chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout flare ups during the 2 covid vaccines; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 20Jan2021 10:30 AM (at the age of 46-years-old) as single dose for Covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 10Feb2021 10:30 AM (at the age of 46-years-old) as single dose for Covid-19 immunization. The patient's medical history included hypertension from an unknown date and unknown if ongoing and and ongoing gout. The patient's concomitant medications were not reported. On 23Jan2021, the patient got gout flare ups during the 2 covid vaccines and no treatment received. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache it aches very pain; headache it aches very pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache it aches very pain. It was reported by the patient that "The patient had the second vaccine on the 8th of February and now the (inaudible) was ok but headache it aches very pain. Explained how took 3 pills of Tylenol a day but still had headache". Therapeutic measures were taken as a result of headache it aches very pain, treatment received with 3 pills of Tylenol a day. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever 99.8F; Body aches; Headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 24-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported),via an unspecified route of administration, administered in Arm Left on 16Feb2021 07:45 at the age of 24 years old,as Dose 2,single for covid-19 immunization.The patient medical history was not reported.There were no concomitant medications.The patient experienced fever 99.8f, body aches and  headache on 16Feb2021 16:00.The patient underwent lab tests and procedures which included body temperature: 99.8 fahrenheit on 16Feb2021.The patient received no treatment for the adverse event.The patient had no allergies.The patient was not tested for covid19 post vaccination and not diagnosed with covid prior vaccination.The outcome of the event was resolving.The patient had not received any other vaccines within 4 weeks before taking covid vaccination.The patient had not received any medication in 2 weeks.The adverse event doesn't result in patient emergency room or physician clinic visit.  Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I had a sore arm and a low grade fever for approximately 48 hours; I had a sore arm and a low grade fever for approximately 48 hours; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 26-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 15Feb2021 12:00 as dose 2, single (at the age of 26-years-old) for COVID-19 immunization. Facility type vaccine was reported as Workplace clinic. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination. Patient was not tested for COVID-19, post the vaccination. Patient was not a pregnant at the time of vaccination. Patient medical history included asthma. The concomitant therapy included birth control pills. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in right arm on 25Jan2021 12:00 for COVID-19 immunization. The patient experienced sore arm and a low-grade fever for approximately 48 hours on 15Feb2021. Patient did not receive any treatment for the adverse events. The outcome of event was resolved on 17Feb2021.     No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Heart rate, Heart rate increased
Clinical narrative: his heart rate didn't go below 89; cold chills; very tired; lack of energy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN) and clopidogrel bisulfate (PLAVIX). Historical vaccine includes first dose of BNT162B2 for covid-19 immunization and experienced no side effects. The patient reported, he received the second dose of Covid 19 vaccine on Thursday, he takes aspirin and Plavix regularly, he took them the morning he received the vaccine, the following day he had cold chills, was feeling very tired, and lack of energy, his heart rate didn't go below 89, it lasted one day. On Friday he was dried out, on Saturday he started to feel better and on Sunday his heart rate was on 70s-60s. The patient underwent lab tests and procedures which included heart rate: didn't go below 89, heart rate: 70s-60s on an unspecified date. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Toothache
Clinical narrative: That night she had a sore arm; molar hurt; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that night she had a sore arm leading to pain in extremity and her molar hurt leading to toothache on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this with Tylenol. She also wants to know if she can go on an antibiotic for her toothache.   Follow-up (11Feb2021): This is a follow up spontaneous report from a Pfizer sponsored program. A contactable consumer reported that:She had eaten popcorn and tooth had cracked. Was reading online and it said not to take Tylenol, Advil or anything. Wasn't sure about Benadryl. Said had to get up in middle of night and took 1 extra strength Tylenol. It did help but worried it will affect vaccine. Wanted to know what is suggested.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: swelling tongue; bottom lip was numb; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program Covax US Support. A female patient of an unspecified age 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 on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced swelling tongue, bottom lip was numb. Verbatim and event description: Reporter received first dose and experienced swelling tongue and bottom lip was numb for about 30 min Facility doesn't want to give her the second dose because of it, what should she do. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took warfarin. On an unspecified date patient experienced since having her 1st vaccination, her inr levels have gone to critical levels requiring vitamin k (international normalised ratio increased). The patient underwent lab tests which included international normalised ratio: had consistent inr levels within therapeutic range on had consistent INR levels within therapeutic range per her physicians preference , international normalised ratio: her inr levels have gone to critical levels on Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K on 2 separate dates. Therapeutic measures were taken as a result of event. I am inquiring about the possibility of the Pfizer COVID-19 vaccine affecting a patients INR levels. I currently work in an Assisted Living and have a resident who is on warfarin and previous to getting her COVID vaccination, had consistent INR levels within therapeutic range per her physicians preference. Since having her 1st vaccination, her INR levels have gone to critical levels requiring Vitamin K on 2 separate dates. We have investigated all other possibilities for this unusual INR increase and have came up with no other explanation being found. I would greatly appreciate any information/insight you may be able to give me. The outcome of event was unknown.  Information on lot number/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: pain on kidney; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had first Pfizer dose on 10th. On an unknown date, the patient experienced the pain on kidney but stated that it was not related to the vaccine. The patient was asked for percentage of swelling. The outcome of the event was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller received vaccine last Tuesday and was sick; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced caller received vaccine last tuesday and was sick. She was told she can still get it, she still feels sick and was wondeing if thats okay. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Technician was given the vaccine that was dosed twice; This is a spontaneous report from Regulatory Authority.  A patient of unspecified age and gender received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Pharmacy tech has concern with covid vaccine. Technician was given the vaccine that was dosed twice on an unspecified date. the event outcome was Unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: feeling achy; fever; sore arm; Muscle ache; feeling Lousy; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:30 as single dose for covid-19 immunization (71 years at the age of vaccination). Medical history included High Blood pressure, Arthritis both from an unknown date and unknown if ongoing. There were no concomitant medications. Family Medical history included heart problems (Both of her parents had heart problems).Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in Arm Left on 26Jan2021 as single dose for covid-19 immunization and experienced Sore arm. Patient did not receive other vaccines on the same day or in the 4-week period prior to vaccination. It was reported that mother received second dose yesterday and last night developed fever, feeling achy, took extra strength tylenol and been using ice. Patient wanted to know Is it okay to continue using Tylenol.  The patient experienced feeling achy on 16Feb2021, feeling lousy on Feb2021, fever, sore arm and  muscle ache on 16Feb2021. it was reported that patient had her last shot yesterday and so did her daughter. They both had muscle aches. patient had a fever and was achy. Her daughter had flu like symptoms. Caller stated that she herself has a sore arm and used ice on it. Both her and her daughter are feeling Lousy. Patient had her first shot and had little sore arm, but this time with the second shot both her and her daughter felt bad. her daughter has been on the couch. daughter on the couch. The patient underwent lab tests and procedures which included weight: she lost 46lbs lbs. Therapeutic measures were taken as a result of fever, feeling achy, muscle ache. Sore arm. The outcome for the events was reported as unknown at the time of this report.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: feeling achy; fever; sore arm; Muscle ache; feeling Lousy; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:30 as single dose for covid-19 immunization (71 years at the age of vaccination). Medical history included High Blood pressure, Arthritis both from an unknown date and unknown if ongoing. There were no concomitant medications. Family Medical history included heart problems (Both of her parents had heart problems).Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration, administered in Arm Left on 26Jan2021 as single dose for covid-19 immunization and experienced Sore arm. Patient did not receive other vaccines on the same day or in the 4-week period prior to vaccination. It was reported that mother received second dose yesterday and last night developed fever, feeling achy, took extra strength tylenol and been using ice. Patient wanted to know Is it okay to continue using Tylenol.  The patient experienced feeling achy on 16Feb2021, feeling lousy on Feb2021, fever, sore arm and  muscle ache on 16Feb2021. it was reported that patient had her last shot yesterday and so did her daughter. They both had muscle aches. patient had a fever and was achy. Her daughter had flu like symptoms. Caller stated that she herself has a sore arm and used ice on it. Both her and her daughter are feeling Lousy. Patient had her first shot and had little sore arm, but this time with the second shot both her and her daughter felt bad. her daughter has been on the couch. daughter on the couch. The patient underwent lab tests and procedures which included weight: she lost 46lbs lbs. Therapeutic measures were taken as a result of fever, feeling achy, muscle ache. Sore arm. The outcome for the events was reported as unknown at the time of this report.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: bunch of energy; This is a spontaneous report from a contactable consumer or other non-hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bunch of energy on an unspecified date. Caller reported that, he had both doses of COVID vaccine and said he did not have any side effects. The vaccine gave him a bunch of energy and he was calling to report that. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: extreme joint pain; muscle pain; headache; nausea; chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 74 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EL9262; Expiration Date: May2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing autoimmune thyroiditis Hashimoto's thyroiditis , ongoing osteoarthritis. Concomitant medication(s) included meloxicam (MELOXICAM) taken for osteoarthritis, start and stop date were not reported. The recipient discontinue Meloxicam 2-3 days before immunization.The patient experienced extreme joint pain, muscle pain, headache, nausea and chills on 04Feb2021 with outcome of recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Pain in extremity
Clinical narrative: throat starts getting dry; sore arm; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date in Feb2021 at around 2-3am, patient throat started getting dry and she experienced sore arm all through night until morning when got up had sharp pain under her arm. Patient asked what type of pain reliever she could take. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: persistent runny nose; Pain in joints; left arm joint and deep tendon pain extends from the shoulder to the arm and hand.; left arm joint and deep tendon pain extends from the shoulder to the arm and hand.; Also joint pain in left hip, right hip. both knees.; Also joint pain in left hip, right hip. both knees.; This is a spontaneous report from a contactable Nurse(patient). A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL3302), via an unspecified route of administration on 28Jan2021 at 07:15 (at the ag e of 64-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history of the patient included osteoporosis and arthritis. The know allergies were reported as Sulfa. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested negative with covid-19. On 06Feb2021 at 12:00, the patient experienced persistent runny nose, pain in joints, left arm joint and deep tendon pain extends from the shoulder to the arm and hand, also joint pain in left hip, right hip. both knees. The patient underwent lab tests and procedures which included Nasal Swab sars-cov-2 test: negative on 01Feb2021. The outcome of the events was reported as not resolved.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: has a mild fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable male consumer (patient, age unspecified) reported that he received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 10Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that patient was wondering if he had virus or if it's just side effects. On an unspecified date in Feb2021, the patient experienced has a mild fever. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: reported experiencing high fever; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 for covid-19 immunisation. On an unspecified date the patient experienced reported experiencing high fever. Description of the event, comment, or concern as provided by the reporter: Employees received the 2nd dose of the Pfizer COVID-19 vaccine. Following the dose said employees reported experiencing high fever to their employer. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle strength abnormal, Pain in extremity, Pyrexia
Clinical narrative: No muscle strength to stand or walk or even move her legs; High fever; Shivering from head to toe; Sore arm; This is a spontaneous report from a contactable consumer. A 78-years-old female patient (mother) received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller was calling in behalf of her mom who has been experiencing side effects after getting the second dose yesterday on 16Feb2021. The patient had no muscle strength to stand or walk or even move her legs, high fever, shivering from head to toe, sore arm. They have not reported the side effects yet. asking for guidance on what to do. The outcome of event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Axillary and neck rashes; This is a spontaneous report from a contactable other hcp. A 25-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 03Feb2021 (age at vaccination 25years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Topical antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in 2 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced axillary and neck rashes on 05Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The patient received treatment for the adverse events with hydrocortisone. The clinical outcome of the event was re-covering. Therapeutic measures were taken as a result of axillary and neck rashes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Flat splotchy non-itchy red rash across upper abdomen; This is a spontaneous report received from a contactable other hcp. A 46-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported),via an unspecified route of administration, administered in Arm Left on 15Feb2021 15:30,at the age of 46 years old,as Dose 2,single for covid-19 immunization.Medical history included asthma,osteoporosis,anxiety,attention deficit hyperactivity disorder and food allergy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took bnt162b2 for covid-19 immunisation, biaxin and bactrian [cetrimonium bromide] and experienced drug hypersensitivity.The patient experienced flat splotchy non-itchy red rash across upper abdomen on 17Feb2021 05:00.The patient didn't receive any treatment for the adverse event.The patient was not tested for covid19 prior vaccination and not tested prior vaccination.The patient had not received any other vaccine within 4 weeks prior to covid19 vaccine.The outcome of the event was not recovered.  Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left Side of the face numbness; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, at age of vaccination 49 years), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EL9266) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took when she was younger, she had an allergic reaction to Erythromycin but later on in life she had product with Erythromycin and was fine with no problems, so she doesn't know. She had no Lot or Expiry for Erythromycin. Caller stated that she was calling about the Covid Vaccine, she just took it, and an half an hour later when she got into her car, she started feeling numbness as if like when going to the dentist and when they give Novocain or something. Her left cheek and eye lid were numb. She wanted to know if this was considered a normal side effect or if this was an allergic side effect. She was a Teacher. Her first dose was on 17Feb2021 at either 12:10 or 12:15 noon, the numbness was about a half hour later, close to 1PM. Caller stated that she hasn't seen anybody with this side effect. She was not worse; she was a little better, but it was still there. When queried for product details caller stated that just wanted to know if she should be taking Benadryl or if this is an allergic reaction, she would love to sit here on the phone all day, but she had already sat on the phone for an hour and a half waiting. She just wanted to know she was not getting paralyzed or something here. Caller wished to end safety report here and wanted to be transferred for her question. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Eye pain, Eye pruritus, Fatigue
Clinical narrative: on-going fatigue; Eye issues started on day 3:  light sensitivity; eye soreness; itchy eye; burning feeling in eye; Have some chills; headache; This is a spontaneous report from a contactable consumer or other non hcp reported about herself (patient).    A 80-year-old female patient received bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL9262), via an unspecified route of administration, administered in left arm as dose number unknown, single on 10Feb2021 (at the age of 80-year-old) for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's medical history included atrial tachycardia and no known allergies. Concomitant medications included flecainide, losartan, diltiazem and ropinirole all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medication within 2 weeks of vaccination: flecainide, losartan, diltiazem and ropinirole. On 12Feb2021, the patient experienced fatigue starting next day, eye issues started on day 3: Light sensitivity, soreness, itchy, burning feeling and had some chills, headache, on-going fatigue. No therapeutic measures were taken as a result of events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for nasal swab COVID-19 POC was negative on 17Feb2021. Lab tests and procedures which included SARS-COV-2 test: negative on 17Feb2021. At the time of this report, outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Photophobia, SARS-CoV-2 test
Clinical narrative: on-going fatigue; Eye issues started on day 3:  light sensitivity; eye soreness; itchy eye; burning feeling in eye; Have some chills; headache; This is a spontaneous report from a contactable consumer or other non hcp reported about herself (patient).    A 80-year-old female patient received bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL9262), via an unspecified route of administration, administered in left arm as dose number unknown, single on 10Feb2021 (at the age of 80-year-old) for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's medical history included atrial tachycardia and no known allergies. Concomitant medications included flecainide, losartan, diltiazem and ropinirole all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medication within 2 weeks of vaccination: flecainide, losartan, diltiazem and ropinirole. On 12Feb2021, the patient experienced fatigue starting next day, eye issues started on day 3: Light sensitivity, soreness, itchy, burning feeling and had some chills, headache, on-going fatigue. No therapeutic measures were taken as a result of events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for nasal swab COVID-19 POC was negative on 17Feb2021. Lab tests and procedures which included SARS-COV-2 test: negative on 17Feb2021. At the time of this report, outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: lymph node swelling both armpits; Pins and needles under both forearms; Right arm swelling; pain; Left chest wall swelling; This is a spontaneous report from a contactable consumer, the patient. A 83-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration, administered in the arm right on 02Feb2021 13:15 as dose 1, single (at the age of 83-years-old) for covid-19 immunization. Medical history included left mastectomy, stroke, ongoing high blood pressure, pacemaker and allergies to penicillin, simvastatin, hydrochlorothiazide and letrozole. The patient did not have thyroid. Concomitant medications included apixaban, rosuvastatin, chlorthalidone and thyroid (ARMOUR THYROID). On 04Feb2021, the patient experienced right arm swelling. Pain and lymph node swelling both armpits. Left chest wall swelling and pain. Pins and needles under both forearms. Symptoms developed and had persisted. The patient performed mammogram and ultrasound for the events. The patient visited the doctor or other healthcare professional office/clinic. The patient did not receive the any other vaccine in four weeks. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. Therapeutic measures were taken for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound testes
Clinical narrative: lymph node swelling both armpits; Pins and needles under both forearms; Right arm swelling; pain; Left chest wall swelling; This is a spontaneous report from a contactable consumer, the patient. A 83-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration, administered in the arm right on 02Feb2021 13:15 as dose 1, single (at the age of 83-years-old) for covid-19 immunization. Medical history included left mastectomy, stroke, ongoing high blood pressure, pacemaker and allergies to penicillin, simvastatin, hydrochlorothiazide and letrozole. The patient did not have thyroid. Concomitant medications included apixaban, rosuvastatin, chlorthalidone and thyroid (ARMOUR THYROID). On 04Feb2021, the patient experienced right arm swelling. Pain and lymph node swelling both armpits. Left chest wall swelling and pain. Pins and needles under both forearms. Symptoms developed and had persisted. The patient performed mammogram and ultrasound for the events. The patient visited the doctor or other healthcare professional office/clinic. The patient did not receive the any other vaccine in four weeks. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. Therapeutic measures were taken for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for an Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller was calling on behalf of her neighbour. She said her neighbour was supposed to get the second dose of Vaccine today but was not able to get it because her neighbour was experiencing severe back pain. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dizziness, Headache
Clinical narrative: felt very dizzy; severe headache for 2-3 days; lips turned blue but returned to normal color an hour later; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:15 (at the age of 23-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced felt very dizzy, severe headache for 2-3 days, lips turned blue but returned to normal color an hour later. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received as a result of events. The outcome of the events felt very dizzy, severe headache for 2-3 days were recovering, lips turned blue but returned to normal color an hour later was recovered on an unspecified date in 2021.    Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rash, Vein disorder
Clinical narrative: sort of a rash on my toes its like that COVID, it almost like kill veins; sort of a rash on my toes its like that COVID, it almost like kill veins; It' painful; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. The patient experienced sort of a rash on the toes its like that covid, it almost like kill veins its painful on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Lymph node issues (upper right clavicle area). Painful and swollen.; Feverish; extreme fatigue; Lymph node issues (upper right clavicle area). Painful and swollen.; This is a spontaneous report from a contactable other health care professional (patient).   A 63-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EJ1683) via intramuscularly on 08Jan2021 08:15 AM (at the age of 63-year-old) on right arm as a dose 2, single for COVID-19 immunization. Patient previously received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), as a dose 1, single for COVID-19 immunization. The patient medical history included hyperlipidemia. Patient was allergic to Sulfa Drugs, Cephalexin, Statins. The concomitant medication in two weeks included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), vitamin B complex (VITAMIN B), vitamin C ascorbic acid (VITAMIN C ASCORBIC ACID), and vitamin D3 (VITAMIN D3). The patient did not receive any other vaccines within four weeks. patient was not tested to covid post vaccination and doesnt had COVID prior vaccination. On 09Jan2021 10:30 AM, patient experienced Lymph node issues (upper right clavicle area). Painful and swollen. Feverish and extreme fatigue. Patient had not received any treatment for the events. Patient was visited to doctor or other healthcare professional office/clinic. Outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Intense chills; high fever of 102; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262) via an unspecified route of administration in Arm Right on 10Feb2021 10:15 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation at workplace clinic. Medical history included diabetes, high blood pressure, cholesterol, quadruple bypass, defibrillator, 1 eye, allergies to statin medication. Concomitant medication(s) included clopidogrel (CLOPIDOGREL), captopril (CAPTOPRIL), glipizide (GLIPIZIDE), metformin (METFORMIN), all taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. On 15Feb2021 02:00 the patient experienced intense chills, high fever of 102, which lasted for 6 hours. Disappeared after taking 2 extra strength tylenol. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 15Feb2021. Therapeutic measures were taken as a result of intense chills, high fever of 102. Outcome of all the events were recovered on 15Feb2021 08:00.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Neck pain, Pyrexia
Clinical narrative: 3rd day my joints, neck and back hurt for the next 3 days; 3rd day my joints, neck and back hurt for the next 3 days; 3rd day my joints, neck and back hurt for the next 3 days; feeling like I was going to get fever; cheeks and ears turned red and hot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3249 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Jan2021 at 12:00 PM (age at vaccination: 45 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's, lichen planopilaris, stroke, brain aneurysm, degenerate disc disease, and adhesive, dust, mold, mildew allergy. The past drug included Morphine and Darvocet which had allergies. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on first night she started feeling like she was going to get a fever, cheeks and ears turned red and hot. Took temp but not out of ordinary. Second night she was fine. On 3rd day her joints, neck and back hurt for the next 3 days on 28Jan2021 at 06:00 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered with lasting effects or sequel on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: chills; body aches; 102.3 degree fever; headache; This is a spontaneous report from a contactable other healthcare professional. A 27-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00 (Batch/Lot Number: EN6201) (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included generalised anxiety disorder. There were no known allergies reported. Concomitant medications included dicyclomine, fish oil, iron and acetylcysteine (NAC 500). All taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 10:00 (Batch/Lot Number: EL8982) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. The patient did not have covid prior to vaccination and was not tested for covid since vaccination. On 16Feb2021 12:30, the patient experienced headache, chills, body aches and 102.3 degree fever. It was reported that exactly 13 and a half hours after receiving second vaccine, the patient developed sever chills and at about 15 hours she developed significant body aches and a 102.3 degree fever. The fever continued for the remainder of the day and fell below 100 only twice. 48 hours after the second vaccine the ppatient still have a severe headache. However, the body aches and headache seem to have subsided. Laboratory tests included body temperature: 102.3 degree. The clinical outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot
Clinical narrative: At first feeling "hot" inside and then at night total body ache(joint/muscle); feeling "hot" inside; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 47 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 10:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced at first feeling "hot" inside and then at night total body ache joint or muscle on 13Feb2021 23:00 with outcome of recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained