chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Rash, Somnolence
Clinical narrative: rash; tired; sore; dont want to wake; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash all up the right side of leg, very tired, sore, didn't want to wake up and flu like symptoms on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: feels unwell; has a temperature of 99.4 F/fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 at 12:46 as DOSE 2, SINGLE (at the age of 66-years-old) for covid-19 immunisation. The patient medical history was not reported. The patient had no history of drinking, smoking or doing drugs. No prior vaccinations (within 4 weeks). The patient concomitant medications included ongoing aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) (81 mg once daily) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole and experienced drug hypersensitivity presented as an all over body rash that started on the 10th day of a 10 day regimen, prednisone and experienced drug hypersensitivity, ampicillin and experienced drug hypersensitivity on day 3 of a 10 day regimen and compazine [prochlorperazine maleate] for nausea and experienced drug hypersensitivity. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Mar2021 at 12:46 as DOSE 1, SINGLE (at the age of 66-years-old) for covid-19 immunisation. The patient experienced injection site pain on 31Mar2021, feels unwell on an unspecified date. The patient had a temperature of 99.4 f on 01Apr2021. She knew her temperature every hour of every day. Since the Covid 19 virus started she had taken her temperature a lot. She had already on her second digital thermometer. Her temperature today was 99.3F. She was asking when she can start to take tylenol for her fever. She did not want the fever to get worse, she wanted tonip it in the bud. She reported the fever began within 23 hours of receiving her second covid 19 vaccine. Adverse events did not require a visit to emergency room/ physician office. The patient underwent lab tests and procedures which included body temperature: 99.3 fahrenheit on an unspecified date. The clinical outcome of the event temperature of 99.4 f was not recovered and other events were unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip pruritus, Lip swelling, Oral pruritus, Paraesthesia
Clinical narrative: itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"/itching on her arm /itching was on the caller's neck /spreading to her face and chin; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; lips were itching and swelling; Had allergic reaction to the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age (Age: 60; Unit: Unknown as reported) received first dose bnt162b2 (Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included asthma, diabetes, shellfish allergy. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for asthma. The patient previously took Advair for asthma. On an unspecified date, the patient experienced itching and tingling in her "lips, mouth, and skin" and stated the next day these symptoms transferred to her face and her chin. She reported having no trouble breathing, no weakness, no fast heartbeat, no swelling in the face or throat, and no dizziness. She stated that she spoke with a pharmacist who recommended she take Benadryl so she did for a week, which was how long her symptoms lasted before going away. 10 mins after the vaccine the caller was itching on her arm. The next day the itching was on the caller's neck. And then the next day the caller's lips were itching and swelling, and it was spreading to her face and chin the next couple of days. The caller called her primary care about this but no one was there. The caller then called the pharmacist and the pharmacist told her to get some Benadryl which she took for over a week. Second immunization coming up. Had allergic reaction to the first dose. The 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: Paraesthesia oral, Pruritus
Clinical narrative: itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"/itching on her arm /itching was on the caller's neck /spreading to her face and chin; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; itching and tingling in her "lips, mouth, and skin"; lips were itching and swelling; Had allergic reaction to the first dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age (Age: 60; Unit: Unknown as reported) received first dose bnt162b2 (Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included asthma, diabetes, shellfish allergy. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for asthma. The patient previously took Advair for asthma. On an unspecified date, the patient experienced itching and tingling in her "lips, mouth, and skin" and stated the next day these symptoms transferred to her face and her chin. She reported having no trouble breathing, no weakness, no fast heartbeat, no swelling in the face or throat, and no dizziness. She stated that she spoke with a pharmacist who recommended she take Benadryl so she did for a week, which was how long her symptoms lasted before going away. 10 mins after the vaccine the caller was itching on her arm. The next day the itching was on the caller's neck. And then the next day the caller's lips were itching and swelling, and it was spreading to her face and chin the next couple of days. The caller called her primary care about this but no one was there. The caller then called the pharmacist and the pharmacist told her to get some Benadryl which she took for over a week. Second immunization coming up. Had allergic reaction to the first dose. The 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: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: headache; fever of 100.5-100.7 F; aching at the injection site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Jan2020 to an unknown date.  The patient's concomitant medications were not reported. On an unspecified date, the patient experienced headache, fever of 100.5-100.7 F, and aching at the injection site. It was reported by the patient that she was told to receive the 1st dose 3 months after recovering from the virus but she received it 2 months after. The patient wanted to know if she should receive the 2nd dose 3 or 4 weeks after her 1st dose instead so that it would be 3 months after she had COVID. 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Body temperature, Chills
Clinical narrative: Weakness; 100.2 degree fever; body aches; chills; severe headache; sinus and chest congestion; sinus and chest congestion; nausea; dry heaves; loss of appetite/no appetite; loss of taste/not taste; loss of smell/no smell; sore throat; runny nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 24Mar2021 at 18:45 (at the age of 45 years old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunisation. Medical history included no (reported other medical history- No). The patient's concomitant medications were not reported.  The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID-19 prior to vaccination. The patient had been tested for COVID post-vaccination.  On 25Mar2021, the patient experienced sore throat and runny nose. On 26Mar2021, the patient experienced body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, and loss of smell. On 27Mar2021, the patient experienced 100.2 degree fever. On 28Mar2021, the patient experienced weakness. The course of the events was as follows: Day 1: sore throat, runny nose; Day 2: body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, loss of smell; Day 3: 100.2 degree fever, severe headache, sinus and chest congestion, body aches, chills, no appetite, not taste, no smell; Day 4: Weakness, minor headaches, minor sinus and chest congestion, cough, return of some appetite taste and smell. No treatment was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 RT-PCR): negative on 29Mar2021 and SARS-CoV-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Weakness; 100.2 degree fever; body aches; chills; severe headache; sinus and chest congestion; sinus and chest congestion; nausea; dry heaves; loss of appetite/no appetite; loss of taste/not taste; loss of smell/no smell; sore throat; runny nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 24Mar2021 at 18:45 (at the age of 45 years old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunisation. Medical history included no (reported other medical history- No). The patient's concomitant medications were not reported.  The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID-19 prior to vaccination. The patient had been tested for COVID post-vaccination.  On 25Mar2021, the patient experienced sore throat and runny nose. On 26Mar2021, the patient experienced body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, and loss of smell. On 27Mar2021, the patient experienced 100.2 degree fever. On 28Mar2021, the patient experienced weakness. The course of the events was as follows: Day 1: sore throat, runny nose; Day 2: body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, loss of smell; Day 3: 100.2 degree fever, severe headache, sinus and chest congestion, body aches, chills, no appetite, not taste, no smell; Day 4: Weakness, minor headaches, minor sinus and chest congestion, cough, return of some appetite taste and smell. No treatment was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 RT-PCR): negative on 29Mar2021 and SARS-CoV-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Retching, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Weakness; 100.2 degree fever; body aches; chills; severe headache; sinus and chest congestion; sinus and chest congestion; nausea; dry heaves; loss of appetite/no appetite; loss of taste/not taste; loss of smell/no smell; sore throat; runny nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 24Mar2021 at 18:45 (at the age of 45 years old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunisation. Medical history included no (reported other medical history- No). The patient's concomitant medications were not reported.  The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID-19 prior to vaccination. The patient had been tested for COVID post-vaccination.  On 25Mar2021, the patient experienced sore throat and runny nose. On 26Mar2021, the patient experienced body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, and loss of smell. On 27Mar2021, the patient experienced 100.2 degree fever. On 28Mar2021, the patient experienced weakness. The course of the events was as follows: Day 1: sore throat, runny nose; Day 2: body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, loss of smell; Day 3: 100.2 degree fever, severe headache, sinus and chest congestion, body aches, chills, no appetite, not taste, no smell; Day 4: Weakness, minor headaches, minor sinus and chest congestion, cough, return of some appetite taste and smell. No treatment was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 RT-PCR): negative on 29Mar2021 and SARS-CoV-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Weakness; 100.2 degree fever; body aches; chills; severe headache; sinus and chest congestion; sinus and chest congestion; nausea; dry heaves; loss of appetite/no appetite; loss of taste/not taste; loss of smell/no smell; sore throat; runny nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 24Mar2021 at 18:45 (at the age of 45 years old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunisation. Medical history included no (reported other medical history- No). The patient's concomitant medications were not reported.  The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID-19 prior to vaccination. The patient had been tested for COVID post-vaccination.  On 25Mar2021, the patient experienced sore throat and runny nose. On 26Mar2021, the patient experienced body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, and loss of smell. On 27Mar2021, the patient experienced 100.2 degree fever. On 28Mar2021, the patient experienced weakness. The course of the events was as follows: Day 1: sore throat, runny nose; Day 2: body aches, chills, severe headache, sinus and chest congestion, nausea, dry heaves, loss of appetite, loss of taste, loss of smell; Day 3: 100.2 degree fever, severe headache, sinus and chest congestion, body aches, chills, no appetite, not taste, no smell; Day 4: Weakness, minor headaches, minor sinus and chest congestion, cough, return of some appetite taste and smell. No treatment was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 RT-PCR): negative on 29Mar2021 and SARS-CoV-2 test (Nasal Swab): negative on 29Mar2021. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in site, and in forearm, that also happened when vaccine was injected; pain in site, and in forearm, that also happened when vaccine was injected; chills; fever; congestion; achy; This is a spontaneous report from a non-contactable other health care professional (nurse). A female patient of a 68 (units unknown) age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, Expiry date: not reported), dose 1 via an unspecified route of administration, administered at unspecified anatomical location on 19Mar2021 (age at vaccination was 68 (units unknown) as dose 1, single for COVID-19 immunization. Medical history included shortness of breath. The patient concomitant medications were not reported. In Mar2021, The patient experienced chills, fever, congestion. On 19Mar2021, patient also experienced pain in site, and in forearm, that also happened when vaccine was injected. on an unspecified date, experienced achy. The patient stated that she did not take any medications and suspected that she may have had covid 3 or 4 months before it hit her region, but no testing was done, so she never had a PCR test. The patient may be a little bit of long hauler with ongoing symptoms. The patient had shortness of breath with the virus but haven't taken pulse ox in a while. The patient major concern is because she had 18 hours of achy, chills, after the first dose, and thinking, this may be a little bit more information toward (or indicating) that she did have it last year. The patient plan was to wait two weeks and donate blood. to decrease her volume by 10 % and a week later when she has a chance to recoup get the second dose, hoping that it may lessen the response from the second dose. Long haulers from the virus have not found a good way to alleviate those symptoms, they try, vitamin C, NAC, heat, ice. A couple of issues to help with symptoms, but not working much. There are people who have had the virus that respond to the first dose and respond to the second dose with a spiking temp and getting symptoms again, and then it clears, and their energy comes back, they don't experience as much shortness of breath and there is a lifting of brain fog, they basically feel 80 % back to normal. The patient wanted to know whether she can donate blood, if she chooses to donate blood tomorrow she should have some antibodies, it's good for them they get a unit of blood and a unit of blood with antibodies. The patient was wondering if by donating blood would it lessen the effects of the second dose. The (institution name) says if you are 3 days away from the injection you are good to donate. The patient wanted to know whether she can be in clinical trial. Where she one of population in 1.5 million people, only 300,000 have registered for the vaccine. The outcome of chills, fever, congestion, vaccination site pain, pain was unknown and outcome of pain in extremity was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: very sick; This is a spontaneous report from a contactable consumer (patient). This is a report based on information received by Pfizer from (Mylan) GI-2021-2909, license party for pneumococcal 13-val conjugate vaccine. An 86-years-old female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (reported as last January, year unknown) (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. Patient took a Pneumococcal flu shot and was very sick. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: First vaccine 18Feb2021, raised rash inner arms, arm pits, body sides, stomach inner thighs.  After second dose moved to upper thighs and back; This is a spontaneous report from a contactable consumer.   A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 11Mar2021 (Batch/Lot Number: En6199) as dose 2, single (at the age of 78 years old) for COVID-19 immunisation.  Medical history included osteoporosis taking pravastatin, gabapentin, omeprazole.  The patient's concomitant medications included pravastatin, gabapentin, omeprazole start and stop date not reported for unknown indication.  The patient previously took first vaccine 18Feb2021 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) for COVID-19 immunisation and experienced raised rash inner arms, arm pits, body sides, stomach inner thighs. From first vaccine, raised rash inner arms, arm pits, body sides, stomach inner thighs and after second dose moved to upper thighs and back on Mar2021. Resulted in doctor or other healthcare professional office/clinic visit. Treatment was first a steroid shot, then on 29Mar2021, prednisone.  The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Pyrexia
Clinical narrative: extreme fatigue; fever/Fever is jumping from 100 to 104; Sick; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included spleen removal 25 years ago. The patient's concomitant medications were not reported. The patient reported that he has a fever, and extreme fatigue on an unknown . The patient had the shot Tuesday morning, on an unknown, he meant hours kept me sick. Fever was jumping from 100 to 104 and asked for data regarding people like him that do not have a spleen and their experience with the Pfizer shot. The patient underwent lab tests which included body temperature jumping from 100 to 104 on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: rash on my face, all over my arm, on my back, on my stomach; fever; muscle pain; lymph nodes are swollen; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration date: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunization. Medical history included birth control. Concomitant medication(s) included paracetamol (TYLENOL); diphenhydramine hydrochloride (BENADRYL); ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for birth control, start and stop date unknown. On an unspecified date, patient experienced rash on my face, all over my arm, on my back, on my stomach, fever about 30 minutes ago, muscle pain, lymph nodes are swollen, chills. On an unspecified date, patient underwent lab tests and procedures which included body temperature was 101. Patient would like to know what she should do about side effects and if it is  safe to get second dose of vaccine. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my face, all over my arm, on my back, on my stomach; fever; muscle pain; lymph nodes are swollen; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration date: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 20-years-old) as dose 1, single for covid-19 immunization. Medical history included birth control. Concomitant medication(s) included paracetamol (TYLENOL); diphenhydramine hydrochloride (BENADRYL); ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for birth control, start and stop date unknown. On an unspecified date, patient experienced rash on my face, all over my arm, on my back, on my stomach, fever about 30 minutes ago, muscle pain, lymph nodes are swollen, chills. On an unspecified date, patient underwent lab tests and procedures which included body temperature was 101. Patient would like to know what she should do about side effects and if it is  safe to get second dose of vaccine. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphonia, Painful respiration, Parosmia
Clinical narrative: strange taste in mouth / tasting sauteed green onions and green peppers; smelling and tasting sauteed green onions and green peppers; voice a little hoarse; chest hurts when taking a deep breath; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered on right arm (reported as right upper arm) on 25Mar2021 at 13:00 (age at vaccination was 53-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing optic neuritis (had for 7 years; in both eyes), ongoing thyroid problems (had probably 20 years or so), ongoing gastrointestinal problems, gall bladder issues, migraine and allergies. The patient's concomitant medications included ongoing fluoxetine 20 mg capsule, latanoprost eye drops, levothyroxine sodium 75 mg for thyroid, ongoing pantoprazole sodium 40 mg tablet, ongoing valproic acid 250 mg capsule for migraine and an over the counter medicine for allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 26Mar2021, the patient experienced strange taste in mouth; smelling and tasting sauteed green onions and green peppers; voice a little hoarse and chest hurts when taking a deep breath. It was further reported that the strange taste in her mouth started day after the vaccine and slowly started to linger away or dwindle. The patient was smelling and tasting sauteed green onions and green peppers and it was out of the blue when it came but was slowly disappearing. It was reported that her voice has been a little hoarse and was still the same until the report. Her chest hurts when she takes a deep breath in sometimes, she describe it like the feeling you get when you are out in the cold and it hurts; and was still the same until the report. The patient wants to know if there was a certain time to wait for the symptoms and if she should go to see her doctor. No therapeutic measures taken as a result of the events. The outcome of the events strange taste in mouth; and smelling and tasting sauteed green onions and green peppers were recovering while other reported events were not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: feeling crappy; nausea; headache; equilibrium is off; fever; tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling crappy, nausea, headache, equilibrium is off, fever, and tired. 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling crappy; nausea; headache; equilibrium is off; fever; tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling crappy, nausea, headache, equilibrium is off, fever, and tired. 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hot flush, Influenza like illness, Limb discomfort
Clinical narrative: lymph nodes in arm pit swollen (about half the size of a softball); Fatigue/tired; Slight fever; heavy legs; achy, sore; Flu-like symptoms; he was warm and flushed; feeling bad; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).     A 52-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in arm left on 24Mar2021 at 11:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery (also reported as the patient had 4-and-a-half-hour surgery and gave blood thinners), prostate cancer, prostatectomy (recovering, 03Mar2021, also reported as 4 weeks ago), incontinence and erectile dysfunction. Concomitant medication included tadalafil (CIALIS, taking a low dose) taken for prostatectomy from 13Mar2021 and ongoing. On 25Mar2021, the patient experienced lymph nodes in arm pit swollen (about half the size of a softball, discovered the node when he went to take a shower), fatigue, slight fever, heavy legs, achy, sore, and tired, flu-like symptoms, warm and flushed, feeling bad (about 24 hours later). The patient stated that he hasn't done anything today because movement makes it worse. Patient prior vaccinations within 4 weeks were reported as none and adverse events following prior vaccination reported also as none. The adverse events did not result to emergency room or physician office visit. The outcome of the events lymph nodes in arm pit swollen and fatigue was recovering; outcome of warm and flushed, feeling bad was unknown; outcome of all the other events was recovered on 26Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: lymph nodes in arm pit swollen (about half the size of a softball); Fatigue/tired; Slight fever; heavy legs; achy, sore; Flu-like symptoms; he was warm and flushed; feeling bad; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).     A 52-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in arm left on 24Mar2021 at 11:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery (also reported as the patient had 4-and-a-half-hour surgery and gave blood thinners), prostate cancer, prostatectomy (recovering, 03Mar2021, also reported as 4 weeks ago), incontinence and erectile dysfunction. Concomitant medication included tadalafil (CIALIS, taking a low dose) taken for prostatectomy from 13Mar2021 and ongoing. On 25Mar2021, the patient experienced lymph nodes in arm pit swollen (about half the size of a softball, discovered the node when he went to take a shower), fatigue, slight fever, heavy legs, achy, sore, and tired, flu-like symptoms, warm and flushed, feeling bad (about 24 hours later). The patient stated that he hasn't done anything today because movement makes it worse. Patient prior vaccinations within 4 weeks were reported as none and adverse events following prior vaccination reported also as none. The adverse events did not result to emergency room or physician office visit. The outcome of the events lymph nodes in arm pit swollen and fatigue was recovering; outcome of warm and flushed, feeling bad was unknown; outcome of all the other events was recovered on 26Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Pruritus
Clinical narrative: itching / scratchy / head is itchy where her hairline is; some little pimples, kind of like a rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Mar2021, the patient experienced itching / scratchy / head is itchy where her hairline is; and some little pimples, kind of like a rash. It was further reported that she was calling because on the 10th she got her vaccine and a couple days ago she had itching and some little pimples, kind of like a rash. It was reported that it was scratchy like a mosquito bite. She has some on her arms, her stomach, her back, her legs and her head is itchy where her hairline is. The caller wanted to know what to do since tomorrow was her due for her second dose. She asked if she needed to cancel it or get the second vaccine. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6207), at the vaccination age of 79, via an unspecified route of administration, in left arm (reported as left upper arm), on Mar 16, 2021, at 13:30, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications: none. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On Mar 18, 2021, patient experienced rash on her upper left arm, chest, back and neck (just the left-side). The outcome of the event: recovering. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Sneezing
Clinical narrative: Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; This is a spontaneous report from a contactable consumer (Reporter is calling on behalf of her aunt). A unspecified age of female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/lot number: Not Provided) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The patients medical history and concmittant medications were not reported. On unspecified date, the patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow. Reporter states she is going to tell the patient to just go next week for second vaccine. Reporter is calling on behalf of her aunt, who received the first dose of Covid-19 vaccine on 10Mar and had a scheduled appointment for a second dose due tomorrow, 31Mar. She mentioned that her aunt has an allergy and body ache yesterday so she cannot go tomorrow. Asked if she can cancel her appointment tomorrow and go next week. The oucome of events was unknown.  Follow-up (05Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query: Please see the attached source document with a medical inquiry. AER# 2021361419.Response: This is to confirm receipt of inquiry. Please see case in GRACE, INT-#  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over; on her chest, arms, and neck; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in right arm on 17Mar2021 at 12:00 (age at vaccination was 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Sjogren's syndrome (for 5 years and it was an autoimmune disease; took 2 medications) from an unspecified date of 2016 and high cholesterol. The patient's concomitant medications were reported as none. The patient previously took hydroxychloroquine sulfate (PLAQUENIL) and pilocarpine hydrochloride (SALAGEN); both for Sjogren's syndrome; and atorvastatin for high cholesterol. The patient did not receive any other vaccine within 4 weeks. On Mar2021, the patient experienced a rash all over; on her chest, arms, and neck. It was reported that the patient was trying to make an appointment with a dermatologist. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Pain in extremity, Peripheral swelling
Clinical narrative: swollen arms; lymph node, arms and wrists hurt; arms and wrists hurt; wrists hurt; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN620G), via an unspecified route of administration, administered in left arm on 24Feb2021 (age at vaccination was 63-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient received concomitant medications in two weeks. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The facility where the COVID-19 vaccine was administered was in hospital. On 24Feb2021 at 16:00, the patient experienced swollen arms; and lymph node, arms and wrists hurt. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Fatigue, Headache
Clinical narrative: coughing; nasal started dripping and burning; nasal started dripping and burning; Headache; aching; wants to puke all the time; arm was sore; Nauseous; Weak; tired; Chills; sweat; left arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 60-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 29Mar2021 at 07:30 (Batch/Lot Number: ER8733) (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma. The patient had no family medical history relevant to the adverse event. The patient did not undergo any relevant tests. The patient had no concomitant medications. The patient had no history of all previous immunisation with Pfizer vaccine considered as suspect. The patient received no vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced arm was sore, nauseous, weak and tired, headache, aching, wants to puke all the time, chills on 29Mar2021; coughing, nasal started dripping and burning on 29Mar2021 at 21:00; left arm was swollen, sweat on an unspecified date in Mar2021. The patient did not have the cough anymore. The patient was fine all day until 9:00 pm. The events did not result in physician's office visit or emergency room visit. The outcome of events nauseous, weak, nasal started dripping and burning was not recovered; outcome of events arm was sore, tired and chills was recovering; outcome of events headache, aching, wants to puke all the time, left arm was swollen, sweat was unknown; outcome of event coughing was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasal discomfort, Nausea, Pain, Pain in extremity
Clinical narrative: coughing; nasal started dripping and burning; nasal started dripping and burning; Headache; aching; wants to puke all the time; arm was sore; Nauseous; Weak; tired; Chills; sweat; left arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 60-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 29Mar2021 at 07:30 (Batch/Lot Number: ER8733) (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma. The patient had no family medical history relevant to the adverse event. The patient did not undergo any relevant tests. The patient had no concomitant medications. The patient had no history of all previous immunisation with Pfizer vaccine considered as suspect. The patient received no vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced arm was sore, nauseous, weak and tired, headache, aching, wants to puke all the time, chills on 29Mar2021; coughing, nasal started dripping and burning on 29Mar2021 at 21:00; left arm was swollen, sweat on an unspecified date in Mar2021. The patient did not have the cough anymore. The patient was fine all day until 9:00 pm. The events did not result in physician's office visit or emergency room visit. The outcome of events nauseous, weak, nasal started dripping and burning was not recovered; outcome of events arm was sore, tired and chills was recovering; outcome of events headache, aching, wants to puke all the time, left arm was swollen, sweat was unknown; outcome of event coughing was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rhinorrhoea, Vomiting
Clinical narrative: coughing; nasal started dripping and burning; nasal started dripping and burning; Headache; aching; wants to puke all the time; arm was sore; Nauseous; Weak; tired; Chills; sweat; left arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 60-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 29Mar2021 at 07:30 (Batch/Lot Number: ER8733) (at the age of 60 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma. The patient had no family medical history relevant to the adverse event. The patient did not undergo any relevant tests. The patient had no concomitant medications. The patient had no history of all previous immunisation with Pfizer vaccine considered as suspect. The patient received no vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced arm was sore, nauseous, weak and tired, headache, aching, wants to puke all the time, chills on 29Mar2021; coughing, nasal started dripping and burning on 29Mar2021 at 21:00; left arm was swollen, sweat on an unspecified date in Mar2021. The patient did not have the cough anymore. The patient was fine all day until 9:00 pm. The events did not result in physician's office visit or emergency room visit. The outcome of events nauseous, weak, nasal started dripping and burning was not recovered; outcome of events arm was sore, tired and chills was recovering; outcome of events headache, aching, wants to puke all the time, left arm was swollen, sweat was unknown; outcome of event coughing was recovered on 30Mar2021.  No follow-up attempts are possible. No further information is expected.