chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Product use issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chill like sensations; Aches; Dyspnea on Exertion; General Malaise; Fever; Persistent headache that is not relieved with pain killers; other vaccine same date vaccine date 22Dec2020, dose number 1; other vaccine same date vaccine date 22Dec2020, dose number 1; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date not reported), intramuscular in the right arm on 22Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL IR), vitamin d3, calcium ascorbate (VITAMIN C), vitamin b complex, magnesium, cynara cardunculus extract (ARTICHOKE EXTRACT), and vaccinium macrocarpon (CRANBERRY EXTRACT). On 23Dec2020 07:00, the patient experienced chill like sensations, aches, dyspnea on exertion, general malaise, fever, persistent headache that is not relieved with pain killers. It was also reported that other vaccine with same date vaccine date on 22Dec2020, dose number 1. The patient underwent lab tests and procedures which included salivary sample (SARS-cov-2 test): negative on 01Dec2020  . No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; Swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration in the left arm on 07Jan2021 at 15:45 (at the age of 51-years-old) as a single dose, for COVID-19 vaccination. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were unknown. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 10:00 PM, the patient experienced swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar. The events were reported as non-serious and continued 2 weeks after the first injection. The patient did not receive any treatment for the events. The clinical outcome of swelling, redness, irritation, itching, a visible bump approximately the size of a quarter on the arm and irritation site is the size of a 1/2 dollar were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever 99 or above; Muscle pain; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: el3249, expiry: unknown), via an unspecified route of administration on the left arm on 18Jan2021 06:00 at a single dose for COVID-19 immunization at a hospital. Medical history included hyper thyroid, type 1 diabetic and fatty liver. The patient has no known allergies. Concomitant medications included insulin glargine (LANTUS) and insulin lispro (HUMALOG). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: ej1685, expiry: unknown) on 30Dec2020 at 16:30 in the left arm for COVID-19 immunization.  The patient experienced fever 99 or above and muscle pain on 18Jan2021 19:00. The events were not treated. The patient was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: developed pneumonia; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from contactable nurse, the patient.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  On 26Dec2020, the patient tested positive for COVID-19 and subsequently developed pneumonia on an unknown date. Due to this, the patient did not get her second dose which was scheduled on 12Jan2021 as she was still ill. The clinical outcomes of COVID-19 and subsequently developed pneumonia were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Headache, Nasal congestion
Clinical narrative: Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Site pain; Headache; Nauseous; Cough; Felt congested; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EF9231; Expiration date was not reported) on 11Jan2021 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer and hypertension. The patient's concomitant medications were not reported. On 18Jan2021, the patient had site pain; headache; and was nauseous. On 13Jan2021, the patient had cough. In Jan2021, after the vaccination, the patient had felt congested. In Jan2021, almost two weeks after the vaccination, the patient had no taste or smell. The reported events had resulted in the emergency room/department or urgent care. The outcome of the events, 'site pain', 'headache', 'nauseous', 'cough', 'felt congested' and 'had no taste or smell', was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021, the patient had a nasal swab COVID-19 test, and was negative.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: nasal congestion; headache; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 16Jan2021 20:15 at a single dose on the right arm for COVID-19 immunization. Medical history included high blood pressure, NTM lung infection, and laryngopharyngeal reflux (LPR). Concomitant medications included amlodipine, HCTZ, potassium bicarbonate, sodium alginate (GAVISCON ADVANCE), and telmisartan. The patient has no known allergies. Patient is not pregnant. The patient did not receive other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. On 18Jan2021, the patient experienced nasal congestion and headache. No treatment was received. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Investigation, Nasal congestion, Oropharyngeal pain
Clinical narrative: Runny nose; fever of 100 degrees; Chills; sore throat; congestion; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned after taking the first shot, she had a runny nose, fever of 100 degrees, chills, congestion, sore throat. Wanting to know if it's possible that she was tested positive before taking the vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; fever of 100 degrees; Chills; sore throat; congestion; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned after taking the first shot, she had a runny nose, fever of 100 degrees, chills, congestion, sore throat. Wanting to know if it's possible that she was tested positive before taking the vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BTN162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E13246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 13Jan2021, the patient experienced pain in left arm and at injection site and large bruise, which were assessed as non-serious. One week after the injection, she still had pain in left arm and at injection site and also a large bruise. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for a Sars-Cov-2 infection; tested positive for a Sars-Cov-2 infection; This is a spontaneous report from a contactable consumer (patient).  This 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 18Dec2020 at the age of 38-years-old at single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 05Jan2021, the patient tested positive for a SARS-COV-2 infection. The patient was asking how to proceed with getting his second dose; at the time of the report, he was 2 weeks post diagnosis and he was 32 days since his first shot. At the time of the report, the outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: elevated heart rate and heart palpitations; elevated heart rate and heart palpitations; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included Covid-19 and recovered. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced elevated heart rate and heart palpitations. It was reported that the patient received his 1st dose about 3 weeks ago shortly after he recovered from Covid-19. Patient was asking if he should receive second dose right away or if there was any data on possible exacerbated side effects with patients who recently recovered from COVID-19 before the vaccine. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Therapeutic response unexpected
Clinical narrative: My arthritis pain is gone; vivid dreams; This is a spontaneous report from a contactable consumer.  A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 12Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to IVP DYE, and osteoporosis from an unknown date. Concomitant medication included alendronate sodium (ALENDRONATE).  The patient previously took varicella zoster vaccine (shingles vaccine on 03Dec2020), and povidone in generic tablets and experienced allergy. On 15Jan2021, the patient experienced her arthritis pain was gone. The patient also mentioned that she had vivid dreams in Jan2021 and haven't dreamed in years. The outcome of the event swas unknown. The patient did not received treatment for the event. The patient diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: a side effect that lasted a few minutes in her mouth an hour later from her first dose of the COVID-19 vaccine on 29Dec2020.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a side effect that lasted a few minutes in her mouth, an hour later from her first dose of the COVID-19 vaccine on 29Dec2020. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; received the first dose of the COVID-19 vaccine on 22Dec2020/tested positive after taking the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the pharmacist understood that the undiluted vials could be stored up to 120 hours in the refrigerator. She mentioned that their vials are already close to 120 hours stored in the refrigerator. She also knows that if you draw it up in a syringe, the vaccine has a 6-hr viability. She wanted to know if the vial expires after 120 hours or it would mean an additional 6 hours on top of the 120 hours. It was reported that "The allowable time in the refrigerator (5 days or 120 hours), starts when the vaccine is removed from storage under ultra-low temperatures. From the point of dilution, the vaccine may be stored at 2 degrees C to 30 degrees C for up to 6 hours." also shared extended stabiilty information of diluted vials". It was then reported that the patient received the first dose of the COVID-19 vaccine on 22Dec2020. However, the patient tested positive after taking the first dose. The pharmacist asked if the patient should be revaccinated with first dose and then wait for the another 2 weeks for the second dose. Pharmacist further asked if not, is it ok giving it at 8 days after the 21 day-interval, how to proceed, and dose the Regulatory recommendations included people who had COVID-19. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive after taking the first dose".
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: muscle ache at the injection site; total body ache and soreness; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL1283) via an unspecified route of administration in the left arm on 19Jan2021 at 08:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included a pacemaker, chronic obstructive pulmonary disease (COPD), asthma, and high blood pressure (HBP). Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not have any allergies. Concomitant medications included aspirin; lisinopril; fluticasone furoate, umeclidinium bromide, vilanterol (TRELEGY); and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 11:00 the patient experienced muscle ache at the injection site, total body ache and soreness, and headache. The patient did not receive treatment for the events. The outcomes of injection site, total body ache and soreness, and headache were not recovered. It was also reported that since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: hack up from lungs to spit out and it was blood/spitting a blood about seven or eight times; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the arm on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified blood thinners. The consumer is a veteran and had the Pfizer COVID 19 vaccine first dose yesterday on 14Jan2021. He had it in his arm and got a print-out that he took out and it says something about if you have a bleeding disorder and are on blood thinners. His provider did not ask him. He wanted to know if this vaccine is a blood thinner. He felt good after getting it and went to sleep last night. He got up and sort of hack up from lungs to spit out and it was blood and was like that from 6am-7am on 15Jan2021. It was also reported that he was spitting a blood about seven or eight times but then it stopped. He is okay now. Nothing is happening. He wanted to know if he should take a blood thinner when he gets the second one. He would feel like he should not take the blood thinner when he gets the second one. The outcome of the event was recovered on 15Jan2021.  Information about lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling drunk, Hypersomnia, Vertigo
Clinical narrative: out of the body experience as he has a sensation like he feels like a different person and sees everything different/feels weird; feels dizzy/has dizziness/when he sits, he feels like he was moving; vertigo; feels like he was drunk but was not drinking; overslept; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249, expiry date 31May2021) via an unspecified route of administration (right arm), on 19Jan2021, at single dose, for covid-19 immunization. Medical history included Wolff-Parkinson-White syndrome from Nov2019 wherein the patient had surgery to correct. There were no concomitant medications. The patient just received the vaccine yesterday and wanted to report side effects. He stated he overslept this morning on 20Jan2021, and he was supposed to be at work at 7am. He rushed to get into his vehicle, and he was sitting at a stop light and started feeling this way at 8am. He stated that on 20Jan2021 08:00 he has an out of the body experience as he has a sensation like he feels like a different person and sees everything different. He feels dizzy/has dizziness kinda like vertigo on 20Jan2021 08:00. He added it feels like vertigo, but it was not vertigo, he was unsure if it was vertigo. Everything feels weird. He feels like he was drunk but was not drinking and, when he sits, he feels like he was moving on 20Jan2021 08:00. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after getting the first dose of vaccine; tested positive for Covid after getting the first dose of vaccine; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of on 16Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient had previously received the first dose of shingles shot as immunization on an unknown date. It was stated that the patient tested positive for COVID after getting the first dose of vaccine in Jan2021.  The patient also mentioned that he was scheduled to have a second dose of PFIZER-BIONTECH COVID-19 VACCINE on 06Feb2021 and his second shot of shingles shot on 09Feb2021. Outcomes of the events were unknown.   Information on Lot/Batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: I could not hear anything; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: el8982), via an unspecified route of administration at the left arm on 18Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hearing problem, CAD and glaucoma. The patient has no allergies to medications, food, or other products. Concomitant medication included tamsulosin, levothyroxine sodium (LEVOXYL), omeprazole, acetylsalicylic acid (BABY ASPIRIN) and astorta. On 19Jan2021, 1 day after injection around 5pm the patient reported to have taken a nap, and when he woke up, he could not hear anything.  The patient has a hearing problem only have 10% hearing. He was going to see ENT. The event resulted to doctor or other healthcare professional office/clinic visit. The reporter assessed the event as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included asthma and environmental allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications were unspecified (had other unspecified medications in two weeks). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date unknown), via an unspecified route of administration in the left arm, on 31Dec2020 13:30, for COVID-19 immunization. The patient was lightheaded, dizzy for 4 hours and experienced toes, fingers and lips numb and tingly for 2 hours, all on 19Jan2021 16:45. The events resulted in emergency room/department or urgent care visit. No treatment was provided. The patient recovered from dizzy for 4 hours on 19Jan2021 20:45 and from toes, fingers and lips numb and tingly for 2 hours on 19Jan2021 18:45.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache
Clinical narrative: pounding headache; Chills; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 19Jan2021 13:45 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included bifidobacterium lactis (PROBIOTIC), ascorbic acid (VIT C) and a multivitamins. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 04:00 AM, the patient stated, "In the middle of the night after my vaccination, I had a pounding headache that is still ongoing as of 11:18 am eastern. I am also now experiencing chills for the last 2 hours (my current body temp is 95 degrees)". The outcome of the events was not recovered. No treatment was given to the patient for the events.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated after took the first shot last on 14Jan2021 he experienced little diarrhea in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Platelet disorder
Clinical narrative: severe platelet problem after receiving the vaccine; This is a spontaneous report from a contactable consumer. A patient (doctor) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a severe platelet problem after receiving the vaccine. The reporter was looking for information on patients with autoimmune diseases (specifically scleroderma and thrombocytopenia) who received the vaccine. The outcome of the event severe platelet problem was unknown.   Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; he tested positive for COVID-19 between the 1st and 2nd dose of the vaccination schedule; Fever; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 between the first and second dose of the vaccination schedule. The reporter asked if it would be safe for him to receive the second dose (COVID-19 vaccine) on an unspecified date (reported as tomorrow). He has been fever-free for 5 days. Outcome of the event fever was recovered on an unspecified date in Jan2021 and of the other events was unknown.  Information on the lot/ batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hangover, Hyperhidrosis, Hypersomnia, Malaise
Clinical narrative: Woke up 1:30 AM with rigors for 2 hours; woke up in puddle of sweat; felt hungover; malaise; slept most of the day; sore arm; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 14Jan2021 at a single dose on Left arm for COVID-19 immunization. Medical history included none. No concomitant medications were received. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, "lot unknown=False"), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient woke up 1:30 AM on 14Jan2021 with rigors for 2 hours; after that fell back asleep and woke up in puddle of sweat. In AM felt "hungover"; malaise, slept most of the day and woke up around 5:30 PM; was almost back to normal except sore arm. No treatment received for the event. The outcome of the event sore arm was not recovered while the rest of the events was recovered on 14Jan2021. The events were considered as non-serious. The patient was not pregnant at the time of vaccination.  Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Woke up 1:30 AM with rigors for 2 hours; woke up in puddle of sweat; felt hungover; malaise; slept most of the day; sore arm; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 14Jan2021 at a single dose on Left arm for COVID-19 immunization. Medical history included none. No concomitant medications were received. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, "lot unknown=False"), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient woke up 1:30 AM on 14Jan2021 with rigors for 2 hours; after that fell back asleep and woke up in puddle of sweat. In AM felt "hungover"; malaise, slept most of the day and woke up around 5:30 PM; was almost back to normal except sore arm. No treatment received for the event. The outcome of the event sore arm was not recovered while the rest of the events was recovered on 14Jan2021. The events were considered as non-serious. The patient was not pregnant at the time of vaccination.  Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Nausea, Pain, Pyrexia
Clinical narrative: severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Defaecation urgency, Diarrhoea, Headache, Pain in extremity
Clinical narrative: The following morning, he experienced headache and loose stools./had really loose stool and was squirting liquid/ diarrhea; The following morning, he experienced headache and loose stools.; arm soreness; He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on left arm on 12Jan2021 at a single dose for COVID-19 vaccination. Medical history included Chronic obstructive pulmonary disease (COPD) (he has had it for years. He says he uses a machine when he goes to bed, a mask). The patient's concomitant medications were not reported. The patient previously took flu shot (unspecified) one injection a few (also reported as 3) weeks ago. The patient received the Pfizer-BioNTech COVID-19 vaccine on 12Jan2021 in the evening about 05:30-06:00PM. The following morning on 13Jan2021, he experienced headache and loose stools. The loose stools were described as "squirting" of over the next 5 days and then the loose stools started to improve. He says starting Wednesday he had really loose stool and was squirting liquid and it has bad for about 3 days. He says Saturday he started having loose, real loose stools, not squirting, but this has gone through to today. He says he still has a feeling kind of like he needs to go to the bathroom all the time. He says he never had a loose stool as far back as he can remember before, he didn't take anything for it, his doctor isn't giving the vaccine so he didn't contact him. He says he also didn't want to mess up by taking anything. He was squirting and had loose stool Wednesday morning and then that continued until today, he was not squirting, was having very loose stool, that was better, since he was not squirting. He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom. The headache gradually improved after the initial injection and he only has a little headache left currently. Patient had a headache the first couple of days, it was real light until now, he was still kind of not back to normal. He wanted to know if this will go away, since he is due for next virus shot in a week or so and was kind of dubious about taking it. On unspecified date in Jan2021, the patient had arm soreness that went away and was gone, he was sore for a couple days. The outcome of the events diarrhea and headache was recovering; event "He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom" was not recovered; and arm soreness was recovered in Jan2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Swollen lymph nodes; Lymph nodes are really itchy/The itching is worse/worsened; This is a spontaneous report from a contactable consumer via medical information team. A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on the left arm on 09Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included ongoing diabetes: diagnosed before 2000, the condition was controlled; ongoing blood pressure high: diagnosed about the same time as the diabetes (before 2000), the condition was controlled; breast cancer twice: first time she had breast cancer was in 2008, the second time was in 2017; and had surgery and lymph nodes were removed: four lymph nodes were removed on the side where the shot was done (left). There patient had no concomitant medications. On 19Jan2021, the patient experienced swollen lymph nodes, lymph nodes were really itchy and the itching is worse/worsened in Jan2021. The patient received the COVID vaccine 10 days ago (also reported as almost 2 weeks ago) and experienced swollen lymph nodes. The vaccine was given to her in the same arm where she had her lymph nodes removed. She added that within the last 2 days, her lymph nodes on one side were swelling and really itchy. She added that "it's itchy to the point she would like to rip her arm off". The patient was scheduled to have her second dose on the 30th. It was explained to her that she shouldn't have a problem with getting the second dose, but the vaccine was injected into her left arm and that was the side where her lymph nodes were removed and now it was itchy. The swelling and itching started first thing in the morning on the 19Jan2021, she woke up with it. The itching was worse, or she doesn't know actually. She doesn't know if it's worse or its just annoying because it has now been 2 days of it. The itching and swelling hasn't gotten any better. Initially she was thinking it was a bug bite. She was thinking it would be better today, but its not. She wanted to make sure it had nothing to do with her breast cancer. The consumer wanted to know how long it took for the swollen lymph nodes to go down and should she take the second dose of the vaccine. She also wanted to know if she should take BENADRYL or apply any ointment on the swollen lymph nodes. The adverse event did not require a visit to the emergency room or the physician office. No relevant tests were done. The patient has not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Cold sweat, Nervousness, Pyrexia
Clinical narrative: Spinal stenosis; More anxious; Fever of 101; Rash; Pain in the arm where she got the shot; Feeling clammy and nervous; Feeling clammy and nervous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration on arm from 15Jan2021 to 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took trazodone and antibiotics and had problems with them. Caller also stated she might be having withdrawals from a sugar high, has been coming off gabapentin for 2 years. Caller stated she got the first dose of the COVID-19 vaccine on Friday 15Jan2021. Caller reports pain in the arm where she got the shot on Saturday, a rash started Sunday night and fever of 101 started Monday morning, had a fever Tuesday morning and it went away and took more Benadryl for the rash. Caller stated she took Benadryl. Caller states she has been more anxious since Tuesday. Caller states she is feeling clammy and nervous and wants to know if this is normal. Caller had a root canal on Thursday and has spinal stenosis. Could be too much Benadryl or mind over matter issue as she has been reading information online about the vaccine. The outcome of the event fever was recovered; while the other events was unknown.  Information on the lot/batch number has been requested.