chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I had my first shot for the vaccine and the next day I wasn't really feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 "I had my first shot for the vaccine and the next day I wasn't really feeling well". Clinical course: Patient had the first shot for the vaccine and the next day, wasn't really feeling well. Patient was due to get the second and was hesitating to do that. Patient was asking for advice.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer-sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache and chills, onset Mar 2021, with outcome of unknown. Additional information: The patient wanted to know if this was due to the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient).  A female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 13, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation; and had a reaction(s): stomach cramps (after first dose of vaccination as well but not as intense). The patient again experienced upper abdominal pain/extreme stomach cramps and nausea/nauseous, onset Mar 14, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:30 (Lot number: EL3247) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 12:00, outcome "recovering", described as "Chills". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: States she had stomach cramps after first dose of vaccination as well but they were not as intense.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "States she had stomach cramps after first dose of vaccination as well but they were not as intense.". 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: Blister, Dyskinesia, Pain, Pain in extremity
Clinical narrative: Very small blister to interior portion of hand beneath the ring finger on same arm of injection (Left hand); I had involuntary movement to my left hand; pain radiating up and down my left arm; pain radiating up and down my left arm; 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 18Mar2021 14:00 (Lot number: ER2613) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "frontal fibrosing alopecia" (unspecified if ongoing); "known_allergies: Singular" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN [SALBUTAMOL]; TRELEGY; ALBUTEROL SULFATE; SIMETHICONE. The following information was reported: BLISTER (non-serious) with onset 19Mar2021 10:00, outcome "not recovered", described as "Very small blister to interior portion of hand beneath the ring finger on same arm of injection (Left hand)"; DYSKINESIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "I had involuntary movement to my left hand"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "pain radiating up and down my left arm". Therapeutic measures were taken as a result of blister.  Additional information: Patient was not Pregnant at the time of Vaccination. Patient received recent COVID-19 vaccine in Hospital facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to vaccination, patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. blisters required antibiotics and creams.
Sex: M
Vaccine: COVID19
Symptoms: Hangover
Clinical narrative: This is a spontaneous report received from a non-contactable consumer or other non-HCP. A 40-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient experienced a minor hangover, with outcome of unknown. Additional information: Patient was generally in good health and very excited to receive the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Mar2021 (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: Bnt162b2, administration date: 17Feb2021, for covid-19 immunisation, reaction(s): "Blood pressure high". The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 16, 2021, at 15:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a hot flush/short hot flash, onset Mar 16, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; 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 male 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: FATIGUE (non-serious), outcome "unknown", described as "fatigued". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: felt dizzy; headache; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program -159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt dizzy"; HEADACHE (non-serious), outcome "unknown", described as "headache". Clinical course: The patient got the vaccine 2 weeks ago but has not received any email confirmation about the appointment of her 2nd dose. She added that she felt dizzy and experienced a headache after the 1st dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for(RA). 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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 62-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 62, on Mar 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient had dizziness, onset Mar 16, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 62-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 62, on Mar 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient had dizziness, onset Mar 16, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: had diarrhea twice today; This is a spontaneous report received from a 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), administration date 16Mar2021 (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: DIARRHOEA (non-serious) with onset 16Mar2021, outcome "unknown", described as "had diarrhea twice today".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills/ experienced chills both times day after receiving shot; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional; patient's wife).  An 88-year-old male patient received the second dose of bnt162b2 (BNT162B2) via an unspecified route of administration, administered in the right arm on 20Feb2021 03:00 (batch/lot number: EN6203) at the age of 88 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient had no medical history (including any illness at time of vaccination). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, administered in the left arm on 30Jan2021 04:00 (batch/lot number EL9262 and expiration date unknown) at 88 years old, as DOSE 1, SINGLE, when the patient was 88 years old, for COVID-19 immunization; reactions: "he started feeling weak and chills." The following information was reported: CHILLS (non-serious) with onset 21Feb2021, outcome "unknown" described as "chills/ experienced chills both times day after receiving shot." The event did require a visit to Emergency Room and Physician office and did not require hospitalization.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112171 Same reporter/ patient/ drug;  different dose/ different events
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache ".  Additional information: patient was experiencing a headache and wondering if she can take a pain reliever.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Memory impairment, Nervousness, Tinnitus
Clinical narrative: Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EN6200) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine headache" (unspecified if ongoing), notes: 40 years ago; "thyroid" (unspecified if ongoing); "headache" (unspecified if ongoing). Concomitant medication(s) included: IMITREX taken for migraine, headache; SYNTHROID taken for thyroid disorder. The following information was reported: TINNITUS (non-serious), BALANCE DISORDER (non-serious), MEMORY IMPAIRMENT (non-serious), NERVOUSNESS (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "Extreme wild ringing in ear, overwhelming and making me a little bit off balance; messed my mind up to make me forget; didn't hear; nervous with the ringing". Therapeutic measures were not taken as a result of tinnitus, balance disorder, memory impairment, nervousness.  Additional information: The patient reported that she wanted to tell about the side effects. She wanted to report side effects: a wild ringing in her ear with the day she had it done yesterday (23Mar2021) the vaccine and she had an extreme wild ringing in ear. She had a very little bit tinnitus and then now this morning, it's overwhelming. This, the ringing in her ear was overwhelming and it was also making her a little bit off, when she walks she was little bit off balance. Vaccine expiration date: 32321 (Further not clarified the date. Hence, not captured in the tab). When asked for due date for second shot, consumer, stated, this was first shot, she had an appointment for 13Apr. When asked for any treatment for the problem (event), patient stated, no just Imitrex and Fioricet (not clarified) for Migraine. The patient asked if she was supposed to go for the second shot because it was after 3 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in my left arm where I had received vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in Arm right, administration date 08Mar2021 11:15 (Lot number: EL3247) at the age of 36 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: INJECTION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in my left arm where I had received vaccination".  Additional information: Therapeutic measures were not taken as a result of injection site pain.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Paraesthesia, Tremor
Clinical narrative: Severe paresthesias in face, tongue, chest wall, limbs; Tremors; Headaches; Weakness/incapacitated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: PARAESTHESIA (non-serious), outcome "unknown", described as "Severe paresthesias in face, tongue, chest wall, limbs"; TREMOR (non-serious), outcome "unknown", described as "Tremors"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness/incapacitated".  Additional information: It was reported that, patient for the past 9 weeks had severe paraesthesia in face, tongue, chest wall, limbs; headaches, tremors, weakness; and patient was incapacitated. Patient had a consult with the neurology department-they are seeing many people with similar reactions and believe it was similar to what the long haul covid patients have. Caller stated that, they believe she may recover slowly but it might takes months or a year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Headache, Nausea, Vomiting
Clinical narrative: Severe prolonged headache; Nausea; Strong vomiting; Night-time bowel movement though not diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:15 (Lot number: ER8732) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM. Past drug history included: Tylenol, reaction(s): "Allergies", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Tylenol, reaction(s): "Vomiting", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Codeine, reaction(s): "Allergies", notes: known allergies: Possibly codeine (vomiting with codeine tylenol); Codeine, reaction(s): "Vomiting", notes: known allergies: Possibly codeine (vomiting with codeine tylenol). The following information was reported: HEADACHE (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Severe prolonged headache"; NAUSEA (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Strong vomiting"; BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 30Mar2021 22:00, outcome "not recovered", described as "Night-time bowel movement though not diarrhea". Therapeutic measures were not taken as a result of headache, nausea, vomiting, bowel movement irregularity.  Additional information: Concomitant medications included probiotic and multivitamin for an unknown indication. The patient had known allergy to possibly codeine and experienced vomiting with codeine and paracetamol (TYLENOL). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. it was reported that event night-time bowel movement though not diarrhea. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events severe prolonged headache, nausea including strong vomiting and night-time bowel movement though not diarrhea.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Lot number: EN6202) as dose 1, single and administration date 19Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: Verbatim: Rheumatoid arthritis, Diagnosed 5-6 years ago. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 19Feb2021, outcome "not recovered", described as "has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine".  Additional Information: The reporter stated she wanted to report a positive reaction to the Covid 19 vaccine. She has had 2 doses already for 6 weeks. She has Rheumatoid Arthritis, and her severe pain has disappeared since receiving the vaccine. Stated it seems to have a positive effect on her immune system. Clarifies she has no more severe pain. Events neither required Emergency Room nor Physician Office visit. The patient age at vaccination was 66 years. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Vaccination Facility Type: Pharmacy. Prior Vaccinations (within 4 weeks): Received both first and second doses of the Pfizer Covid Vaccine. There were no adverse event following prior vaccinations. There was no relevant family medical history.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left and right side of upper chest, middle lower back, between chest and abdomen, start coming on the side of the ribs; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old-male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via unspecified route of administration on 26Mar2021, (at the age of 53 years old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205), via an unspecified route of administration in the right arm on 05Mar2021 at 09:15, (at the age of 53 years old) as a single dose for COVID-19 immunisation. On 12Mar2021, the patient experienced rash on left and right side of upper chest, middle lower back, and between chest and abdomen, start coming on the side of the ribs. No therapeutic measures were taken as a result of reported event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of rash on left and right side of upper chest, middle lower back and between chest and abdomen, start coming on the side of the ribs was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: updated Age at Vaccination as 53 years
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain, Rash pruritic
Clinical narrative: Itchy rash; Muscle pain; Red; Pain worse going up neck and into back of head; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerated colinitis and heart stent. The patient received unspecified medication within two weeks of vaccination. The patient did not have allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 07:00 the patient experienced red, itchy rash, muscle pain and on an unknown date in Apr2021 patient experienced pain which got worse and goes up to neck and back of head. The event resulted in doctor or other health care professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with cream, over counter pain medicine and heating pad. The clinical outcome of the red, itchy rash, muscle pain and pain which got worse and goes up to neck and back of head was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: amended medical history data and event data.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ocular hyperaemia
Clinical narrative: 48 hours after vaccine, half of my right eye (right side of pupil) turned red. No itching, no watering, no pain, no effect on eye sight. It remained red for 72 hours. Used Clear eyes drops once a day; This is a spontaneous report from a contactable consumer, the patient. A 59-years-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8733), via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, since an unspecified date of 2020 (last year) (140-90). Concomitant medications included lisinopril/hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for blood pressure and unknown if ongoing. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31Mar2021 at 13:00, 48 hours after the vaccination, the patient experienced half of the right eye (right side of the pupil) turned red. No itching, no watering, no pain, no effect on eyesight. It remained red for 72 hours. The treatment included Clear eyes drops once a day for the reported event. The clinical outcome of the event half of the right eye (right side of the pupil) turned red was recovered on 03Apr2021, after the duration of 72 hours.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: updated age at vaccination, medical history data and event data.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Myalgia, Nausea
Clinical narrative: Cough; nausea; muscle soreness; tiredness; sore throat; weak; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had no known allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00, the patient experienced cough, nausea, muscle soreness, tiredness, sore throat and weak. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/dep artment or urgent care. The clinical outcome of the events cough, nausea, muscle soreness, tiredness, sore throat and weak was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated lead statement and medical history data.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Cough; nausea; muscle soreness; tiredness; sore throat; weak; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had no known allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 16:00, the patient experienced cough, nausea, muscle soreness, tiredness, sore throat and weak. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/dep artment or urgent care. The clinical outcome of the events cough, nausea, muscle soreness, tiredness, sore throat and weak was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated lead statement and medical history data.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches; Sore; Low energy; Woke up at midnight with severe chills; Fever; Swollen lymph nodes under left arm; shivered for two hours; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737 19606) via an unspecified route of administration in the left arm on 06Apr2021 at 09:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medications included mesalazine (LIALDA) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208 19678) via an unspecified route of administration in the left arm on 16Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:00, the patient woke up at midnight with severe chills, fever shivered for two hours, had body aches, low energy, was sore and had swollen lymph nodes under left arm. The patient did not receive treatment for the reported events. The clinical outcome of events severe chills, fever shivered for two hours, body aches, low energy, sore and swollen lymph nodes under left arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated event "shivering" and updated Lot Number.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue, Hypoaesthesia, Insomnia, Nausea
Clinical narrative: immediate cognitive impairment; severe numbness/tingling/buzzing sensation all over my body,; severe numbness/tingling/buzzing sensation all over my body; severe numbness/tingling/buzzing sensation all over my body; extreme fatigue; insomnia; nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:30 (at the age of 42-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included interstitial cystitis, low back pain/disc herniation and COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO); both from an unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was 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 four weeks prior to the vaccination. On 25Mar2021 at 09:45 the patient felt immediate cognitive impairment, almost was worried to drive home. On an unknown date in Mar2021, within 3-4 days of vaccination, the patient experienced severe numbness/tingling/buzzing sensation all over the body, extreme fatigue, insomnia, nausea, and severe cognitive impairment. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event cognitive impairment, numbness, tingling, buzzing sensation all over the body, extreme fatigue, insomnia and nausea were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Relevant medical history added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia
Clinical narrative: immediate cognitive impairment; severe numbness/tingling/buzzing sensation all over my body,; severe numbness/tingling/buzzing sensation all over my body; severe numbness/tingling/buzzing sensation all over my body; extreme fatigue; insomnia; nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:30 (at the age of 42-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included interstitial cystitis, low back pain/disc herniation and COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO); both from an unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was 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 four weeks prior to the vaccination. On 25Mar2021 at 09:45 the patient felt immediate cognitive impairment, almost was worried to drive home. On an unknown date in Mar2021, within 3-4 days of vaccination, the patient experienced severe numbness/tingling/buzzing sensation all over the body, extreme fatigue, insomnia, nausea, and severe cognitive impairment. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event cognitive impairment, numbness, tingling, buzzing sensation all over the body, extreme fatigue, insomnia and nausea were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Relevant medical history added.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Headache, Pyrexia
Clinical narrative: Vomiting three times; very bad headache; very bad joint pain; tail bone pain; both ankles pain; fever( 99.3 F); sleepiness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) in the left arm on 09Apr2021 at 10:15 (at the age of 29-year-old) as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) in the right arm on 19Mar2021 at 13:00 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:30, the patient had experienced vomiting three times, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness. The patient underwent lab tests and procedures which included SARS-CoV-2 test via Nasal Swab and the result was negative. On 09Apr2021, the patient also underwent body temperature test and the result was 99.3 degree fahrenheit. Therapeutic measures were taken as the result of adverse event which included two tylenol. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events vomiting, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (10Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information: Lab data information and narrative were updated.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Spinal pain, Vomiting
Clinical narrative: Vomiting three times; very bad headache; very bad joint pain; tail bone pain; both ankles pain; fever( 99.3 F); sleepiness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) in the left arm on 09Apr2021 at 10:15 (at the age of 29-year-old) as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) in the right arm on 19Mar2021 at 13:00 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:30, the patient had experienced vomiting three times, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness. The patient underwent lab tests and procedures which included SARS-CoV-2 test via Nasal Swab and the result was negative. On 09Apr2021, the patient also underwent body temperature test and the result was 99.3 degree fahrenheit. Therapeutic measures were taken as the result of adverse event which included two tylenol. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events vomiting, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (10Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information: Lab data information and narrative were updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extreme Vomiting for 12 hours; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: ER8732) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1. Extreme Diarrhea for 12 hours. Somewhere between day 5-7., lot number= EN6207, Administration time=09:00 AM, Vaccine location=Left arm), administration date: 18Mar2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Extreme Diarrhea for 12 hours".  The following information was reported: VOMITING (non-serious) with onset 12Apr2021 19:00, outcome "recovering", described as "Extreme Vomiting for 12 hours". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had no known allergies. The 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.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: serious and more headaches which are not normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male 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: HEADACHE (non-serious), outcome "unknown", described as "serious and more headaches which are not normal".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: severe debilitating dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "severe debilitating dizziness".  Additional information: The patient "I had the normal side effects that are listed on the information sheet" reporting that they started about 5 minutes after getting the vaccine. Caller reports that 9 days after the shot, she experienced "severe debilitating dizziness".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: experiencing some pain and do not know if its from the vaccine or previous condition from his stroke.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experiencing some pain and do not know if its from the vaccine or previous condition from his stroke.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.