chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Body temperature at 101; Chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 28Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient did not receive any concomitant medications. The patient previously received 'coconut' for an unknown indication from an unspecified date. 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 07Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 around 22:30, the patient experienced chills. On 28Apr2021 at 23:30, the patient experienced body temperature at 101 (unspecified units). The patient reported that he drank water had a thick robe and blanket on. The clinical outcome of the events chills and body temperature at 101(unspecified units) was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Got the 2nd vaccine and still on my menstrual cycle 15 days and counting; This is a spontaneous report from a Pfizer of a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for  injection, Batch/Lot number was not reported) dose 2 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 historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for  injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient received the second vaccine and still on her menstrual cycle 15 days and counting. The patient reported that, more trials of COVID-19 should be done on women specifically. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Welt and swelling at the injection site bigger than a quarter; Swelling at the injection site bigger than a quarter; Redness in big circle at injection site; Injection site was very itchy; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and hypertension; both from an unknown date. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 11:00, the patient experienced welt and swelling at the injection site bigger than a quarter, redness in big circle at injection site and injection site very itchy. The clinical outcome of the events welt and swelling at the injection site bigger than a quarter, redness in big circle at injection site and injection site very itchy was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 19Feb2021 at 17:30 (at the age of 79-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201)  via an unspecified route of administration in the left arm on an unspecified date ; as a single dose for COVID-19 immunisation. Medical history included arthritis, two hip replacement, two knee replacement, shots in hands and feet every three months and low kidney function. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 11:00 the patient experienced constant diarrhea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea and included treatment with unspecified antibiotic prescribed by the doctor. The clinical outcome of the event constant diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Mass, Neck mass
Clinical narrative: after his 2nd dose of the vaccine the lump got even larger; after his 2nd dose of the vaccine the lump got even larger; states that after the 2nd dose, he had a second lump; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 25-year-old male son (Patient).  A 25-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 19Apr2021 15:30 (at the age of 25-years-old) as dose 2, single for COVID-19 immunisation. Reason for no lot number: of Pfizer COVID Vaccine: Other: Caller states Reporter has no lot numbers, expiry dates or NDC numbers to provide as her son is not there and he has his patient card for the Pfizer COVID vaccine. Medical history included gene mutation (they have a weird gene mutation called SCN5A). The patient concomitant medications were not reported. The patient has not had any vaccines since Dec2020 when his mother made him get a flu shot and has had no others prior to that for a year. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration, administered in Arm left on 29Mar2021 11:45 as dose 1, single for COVID-19 immunisation and experienced lump on neck. No Investigation Assessment reported. The reporter stated she was calling about the Pfizer COVID vaccine and was calling regarding her 25-year-old son and he got the two different Pfizer COVID vaccine doses. Reporter stated after his second dose of the vaccine the lump on his neck got even larger and was probably the size of a large grape and has also gotten firmer. Reporter further stated that after the 2nd dose, patient had a second lump, and it was probably the size of like between a raisin or a small green olive. Reporter stated the second lump happened the same day as the 2nd dose of the Pfizer COVID Vaccine on 19Apr2021. Reporter wanted to know if that was normal or if it was something they need to be concerned about and at what point do they see the HCP. Reporter stated the patient has not yet had any treatment for the reported events. Adverse events did not require a visit to ER or MD office. Reporter seriousness for the events was reported as unspecified. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body ache; Chills that wont stop,; Fever; This is a spontaneous report from a contactable consumer, the patient. A 29-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 28Apr2021 at 11:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date. 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 07Apr2021 at 11:45 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. The patient previously took sulfas (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 23:00, the patient experienced chills that would not stop, fever and  body ache. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen. The clinical outcome of the events of chills, fever and general body pain were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever; Physical exhaustion; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 25-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 arm left on 28Apr2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluvoxamine (MANUFACTURER UNKNOWN) at a dose of 150 mg, levomefolic acid (L-METHYLFOLATE) at a dose of 15 mg; both were taken for unspecified indication started on an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0169) via an unspecified route of administration in the arm left on 07Apr2021 at 18:00 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 07:00, the patient experienced fever, physical exhaustion and sore arm but that was not abnormal with any shot. The clinical outcome of the events fever, physical exhaustion and sore arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Myalgia
Clinical narrative: Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site inflammation
Clinical narrative: Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Headache; Fatigue; Right arm injection site swollen; Right arm injection site red; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-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 right arm on 26Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included ascorbic acid (VITAMIN C) from an unknown date and for an unknown indication. The patient previously took duricef and shellfish. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced headache, fatigue, right arm injection site swollen and red and sore arm. The clinical outcome of the events headache, fatigue, right arm injection site swollen and red and sore arm were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Nausea
Clinical narrative: Aches and sore all over; Headaches/ developed headaches; Fever; Very tired/ extremely tired; Increased indigestion; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732/ER8729) via an unspecified route of administration in the arm left on 13Apr2021 at 10:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. Past drug history included hazelnut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 18:45 the patient was extremely tired and on 14Apr2021 patient experienced aches and sore all over, headaches and fever. On an unknown date in Apr2021 (over the next two weeks) the patient experienced increased indigestion, nausea and diarrhea. The clinical outcome of the events extremely tired, aches and sore all over, headaches, fever, increased indigestion, nausea and diarrhea were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches and sore all over; Headaches/ developed headaches; Fever; Very tired/ extremely tired; Increased indigestion; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732/ER8729) via an unspecified route of administration in the arm left on 13Apr2021 at 10:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. Past drug history included hazelnut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 18:45 the patient was extremely tired and on 14Apr2021 patient experienced aches and sore all over, headaches and fever. On an unknown date in Apr2021 (over the next two weeks) the patient experienced increased indigestion, nausea and diarrhea. The clinical outcome of the events extremely tired, aches and sore all over, headaches, fever, increased indigestion, nausea and diarrhea were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, SARS-CoV-2 antibody test
Clinical narrative: Several days with flu like symptoms.; Developed a cough that took about a week to go away.; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP75533), via an unspecified route of administration in the right arm on 07Apr2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included landau-kleffner syndrome and gene mutation. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced flu like symptoms for several days and had developed a cough. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent COVID-19 antibody blood test and the result was negative. The clinical outcome of the events cough was resolved on 15Apr2021 (took about a week to go away) and flu like symptoms was resolved in Apr2021. The 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 28Apr2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Pain in extremity
Clinical narrative: Arm pain; Fatigue; Chills; Flu like symptoms; Chest fluttering; Sweats; Itchy rash stared on both forearms, then chin line, forehead, back of neck; both lower shins; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0170), via an unspecified route of administration in the left arm on 26Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shellfish for an unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8T34), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, during the first 24 hours after vaccination, the patient experienced arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering. On an unspecified date in Apr2021, which the patient reported to be the second or third day, the patient experienced a very itchy rash which started on both forearms, then the chin line, forehead, back of neck and both lower shins. The clinical outcome of the events arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering and itchy rash was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash pruritic
Clinical narrative: Arm pain; Fatigue; Chills; Flu like symptoms; Chest fluttering; Sweats; Itchy rash stared on both forearms, then chin line, forehead, back of neck; both lower shins; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0170), via an unspecified route of administration in the left arm on 26Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shellfish for an unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8T34), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, during the first 24 hours after vaccination, the patient experienced arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering. On an unspecified date in Apr2021, which the patient reported to be the second or third day, the patient experienced a very itchy rash which started on both forearms, then the chin line, forehead, back of neck and both lower shins. The clinical outcome of the events arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering and itchy rash was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash
Clinical narrative: Rash on left side of body; Extreme tiredness; Head aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 27Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021 at 10:00, the patient experienced rash on left side of body, extreme tiredness and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events rash on left side of body, extreme tiredness and headaches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pigmentation disorder, Pyrexia, Rash
Clinical narrative: Fatigue; Chills; Low grade temperature; Rash developed on ankles and the tops of feet; It began as a mottled pigment change right after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 14:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure and  COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), fluticasone propionate, salmeterol xinafoate (ADVAIR), salbutamol (VENTOLIN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient previously took penicillin, sulfur, Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Apr2021 at 15:00, the patient experienced normal symptoms of fatigue, chills, low grade temperature, began as a mottled pigment changed right after the vaccination into a rash developed on ankles and the tops of feet. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, chills, low grade temperature, mottled pigment and rash was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, SARS-CoV-2 test
Clinical narrative: Severe abdominal pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) in the arm left on 23Mar2021(at the age of 23-years-old) at 16.00 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient's past drug history was reported as avocado. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) in the left arm on 02Mar2021 at 11.00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 17:00, the patient experienced headache and severe abdominal pain 25 hours after receiving second dose. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 02Apr2021 and tested negative. The clinical outcome of the events headache and severe abdominal pain was recovered on an unknown date on unknown date of 2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Feeling hot, Hypersensitivity, Pruritus, Vaccination site pain
Clinical narrative: Allergic reaction (non-life threatening) where I had itchy eyes, nose, throat, and neck; Allergic reaction (non-life threatening) where the patient had itchy eyes, nose, throat, and neck; eyes were burning; felt very hot; soreness in the right arm (where the shot was given); This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 27Apr2021 at 10:00(at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient's past drug included stone fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 27Apr2021, about 2 hours after the vaccination, the patient experienced soreness in the right arm (where the shot was given) which continued for another 48 hours. On 29Apr2021 at 09:00, the patient experienced an allergic reaction (non-life threatening) where she had itchy eyes, nose, throat, and neck and her eyes were burning and felt very hot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and ALLEGRA. The clinical outcome of the events vaccination site pain, allergic reaction, burning eyes, feeling hot and itchy was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Rash pruritic
Clinical narrative: Lymph nodes under left arm and side of left breast swollen and very painful; Lymph nodes under left arm and side of left breast swollen and very painful; Measles like rash on torso front and back. prickly and itchy.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 at 12:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as no. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 31Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the patient experienced swollen and very painful lymph nodes under left arm and side of left breast and measles like prickly and itchy rash on torso front and back. The clinical outcome of the events swollen and very painful lymph nodes under left arm and side of left breast and measles like prickly and itchy rash on torso front and back was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: Extreme itching of entire body; Swollen face and throat; Swollen face and throat; entire body slightly puffy; hives on back; This is a spontaneous report from a contactable consumer, the patient. A 21-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 arm left on 28Apr2021 at 17:30(at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD, depression and anxiety. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and depression meds; both from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation and Penicillin on an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 20:30 after 3 hours of vaccination, the patient experienced Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back. Therapeutic measures were taken as a result of the reported events and included treatment herself with Ibuprofen but hadn't helped yet. The clinical outcome of the Extreme itching of entire body, Swollen face and throat, entire body slightly puffy and hives on back was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Fuzziness in  head; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker for accelerated afib. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), simvastatin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ), all for unknown indications from an unknown dates. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient previously taken mustard (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 16:00, the patient experienced fuzziness in head, not dizzy or losing balance since the second dose but just not normal. The clinical outcome of the event of fuzziness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Extreme fatigue; chills; achy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 19Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unspecified date. Concomitant medications included vitamin d nos (VITAMIN D) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. On an unknown date, the patient underwent a COVID-19 virus test and the result was positive COVID-19 test. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced Extreme fatigue, chills, achy. The clinical outcome of the events extreme fatigue, chills, achy was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 24Apr2021 at 18:30 as a single dose(at the age of 24-years-old) for COVID-19 immunisation. Concomitant medications included cholecalciferol (VITAMIN D3) from unknown date for unknown indication, magnesium supplement (MANUFACURER UNKNOWN) from unknown date for unknown indication and multivitamin (MANUFACURER UNKNOWN) from unknown date for unknown indication. The patient previously took cefdinir. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 06:00, the patient experienced extreme dizziness. Therapeutic measures taken were not reported. The clinical outcome of the event extreme dizziness was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaginal haemorrhage
Clinical narrative: vaginal cramping; spotting; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 11Mar2021 at 10:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 06:30 the patient experienced vaginal cramping and spotting the morning after the vaccination was received. The clinical outcome of the event spotting vaginal, cramp was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Pain
Clinical narrative: Carpal Tunnel both hands; pain; numbness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 04Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced Carpal Tunnel both hands, pain, numbness. The patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event carpal tunnel syndrome, pain, numbness was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Taste disorder
Clinical narrative: I had a drink of coffee and asked my husband if he brunt it because it tasted odd, then since then my taste on several food and drink items has changed.  It's a gross taste in my mouth upon smell the item and even while eating.; I can't really smell bleach, my toothpaste (2 different brands) and other food all taste/smell the same.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0150), via an unspecified route of administration in the left arm on 07Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication taken within two weeks included ethinylestradiol; norgestimate (SPRINTEC) from an unknown date for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 11Apr2021 at 08:00, the patient experienced taste change and smell loss. The patient had a drink of coffee and asked her husband if he had brunt it because it tasted odd, then since then her taste on several food and drink items had changed. It was gross taste in her mouth upon smell the item and even while eating. There were several things the patient just couldn't eat because it was gross but she used to highly enjoy them. The patient couldn't really smell bleach, her toothpaste (2 different brands) and other food all tasted/smelled the same. The clinical outcome of the event taste change and smell change was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0179), via an unspecified route of administration in the left arm on 28Apr2021 at 18:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation and the adverse events for the second dose were not reported.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: Body aches; heart palpitations; Low grade fever; five days post shot extreme fatigue/exhaustion to point I could not get out of bed; First and second day post shot a little tired;; This is a spontaneous report from a contactable consumer, the patient. A 62-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 arm right on 15Apr2021 at 11:15(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and reaction to preservatives(Preservatives in shots). Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC),famotidine (MANUFACTURER UNKNOWN) and Estrogen patch(Manufacturer unknown) from unknown dates for unknown indication. The patient previously received Biaxin, Sulfur and penicillin. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER2613 ) via an unspecified route of administration in the arm right on 22Mar2021 at 13:15(at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 the patient experienced little tired First and second day post shot. On 20Apr2021 at 08:00 five days post shot extreme fatigue/exhaustion to point she could not get out of bed, heart palpitations, low grade fever, body aches. The clinical outcome of the event First and second day post shot a little tired; was recovered. The clinical outcome of the event Body aches was recovered. The clinical outcome of the event heart palpitations was recovered. The clinical outcome of the event Low grade fever was recovered. The clinical outcome of the event five days post shot fatigue/exhaustion was recovered.  No follow-up attempts are needed. No further information is expected.