chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Palpitations, SARS-CoV-2 test, Tension, Vertigo
Clinical narrative: Heavy Heart Palpitations; Chest Pain; Breath Issues- Heavily Breathing; Chest Feels Heavy; High Blood Pressure; Anxiety; Scared for everything/fear; Dizziness; Head revolving; tension; getting irritated; feel like shout and cry a lot; Sweating in legs and hands inside; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration on 19Apr2021 at 14:30 (at the age of 40-years-old) in left arm as a single dose for covid-19 immunization. The patient previously took Perinorm injection for nausea and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Concomitant medication received within 2 weeks of vaccination included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8732) on 25Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced heavy heart palpitations, breath issues- heavily breathing, chest feels heavy, high blood pressure, sweating in legs and hands inside, scared for everything/fear, feeling tired, dizziness, head revolving, anxiety was coming for everything like crying a lot so that anxiety was reduced, getting anxiety for work pressure/delivery on time/if miss timelines, any noise/sounds, he got irritated, chest pain, tension and she felt like shout and cry a lot on 20Apr2021 at 22:00. The events were assessed as non-serious. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with aspirin tablets. Post vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures on 22Apr2021 which included SARS-COV-2 (COVID-19) test and RSV by PCR both nasal swab: negative, Influenza A and B by PCR (nasal swab): negative. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Hyperhidrosis, Nightmare, Pyrexia
Clinical narrative: Every night have weird nightmares; Am water tortured where I wake feeling as though a gallon of water has been dumped on me; Head has an awful manufactured feeling; Phantom fevers/ high fever; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 29Apr2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included laryngopharyngeal reflux (LPR) and intolerance for Silicone contacts. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Minocycline (MANUFACTURER UNKNOWN), Dicloxacillin (MANUFACTURER UNKNOWN), Levaquin (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was very active, healthy female, after shot 1 it took her until 25Apr2021 before she felt 100 percent (%) better.  The patient's symptoms post 1 & 2 were in alignment, but more intense for the 2nd. On 30Apr2021 at 07:00, after second dose, the patient experienced every night she had weird nightmares and feeling like water tortured (a gallon of water had been dumped on her), as phantom fevers break. They broke through the day as well but not as often. The patient had been taking her temperature around the clock as her biggest complaint was her head. The patient felt like she had a high fever but actually haven't had a fever even once. The patient experienced an awful manufactured feeling. The patient had 2 thoughts: She had a sensitivity to one of the ingredients in the vaccine. Although her symptoms were ever present, they subside slightly as the day went on and she was convinced to herself because she was taking so many fluids during the days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of every night have weird nightmares, heavy sweating, phantom fevers/high fever and head has an awful manufactured feeling were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Diarrhoea, Food intolerance, Nausea
Clinical narrative: Nausea; Vomiting; Unable to tolerate food; Lack of appetite; The recipient was "down & out" for a week after receiving 1st dose.; diarrhea; This is a spontaneous report from a contactable Consumer. An unspecified age male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: not provided), via an Intramuscular route of administration on an unspecified date Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. It was unknown whether the patient received any other vaccine within 2 weeks. It was unknown if Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if Since the vaccination, the patient had been tested for COVID-19. On an unspecified date Apr2021, the patient had "down & out" for a week after receiving 1st dose. Nausea, vomiting, diarrhea, unable to tolerate food (including PediLyte), lack of appetite. It was unknown whether the patient received any other treatment medication. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Unable to tolerate food; Lack of appetite; The recipient was "down & out" for a week after receiving 1st dose.; diarrhea; This is a spontaneous report from a contactable Consumer. An unspecified age male patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: not provided), via an Intramuscular route of administration on an unspecified date Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. It was unknown whether the patient received any other vaccine within 2 weeks. It was unknown if Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if Since the vaccination, the patient had been tested for COVID-19. On an unspecified date Apr2021, the patient had "down & out" for a week after receiving 1st dose. Nausea, vomiting, diarrhea, unable to tolerate food (including PediLyte), lack of appetite. It was unknown whether the patient received any other treatment medication. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Eye pruritus, Photophobia
Clinical narrative: Continuing to feel sensitive to light, itchy and sore; Eyes began to get sore; Eyes began to get sore, dry; eyes began to get sore, dry and sensitive to light; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 06May2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 15Apr2021 at 09:30 (at the age of 39-years-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. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that first dose had no side effects, not even soreness in the arm. On 06May2021 at 11:30, after 2 hours of vaccination, the patient's eyes began to get sore, dry and sensitive to light. On 07May2021 at 10:30, after 25 hours of vaccination, the patient's eyes were continuing to feel sensitive to light, itchy and sore. They were not swollen however it hurt to keep them open. The patient did not wear makeup or used any products on her face. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events eyes began to get sore, dry, sensitive to light and itchy eye was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Heart rate, Heart rate increased, Insomnia, Lacrimation increased
Clinical narrative: she felt a rash on her arm and the area close to her breast.; she had a fever; she felt cold then warm; she became tachycardic; pulse going up to 110 bpm versus her normal rate of 70-80 bpm.; She began sneezing; a runny nose; and was congested.; Her eyes had a lot of water but she could breathe.; She could not sleep last night.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0176) via an unspecified route of administration on 03May2021 (at the age of 43-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that within 1st hour after vaccination on 03May2021, she became tachycardic with pulse going up to 110 bpm versus her normal rate of 70-80 bpm. By the 2nd day on 04May2021, she felt cold then warm which felt different to her as she had never felt like that before. By the 3rd day on 05May2021, she had fever which she considered normal. On 06May2021 she felt rash on her arm and the area close to her breast. She was sneezing, had runny nose, and was congested. Her eyes had lot of water, but she could breathe. She reported that she could not sleep at night. The events were reported as non-serious. She asked what to be done. The patient underwent lab tests and procedures which included heart rate: going up to 110 bpm on 03May2021. The outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Rash, Rhinorrhoea, Sneezing
Clinical narrative: she felt a rash on her arm and the area close to her breast.; she had a fever; she felt cold then warm; she became tachycardic; pulse going up to 110 bpm versus her normal rate of 70-80 bpm.; She began sneezing; a runny nose; and was congested.; Her eyes had a lot of water but she could breathe.; She could not sleep last night.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0176) via an unspecified route of administration on 03May2021 (at the age of 43-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that within 1st hour after vaccination on 03May2021, she became tachycardic with pulse going up to 110 bpm versus her normal rate of 70-80 bpm. By the 2nd day on 04May2021, she felt cold then warm which felt different to her as she had never felt like that before. By the 3rd day on 05May2021, she had fever which she considered normal. On 06May2021 she felt rash on her arm and the area close to her breast. She was sneezing, had runny nose, and was congested. Her eyes had lot of water, but she could breathe. She reported that she could not sleep at night. The events were reported as non-serious. She asked what to be done. The patient underwent lab tests and procedures which included heart rate: going up to 110 bpm on 03May2021. The outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: she felt a rash on her arm and the area close to her breast.; she had a fever; she felt cold then warm; she became tachycardic; pulse going up to 110 bpm versus her normal rate of 70-80 bpm.; She began sneezing; a runny nose; and was congested.; Her eyes had a lot of water but she could breathe.; She could not sleep last night.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0176) via an unspecified route of administration on 03May2021 (at the age of 43-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that within 1st hour after vaccination on 03May2021, she became tachycardic with pulse going up to 110 bpm versus her normal rate of 70-80 bpm. By the 2nd day on 04May2021, she felt cold then warm which felt different to her as she had never felt like that before. By the 3rd day on 05May2021, she had fever which she considered normal. On 06May2021 she felt rash on her arm and the area close to her breast. She was sneezing, had runny nose, and was congested. Her eyes had lot of water, but she could breathe. She reported that she could not sleep at night. The events were reported as non-serious. She asked what to be done. The patient underwent lab tests and procedures which included heart rate: going up to 110 bpm on 03May2021. The outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Decreased appetite, Disturbance in attention, Dizziness
Clinical narrative: Dizzy; Loss of appetite; Headache; Fever; Hot and cold chills; Tender lump in armpit; Body aches; Lack of focus; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 05May2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient was allergic to onion (food allergy). The patient has taken amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Concomitant medication included fluoxetine (MANUFACTURER UNKNOWN) once daily, started on an unknown start date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 14Apr2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 00:00, the patient experienced dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue. The adverse events did not result in a visit to doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of these events. The clinical outcome of the events dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Dizzy; Loss of appetite; Headache; Fever; Hot and cold chills; Tender lump in armpit; Body aches; Lack of focus; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 05May2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient was allergic to onion (food allergy). The patient has taken amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. Concomitant medication included fluoxetine (MANUFACTURER UNKNOWN) once daily, started on an unknown start date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 14Apr2021 at 15:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 00:00, the patient experienced dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue. The adverse events did not result in a visit to doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of these events. The clinical outcome of the events dizzy, loss of appetite, headache, fever, hot and cold chills, tender lump in armpit, body aches, lack of focus and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lip disorder
Clinical narrative: White blisters on the lips after 2 weeks of vaccination; A series of 3 white bumps, not opensores.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 12:45(at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included cold sores. The patient had a history of allergy to tetracycline. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), estradiol (MANUFACTURER UNKNOWN) , estradiol (ESTROGEN) all from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Feb2021 at 13:15 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 08:00, the patient experienced 3 white bumps on lips and 3 white blisters on the lips after 2 weeks of vaccination. The patient had the worst and weirdest occurrence ever had on lip. At age 66, the patient perhaps typically has an outbreak maybe once a year, following a cold. It lasts may be a week, and has a typical appearance. This appearance, occurring almost 2 weeks after the vaccine, looks like nothing ever seen on lip and was still there. A series of 3 white bumps, not open sores. They were still present, though very small. The next day another occurrence of 3 white little blisters (no open sores) appeared on another part of lip. The patient promptly took valacyclovir and applied acyclovir on it and they were gone in the morning on the day of report, though the original was still present. The patient has never seen sores like this, nor have those and have had ever lasted more than a week or so and was incredibly weird. The patient already have medication for cold sores, so did not go to the doctor and so much on hand because the patient never have had to use it before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with valacyclovir and an ointment acyclovir. The clinical outcome of the event's 3 white bumps on lips and white blisters on the lips after 2 weeks of vaccination was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Neck pain
Clinical narrative: High resting heart rate all next day 100-140, and a bad headache all day and neck pain; High resting heart rate all next day 100-140, and a bad headache all day and neck pain; High resting heart rate all next day 100-140, and a bad headache all day and neck pain; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 05May2021 at 16:45 (at the age of 36-years-old) (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration, administered in the left arm on 12Apr2021 at 10:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included allergies to sulfa drugs. There were no concomitant medications. The patient was not pregnant at the time of the events. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines in four weeks. No medication was received in two weeks. On an unspecified date, the patient experienced high resting heart rate all next day 100-140, and a bad headache all day and neck pain. No treatment was received for the events. The patient was not tested for COVID post-vaccination. The patient underwent lab tests and procedures which included heart rate: high, 100-140. The outcome of the events was recovered/resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills; Aches/pains; tiredness; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 06May2021 09:30, at the age of 32-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included none.   There were no concomitant medications. The patient did not have COVID-10 prior vaccination.  On 06May2021, the patient experienced chills, aches, pains, and tiredness. The outcome of the events was recovering.  The patient has not been tested for COVID-19 post vaccination. No treatment was received for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme tinnitus in left ear one week after second dose and continuing to present; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 08Feb2021 09:00 (Batch/Lot Number: EM9809) (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications included pantoprazole and atorvastatin; both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in right arm (Batch/Lot Number: EI32u7) (at the age of 48-years-old) on 18Jan2021 COVID-19 immunisation. The patient experienced extreme tinnitus in left ear one week after second dose and continuing to present on 15Feb2021. The patient was treated with Acupuncture for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: her arm does not hurt that much; second vaccine may have been adversely impacted by the anti-inflammatory (Naproxen); a little tired for one hour; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 09May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 08May2021 as dose 2, single for COVID-19 immunisation; naproxen (Batch/Lot number was not reported), via an unspecified route of administration from 04May2021 to 08May2021 at an unspecified frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: not reported), via an unspecified route of administration on 17Apr2021 as dose 1, single for COVID-19 immunisation and experienced arm felt like it weighs 500 pounds. The patient reported to be on another medication (Naproxen). The patient had asked her pharmacy if there would be any issues with her taking this medication and being on the vaccine and they said "No". The patient reported that she didn't have any symptoms. The patient looked up if being on anti-inflammatory (Naproxen) can impact the vaccine effectiveness and she read yes. The patient had minimal symptoms to the second vaccine and was concerned that the second vaccine may have been adversely impacted by the anti-inflammatory (Naproxen) and wanted to find out what she should do. Furthermore, it was reported that on an unspecified date the patient took a nap for an hour and reported to be a little tired for one hour, no fever, no ache or no chills and even her arm does not hurt that much. In her first vaccine her arm felt like it weighs 500 pounds. The patient said that it had been because she had to wake up very early in the morning to get the vaccine. Outcome of fatigue was recovered on an unspecified date and unknown for all other events. The action taken in response to the event for naproxen was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Lot Number: ER8736) as dose number unknown, single for COVID-19 immunization; ibuprofen, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: like the size of the tennis ball under his arm, in the lymph node; This is a spontaneous report received from a contactable consumer (parent). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, a day after receiving the vaccine, the patient got "like the size of the tennis ball under his arm, in the lymph node". The reporter was asking whether the patient should use hot or cold compressions to alleviate the symptoms. The outcome of the reported event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Depression, Fatigue, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: worsened her depression; fatigue/ did not want to get out of bed; lowered by blood glucose readings related to her diabetes; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 27Mar2021, at 10:45 (Lot Number: ER8732, at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The vaccine was administered in a pharmacy or drug store. Medical history included diabetes, high blood pressure, depression, and known allergies: Sulfa drugs. She was not pregnant at the time of report. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine but she received other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 06Mar2021, at 10:00 (Lot Number: EN6199, at the age of 67 years old) for COVID-19 immunisation. On 29Mar2021, at 06:00, the patient experienced worsened her depression. The patient reported fatigue and did not want to get out of bed. She also had lowered by blood glucose readings related to her diabetes. The events were described as non-serious. She was not diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 07Apr2021. No treatment was received for the events. The patient was recovering from the events at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Numbness and/or tingling in the lips; Numbness and/or tingling in the lips; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 44-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered on left arm on 25Apr2021 16:00 (at age of 44 years old) as dose 2, single for COVID-19 immunization. The patient's medical history included sulfa allergy eventually resulted in small dose epinephrine injection, asthma, and COVID-19. The patient's relevant past drug history included sulfa, all -mycins, latex, and aspartame. The patient previously received Pfizer COVID-19 (Batch/Lot number: unknown), via an unspecified route of administration, administered on left arm on 29Mar2021 17:30 as dose 1, single for COVID-19 immunization. On 29Apr2021 07:45, the patient experienced numbness and/or tingling in the lips. The hospitalization prolonged was reported as no. The facility where the most recent COVID-19 vaccine was administered in a Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered/not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Vaccination site reaction
Clinical narrative: a little bit of headache; a little bit of tiredness; got reaction too on vaccination site; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscularly, administered in left arm, on 08Mar2021 (Batch/Lot Number: EN6128; Expiration Date: 30Jun2021) (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. Medical history included reactive high blood pressure; hormone replacement therapy use. Concomitant medication included estradiol taken as hormone replacement therapy. The patient experienced a little bit of headache, a little bit of tiredness, and got a reaction too on vaccination site on an unspecified date in Mar2021. The patient underwent lab tests and procedures on an unspecified date which included a negative COVID test. The patient reported that she has had 12 COVID test and none of them were positive, from Mar2020 until the time of the report, May2021. The patient reported to received azelastine nasal spray and paracetamol (TYLENOL) as treatment for the events. The patient has recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Moderate to severe diarrhea since 2-3 days after first shot; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8731) via an unspecified route of administration in the left arm on 29Mar2021 at 08:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient has known allergies to mercury derivatives. The patient received other medications (unspecified) within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, 2-3 days after first shot the patient experienced moderate to severe diarrhea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea and included treatment with KAOPECTATE which slowed it down, and IMODIUM controlled it for 1-2 days and then it returned. The clinical outcome of the event moderate to severe diarrhea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness, Muscle spasms, Muscle twitching, Muscular weakness
Clinical narrative: Flu-like symptoms; Twitching in legs; Cold sensations in shins of both leg; Tingling in shins of both leg; Weakness in one leg/foot/ankle; twitching/Spasms in both feet; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and seasonal allergies. Concomitant medications included mometasone furoate (FLONASE) and gliclazide (CLARITIN) from an unknown date for seasonal allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs. The patient had flu-like symptoms for 1.5 days and twitching in legs. It was also reported that 2 weeks from her second dose and she still had nonstop twitching in her feet. Also some tingling/cold sensations in her shins of both legs. She had weakness in one leg/foot/ankle which may be related to a knee issue but not sure yet but looked into that. But the twitching/spasms in both feet started after second dose and had not stopped (and that was definitely not related to a possible knee thing because it was both legs). She had never had this before. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Flu-like symptoms; Twitching in legs; Cold sensations in shins of both leg; Tingling in shins of both leg; Weakness in one leg/foot/ankle; twitching/Spasms in both feet; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and seasonal allergies. Concomitant medications included mometasone furoate (FLONASE) and gliclazide (CLARITIN) from an unknown date for seasonal allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs. The patient had flu-like symptoms for 1.5 days and twitching in legs. It was also reported that 2 weeks from her second dose and she still had nonstop twitching in her feet. Also some tingling/cold sensations in her shins of both legs. She had weakness in one leg/foot/ankle which may be related to a knee issue but not sure yet but looked into that. But the twitching/spasms in both feet started after second dose and had not stopped (and that was definitely not related to a possible knee thing because it was both legs). She had never had this before. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Nauseated; Miserable; Tired; This is a spontaneous report from a contactable healthcare professional (consumer) (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. Medical history included fibromyalgia, she was taking gabapentin for it, rheumatoid arthritis and an ongoing pain. The patient's concomitant medication included gabapentin for fibromyalgia . The patient experienced nauseated, tired and "miserable on May2021 for a few days after the vaccine. The patient stated she was not sure if it was due to the vaccine or missing XELJANZ. The action taken for tofacitinib citrate is post-therapy. The outcome of events nauseated, tired and "miserable" was recovered on an unspecified date in May2021. The patient underwent lab tests and procedures which included blood test: inflammation levels decreased.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain of skin, Pruritus, Skin burning sensation
Clinical narrative: Scalp burning; Scalp burning and total itching.; Tenderness still to touch and burning sensation on right side of skull; Burning sensation on right side of skull; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 46-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 28Apr2021 at 11:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 00:00, the patient experienced scalp burning and total itching. Tenderness still to touch and burning sensation on right side of skull. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events burning sensation scalp, itchy scalp, scalp tenderness and burning sensation on right side of skull were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.