chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 101f for 11 days along with body ache,; First dose she had a fever of 101f for 11 days along with body ache, site of injection pain, and mild nausea; Site of injection pain; Mild nausea; This is a spontaneous report from a contactable healthcare professional. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via intramuscular route of administration in the left arm on 12Mar2021 14:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included hypothyroidism, arteriosclerosis, arthritis, migraine and ischemic brain disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had no known allergies. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. 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 an unspecified date, the patient experienced fever of 101f for 11 days along with body ache, site of injection pain and mild nausea. No therapeutic measures were taken as a result of these events. The clinical outcome of the event fever was recovered on an unspecified date and rest events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021391438 similar report from same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Pain, Rhinorrhoea
Clinical narrative: second dose began with 5 days of chills body ache, decreased appetite; second dose began with 5 days of chills body ache, decreased appetite; body ache; runny nose; persistent cough; This is a spontaneous report from a contactable other health care professional. A 71-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 02Apr2021 14:00 (at the age of 71-Years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, arteriosclerosis, arthritis, migraine and ischemic brain disease. Concomitant medication included warfarin sodium (COUMADIN) taken for an unspecified indication, lamotrigine (LAMICTAL) taken for an unspecified indication, levothyroxine taken for an unspecified indication, omeprazole magnesium (PRILOSEC) taken for an unspecified indication, furosemide taken for an unspecified indication and atorvastatin calcium (ATORVASTIN) taken for an unspecified indication. Patient did not receive other vaccine in four weeks. Patient did not had covid prior to vaccination. Patient was not tested for covid-19 post vaccination. No known allergies were reported. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 intramuscular, administered in Arm right on 12Mar2021 14:00 (at the age of 71-Years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and experienced Fever, body ache, site of injection pain and mild nausea. On 02Apr2021 19:00, the patient after second dose began with 5 days of chills body ache, decreased appetite, runny nose, persistent cough. Therapeutic measures were not taken with respect to event. At the time of this report, the outcome of events chills body ache, decreased appetite was recovered with sequel on 07Apr2021 and other events recovered with sequel on an unknown date in 2021.  The lot number for the vaccine,(Pfizer/BioNTech COVID-19 vaccine), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391423 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Nausea, Pain in extremity
Clinical narrative: burning up all day; pain in her hip and it went to her toes; pain in her hip and it went to her toes; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 90-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 90-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced burning up all day, pain in her hip and it went to her toes (One night), nausea and by the time she got a bowl it was gone. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pain in extremity, Peripheral swelling
Clinical narrative: hands swelled up; hand and wrist joints got sore beyond what caused by osteoarthritis; hand and wrist joints got sore beyond what caused by osteoarthritis; lost strength in fingers; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at age of 71-years-old) 20:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included not sure this is shot-related; may be reaction to blood pressure meds on unknown date and unknown if ongoing. Concomitant medications were not known (reported as quite a few). The patient had known allergies to morphine. The patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left shoulder on 21Mar2021 (Batch/Lot Number: ER2613) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 27Feb2021, the patient experienced hands swelled up, hand and wrist joints got sore beyond what caused by osteoarthritis and lost strength in fingers. The patient received treatment for adverse event as steroid shot. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: off tasting of food; Dizziness; Exhaustion; Body aches; This is a spontaneous report from a contactable consumer, the patient. This is the second of two reports. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 08Apr2021 at 15:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatism, vitiligo and allergy to "many and many things" and a coworker tested positive for COVID from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (ACETAMINOPHEN), ubidecarenone (COENZYME Q10) and calcium (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and stop date. The patient previously 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 15:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation and experienced nausea and dizziness. 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 at 10:30, the patient experienced all foods and beverages taste 'off'/off tasting of food. Sweet foods and beverages were so much sweeter that they were not even comfortable to eat. Savory foods and beverages were quite bitter. It made her not want to eat anything. The patient inquired that how long would this weird taste continue. After the second dose, the patient also had dizziness, exhaustion and body aches. The patient previously never experienced COVID symptoms but was tested months ago on unknown date after a coworker tested positive for COVID and the result came back negative. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events off tasting of food, dizziness, exhaustion and body aches was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 18:30 (Batch/Lot Number: EN6204) (at the age of 51-years-old) as dose 1, single for covid-19 immunisation. There was no medical history reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient had received no other medications in two weeks. The patient had not covid-19, prior vaccination. The patient had not been tested covid-19, post vaccination. The patient experienced headaches for about 3 days on 19Mar2021 06:00 and on the same date patient experienced joint aches: not able to wear wedding ring for about 5 days. The clinical outcome if the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Lymphadenopathy, Muscle tightness
Clinical narrative: Sore arm; Swelling of my lymph nodes by my collarbone/neck on injection site side only; Tired; Weakness; A slight sporadic vibration in my lip on the right side that disappeared afer a week; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; Muscle tightness; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Right on 25Mar2021 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); fish oil (FISH OIL); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). No allergies reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6203) via an unspecified route of administration at Arm Right on 04Mar2021 11:15 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation and reported sore arm and bruising for about a week. Facility where the most recent COVID-19 vaccine was administered reported as pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced really sore arm and swelling of my lymph nodes by my collarbone/neck on injection site side only. Incredibly tired for two weeks with some weakness. A slight sporadic vibration in my lip on the right side that disappeared after a week. Though today is 2 weeks after 2nd dose and swelling of lymph nodes is still visible/tender & tightness near collarbone. Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck. Reporter assessed case as non-serious. Patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event A slight sporadic vibration in my lip on the right side that disappeared after a week was recovered on 2021 and rest all was not recovered.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021385684 Same patient, same product with different dose, partial same event
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oral discomfort, Pain in extremity
Clinical narrative: Sore arm; Swelling of my lymph nodes by my collarbone/neck on injection site side only; Tired; Weakness; A slight sporadic vibration in my lip on the right side that disappeared afer a week; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; Muscle tightness; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Right on 25Mar2021 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); fish oil (FISH OIL); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). No allergies reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6203) via an unspecified route of administration at Arm Right on 04Mar2021 11:15 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation and reported sore arm and bruising for about a week. Facility where the most recent COVID-19 vaccine was administered reported as pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced really sore arm and swelling of my lymph nodes by my collarbone/neck on injection site side only. Incredibly tired for two weeks with some weakness. A slight sporadic vibration in my lip on the right side that disappeared after a week. Though today is 2 weeks after 2nd dose and swelling of lymph nodes is still visible/tender & tightness near collarbone. Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck. Reporter assessed case as non-serious. Patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event A slight sporadic vibration in my lip on the right side that disappeared after a week was recovered on 2021 and rest all was not recovered.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021385684 Same patient, same product with different dose, partial same event
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: fever; cold sweats; body aches; migraine; fatigue; This is a spontaneous report from a contactable consumer (Patient).   A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 03Apr2021 at 11:45 (age at vaccination: 32 year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were reported as none. 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 13Mar2021 at 00:00 (at the age of 32-year-old) as dose 1, single for COVID-19 immunization and experienced minor chills and body aches. Allergies to medications, food, or other products were reported as none. 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 04Apr2021 at 04:00, the patient experienced fever, cold sweats, body aches, migraine and fatigue the first and third day after vaccination. No treatment received for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Flushing, Vaccination site pain
Clinical narrative: pain at injection site (for 1-3 days)/Pain during injection of second dose; More fatigue; Some stomach discomfort; Flushing- redness of face; This is a spontaneous report from a non-contactable consumer (Patient). A 68-years-old (non-pregnant) female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown) 07Apr2021 at 14:45 via an unspecified route of administration in the left arm as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination:68-years-old). The patient medical history included unspecified allergies to medications, food or other products. 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 COVID-19 vaccination.Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unknown), via an unspecified route of administration in the left arm on 10Mar2021 at 15:15 as DOSE 1, SINGLE for COVID-19 immunisation. After the first dose, the patient experienced pain at injection site (pain at site for 1-3 days), slight swelling at injection site and fatigue. The patient concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin and ibuprofen since an unspecified date for unknown indications. On 07Apr2021, the patient experienced pain during injection of second dose, flushing-redness of face. The patient also experienced pain at injection site (for 1-3 days), fatigue, some stomach discomfort. 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. The clinical outcome of the events flushing-redness of face, more fatigue and "some stomach discomfort" was unknown. The outcome of the event pain at injection site (for 1-3 days)/Pain during injection of second dose was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: had my period for almost 5 weeks straight; heavier bleeding than usual; Much stronger cramps; It also lasted 7 days with light bleeding for several more days. There were about 2 days with no bleeding and then I started another menstrual cycle; This is a spontaneous report from a contactable consumer (Patient). A 30-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 05Mar2021 12:45 PM as DOSE 1, SINGLE for covid-19 immunisation (at the age of 30 years). Medical history included polycystic ovaries from an unknown date and unknown if ongoing. No known allergies and other medical history. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not received other vaccine in four weeks. No covid prior vaccination and also no covid tested post vaccination. The patient experienced on 08Mar2021 she have had her period for almost 5 weeks straight. The patient first started her menstrual cycle about 3 days after the first vaccine. She didn't think much about it, but it did not feel normal. Much stronger cramps and heavier bleeding than usual. It also lasted 7 days with light bleeding for several more days. There were about 2 days with no bleeding and then she started another menstrual cycle. This time it felt similar to her usual periods. The patient then got her 2nd vaccine and had very light bleeding for about a week and a half. She have now started another period and this one seems to be similar to the one she had after the first dose. The patient should note that she have never had periods for this long or this frequent. She have PCOS so her body is used to not having them for months. Even after going a year without one while pregnant and nursing, it still only lasted 5 days she had no other symptoms other than a slightly sore arm at the injection site. The patient did not received any treatment for the events. The clinical outcome of all the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Pruritus, Rash papular
Clinical narrative: Rash resembles contact dermatitis; mild pruritis; Papular rash noted on left arm/rash has spread to encompass arm - mainly inside of arm (adjacent to main vasculature); This is a spontaneous report from a contactable other healthcare professional (regarding a patient). A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) (age at the time of vaccination was 37 years, patient was non-pregnant at the time of vaccination), via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 37-year-old) as a dose 2, single for COVID-19 immunization. Concomitant medications included venlafaxine (VENLAFAXINE) and numerous supplements recommended by primary care provider from unknown date for unspecified indications. The patient previously received morphine injections and experienced adverse cutaneous reaction. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration in the left arm on 12Mar2021 at 16:00 (at the age of 37-year-old) as a single dose for COVID-19 immunization. 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 at 18:00 the patient experienced papular rash on left arm approximately two hours after vaccination, seemed to coincide with the flush side effect of onset on niacin 1000mg supplementation. 18hours post vaccination, rash has spread to encompass arm mainly inside of arm adjacent to main vasculature. The rash resembled contact dermatitis with mild pruritus. The patient didn't visited physician or other health professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with self administered diphenhydramine. The outcome of the events was not recovered at the time of this report.  No follow-up attempts were needed. No further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 24, via an unspecified route of administration, on an unknown date, for COVID-19 immunisation. Medical history and concomitant medication not reported. The patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization; and experienced sore arm. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unknown date, patient experienced extremely sore arm, heavy body, fatigue, chills and minor fever. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. The outcome of extremely sore arm, fatigued, heavy body, chills and minor fever: unknown (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Musculoskeletal stiffness, Myalgia, Pruritus
Clinical narrative: significant shoulder/neck stiffness; headache; raised red rash on stomach and chest, not really itchy/Rash still here am; raised red rash on stomach and chest, not really itchy; muscle soreness and headache back to mild; raised red rash on stomach and chest, not really itchy/Rash still here am; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 48-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in arm left on 06Apr2021 08:45 (at the age of 48-year-old) at dose 2, single for covid-19 immunisation. Medical history included hypothyroid and allergies to sesame seeds, severe abd pain, allergy verified by blood test, chia seeds anaphylaxis. Latex rash and allergy verified by blood test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHY-ROXINE); lysine (LYSINE); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); vitamins nos (MULTIVITAMIN [VITAMINS NOS]), all taken for an unspecified indication, start and stop date were not reported, patient received these medications within 2 weeks of vaccination. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in arm left on 16Mar2021 08:45 (at the age of 48-year-old) at dose 1, single for covid-19 immunisation after 1st dose patient experienced mild shoulder/neck stiffness, arm sore, not bad. On 07Apr2021 19:00 the patient experienced adverse event after 2nd dose significant shoulder/neck stiffness, headache and eve of 4/7 raised red rash on stomach and chest, not really itchy. Rash still here am of 4/8/21 but muscle soreness and headache back to mild. The patient underwent lab tests and procedures which included blood test: allergy on an unspecified date (allergy verified by blood test). Patient did not received treatment for the adverse events. Outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: significant shoulder/neck stiffness; headache; raised red rash on stomach and chest, not really itchy/Rash still here am; raised red rash on stomach and chest, not really itchy; muscle soreness and headache back to mild; raised red rash on stomach and chest, not really itchy/Rash still here am; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 48-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in arm left on 06Apr2021 08:45 (at the age of 48-year-old) at dose 2, single for covid-19 immunisation. Medical history included hypothyroid and allergies to sesame seeds, severe abd pain, allergy verified by blood test, chia seeds anaphylaxis. Latex rash and allergy verified by blood test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine (LEVOTHY-ROXINE); lysine (LYSINE); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); vitamins nos (MULTIVITAMIN [VITAMINS NOS]), all taken for an unspecified indication, start and stop date were not reported, patient received these medications within 2 weeks of vaccination. Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in arm left on 16Mar2021 08:45 (at the age of 48-year-old) at dose 1, single for covid-19 immunisation after 1st dose patient experienced mild shoulder/neck stiffness, arm sore, not bad. On 07Apr2021 19:00 the patient experienced adverse event after 2nd dose significant shoulder/neck stiffness, headache and eve of 4/7 raised red rash on stomach and chest, not really itchy. Rash still here am of 4/8/21 but muscle soreness and headache back to mild. The patient underwent lab tests and procedures which included blood test: allergy on an unspecified date (allergy verified by blood test). Patient did not received treatment for the adverse events. Outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: 100 degree temp; swollen lymph nodes under arm; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 12Mar2021 at 12:15 as dose 1, single (at the age of 47-years-old) for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 59267-1000-01, Expiration date: Unknown), via an unspecified route of administration on 09Apr2021 at 12:15 as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included blood pressure abnormal, allergy to cephalosporins and ob/gynae issues (gynaecological examination abnormal) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications included iron, vaccinium macrocarpon (CRANBERRY), vitamin D, birth and blood pressure medications taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 at 12:30, the patient experienced 100 degree temp and swollen lymph nodes under arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 03Apr2021. Therapeutic measures were not taken as a result of the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Depression, Dizziness
Clinical narrative: depression; mania; I had to go to bed; Vaccination hurt going in and I could feel it in my arm; light headed/Dizzy; weak; nausea; chills; body aches; low grade fever; extreme fatigue; anxious; This is a spontaneous report received from a contactable other HCP (nurse) (patient). A 70-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 (at the age of 70-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included fibromyalgia, ADHD (Attention deficit hyperactivity disorder), hypertension, asthma and COVID-19 on an unspecified date in Mar2021 and patient still have no smell or taste. Concomitant medications were not reported. the patient previously took Macrobid and experienced allergy. Prior vaccinations within four weeks were reported as none. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Dec2020, the patient experienced vaccination hurt going in and she could feel it in her arm, within 1 hour she started getting lightheaded, weak and dizzy, she had to go to bed. On 26Dec2021, the patient reported that she had nausea, chills, body aches, low grade fever and then extreme fatigue which lasted for 2 days, light fatigue and nausea for 4 days, she was anxious and then one morning fell into a deep, deep depression the next week, after about 4 hrs it turned into mania. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Mar2020, negative; Nasal Swab on Jan2021 and Feb2021. Adverse events did not require Emergency room/Physician office visit. The patient did not receive any treatment for the events. The outcome of the events (extreme fatigue, depression) was not recovered, events (Vaccination hurt going in and I could feel it in my arm, lightheaded/Dizzy, weak, chills, body aches, low grade fever) was recovered on 28Dec2020, event (nausea) was recovered on 30Dec2020, and event (anxiety, mania) was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mania, Nausea, Pain, Pain in extremity
Clinical narrative: depression; mania; I had to go to bed; Vaccination hurt going in and I could feel it in my arm; light headed/Dizzy; weak; nausea; chills; body aches; low grade fever; extreme fatigue; anxious; This is a spontaneous report received from a contactable other HCP (nurse) (patient). A 70-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 (at the age of 70-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included fibromyalgia, ADHD (Attention deficit hyperactivity disorder), hypertension, asthma and COVID-19 on an unspecified date in Mar2021 and patient still have no smell or taste. Concomitant medications were not reported. the patient previously took Macrobid and experienced allergy. Prior vaccinations within four weeks were reported as none. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Dec2020, the patient experienced vaccination hurt going in and she could feel it in her arm, within 1 hour she started getting lightheaded, weak and dizzy, she had to go to bed. On 26Dec2021, the patient reported that she had nausea, chills, body aches, low grade fever and then extreme fatigue which lasted for 2 days, light fatigue and nausea for 4 days, she was anxious and then one morning fell into a deep, deep depression the next week, after about 4 hrs it turned into mania. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Mar2020, negative; Nasal Swab on Jan2021 and Feb2021. Adverse events did not require Emergency room/Physician office visit. The patient did not receive any treatment for the events. The outcome of the events (extreme fatigue, depression) was not recovered, events (Vaccination hurt going in and I could feel it in my arm, lightheaded/Dizzy, weak, chills, body aches, low grade fever) was recovered on 28Dec2020, event (nausea) was recovered on 30Dec2020, and event (anxiety, mania) was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: depression; mania; I had to go to bed; Vaccination hurt going in and I could feel it in my arm; light headed/Dizzy; weak; nausea; chills; body aches; low grade fever; extreme fatigue; anxious; This is a spontaneous report received from a contactable other HCP (nurse) (patient). A 70-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 (at the age of 70-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included fibromyalgia, ADHD (Attention deficit hyperactivity disorder), hypertension, asthma and COVID-19 on an unspecified date in Mar2021 and patient still have no smell or taste. Concomitant medications were not reported. the patient previously took Macrobid and experienced allergy. Prior vaccinations within four weeks were reported as none. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Dec2020, the patient experienced vaccination hurt going in and she could feel it in her arm, within 1 hour she started getting lightheaded, weak and dizzy, she had to go to bed. On 26Dec2021, the patient reported that she had nausea, chills, body aches, low grade fever and then extreme fatigue which lasted for 2 days, light fatigue and nausea for 4 days, she was anxious and then one morning fell into a deep, deep depression the next week, after about 4 hrs it turned into mania. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Mar2020, negative; Nasal Swab on Jan2021 and Feb2021. Adverse events did not require Emergency room/Physician office visit. The patient did not receive any treatment for the events. The outcome of the events (extreme fatigue, depression) was not recovered, events (Vaccination hurt going in and I could feel it in my arm, lightheaded/Dizzy, weak, chills, body aches, low grade fever) was recovered on 28Dec2020, event (nausea) was recovered on 30Dec2020, and event (anxiety, mania) was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: difficulty breathing/shortness of breath; About 3 hours after receiving the shot, I started having sharp chest pain.; pulse rate was very elevated. About 115-120 bpm; tightness in my chest; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8729, Expiry date: not reported), via an unspecified route of administration in left arm on 09Apr2021 13:45 (at age of 24-years-old) as dose 1, single for COVID-19 immunization in pharmacy or drug store. The patient was not pregnant at the time of vaccination. Medical history included leukopenia, eczema and allergies to nitrates. Concomitant medication(s) included apple cider vinegar (APPLE CIDER VINEGAR) taken for an unspecified indication, start and stop date were not reported; Birth control and black elderberry taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentin [amoxicillin;clavulanic acid] and experienced allergy. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reporter stated that on 09Apr2021 at 16:45, about 3 hours after receiving the shot, I started having sharp chest pain, pulse rate was very elevated. About 115-120bpm. About an hour after that, I began to have tightness in my chest and difficulty breathing/shortness of breath. The events were assessed as non-serious. The patient underwent lab tests and procedures which included heart rate: on 09Apr2021 Elevated, 115-120 bpm. No therapeutic measures were taken in response to the events. It was reported that (all of those symptoms remained for the next 24 hours. The events recovered on an unspecified date in Apr2021. ~ No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Severe soreness of arm where injected (could not lift arm up for several hours); Mild fever (100F); This is a spontaneous report from a contactable consumer (herself). This is first of two reports. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP8734) via an unspecified route of administration, administered on Arm Right on 17Mar2021 at 10:15 as a DOSE 1, SINGLE for COVID-19 immunisation (at the age of 51 years). Medical history included in 2019 ongoing breast cancer (Breast cancer- dx 2019, ongoing treatment with aromatase inhibitor) and on unknown date COVID-19. Concomitant medications included anastrozole (ARIMIDEX) and calcium carbonate, vitamin d nos (CALCIUM + VIT D). The patient previously took ciprofloxacin antibiotic and experienced drug allergy on an unknown date. 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 an unspecified date in Mar2021, the patient experienced severe soreness of arm where injected and mild fever of 100F. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient underwent body temperature test and the result was 100 F. The clinical outcome of the events severe soreness of arm where injected and mild fever of 100F was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Fever; Nausea; Fatigue; Extreme muscle pain all over body; Extreme joint pain all over to include hands; Severe headache.; This is a spontaneous report from a non-contactable other healthcare professional (patient). This is the second of two reports. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 13:30 (at the age of 38-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The medical history included asthma. The patient had known allergies included tree nut allergy. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (VITAMIN D NOS), melatonin, ibuprofen and paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204) via an unspecified route of administration in the right arm in Mar2021 at 13:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced soreness at the injection site. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After the 2nd dose of the Pfizer Vaccine, on 07Apr2021 at 01:30, approximately 12 hours after the injection the patient experienced chills, fever, nausea, fatigue, extreme muscle pain all over body, extreme joint pain all over to include hands, and severe headache. The aforementioned effects lasted about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The outcome of the events was recovered on 08Apr2021 at 13:30.   No follow-up attempts are possible. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills; Fever; Nausea; Fatigue; Extreme muscle pain all over body; Extreme joint pain all over to include hands; Severe headache.; This is a spontaneous report from a non-contactable other healthcare professional (patient). This is the second of two reports. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 13:30 (at the age of 38-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The medical history included asthma. The patient had known allergies included tree nut allergy. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (VITAMIN D NOS), melatonin, ibuprofen and paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6204) via an unspecified route of administration in the right arm in Mar2021 at 13:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced soreness at the injection site. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After the 2nd dose of the Pfizer Vaccine, on 07Apr2021 at 01:30, approximately 12 hours after the injection the patient experienced chills, fever, nausea, fatigue, extreme muscle pain all over body, extreme joint pain all over to include hands, and severe headache. The aforementioned effects lasted about 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The outcome of the events was recovered on 08Apr2021 at 13:30.   No follow-up attempts are possible. No further information was expected.