chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on face, ears, arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 18Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 02May2021, two weeks after the second dose of vaccination, the patient experienced hives on the face, ears and later spread to arms and legs. The event resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of hives on the face, ears, arms and legs which included treatment with prednisone steroid (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives on face, ears, arms and legs was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Massive migraine; Entire right upper arm swollen; Entire right upper arm hot to touch for past 2 days; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. 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 03May2021 (also reported as at 15:45),  the patient experienced fever, massive migraine, entire right upper arm swollen and hot to touch for past 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. 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 fever, massive migraine, entire right upper arm swollen and hot to touch for past 2 days 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Continuous headache and vertigo; Continuous headache and vertigo; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at the age of 40-years-old as a single dose for COVID-19 immunisation. Medical history included anxiety and attention deficit disorder (ADD). The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included ZOLOFT and BUSPIRONE, both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021, the patient experienced continuous headache and vertigo. 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 continuous headache and vertigo was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: More tender injections site; Tiredness; Chills; Body aches; Fever of 100; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 56-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 27Apr2021 at 12:00 at the age of 56-years-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. 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 unspecified antibiotic, taken for an unspecified indication from an unknown date and unknown if ongoing. 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 left arm on 05Apr2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 02:00, in regards to the second shot, 14 hours after the injection, the patient experienced more tender injection site, tiredness, chills, body aches, fever of 100 (unspecified units), nausea, and feeling unwell which had lasted for 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 more tender injection site, tiredness, chills, body aches, fever of 100, nausea, and feeling unwell was resolved on 28Apr2021.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: More tender injections site; Tiredness; Chills; Body aches; Fever of 100; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 56-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 27Apr2021 at 12:00 at the age of 56-years-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. 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 unspecified antibiotic, taken for an unspecified indication from an unknown date and unknown if ongoing. 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 left arm on 05Apr2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 02:00, in regards to the second shot, 14 hours after the injection, the patient experienced more tender injection site, tiredness, chills, body aches, fever of 100 (unspecified units), nausea, and feeling unwell which had lasted for 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 more tender injection site, tiredness, chills, body aches, fever of 100, nausea, and feeling unwell was resolved on 28Apr2021.  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: Migraine
Clinical narrative: migraine today 08may it had still not gone away and was getting worse; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-year-old non pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EN5313) via an unspecified route of administration, administered in arm left on 04May2021 12:45 pm (at the age of 33 years) as dose 2, single for COVID-19 immunisation. The medical history included as none relevant history. Concomitant medication were metformin hydrochloride (METFORMIN ER); spironolactone (SPIRONOLACTONE), all from an unspecified date to an unspecified date taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EL9267) via an unspecified route of administration, administered in arm left on 13Apr2021 12:45 pm as dose 1, single for COVID-19 immunisation. She had no known allergies. She was not diagnosed with COVID prior to vaccination. she was not tested for COVID post vaccination. She did not receive any other vaccine in four weeks. On 05May2021 03:30, the patient experienced migraine today 08may it had still not gone away and was getting worse. The resulted events lead to visit emergency room. Therapeutic measures were taken. The clinical outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Severe headaches; dizziness; nonstop nose bleed; early start and much longer; much heavier menstrual cycle; This is a spontaneous report from a Contactable Consumer or other non-health care professional (Patient).  A 48-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch No: Not reported/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Right on 24Apr2021 12:30 PM (age at vaccination 48 years old) as dose 1, single for covid-19 immunization, at Pharmacy or Drug Store. Medical history included migraine. Concomitant medications included other medications within two weeks of vaccination was fluoxetine hydrochloride (PROZAC); bupropion (BUPROPION); sumatriptan succinate (IMITREX) all were taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. No other vaccine taken in four weeks of vaccination. It was unknown patient had covid-19 prior vaccination and not tested post vaccination. On 24Apr2021 at 22:45, patient experienced with severe headache, dizziness, non-stop nosebleed (Patient do not get nose bleeds) and early start and much longer/much heavier menstrual cycle. Information on whether patient experienced Covid-19 prior vaccination was unknown. No therapeutic measures were taken as a result of events. The outcome for the reported events were not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021555112 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: itchiness on arm and leg/my arms and legs are very itchy; Feeling warm a little bit; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via an unspecified route of administration on 08May2021, as dose 2, single for Covid 19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of 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 an unspecified date as dose 1, single for Covid-19 immunization. The patient received second dose of vaccine yesterday morning (08May2021). The patient was really itchy last night (on 08May2021) and so went to sleep and woke up really itchy, her arms and legs were very itchy. In May2021, the patient was feeling warm a little bit but not like anything super serious. Outcome of events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Flatulence, Headache, Musculoskeletal chest pain
Clinical narrative: Vomiting; joint pain; fever; constant right intercostal pain; lack of energy; headache; intestinal flatulence; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 56-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Er8737, expiry date: not reported ), via an unspecified route of administration, administered in Arm Right on 12Apr2021 18:00 (at the age of 56-years old) as dose 1, single for covid-19 immunisation. Medical history included COVID-19 (covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. On 04May2021 05:00, the patient experienced vomiting, joint pain, fever, constant right intercostal pain, lack of energy, headache, intestinal flatulence. All these symptoms persist after one week of vaccination ( as reported) .The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; joint pain; fever; constant right intercostal pain; lack of energy; headache; intestinal flatulence; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 56-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Er8737, expiry date: not reported ), via an unspecified route of administration, administered in Arm Right on 12Apr2021 18:00 (at the age of 56-years old) as dose 1, single for covid-19 immunisation. Medical history included COVID-19 (covid prior vaccination: Yes). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. On 04May2021 05:00, the patient experienced vomiting, joint pain, fever, constant right intercostal pain, lack of energy, headache, intestinal flatulence. All these symptoms persist after one week of vaccination ( as reported) .The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Headache, Malaise
Clinical narrative: tiredness; Headache; Muscle pain; Some chills; fever; Nausea; just feeling not well; This is a spontaneous report from a contactable consumer.   A 59-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (age at vaccination: 59 years), as dose 1, single dose for COVID-19 immunisation. The patient's medical history included Rheumatoid arthritis. The patient's concomitant medication included lisinopril, sulfasalazine and hydroxychloroquine, all from unknown dates for unspecified indications. The patient stated that the patient was having reactions to the COVID19 vaccine. On an unspecified date, the patient experienced tiredness, headache, muscle pain, some chills, fever, nausea and just feeling not well. The patient was just wondering what to do. The patient had two doses and it's been about 3 weeks out on second dose and was still having tiredness, headache, muscle pain, some chills, fever and nausea and discriminant well basically. The patient stated that the patient had in both times, and it seems like second dose has been more severe. The patient asked that what do I need to do for, whether the patient needs to go to the doctor or needs to go to the hospital. The patient asked for treatment taken in response to adverse events and the patient said that just resting. The patient underwent lab tests included blood test for anemia on an unspecified date. Outcome of the events tiredness, headache, muscle pain, some chills, fever, nausea were not recovered and for just feeling not well was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: tiredness; Headache; Muscle pain; Some chills; fever; Nausea; just feeling not well; This is a spontaneous report from a contactable consumer.   A 59-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 (age at vaccination: 59 years), as dose 1, single dose for COVID-19 immunisation. The patient's medical history included Rheumatoid arthritis. The patient's concomitant medication included lisinopril, sulfasalazine and hydroxychloroquine, all from unknown dates for unspecified indications. The patient stated that the patient was having reactions to the COVID19 vaccine. On an unspecified date, the patient experienced tiredness, headache, muscle pain, some chills, fever, nausea and just feeling not well. The patient was just wondering what to do. The patient had two doses and it's been about 3 weeks out on second dose and was still having tiredness, headache, muscle pain, some chills, fever and nausea and discriminant well basically. The patient stated that the patient had in both times, and it seems like second dose has been more severe. The patient asked that what do I need to do for, whether the patient needs to go to the doctor or needs to go to the hospital. The patient asked for treatment taken in response to adverse events and the patient said that just resting. The patient underwent lab tests included blood test for anemia on an unspecified date. Outcome of the events tiredness, headache, muscle pain, some chills, fever, nausea were not recovered and for just feeling not well was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Pain in extremity, Pyrexia
Clinical narrative: Severe back and stomach pain; the back pain is now just in the front of my stomach and in middle of my back, its like my liver area; Chills; Fever; Severe back and stomach pain; the back pain is now just in the front of my stomach and in middle of my back, its like my liver area; Soreness in my arm; This is a spontaneous report from a contactable consumer or other Non-Health Care Professional.  A 28years old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172) intramuscular administered left arm on 04May2021 (At the age of 28 years) dose 2, single for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration left arm on 20Apr2021 (At the age of 28 years) dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included drospirenone, ethinylestradiol (NIKKI) 3 mg tablet, once a day, orally taken for contraception, start and stop date were not reported. On 14May2021, the patient experienced severe back and stomach pain; the back pain is now just in the front of my stomach and in middle of my back, its like my liver area (back pain), chills (chills), fever (pyrexia) and soreness in my arm (pain in extremity). I have had mono in the past and I was told by doctor that because of mono (further not clarified), I can't take Tylenol. So, I think there might be something to let others know, if they also have reactions with Tylenol, just seeing various side effects, I am taking Tylenol twice a day, but it only helps with fever, it really did not help with any thing else. The outcome of the events were unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Had a little weakness; Very mild fever; This is a spontaneous report from a contactable consumer (Patient's daughter). This is report 3 of 4, caller reporting on her mother. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. No known allergies, medical history and concomitant medications were reported. The patient experienced had a little weakness and very mild fever after the first vaccine on an unspecified date. Caller stated her family all took the vaccine together, and some of her family had slight weakness. Caller confirmed herself, her father, her mother and her husband, took the vaccine together, on 22Apr2021. The patient was scheduled second vaccine 25 days after the first vaccine. Due to get second vaccine on 17May2021. The clinical outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Condition aggravated, Fatigue
Clinical narrative: tiredness; Headache; Muscle pain; Some chills; fever; Nausea; second dose has been more severe; joint pain; just feeling not well; This is a spontaneous report from contactable consumer. An unspecified age and gender patient reported for (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 2 Single, via an unspecified route of administration, on 14Apr2021 for covid-19 immunisation. The historical vaccine was, (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, on 23Mar2021 for covid-19 immunisation. The patient medical history Rheumatoid arthritis with Investigation Assessment and blood pressure was reported. The patient's concomitant medications was LISINOPRIL, SULFASALAZINE, and HYDROXYCHLOROQUINE was reported and patient also stated that I am taking arthritis medication and blood pressure medication. On an unknown date patients experienced that I am having reactions to the COVID19 vaccine, I have had two doses it's been about 3 weeks out on second dose, and I am still having tiredness, headache, muscle pain, some chills, fever, and nausea, and discriminant well basically. Patient also stated that No I had in both times, it seems like second dose has been more severe, what do I need to do for, do I need to go to the doctor or do I need to go to the hospital. The patient also stated that he taken a rest. Lab work included Blood test and it was just for anaemia. The out come of events was unknown. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: tiredness; Headache; Muscle pain; Some chills; fever; Nausea; second dose has been more severe; joint pain; just feeling not well; This is a spontaneous report from contactable consumer. An unspecified age and gender patient reported for (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 2 Single, via an unspecified route of administration, on 14Apr2021 for covid-19 immunisation. The historical vaccine was, (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, on 23Mar2021 for covid-19 immunisation. The patient medical history Rheumatoid arthritis with Investigation Assessment and blood pressure was reported. The patient's concomitant medications was LISINOPRIL, SULFASALAZINE, and HYDROXYCHLOROQUINE was reported and patient also stated that I am taking arthritis medication and blood pressure medication. On an unknown date patients experienced that I am having reactions to the COVID19 vaccine, I have had two doses it's been about 3 weeks out on second dose, and I am still having tiredness, headache, muscle pain, some chills, fever, and nausea, and discriminant well basically. Patient also stated that No I had in both times, it seems like second dose has been more severe, what do I need to do for, do I need to go to the doctor or do I need to go to the hospital. The patient also stated that he taken a rest. Lab work included Blood test and it was just for anaemia. The out come of events was unknown. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: On my right arm at the injection end it just had a big bruise; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a big bruise on the right arm at the injection end. It was reported that the patient received the Pfizer shot 3 weeks ago and then the patient got the second dose yesterday. After the first injection about 3 or 4 days, about 3 days, the patient was sitting in the wheelchair and noticed in the mirror something on the right arm at the injection end, it just had a big bruise. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe bloody nose, lasting for 20-30 minutes. No accident or incident, it just started bleeding profusely; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported herself that:  A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 20Apr2021 09:15 as dose 1, single for covid-19 immunisation (age at the vaccination 41 years old). Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Vaccine was administered in hospital. It was reported that on 30Apr2021 14:15 patient experienced severe bloody nose, lasting for 20-30 minutes. There was no accident or incident, it was just bleeding profusely. No treatment for the event was received. She did not receive any other vaccines within four weeks prior to the covid vaccine. She was not diagnosed with covid prior to vaccination. She was not tested for covid since the vaccination. The outcome for the event was unknown.  Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Vertigo
Clinical narrative: Awakened by severe dizziness/ It was followed by bouts of dizziness for days following. Continue to have bouts up to the present day.; Awakened by severe dizziness/vertigo (head spinning),; Rapid eye movement; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 09Apr2021 at 15:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergies (unspecified). 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. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 11:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 02:00, early morning, the patient was awakened by severe dizziness / vertigo (head spinning) along with rapid eye movement. It was followed by bouts of dizziness for days following, continued to have bouts up to the day of reporting. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with vestibular physical therapy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, severe dizziness and vertigo (head spinning) along with rapid eye movement was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: fever; general malaise; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: er8737), via an unspecified route of administration on 19Apr2021 (at the age of 44-year-old) as dose number unknown, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccine in four weeks and any other medications in two weeks. The patient had no known allergies. The patient had no covid prior vaccination and had not tested covid post vaccination. On 20Apr2021, the patient experienced fever, general malaise. The patient did not receive any treatment for the events. The outcome of both the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dry throat, Illness
Clinical narrative: scratchy throat; body aches; flu-like symptoms; sick; scratchy throat/dry scratchy feeling that occasionally feels sore; Light headedness; muscle pain; chills; cough; Sore throat; This is a spontaneous report from a sponsored program.   A 38-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) via an unspecified route of administration, administered in Arm Left on 29Apr2021 (At the age of 38 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller is a consumer who states she and her husband developed symptoms 9-10 days after they received their second dose of the Pfizer covid 19 vaccine. On an unspecified date, the patient had experienced scratchy throat, scratchy throat/dry scratchy feeling that occasionally feels sore, sick and bodyaches flu-like symptoms. On 08May2021, the patient had experienced muscle pain, chills, Sore throat and cough. On 09May2021, the patient had experienced light headedness. Her scratchy throat started Friday night or Saturday morning. It is that dry scratchy feeling that occasionally feels sore. They haven't been taking medicine. They have been taking a kind of Chloraseptic spray. It is just called Chloraseptic spray, it says sore throat relief. She does not have it on her right now. She took some Tylenol and stuff that is recommended. On 09May2021, the event chill was recovered. At the time of reporting, the event sore throat, cough, scratchy throat, Light headedness and muscle pain was not recovered and the outcome of the events body aches, flu-like symptoms, sick and scratchy throat/dry scratchy feeling that occasionally feels sore were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain, Pain, Throat irritation
Clinical narrative: scratchy throat; body aches; flu-like symptoms; sick; scratchy throat/dry scratchy feeling that occasionally feels sore; Light headedness; muscle pain; chills; cough; Sore throat; This is a spontaneous report from a sponsored program.   A 38-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported) via an unspecified route of administration, administered in Arm Left on 29Apr2021 (At the age of 38 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller is a consumer who states she and her husband developed symptoms 9-10 days after they received their second dose of the Pfizer covid 19 vaccine. On an unspecified date, the patient had experienced scratchy throat, scratchy throat/dry scratchy feeling that occasionally feels sore, sick and bodyaches flu-like symptoms. On 08May2021, the patient had experienced muscle pain, chills, Sore throat and cough. On 09May2021, the patient had experienced light headedness. Her scratchy throat started Friday night or Saturday morning. It is that dry scratchy feeling that occasionally feels sore. They haven't been taking medicine. They have been taking a kind of Chloraseptic spray. It is just called Chloraseptic spray, it says sore throat relief. She does not have it on her right now. She took some Tylenol and stuff that is recommended. On 09May2021, the event chill was recovered. At the time of reporting, the event sore throat, cough, scratchy throat, Light headedness and muscle pain was not recovered and the outcome of the events body aches, flu-like symptoms, sick and scratchy throat/dry scratchy feeling that occasionally feels sore were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Chromaturia, Decreased appetite, Fatigue
Clinical narrative: she can be cold sometimes and hot sometimes; purple spot on arm; Pee is very yellow; not much of an appetite; chest hurts; fever; chills; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04May2021 at 9:00 am as DSOE 1, SINGLE for covid-19 immunisation (at the age of 47 years). The patient medical history includes she is allergic to sulfa. The patient's concomitant medications were not reported. The patient reported no investigation assessment. No history of all previous immunization with the Pfizer vaccine considered as suspect and also no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not received prior Vaccinations within 4 weeks and no adverse events following prior vaccinations. The patient experienced on 04May2021 that she received her first vaccine injection on Tuesday and about 2 hours afterward she started getting a fever, chills and feeling tired and it has lasted on and off ever since them. She also reported that her pee is very yellow on 05May2021. She reported that if she drinks a lot of water it changes the color of my pee. And also reported a purple spot on her arm where she got the shot on 06May2021. Stated fever is not worse because she is taking Tylenol. It comes and goes. Caller stated that right now she is okay but she gets more tired in the afternoon. When she gets more tired, the chills start. When she breathes it starts to hurt her chest on 04May2021. She stated that maybe she should call the doctor because she doesn't know how long she is going to be like this. And she doesn't know if its normal from the shots. Also stated that she can be cold sometimes and hot sometimes. She doesn't want to do anything, just be in bed, and she doesn't have much of an appetite either on 05May2021. It was reported that everyone is saying to get the vaccine for their safety, she stated that her husband said she should do it and because she has a granddaughter, so for her and for everyone's safety. Now she is not sure she should of done it. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the events fever, chills, feeling tired, pee is very yellow, not much of an appetite, chest hurts, purple spot on arm was not recovered, she can be cold sometimes and hot sometimes outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Limb discomfort, Pyrexia
Clinical narrative: she can be cold sometimes and hot sometimes; purple spot on arm; Pee is very yellow; not much of an appetite; chest hurts; fever; chills; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04May2021 at 9:00 am as DSOE 1, SINGLE for covid-19 immunisation (at the age of 47 years). The patient medical history includes she is allergic to sulfa. The patient's concomitant medications were not reported. The patient reported no investigation assessment. No history of all previous immunization with the Pfizer vaccine considered as suspect and also no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not received prior Vaccinations within 4 weeks and no adverse events following prior vaccinations. The patient experienced on 04May2021 that she received her first vaccine injection on Tuesday and about 2 hours afterward she started getting a fever, chills and feeling tired and it has lasted on and off ever since them. She also reported that her pee is very yellow on 05May2021. She reported that if she drinks a lot of water it changes the color of my pee. And also reported a purple spot on her arm where she got the shot on 06May2021. Stated fever is not worse because she is taking Tylenol. It comes and goes. Caller stated that right now she is okay but she gets more tired in the afternoon. When she gets more tired, the chills start. When she breathes it starts to hurt her chest on 04May2021. She stated that maybe she should call the doctor because she doesn't know how long she is going to be like this. And she doesn't know if its normal from the shots. Also stated that she can be cold sometimes and hot sometimes. She doesn't want to do anything, just be in bed, and she doesn't have much of an appetite either on 05May2021. It was reported that everyone is saying to get the vaccine for their safety, she stated that her husband said she should do it and because she has a granddaughter, so for her and for everyone's safety. Now she is not sure she should of done it. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the events fever, chills, feeling tired, pee is very yellow, not much of an appetite, chest hurts, purple spot on arm was not recovered, she can be cold sometimes and hot sometimes outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Gland under armpit inflammation and pain; Gland under armpit inflammation and pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW-0165) via an unspecified route of administration in the left arm on 04May2021 at 01:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccination. Concomitant medication taken within two weeks of vaccination was not reported. On 05May2021, the patient experienced gland under armpit inflammation and pain. 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 gland under armpit inflammation and pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Tooth disorder
Clinical narrative: tired; arm was sore; her wisdom teeth pulled and she is on antibiotics; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was tired, arm was sore, her wisdom teeth pulled and she is on antibiotics. Caller wanted to know if she could take her second dose of the bnt162b2 vaccine. Caller stated that she would just forget about taking the second dose. The caller said she had not received any confirmation about her second dose appointment. She hasn't had the second shot. She was inquiring about the scheduling of the second bnt162b2 vaccine. The caller explained that she just wanted to know will the second shot be okay to get since the first shot was back in 01Mar2021, was she fine with getting the second shot, will the first shot just be good and should she even bother with the second shot. Therapeutic measures were taken as a result of the event her wisdom teeth pulled and she is on antibiotics. 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Product dose omission issue, Rash, Skin weeping
Clinical narrative: Could not and did not go back for second dose; Both arms broke out in a terrible rash; Redness, red marks, and oozing; Redness, red marks, and oozing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient himself). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206, Expiry Date: Unknown not provided on vaccine card via intramuscular route of administration in right arm on 06Apr2021 in the morning at the age of 66 years-old as dose 1, single for COVID-19 immunization reported as to prevent self from getting Covid disease. The patient medical history (including any illness at time of vaccination) reported as none. The concomitant medications (other Products) were not reported. Family medical history relevant to adverse events was none. Historical vaccine included Shingles vaccine (shot) (VARICELLA ZOSTER VACCINE, Lot number- UNKNOWN) via an unspecified route of administration an unspecified date as dose 1, single and Shingles vaccine (VARICELLA ZOSTER VACCINE, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 12Mar2021 as dose 2, single for immunization. Adverse events following prior vaccinations reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the pfizer suspect reported as none. Vaccination facility type reported as organized through Medicare and vaccine was not vaccine administered at facility. The patient experienced both arms broke out in a terrible rash bilateral upper extremity rash that is persisting on 07Apr2021. Patient states there is redness, red marks, and oozing on an unspecified date in 2021. He was supposed to have received the second dose 30Apr2021. Patient could not and did not go back for second dose on 30Apr2021. Patient missed his second dose of the Pfizer Covid vaccine and wants to know if he can receive the Johnson and Johnson vaccine, is that ok to do. He had a horrible reaction. The report is not related to a study or programme. No investigation assessment was done. The rash has improved about 50%. Relevant tests reported as none. The patient visited physician office for both arms broke out in a terrible rash. The doctor prescribed Prednisone for the rash. The clinical outcome of the events both arms broke out in a terrible rash, redness, red marks, and oozing was recovering (reported as improving, Ongoing).  No follow-up attempts are needed. No further information is expected.