chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; body aches; lethargy; sweats; headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old consumer of an unspecified gender received first dose of BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection) on 21Jan2021 01:15 PM to left arm at single dose for Covid-19 immunization. The patient's medical history included thyroidectomy. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included liothyronine sodium (CYTOMEL) and levothyroxine sodium (TIROSINT) which were received within two weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Jan2021 05:00 PM, the patient experienced fever, chills, body aches, lethargy, sweats and headache. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had tested for Covid-19 by polymerase chain reaction (PCR) test. On 30Jan2021, Covid tests post vaccination included nasal swab and PCR, which showed negative. The patient received antibiotics (doctor thought that the patient had Covid) as the treatment for the events. Outcome of the event was recovering. Vaccine Facility information and ethnicity information was available.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscular weakness, Pain in extremity
Clinical narrative: administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so painful unable to stretch it out or to lift anything with that hand; arm so painful unable to stretch it out or to lift anything with that hand; This is a spontaneous report from a contactable other hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3248, Expiration date: unknown),  dose 2 via an unspecified route of administration, administered in Arm Right on 08Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was administered the dose 1 on 22Dec2020 and dose 2 on 08Jan2021 (inappropriate schedule of product administration) with outcome of unknown). The patient has experienced severe pain where the patient is unable to stretch it out or to lift anything with that hand (pain in extremity) on 08Jan2021 with outcome of not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Investigation, Myalgia, Nasal congestion
Clinical narrative: Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm sore; Slight headache; This is a spontaneous report from a Pfizer sponsored program, Pfizer, received from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection Batch/Lot number and Exp Date: not reported), via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced minor symptoms like sore arm and slight headache on an unknown date, a day after she got the vaccine. Outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Eye irritation, Headache, Heart rate
Clinical narrative: sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Paraesthesia oral, Vaccination site pain
Clinical narrative: sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Taste disorder
Clinical narrative: my sense of taste became altered with everything tasting bland or bitter; administration date=12Jan2021, dose number=2/administration date=26Dec2020, dose number=1; This is a spontaneous report from a contactable nurse for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL 1284) via intramuscular route of administration in the right arm on 12Jan2021 18:30 at SINGLE DOSE for COVID-19 Immunization in the workplace clinic. The patient had no medical history. The patient's concomitant medications were not reported. The patient had allergies to doxycycline, ciprofloxacin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EK 9231) via intramuscular route of administration in the right arm on 26Dec2020 07:45 at SINGLE DOSE for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking second dose on 14Jan2021 08:00 the patient's sense of taste became altered with everything tasting bland or bitter. He has been told by workplace this was symptom and not a known side effect and to get COVID- 19 virus test, which was negative. The event assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent saliva test for COVID-19 on 15Jan2021 which was negative. Symptoms resolved on its own on 16Jan2021. The patient did not receive treatment. The outcome of the event was recovered on 16Jan2021 and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Vaccination site pain
Clinical narrative: fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches on my whole body; This is a spontaneous report from a contactable consumer reported for himself. A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3248, Expiration date was not reported), via an unspecified route of administration of left arm on 20Jan2021 10:45 as single dose for covid-19 immunisation. Relevant medical history reported as none. The patient concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Patient experienced muscle aches on whole body on 22Jan2021 12:15 am. 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 was not tested for COVID-19. Patient did not receive treatment for the adverse event. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: the patient woke up in the morning with right big toe- swelling, red and inflamed; the patient woke up in the morning with right big toe- swelling, red and inflamed; the patient woke up in the morning with right big toe- swelling, red and inflamed; This is as spontaneous report received from a contactable consumer (Patient). A 84-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263/Expiration date: unknown) via unspecified route on 27Jan2021, in the left shoulder as a single dose for COVID-19 immunization. Patient's medical history included regular flu shot about 2 months ago and reported that he doesn't hear very well was that he has been going on for years and prior to the vaccine. Concomitant medications were none. Family history were none. On 01Feb2021, the patient woke up in the morning with right big toe- swelling, red and inflamed which lasted for 12-15 hours. After multiple attempts to get caller to phone, on 01Feb2021 a call back was made to the patient however, allowed phone to ring for 1 minute and not answered. On 02Feb2021, the call was successful and further information was received. As of 02Feb2021 the events were healed. Clinical course of the event was as follows caller clarifies that the shot was administered on 27Jan2021 and he actually woke up at 1am on 01Feb2021 to his toe being inflamed and hurting. It doesn't hurt right now but he is not wearing any shoes and is just sitting there in socks. Caller doesn't know that he has ever gotten a Pfizer vaccine. The patient had no information on the facility the clinic who was providing the clinic. The events were not treated. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date were none. As of last observation events were not resolved. The outcome of the events was recovered.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling face
Clinical narrative: Swelling /inflammation of face on left cheek near nose; periorbital swelling around eye; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Arm Left on 30Jan2021 17:00 as single dose for covid-19 immunisation (age at vaccination 67 years) at Clinic. Medical history included sulfa drugs allergy, asthma, GERD (gastrooesophageal reflux disease), glaucoma, high BP (Blood pressure), hypothyroidism, depression. Concomitant medications the patient received within 2 weeks of vaccination included acetaminophen; albuterol sulfate; brimonidine tartrate. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 at 01:00 A.M, the patient experienced swelling /inflammation of face on left cheek near nose and another site as periorbital swelling around eye; both occurring on left side of face only. Patient spoke with triage nurse who indicated to use ice. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Case was reported as non-serious. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; headache; Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla; This is a spontaneous report from a contactable Other Health Professional. A 49-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 14:30 (Batch/Lot Number: EL8982) as single dose for covid-19 immunization.  Medical history included historical vaccine, dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 at 14:45 (Batch/Lot Number: EJ1685) as single dose for covid-19 immunization. Concomitant medication included lansoprazole (PREVACID) taken for an unspecified indication, from unspecified date. Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla on 02Jan2021 08:00 AM. The patient had fever and headache The patient was treated ibuprofen for fever and headache. The patient underwent lab tests and procedures which included, Nasal Swab (labcorp pixel): negative on 29Jan2021. Facility type vaccine is Clinic Name. The outcome Lymphadenopathy, axillary left arm. Mild for 1st dose, moderate-severe for 2nd dose, still present 13 days post 2nd dose. Mild lymphadenopathy other axilla was not recovered and outcome for fever and headache was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: if she put ice or heat compress in her injection site because of pain; This is a spontaneous report from a sponsored program via a contactable consumer (self). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller wanted to know if she put ice or heat compress in her injection site because of pain, after the 1st dose of Covid-19 vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pain, X-ray
Clinical narrative: mild reaction, soreness; Fatigue; mild reaction, soreness; This is a spontaneous report from a contactable physician. A 50-years-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Deltoid Right on 14Jan2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included Herniated Disc from 07Dec2017 to 14Mar2018, ongoing pain and inflammation. Concomitant medication included naproxen taken for pain, inflammation, from27Dec2020 to 01Jan2021 at a dose of 500 mg twice a day. The patient previously took first dose of BNT162B2 (Batch/Lot number:EK9231 and expiration date: 30Apr2021) Route of administration: Deltoid on 26Dec2020 at 12:40 for COVID-19 immunization/Front line worker and experienced fatigue, unable to lift arm 27Dec2020 AM. Unable to work and Afterward noticed increasing pain. The patient previously administrated Ibuprofen Motrin 600 mg prior to injection was given in Deltoid. The patient experienced mild reaction, soreness and fatigue on an unspecified date. The patient underwent lab tests and procedures which included x-ray: neg/no fracture on 07Jan2021 at urgent care to rule out. The outcome of the events was reported as unknown. Causality reported as a reasonable possibility that the events is related to suspect product.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: Left arm is sore at injection site; This is a spontaneous report received from a sponsored program. A contactable consumer (patient) reported that a 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, Expiry date 01Apr2021), via an unspecified route of administration on 19Jan2021 as single dose for COVID-19 immunization. Medical history included Cancer. Concomitant medication included palbociclib (IBRANCE) taken for neoplasm malignant, start and stop date were not reported. It was reported that patient had the first injection yesterday (19Jan2021) and she was doing great. She did not had any kind of reaction from it except her arm was a little bit sore. That was all, no big deal. But she have cancer and she was on old chemo called Ibrance and she did not inform vaccination providers of her taking Ibrance regularly wanted to know if she should have informed them. And was asking that, should she have to tell them and does it matter. When informed about Medical Information department, consumer stated, "That was okay. She mean, she was not going to sit and wait on the phone call any more. She was not having any kind of reaction or anything. Oncologist wanted her to have the shot. So, she guess she would have told. As such no treatment she just massaged it and she have taken Tylenol. No big deal. It was just barely sore. Patient stated, she do not know what they were. She just had to go to her oncologist. She had cancer. They always draw blood. she has no idea what it for was. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: her blood sugar up so high; This is a spontaneous report received from a Pfizer-sponsored Program. A contactable consumer (patient herself) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included type 1 diabetic. Concomitant medications were not reported. It was reported that the patient spoke to the two departments and did not wanted to be on hold again as she was on hold for 2.5 hour. It was further stated that she received her first dose of the Pfizer COVID vaccine last Friday and blood glucose went up so high. She wanted to know what is in the vaccine that made it go high. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Dizziness; Vomiting; Fever; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified medications. On 21Jan2021, consumer stated, "I got the Pfizer vaccine on Thursday (21Jan2021) at 13:00 and I started having at 13:23 I started having nausea and a little dizziness and then I have had nausea and vomiting twice but nausea was constant. On an unspecified date in Jan2021, the patient had fever. Consumer stated, I am kind of dizzy. So, I got to walk slow. Therapeutic measures were taken as a result of events included pepcid for nausea and Tylenol for fever. The consumer stated, "I am really having side effects. I thought it is going way. And I wanted to know how long I would have side effects." The outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling unwell like the flu/awful; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) intramuscularly on 21Jan2021 at single dose in left arm for COVID-19 Immunization. Medical history and Concomitant medications were not reported. It was reported that she wanted to report reaction to Pfizer Covid 19 vaccine. stated she was very tired, headache, muscle pain, joint pain, nausea, feeling unwell like the flu. Was injected on 21Jan2021 and this started on 22Jan2021. stated that it has been awful since then. Is her first shot. Stated that since she had such a bad time with the first one should she get the second one. stated that the outcome of feeling very tired and muscle pain varies and cannot be directly determined. Stated that feeling very tired and muscle pain is ongoing. Treatment was reported as none. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling unwell like the flu/awful; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) intramuscularly on 21Jan2021 at single dose in left arm for COVID-19 Immunization. Medical history and Concomitant medications were not reported. It was reported that she wanted to report reaction to Pfizer Covid 19 vaccine. stated she was very tired, headache, muscle pain, joint pain, nausea, feeling unwell like the flu. Was injected on 21Jan2021 and this started on 22Jan2021. stated that it has been awful since then. Is her first shot. Stated that since she had such a bad time with the first one should she get the second one. stated that the outcome of feeling very tired and muscle pain varies and cannot be directly determined. Stated that feeling very tired and muscle pain is ongoing. Treatment was reported as none. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Chills; Headache; Nausea; Sore arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number; not provided) reason for no lot number; caller unwilling to complete the report, is COVID vaccine a Pfizer product, COVID vaccine manufacturer; unspecified, NDC number, expiry date; not provided via an unspecified route of administration from an unknown date in Jan2021 to an unknown date in Jan2021 at single dose (dose number; 1) for covid-19 immunization. Patient's medical history and concomitant medications were not reported. Patient experienced chills, headache, nausea and sore arm on an unknown date in Jan2021 to unspecified. Caller, who is reporting on the COVID vaccine explains that she had the shot 2 weeks ago. Also it is noted that 7 months ago the virus. After she got the first shot she had chills, headache, and nausea. She reports that she took Advil. It is also relayed she had a sore arm for 3 days but that is gone now. The caller wants to know for the second shot, can she take Advil afterwards. The outcome of sore arm was recovered on an unknown date and for other events was unknown. Investigation assessment was not provided.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral viral infection
Clinical narrative: virus in the mouth; This is a spontaneous report received from a contactable consumer (reporting for herself) via sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date not reported), via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had the first dose of Covid 19 Vaccine 18Jan2021. and second dose was scheduled for 08Feb2021 and on the 30Jan2021 (Saturday), she experienced a problem with her mouth. Went to find out what was the problem, Dentist said that it was some kind of a virus in the mouth and it will clear up by itself and no medications needed, but the Caller (patient) was just letting us know about this situation because she really wants to take the second dose on the 08Feb2021. She was feeling good and no side effects just like what they read in the fact sheet. She was worried because there are enough doses left in their facility. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 16:30 (Batch/Lot Number: EK9231) as single dose for an Covid-19 immunization.The patient had none medical his-tory There were no concomitant medications.Calling about the Covid-19 Vaccine she states that she got her 1st dose yesterday, 28Jan2021. About 15 minutes after, she got an odd metallic taste in her mouth that she still has. she enquired that this is not a side effect that was listed.Vaccination Facility type is Hospital.The outcome was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Malaise, Nausea, Pain
Clinical narrative: not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration, administered left arm on 19Jan2021 09:30 AM (at the age of 70-years-old) at single dose for covid-19 immunization. The patient was not pregnant. Other vaccine details were First dose Pfizer biotech Covid-19 vaccine EUA with vaccination date 26Jan2021 (Other vaccine same date vaccine date) at left arm. Patient's medical history included 6 months post chemo for lymphoma. No known allergies reported. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 27Jan2021 01:00 AM the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. The outcome of event was recovering.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration, administered left arm on 19Jan2021 09:30 AM (at the age of 70-years-old) at single dose for covid-19 immunization. The patient was not pregnant. Other vaccine details were First dose Pfizer biotech Covid-19 vaccine EUA with vaccination date 26Jan2021 (Other vaccine same date vaccine date) at left arm. Patient's medical history included 6 months post chemo for lymphoma. No known allergies reported. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 27Jan2021 01:00 AM the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. The outcome of event was recovering.  Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: My face started swelling, itching, red; My face started swelling, itching, red; My face started swelling, itching, red; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient receivedfirst dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982), via intramuscular route of administration, in the left arm on 27Jan2021 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive concomitant medications. The patient did not underwent any lab investigation. Consumer stated, "I am just reporting that I did had a reaction slight reaction to the Shot, Pfizer Shot that I received two days ago. It came about approximately 8 hours after I had the shot my face started swelling, itching, red, so I took couple Benadryl at night, got up the next morning and it was still really swollen, itchy, red. So, I have been on the Benadryl for the last two days. When I got up this morning it is considerably better but I just wanted to let you know that there was a reaction, I am assuming that's probably but easiest way to handle it just take Benadryl until it goes away. Is that correct?". When paraphrased the above concern, consumer stated, "I have already taken Benadryl and it helped and I am just kind of wondering how this will probably last?". Consumer stated, "Well it is getting better, I mean I don't need to go to the doctor. I just want to make a report because I know you are trying to get all the information you can on vaccination." Consumer stated, "Just when I took it or they gave it to me, is that what you want? 27Jan2021, that is when I received the shot." Consumer added, "I haven't received the second one yet. It's due in February." Outcome of the events were recovering.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dyspepsia, Eructation, Gastric disorder
Clinical narrative: Stomach started having problem like souring like tingling or agitating; Belching; Sensitive stomach; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL1283, expiry date; Apr2021), Is COVID-19 Vaccine a Pfizer product; yes, COVID-19 Vaccine manufacturer; unspecified, NDC number, UPC number; unknown via an unspecified route of administration from 28Jan2021 to 28Jan2021 at single dose (dose number; 1) for covid-19 immunization, l-methylfolate, batch/lot number; unknown, Is L-methylfolate a Pfizer product, L-methylfolate manufacturer; unspecified, NDC number, UPC number; unknown, reason for no lot number: of L-methylfolate: complaint identified after call completed, expiry date; unknown via an unspecified route of administration from 29Jan2021 to an unspecified date at unknown doe and frequency for an unspecified indication. The patient was 73 years old at the time of vaccination with weight; 75.75 kg and height as 173 cm. Patient's medical history included COPD (Chronic obstructive pulmonary disease), two stents in my heart and defibrillator (dates unspecified). Concomitant medications included Carvedilol (therapy dates, indication; unspecified). On 29Jan2021, patient experienced stomach started having problem like souring like tingling or agitating, belching and sensitive stomach. Consumer stated, "Have you all had any call about vitamin or L-methylfolate reacting with it. Have you had anyone called about vitamins or L-methylfolate reacting with it?" Consumer added, "I took it yesterday at noon the vaccine (Clarified as Pfizer COVID-19 Vaccine) but this morning when I took L-methylfolate, you know the vitamin B capsule (Captured as L-methylfolate), my stomach started having problem like souring like tingling or agitating or whatever you know, belching a little bit, so I am asking has anybody else reported that. It is kind of confusing, its 'sour' kind of tasted. I just want to know has anybody else called. I guess I should stop taking (L-methylfolate) that until what, three weeks or so. Consumer stated, "It's like tingling like sour stomach and belching. You know sour stomach, belching you know. It's not nausea. I got sensitive stomach anyway." Consumer added, "I have two stents in my heart and defibrillator." Consumer was informed. Consumer further added, "I was just asking if you have anybody else report the same thing. I do not think it is an emergency but I do not know if this is bothering somebody else. I will stop taking (incomplete sentence)". The outcome of events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Gingival pain, Oral pain, Pain in jaw, Toothache
Clinical narrative: Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered  Information on Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered  Information on Lot/Batch number has been requested.