chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain, Vaccination site pruritus
Clinical narrative: Raised irregular rash (3 inches x 6 inches) on upper left arm around injection site; Rash was quite itchy but was not painful (potentially COVID arm); Severe headache; swollen gland in left side of neck (near clavicle); tiredness; aches; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 24Mar2021 11:45 (Lot Number: EL3247) (at the age of 48-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to bees and mold. The patient received birth control and vitamins as concomitant medications within 2 weeks of vaccination. The patient previously took some antibiotics and experienced allergy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 11:45 (Lot Number: EL3247) (at the age of 48-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 04:30, the patient experienced severe headache, swollen gland in left side of neck (near clavicle), tiredness and aches. On 27Mar2021 06:00, the patient had raised irregular rash (3 inches x 6 inches) on upper left arm around injection site; rash was quite itchy but was not painful (potentially COVID arm). The patient did not receive any treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Raised irregular rash (3 inches x 6 inches) on upper left arm around injection site; Rash was quite itchy but was not painful (potentially COVID arm); Severe headache; swollen gland in left side of neck (near clavicle); tiredness; aches; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 24Mar2021 11:45 (Lot Number: EL3247) (at the age of 48-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to bees and mold. The patient received birth control and vitamins as concomitant medications within 2 weeks of vaccination. The patient previously took some antibiotics and experienced allergy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 11:45 (Lot Number: EL3247) (at the age of 48-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 04:30, the patient experienced severe headache, swollen gland in left side of neck (near clavicle), tiredness and aches. On 27Mar2021 06:00, the patient had raised irregular rash (3 inches x 6 inches) on upper left arm around injection site; rash was quite itchy but was not painful (potentially COVID arm). The patient did not receive any treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Lymph node pain, Pain
Clinical narrative: my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; By 530 I started sweating; I woke up at 3am the morning of the 24th with uncontrollable chills; I then determined that I had a fever of 101.2; I got out of bed and noticed my body was aching all over; My arm that received the shot was tender/my underarm is swollen and painful; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient woke up in the morning with uncontrollable chills, had a fever of 101.2 on 24Mar2021 03:00, on 24Mar2021 05:30 he started sweating, on 24Mar2021, he got out of bed and noticed the body was aching all over, arm that received the shot was tender. On 25Mar2021, left lymph node (shot was received in left arm) was hurting, underarm is swollen and painful. The patient underwent lab tests and procedures which included body temperature: 101.2 on 24Mar2021. 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: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; my left lymph node (shot was received in left arm), was hurting and my underarm is swollen and painful; By 530 I started sweating; I woke up at 3am the morning of the 24th with uncontrollable chills; I then determined that I had a fever of 101.2; I got out of bed and noticed my body was aching all over; My arm that received the shot was tender/my underarm is swollen and painful; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient woke up in the morning with uncontrollable chills, had a fever of 101.2 on 24Mar2021 03:00, on 24Mar2021 05:30 he started sweating, on 24Mar2021, he got out of bed and noticed the body was aching all over, arm that received the shot was tender. On 25Mar2021, left lymph node (shot was received in left arm) was hurting, underarm is swollen and painful. The patient underwent lab tests and procedures which included body temperature: 101.2 on 24Mar2021. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza virus test, Myalgia, Neuralgia
Clinical narrative: Achy arm; It felt more like a nerve ache; It felt more like a nerve ache than a muscle ache.; Aching all over; Little achy in the shoulders; Slight headache/Severe headache; 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, lot number: EN6208, expiration date was not reported) via an unspecified route of administration, in left arm, on 16Mar2021 (at the age of 60-years-old), at dose 1, single for covid-19 immunization. Medical history included arthritis. Concomitant medications included Vitamins (VITAMIN NOS) and a hormone patch (unspecified). Historical vaccine included flu shot (INFLUENZA VACCINE) and had a reaction before/after the shot. The patient experienced little achy in the shoulders on the night of the shot, slight headache and by sometime in the morning it was gone/ severe headache on 16Mar2021, aching all over; it felt more like a nerve ache than a muscle ache on 21Mar2021, achy arm; not the one she had the shot on an unspecified date. The patient went to the urgent care for achy arm. The patient underwent lab tests and procedures which included rapid test and a test for the flu, and both came back negative, the three-day test showed on Wednesday some blood in her urine on an unspecified date. Therapeutic measures took for all the events were included Tylenol sinus, Tylenol extra strength; acetaminophen for achiness and headache, someone suggested the headache might be sinus, took arthritis Tylenol extended release every 6 hours. Arthritis Tylenol extended release helped and the condition improved. The patient still had some of the aching all over, she will feel normal with the Tylenol. After the time to take the medicine it comes back and noticed it most in the mid night. The other night she had to get out of bed and come down, maybe the headache was so bad because she was lying down, that was before she started the arthritis Tylenol 650mg. The outcome of the events little achy in the shoulders recovered on 17Mar2021, achy arm was unknown, and outcome of all other events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test, Urine analysis
Clinical narrative: Achy arm; It felt more like a nerve ache; It felt more like a nerve ache than a muscle ache.; Aching all over; Little achy in the shoulders; Slight headache/Severe headache; 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, lot number: EN6208, expiration date was not reported) via an unspecified route of administration, in left arm, on 16Mar2021 (at the age of 60-years-old), at dose 1, single for covid-19 immunization. Medical history included arthritis. Concomitant medications included Vitamins (VITAMIN NOS) and a hormone patch (unspecified). Historical vaccine included flu shot (INFLUENZA VACCINE) and had a reaction before/after the shot. The patient experienced little achy in the shoulders on the night of the shot, slight headache and by sometime in the morning it was gone/ severe headache on 16Mar2021, aching all over; it felt more like a nerve ache than a muscle ache on 21Mar2021, achy arm; not the one she had the shot on an unspecified date. The patient went to the urgent care for achy arm. The patient underwent lab tests and procedures which included rapid test and a test for the flu, and both came back negative, the three-day test showed on Wednesday some blood in her urine on an unspecified date. Therapeutic measures took for all the events were included Tylenol sinus, Tylenol extra strength; acetaminophen for achiness and headache, someone suggested the headache might be sinus, took arthritis Tylenol extended release every 6 hours. Arthritis Tylenol extended release helped and the condition improved. The patient still had some of the aching all over, she will feel normal with the Tylenol. After the time to take the medicine it comes back and noticed it most in the mid night. The other night she had to get out of bed and come down, maybe the headache was so bad because she was lying down, that was before she started the arthritis Tylenol 650mg. The outcome of the events little achy in the shoulders recovered on 17Mar2021, achy arm was unknown, and outcome of all other events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: muscle and joint pain; muscle and joint pain; chills; This is a spontaneous report from Pfizer colleague. A contactable consumer or other non-HCP (patient) reported that: A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 23Mar2021 (Lot number: EP6955) as single dose and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 01Mar2021 14:30 (Lot number: EL3247, at the age of 58-year-old) as single dose both via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications within 2 weeks of vaccination included vitamins via an unspecified route of administration from an unknown date for an unspecified indication unknown if ongoing. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 24Mar2021 patient experienced muscle and joint aches, chills. Therapeutic measures were taken as a result of the event muscle and joint aches which included medication for pain and muscle spasms (Tylenol). Events were non-serious. Outcome of the event chills recovered on 25Mar2021. Outcome of the event muscle and joint aches recovered on 26Mar2021.  No follow-up attempts are needed, no further information is expected
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on Feb2021 (at the age of 76-year-old) as DOSE 1, SINGLE, for covid-19 immunization in Pharmacy or Drug Store. Medical history included chronic obstructive pulmonary disease, asthma, hypertension, blood cholesterol, and penicillin allergy. Concomitant medications included hctz, atorvastatin, lisinopril, fluticasone propionate, salmeterol (WIXELA INHUB), albuterol (salbutamol). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient experienced complete loss of smell and taste on 14Mar2021. It was reported that events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included anosmia: smell test and computerized tomogram on unknown date, result unknown for both, sars-cov-2 test: negative   on 17Mar2021. Therapeutic measures were taken as a result of events included Flonase. The outcome of the events was Not recovered at time of report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash after 2nd dose; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after second dose, patient experienced rash. It was reported that event took place after the use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site bruising
Clinical narrative: headache; body aches; slight bruising at injection site; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced headache, body aches, and slight bruising at injection site. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: solid red rash; Arm pain; Arm itches; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730) dose 2, via an unspecified route of administration, administered in arm left on 25Mar2021 at 05:45 PM (age at vaccination 59 years) as dose 2, single for COVID-19 immunization. Medical history included diabetes type 2, high blood pressure, high cholesterol, IBS-D (Irritable bowel syndrome with diarrhoea), low acting thyroid, anxiety and allergy to cats. The patient previously took sulfa, polysporin, erythromycin and experienced allergy, cephale and experienced rash. Concomitant medications included dapagliflozin propanediol monohydrate (FARXIGA) 5mg, Levothyroxine 100mcg, Lisinopril 10mg M. Covid prior vaccination and covid tested post vaccination was reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration, administered in arm left on 04Mar2021 06:15 PM (age at vaccination 59 years) as dose 1, single for COVID-19 immunization. On 27Mar2021, patient experienced arm pain was going away, arm itches and there was a solid red rash. Seriousness of the events were non serious. The patient did not receive any treatment for the adverse events however Calamine lotion helps. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test, Swelling
Clinical narrative: first dose in the left arm and had underarm pain and swelling/left under arm pain; first dose in the left arm and had underarm pain and swelling/left under arm swelling; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL3247, expiration date was not reported) via an unspecified route of administration, in left arm, on 08Feb2021 (at the age of 42-years-old) at dose 1, single for covid-19 immunization. Medical history included spleen removed and other conditions (unspecified) at least before 13 years. Concomitant medication included botulinum toxin type a (BOTOX) taken as a facial paralyzer from Feb2021. The patient received the first dose of vaccination in the left arm and had underarm pain/left under arm pain and swelling/left under arm swelling on 10Feb2021. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6201) on 03Mar2021 for covid-19 immunization. The patient underwent lab tests and procedures which included covid-19 test: negative on 24Mar2021. The outcome of the events was recovered on 20Feb2021.     No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; a slight fever; had a sore arm; This is a spontaneous report from a contactable consumer (patient). A 31-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EK5730 and expiry date not reported), via an unspecified route of administration on 24Mar2021 (at the age of 31-year-old), as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation and experienced soreness around the injection spot. On 24Mar2021, the first day, the patient experienced a sore arm. On 25Mar2021 (reported as today), the patient experienced body aches and a slight fever. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: I have since then  have had a first dose of Covid vaccine  I still have some isolated itching but nothing like it was before.; the thing on my shoulder that looks like a lymph node or the cyst; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 20Mar2021, as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously took pantoprazole and experienced itching and had an allergic reaction.  The patient experienced some isolated itching and a thing on her shoulder that looks like a lymph node or the cyst on Mar2021.The patient further stated that it is located on the side of the arm where she got vaccinated, stated that it is almost on her shoulder blade. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: large bruise the size of a baseball at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 13Mar2021 13:40 at the age of 62-year-old as dose 1, single for covid-19 immunisation. The patient's medical history was none. 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 15Mar2021, patient experienced large green and yellow bruise; each day it got darker and it seemed to get a little larger. For 5 days she had a large bruise the size of a baseball at the injection site. It seems to be fading now. Adds when they draw blood from inside of her elbow she sometimes gets a small bruise but never like this and she never had a reaction, like a bruise like this with any other vaccine. Patient did not visit emergency room/physician office in response event. She is planning to receive the second dose of the vaccine on 03Apr2021. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 56-year-old), dose 2, single for COVID-19 immunisation. Medical history included casein allergy, coffee allergy, wheat intolerance, and COVID-19. Concomitant medication included sertraline hydrochloride (ZOLOFT); losartan; diclofenac (VOLTAREN); alpha lipoic acid. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) administered via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-year-old), dose 1, single for COVID-19 immunisation and experienced pain at injection site, tiredness, headache, fever. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 24Mar2021 at 07:00, the patient experienced headache, fever, chills. The patient received treatment medications acetaminophen and advised to sleep. The events were reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered in Mar2021.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021235505 same reporter/patient/product, different dose/similar event
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: developed a rash on the trunk of my body/with a much milder version of the same rash; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3248), via intramuscular, administered in Arm Left on 24Mar2021 13:30 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via intramuscular, administered in Arm Left on 02Mar2021 13 :30as dose 1, single for COVID-19 immunisation. On 26Mar2021 when patient woke up morning rash covered trunk her body pain got more as day went on and travelled to neck Rash was flat, red and spotty but was not raised. The rash started milder and then got more red as the day went on. The outcome of event was recovered on an unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: sweating; I have a slight fever and I am nauseous; I have a slight fever and I am nauseous; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that on unspecified date, they woke up on the 3rd morning after vaccine was administered sweating. They have a slight fever and was nauseous. 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: Following 2nd dose of COVID 19 injection (lot EP6955) localized soreness around injection site; Dizziness; Low grade fever of 99.1; Joint soreness; Mild headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (at the age of 51-year-old) (Lot Number: EP6955; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (Lot Number and Expiration Date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced localized soreness around injection site, dizziness, and by evening low grade fever of 99.1, joint soreness. Next morning the patient continued to have localized soreness around injection site, milder joint pain, mild headache, and fatigue. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Following 2nd dose of COVID 19 injection (lot EP6955) localized soreness around injection site; Dizziness; Low grade fever of 99.1; Joint soreness; Mild headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (at the age of 51-year-old) (Lot Number: EP6955; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on an unspecified date (Lot Number and Expiration Date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced localized soreness around injection site, dizziness, and by evening low grade fever of 99.1, joint soreness. Next morning the patient continued to have localized soreness around injection site, milder joint pain, mild headache, and fatigue. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This is a spontaneous report from a non-contactable nurse(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot n umber and expiration date was not reported), via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced nose bleed on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hypersomnia, Pain, Vaccination site pain
Clinical narrative: Everything ached; No arthritis pain until Wednesday (after shot on tuesday)/Sprained ankle in January - hasn't hurt in weeks, it ached; Ended up sleeping a lot and couldn't get warm but never ran a fever; Had a bit of a sore arm at injection site, but not as severe as the first shot; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in right arm on 23Mar2021 13:00 (at the age of 54-years-old) as dose 2, single for covid-19 immunization at  Workplace clinic. The medical history included sprained ankle in January, hasn't hurt in weeks, it ached and breast cancer from Sep2018 to an unknown date. Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]), celecoxib (CELEBREX), tamoxifen (TAMOXIFEN) and Multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 01Mar2021 10:45 (at the age of 54-years-old) as dose 1, single for covid-19 immunisation and experienced sore arm at injection site. Patient had allergies to medications, food, or other products: sulfa drugs and levequin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported everything ached. Did a lot of hand needle work over the weekend, no arthritis pain until Wednesday (after shot on Tuesday) on 24Mar2021. Sprained ankle in January, hasn't hurt in weeks, it ached. Ended up sleeping a lot and couldn't get warm but never ran a fever. Woke up at 1 am and many of the aches were gone. Also had a bit of a sore arm at injection site, but not as severe as the first shot. The patient reported I began feeling unwell the afternoon at 12:00 of 24Mar2021, (approximately 24 hours after 2nd dose). At 3 pm I went to take a nap and was in bed until the next morning. I reported first thing in the morning on 25Mar2021, and I was feeling much better by then. The outcome was recovering for the events.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Gastrointestinal disorder, Migraine, Muscle spasms
Clinical narrative: Patient had extreme muscle and joint pain that evening,; Patient had extreme muscle and joint pain that evening,; unable to walk for an hour; spasms in hands, feet and legs; The next day the consumer experienced migraine 35 hours after injection.; Migraine accompanied by severe GI symptoms and vomiting, which concluded after 2 hours.; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8730, expiration date was not reported) via an unspecified route of administration, on 24Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced extreme muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs. These symptoms passed after one hour. It was also reported that the next day he experienced migraine (35 hours after injection), accompanied by severe GI (gastrointestinal) symptoms and vomiting, which concluded after 2 hours. The outcome of muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs were recovered on 24Mar2021 and all the other events were recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: Patient had extreme muscle and joint pain that evening,; Patient had extreme muscle and joint pain that evening,; unable to walk for an hour; spasms in hands, feet and legs; The next day the consumer experienced migraine 35 hours after injection.; Migraine accompanied by severe GI symptoms and vomiting, which concluded after 2 hours.; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8730, expiration date was not reported) via an unspecified route of administration, on 24Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced extreme muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs. These symptoms passed after one hour. It was also reported that the next day he experienced migraine (35 hours after injection), accompanied by severe GI (gastrointestinal) symptoms and vomiting, which concluded after 2 hours. The outcome of muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs were recovered on 24Mar2021 and all the other events were recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Swelling, Vaccination site swelling
Clinical narrative: Area where I had the shot is swollen; Shoulder area where the shot was put is swollen; Swelling and pain on left shoulder; Pain radiated to right shoulder; This is a spontaneous report from a contactable consumer (patient) reported. A 88-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient previously included ongoing high blood pressure and breathing from an unknown date. Concomitant medication included tiotropium bromide (SPIRIVA) taken for Breathing from an unspecified start date and ongoing. On 26Mar2021 the patient experienced swelling and pain on left shoulder and pain radiated to right shoulder. On an unspecified date the patient experienced area where she had the shot is swollen; shoulder area where the shot was put is swollen. Patient had the injection, clarified as the Pfizer Covid-19 injection today, 26Mar2021, and she was having issues on her left side. On her left shoulder and it's swollen, the pain radiated over to her right shoulder. Patient clarifies that it is not swollen on right side, it is just swollen on the left side. Patient can feel the swelling on the left side. Patient was unable to provide an outcome as she cannot really say. She can still feel it for the swelling and pain on left shoulder. Patient takes a lot of medications and declines to go through medications at this time. The area where patient had the shot was swollen. The outcome of the events swelling and pain on left shoulder and area where patient had the shot was swollen; shoulder area where the shot was put was swollen was unknown. The outcome of the event swelling and pain on left shoulder was not resolved, and pain radiated to right shoulder was resolving and unknown for other event.  Follow-up attempts completed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site bruising
Clinical narrative: bruise at injection site; body aches; This is a spontaneous report from a contactable consumer (patient).   A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6203 and Expiration Date: Jun2021), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and Expiration Date: not reported) , on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. The patient experienced bruise at injection site and body aches on an unspecified date. The outcome of the events was unknown at time of report.  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot; Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot/fatigue; Im feeling unwell (tired, achy, etc) after yesterdays 2nd shot/body aches; low fever; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 25Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 26Mar2021, the patient woke up with body aches, fatigue, a low fever and the patient was feeling unwell (tired, achy, etc) after the second shot. Patient was rested and drank fluids, took ibuprofen (ADVIL) for fever. Patient was rested for all day on 26Mar2021 and 27Mar2021. By 28Mar2021, the patient felt fine. The outcome of the events was recovered on 28Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Peripheral coldness, Pyrexia
Clinical narrative: she turned hot, don't know how hot, she was very warm to the touch, hot to the touch/forehead was warm; she got a fever; not feeling well; Her forehead was warm and her foot was cold; This is a spontaneous report from a contactable consumer. This consumer reported information for two different patients. This is report first of two reports. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 10:30 (at the age of 72-years-old), at dose 2, single for covid-19 immunization. Medical history included Huntington's disease and depression. Concomitant medications included ongoing tetrabenazine taken for Huntington's disease; donepezil hydrochloride (DONEPEZIL HCL); levothyroxine sodium (LEVOTHYROXIN); rosuvastatin; bupropion taken for depression. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 03Mar2021 at approximately 10:30 (at the age of 72-years-old), at dose 1, single for covid-19 immunization and not experienced any events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on same date of vaccination. On 25Mar2021, the patient turned hot, she was very warm to the touch, hot to the touch and she got a fever on morning, she was not feeling good; clarified as not feeling well, she also experienced her forehead was warm and her foot was cold on 25Mar2021. Therapeutic measures were taken included aspirin. There were no investigational assessments. The outcome of the events fever and cold feet was unknown, all the other events were recovering.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346113 Same reporter/ drug and different patient/events
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Insomnia, Pain, Pruritus
Clinical narrative: Extremely dizzy; A lot of body rashes; Some fever; aching/ pain all over his bod/ Severe body aches; Tired; First night didn't sleep at all; itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees.; This is a spontaneous report from a contactable nurse and a consumer(patient). A 73-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208; Expiration Date: 08Mar2022), via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 at the age of 73-year-old as dose 2, single for covid-19 immunisation.  Medical history included covid-19 from Oct2020 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient previously received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at the age of 73-year-old as dose 1, single for covid-19 immunisation and had Itching on both ears, back of neck, left arm and behind both knees. Patient did not visits emergency room or physician office in response to the event. On 18Mar2021 after receiving second dose of Vaccine he experienced aching, and tired, and the first night didn't sleep at all. Patient says he didn't sleep the day after he was achy, tired, and pain all over his body. Husband says he currently has itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees. Patient also experienced severe body aches, some fever, extremely dizzy, a lot of body rashes. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Extremely dizzy; A lot of body rashes; Some fever; aching/ pain all over his bod/ Severe body aches; Tired; First night didn't sleep at all; itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees.; This is a spontaneous report from a contactable nurse and a consumer(patient). A 73-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208; Expiration Date: 08Mar2022), via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 at the age of 73-year-old as dose 2, single for covid-19 immunisation.  Medical history included covid-19 from Oct2020 to an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient previously received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at the age of 73-year-old as dose 1, single for covid-19 immunisation and had Itching on both ears, back of neck, left arm and behind both knees. Patient did not visits emergency room or physician office in response to the event. On 18Mar2021 after receiving second dose of Vaccine he experienced aching, and tired, and the first night didn't sleep at all. Patient says he didn't sleep the day after he was achy, tired, and pain all over his body. Husband says he currently has itching on both ears, itching on the back of neck, itching on left arm, itching behind both knees. Patient also experienced severe body aches, some fever, extremely dizzy, a lot of body rashes. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Neck pain, Pain in extremity
Clinical narrative: pain in her arm; pain in her shoulder; pain in her neck; headache; does not feel good; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 24Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in her arm, pain in her shoulder, pain in her neck, headache and does not feel good on 24Mar2021. Patient wanted to know if she could get a pill for pain or ice for it. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.