chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Haematemesis, Headache, Malaise
Clinical narrative: vomited; vomit blood; nausea; body was very painful; headache; chills; fever; felt ill; weak; The initial case was missing the following minimum criteria: unspecified AE). Upon receipt of follow-up information on 17May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer.  A 53 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 29Jan2021 at 14:30 at single dose via an unspecified route of administration on left shoulder for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: EL3248) on 08Jan2021 at 16:00. On 30Jan2021 the patient woke around 3.00am, she slightly moved, nausea and vomited so violently occurred. Patient reported she vomited blood. Body was very painful, patient had a splitting headache, chills, fever and all slight movement brought on nausea and vomiting. She also informed  ate no meals on 30Jan2021. On the same day (30Jan2021) patient also felt ill and weak for fear and vomiting. Provided pulse oxygen was 129. It took two weeks to completely void of symptoms (as reported). Patient reported body pain made her cry. The patient was not treated for pain and nausea. Treatment for headache was not reported, while treatment was received for other reported events. The patient recovered from the events on an unspecified date in 2021.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Pain, Pyrexia, Vomiting
Clinical narrative: vomited; vomit blood; nausea; body was very painful; headache; chills; fever; felt ill; weak; The initial case was missing the following minimum criteria: unspecified AE). Upon receipt of follow-up information on 17May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer.  A 53 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 29Jan2021 at 14:30 at single dose via an unspecified route of administration on left shoulder for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: EL3248) on 08Jan2021 at 16:00. On 30Jan2021 the patient woke around 3.00am, she slightly moved, nausea and vomited so violently occurred. Patient reported she vomited blood. Body was very painful, patient had a splitting headache, chills, fever and all slight movement brought on nausea and vomiting. She also informed  ate no meals on 30Jan2021. On the same day (30Jan2021) patient also felt ill and weak for fear and vomiting. Provided pulse oxygen was 129. It took two weeks to completely void of symptoms (as reported). Patient reported body pain made her cry. The patient was not treated for pain and nausea. Treatment for headache was not reported, while treatment was received for other reported events. The patient recovered from the events on an unspecified date in 2021.   Information about batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After second dose - large swollen lymph node on neck; This is a spontaneous report from a contactable other health care professional (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EH9899), via an unspecified route of administration on 27Dec2020 (at the age of 31-years-old) as 1st dose single for Covid-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EK4176), via an unspecified route of administration on 30Jan2021 (at the age of 31-years-old) as 2nd dose single for covid-19 immunization. The patients medical history included allergy to amoxicillin. The patients concomitant medications included unspecified birth control medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that after second dose, the patient experienced large swollen lymph node on neck on the left side, same side as injection site started on 18Jan2021 and been 2 weeks and still very large. Adverse event resulted in doctor or other healthcare professional office clinic visit. The treatment for the adverse event included an antibiotic script. The reporter assessed adverse event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused prolonged hospitalization, Disabling Incapacitating, Congenital anomaly/birth defect. The outcome of the event, large swollen lymph node on neck was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Left arm numbness and pain; Left arm numbness and pain; headache; nausea; stiff neck and back; inability to stand for more than a few seconds without becoming weak; inability to stand for more than a few seconds without becoming weak; Patient received BNT162B2/ breastfeeding; Patient received BNT162B2/ breastfeeding; This is a spontaneous report from a contactable other healthcare professional (patient herself). This other healthcare professional reported information for both mother and baby. This is the mother report. A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm on 01Feb2021 at 13:00 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, ongoing breastfeeding, allergies to medications, food, or other products: Hydrocodone, Vicodin, dialaudid, morphine. Concomitant medications were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient received BNT162B2/ breastfeeding on 01Feb2021 at 13:00. The patient experienced left arm numbness and pain, headache, nausea, stiff neck and back, inability to stand for more than a few seconds without becoming weak on 01Feb2021 at 19:00. It was unknown whether the treatment received for the adverse events or not. The events were considered as non-serious by the other healthcare professional. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125300 baby case
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain in extremity, Product use issue
Clinical narrative: Left arm numbness and pain; Left arm numbness and pain; headache; nausea; stiff neck and back; inability to stand for more than a few seconds without becoming weak; inability to stand for more than a few seconds without becoming weak; Patient received BNT162B2/ breastfeeding; Patient received BNT162B2/ breastfeeding; This is a spontaneous report from a contactable other healthcare professional (patient herself). This other healthcare professional reported information for both mother and baby. This is the mother report. A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm on 01Feb2021 at 13:00 (at the age of 25-year-old) as a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, ongoing breastfeeding, allergies to medications, food, or other products: Hydrocodone, Vicodin, dialaudid, morphine. Concomitant medications were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Patient received BNT162B2/ breastfeeding on 01Feb2021 at 13:00. The patient experienced left arm numbness and pain, headache, nausea, stiff neck and back, inability to stand for more than a few seconds without becoming weak on 01Feb2021 at 19:00. It was unknown whether the treatment received for the adverse events or not. The events were considered as non-serious by the other healthcare professional. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125300 baby case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chest discomfort, Chest pain
Clinical narrative: Stomach upset within one hour; fatigue; severe headache; muscle aches; joint, and lower back pain; joint, and lower back pain; chest discomfort; chest pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EK59231), dose 2 intramuscular, administered in arm left on 20Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included Allergies to medications, food, or other products. On 20Jan2021, patient experience stomach upset within one hour of vaccination. For five days patient had fatigue, severe headache, muscle aches, joint, and lower back pain, chest discomfort, and chest pain that comes and goes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications were received by patient within 2 weeks of vaccination. After seven days, adverse effects were gone. Patient did not receive any treatment for the adverse event. The patient had other medical history. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The events were reported as non-serious. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Stomach upset within one hour; fatigue; severe headache; muscle aches; joint, and lower back pain; joint, and lower back pain; chest discomfort; chest pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EK59231), dose 2 intramuscular, administered in arm left on 20Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included Allergies to medications, food, or other products. On 20Jan2021, patient experience stomach upset within one hour of vaccination. For five days patient had fatigue, severe headache, muscle aches, joint, and lower back pain, chest discomfort, and chest pain that comes and goes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications were received by patient within 2 weeks of vaccination. After seven days, adverse effects were gone. Patient did not receive any treatment for the adverse event. The patient had other medical history. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The events were reported as non-serious. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Pain at inject site; Myalgia at the injection site; This is a spontaneous report from a contactable physician (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at 09:30AM as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient did not receive other vaccinations with 4 weeks of COVID-19 vaccine. The patient did not undergo any lab test. On 09Jan2021, the patient experienced injection site pain and myalgia for three days. The patient did not require a visit to physician or ER (emergency room). The outcome of the event was resolved on 12Jan2021. The reporter assessed the events injection site pain and myalgia as related.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia
Clinical narrative: had trouble staying asleep at night; This is a spontaneous report from a contactable Other Health Professional (Patient). A 43-year-old female non-pregnant patient (Age at vaccination: 43) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. No Allergies to medications, food, or other products. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose COVID-19 Prior to vaccination. Patient was not tested for COVID-19 Since the vaccination. The patient experienced had trouble staying asleep at night on 18Dec2020. No other Seriousness criteria was reported. The outcome of event was not recovered.  Information on the lot/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain
Clinical narrative: chills; body aches; nausea; dizziness; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 42-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration in left arm on 29Jan2021 at 16:00 (at the age of 42-years-old) at single dose for COVID-19 immunization. Medical history included depression, obesity, hypertension, asthma. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Jan2021 at 19:00, the patient experienced chills, body aches, nausea, dizziness. The patient did not receive any treatment for the event. Outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: stated when he took the shot that he is breathing harder than he was before; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Jan2021 (age at vaccination 93-year-old) at 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hearing problem, hearing aid user, amyloidosis. The patient's past drug included Coumadin and Vyndamax. The patient's concomitant medications were not reported.  On an unspecified date, the patient stated that he had a Pfizer shot on 19Jan and is due to get another on 09Feb. he is 93 years of age. He stated that he was diagnosed with amyloidosis and was using a Pfizer medication called Vyndamax to help him keep the protein off the major parts of his body. He took the shot that he was breathing harder than he was before.  He wanted to know if this is possible and also stated that he had a hearing problem and hearing aids before the shot. Stated that he was diagnosed with amyloidosis and taking Coumadin and Vyndamax before the shot. The outcome of events was unknown.   Reporter details: Stated that he was going for medicine many years ago but ended up in business.   Follow-up (01Feb2021): New information received from a contactable consumer.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose, Blood glucose decreased, Dizziness, Feeling abnormal
Clinical narrative: Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Ocular discomfort, Tremor
Clinical narrative: Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: very mild swelling of the area; sorest left arm where the injection was; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Batch/Lot Number: EL1284) dose 1 via an unspecified route of administration, administered in Arm Left on 24Dec2020 09:30 as 1ST DOSE, SINGLE DOSE (at the age of 35-year-old) for covid-19 immunisation. Medical history was not reported and concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ; colecalciferol (VITAMIN D [COLECALCIFEROL]). On 24Dec2020, the patient experienced very mild swelling of the area (vaccination site swelling), sorest left arm where the injection was (vaccination site pain). Clinical course of events includes; on 24Dec2020 upon 1st dose had the sorest left arm where the injection was out of all vaccinations for one day and there might have been very mild swelling of the area. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021, sars-cov-2 test: negative on 22Jan2021. The outcome for the events was recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: R cheek numbness; This is a spontaneous report from a non-contactable pharmacist. A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 28Jan2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. After the patient received the vaccine, she experienced R cheek numbness. On 30Jan2021 (2 days post-vaccine) the patient took Aleve and the numbness went away halfway through the day. 01Feb2021, was first day without numbness. Her face still feels tight on the affected side. Reporter assessed the event as non serious. It was unknown if the patient has been tested for COVID-19 since the vaccination. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 02Feb2021 at 10:15 as 2nd dose, single for COVID-19 immunization; Historical vaccine included bnt162b2 (lot number=El3248) via an unspecified route of administration, administered in left arm on 12Jan2021 at 10:15 as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Other medications the patient received within 2 weeks of vaccination included vitamins. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 10:45, the patient experienced itching all over. Patient had not received treatment for the adverse event. The clinical outcome of the event was not resolved.        Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1 hour and 15 minutes after I received the vaccine, without any warning I began to throw up.  I was not nauseous before or after.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810) dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 17:45 (at the age of 58-years-old ) as 1ST DOSE, SINGLE for covid-19 immunization in school or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Patient relevant medical history included allergies to medications, food, or other products was penicillin, Sulfa, Bactrim. The patient previously took bactrim and experienced drug hypersensitivity.The patient concomitant medication(s) included lisinopril (LISINOPRIL) 10 mg; ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN); krill oil (KRILL OIL). On 02Feb2021 19:00, The patient experienced 1 hour and 15 minutes after vaccination, without any warning  the patient began to throw up.The patient was not nauseous before or after. No treatment received for the adverse event. The outcome of event was recovered. The reporter assessed the event as non serious. Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynaud's symptoms in my lt. distal 2nd phalange and my rt. 3rd distal phalange.; This is a spontaneous report from a contactable other hcp (Patient himself). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EK 9231), via an unspecified route of administration, administered in Arm Left on 19Jan2021 08:30 (Age at time of vaccination 60-years-old) as UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Tequin or any Quinolone antibiotic. Concomitant medication(s) included (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) patient received within 2 weeks of vaccination for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Hospital. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for AE. On 19Jan2021 14:30 The patient experienced raynaud's symptoms in my lt. distal 2nd phalange and my rt. 3rd distal phalange. No Seriousness criteria reported. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oxygenation index, Palpitations, Pyrexia
Clinical narrative: feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Circumstance or information capable of leading to medication error, Pain in extremity
Clinical narrative: sore arm; I am little concerned; Caller is concerned that the motrin affected the efficacy of her second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021, as a single dose for COVID-19 immunization (to protect myself). The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: "EL3249" and expiry date was not reported), via an unspecified route of administration, on 14Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included that on Monday, she had slight procedure done on her leg and she was instructed by her physician to take Motrin. Concomitant medication included ibuprofen (MOTRIN). The patient reported that she had a procedure on Monday and took MOTRIN yesterday morning on 02Feb2021. She took her second shot late afternoon. The patient asked did she need to really worried that it was little you know the effectiveness of having the Motrin from the morning. She had her second dose of the Pfizer vaccine yesterday afternoon and she was concerned that the MOTRIN affected the efficacy of her second dose on 02Feb2021. The patient reported that this morning she didn't really feel that she had a side effect, and she was just having slight sore arm not much (no big deal) after the second dose of the Pfizer COVID 19 vaccine on 03Feb2021 and she was little concerned. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: tired; chills; the area around the injection site is red and swollen; the area around the injection site is red and swollen; feverish; This is a spontaneous report received from a contactable consumer via medical information team. A female patient (Age: 66 unit: unspecified) received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration, on 31Jan2021 (Sunday), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, patient had reported being tired (on Monday) and having chills, Feverish, not today but that was for both two days, Monday and Tuesday. Patient had reported the area around the injection site is red, hot to the touch and swollen and wants to know how long this will last. Patient stated, "was it normal reaction to the injection to the vaccine, to the Pfizer COVID vaccine. "And they could tell her if it is okay, she thought it was but she just want to double check on that." Outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection, Toothache
Clinical narrative: infections on my tooth; Toothache; This is a spontaneous report was received from a contactable consumer (patient). A 54-years-old male patient of weight 92.99 kilograms and height 175 centimetres received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 31Jan2021 at 09:00 (at the age of 54-years-old) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that he had his first dose of the Pfizer vaccine on Sunday 31Jan2021. He said on 02Feb2021, he had a toothache and was going to the dentist, he was expecting to be started on an antibiotic. The patient wanted to know if he could take an antibiotic and Aleve (as reported) since he had taken the vaccine. He would also like to know if he can drink alcohol after receiving the vaccine. On 02Feb2021, the patient had a tooth infection and was prescribed Amoxicillin. He was asking if it was okay to take antibiotics after the first dose and wanted to know whether it would affect. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: shingles; rashes coming out of the belly, under of breasts, from the left side to her back; have pain under the rib on the left side/ On Tuesday (26Jan2021), the pain increased; This is a spontaneous report from a contactable other health care professional (Nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 20Jan2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced pain under the rib on the left side. On 24Jan2021, the pain was still there, it never left but just continued. The patient went to the emergency room to get checked by results returned okay so patient returned home. On 26Jan2021, the pain increased, more tests returned normal. On 28Jan2021, the patient noticed rashes coming out of the belly, under of breasts, from the left side to her back. On 29Jan2021, she had a doctor's appointment, and with a cardiologist on 02Feb2021. The cardiologist confirmed that patient's heart was fine, and gave Valtrex for shingles. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Palpitations
Clinical narrative: she "literally got woken up" with her heart pounding and racing; heart rate was 110-120 bpm; literally got woken up / wake up from her sleep; felt more tired than usual; had a headache; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 02Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was reported that, enquired on auto-call back, caller started off by saying she was fine. She had the second shot of the Pfizer BioNTech COVID-19 vaccine yesterday on 02Feb2021 at 4PM. On 02Feb2021 at 10PM, last night she felt more tired than usual. She also had a headache. She was feeling tired and had a bad headache, but she didn't take anything. Stated that, she didn't drank any medication for that. Stated that, on 02Feb2021, at around 11pm of the same day, she literally got woken up with her heart pounding and racing. It was like a pounding heart rate and It was a hard beat. It may hit 110 when exercising. It made her wake up from her sleep. She monitored her heart rate and the lowest was at 110 bpm and the highest was 122 bpm. It was on 117 most of the time. This event lasted for 30-40 minutes. Stated that, she had no problem breathing. She tried to do breathing exercises to calm her heart down, but it didn't work. Stated that, she was a healthy person with no issues and her normal heart rate is at 61 bpm (generally a very calm person). Reporter had a question that She had a weird thing happen last night. She got her second shot of the COVID vaccine. She had a weird thing happen. She is wondering if it is connected. She mentioned that her doctor asked her to call Pfizer. Offered caller to be transferred but due to long hold time to Med Info (about an hour), she declined. The patient underwent lab tests and procedures included heart rate, resulted as resting heart rate was 60-61 on an unspecified date, on 02Feb2021, heart rate was resulted as 110-122 bpm, for about 30-40 minutes, this has never happened before and on 02Feb2021, heart rate was resulted as 115-120. The outcome of the events for fatigue, headache and disturbed sleep were unknown while for the other events were recovered.   Information of lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: she "literally got woken up" with her heart pounding and racing; heart rate was 110-120 bpm; literally got woken up / wake up from her sleep; felt more tired than usual; had a headache; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 02Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was reported that, enquired on auto-call back, caller started off by saying she was fine. She had the second shot of the Pfizer BioNTech COVID-19 vaccine yesterday on 02Feb2021 at 4PM. On 02Feb2021 at 10PM, last night she felt more tired than usual. She also had a headache. She was feeling tired and had a bad headache, but she didn't take anything. Stated that, she didn't drank any medication for that. Stated that, on 02Feb2021, at around 11pm of the same day, she literally got woken up with her heart pounding and racing. It was like a pounding heart rate and It was a hard beat. It may hit 110 when exercising. It made her wake up from her sleep. She monitored her heart rate and the lowest was at 110 bpm and the highest was 122 bpm. It was on 117 most of the time. This event lasted for 30-40 minutes. Stated that, she had no problem breathing. She tried to do breathing exercises to calm her heart down, but it didn't work. Stated that, she was a healthy person with no issues and her normal heart rate is at 61 bpm (generally a very calm person). Reporter had a question that She had a weird thing happen last night. She got her second shot of the COVID vaccine. She had a weird thing happen. She is wondering if it is connected. She mentioned that her doctor asked her to call Pfizer. Offered caller to be transferred but due to long hold time to Med Info (about an hour), she declined. The patient underwent lab tests and procedures included heart rate, resulted as resting heart rate was 60-61 on an unspecified date, on 02Feb2021, heart rate was resulted as 110-122 bpm, for about 30-40 minutes, this has never happened before and on 02Feb2021, heart rate was resulted as 115-120. The outcome of the events for fatigue, headache and disturbed sleep were unknown while for the other events were recovered.   Information of lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Chills, Headache
Clinical narrative: "flu-like" symptoms; 10.6 temperature; all sorts of aches; chills; headaches; joint aches; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 02Feb2021 as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, single for covid-19 immunisation. The patient received the second dose of the COVID-19 vaccine 02Feb2021 (yesterday) afternoon. The patient was experiencing "flu-like" symptoms on 03Feb2021 (today) and listed the following: "chills, 10.6 temperature, all sorts of aches, headaches, and joint aches". The patient specified she "woke up during the night with a very bad headache" and she "took two TYLENOL" as therapeutic measures. The patient underwent lab tests and procedures which included Body temperature as 10.6 on 03Feb2021. The outcome for all the events was unknown.  Information on the Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: "flu-like" symptoms; 10.6 temperature; all sorts of aches; chills; headaches; joint aches; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 02Feb2021 as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, single for covid-19 immunisation. The patient received the second dose of the COVID-19 vaccine 02Feb2021 (yesterday) afternoon. The patient was experiencing "flu-like" symptoms on 03Feb2021 (today) and listed the following: "chills, 10.6 temperature, all sorts of aches, headaches, and joint aches". The patient specified she "woke up during the night with a very bad headache" and she "took two TYLENOL" as therapeutic measures. The patient underwent lab tests and procedures which included Body temperature as 10.6 on 03Feb2021. The outcome for all the events was unknown.  Information on the Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: a dark bruise on her chin / she found a bruise on her chin that was sore and tender; This is a spontaneous report from a contactable consumer (patient herself). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9263, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 16:00 (at the age of 80-year-old) as 1st dose, single for covid-19 immunisation. Medical history was not reported. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN, 81 mg once daily by mouth). Additional Information for Concomitant Products Baby Aspirin is- It is just preventative. She is not prescribed it, she just takes it. On 29Jan2021, patient states that noticed later that evening she had a dark bruise on her chin. patient does not remember hitting anything or running into anything that would have caused this bruise to form on her chin and she is asking if this could be a potential side effect of the vaccine. She denies any swelling of the face, throat or mouth. She denies any difficulty breathing. patient states, if you saw my face you would think I've been in a fight" and it was exacerbated but it is quite black and blue, she knows it takes time to go down. Patient noticed the bruise later the same day and it is still tender like underneath your chin towards the gland, it is fading but it is still blue. It is just a tad fading, starting to fade. She says she also takes a minor dose of a blood pressure medication that she cuts in half actually but she is not sure if there maybe properties of that with something in the vaccine that might have done it. No further information provided. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.