chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 03Feb2021 (at the age of 75 years old) (Lot Number: EL9264) as dose 2, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia from an unknown date and unknown if ongoing (CLL, or chronic lymphocytic leukemia, which he is at stage zero, so requires no active treatment at all) and headache from an unknown date and unknown if ongoing (which started before he got the vaccine doses). Concomitant medications included acetaminophen taken for headache, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for headache, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 13Jan2021 for COVID-19 immunisation. On an unspecified date, the patient experienced headache. It was reported that the headaches probably started in April or May last year, it bothers him for a few weeks then went away then returned about a month ago after his second dose of the Pfizer COVID-19 vaccine, about 8 weeks ago. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on 03Mar2021 has had two antibody tests which came back negative and SARS-CoV-2 antibody test negative: negative on 22Mar2021 (SARS-CoV-2 antibody test negative). The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: A burning pain in "my" shoulder after 2 weeks; "My" arm was sore after shot. Still sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and known allergies to peanuts and strawberry. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all for an unknown indication from an unknown date and unknown if ongoing. On 31Mar2021 at 20:00 the patient's arm was sore after shot. Still sore arm at injection site. On an unknown date in Apr2021 the patient experienced a burning pain in her shoulder after 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The patient also reported she was going to doctor that week. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm was sore after shot, still sore arm at injection site and burning pain in shoulder after 2 weeks was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting and explosive diarrhoea for 4 hours; Vomiting and explosive diarrhoea for 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hernia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced vomiting and explosive diarrhoea for 4 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events vomiting and explosive diarrhoea for 4 hours was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; Chest congestion; Immense muscle pain; Debilitation back pain; Over tiredness; Sleeping over 18 hours per day; Severe congestion; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 15:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to just nickel metal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 10Apr2021 at 16:00, the patient experienced severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Somnolence
Clinical narrative: Sore throat; Chest congestion; Immense muscle pain; Debilitation back pain; Over tiredness; Sleeping over 18 hours per day; Severe congestion; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 09Apr2021 at 15:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to just nickel metal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 10Apr2021 at 16:00, the patient experienced severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe congestion, sore throat, chest congestion, immense muscle pain, debilitation back pain, over tiredness and sleeping over 18 hours per day were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lacrimation increased
Clinical narrative: his eyes got swollen, watery, swelling almost shut; his eyes got swollen, watery, swelling almost shut; This is a spontaneous report from a contactable Pharmacist received via Pfizer-sponsored program . A 26-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Apr2021 (Age at vaccination 26 years old), as Dose 1, Single for covid-19 immunization. The patient's medical history included allergy to all types of pollen. The patient's concomitant medications were not reported. The reporter stated that the patient felt fine for the initial 30 minutes of observation. However, he informed the pharmacist that shortly after leaving his eyes got swollen, watery, swelling almost shut. He did not require the EpiPen he had at home. The patient said the following Monday went back to normal. The patient experienced his eyes got swollen, watery, swelling almost shut on 03Apr2021. Pharmacist had patient who received first dose of vaccine reported that 30 minutes after experiencing eyes swollen up to the point where almost swollen shut. The reporter said the following Monday went back to normal. The reporter wanted to know if swelling of the face was a common side effect. The reporter enquired if he patient should receive the 2nd dose of the covid vaccine. Outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Vomiting projectile
Clinical narrative: Projectile vomiting; Chills; Dizziness; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN) and vicodin  (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 12Apr2021 at 14:00, one hour after the booster shot the patient experienced nausea and headache. On 12Apr2021 at 17:00, 4 hours after the injection, the patient experienced chills and dizziness, then followed by projectile vomiting for 6 times on 12Apr2021 at 19:00, 5 hours after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, chills, dizziness and projectile vomiting was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the left arm where vaccine was injected; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown, whether the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced pain in the left arm where vaccine was injected. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in the left arm where vaccine was injected was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in various parts of the body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ep7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 06Apr2021 at 12:00 pm (age at vaccination was 36 years) as dose 2, single for COVID-19 immunization. The patient's medical history included Caesarean section performed. Concomitant medication included acetaminophen taken for an unspecified indication. The patient previously took NSAIDS and experienced allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 19:00 pm, the patient experienced rash in various parts of the body. No treatment was received for the adverse event. The outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This is a spontaneous report from a noncontactable consumer or other non-HCP (reporter's wife). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (one week after first dose), patient experienced nosebleed. Caller reported on behalf of wife who experienced nosebleed 7-8 days after the first dose. Unsure as their room is also humid. Asked if this is normal and if she should still get the second dose. Said in the news she heard that nosebleed is normal. Wanted to know if a nosebleed one week after the first Pfizer COVID-19 vaccine is an adverse event; and if you have this reaction, do you still get the second dose. The outcome of event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient experienced slight fever and tiredness after second vaccine shot.; Patient experienced slight fever and tiredness after second vaccine shot.; This is a spontaneous report from non-contactable Non-healthcare Professional. This Non-healthcare Professional reporting for a 74-year-old male patient. A 74-year-old male patient received second dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number: Not available), via an unspecified route on 10Apr2021 (age at vaccination: 74-year-old), as a single dose for covid-19 immunization. Medical history included cancer prostate. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number: Not available) at the age of 74-year, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 10Apr2021, patient experienced slight fever and tiredness after second vaccine shot. It was unknown if patient received any treatment for the events. The clinical outcome of the events was recovered in 2021.  No follow-up attempts possible. Information about Batch/ Lot number cannot be obtained.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: broke out in hives 24 hours later; This is a spontaneous report from a contactable physician. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for immunization and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date (lot number was not reported) dose 2, single for immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of Menactra and the first dose of Trumenba on the same visit and the patient broke out in hives 24 hours later. The patient took Benadryl for hives and no breathing problems was reported. 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: Right eye seems to stay red; Daughter noticed that on the 3rd that my eye was red, that I felt it was itching; Wake up every day with my eye red; Right eye seems to stay red; Daughter noticed that on the 3rd that my eye was red, that I felt it was itching; Wake up every day with my eye red; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) as dose number unknown, 0.3ml single (at the age of 58-year-old) for covid-19 immunisation. Medical history included high blood pressure for 15 years ago, Allergy, gout, asthma. Concomitant medication(s) included montelukast sodium (MONTELUKAST SODIUM) 10 mg, once a day, orally taken for asthma; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) 100-25 mg, one tablet by mouth everyday taken for High Blood pressure. Historical vaccine included took allergy shots, so I took my two allergy shot 3 weeks ago from the shot for allergy. The patient experienced right eye seems to stay red; daughter noticed that on the 3rd that my eye was red, that I felt it was itching; wake up every day with my eye red on 03Apr2021. Treatment reported as No, I only take my daily medication, I don't take anything, my daily medications which is my high blood pressure, I think my gout medication. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test abnormal, Pyrexia
Clinical narrative: Fever; tested positive for rapid tests and molecular tests; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent) reported that a 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot number was not reported), via an unspecified route of administration on 09Apr2021 (at the age of 17-year-old) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The consumer called on behalf of her daughter who received Pfizer meningococcal group b rlp2086 (TRUMENBA) vaccine on the 09Apr2021 and developed a fever on unspecified date in 2021. This morning she was relieved, and the fever was gone. She tested positive for rapid tests and molecular tests on unspecified date in 2021. The patient recovered from fever on unspecified date in 2021. The outcome of the remaining event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Erythema of eyelid, Eyelid oedema, Eyelid rash, Eyelids pruritus
Clinical narrative: Redness, edema, rash and itchiness in nasal bridge and Eyelids; Redness, edema, rash and itchiness in nasal bridge and Eyelids; edema; rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; This is a spontaneous report from a contactable consumer (patient). A 44-year old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in Arm Left on 10Apr2021 12:30 (44-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. Concomitant medications included quetiapine, lithium, drospirenone, ethinylestradiol (YASMIN); levothyroxine sodium (EUTIROX) all for unknown indications from unknown dates and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Arm Left on 20Mar2021 as dose 1, single for COVID-19 immunization. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 12Apr2021 01:00, the patient experienced redness, edema, rash and itchiness in nasal bridge and eyelids. Therapeutic measures were taken as a result of the events using Cetirizine 10mg. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pruritus, Rash
Clinical narrative: Redness, edema, rash and itchiness in nasal bridge and Eyelids; Redness, edema, rash and itchiness in nasal bridge and Eyelids; edema; rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; Redness, edema, rash and itchiness in nasal bridge and eyelids; This is a spontaneous report from a contactable consumer (patient). A 44-year old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in Arm Left on 10Apr2021 12:30 (44-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. Concomitant medications included quetiapine, lithium, drospirenone, ethinylestradiol (YASMIN); levothyroxine sodium (EUTIROX) all for unknown indications from unknown dates and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Arm Left on 20Mar2021 as dose 1, single for COVID-19 immunization. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 12Apr2021 01:00, the patient experienced redness, edema, rash and itchiness in nasal bridge and eyelids. Therapeutic measures were taken as a result of the events using Cetirizine 10mg. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Feeling abnormal, Illness, Lower respiratory tract congestion
Clinical narrative: chest congestion; a lot of pain in the joints; My body aches terrible, all body pains; coughing; sick; Feeling miserable; This is a spontaneous report from contactable female consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration on 07Apr2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced chest congestion, a lot of pain in the joints, body aches terrible with all body pain, coughing, sick and feeling miserable. Patient stated, after I got the vaccine Wednesday I felt terrible chest congestion, like I wanted to cough from the bottom of my stomach, something like that I felt, a lot of congestion, a lot of pain in the joints that I know is a part of side effects. But the problem congestion under my chest that is I am more concerned is that. My body aches terrible, all body pains. I think that the congestion is a more problem for me. I feel more of a concern because like coughing. I want to know what else I can take. Do I need to take some kind of medicine or something for this because I feel miserable. Patient further stated, this is a terrible service and I cannot believe I got sick and still do not have a help. Outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chest congestion; a lot of pain in the joints; My body aches terrible, all body pains; coughing; sick; Feeling miserable; This is a spontaneous report from contactable female consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration on 07Apr2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced chest congestion, a lot of pain in the joints, body aches terrible with all body pain, coughing, sick and feeling miserable. Patient stated, after I got the vaccine Wednesday I felt terrible chest congestion, like I wanted to cough from the bottom of my stomach, something like that I felt, a lot of congestion, a lot of pain in the joints that I know is a part of side effects. But the problem congestion under my chest that is I am more concerned is that. My body aches terrible, all body pains. I think that the congestion is a more problem for me. I feel more of a concern because like coughing. I want to know what else I can take. Do I need to take some kind of medicine or something for this because I feel miserable. Patient further stated, this is a terrible service and I cannot believe I got sick and still do not have a help. Outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Periorbital swelling, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 63-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot#, expiry date not reported), at the age of 63, via an unspecified route of administration, on Mar 22, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Mar 2021 (5 hours after the vaccination), patient's eyes got puffy (swelling), stuffy nose, and itchy throat (which did not swell and never closed). The events lasted half an hour; everything went away 30 minutes later. Patient took Benadryl for the events. Patient was told that the second dose was more potent. Reportedly, patient went for the second shot but unable to get it because he had a reaction to the first one. His primary doctor wrote a letter to say he can get the shot. He has another appointment to get the dose. His wife called the CDC. They told her if within 4 hours he had wheezing, hives, difficulty breathing, swelling; then it would not be recommended. The outcome of itchy throat not recovered; whereas other events recovered on an unspecified date in 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's comments: Linked report(s): US-PFIZER INC-2021410153 similar report from same reporter.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Erythema, Musculoskeletal stiffness, Pain
Clinical narrative: Severe lower back pain with red patch (size about 1 inch diameter); Severe lower back pain with red patch (size about 1 inch diameter); Extreme pain while changing posture, sitting, standing; Lot of stiffness in lower back; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Apr2021 at 06:00, the patient experienced severe lower back pain with red patch (size about 1 inch diameter), had extreme pain while changing posture, sitting, standing, etc. and lot of stiffness in lower back. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of events and included treatment with menthol/methyl salicylate (BENGAY) for 2 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe lower back pain with red patch (size about 1 inch diameter), extreme pain while changing posture, sitting, standing and lot of stiffness in lower back were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Migraine, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: "I" immediately felt the vaccine travel through "my" chest. Within 2 minutes "my" heart was racing and "I" had difficultly swallowing.; "I" immediately felt the vaccine travel through "my" chest. Within 2 minutes "my" heart was racing and "I" had difficultly swallowing.; "I" am prone to migraines but this gave "me" a severe one almost instantly; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and buspirone (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 13Apr2021 at 14:30, immediately after the vaccination, the patient felt the vaccine travel through her chest and within 2 minutes her heart was racing and the patient had difficulty in swallowing. The patient was prone to migraines but the vaccine gave her a severe one almost instantly. The patient also had a stiff and sore neck and arm on the opposite side of the injection, all within 5 minutes of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she immediately felt the vaccine travel through her chest within 2 minutes her heart was racing and she had difficulty in swallowing, she was prone to migraines but this gave her a severe one almost instantly and also have a stiff and sore neck and arm on the opposite side of the injection, all within 5 minutes of the vaccine was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: "I" immediately felt the vaccine travel through "my" chest. Within 2 minutes "my" heart was racing and "I" had difficultly swallowing.; "I" immediately felt the vaccine travel through "my" chest. Within 2 minutes "my" heart was racing and "I" had difficultly swallowing.; "I" am prone to migraines but this gave "me" a severe one almost instantly; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; "I" also have a stiff and sore neck and arm on the opposite side of the injection, all Within 5 minutes of the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and buspirone (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 13Apr2021 at 14:30, immediately after the vaccination, the patient felt the vaccine travel through her chest and within 2 minutes her heart was racing and the patient had difficulty in swallowing. The patient was prone to migraines but the vaccine gave her a severe one almost instantly. The patient also had a stiff and sore neck and arm on the opposite side of the injection, all within 5 minutes of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she immediately felt the vaccine travel through her chest within 2 minutes her heart was racing and she had difficulty in swallowing, she was prone to migraines but this gave her a severe one almost instantly and also have a stiff and sore neck and arm on the opposite side of the injection, all within 5 minutes of the vaccine was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: A low grade fever; "Foggy brain"; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date, as dose number unknown, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if prior to vaccination the patient diagnosed with COVID-19 and since the vaccination, was the patient been tested for COVID-19 reported. On unspecified date, the patient reported a low grade fever and "foggy brain" after vaccination which lasted for one day. The reporter assessed the seriousness of the events as non-serious. On unspecified date the patient underwent lab tests and procedures which included body temperature: unknown result, low grade fever. It was unknown if the patient received treatment for the event. The clinical outcome of event was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Rash
Clinical narrative: Rash around eyes and on forehead, looks like pimples; Rash around eyes and on forehead, looks like pimples; This is a spontaneous report from a contactable consumer. This consumer reported for a 27-year-old male patient that.  A 27-years-old male patient received (BNT162B2, formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 18Mar2021 17:15 PM (age at vaccination 27-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) ibuprofen (ADVIL [IBUPROFEN]) alclometasone dipropionate cream 0.05% (ALCLOMETASONE DIPROPIONATE) all from taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.On Mar2021 the patient experienced rash around eyes and on forehead, looks like pimples and rash around eyes and on forehead, looks like pimples both events.The clinical outcome of the events was recovered on2021.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccines within two  weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 00:30 the patient experienced, sore arm and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and shortness of breath was recovered on 14Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Injection site soreness/tenderness; Fatigue; Malaise; Chills; Nausea; Dizziness/foggy; Dizziness/foggy; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included congenital complete heart block and anxiety. Concomitant medications taken within two weeks of vaccination included estrogens conjugated (PREMARIN) and omeprazole (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient previously received prednisone (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) and experienced drug allergy to both drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 15:45, the patient experienced injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Injection site soreness/tenderness; Fatigue; Malaise; Chills; Nausea; Dizziness/foggy; Dizziness/foggy; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included congenital complete heart block and anxiety. Concomitant medications taken within two weeks of vaccination included estrogens conjugated (PREMARIN) and omeprazole (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient previously received prednisone (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) and experienced drug allergy to both drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 15:45, the patient experienced injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness or tenderness, fatigue, malaise, chills, nausea, dizziness or foggy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Pyrexia
Clinical narrative: low grade fever; After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days; After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days; This is a spontaneous report from a contactable female nurse (patient) via Pfizer-sponsored program. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included pre-existing bruise. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization and experienced arm soreness/sore arm/her arm was a moderate level of pain, around 4-5, she was exposed to a COVID positive, then a day after her 1st dose she was exposed again. Now the caller is COVID positive and experienced a cold, part of soreness of the injection site, temperature did get higher/temperature was 99.4/elevated temperature and feeling kind of punky and draggy and after first injection, pain in arm exacerbated possible by a pre-existing bruise. On an unspecified date in 2021, the patient experienced low grade fever, after 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days. Verbatim and event description: Patient said that she has been using an app through (Name) after her covid-19 vaccines and received paperwork from drug and safety to contact Pfizer, patient had her first dose of the vaccine on 23Feb2021 and noted that she had a sore arm, her second dose was 14Mar2021 and noted that she had a low-grade fever. After 1st injection, pain in arm exacerbated possible by a pre-existing bruise. After 2nd injection had symptoms as if was beginning of cold or flu only a couple 1-2 days. Patient was fine. Patient had never been COVID Positive and never had symptoms of covid. Patient had only ever had post vaccine symptoms common to a number of different vaccines (arm soreness, transient flu-like). Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.