shot she could eat 10 foods without feeling pain and now can only eat one food that is rice; has inflammation in her body but does not elaborate further; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Apr2021 as single dose for COVID-19 immunization. The patient medical history was none and concomitant medication was not reported. It was reported that the patient stated that she had the 1st dose of the BNT162b2 shot on 01Apr2021 and states on an unknown date in 2021, she had digestive problems and before she got the shot, she could eat 10 foods without feeling pain and now can only eat one food that was rice and was wondering how long this was going to go on for because it has been a week. The patient also had inflammation in her body on an unknown date in 2021 and would like to know if there was an interaction between inflammation in a person's body in general and the immunization that happens with the Pfizer BioNTech COVID-19 vaccine. Caller would like to know how long side effect was expected to last. The outcome of the events was unknown.  No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: contracted Covid19 illness about 2 weeks after receiving his first dose of the Pfizer-Biontech Covid19 vaccine; contracted Covid19 illness about 2 weeks after receiving his first dose of the Pfizer-Biontech Covid19 vaccine; felt sick; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . A 30-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient contracted Covid19 illness about 2 weeks (as reported) after receiving his first dose of the Pfizer-Biontech Covid19 vaccine.  He has since recovered, reporting that he feels "much better now" and wanted to know if he can still get his second dose on 14Apr2021 or he needs to wait 2 months. It was reported that, 2nd dose of the vaccine- dx with covid 2 weeks after the first dose, feeling much better now. He wanted to know he can get the second dose on 14Apr2021 as scheduled. Also, the second shot is considered just as effective, or he would need additional doses. He wanted to know if the second dose will still be effective or if he needs to re-start the series. The patient got his first dose of the vaccine last on 23Mar2021. He tested positive for Covid-19 two days (as reported) after the first dose. He mentioned that he felt sick but better now. He was due to have his second dose on 14Apr2021. He called in to ask if he should wait for 3 months before getting the second dose or can he take it on the 14th. Outcome of the event drug ineffective was unknown and other events was recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She was tested positive to Covid19.; She was tested positive to Covid19.; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on 08Mar2021, however she was tested positive to COVID-19 on an unspecified date. Her husband was supposed to have the vaccine 10Mar2021 and supposed to have the first dose of the vaccine 17Mar2021. They told her not to take the vaccine within 90 days. She was scheduled for the second dose on 08Apr2021. She wants to confirm if it's the date she has to take the vaccine. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: However, they tested positive for COVID-19/Tested Positive for Covid after first dose Vaccine; Fever; sick; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. A 60-years-old female patient reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6205) via an unspecified route of administration in upper left arm on 20Mar2021 at 14:00 (at the age of 60-year-old)  as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and Concomitant medications were not reported. The reporter stated that she had gained a little weight since last weigh in at the doctor, confirms this weight gain happened prior to receiving first dose Pfizer COVID Vaccine.   On 31Mar2021, the patient tested Positive for COVID after first dose Vaccine and had been sick. The patient second dose was scheduled on Saturday 10Apr2021. After testing positive for COVID the patient received treatment with Tylenol and Ibuprofen pills. The Tylenol was extra strength 250 or 200 each pill, the patient took Ibuprofen 200 sometimes 2 pills, sometimes 3 pills, sometimes 4 pills, depending on the level of the fever. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021, the patient had a nasal swab test (SARS-CoV-2 test) left and right at two diff pharmacies. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389801 same reporter/drug/event, different patients
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Can't use arms or legs because they are hurting so badly; Can't use arms or legs because they are hurting so badly; Sounds very weak; This is a spontaneous report from a contactable consumer (caregiver). A 48-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 48 years old. The patient's medical history and concomitant medications were not reported. The patient experienced can't use arms or legs because they are hurting so badly (non-serious), sounds very weak (non-serious), both on 08Apr2021 with outcome of unknown. Caller was calling for her 49 year old daughter, who received her 1st Pfizer COVID Shot this morning and was experiencing a terrible reaction. She mentioned that her arms and legs were so sore that she cannot get out of bed. She already took Tylenol for it but it did not help. She mentioned that her daughter was healthy and does not get sick often. She was asking how long these side effects may last. Caller reported that she called the patient earlier, and the patient said that she can't use her arms or legs because she was hurting so badly and that all she can do is lay down. Caller reported that the patient was supposed to be traveling to downsouth this weekend to visit the caller.  Caller reported that she called the patient to see if she needed anything and that the patient sounded really weak.  The patient reported to the caller that she was in bed, her arms and legs hurt so badly, and that was miserable. Caller stated that she is very worried about the patient.  Caller inquired if what the patient was experiencing was a common reaction, and how long the side effects will last. Treatment received included the patient took Tylenol.  Follow up information completed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Hip fracture
Clinical narrative: broke her hip; She described her mother-in-law as being frail and explained she fell; She described her mother-in-law as being frail and explained she fell; This is a spontaneous report from a contactable consumer (reporting for her mother-in-law) via the Pfizer-sponsored program. A 96-Year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 02Mar2021 (received at 96-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter described her mother-in-law as being frail and explained she fell, broke her hip, and had a hip surgery after getting vaccination. She added that her mother-in-law is now in a rehabilitation center. She asked what the longest interval is allowed for getting the second dose of the vaccine. She also asked if the vaccination series will need to be repeated when the second dose if given past 6 weeks. Therapeutic measures were taken as a result of broke her hip (hip fracture). Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a contactable consumer (patient). A pregnant 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 17:00 (at the age of 31 years old) (Lot Number: EN6204, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included anxiety. No known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and unspecified prenatal vitamins.  The patient reported that following the vaccine on 18Mar2021 at 23:00 (11:00 pm), she began spotting vaginally which persisted for two weeks and resulted in a miscarriage at 7 weeks pregnant. The patient is pregnant on 04Jan2021. The mother was supposed to deliver on 19Nov2021.  The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks.  The patient is recovering from the events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 antibody test
Clinical narrative: sick; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer reported for herself. A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 25Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient was scheduled to receive the 2nd dose on 15Apr2021. Unfortunately she became sick and tested for Covid-19 virus but no results yet. Lab data included SARS-CoV-2 antibody test on an unknown date (reported as "last Friday" as of 05Apr2021) with an unknown results. Outcome of the event was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed with covid 06Apr2021; Diagnosed with covid 06Apr2021; This is an initial spontaneous report from a contactable other health care professional(patient). A 44-years-old male patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: EK 4176, Expiration date unknown), via an unspecified route of administration in left arm on 13Jan2021 (at the age of 44-years old) at a single dose for COVID-19 immunization. The patient medical history included historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EJ 1685), via intramuscular Left arm on 23Dec2021 at single dose for COVID-19 immunization (at the age of 44-years). Concomitant medications were included Zolpidem tartrate (AMBIEN), Advil (IBUPROFEN), and Naproxen sodium (ALEVE) which were taken for unspecified indication. The patient did not have any known allergies to medications. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 06Apr2021, the patient tested positive for sars-cov-2 from a PCR test via nasal swab and diagnosed with covid on 03Apr2021. The events were assessed as serious- medically significant. The patient did not receive any treatment for the event. The outcome of event was recovering.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Insomnia, Lethargy
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Body height, Chills
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Epistaxis, Fall, Fatigue
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Insomnia, Joint injury
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Malaise, Musculoskeletal stiffness, Myalgia, Nasal injury
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: lethargy; tiredness; weakness; insomnia/having troubles with sleeping/cannot sleep; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 27Mar2021. A week later, he said he was still experiencing lethargy, tiredness, and weakness. He wanted to know if this was a normal reaction to the vaccine. Consumer also wanted to know if there had been any reports on having Covid insomnia associated with the vaccine, because he was having troubles with sleeping. He did note that he already had a pre-existing insomnia, but now even with sleep medications and wine, he still cannot sleep. This report was non-serious per the reporter. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: I have tested positive for COVID -19 on 05Apr2021; I have tested positive for COVID -19 on 05Apr2021; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), (Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 25Jan2021 as SINGLE DOSE for covid-19 immunization. The historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 05Apr2021, the patient has tested positive for COVID -19. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 05Apr2021. The outcome of the events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A 28-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in Arm Right on 22Mar2021 13:30 (Batch/Lot Number: EP7534) as single dose for covid-19 immunisation.  Medical history included asthma and food allergy. There were no concomitant medications. It was reported, on 08Apr2021, the patient experienced tested positive for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Computerised tomogram, Computerised tomogram spine, Feeling abnormal
Clinical narrative: numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left,  at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation.  Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and  wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it,  moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left,  at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation.  Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and  wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it,  moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: had numbness in her arms and hands, and the right side of her face; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  numbness in her hands and arms, which is ongoing.  The numbness is also felt on the right side of her face (cheek) and only presents during exercise. When she walks long distances her legs become numb, as well.   The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Felt "tired"; A little bit of itching; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient stated that after the injection, she felt "tired" and that night she experienced "a little bit of itching". She added the next day, she "was fine" then the itching came back therefore she went to the ER. She specified the doctor prescribed benadryl which she started yesterday. She asked if her symptoms were reported as side effect to the vaccine. The patient asked if she should be concerned about the itchiness she is experiencing and after getting the first dose and in response that reiterated risks of the vaccine, provided antihistamine usage info and encouraged consultation with HCP for further guidance. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haematoma, Headache
Clinical narrative: small hematoma, dime size on stomach; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunization, at the age at vaccination of 67 years old.  Medical history reported as no. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 04Mar2021 10:00 (Lot number: EN6199) for COVID-19 immunisation. The patient experienced small hematoma, dime size on stomach on 01Apr2021, headache on 01Apr2021, fatigue on 01Apr2021, all with outcome of recovered on unknown date. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspepsia, Fatigue, Feeling of body temperature change
Clinical narrative: chills/intense shivering; nausea; vomiting; muscle cramps; exhaustion; heartburn/acid reflux even with only water; heartburn/acid reflux even with only water; lack of appetite; Feeling hot and cold; mild sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 11:30 (lot number ER8752) on Left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Medical history was reported as none. Concomitant medications included ibuprofen (ADVIL), cyclobenzaprine, guaifenesin, pseudoephedrine hydrochloride (SUDAFED). Historical Vaccine included first dose of BNT162B2 (lot number EN6208) on 12Mar2021 12:30 PM on Left arm for COVID-19 immunization. First night of second dose on 31Mar2021, the patient experienced mild sore arm. Morning after felt fine. First night was fine. 2nd night on 01Apr2021 the patient experienced chills, nausea, vomiting, muscle cramps and intense shivering. 3rd day and onward in Apr2021, the patient experienced exhaustion, muscle cramps, heartburn/acid reflux even with only water, lack of appetite, hot and cold flashes. No treatment was received for the adverse events. The outcome of event sore arm was resolved on 01Apr2021, outcome of other events were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Muscle spasms, Nausea, Pain in extremity, Vomiting
Clinical narrative: chills/intense shivering; nausea; vomiting; muscle cramps; exhaustion; heartburn/acid reflux even with only water; heartburn/acid reflux even with only water; lack of appetite; Feeling hot and cold; mild sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 11:30 (lot number ER8752) on Left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Medical history was reported as none. Concomitant medications included ibuprofen (ADVIL), cyclobenzaprine, guaifenesin, pseudoephedrine hydrochloride (SUDAFED). Historical Vaccine included first dose of BNT162B2 (lot number EN6208) on 12Mar2021 12:30 PM on Left arm for COVID-19 immunization. First night of second dose on 31Mar2021, the patient experienced mild sore arm. Morning after felt fine. First night was fine. 2nd night on 01Apr2021 the patient experienced chills, nausea, vomiting, muscle cramps and intense shivering. 3rd day and onward in Apr2021, the patient experienced exhaustion, muscle cramps, heartburn/acid reflux even with only water, lack of appetite, hot and cold flashes. No treatment was received for the adverse events. The outcome of event sore arm was resolved on 01Apr2021, outcome of other events were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Convulsion; Syncope; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 (2:15 PM) (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no covid prior vaccination and not covid tested post vaccination. There were no other vaccines in four weeks. It was reported that the patient experienced Syncope and Convulsion on 08Apr2021 at 14:30 (2:30 PM). The outcome of the events was recovered in Apr2021. No treatment for the reported events. The event resulted in Emergency room/department or emergent treatment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: allergic reaction (anaphylactic); This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received second dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 05Apr2021 09:15 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included hypersensitivity. There were no concomitant medications. The patient experienced allergic reaction (anaphylactic) (anaphylactic reaction) on 05Apr2021 09:15 few seconds after the second dose had taken Claritin the night before both shots and Benadryl 30 min before and on 2nd shot. 3 h later the reaction repeated and I took 2 more Benadryl Therapeutic measures were taken as a result of allergic reaction (anaphylactic) (anaphylactic reaction). The patient had recovered from the events.  No follow-up attempts are possible. No further information is expected. .; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Dermatitis contact, Fatigue, Influenza like illness, Pain
Clinical narrative: Itching and rash under the central line dressing; very tired (fatigue); pain; temperature of 104(pyrexia); flu like symptoms (influenza like illness); This is a spontaneous report from a non-contactable consumer (patient) via a pharmacy. A 42-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Mar2021 (Lot Number: 2101713; Expiration Date: 31Mar2022) as single dose for covid-19 immunisation, treprostinil sodium (REMODULIN, injection, strength 1.0 mg/ml), current dose was reported as 0.0355 ug/kg, continuous, taken for primary pulmonary arterial hypertension from 09Apr2020 and ongoing.  Medical history included pulmonary arterial hypertension and adhesive tape allergy. Concomitant medications included sildenafil citrate (SILDENAFIL CITRATE) taken for an unspecified indication, start and stop date were not reported; macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 31Mar2021, the patient experienced the events of pain (pain), flu like symptoms (influenza like illness) and temperature of 104(pyrexia). On an unreported date, patient experienced the event of itching and rash under the central line dressing (dermatitis contact). On 31Mar2021, 6 months 28 days (as reported), after initiating IV (intravenous) Remodulin, the patient had received her second COVID Vaccine the previously day (of the reporting date) and was experiencing pain, flu-like symptoms, and temperature of 104. She has been informed to take tylenol and to stay hydrated. The patient was going to call her doctor if fever does not come down after taking Tylenol. Moreover, patient also complained of itching and rash under the central line dressing. Also, she had used different dressings but itching continued. On an unreported date, the patient experienced the event of very tired (fatigue). Action taken with IV Remodulin was unknown for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue. Action taken with Covid-19 vaccine was not applicable for the events. At the time of report, the outcome of pain, influenza like illness and pyrexia, and fatigue was unknown. At the time of report, the outcome of dermatitis contact was not resolved. The reporter did not provide causality for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Itching and rash under the central line dressing; very tired (fatigue); pain; temperature of 104(pyrexia); flu like symptoms (influenza like illness); This is a spontaneous report from a non-contactable consumer (patient) via a pharmacy. A 42-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Mar2021 (Lot Number: 2101713; Expiration Date: 31Mar2022) as single dose for covid-19 immunisation, treprostinil sodium (REMODULIN, injection, strength 1.0 mg/ml), current dose was reported as 0.0355 ug/kg, continuous, taken for primary pulmonary arterial hypertension from 09Apr2020 and ongoing.  Medical history included pulmonary arterial hypertension and adhesive tape allergy. Concomitant medications included sildenafil citrate (SILDENAFIL CITRATE) taken for an unspecified indication, start and stop date were not reported; macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 31Mar2021, the patient experienced the events of pain (pain), flu like symptoms (influenza like illness) and temperature of 104(pyrexia). On an unreported date, patient experienced the event of itching and rash under the central line dressing (dermatitis contact). On 31Mar2021, 6 months 28 days (as reported), after initiating IV (intravenous) Remodulin, the patient had received her second COVID Vaccine the previously day (of the reporting date) and was experiencing pain, flu-like symptoms, and temperature of 104. She has been informed to take tylenol and to stay hydrated. The patient was going to call her doctor if fever does not come down after taking Tylenol. Moreover, patient also complained of itching and rash under the central line dressing. Also, she had used different dressings but itching continued. On an unreported date, the patient experienced the event of very tired (fatigue). Action taken with IV Remodulin was unknown for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue. Action taken with Covid-19 vaccine was not applicable for the events. At the time of report, the outcome of pain, influenza like illness and pyrexia, and fatigue was unknown. At the time of report, the outcome of dermatitis contact was not resolved. The reporter did not provide causality for the events of pain, influenza like illness, pyrexia and dermatitis contact and fatigue.   No follow-up attempts are needed. No further information is expected.