chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 15:00 (Lot number: EL3302) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: DROSPIRENONE;ETHINYLESTRADIOL taken for contraception (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jan2021, outcome "recovered" (16Jan2021), described as "sore arm"; FATIGUE (non-serious) with onset 14Jan2021, outcome "recovered" (16Jan2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Vaccines Administered on Same Date of the Pfizer Suspect and Prior Vaccinations (within 4 weeks) was reported as none. Patient's Medical History (including any illness at time of vaccination), Family History, Relevant test was reported as none. Patient History: No. Investigation Assessment: Yes. On same day of vaccination she experienced fatigue; had a sore arm and then went to bed early. All of these effects cleared up in a day or so.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: increase in tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 15:00 (Lot number: ER8730) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing); "two stem cell transplants" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PRAVASTATIN; LEVOTHYROXINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: TINNITUS (non-serious) with onset 25Mar2021, outcome "unknown", described as "increase in tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: I have noticed recent increase in tinnitus that may have started after the first vaccine. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. The patient did not have COVID prior vaccination and not tested post vaccination for Covid.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Didn't feel great this morning; Stiff neck on the side she got the shot the second time the left side; Left arm soreness; A little bit chilled last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 (Dose number :1, First dose administered on 25Mar2021 , Anatomical location (left arm)), administration date: 25Mar2021, for COVID-19 Immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 15Apr2021, outcome "unknown", described as "Stiff neck on the side she got the shot the second time the left side"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "Left arm soreness"; CHILLS (non-serious) with onset 15Apr2021, outcome "unknown", described as "A little bit chilled last night"; MALAISE (non-serious) with onset 16Apr2021, outcome "unknown", described as "Didn't feel great this morning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Throat irritation
Clinical narrative: feeling sick; scratchy throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling sick"; THROAT IRRITATION (non-serious), outcome "unknown", described as "scratchy throat".  Additional information: This is a spontaneous report from a Pfizer-sponsored program. Patient wanted to know if it was okay to get vaccine after having scratchy throat and feeling sick. This was for the patient's second dose as she was scheduled for her 2nd shot on Monday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Listless, Musculoskeletal stiffness
Clinical narrative: Strange sensation in neck progressing into a stiff neck, like you slept on the wrong side of your neck; Spacy and light headed and dizzy-ish; light headed and dizzy-ish; listlessness came back slightly, then that was it. Confirmed the spaciness and listlessness went hand in hand.; Everything was sore/but last night his right shoulder did get sore right away eventually; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: Verbatim: migraines; "leaky gut" (unspecified if ongoing), notes: History leaky gut; "Bronchial hyperreactivity" (unspecified if ongoing), notes: Reactive airways disease; "High Iron" (unspecified if ongoing), notes: occasionally high iron; "erratic heart beat" (unspecified if ongoing), notes: Erratic heart beat; "heart palpitations" (unspecified if ongoing), notes: 5 years ago he had sudden onset heart palpitations,. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Mar2021, outcome "recovered" (29Mar2021), described as "Strange sensation in neck progressing into a stiff neck, like you slept on the wrong side of your neck"; FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "Spacy and light headed and dizzy-ish"; DIZZINESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "light headed and dizzy-ish"; LISTLESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "listlessness came back slightly, then that was it. Confirmed the spaciness and listlessness went hand in hand. "; ARTHRALGIA (non-serious) with onset 25Mar2021, outcome "recovered" (29Mar2021), described as "Everything was sore/but last night his right shoulder did get sore right away eventually".  Additional information included Caller does mention that a couple of hours before both doses of the Pfizer COVID-19 vaccine he took  a half of a pill of over the counter generic 12 hour Claritin a couple of hours before each shot before each shot. Caller also adds that him or his wife didn't drink four days after the first dose of Pfizer COVID-19 vaccine  taking supplements have to do with anti-clotting and blood thinning attributes like fish oil and turmeric. Caller states he does take an 81mg aspirin from time to time, and has taken 2 in the last couple of days. Caller states he does not normally take them that often. With no to Emergency Room and Physician Office. Caller states he tested negative for 01Mar2021 antibodies. He wanted to make sure he didnt have antibodies or exposed to covid prior to the shot.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, C-reactive protein, Full blood count, Investigation, Metabolic function test
Clinical narrative: arm discomfort and muscle ache at site of injection; arm discomfort and muscle ache at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician).  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mildly elevated cholesterol" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Mild radiculopathy on right arm" (unspecified if ongoing); "Glaucoma in left eye" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for seasonal allergy; NAPROXEN taken for radiculopathy; LATANOPROST taken for glaucoma; COSOPT taken for glaucoma. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "arm discomfort and muscle ache at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site pain.  Additional information: The patient's concomitant medication also included 'Rodessa' taken for glaucoma in left eye. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient took TYLENOL as treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Red blood cell sedimentation rate, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
Clinical narrative: arm discomfort and muscle ache at site of injection; arm discomfort and muscle ache at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician).  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mildly elevated cholesterol" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Mild radiculopathy on right arm" (unspecified if ongoing); "Glaucoma in left eye" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for seasonal allergy; NAPROXEN taken for radiculopathy; LATANOPROST taken for glaucoma; COSOPT taken for glaucoma. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "arm discomfort and muscle ache at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site pain.  Additional information: The patient's concomitant medication also included 'Rodessa' taken for glaucoma in left eye. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient took TYLENOL as treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: arm discomfort and muscle ache at site of injection; arm discomfort and muscle ache at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician).  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mildly elevated cholesterol" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Mild radiculopathy on right arm" (unspecified if ongoing); "Glaucoma in left eye" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for seasonal allergy; NAPROXEN taken for radiculopathy; LATANOPROST taken for glaucoma; COSOPT taken for glaucoma. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "arm discomfort and muscle ache at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site discomfort, vaccination site pain.  Additional information: The patient's concomitant medication also included 'Rodessa' taken for glaucoma in left eye. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient took TYLENOL as treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: After taking the 1 (lot #6200 Vaccine Shot only site and arm pain and a feeling like Blood moving through my body about 6-8 hours after shot; After taking the 1 (lot #6200 Vaccine Shot only site and arm pain and a feeling like Blood moving through my body about 6-8 hours after shot; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 62 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Feb2021 14:00 (Lot number: EN6200) at the age of 62 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Coronary Heart Disease" (unspecified if ongoing); "Contact dermatitis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "allergies:Penicillin" (unspecified if ongoing). Concomitant medications included: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE; ROSUVASTATIN. Past drug history included: Tylox, reactions: "Known allergies"; Lotrel, reactions: "known allergies". The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Feb2021, outcome "recovered" (2021) and all described as "After taking the 1 (lot #6200 Vaccine Shot only site and arm pain and a feeling like Blood moving through my body about 6-8 hours after shot".  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills; fatigue; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 11:00 (Batch/Lot number: unknown) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number 1, Time: 11:15, vaccine location Right arm), administration date: 27Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Apr2021 13:00, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 18Apr2021 13:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 18Apr2021 13:00, outcome "recovering", described as "body aches". Therapeutic measures were taken as a result of chills, fatigue, pain. Additional information: Patient had no other medications in two/four weeks. Patient had no COVID prior vaccination and is not COVID tested post vaccination. Patient also had no known allergies. Patient treatment was reported as Advil.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: my eyesight began to change dramatically. I developed "holes" in my sight; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 13Apr2021 11:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown, Anatomical location: Right arm, Administration time: 10:00 AM), administration date: 23Mar2021, when the patient was 55 years old, for covid-19 immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 14Apr2021 07:00, outcome "not recovered", described as "my eyesight began to change dramatically. I developed "holes" in my sight". Therapeutic measures were not taken as a result of visual impairment.  Additional information: After the second dose, her eyesight began to change dramatically. She developed "holes" in her sight that have made it almost impossible to read a computer and perform other tasks. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mood altered, Psychotic disorder, Thinking abnormal
Clinical narrative: Tired; Moody; psychotic with dark thoughts; psychotic with dark thoughts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "Known allergies: sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: PROZAC. The following information was reported: FATIGUE (non-serious) with onset 18Apr2021 09:00, outcome "not recovered", described as "Tired"; MOOD ALTERED (non-serious) with onset 18Apr2021 09:00, outcome "not recovered", described as "Moody"; PSYCHOTIC DISORDER (non-serious), THINKING ABNORMAL (non-serious) all with onset 18Apr2021 09:00, outcome "not recovered" and all described as "psychotic with dark thoughts". Therapeutic measures were not taken as a result of fatigue, mood altered, psychotic disorder, thinking abnormal. Additional information: The patient had no other vaccine in four weeks. The patient was had no covid prior vaccination and was not tested for covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Palpitations
Clinical narrative: It has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint; My heart started pounding; I got weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2) (Lot number: EN6204) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: DIZZINESS (non-serious) with onset 14Apr2021, outcome "unknown", described as "It has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint"; PALPITATIONS (non-serious) with onset 14Apr2021, outcome "unknown", described as "My heart started pounding"; FEELING ABNORMAL (non-serious) with onset 14Apr2021, outcome "unknown", described as "I got weird".  Additional information: Consumer stated, "I was not sure if I need to call you or not I was just going to, it's been two weeks exactly since I got my second Pfizer shot. It was from LOT# EN6204. And I don't know if I reached the right person but I was just I don't even know if I am at right department, but let me just tell you this morning I got weird, anyway 'I was spinning' (not clear). When confirmed if the consumer wanted to report this or have some questions, consumer stated, "I was just telling you that I think I might have had a reaction today. I am not sure if that's caused by the, it's been two weeks and I am not sure if it is caused by the vaccine." Confirmed the name if the vaccine as Pfizer COVID Vaccine, consumer stated, "Pfizer EN6204.'' Follow-up: Consumer stated, "Sure, but I hope there was not anything to follow-up. This morning, it has been two weeks I have taken second Pfizer shot and everything started spinning and went black, like I was going to faint but I didn't lose consciousness. My heart started pounding and I was very (word not clear) afterwards, I am fine now." Concomitant medication: Consumer stated, "I am taking other medications, I take vitamin C and vitamin D and I am in a wheel chair and I take stool softener." (not clarified further). Consumer stated, "No, I was just telling you in case you want to add this to you (incomplete sentence)."  Reason for delay: Daily spike of incoming calls due to COVID 19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Injection site soreness; headache; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 10:30 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EP6955, administration time: 10:30, vaccine location: Left arm), administration date: 27Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Apr2021, outcome "recovering", described as "Injection site soreness"; HEADACHE (non-serious) with onset 18Apr2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 18Apr2021, outcome "recovering", described as "general fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.  Additional Information: The facility where the most recent COVID 19 vaccine was administered at a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19 and has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. The events were reported as non-serious and did not result in death, was not life-threatening, caused/prolonged hospitalization disabling/Incapacitating nor congenital anomaly/birth defect. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Feeling abnormal, Headache, Heart rate
Clinical narrative: Accelerated heart rate; high blood pressure 136/83; Headache; felt a weird sensation in my brain; Chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. Past drug history included: Diflucan, reaction(s): "allergies"; Bactrim, reaction(s): "allergies".  The following information was reported: HEART RATE INCREASED (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "Accelerated heart rate"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "high blood pressure 136/83"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "felt a weird sensation in my brain"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Chills"; NIGHT SWEATS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension, headache, feeling abnormal, chills, night sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Night sweats
Clinical narrative: Accelerated heart rate; high blood pressure 136/83; Headache; felt a weird sensation in my brain; Chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. Past drug history included: Diflucan, reaction(s): "allergies"; Bactrim, reaction(s): "allergies".  The following information was reported: HEART RATE INCREASED (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "Accelerated heart rate"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "recovered" (07Mar2021), described as "high blood pressure 136/83"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Headache"; FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "felt a weird sensation in my brain"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "Chills"; NIGHT SWEATS (non-serious) with onset 04Mar2021, outcome "recovered" (2021), described as "night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension, headache, feeling abnormal, chills, night sweats.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain and swelling; injection site pain and swelling; headache; muscle pain near injection site; neck ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:45 (Lot number: ER8732) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 23Mar2021, outcome "recovered" and all described as "injection site pain and swelling"; HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered", described as "headache"; MYALGIA (non-serious) with onset 23Mar2021, outcome "recovered", described as "muscle pain near injection site"; NECK PAIN (non-serious) with onset 23Mar2021, outcome "recovered", described as "neck ache". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, headache, myalgia, neck pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 week prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt a little bit".  Additional information: Caller was calling about her son, at which time she also mentions that she and her son's father both had side effects. Report 3 of 3. Caller was discussing her son's symptoms and added that her son's father's arm hurt. Caller added that the father's arm hurt a little bit, but she does not want to file a report regarding this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 19Mar2021 14:45 (Lot number: EP6955) at the age of 44 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive other vaccines in four weeks. The patient did not have COVID prior vaccination. The patient had not been tested for COVID post- vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, C-reactive protein, C-reactive protein increased, Endoscopy, Gastritis
Clinical narrative: C-reactive protein of 183; gastritis; severe epigastric pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 (Lot number: EL8982) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; XYZAL; OSTEO BI-FLEX EASE; MAGNESIUM; ASPIRIN (E.C.). Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Multaq, reaction(s): "Known allergies: Multaq"; Triamcinalone, reaction(s): "Known allergies: Triamcinalone". Vaccination history included: Bnt162b2 (Lot number:  EL3246, on 01:00 PM via Intramuscular, administered on Left arm as dose 1), administration date: 08Jan2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: C-REACTIVE PROTEIN INCREASED (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "C-reactive protein of 183"; GASTRITIS (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "gastritis"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Feb2021 20:00, outcome "recovered", described as "severe epigastric pain". The events "c-reactive protein of 183", "gastritis" and "severe epigastric pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of c-reactive protein increased, gastritis, abdominal pain upper. Additional information: Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination. The treatment received for the events was reported as Endoscopy and prilosec therapy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Influenza like illness, Pain, Vomiting
Clinical narrative: felt like I had the flu; achy; sweating; Diarrhoea; throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "felt like I had the flu"; PAIN (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "achy"; HYPERHIDROSIS (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "sweating"; DIARRHOEA (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "Diarrhoea"; VOMITING (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "throwing up".  Additionl Information: Reporter reported that she received her first dose of the Pfizer shot on Saturday. "Last night, (she feel a little be better now) at 2am she was achy, sweating couldn't get comfortable got worse went to the bathroom had diarrhea and throwing up. She couldn't get comfortable. This morning I laid at home and felt like she had the flu. She is on erythromycin antibiotics,  she spoke with someone prior to Pfizer MI and gave information regarding her experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 15Apr2021, outcome "recovered" (Apr2021), described as "fatigue". It was unknown if therapeutic measures were taken as a result of fatigue. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: felt nauseous the first day; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; injection site hot, red, hard, swollen for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:00 (Lot number: EN6206) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "hashimotos disease" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; SYNTHROID; ROSUVASTATIN. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "felt nauseous the first day"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "injection site hot, red, hard, swollen for 3 days".  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: their arm was barely sore; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "their arm was barely sore".  Additional information: First shot barely sore for about 24 hours. Second same as first for about 24 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciatica pain/intensified sciatica pain on left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 16:00 (Lot number: EN6206) at the age of 52 years as dose 1, single and administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Ace inhibitors" (unspecified if ongoing), notes: Known allergies: Ace inhibitors; "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: POTASSIUM CHLORIDE; DOXAZOSIN; DILTIAZEM. Past drug history included: Gabapentin, reaction(s): "Drug allergy", notes: Known allergies: gabapentin; Amlodipine, reaction(s): "Drug allergy", notes: Known allergies: amlodipine; Metoprolol, reaction(s): "Drug allergy", notes: Known allergies: metoprolol. The following information was reported: SCIATICA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Sciatica pain/intensified sciatica pain on left side". The event "sciatica pain/intensified sciatica pain on left side" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sciatica.  No follow-up attempts are possible. No further information is expected.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event sciatica pain which included acupuncture treatment on both sides and homeopathic injection in the left buttock and left leg from 19Apr2021. It was reported that after using paracetamol (TYLENOL), heat and tens electric stim, the patient did not get relief. The patient had scheduled more treatment on 23Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Fatigue, Malaise
Clinical narrative: not feeling well for a couple days and then was ok; then about a week later felt unwell and fatigue was setting in; it has been a month of feeling unwell and well cycle./his mother is also experiencing this and hers is lasting longer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown, first vaccine dose on 7thMar). The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well for a couple days and then was ok"; FATIGUE (non-serious), outcome "unknown", described as "then about a week later felt unwell and fatigue was setting in"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "it has been a month of feeling unwell and well cycle./his mother is also experiencing this and hers is lasting longer".  Additional information: Stated last week he wasn't feeling well and has been feeling well the last 3 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021432691 same reporter/drug, similar event, different patient
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Felt Really Fatigued; Left Arm Hurt after First Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 18Mar2021 17:10 (Lot number: EN6208) at the age of 60 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "hospitalization", start date: 15Oct2020, stop date: 27Oct2020, notes: gave him some tests, like COVID experimental drugs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovered" (25Mar2021), described as "Left Arm Hurt after First Dose"; FATIGUE (non-serious) with onset 19Mar2021, outcome "recovered" (20Mar2021), described as "Felt Really Fatigued".  No follow-up attempts are possible. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Inappropriate schedule of product administration, Panic attack
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 91 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "deaf" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose of the vaccine: Given on 16Mar2021; Lot Number: Unknown by caller; Given in patient's left arm), administration date: 16Mar2021, when the patient was 91 years old, for Covid-19 Immunisation, reaction(s): "Pneumonia", "Felt a little off". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Mar2021, outcome "unknown", described as "Patient had first dose of vaccine on 16Mar2021 and the second one on 30Mar2021"; ANXIETY (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Severe Anxiety was worsened/ sense of doom"; PANIC ATTACK (non-serious) with onset 2021, outcome "unknown", described as "panic attacks". The event "severe anxiety was worsened/ sense of doom" was evaluated at the physician office visit and emergency room visit. Additional information: Caller would like to know what can be done at this point regarding the side effects; anxiety and sense of doom, that her father experienced after receiving the Covid-19 vaccine. On 30Mar2021, he received the 2nd shot. Now he had panic attacks. He had anxiety and sense of doom since the vaccine. She said he was being treated already. Caller denied any medications, medical conditions, labs, testing or treatments relevant to report. Caller stated her father is very healthy. Caller stated her father was scared to be alone. Stated that her and her sister had been taking them everywhere with them. Vaccine not administered at "PRIVATE" Facility. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not received other vaccines within 4 weeks prior to the COVID-19 vaccine. No AE(s) following prior vaccinations. No family medical history relevant to AE(s). Relevant tests conducted was reported as none. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.