chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: a low grade fever of 99.7; developed total body aches; This is a spontaneous report from a non-contactable nurse (Patient). A 31-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL0142, Expiration date: Unknown) via an unspecified route of administration in Arm Right on 18Jan2021 16:00 as single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. Allergies to medications, food, or other products: Bactrim. The patient received levothyroxine, daily multivitamin, collagen within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0140) via an unspecified route of administration in left arm on 28Dec2020 03:45 pm as a single dose for COVID-19 immunization. On 19Jan2021 10:30, the patient experienced a low-grade fever of 99.7 and developed total body aches. As a therapeutic measure, ibuprofen was taken. On 25Jan2021, nasal swab was taken and the result was negative. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Swelling face
Clinical narrative: Metallic taste in my mouth; Mild face swelling; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL9265 Exp Date:not reported),via an unknown route of administration in right arm (at the age of  39-year-old) on 27Jan2021 at 4pm at a single dose  for COVID-19 immunization. Medical history included asthma, obesity and post-traumatic stress disorder, all from an unknown date and unknown if ongoing. Patient has allergies with bee stings from unknown date and unknown if ongoing.  It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. Patient was also reported not to be pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and ibuprofen (MOTRIN), both taken for an unspecified indication and start and stop date were not reported.  Patient previously received Hepatitis A vaccine and had allergies. The patient experienced mild face swelling at 4:45pm (about 45 minutes after injection, as reported) then she had a metallic taste in her mouth that started about 6:30pm (about 2.5 hours after injection) and lasted until about 8 pm. She reported that she could still taste the food. Patient  has not been tested for COVID-19 since vaccination. The outcome of mild face swelling  was recovered on an unknown date while metallic taste recovered on 27Jan2021 at 8pm.   No follow-up attempts are possible; information about lot/batch number already obtained
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous report from a contactable 70-year-old female consumer (patient, non-pregnant) received second dose BNT162B2 (Solution for injection, brand: Pfizer, lot number: EL3246) via an unspecified route of administration in Arm Left on 23Jan2021 at 08:15 AM for COVID-19 immunization. Patient medical history included High BP, Hyatal hernia. Concomitant medications included fish oil, atenolol, omeprazole, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER). Patient previously took rosa canina (ROSE HIPS, need to take over time) and had allergy. Historical vaccine included first dose BNT162B2 (COVID19, brand: Pfizer, lot number: EK9231) on 02Jan2021 at 08:45 AM on Left arm for COVID-19 immunization. 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 has not been tested for COVID-19. On 23Jan2021 20:45, patient had tired, headache, chills, fever, nausea, dizziness, weakness body shook for about a hour and half. No Seriousness criteria was reported. Outcome of events was recovering.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Tired; headache; chills; fever; nausea; dizziness; weakness; body shook; This is a spontaneous report from a contactable 70-year-old female consumer (patient, non-pregnant) received second dose BNT162B2 (Solution for injection, brand: Pfizer, lot number: EL3246) via an unspecified route of administration in Arm Left on 23Jan2021 at 08:15 AM for COVID-19 immunization. Patient medical history included High BP, Hyatal hernia. Concomitant medications included fish oil, atenolol, omeprazole, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER). Patient previously took rosa canina (ROSE HIPS, need to take over time) and had allergy. Historical vaccine included first dose BNT162B2 (COVID19, brand: Pfizer, lot number: EK9231) on 02Jan2021 at 08:45 AM on Left arm for COVID-19 immunization. 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 has not been tested for COVID-19. On 23Jan2021 20:45, patient had tired, headache, chills, fever, nausea, dizziness, weakness body shook for about a hour and half. No Seriousness criteria was reported. Outcome of events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Feeling abnormal, Muscle spasms
Clinical narrative: Could not stay awake fully; Arm pain persistent; Growing lower back pain; Fever; Night sweats; Chills; General body aches (especially at shoulder joints in both arms); General body aches (especially at shoulder joints in both arms); Brain fog; Very specific muscle spasm in left upper thigh on backside/persistent muscle spasm; This is a spontaneous report from a contactable 31-year-old female other health professional reported that: A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) as single dose and on unspecified date, route of administration patient received bnt162b2for covid-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medications received from unspecified date frequency and unspecified indication were levothyroxine (LEVOTHYROXINE) dose was at 88mcg, ethinylestradiol, norgestimate (TRI-LO-SPRINTEC). The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient was not pregnant at the time of vaccination. The patient was not allergic to medications, food, or other products. On 26Jan2021, the patient experienced fever, night sweats, chills, general body aches, brain fog, very specific muscle spasm in left upper thigh on backside/persistent muscle spasm, could not stay. On 27Jan2021, awake fully, arm pain persistent, growing lower back pain, growing back pain.  Reported event was reported post 2nd vaccination: 1st night experienced fever, night sweats, chills, general body aches (especially at shoulder joints in both arms), brain fog, and very specific muscle spasm in left upper thigh on backside; 1st day post could not stay awake fully with arm pain persistent and growing lower back pain; 2nd night post continued to experience night sweats and w/ persistent muscle spasm that was previously mentioned in left back thigh and growing back pain. The patient was not received treatment. Outcome of the events were recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Could not stay awake fully; Arm pain persistent; Growing lower back pain; Fever; Night sweats; Chills; General body aches (especially at shoulder joints in both arms); General body aches (especially at shoulder joints in both arms); Brain fog; Very specific muscle spasm in left upper thigh on backside/persistent muscle spasm; This is a spontaneous report from a contactable 31-year-old female other health professional reported that: A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) as single dose and on unspecified date, route of administration patient received bnt162b2for covid-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medications received from unspecified date frequency and unspecified indication were levothyroxine (LEVOTHYROXINE) dose was at 88mcg, ethinylestradiol, norgestimate (TRI-LO-SPRINTEC). The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient was not pregnant at the time of vaccination. The patient was not allergic to medications, food, or other products. On 26Jan2021, the patient experienced fever, night sweats, chills, general body aches, brain fog, very specific muscle spasm in left upper thigh on backside/persistent muscle spasm, could not stay. On 27Jan2021, awake fully, arm pain persistent, growing lower back pain, growing back pain.  Reported event was reported post 2nd vaccination: 1st night experienced fever, night sweats, chills, general body aches (especially at shoulder joints in both arms), brain fog, and very specific muscle spasm in left upper thigh on backside; 1st day post could not stay awake fully with arm pain persistent and growing lower back pain; 2nd night post continued to experience night sweats and w/ persistent muscle spasm that was previously mentioned in left back thigh and growing back pain. The patient was not received treatment. Outcome of the events were recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welts over my chest and back as well as neck and face.; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL1283; expiration date not reported), via an unspecified route (administered on left arm) at the age of 59-years-old, on 22Jan2021 01:00 PM as single dose for COVID-19 immunization. Medical history included childhood asthma from an unknown date and unknown if ongoing which the patient has out grown. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included simvastatin taken for an unspecified indication, start and stop date were not reported. The patient didn't take any vaccine within 4 weeks prior to the Covid vaccine. The patient experienced welts over his chest and back as well as neck and face on 22Jan2021 02:00 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event included Benadryl 125 mg over 6 hours. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site pain
Clinical narrative: Pain at injection site; Bruising; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number:  EL3247) via an unspecified route of administration in left arm on 27Jan2021 14:00 as SINGLE DOSE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included letrozole 2.5mg, aspirin 81 mg, multivitamins (within 2 weeks of vaccination). The patient had allergies to Amoxicillin. On 27Jan2021 14:00 the patient experienced pain at injection site, bruising. The most recent COVID-19 vaccine was administered at the workplace clinic. No other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. The reporter reported seriousness criteria as non-serious. The outcome of event was recovering.  No further follow-up is possible. No information is required.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pain in extremity
Clinical narrative: migraine; malaise; arm soreness; This is a spontaneous report from a contactable other hcp (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route on unspecified date as single dose for COVID-19 immunization. Medical history included Crohn's disease and on chronic steroids from an unknown date and unknown if ongoing. The patient's concomitant medications included chronic steroids for Crohn's disease. The patient experienced migraine, malaise and arm soreness on an unspecified date and asked if these are typical side effects and if she didn't have any side effect after the first dose, would that mean she didn't get the dose? Patient would like to know if she got the full dose and was asking for information about the efficacy of the Covid vaccine while taking a steroid. Patient was on chronic steroids for Crohn's disease and asked if this would minimize the efficacy. She also asked if this means she should get a third vaccine dose and if there was an antibody test she should get to see if the shot was effective or that she got it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Can acyclovir or valcyclovir for shingles be administer during Covid 19 vaccinations; This is a spontaneous report received from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was asked if acyclovir or valaciclovir for shingles could be administered during COVID-19 vaccinations, patient had received (reported as rec'd) first dose and due second dose in 5 days. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Mild headache; arm sore; This is a spontaneous report from a non-contactable consumer (patient herself). An adult female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/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 mild headache and arm sore. The outcome of these events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: fatigue; she threw up; her appetite is worse/lack of appetite; dizziness; nausea; This is a spontaneous report from a contactable other hcp. A 65-years-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Jan2021 (Batch/Lot Number: EL8982; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included renal cancer from Sep2005 to an unknown date, nephrectomy from 05Oct2005 to an unknown date, spinal fusion surgery from 23Nov2020 to an unknown date, compression fracture from Dec2020 to an unknown date, spinal fusion surgery from 22Apr2020 to an unknown date, compression fracture from 2020 to an unknown date, neoplasm from an unknown date and unknown if ongoing, vertebral body replacement from an unknown date and unknown if ongoing, lung neoplasm malignant from an unknown date and unknown if ongoing, metastases to spine from an unknown date and unknown if ongoing. Concomitant medication(s) included fentanyl (FENTANYL) taken for pain from an unspecified start date and ongoing; oxycodone taken for pain, start and stop date were not reported; paracetamol (TYLENOL) taken for pain from 23Apr2020 and ongoing; calcium taken for supplementation therapy from an unspecified start date and ongoing; panax ginseng (GINSENGIN) taken for fatigue from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for supplementation therapy from an unspecified start date and ongoing; vitamin d3 (VITAMIN D3) taken for bone disorder from 02Jan2021 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy from an unspecified start date and ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from an unspecified start date and ongoing; tart cherry (TART CHERRY) taken for inflammation from an unspecified start date and ongoing.  The patient experienced dizziness (non-serious) on 24Jan2021, nausea (non-serious) on 24Jan2021 with outcome of not recovered , she threw up (vomiting) (non-serious) on 28Jan2021, her appetite is worse/lack of appetite (appetite disorder) (non-serious) on 24Jan2021, fatigue (non-serious) on an unspecified date.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of fatigue (fatigue). The outcome of the events dizziness, nausea, vomiting and appetite disorder were reported as not recovered, The outcome of the event fatigue was unknown.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain
Clinical narrative: feeling fatigued; achy; light case of the common cold; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL3247; expiration date were not reported),  via unspecified route (administered in left arm)  at the age of 25-years-old, on 27Jan2021 08:45 AM as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient didn't had covid prior vaccination and didn't take covid test post vaccination. The patient experienced feeling fatigued, achy and light case of the common cold on 28Jan2021 10:00 AM. No treatment was received for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left armpit lymph node swelling; This is a spontaneous report from a contactable nurse. This 38-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL 3249) via an unspecified route of administration from 27Jan2021 at 09:00 am to 27Jan2021 at 09:00 am at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported as hospital. Patient was 38 years old and not pregnant at the time of vaccination. Patient's medical history included Grave's disease, factor 5 Leiden, Hashimotos, known allergies: PCN (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EJ1685) via an unspecified route of administration from 06Jan2021 at 08:30 am to 06Jan2021 at 08:30 am at single dose (dose number; 1) on right arm for Covid-19 immunisation. Patient's concomitant medications (other medications in two weeks) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), acetylsalicylic acid (ASA) and Vitamin D nos (therapy dates unspecified) for an unspecified indication. If other vaccine in four weeks; no. Patient experienced left armpit lymph node swelling on 28Jan2021 at 08:00 pm. Treatment received for adverse event was reported as no. Patient did not have covid-19 prior vaccination and was not tested for covid-19 post vaccination. The outcome of event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Tremor
Clinical narrative: Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Chills; Stomach pain; Slight headache; Uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 at 14:00 (at the age of 68-years-old) at a single dose for covid-19 immunisation. Medical history included bronchiectasis and dysthymia. Allergies to medications, food, or other products included Rash with amoxicillin. Concomitant medication patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT) and ovata (METAMUCIL [PLANTAGO OVATA]). The patient previously took amoxicillin and experienced rash. The patient experienced nausea, vomiting, chills, stomach pain, slight headache and uncontrollable shaking on 28Jan2021 at 21:30 PM. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering form all the events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Dizziness
Clinical narrative: Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible, No further information available
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible, No further information available
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible, No further information available
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever (37.7); fatigue; achiness; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever (37.7), fatigue and achiness on 27Jan2021. The symptoms onset day after vaccination; symptoms resolved within 24 hours. The patient underwent lab tests and procedures which included Low grade fever: 37.7 on 27Jan2021. Outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Palatal swelling, Paraesthesia oral
Clinical narrative: Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: her arm was sore and there was redness and slight swelling; her arm was sore and there was redness and slight swelling; her arm was sore and there was redness and slight swelling/ redness underneath injection site; This is a spontaneous report from a contactable 74-year-old female consumer reported for herself that she received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. The medical history and concomitant medications were not reported. On an unknown date, the patient experienced arm was sore and there was redness and slight swelling and she had some discomfort and redness underneath injection site that lasted a few days and first day it was bad but then as the days went on the swelling got better and eventually resolved by the fourth or fifth day. The outcome of the events was unknown whereas the event Vaccination site swelling resolved on an unknown date.   Information about Lot/batch number is requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Throat tightness
Clinical narrative: swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that 'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain, Somnolence
Clinical narrative: Lightheaded; Like kind of lost a little bit; Sleeping a lot /All day I was sleepy, all the time I was sleepy, I slept a lot; Bodyaches; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Brand: PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced lightheaded, like kind of lost a little bit, sleeping a lot /all day she was sleepy, all the time she was sleepy, she slept a lot (somnolence) and bodyaches. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events were reported as unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Vaccination site pain
Clinical narrative: belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263 ), dose 1 administered in Arm Left on 29Jan2021 11:15  as single for covid-19 immunisation. Medical history included breast cancer from 1984 and it was fully recoverd and cured. The patient's concomitant medications were not reported.  It was reported that On 29Jan2021 03:00 PM after 3 hours of vaccination patient experienced felt belly cramps, watery bowel. Felt tired, had nap. Much better evening. No pain or red at injection site just little tender to touch. It was reported that all the events were recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling jittery, Heart rate increased
Clinical narrative: muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nervousness, Pyrexia
Clinical narrative: muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Malaise
Clinical narrative: sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Somnolence, Vaccination site pain
Clinical narrative: sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Fatigue, fever of 101.4°, chills, muscle aches, muscle weakness, slight nausea, muscle pain in arm at injection site. Currently taking ibuprofen for fever and aches. Will contact a doctor if it hasn't improved by tomorrow, 01-Apr-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fatigue, fever of 101.4°, chills, muscle aches, muscle weakness, slight nausea, muscle pain in arm at injection site. Currently taking ibuprofen for fever and aches. Will contact a doctor if it hasn't improved by tomorrow, 01-Apr-2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Mild fever, aches, and general lethargy
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Had breakthrough menstral bleeding this morning. I am 2 weeks away from menstration. Very light spotting.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: 24 hour fever that reached 102. It would fluctuate; Body chills and body aches; Body chills and body aches; This is a spontaneous report from a contactable other Health Professional reported for herself. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Formulation: solution for injection, Lot Number: EL9261, Expiration date: Unknown, Brand: Pfizer), via intramuscular route of administration in the left arm on 28Jan2021 06:15, as SINGLE DOSE for COVID-19 immunization in the hospital. Medical history was not reported. There was no special history of allergies to medications, food, or other products allergy. Concomitant medication included topiramate 50 mg and the patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 28Jan2021 19:30, the patient experienced 24 hour fever that reached 102, it would fluctuate, body chills and body aches. The events were assessed as non-serious by the reporter. The patient has not been tested for COVID-19 since the vaccination, the patient underwent lab tests and procedures which included body temperature: fever that reached 102 on 28Jan2021. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were recovered on an unspecified date in 2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood pressure measurement, Dizziness, Heart rate, Vertigo
Clinical narrative: A week after injection I developed vertigo and lightheadedness I went to my ENT Dr. my ears are fine went to my medical doctor and he diagnosed me with vertigo and recommended that I didn't get the second vaccine or at least postpone it
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Headache
Clinical narrative: reported r. sided (only) headache & r. facial discomfort;  VS - 132/80 - 52- 96% SpO2;  A&O x 3;  symptoms resolved w/ mask removal, fresh air, emotional support & water.  Remained in observational lot total of 40 mins.  Drive home by spouse.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Moderate aches, fatigue and headache for 24 hours followed by lymph node inflammation in left armpit which is ongoing, though improving slightly every day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asphyxia, Blood pressure measurement, Burning sensation, Dyspnoea, Electrocardiogram
Clinical narrative: SHORTNESS OF BREATH,  SUFFOCATION, IRRITATION/BURNING IN LUNGS, BURNING/ITCHING IN THE MOUTH
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Oxygen saturation
Clinical narrative: SHORTNESS OF BREATH,  SUFFOCATION, IRRITATION/BURNING IN LUNGS, BURNING/ITCHING IN THE MOUTH
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Familial risk factor, Fatigue, Flushing, Palpitations, Rash
Clinical narrative: Both of my vaccination, within 10 minutes, I felt like a wave came over me, flushed and palpitations. They monitored me for an hour.  I did get the rash on arm, was not as extensive as the first vaccine. I took antihistamines.  I was in bed for 1 day; fatigue. Next day I was fine. Telehealth with allergist and cardiologist; family hx of afib. Told me to take medication for palpitations but I chose not to because my BP tends to run low.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus (ringing in ears)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe Tinnitus that has not dissipated as of March 31, 2021