chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Irritability, Pain in extremity, Somnolence
Clinical narrative: stomach aches; chest aches; Exhaustion; Feeling unwell; Headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that an 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine, BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration on 12Feb2021 (Age 84-year-old at time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The historical vaccine included, bnt162b2 (BNT162B2, Batch/Lot Number: EL0142), dose 1 via an unspecified route of administration on an unspecified date (Age at time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that her and another best friend of hers went to take the shot last month and they were trying to find out, they still had different abnormal response to the vaccine after the second one. It has been 2 weeks since they had the second one and the still had tiredness and extreme fatigue, feeling unwell in Feb2021 and they were calling to see if there were suggestions, or something take or do after the second shot. She clarified she was calling about the second Pfizer COVID 19 vaccine. She said the patient was also on the line they went to together to get the vaccine and he was the other person; he was also on the call. She confirmed his first dose says EL0142 or the 2 could be a 6. And the second dose says EL3302. And the zero has a slash in the middle and that was on 12Feb2021 and it has AMC-S. She said the dates were the same for them because they went together on the same day to get both doses. She said he had been worse off than her. He was having feeling unwell, exhaustion, he had headache and stomach aches and his chest aches in Feb2021 and still had. Physically there was nothing wrong with him he has been to the doctor and had a physical and the doctor did not seem to be anything wrong with his physical being. The outcome of the event was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Mild fever; Sore arms; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 01Mar2021 09:00 (Age at vaccination:35-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't had covid prior to vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. The patient experienced sore arms on Mar2021, headache on 03Mar2021 09:00, mild fever on 03Mar2021 09:00. No therapeutic measures were taken for the events. Patient was not tested to covid to post vaccination. The outcome of the events pain in extremity, headache, pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin tightness, Vaccination site erythema, Vaccination site rash
Clinical narrative: Skin at site seems to have tightened or hardened under the rash; Red rash approximately 4 inches in diameter at injection site on left upper arm.; Rash started about 2-3 days after injection and is continuousl itchy; Red rash approximately 4 inches in diameter at injection site on left upper arm.; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204), via an unspecified route of administration, administered in arm left on 27Feb2021 09:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included low platelet count, heart valve transplant from a cow, bladder cancer with surgery removing cancerous tumour (no recurring signs), tendency for increased blood pressure from unknown date and unknown if ongoing. Concomitant medications included n-plate, amiodarone, amlodipine, aspirin and atorvastatin taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. No other vaccine in four weeks. The patient experienced red rash approximately 4 inches in diameter at injection site on left upper arm. Rash started about 2-3 days after injection and was continuously itchy. Skin at site seems to have tightened or hardened under the rash on 04Mar2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information was expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lip swelling, Paraesthesia, Pruritus, Swelling
Clinical narrative: I was swelling; My tongue started to feel heavy and my lips were swelling; My tongue started to feel heavy and my lips were swelling; I started to feel itchy towards the end of that time; I was getting hot; my face started to have a tingling sensation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, in left arm, on 05Feb2021 11:15 (at the age of 36-years-old), at dose 1, single for covid-19 immunization from school or student health clinic. Medical history included asthma, high blood pressure and known allergies to penicillin, ciprofloxacin, and hydrocodone. Concomitant medications included nifedipine, omeprazole and hydro (as reported). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient started to feel itchy, getting hot, her face started to have a tingling sensation, tongue started to feel heavy and lips were swelling on 05Feb2021. On 05Feb2021 12:40, she was swelling. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient visited the nurse station and therapeutic measures were taken; took Benadryl, also received EpiPen and then sent to the hospital to be evaluated. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: I was swelling; My tongue started to feel heavy and my lips were swelling; My tongue started to feel heavy and my lips were swelling; I started to feel itchy towards the end of that time; I was getting hot; my face started to have a tingling sensation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, in left arm, on 05Feb2021 11:15 (at the age of 36-years-old), at dose 1, single for covid-19 immunization from school or student health clinic. Medical history included asthma, high blood pressure and known allergies to penicillin, ciprofloxacin, and hydrocodone. Concomitant medications included nifedipine, omeprazole and hydro (as reported). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient started to feel itchy, getting hot, her face started to have a tingling sensation, tongue started to feel heavy and lips were swelling on 05Feb2021. On 05Feb2021 12:40, she was swelling. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient visited the nurse station and therapeutic measures were taken; took Benadryl, also received EpiPen and then sent to the hospital to be evaluated. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Lethargy
Clinical narrative: Chills; Fever; Sweating; Severe headache; Nausea; Lethargy; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: EL3247) as dose 2, single for COVID-19 immunization. Medical history included was not reported. Patient had known penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, fever, sweating, severe headache, nausea, lethargy, dizziness on 23Feb2021. The patient received paracetamol (TYLENOL). The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; Fever; Sweating; Severe headache; Nausea; Lethargy; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: EL3247) as dose 2, single for COVID-19 immunization. Medical history included was not reported. Patient had known penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (Lot Number: not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, fever, sweating, severe headache, nausea, lethargy, dizziness on 23Feb2021. The patient received paracetamol (TYLENOL). The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247; Expiration Date: May2021), via an unspecified route of administration on 01Mar2021 at the age of 39-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Feb2021 at the age of 39-year-old as dose 1, single for covid-19 immunisation and had he got fever and chills. On 01Mar2021, patient experienced rash at night on genitals has not gone away and chills not so bad as first dose. He has not consulted his physician yet. Patient don't know what it to or visit the doctor or wait until it is go away on it own. Patient tried some cream, topical cream for the rash. The outcome of the event rash was not recovered, and event chill was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: chills; temperature of up to 99.0 degrees / fever; joint aching/Had aches in my joints; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 02Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included COVID-19 from 22Dec2020 which was really bad for about a week and a half and she was not sure if that made her side effects worse or not. The patient's concomitant medications were not reported. The patient experienced a small reaction which includes chills, a temperature of up to 99.0 degrees and joint aching. The patient wants to know if she should receive the second dose of the Pfizer COVID-19 vaccine since she had this reaction after the first dose and if she experiences a similar reaction, if it was okay to take Tylenol for these symptoms. She denied any signs of a serious allergic reaction. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Malaise
Clinical narrative: injection site pain; Headache; Mucscle and joint pain; Mucscle and joint pain; chills; feeling unwell; swollen Lymph nodes; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Enu2v2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 01:45 (at the age of 76 year old) as dose 2, single for COVID-19 immunisation.  Medical history included Celiac disease/gluten Free . Concomitant medications included atorvastatin (LIPITOR); amlodipine; losartan, hydrocodone, all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, the patient was not diagnosed with COVID and did not receive other vaccines in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EM9809, via an unspecified route of administration in left arm,  on 08Feb2021 11:45 (at the age of 76 year old), as single dose for COVID-19 immunization. On 03Mar2021, patient experienced injection site pain, headache, muscles and joint pain, chills, feeling unwell and swollen lymph nodes. Since the vaccination patient had not been tested for COVID. No treatment was received in response to the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: injection site pain; Headache; Mucscle and joint pain; Mucscle and joint pain; chills; feeling unwell; swollen Lymph nodes; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Enu2v2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 01:45 (at the age of 76 year old) as dose 2, single for COVID-19 immunisation.  Medical history included Celiac disease/gluten Free . Concomitant medications included atorvastatin (LIPITOR); amlodipine; losartan, hydrocodone, all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, the patient was not diagnosed with COVID and did not receive other vaccines in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EM9809, via an unspecified route of administration in left arm,  on 08Feb2021 11:45 (at the age of 76 year old), as single dose for COVID-19 immunization. On 03Mar2021, patient experienced injection site pain, headache, muscles and joint pain, chills, feeling unwell and swollen lymph nodes. Since the vaccination patient had not been tested for COVID. No treatment was received in response to the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Face Warm; Face was beet red/big bright red streak on left side of face; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 03Mar2021 08:30 (at the age of 75-years-old) as dose 2, single for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included hydrocortisone acetate (CORTISONE [HYDROCORTISONE ACETATE]) taken on 02Mar2021. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE , lot number: unknown) via unspecified route administered on 11FEB2021; 8:25 as dose 1, single for covid-19 immunization. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. On the day of second dose, at 18:00, patient looked in mirror and her face was beet red. She states that she didn't know what to do, she would normally say it was allergic reaction and take Benadryl but she did not do that, she took 2 Tylenol as treatment. She went to bed at 11:00 pm and her face was still red and she thought she would give it time. When she woke up next day morning, the right side of her face cleared up and left side of her face, which was same side that she had vaccine on, the area was smaller but still a big bright red streak and its warm. She states that she was feeling fine and wants to know if this was an allergic reaction and is she still protected by the vaccine. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pruritus
Clinical narrative: itching/Itchiness; feeling itchy; This is a spontaneous report from a contactable consumer (patient) via medical information team from a Pfizer Sponsored Program. A 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date: Jun2021) via an unspecified route of administration, in left arm, on 24Feb2021 01:36 (at the age of 85-years-old), at dose 1, single for covid-19 immunization from pharmacy/drug store. Medical history included blood pressure high, heart problems, she has had bad vocal cords for 6 years (2016), bones and arthritis (as reported), ongoing cholesterol, asthma, acid reflux (esophageal), glaucoma and chronic constipation. Concomitant medications included isosorbide taken for her heart from 2018 and ongoing; losartan taken for blood pressure from an unspecified start date and ongoing; alendronate sodium (ALENDRONATE) taken for bone disorder, arthritis from 2020 and ongoing; diclofenac taken for arthritis from 2018 and ongoing; simvastatin taken for cholesterol from an unspecified start date and ongoing; lubiprostone (AMITIZA) taken for chronic constipation from 2014 and ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from 2014 and ongoing; omeprazole taken for acid reflux (esophageal) from 2018 and ongoing; latanoprost taken for glaucoma from 2001 and ongoing; dorzolamide hydrochloride, timolol maleate (DORZOLAMIDE TIMOLOL) taken for glaucoma from 2018 and ongoing. She was using some unspecified medication orally for arthritis but changed to something topically that was less invasive, and the details were not provided. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No additional vaccines administered on same date of vaccination. The patient experienced itching/itchiness; feeling itchy on 27Feb2021. The patient underwent lab tests and procedures which included unspecified laboratory test with unknown results on 25Feb2021. Therapeutic measures taken included an unspecified lotion. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Chills; Shaking; Fever 100-101.3; Body aches; Weakness; Dizzy; Headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Feb2021 12:15 (66-year-old) (Lot Number: EL9261) as dose 2, single for COVID-19 immunization. Medical history included none. The patient did not have any known allergies. Concomitant medications included terbinafine; trazodone; vitamin D3 and cranberry syrup, all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination. The patient experienced chills, shaking, fever 100-101.3, body aches, weakness, dizzy, headache on 07Feb2021 01:30. The patient received paracetamol (TYLENOL) for the event fever. The outcome of events was recovered. Since the vaccination, the patient has not been tested for the COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Chills; Shaking; Fever 100-101.3; Body aches; Weakness; Dizzy; Headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Feb2021 12:15 (66-year-old) (Lot Number: EL9261) as dose 2, single for COVID-19 immunization. Medical history included none. The patient did not have any known allergies. Concomitant medications included terbinafine; trazodone; vitamin D3 and cranberry syrup, all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination. The patient experienced chills, shaking, fever 100-101.3, body aches, weakness, dizzy, headache on 07Feb2021 01:30. The patient received paracetamol (TYLENOL) for the event fever. The outcome of events was recovered. Since the vaccination, the patient has not been tested for the COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my knee has been bothering; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included knee pain. The patient's concomitant medications were not reported.  The patient stated that his knee has been bothering, he may have to get a cortisone shot on knee. Patient was scheduled to get a cortisone shot before the 2nd dose of the vaccine on 10Mar2021. The outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Neuralgia, Rash, Skin swelling
Clinical narrative: Full body rash; tightness in chest; sensation of skin swelling; neuropathic skin pain; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date in Feb2021, as dose 1, single, for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. It was unknown if patient had any known allergies. The patient medical history and concomitant medications were not reported. It was unknown if patient received other vaccine in four weeks. It was unknown if patient experienced COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination. It was reported that, 30 min after first dose she developed full body rash, tightness in chest, and a sensation of skin swelling/ neuropathic skin pain. Patient's husband was physician and recommended her to take levocetirizine. The patient visited doctor or other healthcare professional office/clinic visit due to the events. The patient was treated with diphenhydramine. The outcome for the events was resolved. The patient took second dose and experienced no discernable symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: My tongue and face swelled up about 40 minutes after the injection.; My tongue and face swelled up about 40 minutes after the injection.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 49 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypersensitivity to liprinsol from an unknown date and unknown if ongoing , rubber sensitivity from an unknown date and unknown if ongoing. The patient experienced the tongue and face swelled up about 40 minutes after the injection leading to swollen tongue and face on 26Feb2021 11:00 with outcome of recovered.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Skin induration
Clinical narrative: 4x4 inch knot on arm, blotchy redness and arm was firm; blotchy redness; arm was firm; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6198),  via an unspecified route of administration, administered in left arm on 01Mar2021 (at the age of 64-years-old) as dose 2, single for covid-19 immunization.  Medical history included allergies eggs and shellfish. The patient's concomitant medications were not reported. Patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL8982),  via an unspecified route of administration, administered in left arm on 08Feb2021 10:30 (at the age of 64-years-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. The patient had a reaction of 4x4 inch knot on arm, blotchy redness and arm was firm on 03Mar2021. No treatment was taken for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast atrophy, Peripheral swelling
Clinical narrative: left breast has deflated and is not same size; Huge swelling under arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 28Feb2021 13:30 (at the age of 59-years-old) at dose 2, single for covid-19 immunization. Medical history included osteo inflammation and Sjogren's. The patient had no known allergies. Concomitant medications included thyroid; losartan potassium (LOSARTIN); C Zinc D (as reported) elderberry (SAMBUCUS NIGRA); glutathione. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 07Feb2021 12:30 (at the age of 59-years-old) at dose 1, single for covid-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. On 01Mar2021 07:00, the patient experienced huge swelling under arm and 4 days out the left breast has deflated and is not same size. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The outcome of the events was not recovered.      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Rhinorrhoea, Swollen tongue
Clinical narrative: sniffling; hoarse; tongue was swollen; This is a spontaneous report from a contactable Nurse (patient). A 68-year-old 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 11Feb2021 (at the age of 68 years old) as dose 2, single for COVID-19 immunisation. Medical history included penicillin allergy, horrible rash, hospitalization, drug allergy (States 10-15 years ago she was in the hospital for a week after a drug reaction they believe). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Jan2021 (at the age of 68 years old) as single for COVID-19 immunisation and experienced swollen eyes (after the first dose which she states might have been around 20Jan2021 she was fine other than swollen eyes that evening and the next day). The patient experienced sniffling, hoarse, tongue was swollen on 11Feb2021. Reported as, she received the second dose on 11Feb2021 and she was fine after the first 15 minutes when she we waited at the facility. she states then a little later she starting having some sniffling and then 30 minutes later she noticed she was hoarse. She got home about a hour later and her tongue was swollen but she had no problems breathing. two hours later the hoarseness went away. She does have allergies and has become hoarse a couple of other times, there are certain chemicals and things that can cause her to be hoarse. She did have a drug reaction to something a couple of years ago, states they think it was a delayed reaction to penicillin, just a horrible rash, no further information provided. Outcome of the event hoarse, tongue was swollen was recovered on 11Feb2021 and unknown for sniffling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Ear pain, Facial pain, Headache
Clinical narrative: I felt like I had the flu; My head was pounding; Neck hurt; Face and ears hurt; Face and ears hurt; Joints were terrible; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 09:45 (at the age of 72-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes. The patient had known allergies to penicillin, SUDAFED (pseudoephedrine hydrochloride), aspartame, caffeine, FLEXERIL (cyclobenzaprine hydrochloride), bentyl, morphine, minocin, diprivan, belladonna, coated paracetamol (TYLENOL), zantac, progesterone, apples, lactose intolerant, chocolate, mayonnaise, water. Concomitant medications included cetirizine hydrochloride (ZYRTEC); glimepiride; ergocalciferol (VIT D), all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient felt like she had the flu, her head was pounding and had neck hurt, face and ears hurt, reported that joints were terrible, and was dizzy as soon as the burning needle went in and lasted for about 4 hours on 02Mar2021 09:45. The patient reported that the serum was in her arm and didn't move for a long time (as reported). The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Neck pain
Clinical narrative: I felt like I had the flu; My head was pounding; Neck hurt; Face and ears hurt; Face and ears hurt; Joints were terrible; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 09:45 (at the age of 72-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included diabetes. The patient had known allergies to penicillin, SUDAFED (pseudoephedrine hydrochloride), aspartame, caffeine, FLEXERIL (cyclobenzaprine hydrochloride), bentyl, morphine, minocin, diprivan, belladonna, coated paracetamol (TYLENOL), zantac, progesterone, apples, lactose intolerant, chocolate, mayonnaise, water. Concomitant medications included cetirizine hydrochloride (ZYRTEC); glimepiride; ergocalciferol (VIT D), all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient felt like she had the flu, her head was pounding and had neck hurt, face and ears hurt, reported that joints were terrible, and was dizzy as soon as the burning needle went in and lasted for about 4 hours on 02Mar2021 09:45. The patient reported that the serum was in her arm and didn't move for a long time (as reported). The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast abscess, Breast pain, Erythema, Mammogram, Skin irritation
Clinical narrative: severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; an abscess but did not feel any lumps; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at the age of 49-year-old as dose 1, single for covid-19 immunisation. Medical history included irritable bowel syndrome, seasonal allergies , allergies to sulfa drugs , patient have silicone breast implants. In the left breast I also have some silicone free floating due to a silicone implant rupture years ago and they could not remove it all. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medications included claritin, famotidine taken for an unspecified indication, start and stop date were not reported. On 23Feb2021,  patient woke up with severe pain in the left breast along with some redness and irritation, 11 days after the injection. Patient consult a doctor and they started on an antibiotics for an abscess but did not feel any lumps. Redness and pain improved greatly with antibiotics. Mammogram and ultrasound showed nothing that would have caused this. Patient 2nd dose schedule on 05Mar2021 will get in right arm. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; severe pain in the left breast along with some redness and irritation; an abscess but did not feel any lumps; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 12Feb2021 at the age of 49-year-old as dose 1, single for covid-19 immunisation. Medical history included irritable bowel syndrome, seasonal allergies , allergies to sulfa drugs , patient have silicone breast implants. In the left breast I also have some silicone free floating due to a silicone implant rupture years ago and they could not remove it all. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medications included claritin, famotidine taken for an unspecified indication, start and stop date were not reported. On 23Feb2021,  patient woke up with severe pain in the left breast along with some redness and irritation, 11 days after the injection. Patient consult a doctor and they started on an antibiotics for an abscess but did not feel any lumps. Redness and pain improved greatly with antibiotics. Mammogram and ultrasound showed nothing that would have caused this. Patient 2nd dose schedule on 05Mar2021 will get in right arm. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Nausea, Product administered at inappropriate site, Urticaria
Clinical narrative: it was given in a place where there was no muscle so it probably went subcutaneous; nausea; headache; allergic reaction; one large hive on the injection arm but not at the site it was beside it; it grew in size and was very itchy and painful; it grew in size and was very itchy and painful; redness in the area it was given; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6205 and expiry date not reported), dose 1 via an unspecified route of administration on 01Mar2021 (at the age of 52-year-old), as dose 1, single, for COVID-19 immunisation. Medical history included asthma and several allergies to things she doesn't know of but has never had an anaphylactic reaction or used an epi pen for them. Her reactions have been hives and swelling in her mouth. There were no concomitant medications. The patient received the first dose of the Pfizer COVID vaccine on 01Mar2021 (reported as Monday). On the first day there was no issues. On 02Mar2021 (reported as Tuesday), the patient experienced an allergic reaction, one large hive on the injection arm but not at the site it was beside it and it grew in size and was very itchy and painful, she had terrible headache, nausea. The patient went to her primary doctor and they told her they didn't feel as though she had a severe reaction and she should be okay to receive the second dose of the vaccine. The primary doctor told her to ask her allergist for their opinion regarding her receiving the second dose. The patient saw the nurse practitioner there and they thought her reaction was severe and that she should not receive the second dose and told her to call Pfizer to see recommendations. The patient took Zofran for her nausea and Tylenol every 6 hours for headache. Her hives never went all over her body they stayed on her upper arm near injection site. The patient got her first dose on 01Mar2021 and finished her second dose on 22Mar2021 (lot number: EN6205). Two days before her second dose a nurse and her physician told that her first dose of vaccine was given improperly, administered subcutaneously and should have been intramuscularly and that was against protocol. They do not know if she would get the full protection, instead of being like 90 something percent covered she was really going to be like 50-55% covered with one dose, the second dose so she wants to find out if that was true. She also added that her second dose was given correctly. The patient asked if there was a way if she can know if she was protected and if Pfizer can recommend an antibody test. The patient also asked if there were any other vaccines given subcutaneously. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: it was given in a place where there was no muscle so it probably went subcutaneous; nausea; headache; allergic reaction; one large hive on the injection arm but not at the site it was beside it; it grew in size and was very itchy and painful; it grew in size and was very itchy and painful; redness in the area it was given; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6205 and expiry date not reported), dose 1 via an unspecified route of administration on 01Mar2021 (at the age of 52-year-old), as dose 1, single, for COVID-19 immunisation. Medical history included asthma and several allergies to things she doesn't know of but has never had an anaphylactic reaction or used an epi pen for them. Her reactions have been hives and swelling in her mouth. There were no concomitant medications. The patient received the first dose of the Pfizer COVID vaccine on 01Mar2021 (reported as Monday). On the first day there was no issues. On 02Mar2021 (reported as Tuesday), the patient experienced an allergic reaction, one large hive on the injection arm but not at the site it was beside it and it grew in size and was very itchy and painful, she had terrible headache, nausea. The patient went to her primary doctor and they told her they didn't feel as though she had a severe reaction and she should be okay to receive the second dose of the vaccine. The primary doctor told her to ask her allergist for their opinion regarding her receiving the second dose. The patient saw the nurse practitioner there and they thought her reaction was severe and that she should not receive the second dose and told her to call Pfizer to see recommendations. The patient took Zofran for her nausea and Tylenol every 6 hours for headache. Her hives never went all over her body they stayed on her upper arm near injection site. The patient got her first dose on 01Mar2021 and finished her second dose on 22Mar2021 (lot number: EN6205). Two days before her second dose a nurse and her physician told that her first dose of vaccine was given improperly, administered subcutaneously and should have been intramuscularly and that was against protocol. They do not know if she would get the full protection, instead of being like 90 something percent covered she was really going to be like 50-55% covered with one dose, the second dose so she wants to find out if that was true. She also added that her second dose was given correctly. The patient asked if there was a way if she can know if she was protected and if Pfizer can recommend an antibody test. The patient also asked if there were any other vaccines given subcutaneously. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Increased upper airway secretion, Investigation
Clinical narrative: coughing up a lot mucus/ keeps coughing and coughing; spitting up a lot of mucus; This is a spontaneous report from a contactable consumer, caregiver of the patient. A 88-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6200) via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:35 as dose 2, single (age at the time of vaccination: 88 years) for covid-19 immunisation. The patient had stroke last Mar2020 and that 25% of his heart was working. The stroke was in the front lobe, it was small. Then 20-25% of his heart, he had a watchman, clarified, watchmen filters blood clots so they can get the patient off warfarin, the blood thinning medicine. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EM9810) via an unspecified route of administration at dose 1, single. The patient previously received flu shot on an unspecified date and experienced sore arm. There were no concomitant medications. His follow up check ups have been fine. The patient was spitting up a lot of mucus/ spitting up all kinds of mucus in the trash can and was coughing and coughing on 03Mar2021 at 16:00. It was reported that the patient was still coughing even at 8:00 PM when the reporter's shift changed. The patient took Tylenol at 8 hour interval at a dose of 225 mg. No vaccines were administered on same date with the suspect product. The reporter was giving him 2 tablets by mouth and he was feeling better. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.