chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pain in extremity, Vision blurred
Clinical narrative: I had pain in my arms; My vision got little bit blurry in a way for just a second or two; I experience dizziness all yesterday and today also but yesterday about 4 and half hour after getting the shot; I started to get difficulty in breathing; Some pressure on my chest; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration in right arm on 21Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had unspecified allergies. The patient's concomitant medications included allergy medications like nasal spray and allergy tablets, nasal spray was triamcinolone acetonide (NASACORT) taken for allergy; loratadine; and the tablet was Kirkland brand, called loratadine (ALLERCLEAR). About 10 minutes after vaccination on 21Apr2021, the patient's vision got little bit blurry in a way for just a second or two and then she had experience dizziness all day about 4 and half hour after getting the shot and the next day also. The patient reported that she started to get difficulty in breathing and some pressure on her chest. The patient queried if that was a side effect. The patient stated that she did not have trouble breathing that day, but still had the dizziness, which was little bit better than yesterday. The patient also reported pain in her arms. Therapeutic measures were taken as a result of pain in arm and included Tylenol 2 tablets of 500mg each in the morning extra strength and Ibuprofen 200 mg 2 pills at about 20:00 in the evening and then 2 more pills of one at about 01:00 in the morning. Patient had not gone through any lab tests. The outcome of the event difficulty in breathing was recovered on an unspecified date, dizziness was recovering and the other events was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: I could not sleep on my right side due to uncomfortable; after received the dosage I started experiencing chills; muscle pain; joint pain; headache; extremely tired.; Discomfort on the injection site pain.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EW0153, Expiry date: unknown), via an unspecified route in the right arm on 21Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown) as a single dose for covid-19 immunization. On 21Apr2021, couple of hours after second dose of Pfizer vaccine patient started experiencing chills, muscle pain, joint pain, headache and extremely tired. Patient was still experiencing these things now and discomfort on the injection site pain. Patient would not call it same but in my bed last night could not sleep on right side due to uncomfortable. So patient was wondering was it okay if take Tylenol or Ibuprofen or aspirin or something for the discomfort patient was feeling? The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: I could not sleep on my right side due to uncomfortable; after received the dosage I started experiencing chills; muscle pain; joint pain; headache; extremely tired.; Discomfort on the injection site pain.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EW0153, Expiry date: unknown), via an unspecified route in the right arm on 21Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown) as a single dose for covid-19 immunization. On 21Apr2021, couple of hours after second dose of Pfizer vaccine patient started experiencing chills, muscle pain, joint pain, headache and extremely tired. Patient was still experiencing these things now and discomfort on the injection site pain. Patient would not call it same but in my bed last night could not sleep on right side due to uncomfortable. So patient was wondering was it okay if take Tylenol or Ibuprofen or aspirin or something for the discomfort patient was feeling? The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Rash; She has a lot of itching and is very uncomfortable; very uncomfortable; This is a spontaneous report from contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153) (age at time of vaccination was 54 years) via unspecified route of administration, administered in arm left on 13Apr2021 16:30 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing penicillin allergy (told by her Mother it started when she was a baby) and she broke out in hives with Tylenol. She found out she was allergic to it in middle school. She was accidentally given it in the hospital. Concomitant medications were not reported. Historical vaccine included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER2613) (age at time of vaccination was 54 years) via unspecified route of administration, administered in arm left on 23Mar2021 11:30 as DOSE 1, SINGLE for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. It was reported that the patient received her 2nd dose last Tuesday. Yesterday morning (21Apr2021), she woke up with hives. It was reported that the patient was 54 years old when she broke out in a rash. She stated the rash was spreading. She has a lot of itching and was very uncomfortable. She has no other allergies, other than spraying airborne allergies, but she has not been tested for that. Caller has not eaten anything that she was aware of that could have caused this. It was reported that the patient was not sure if this was the vaccine causing the hives or something else. The patient had not visited her physician for this but she left a message with the doctor's nurse. She has not heard back. AEs does not require a visit to emergency room/Physician Office. AEs following prior vaccinations was none. The outcome of the events hives and rash was not recovered/not resolved and unknown for other events.   No follow-up attempts are needed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Hypoacusis, Influenza like illness, Pyrexia
Clinical narrative: had lingering symptoms of ears being clogged like on a plane; mouth sores; feeling flu like; fever 103.2; brain fog; This is a spontaneous report from a contactable consumer on behalf of patient.  A 52-year-old female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737 and expiry date was not reported), via an unspecified route of administration on 05Apr2021 at 17: 30 on left arm as Dose 2, single (Age at vaccination: 52-year-old) for COVID-19 immunization. Medical history included: Multiple sclerosis (MS). The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: En6207) via an unspecified route of administration on 15Mar2021 at 18: 00 on left arm as dose 1, single (Age at vaccination: 52-year-old) for Covid-19 immunization. The patient did not had any significant issues with first dose of vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included: Ascorbic acid (VITAMIN C ACID) and sambucus nigra (ELDERBERRY EXTRACT). The patient had rough couple of days feeling flu like, fever 103.2 and brain fog on 06Apr2021 (A-day after dose 2). The patient had mouth sores on 08Apr2021. On 08Apr2021, the patient had lingering symptoms of ears being clogged like on a plane. Therefore, the patient went to doctor on 14Apr2021. The doctor stated that patients ears were good with no fluid and has suggested Zyrtec which did not help and ears were still clogged. The patient laboratory data included: Rapid RNAPCR (Nasal swab) on 18Mar2021 and resulted negative. The patients body temperature was 103.2 on 06Apr2021. The patient did not receive any treatment for mouth sores, brain fog, fever 103.2 and feeling flu like. Outcome of event: feeling flu like was recovered on an unspecified date; event mouth sores was recovered on 15Apr2021; Event (lingering symptoms of ears being clogged like on a plane) was not recovered and outcome for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Stomatitis
Clinical narrative: had lingering symptoms of ears being clogged like on a plane; mouth sores; feeling flu like; fever 103.2; brain fog; This is a spontaneous report from a contactable consumer on behalf of patient.  A 52-year-old female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737 and expiry date was not reported), via an unspecified route of administration on 05Apr2021 at 17: 30 on left arm as Dose 2, single (Age at vaccination: 52-year-old) for COVID-19 immunization. Medical history included: Multiple sclerosis (MS). The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: En6207) via an unspecified route of administration on 15Mar2021 at 18: 00 on left arm as dose 1, single (Age at vaccination: 52-year-old) for Covid-19 immunization. The patient did not had any significant issues with first dose of vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included: Ascorbic acid (VITAMIN C ACID) and sambucus nigra (ELDERBERRY EXTRACT). The patient had rough couple of days feeling flu like, fever 103.2 and brain fog on 06Apr2021 (A-day after dose 2). The patient had mouth sores on 08Apr2021. On 08Apr2021, the patient had lingering symptoms of ears being clogged like on a plane. Therefore, the patient went to doctor on 14Apr2021. The doctor stated that patients ears were good with no fluid and has suggested Zyrtec which did not help and ears were still clogged. The patient laboratory data included: Rapid RNAPCR (Nasal swab) on 18Mar2021 and resulted negative. The patients body temperature was 103.2 on 06Apr2021. The patient did not receive any treatment for mouth sores, brain fog, fever 103.2 and feeling flu like. Outcome of event: feeling flu like was recovered on an unspecified date; event mouth sores was recovered on 15Apr2021; Event (lingering symptoms of ears being clogged like on a plane) was not recovered and outcome for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: fever/slight fever; painful rash around shot; red and puffy face; red and puffy face; Chills; headache; This is a spontaneous report from a contactable consumer(patient).   A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 20Apr2021 10:00 (at the age of 42-year-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included fibroids, pre-diabetes, asthma from an unknown date and unknown if ongoing and known unspecified allergies to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included metformin, tri-lo sprintec, spirolatcone, zyrtec/allertec, Montelukast and melatonin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) administered in left arm on 23Mar2021 12:00 PM for COVID-19 immunisation. On 20Apr202110:00, the patient experienced red and puffy face, at night she had chills and headache. On second day (21Apr2021) patient had chills, headache, fever and painful rash around shot. On third day (22Apr2021), patient experienced headache, slight fever in the morning, gone by afternoon and painful rash slowly going away on next day. No treatment was taken for adverse events. No Covid prior vaccination. Since the vaccination, the patient had been tested with SDTL SARS-CoV-2 Viral Nucleic Acid Viral Test for COVID-19 of which results are pending at the time of reporting. The patient did not receive any other vaccines within four weeks prior to the vaccination. Outcome of the events headache and slight fever recovered on unspecified date and rest events were recovered on unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site rash
Clinical narrative: fever/slight fever; painful rash around shot; red and puffy face; red and puffy face; Chills; headache; This is a spontaneous report from a contactable consumer(patient).   A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 20Apr2021 10:00 (at the age of 42-year-old) as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included fibroids, pre-diabetes, asthma from an unknown date and unknown if ongoing and known unspecified allergies to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included metformin, tri-lo sprintec, spirolatcone, zyrtec/allertec, Montelukast and melatonin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) administered in left arm on 23Mar2021 12:00 PM for COVID-19 immunisation. On 20Apr202110:00, the patient experienced red and puffy face, at night she had chills and headache. On second day (21Apr2021) patient had chills, headache, fever and painful rash around shot. On third day (22Apr2021), patient experienced headache, slight fever in the morning, gone by afternoon and painful rash slowly going away on next day. No treatment was taken for adverse events. No Covid prior vaccination. Since the vaccination, the patient had been tested with SDTL SARS-CoV-2 Viral Nucleic Acid Viral Test for COVID-19 of which results are pending at the time of reporting. The patient did not receive any other vaccines within four weeks prior to the vaccination. Outcome of the events headache and slight fever recovered on unspecified date and rest events were recovered on unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: About an hour to two hours later. He noticed he is getting itchiness all over his body.; Left arm where he got the vaccine is a little sore; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself that:  A male patient of an unspecified age received first dose BNT162B2 (formulation solution for injection, Batch/Lot number was not reported) via unspecified route of administration in left arm, on 21Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. About an hour to two hours later he noticed he was getting itchiness all over his body. The itchiness was on various spots on his body, it was random spots his left arm where he got the vaccine was little sore on an unspecified date. The patient had not massive itchiness, just slight itchiness. He will get a small spot where it will be slight reddish and it will start itching. After a while it goes away and is back to normal. Then, another part will start the same way. He has had no other concerns with it. The outcome for both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: swollen face/after 5 hours it started on right side of my face is swollen but its still the same; redness of my eye; eye still swollen; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 19Apr2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. On 19Apr2021 patient experienced swollen face because after that patient received second vaccine, after 5 hours it started on patients right side of the face, it was swollen but its still the same and patient does not had pain, the redness of patients eye disappeared on same day on 19Apr2021, but eye was still swollen on 19Apr2021. Outcome of events was not recovered for swollen face/after 5 hours it started on right side of my face is swollen but its still the same, eye still swollen and recovered on redness of my eye on 19Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient).  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, batch number and expiry date were no reported) via an unspecified route of administration on an unspecified date as Dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient experienced hives that erupted 9 days (unspecified date) after the first shot. The patient was looking for advice on if she should get the second shot. Outcome of event was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, SARS-CoV-2 test
Clinical narrative: 2 days after getting vaccine developed bronchial asthma; This is a spontaneous report from a contactable consumer (patient herself, reported as other HCP-nurse).   A 57-year-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via intramuscularly on 04Feb2021 at 11:45 AM in right arm (at the age of 56 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hyperparathyroid and hypothyroid. The concomitant medications included levothyroxine sodium (THYROX). Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via intramuscularly in left arm on 09Jan2021 at 11:45 AM (at the age of 56 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. After 2 days of vaccination the patient developed bronchial asthma. The patient visited emergency room and physician office due to the event. The patient did not diagnose with COVID-19 prior to vaccination and tested COVID-19, since the vaccination. The lad data included nasal swab was negative on 06Feb2021. At the time of this report outcome of the event was recovered.  No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Peripheral swelling
Clinical narrative: first vaccine that her left arm was swollen; left arm was swollen and hurt from first one; could not move it for a week; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734) via unspecified route of administered in left arm on an unspecified date (at the age of 56-year-old) as dose 1, single for covid-19 immunization. Medical history included autoimmune disorder and patient stated that, so she was weak anyway. The patient's concomitant medications were not reported. Patient stated that with the first vaccine that her left arm was swollen and hurt from first one and could not move it for a week, all on an unknown date. Stated that it got better. Outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pyrexia
Clinical narrative: I was feeling messed up; Like feverish; dizziness; This is a spontaneous from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0161) (age at the time of vaccination was 45-years-old) via unspecified route of administration, administered in arm right on 14Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant included Amlodipine, Atorvastatin, Hydrochlorothiazide. It was stated that when I took 1st vaccine last Tuesday, 14th and on Friday I have been feeling like feverish like dizziness. For first 3-4 days I was dizzy like I have been like dizzy since Tuesday (14Apr2021). I have been like low down with fever like this morning I woke up with fever, took Tylenol to came down. What you have been best me to do? I mean I woke with the feverish in this morning (16Apr2021). I took Tylenol and it came down but yesterday I was feeling. I was feeling fine yesterday. The day before yesterday I was feeling messed up (20Apr2021). I am really scared to take that second vaccine you know. It was stated that the patient did not go to the doctor. It was stated that I really want to know if I should take this second shot because had an experience like this you know. The outcome of the event dizziness was recovered in 2021, outcome for feverish was not recovered and unknown for other event.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Malaise, Pain
Clinical narrative: malaise; fatigue; body aches; chills; fever; cough; This is a spontaneous from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that about 8 hours after 2nd vaccine, the patient started experiencing malaise and fatigue which as time wore on she developed body aches, chills, fever and cough. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: malaise; fatigue; body aches; chills; fever; cough; This is a spontaneous from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that about 8 hours after 2nd vaccine, the patient started experiencing malaise and fatigue which as time wore on she developed body aches, chills, fever and cough. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: Screwed up stomach; Chills; Fever; This is a spontaneous report received from a contactable consumer (patient friend) via medical information team. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153, expiry date: unknown) via unspecified route of administration in right arm between 09:00-10:00 on 20Apr2021 (age at vaccination 40-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included bipolar (Diagnosed with over 13 years before, maybe 14 years) and depression (Diagnosed with over 13 years before, maybe 14 years). Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot: EP6955, expiry date: unknown) via unspecified route of administration in right arm between 09:00-10:00 on 22Mar2021 (age at vaccination 40-years-old) as DOSE 1, SINGLE for COVID-19 immunisation, felt soreness in the arm and sleepiness and anxiety attacks after the first dose Pfizer Covid Vaccine. After the second dose, the patient experienced chills and fever which had lasted for 7 days. After receiving the second dose, reporter stated that something screwed up patient stomach on 27Apr2021. The patient used bathroom and felt better after that. The patient was felt better in the morning. The patient has some mental illness that the vaccination has affected after the first dose. The reporter stated that he and his girlfriend had tons of ills because of the shot. The outcome of the event abdominal discomfort was recovering, outcome of fever and chills were recovered in 2021. No follow-up attempts are needed. No further information was expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: moderate pain in middle-upper back muscles; headache; moderate pain in middle-upper back muscles; chills; Injection site was sore; Felt tired; mild fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 44-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: ER 8729, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:15 as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store (at the age of 44-year-old). The patient medical history was not provided. The patient did not have any known allergies. The patient concomitant medications included zinc (ZINC); calcium (CALCIUM); magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. The patient also received vitamin C, D and B. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date, the patient had moderate pain in middle-upper back muscles, chills, and a headache. On 24Apr2021 at 09:00 the patient had events reported as injection site was sore, felt tired and mild fever. The patient did not receive any treatment for the reported events. The reporter reported the seriousness of the case as non-serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: moderate pain in middle-upper back muscles; headache; moderate pain in middle-upper back muscles; chills; Injection site was sore; Felt tired; mild fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 44-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: ER 8729, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:15 as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store (at the age of 44-year-old). The patient medical history was not provided. The patient did not have any known allergies. The patient concomitant medications included zinc (ZINC); calcium (CALCIUM); magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. The patient also received vitamin C, D and B. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date, the patient had moderate pain in middle-upper back muscles, chills, and a headache. On 24Apr2021 at 09:00 the patient had events reported as injection site was sore, felt tired and mild fever. The patient did not receive any treatment for the reported events. The reporter reported the seriousness of the case as non-serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin disorder
Clinical narrative: A very small bump may appear on the skin in some areas but not always; Sporadic itching on various small, random areas of the body; have some redness; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:15 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included dermatitis contact (poison ivy/oak), temperature regulation disorder (temperature), hypersensitivity (Skin is sensitive to fragrance) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not received 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 has not been tested for COVID-19. The patient experienced on 09Apr2021 sporadic itching on various small, random areas of the body. No rash or swelling but will have some redness. A very small bump may appear on the skin in some areas but not always. The itching comes and goes but still persists after 2 weeks from dose 1. The clinical outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: bumpy and itchy; rash has started to develop all over my body; bumpy and itchy; This is a spontaneous report from a contactable consumer (Patient). A 19-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: Ew0153), via an unspecified route of administration, administered in arm left on 14Apr2021 at 14:15 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient received concomitant medications within 2 weeks of vaccination which included citalopram and clonazepam, both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: Fn6207), via an unspecified route of administration, administered in arm left on 17Mar2021 at 14:15 (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient previously took amoxicillin for drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 24Apr2021 at 09:00, the patient experienced bumpy and itchy, rash has started to develop all over my body. Reported Event: 10 days after taking my second dose of the Pfizer COVID-19 vaccine, a rash has started to develop all over my body. It's bumpy and itchy everywhere. Patient did not receive any treatment for the events. The outcome of all the events was not recovered. Device date was 24Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Caller states arm sore for a little while; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein), via an unspecified route of administration on 2019 (Batch/Lot number was not reported) as dose number unknown, single for immunisation; influenza vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), as dose number unknown, single for immunization. Medical history included ongoing diabetic and high blood pressure from an unknown date. The patient's concomitant medications were not reported. The patient experienced arm sore for a little while, no concern or anything referring to both the flu vaccine and the Pneumonia vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: After the first dose I had a headache and chest pain, but it went away quickly; After the first dose I had a headache and chest pain, but it went away quickly; This is a spontaneous report from a contactable consumer (patient). The patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). This is the case for dose 1. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving the first dose the patient had headache and chest pain, but it went away quickly. The outcome of the events was recovered.   No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer COVID 19 Vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and montelukast sodium taken for an unspecified indication for an unspecified date. The patient stated on call after the first dose of the vaccine she was scheduled on April 28 for the second dose. However, caller was experiencing allergies and taking allergy medicine like Zyrtec and Montelukast sodium 10 mg. Caller wants to know if it would effect the vaccine since she had allergies and was taking medication. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: injection site was bleeding; wondering if the full dose was received or should get another vaccine; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support. A contactable consumer reported for a unknown Patient.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had injection site bleeding and patient wondering if the full dose was received or should get another vaccine. It was reported that, It was reported that a patient did not receive the covid-19 vaccine at pharmacy, after patient received the vaccine, the injection site was bleeding and had clear fluid, patient is wondering if the full dose was received or should get another vaccine. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: After my second shot I have not been able to smell. Will this end.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, after his second shot he have not been able to smell. He enquired whether will this end. At the time of this report, the outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: itchy red chest; slept most of the day away; headache; dehydrated; nausea; sore arm/arm extremely sore; tired/ whole body exhausted; This is a spontaneous report from a contactable consumer. This 27-year-old contactable non-pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Csn20451972883, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 24Apr2021 at 10:45 (at the age of 27 years) as dose 2, single for covid-19 immunisation. Medical history included exercise induced asthma. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC), daily taken for an unspecified indication, start and stop date were not reported; cetirizine, daily taken for an unspecified indication, start and stop date were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Csn20451497957, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Apr2021 at 10:00 (at the age of 27 years) as dose 1, single for covid-19 immunisation. No other vaccine was received in four vaccine. No Covid prior vaccination and no Covid tested post vaccination. On 24Apr2021 at 06:30 AM, (1st day) sore arm, tired. On 25Apr2021 (2nd day), whole body exhausted, arm extremely sore, dehydrated, slept most of the day away, headache, nausea. On 26Apr2021 (3rd day), tired, arm sore, itchy red chest, nausea, a little tired. No treatment received. The outcome of events were recovered.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: itchy red chest; slept most of the day away; headache; dehydrated; nausea; sore arm/arm extremely sore; tired/ whole body exhausted; This is a spontaneous report from a contactable consumer. This 27-year-old contactable non-pregnant female consumer (patient) reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Csn20451972883, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 24Apr2021 at 10:45 (at the age of 27 years) as dose 2, single for covid-19 immunisation. Medical history included exercise induced asthma. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC), daily taken for an unspecified indication, start and stop date were not reported; cetirizine, daily taken for an unspecified indication, start and stop date were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Csn20451497957, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 03Apr2021 at 10:00 (at the age of 27 years) as dose 1, single for covid-19 immunisation. No other vaccine was received in four vaccine. No Covid prior vaccination and no Covid tested post vaccination. On 24Apr2021 at 06:30 AM, (1st day) sore arm, tired. On 25Apr2021 (2nd day), whole body exhausted, arm extremely sore, dehydrated, slept most of the day away, headache, nausea. On 26Apr2021 (3rd day), tired, arm sore, itchy red chest, nausea, a little tired. No treatment received. The outcome of events were recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Hyperhidrosis, Rhinorrhoea, Throat irritation
Clinical narrative: Loss of smell; Runny nose; Sweating; Throat irritation; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Apr2021 09:15 (at the age of 26-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included asthma, diabetes, hypertension, allergies, anxiety and COVID-19 (prior to vaccination). Concomitant medication(s) included metformin, valsartan, salbutamol sulfate (VENTOLINE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Neo melubrina and experienced drug allergy. The patient experienced loss of smell, runny nose, sweating, throat irritation on 28Apr2021 07:00. The patient did not receive the treatment for the events. The outcome of events was recovering. The patient was not tested for COVID since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Rash
Clinical narrative: really bad rash on her right wrist area; rash is sweating a lot; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-years-old female patient 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 in left arm (left shoulder) on 21Apr2021 at 11:00 am (age at vaccination was 44 years) as dose 1, single for COVID-19 immunization. The patient's medical history included COVID on 10Jul2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. On 22Apr2021 at 14:00 pm, the patient experienced really bad rash on her right wrist area. Her right wrist area was getting a really bad rash. She stated that the rash was sweating a lot on 22Apr2021. She wanted to ask if that was normal. She wanted to know what to put on it. She stated that there was no doctor. The adverse event did not require a visit to Emergency Room or Physician Office. No treatment was received for the adverse event. No relevant tests were done. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.