chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Body aches; temperature of up to 102.5; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age 78-year-old via an unspecified route of administration in the right arm on 05Feb2021 03:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient did not have covid prior to vaccination. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN); simvastatin; amlodipine; carvedilol and colecalciferol (Vit D); all indication, start and stop date were not reported. The patient did not receive other vaccine in the past four weeks. On Feb2021, the patient experienced chills, body aches and temperature of up to 102.5. The patient reported that she has experienced after receiving the vaccine. She mentioned that she did not have a reaction to the first vaccine until 2 weeks later (Feb2021) she developed a temperature of up to 102.5 and had the chills and body aches. This lasted about 36 hours and she did have a Rapid Covid19 test which came back negative. The patient has not been COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Body temperature increased, Dizziness
Clinical narrative: Shortness of breath; Headache; temperatures right under 100; Dizziness; Weakness; Joint pain; This is a spontaneous report received from a contactable consumer (patient's wife) and a consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6198 and Expiration date: not reported) via an unspecified route of administration on 22Feb2021 (at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The patient was diabetic (ongoing; diagnosed about 6-7 years ago). Concomitant medication was not reported. The patient previously received the 1st dose of BNT162B2 (Lot number: EL9262) on an unspecified date for COVID-19 immunisation and did not feel anything. On 23Feb2021, the patient experienced shortness of breath and a headache (for 3 or 4 days). On unspecified dates in 2021, the patient also experienced "temperatures right under 100", dizziness, weakness, and joint pain. The patient was almost brought to the hospital due to shortness of breath but decided it wasn't bad enough and the patient was just uncomfortable, and that went away. The patient has missed work all week. The outcome of the events shortness of breath was recovered on an unspecified date in Feb2021; headache, dizziness, and weakness were recovering; joint pain was not recovered; while "temperatures right under 100" was unknown.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021223797 Same reporter/product, similar events, different patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Shortness of breath; Headache; temperatures right under 100; Dizziness; Weakness; Joint pain; This is a spontaneous report received from a contactable consumer (patient's wife) and a consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6198 and Expiration date: not reported) via an unspecified route of administration on 22Feb2021 (at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The patient was diabetic (ongoing; diagnosed about 6-7 years ago). Concomitant medication was not reported. The patient previously received the 1st dose of BNT162B2 (Lot number: EL9262) on an unspecified date for COVID-19 immunisation and did not feel anything. On 23Feb2021, the patient experienced shortness of breath and a headache (for 3 or 4 days). On unspecified dates in 2021, the patient also experienced "temperatures right under 100", dizziness, weakness, and joint pain. The patient was almost brought to the hospital due to shortness of breath but decided it wasn't bad enough and the patient was just uncomfortable, and that went away. The patient has missed work all week. The outcome of the events shortness of breath was recovered on an unspecified date in Feb2021; headache, dizziness, and weakness were recovering; joint pain was not recovered; while "temperatures right under 100" was unknown.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-2021223797 Same reporter/product, similar events, different patient.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: head to feet skin rash/ decreased to patch or rash; head to feet skin rash/ decreased to patch or rash; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in the right arm on 16Feb2021, at 13:15 (at the age of 59 years old) as dose 1, single for COVID-19 immunisation. Medical history included PNET cancer, seizures, known allergies: sulfa drugs, etc. Concomitant medications included brivaracetam (BRIVIACT), pregabalin (LYRICA), everolimus (AFINITOR), dexamethasone, and others. He did not receive any other vaccines prior to the COVID vaccine. The patient previously took rifaximin and experienced allergies. On 18Feb2021, at 13:00, the patient got head to feet skin rash on day 3 to 8. It decreased to patch or rash on day 9 (24Feb2021) to 11. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events which included triamcinolone acetonide 0.1% ointment. At the time of report, the patient was still recovering from the events.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Periorbital swelling, Swelling of eyelid
Clinical narrative: eyelids are swollen; red underneath her eyes; they are real puffy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced eyelids are swollen, red underneath her eyes, and they are real puffy. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling
Clinical narrative: some puffy eyes; swollen eyes; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported; at the age of 68 years old) as dose 1, single for COVID-19 immunisation.  Medical history included that she was in the hospital due to penicillin. There were no concomitant medications. The patient previously took penicillin and experienced horrible rash (10-15 years ago she was in the hospital for a week after a drug reaction to penicillin). After receiving the first dose on 20Jan2021, the patient experienced some puffy eyes and swollen eyes in the evening and the next morning on 21Jan2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: coughed up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 85, Unit: unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unknown date in 2021 (lot number was not reported) as dose 1, single for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received the first dose of the vaccine on an unknown date in 2021 and had no reaction but coughed up blood twice on an unknown date in 2021. The reporter wanted to know if this was a side effect of the vaccine. 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knees had been in great pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of vaccination, administered in the left arm, on 22Feb2021 14:00 (Batch/lot number: EN6202), at age 55 years old, as dose 1, single, for COVID-19 immunisation, at a  health clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included joint disorder (reported as "received cortisone shots in both knees" and "weaker knee") from an unknown date, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient previously received cortisone shots in both knees 3 weeks prior to vaccine in 2021 and was feeling great until 2 days after the vaccine. The patient did not receive other vaccines in four weeks. On 24Feb2021 16:45, the patient's knees had been in great pain, the weaker knee was worse than the other. The patient was not sure if she should get the second dose of the vaccine because she was afraid it may get worse. The patient did not receive treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin disorder
Clinical narrative: left arm broke out in bumps and was sore; left arm broke out in bumps and was sore; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 25Feb2021 16:00 (Batch/lot number: EN6202), at age 58 years old, as dose 1, single, for COVID-19 immunisaiton, at a pharmacy/drugstore. The patient was not pregnant at the time of vaccination. Relevant medical history included diabetes and high blood pressure both from unknown dates, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included insulin from an unknown indication, not reported if ongoing or not. The patient did not have other vaccines in four weeks. On 26Feb2021 02:00, the patient's left arm broke out in bumps and was sore. The events resulted to physician's office visit. The patient did not receive treatment for the events. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Erythema, Inflammation
Clinical narrative: Inflammatory response; face turned red; patient sounded as congested although the patient was not; This is a spontaneous report from a contactable consumer (patient) received via the Regulatory Authority. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 01:15 PM (Batch/Lot Number: 68u6203) (at the age of 39 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and hyperthyroidism . The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has known allergies to sulfa and pertussis vaccine. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 04:00 PM, the patient experienced inflammatory response (also reported as within 4 hours), face turned red, and the patient sounded as congested although the patient was not. The patient has taken diphenhydramine (BENADRYL) as treatment for the events. The events went away after the patient took the medicine. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Investigation
Clinical narrative: soreness in the right knee; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN5318 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 28Jan2021 11:00 (at the age of 63 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Concomitant medications included simvastatin, ascophyllum nodosum;ascorbic acid;ascorbyl palmitate;bacopa monnieri leaf;betacarotene;biotin;boron citrate;calcium ascorbate;calcium citrate;calcium pantothenate;calcium succinate;choline bitartrate;chromium nicotinate;colecalciferol;copper citrate;copper glycinate;cyanocobalamin;deanol bitartrate;docosahexaenoic acid;electrolytes nos;folic acid;gamma-aminobutyric acid;huperzia serrata;inositol;inositol nicotinate;iron pentacarbonyl;levoglutamide;magnesium citrate;magnesium malate;magnesium taurate;manganese citrate;molybdenum amino acid chelate;n-acetyltyrosin;nicotinamide;nutrients nos;phosphatidyl serine;potassium ascorbate;potassium aspartate;potassium citrate;pyridoxal phosphate;pyridoxine oxoglurate;riboflavin;selenomethionine;sodium ascorbate;thiamine mononitrate;tocopheryl acid succinate;vaccinium myrtillus fruit;vanadyl sulfate;vinpocetine;vitis vinifera;zinc ascorbate;zinc citrate (FOCUSFACTOR), and ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER) taken for unspecified indications. On 30Jan2021, about 2 days following the first shot, the patient experienced soreness in the right knee that progressively got to the point that the patient couldn't apply pressure on his right leg. On 18Feb2021, the patient saw an orthopedic surgeon for an assessment and they identified some water on the knee; result not reported. The patient was given a cortisone shot. The outcome of the reported event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Eyelid ptosis, Headache, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: swollen face specially cheeks; eyes was swollen; RT eye lid skin was dropping down to the point she cannot use it; Running nose; Head Ache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received BNT162B2, intramuscular, administered in left arm on 22Dec2020 12:00 (Batch/Lot Number: ELo140, also reported as EL0140) at the age of 60 years old as dose 1, single for COVID-19 immunisation. Medical history included high cholestrol. Patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medications were not specified but reported that received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020 04:00 (the next day after she took the vaccination), the patient had running nose that lasts one day and experienced head ache for three days (as reported) which patient took acetaminophen (TYLENOL) for a relief. Then on 27Dec2020 04:00, patient woke up at the middle of the night (as reported) with swollen face specially cheeks and eyes was swollen. Right (RT) cheek was more swollen than the left (LT) side. RT Eye was covered due to RT eye lid skin was dropping down to the point she cannot use it until the next day it retracted back (as reported). Patient still have swollen face, cheeks and eyes. RT eye and RT cheek was more swollen and felt very uncomfortable to wear a mask specially N95. The patient recovered with lasting effects. It was reported that treatment received for events (also reported that no treatment). Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, she has been tested for COVID-19. Nasal Swab: unknown results on 22Feb2021 (COVID test post vaccination), negative on 02Mar2021. Outcome of all events was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen face specially cheeks; eyes was swollen; RT eye lid skin was dropping down to the point she cannot use it; Running nose; Head Ache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received BNT162B2, intramuscular, administered in left arm on 22Dec2020 12:00 (Batch/Lot Number: ELo140, also reported as EL0140) at the age of 60 years old as dose 1, single for COVID-19 immunisation. Medical history included high cholestrol. Patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medications were not specified but reported that received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020 04:00 (the next day after she took the vaccination), the patient had running nose that lasts one day and experienced head ache for three days (as reported) which patient took acetaminophen (TYLENOL) for a relief. Then on 27Dec2020 04:00, patient woke up at the middle of the night (as reported) with swollen face specially cheeks and eyes was swollen. Right (RT) cheek was more swollen than the left (LT) side. RT Eye was covered due to RT eye lid skin was dropping down to the point she cannot use it until the next day it retracted back (as reported). Patient still have swollen face, cheeks and eyes. RT eye and RT cheek was more swollen and felt very uncomfortable to wear a mask specially N95. The patient recovered with lasting effects. It was reported that treatment received for events (also reported that no treatment). Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, she has been tested for COVID-19. Nasal Swab: unknown results on 22Feb2021 (COVID test post vaccination), negative on 02Mar2021. Outcome of all events was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dry skin, Pruritus, Skin disorder, Vaccination site erythema
Clinical narrative: itch; Red at injection site; Bruising; skin was a little more rough and more leathery than normal; skin was a little more rough and more leathery than normal; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 01Feb2021 14:40 (Batch/lot number: EL9265), at age 78 years old, as dose 2, single, for COVID-19 immunisation, at a hospital. Relevant medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), received on 11Jan2021 (Batch/lot number: ELO142), at 78 years old, as dose 1 single, for COVID-19 immunisation after which the patient experienced rash at injection site, bruise, vaccination site pruritus, vaccination site erythema, vaccination site swelling and her skin was a little more rough and more leathery than normal. On an unspecified date, after the second vaccination, the patient experienced itch, red at injection site, bruising and her skin was a little more rough and more leathery than normal. The patient received an unspecified flu vaccine in Sep2021. No treatment was received for events itch, bruising, and skin was a little more rough and more leathery than normal. The outcome of bruising was not recovered. The outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash pruritic, Vaccination site pain
Clinical narrative: arm pain at injection site; headache; slight itchy rash on hand of injection arm; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 23Feb2021 09:30 (lot number: EL3247; expiry date: unknown) at the age of 35-years-old, as dose 1, single, for Covid-19 immunization. Medical history included hypertension and obesity. Concomitant medications included metoprolol, ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO), and vitamins NOS both taken for unspecified indications, start and stop dates were not reported. The patient previously received cefaclor (CECLOR) and experienced allergies. The vaccine was administered in a workplace clinic. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 24Feb2021 at 19:00, the patient experienced arm pain at injection site, headache and slight itchy rash on hand of injection arm. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sharp muscle and joint pain after her first and second shot of the vaccine; it was more painful after her second shot, also developed rashes (about 3 inches in diameter) around the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Lymphadenopathy
Clinical narrative: Severe swelling of both throat located lymph nodes; discomfort/pain extending to middle of chest; discomfort/pain extending to middle of chest; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 28Feb2021 08:15 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included hypertension, congestive heart failure and type 2 diabetes (in remission). Concomitant medications included clonidine; amlodipine; dipyridamole (METROPOLYN); potassium; furosemide, and potassium chloride (LASIKAL); all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Skelaxin, Ceclor and Lamisil, and experienced drug allergy. On 28Feb2021 14:15, the patient experienced severe swelling of both throat located lymph nodes, with discomfort, and pain extending to middle of chest. No treatment was provided for the reported events. The reported events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Sinus disorder
Clinical narrative: Sinus problems; While blowing nose noticed blood clots and partial nose bleed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONETCH COVID-19 VACCINE; Lot Number: EL9267), via an unspecified route of administration in left arm, on 27Feb2021 at 01:30 PM (13:30) (at the age of 77 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included lung cancer and throat cancer. The patient's concomitant medications included tamsulosin, diltiazem, omeprazole, atorvastatin calcium (AZTOR), and fluticasone propionate. The patient previously took paracetamol/ pentazocine hydrochloride (TALACEN) and experienced allergies; and the first dose of BNT162B2 (Lot Number: EL8982) on 29Jan2021 at 12:30 PM (at the age of 77 years) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 28Feb2021 at 09:45 AM, the patient had sinus problems and while blowing nose noticed blood clots and partial nose bleed. The patient was also using fluticasone propionate but have never notice this before. No treatment was given for the adverse events. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: small mark from the needle; small mark from the needle and after 3 days it increased in size to smaller than a dime, was very itchy, and was beet red; small mark from the needle and after 3 days it increased in size to smaller than a dime, was very itchy, and was beet red; she still has hyperpigmentation from it; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number was not reported), via an unspecified route of administration in Feb2021 as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she had a small mark from the needle and after three days it increased in size to smaller than a dime, was very itchy, and was beet red. She took Benadryl and applied hydrocortisone cream on it and the symptoms resolved later that day. She mentioned that she still had hyperpigmentation from it. Outcome of the event hyperpigmentation was not recovered, while the remaining events recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number could not be requested. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Swelling
Clinical narrative: the area between the eyes became swollen and sore; the area between the eyes became swollen and sore; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 27Feb2021 16:00 (Batch/lot number: EN6198), at age 45 years old, as dose 2, single, for COVID-19 immunisation; and Botulinum toxin type A (BOTOX), via an unspecified route of administration, on 24Feb2021, at an unspecified dose and frequency, for an unspecified indication. The patient was not pregnant at the time of vaccination. Relevant medical history included multiple sclerosis and penicillin allergy both from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included suvorexant (BELSOMRA), gabapentin, escitalopram, and levonorgestrel (MIRENA), all taken for unknown indications, start and stop dates were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 07Feb2021 15:15 (Batch/lot number: EL9269), at age 45 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. On 01Mar2021 at 04:00 (reported as "approximately 36 hours after the second dose of the vaccine"), the area between the eyes became swollen and sore. This was the same area the patient received Botox approximately 5 days earlier. The patient did not receive treatment for the events. The action taken in response to the events for Botulinum toxin type A was unknown. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills; fever at 101.5 F; Body aches; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Mar2021 at 16:30 (Batch/Lot number was not reported; at the age of 40 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (diagnosed with COVID in December of unspecified year) and no thyroid (ongoing) which is controlled by SYNTHROID. No known allergies. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) for no thyroid. No other vaccine in four weeks. On 02Mar2021 at 04:00 am, the patient experienced chills, fever at 101.5 F, and body aches. This is the same reaction she had when she was diagnosed with COVID in December (unspecified year). It was unknown if the patient received treatment for the events. The patient has not been tested for COVID post vaccination. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9264,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 as DOSE1,SINGLE for covid-19 immunisation.The patient medical history and The patient's concomitant medications were not reported. The patient experienced soreness in arm on Feb2021, but it was gone by the next day. And also reported patient was scheduled for the 2nd dose on 26Feb2021. Therapeutic measures were taken as a result of soreness in arm and included treatment with 2 Tylenol. The clinical outcome of the event was recovered on Feb2021.   Follow-up (11MAY2021): Follow-up attempts completed. No further information expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Erythema, Swelling, Urticaria
Clinical narrative: left ring finger burning, swelling, redness was reported as worsened.; left ring finger burning; Swelling; Redness; states specifically the hive is between her ring and middle finger; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection ), via an unspecified route of administration, administered in the left arm on 24Feb2021 at 12:15 (at the age of 71-years-old) (Lot Number: N96200) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EL3246) on 03Feb2021 at 12:14 for COVID-19 immunisation. On 24Feb2021, the patient experienced left ring finger burning, swelling, redness and stated specifically the hive is between her ring and middle finger. It was reported on an unspecified date left ring finger burning, swelling, redness worsened. The outcome of the events burning sensation, swelling, erythema, and urticaria was not recovered/not resolved. Outcome of the event condition aggravated was unknown.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: right hand is swollen and is more painful. It radiates to her elbow; right hand is swollen and is more painful. It radiates to her elbow; right hand is swollen; was a little tired; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 17Feb2021 at 13:40 (Batch/Lot Number: EL9266) (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included joint pain that started at the beginning of her thumbs and meets at the wrist (more in the right hand, has a little on the left); she had this issue before and it was probably arthritis; aching in her shoulder (she thought it might be from shoveling and she felt it before getting the vaccine); had half of her thyroid removed in Sep2014 or Oct 2014. Concomitant medications included levothyroxine sodium (SYNTHROID, 25 ug) taken for an unspecified indication from Sep2014 and ongoing. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient did not receive any additional vaccines on the same date of the vaccination. The patient experienced was a little tired 18Feb2021; right hand was swollen on 23Feb2021; right hand more painful, it radiates to her elbow on 25Feb2021. The adverse events did not require an emergency or physician visit. The outcome of event was a little tired was unknown; outcome of event right hand is swollen was recovering; and outcome of events right hand pain, it radiates to her elbow was not recovered.  No follow up attempts are needed; information on tot/batch cannot be requested. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: lightheaded; shortness of breath; is a spontaneous report from a contactable physician.   A 50-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9810) via intramuscular, administered in arm left on 27Feb2021 10:58 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic hypertension (also reported as Chronic or long-standing health conditions: CHTN) and allergy to anti-malaria medications. The patient's concomitant medications were not reported. On 27Feb2021 11:15, the patient experienced lightheaded and shortness of breath. It was reported that the patient vitals were normal. The type of facility was reported as public health clinic. Patient other illness at the time of vaccination and up to month prior was reported to none. The alt symptoms resolved within IS minutes (as reported) and attributed to vasovagal response/anxiety (as reported). Unknown as reported if patient received treatment on the events. The outcome of the events was recovered on an unspecified date on 2021.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Bad nausea; headache; fever; muscle aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 15Feb2021 (Lot number was not reported, at the age of 24-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, allergies: Pork, bananas, mold, dust and COVID-19. Concomitant medication included other medications in two weeks. The patient previously received the first dose of bnt162b2 administered in right arm on 25Jan2021 (at the age of 24-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. On 16Feb2021 at 03:00AM, the patient experienced bad nausea, headache, fever, muscle aches, fatigue. The patient received no treatment for the events. The patient recovered from the events on unspecified date.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; bad chills; extreme fatigue; low grade fever; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 59-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in right arm on 24Feb2021 15:30 (at the age of 59 years old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. It was reported yes for known allergies. Concomitant medications included pantoprazole, pravastatin, and gabapentin. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 25Feb2021 09:00, the patient experienced sore arm, bad chills, extreme fatigue, low grade fever. The facility type vaccine was reported as school or student health clinic. There was no other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination. There was no treatment received on the events. The outcome of the events was recovered on an unspecified date on 2021.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Low grade fever; body aches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 15Feb2021 at 09:15 (lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included allergy to shellfish on an unknown date. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient did not received other vaccines in 4 weeks. The patient previously received the first dose of BNT162B2 (lot number: unknown) at 48-years-old on 18Jan2021 at 09:15 on the right arm for COVID-19 immunization. The patient was not tested for COVID post vaccination. The patient experienced flu like symptoms, low grade fever, body aches, chills and fatigue on 16Feb2021 at 01:30. The patient did not receive treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) PFIZER INC-2021233912 similar report from same reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Low grade fever; body aches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:15 (lot number and expiry date: unknown) at the age of 48-years-old, as dose 2, single for Covid-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 09:15 AM, at the age of 48-years-old, in the right arm, for Covid-19 immunisation. The vaccine was administered in a hospital. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 16Feb2021, at 01:30 AM, the patient experienced flu like symptoms, low grade fever, body aches, chills, and fatigue. The patient did not receive treatment for the events. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233905 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Fatigue, SARS-CoV-2 test
Clinical narrative: patient was going through actually Covid symptoms; lost sense of taste and smell; lost sense of taste and smell; fatigue and tired; Diarrhea; This is a spontaneous report from a contactable consumer. A male patient (consumer's father) of an unspecified age (reported as patient age: 83; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 17Feb2021 (Batch/Lot number was unknown) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the patient was going through actually Covid symptoms, on an unspecified date in Feb2021, where the patient lost sense of taste and smell. He was fatigue and tired and was now having diarrhea. The patient was having it from past 6 days. The patient underwent lab tests and procedures on 26Feb2021 which included COVID test with unknown results. The consumer wanted to get advice about the events and ideas about what could be happening and what they could do. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: patient was going through actually Covid symptoms; lost sense of taste and smell; lost sense of taste and smell; fatigue and tired; Diarrhea; This is a spontaneous report from a contactable consumer. A male patient (consumer's father) of an unspecified age (reported as patient age: 83; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 17Feb2021 (Batch/Lot number was unknown) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the patient was going through actually Covid symptoms, on an unspecified date in Feb2021, where the patient lost sense of taste and smell. He was fatigue and tired and was now having diarrhea. The patient was having it from past 6 days. The patient underwent lab tests and procedures on 26Feb2021 which included COVID test with unknown results. The consumer wanted to get advice about the events and ideas about what could be happening and what they could do. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling of eyelid
Clinical narrative: swelling of eyelids; Facial redness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disorder from an unknown date. There were no concomitant medications.  The patient previously took hydrocodone/paracetamol (VICODIN) and codeine and had allergies. The patient experienced swelling of eyelids and facial redness on 03Mar2021 at 12:00. Therapeutic measures were taken as a result of the events which included diphenhydramine (BENADRYL). The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Feeling abnormal, Gastrointestinal pain
Clinical narrative: gut hurts; gut area was swollen and described as "looked about 8 months pregnant" as if the patient was exposed to gluten/ extremely bloated; felt terrible; extremely tired; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: E19267 and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 22Feb2021 12:30 (at the age of 51 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Hypothyroid/Hashimoto, ITP (idiopathic thrombocytopenic purpura), and celiac (celiac disease). The patient has known allergies to penicillin, sulfur, statins, peppers, and gluten protein. Concomitant medications included levothyroxine sodium (SYNTHROID) and cetirizine hydrochloride (ZYRTEC) taken for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 22Feb2021, within an hour after receiving the vaccine, the patient's gut area was swollen and described as "looked about 8 months pregnant" as if the patient was exposed to gluten. The patient also felt terrible and was extremely tired. On 26Feb2021, four days after receiving the shot, the patient was still extremely bloated and reported that her gut hurts. The patient will not take the 2nd shot. The patient did not receive any treatment. The outcome of the reported events was recovering.  No follow-up attempts are possible. No further information is expected.