chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza, Migraine, Nasopharyngitis
Clinical narrative: cold; flu symptoms; arm soreness at the injection site; nausea; diarrhea/at least one loose stool daily; aches and pains; wicked headache that was a Migraine at first and now an intermittent headache; wicked headache that was a Migraine at first; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 56-year-old female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 31Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 56-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the vaccination on 31Aug2021, an hour after, the patient experienced a wicked headache that was a Migraine at first. On an unknown date, the patient had now an intermittent headache, cold and flu symptoms that subsided after a few days, arm soreness at the injection site that also subsided after a few days. The patient has also experienced nausea and diarrhea, at least one loose stool daily and aches and pains that was not improving. The patient asking as these were symptoms for the COVID-19 Virus and how long do it side effects. The outcome of events cold, flu symptoms, arm soreness at the injection site reported as recovered on Aug2021, for outcome for events diarrhea/at least one loose stool daily and aches and pains were reported as not recovered and for other events it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: cold; flu symptoms; arm soreness at the injection site; nausea; diarrhea/at least one loose stool daily; aches and pains; wicked headache that was a Migraine at first and now an intermittent headache; wicked headache that was a Migraine at first; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 56-year-old female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 31Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 56-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the vaccination on 31Aug2021, an hour after, the patient experienced a wicked headache that was a Migraine at first. On an unknown date, the patient had now an intermittent headache, cold and flu symptoms that subsided after a few days, arm soreness at the injection site that also subsided after a few days. The patient has also experienced nausea and diarrhea, at least one loose stool daily and aches and pains that was not improving. The patient asking as these were symptoms for the COVID-19 Virus and how long do it side effects. The outcome of events cold, flu symptoms, arm soreness at the injection site reported as recovered on Aug2021, for outcome for events diarrhea/at least one loose stool daily and aches and pains were reported as not recovered and for other events it was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash, Swelling face
Clinical narrative: a bad rash around 1/2 his face and in his eye; shingles; a bad rash around 1/2 his face and in his eye; his face swelled up bad; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 36-year-old male patient.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), as dose 1, single for covid-19 immunisation. On an unspecified date on 2021, days after getting the 2nd dose of Pfizer his face swelled up bad and a bad rash around 1/2 his face and in his eye. The patient's doctor said it was shingles. He had to be given viral medications to help heal it. He still suffers from it and he's only 36 years old. Therapeutic measures taken as result of events. The outcome of events were not recovered.  The response included We have received an adverse drug event report in which your product, covID-19 Vaccine, has been identified as a suspect drug. In accordance with FDA guidelines, we are forwarding the attached information to you for your action as appropriate. fwe receive additional relevant details pertaining to this case, we will forward the information to you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Vaccination site swelling
Clinical narrative: the injection site was swollen the next day; i couldn't get hurt to touch the arm; right after the shot i had a tingling tongue for the whole day; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: fc3184 and expiry date: not reported) via an unspecified route of administration on 02Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient stated that, right after the shot I had a tingling tongue for the whole day on 02sep2021 and the injection site was swollen the next day, I couldn't get hurt to touch the arm on 03sep2021. Outcome of the event right after the shot I had a tingling tongue for the whole day was recovered on an unspecified date 2021 and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX Support. This consumer reported similar events for four patients. This is one of four reports.  A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that he has been doing some research on the amount of people who have died from taking the COVID-19 vaccine and what adverse events they have had after receiving the vaccine. He stated that he has personally gone to 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine but stated he didn't know whether they were Moderna or Pfizer or (Company name withheld) and he doesn't know one person who has died from the actual virus. He just wanted information. The patient died on an unspecified date.  It was not reported if an autopsy was performed.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101252919 same reporter/drug/AE, different patient;US-PFIZER INC-202101252918 same reporter/drug/AE, different patient;US-PFIZER INC-202101252916 same reporter/drug/AE, different patient;US-PFIZER INC-202101252917 same reporter/drug/AE, different patient; Reported Cause(s) of Death: 4 funerals of people who have died 3 to four days after getting the COVID-19 vaccine
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Then somebody else broke out into shingles on the second day; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a patient. A patient with an unspecified gender and age received bnt162b2 (PFIZER-BIOINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown) via unknown route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date, it was reported that then somebody else broke out into shingles on the second day. At the time of this report the outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 4, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Sep 2021, patient experienced dizziness, a higher resting heart rate than normal, heavy brain fog and memory loss. Patient wanted to know if these side effects were previously reported. She also asked if she could get the second dose after a reaction with first dose. Lastly, she asked how much was the protection from COVID-19 prevention to being hospitalized; with receiving only the first dose of the vaccine. The outcome of the events unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral, Swollen tongue
Clinical narrative: tingling and swelling of tongue; tingling and swelling of tongue; lightheadedness; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer First Connect. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on an unspecified date, dose 1, single for COVID-19 immunisation. Medical history included severe allergic reaction to contrast dye that used for a CAT scan to check her lungs. The patient's concomitant medications were not reported. The patient asked about the ingredients before she gets the COVID vaccine on 02Feb2021. The patient was scheduled to get the vaccine on 02Feb2021. The patient had a severe allergic reaction to contrast dye that was used for a CAT scan to check her lungs and she wanted to make sure the ingredients in the vaccine were not similar to ingredients in contrast dye. The patient asked if it was okay to take the vaccine. The patient did not know what the ingredients were in the contrast dye. The patient's doctor said it should be fine to get the vaccine. On 02Feb2021, the patient experienced tingling and swelling of tongue, lightheadedness. The patient was not admitted to the hospital for the event. No treatment was received for the events. The patient was fine from the events as of this report. The outcome of the events was recovered in Feb2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Chills, Fatigue, Pain
Clinical narrative: my armpit started hurting; I had a lump about the size of a ping pong ball in my armpit; Felt a little achy; tired; chills; The first night arm was quite sore; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 64 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 11:30 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation, received historical vaccine bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:30 (Batch/Lot Number: EL9261) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced a little achy on 19Feb2021 19:00 with outcome of recovering, tiredness causing fatigue on 19Feb2021 19:00 with outcome of recovering, chills on 19Feb2021 19:00 with outcome of recovering, the first night arm was quite sore causing pain in extremity on 19Feb2021 19:00 with outcome of recovering, her armpit started hurting causing axillary pain on 20Feb2021 19:00 with outcome of recovering, she had a lump about the size of a ping pong ball in her armpit causing axillary mass on 20Feb2021 19:00 with outcome of recovering.    Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my armpit started hurting; I had a lump about the size of a ping pong ball in my armpit; Felt a little achy; tired; chills; The first night arm was quite sore; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 64 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 11:30 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation, received historical vaccine bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:30 (Batch/Lot Number: EL9261) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced a little achy on 19Feb2021 19:00 with outcome of recovering, tiredness causing fatigue on 19Feb2021 19:00 with outcome of recovering, chills on 19Feb2021 19:00 with outcome of recovering, the first night arm was quite sore causing pain in extremity on 19Feb2021 19:00 with outcome of recovering, her armpit started hurting causing axillary pain on 20Feb2021 19:00 with outcome of recovering, she had a lump about the size of a ping pong ball in her armpit causing axillary mass on 20Feb2021 19:00 with outcome of recovering.    Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Middle insomnia, Rash
Clinical narrative: I woke at 3:00 am; Rash on my face neck and arms/Covered in the rash everywhere; my stomach was hurting; This is a spontaneous report from a contactable other health care professional (patient). A female patient of an unspecified age (reported as 41) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 26Feb2021 14:00 as dose 1, single for COVID-19 immunisation. Medical history included known allergies to hydroxide ion. Concomitant medication included cetirizine and multivitamins taken for an unspecified indication. Patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior vaccination. After the vaccination, on 27Feb2021 04:00, patient woke up with a rash on her face, neck and arms and her stomach was hurting. She went to hospital, treated with Benadryl and sent home. The next morning on 28Feb2021, she woke up at 3:00 am. She was covered in the rash everywhere and stomach was excruciatingly. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had not been tested for COVID-19. Therapeutic measures in response to the events included, Steroids, Steroid cream, Benadryl, and Hydroxyzine. The outcome of the event middle insomnia was unknown and of other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Chills; Headache; fever; skin rash; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EN6203) via an unspecified route of administration on 18Feb2021 (at the age of 74 year old) as dose number unknown, single for COVID-19 immunisation.  Medical history included high blood pressure from an unknown date. Patient has no known allergies. The patient's concomitant medications were not reported. Prior vaccination, patient did not receive any other vaccines within four weeks. Patient was not pregnant at the time of vaccination. On 28Feb2021, patient experienced chills, headache, fever and skin rash. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included, on 02Mar2021, post vaccination, nasal swab (SARS-COV-2 test), was found negative. Therapeutic measures were taken in response to the events included Triamcinolone cream. The outcome of the events was recovering.  No follow-up attempts are Possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema nodosum
Clinical narrative: very tender red bumps also on left forearm/Diagnosed as erythema nodosome; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: en6203), via an unspecified route of administration, administered in right arm on 22Feb2021 14:45 (at the age of 51 year old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to penicillin. There were no concomitant medications.  Prior vaccination, patient was not diagnosed with COVID and did not receive any other vaccines within four weeks. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration in right arm, on 01Feb2021 14:45 (at the age of 51 year old) , as single dose for COVID-19 immunization. On 26Feb2021, the patient had swelling in lower legs with very tender red bumps, on left forearm. which was later diagnosed as erythema nodosome. The event resulted in Doctor or other healthcare professional office/clinic visit. Since vaccination, the patient had not been tested for COVID. Treatment with steroid cream was received in response to the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Skin irritation, Sneezing
Clinical narrative: having a cold with sneezing a lot and blowing her nose; had a very intense irritation on the face; having a cold with sneezing a lot and blowing her nose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021 patient had a very intense irritation on the face. She mentioned that the feeling was similar to having poison ivy on it. She also had cold with sneezing a lot and blowing nose. It was reported that she has not experienced this before. She was asking if she should consult her doctor and her 2nd dose has been scheduled on 23Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: now cannot run; terrible knee pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), 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 received the COVID-19 Vaccine and after the first shot, experienced terrible knee pain on unspecified date. The patient was an avid runner and now cannot run on unspecified date. The case was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Pruritus
Clinical narrative: eczema; itching; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 70-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 12:00 (Batch/Lot Number: EM9809, Expiration date was not reported) (at the age of 70-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing (verbatim: had eczema a few years ago). The patient concomitant medications were not reported. All previous immunization with the Pfizer vaccine considered as suspect were reported as none. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of the Pfizer Suspect. On 02Mar2021, the patient experienced itching and on an unspecified date, the patient experienced eczema. It was reported that, the patient received the first dose of the Covid-19 vaccine two weeks ago. He was scheduled to receive the second dose on 11Mar2021. A week ago, his skin was very itchy. He had eczema a few years ago. This usually happens in Jun or Jul but not in Mar. The doctor gave him Triamcinolone and Zyrtec yesterday. His doctor was not able to tell him if it was ok to get the second shot or not because it is too new. The events resulted in physician office visit. There were no relevant tests provided. The clinical outcome of the event itching was recovering, and eczema was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; her arm was now red, swollen, hot to touch, and painful; This is a spontaneous report from a contactable consumer (child of the patient) via medical information team.   A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot number was not reported) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced her arm was now red, swollen, hot to touch, and painful. She wanted to know if it was normal. The outcome of events was unknown  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: her knee went out/the pain was so bad; This is a spontaneous report from a contactable nurse (patient, self-reported). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 03Mar2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received the first dose of the vaccine and then her knee went out on an unspecified date in Mar2021, and she had a steroid injection today on 09Mar2021 because the pain was so bad, and she couldn't take it anymore. The steroid shot was received this morning. She wanted to know if it was okay to get this with the vaccine. She wanted to know if that will interfere with the covid vaccine. She stated she was scheduled for the second dose on 24Mar2021. Outcome of the events were unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Peripheral swelling, Pyrexia, Rash, Urticaria
Clinical narrative: Feet were slightly swollen; full body rash; Hives; fever; Eyes very red, the sclera were pink, no oozing; Soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp. An 86-years-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single (13:20-13:30 2nd Dose (24-hour clock) for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 24Feb2021, patient had Soreness at injection site. On 04Mar2021, patient experienced fever, Eyes very red, the sclera were pink, no oozing. On 05Mar2021, patient had full body rash and hives and on 07Mar2021, patient experienced Feet were slightly swollen. Reporter states the patient has been taking Prednisone. She states that usually with a food. allergy, after a couple of days it should be better or almost gone. Therapeutic measures were taken as a result of fever and hives. It was reported that, 8 days after receiving the second dose of the vaccine, reporters mother broke out in hives from head to toe for a week. It started in her eyes and it looked like conjunctivitis then it appeared on her arms then all over the body. She also had fever 8 days after receiving the vaccine. In Feb2021, patient was recovered from the event Soreness at injection site. On 09Mar2021, patient recovered from the event Feet were slightly swollen. At the time of report, patient was recovering from eyes very red, the sclera were pink, no oozing while she was not recovered from full body rash and hives. The outcome of event fever was reported as unknown.  Follow-up (27Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a patient.  No follow-up attempts were possible; information about lot/batch number could not be obtained.  No further information was expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Feet were slightly swollen; full body rash; Hives; fever; Eyes very red, the sclera were pink, no oozing; Soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp. An 86-years-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single (13:20-13:30 2nd Dose (24-hour clock) for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 24Feb2021, patient had Soreness at injection site. On 04Mar2021, patient experienced fever, Eyes very red, the sclera were pink, no oozing. On 05Mar2021, patient had full body rash and hives and on 07Mar2021, patient experienced Feet were slightly swollen. Reporter states the patient has been taking Prednisone. She states that usually with a food. allergy, after a couple of days it should be better or almost gone. Therapeutic measures were taken as a result of fever and hives. It was reported that, 8 days after receiving the second dose of the vaccine, reporters mother broke out in hives from head to toe for a week. It started in her eyes and it looked like conjunctivitis then it appeared on her arms then all over the body. She also had fever 8 days after receiving the vaccine. In Feb2021, patient was recovered from the event Soreness at injection site. On 09Mar2021, patient recovered from the event Feet were slightly swollen. At the time of report, patient was recovering from eyes very red, the sclera were pink, no oozing while she was not recovered from full body rash and hives. The outcome of event fever was reported as unknown.  Follow-up (27Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a patient.  No follow-up attempts were possible; information about lot/batch number could not be obtained.  No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass
Clinical narrative: large bruise on the back of the patient's hand covering most of her hand; a small soft lump in the middle of the bruise; This is a spontaneous report from a contactable pharmacist (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 (Batch/Lot Number: el3249) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no history of COVID-19 prior to vaccination. Concomitant medications included atorvastatin; metoprolol; sertraline; ergocalciferol (VIT D); all taken for an unspecified indication, start and stop date were not reported (received within 2 weeks). Historical vaccine included BNT162B2 received by the patient on 08Jan2021 for COVID-19 immunization (Brand: Pfizer, lot number: el1284, administration time: 13:00, vaccine location: Right arm, dose number: 1). No other vaccines received in four weeks. On 07Mar2021 15:00, the patient experienced a large bruise on the back of the patient's hand covering most of her hand. There was a small soft lump in the middle of the bruise. She didn't hit anything, and she have never bruised like this, ever. There is no treatment for the events. The patient has not recovered from the events. Facility type Vaccine: Public Health Clinic. The patient has not been tested for COVID-19 post vaccination.   No follow up attempts are possible. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on injected arm around elbow; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), at age 86 years old, via an unspecified route of administration, administered in the right arm, on 02Mar2021 12:00 (Batch/lot number unknown), at age 86 years old, as dose 2, single, for COVID-19 immunisaiton, at a hospital. Relevant medical history included type 2 diabetes from an unknown date, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included warfarin, metoprolol, lisinopril, insulin lispro (HUMALOG) and insulin detemir (LEVEMIR), all taken for unspecified indications, start and stop dates not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the right arm, on 09Feb2021 12:00 (Batch/lot number unknown), at age 86 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive over vaccines in four weeks. On 08Mar2021, the patient had an itchy rash on the injected arm around the elbow. The patient was not given treatment for the event. The patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Joint stiffness, Joint swelling, Oedema peripheral
Clinical narrative: joint stiffness and swelling right hand >left; joint stiffness and swelling right hand >left; streak of rash dorsal hand/Scattered red non raised rash up arms and less so on chest; dorsal hand with edema and some loss of coordination and strength; some loss of coordination and strength; some loss of coordination and strength; This is a spontaneous report from a contactable nurse (patient herself). A non-pregnant 80-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 intramuscular, at age 80 years (as reported), administered in Arm Left on 23Feb2021 10:30 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes scoliosis and paranoid schizophrenia. No COVID prior vaccination. No known allergies. Concomitant medication(s) included diazepam (VALIUM); temazepam; codeine phosphate, paracetamol (TYLENOL WITH CODEINE); and quetiapine; all taken for an unspecified indication, start and stop date were not reported.  No other vaccine in 4 weeks. On 06Mar2021 at 06:00 PM, the patient complained of joint stiffness and swelling right hand >left, streak of rash dorsal hand with edema and some loss of coordination and strength Scattered red non raised rash up arms and less so on chest. It was unknown if treatment was received. COVID was not tested post vaccination. Facility vaccine type was at a hospital. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: joint stiffness and swelling right hand >left; joint stiffness and swelling right hand >left; streak of rash dorsal hand/Scattered red non raised rash up arms and less so on chest; dorsal hand with edema and some loss of coordination and strength; some loss of coordination and strength; some loss of coordination and strength; This is a spontaneous report from a contactable nurse (patient herself). A non-pregnant 80-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 intramuscular, at age 80 years (as reported), administered in Arm Left on 23Feb2021 10:30 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes scoliosis and paranoid schizophrenia. No COVID prior vaccination. No known allergies. Concomitant medication(s) included diazepam (VALIUM); temazepam; codeine phosphate, paracetamol (TYLENOL WITH CODEINE); and quetiapine; all taken for an unspecified indication, start and stop date were not reported.  No other vaccine in 4 weeks. On 06Mar2021 at 06:00 PM, the patient complained of joint stiffness and swelling right hand >left, streak of rash dorsal hand with edema and some loss of coordination and strength Scattered red non raised rash up arms and less so on chest. It was unknown if treatment was received. COVID was not tested post vaccination. Facility vaccine type was at a hospital. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Body temperature increased, Decreased appetite
Clinical narrative: Headaches; Severe body aches; Increased temperature; Fatigue; Joint Pain; Loss of appetite; brain was foggy almost felt like she had drank too much; very sore arm/pain at injection site; pain coming from injection site across shoulders and down her back; pain coming from injection site across shoulders and down her back; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 04Mar2021 at 13:30 (Lot Number: EN6199) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date. The patient had no known allergies. The patient did not have COVID prior to vaccination. Concomitant medications included ibuprofen (ADVIL); fexofenadine hydrochloride (ALLEGRA); escitalopram oxalate (LEXAPRO); paracetamol (TYLENOL); vitamin d (manufacturer unknown) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in four weeks. The patient previously received the BNT162B2 (lot number: EN6201) on 11Feb2021 at 13:30 in the left arm as dose, 1 single for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 04Mar2021 at 16:30, the patient experienced headaches, severe body aches, increased temperature, fatigue, joint pain, loss of appetite, brain was foggy almost felt like she had drank too much, very sore arm/pain at injection site and pain coming from injection site across shoulders and down her back. The patient received unspecified OTC remedies, rest, fluids, Advil and Tylenol as treatment for the events. The events recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Vaccination site pain
Clinical narrative: Headaches; Severe body aches; Increased temperature; Fatigue; Joint Pain; Loss of appetite; brain was foggy almost felt like she had drank too much; very sore arm/pain at injection site; pain coming from injection site across shoulders and down her back; pain coming from injection site across shoulders and down her back; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 04Mar2021 at 13:30 (Lot Number: EN6199) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date. The patient had no known allergies. The patient did not have COVID prior to vaccination. Concomitant medications included ibuprofen (ADVIL); fexofenadine hydrochloride (ALLEGRA); escitalopram oxalate (LEXAPRO); paracetamol (TYLENOL); vitamin d (manufacturer unknown) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in four weeks. The patient previously received the BNT162B2 (lot number: EN6201) on 11Feb2021 at 13:30 in the left arm as dose, 1 single for COVID-19 immunization. The patient was not tested for COVID post vaccination. On 04Mar2021 at 16:30, the patient experienced headaches, severe body aches, increased temperature, fatigue, joint pain, loss of appetite, brain was foggy almost felt like she had drank too much, very sore arm/pain at injection site and pain coming from injection site across shoulders and down her back. The patient received unspecified OTC remedies, rest, fluids, Advil and Tylenol as treatment for the events. The events recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Short of breath; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 06Mar2021 (Batch/lot number: EN6206), at age 65 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 06Mar2021, after the first dose, the patient felt short of breath. The patient thought it was her mask. The patient stated that she read that a person can't have a mammogram after the vaccine because it shows abnormalities in the lymph nodes. She remarked that she should have never gotten the vaccine as it was too new. The only reason she took it was because she wants to travel to another country. She stated she was not convinced. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Respiratory disorder, Rhinorrhoea, Sinus congestion, Sinusitis
Clinical narrative: Upper airway swelling; nasal plus sinus congestion; nasal plus sinus congestion; Rhinorrhea; acute sinusitis/sinusitis symptoms; This is a spontaneous report from a contactable physician. A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 09Feb2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included asthma and takes inhalers as needed and environmental allergy and takes antihistamine both on unknown dates. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); albuterol [salbutamol] (manufacturer unknown) and cetirizine hydrochloride (ZYRTEC), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Jan2021 for COVID-19 immunization and experienced sinus infection, dizziness, right ear aching, headache, pain in jaw, swelling of bottom lip, rhinorrhea and upper airway swelling. The patient experienced upper airway swelling and nasal plus sinus congestion on an unknown date in 2021. The patient also had rhinorrhea and acute sinusitis/sinusitis symptoms in 2021 which were treated with antibiotics. The events did not require a visit to the emergency department or hospitalization. The patient did not have anaphylaxis. The patient did not have any bilateral wheeze/bronchospasm, respiratory distress, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sensation of throat closure or sneezing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Pharyngeal swelling
Clinical narrative: her throat was swollen; swelling inside of the mouth and under her lip; swelling inside of the mouth and under her lip; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:00 as dose 2, single for covid-19 immunisation.  Medical history included she has a lot of food a lot of food allergies, She is very allergic to poppy seeds. Patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0140), via an unspecified route of administration, administered in Arm Right on 07Jan2021 13:00 as dose 1, single for covid-19 immunisation and experienced swelling of her throat, it felt like it was kind of closing, reflux and . On Jan2021, the patient experienced her throat was swollen, swelling inside of the mouth and under her lip and swelling under her upper lip. Caller mentioned that she received the 1st dose of the vaccine 07Jan2021 and within 24-48 hours felt a little feeling of swelling of her throat. It felt like it was kind of closing. She got an EMT Scope and they saw that her throat was swollen. They thought that it was because of reflux and gave her reflux medications which did not help. She received the 2nd dose of the vaccine 28Jan2021 and about a day or 2 later the same feeling in her throat appeared. She went to the EMT and was told that her throat was swollen. She also reported a swelling inside of the mouth and under her lip. She was prescribed Benadryl and prednisone with the 6, 5, 4, 3, 2, 1 dosing regimen but it did not help her symptoms. She was not better and these symptoms are scaring her. She mentioned that the doctors did not know what to do. She is asking if anybody reported any closing of the throat symptoms (later clarified to allergic reactions) and what to do. Caller asked if having any food allergies could affect the experience with the vaccine. She mentioned that she has a lot of food a lot of food allergies including nuts, and seeds. She is very allergic to poppy seeds and would like to know if any ingredients have been derived from poppy seeds. Therapeutic measures were taken as a result of her throat was swollen, swelling inside of the mouth and under her lip, swelling inside of the mouth and under her lip. The clinical outcome of events were not recovered.  No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Swelling
Clinical narrative: Experiencing a lump under her armpit; Swollen armpit; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 05Mar2021 at 12:30 (Batch/Lot number was not reported) (at the age of 59-years-old) as dose 1, single for covid-19 immunization. The patient did not had any medical history. There were no concomitant medications reported. There were no family medical history reported. There were no additional vaccines administered on same date of the Pfizer suspect.  There were no prior vaccinations within 4 weeks. On 09Mar2021, the patient experienced lump under her armpit, little swollen under the armpit under the arm she had her shot in. It doesn't hurt and it seems to be getting worse. The adverse event not required physician or ER visit. Patient wanted to know if this was normal. She was planning to receive the next dose on 26Mar2021. The outcome of event for swollen armpit was not resolved whereas, for other events it was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.