chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Product administered to patient of inappropriate age, Rash, Rash erythematous
Clinical narrative: The rash is not itchy, it's just red and scaly.; it has progressed to a scaly, plaque like looking rash over the knuckles; small reddish areas over the knuckles on his left hand which is the side where the vaccine was administered; The rash is not itchy, it's just red and scaly.; She states her 10 year old son received the Pfizer COVID 19 vaccine; it feels dry and and it's catching on things.; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 10-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Nov2021 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ERYTHEMA (non-serious) with onset 07Nov2021, outcome "unknown", described as "small reddish areas over the knuckles on his left hand which is the side where the vaccine was administered"; RASH ERYTHEMATOUS (non-serious) with onset 07Nov2021, outcome "unknown", RASH (non-serious) with onset 08Nov2021, outcome "unknown" and all described as "The rash is not itchy, it's just red and scaly."; SKIN PLAQUE (non-serious) with onset 08Nov2021, outcome "unknown", described as "it has progressed to a scaly, plaque like looking rash over the knuckles"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "it feels dry and and it's catching on things."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 06Nov2021, outcome "unknown", described as "She states her 10 year old son received the Pfizer COVID 19 vaccine".  Additional information: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. In a clinical study in children 5 through 11 years of age who received Pfizer COVID-19 Vaccine containing 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (10 mcg modRNA) adverse reactions following administration of any primary series dose included rash (0.3%). Warm transfer 159558. Upon transfer, the caller states she is calling to report these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Skin plaque
Clinical narrative: The rash is not itchy, it's just red and scaly.; it has progressed to a scaly, plaque like looking rash over the knuckles; small reddish areas over the knuckles on his left hand which is the side where the vaccine was administered; The rash is not itchy, it's just red and scaly.; She states her 10 year old son received the Pfizer COVID 19 vaccine; it feels dry and and it's catching on things.; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 10-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Nov2021 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ERYTHEMA (non-serious) with onset 07Nov2021, outcome "unknown", described as "small reddish areas over the knuckles on his left hand which is the side where the vaccine was administered"; RASH ERYTHEMATOUS (non-serious) with onset 07Nov2021, outcome "unknown", RASH (non-serious) with onset 08Nov2021, outcome "unknown" and all described as "The rash is not itchy, it's just red and scaly."; SKIN PLAQUE (non-serious) with onset 08Nov2021, outcome "unknown", described as "it has progressed to a scaly, plaque like looking rash over the knuckles"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "it feels dry and and it's catching on things."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 06Nov2021, outcome "unknown", described as "She states her 10 year old son received the Pfizer COVID 19 vaccine".  Additional information: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. In a clinical study in children 5 through 11 years of age who received Pfizer COVID-19 Vaccine containing 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (10 mcg modRNA) adverse reactions following administration of any primary series dose included rash (0.3%). Warm transfer 159558. Upon transfer, the caller states she is calling to report these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Somnolence
Clinical narrative: Feel like a zombie: can't stay awake, after booster; Feel like a zombie: can't stay awake, after booster; Feel like a zombie: can't stay awake, after booster; 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 third dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE 3 (booster), SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), FEELING ABNORMAL (non-serious), SOMNOLENCE (non-serious), outcome "unknown" and all described as "Feel like a zombie: can't stay awake, after booster".  Additional Information: Caller states she was calling about the PFIZER, COVID shot, all three. She explained that she was a live in caregiver, and she takes care of a patient that has a kidney transplant and a severe diabetic. Caller states she is good at being a caregiver. She stated that herself, and the man whom she caregivers with the kidney transplant and diabetes, both had the Pfizer COVID vaccines. She stated herself, and the man she caregivers, just got the booster COVID vaccine at the end of 30Oct2021. She stated since that time, both herself and the man she caregivers feel like zombies, as they cannot stay awake.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat about 2 hours after vaccine was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 14:30 (Lot number: FK5127) at the age of 10 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: OROPHARYNGEAL PAIN (non-serious) with onset 06Nov2021 16:30, outcome "not recovered", described as "Sore throat about 2 hours after vaccine was administered". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Mild Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Nov2021 12:30 (Lot number: FK5127) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 08:00, outcome "recovered" (Nov2021), described as "Fatigue"; HEADACHE (non-serious) with onset 08Nov2021 08:00, outcome "recovered" (Nov2021), described as "Mild Headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: On 08Nov2021, the patient had mild headache and fatigue without fever. No other vaccine was received in four weeks and other medications in two weeks was Children's Vitamins (unspecified). No Covid prior vaccination and was not tested for covid post vaccination. The patient had no known allergies and none other medical history.  Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 1 (tris), 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) with onset 09Nov2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 10Nov2021, outcome "unknown", described as "woozy".  Additional information: Child experienced headache a couple hours after the vaccination and felt woozy the morning after. Device date was reported as 10Nov2021. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body height, Immunisation, Incorrect route of product administration
Clinical narrative: Booster; COVID-19 VACCINE taken by ENDOCERVICAL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 80-years-old female patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE 3 (booster), SINGLE for covid-19 immunization. Relevant medical history included: "Eyeglasses wearer" (ongoing). Concomitant medication(s) included: ELIQUIS taken for cerebrovascular accident prophylaxis, start date: 2018; CRESTOR; ZETIA; VERAPAMIL; OMEPRAZOLE. Past drug history included: Coumadin, start date: 2011, for AFIB, reaction(s): "Abnormal clotting factor"; Pradaxa, stop date: 2018, for AFIB, reaction(s): "Upset stomach". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19 VACCINE taken by unknown route of administration", "COVID-19 VACCINE taken by unknown route of administration". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "COVID-19 VACCINE taken by ENDOCERVICAL". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow up (15Nov2021): The following information was received from BMS: The query was: Xml provided Suspect drug of "COVID-19 VACCINE" with route "ENDOCERVICAL", it seemed the route not usual and may be error. Please confirm if the route of "COVID-19 VACCINE" was correct, since it will determine split case validity. The response was: The route of administration of Suspect medication COVID-19 VACCINE should be unknown (previously entered as endocervical in error).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Oct2021 13:00 (Lot number: 30125BA) at the age of 56 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose."; BACK PAIN (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose". The events "severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose." all were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia, arthralgia, arthralgia, arthralgia, back pain.  Additional information: The patient had not known allergies. The patient had not vaccination prior to COVID and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks. AE resulted in: Doctor or other healthcare professional office/clinic visit. The patient has not been received any treatment for AEs.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Pain
Clinical narrative: radiating pain along her arm/it was even more intense after the 3rd shot; it was even more intense after the 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 (Lot number: EW0185) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE MONONITRATE. Vaccination history included: Bnt162b2 (first dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm"; Bnt162b2 (second dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm". The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "it was even more intense after the 3rd shot"; PAIN (non-serious) with onset 23Oct2021, outcome "not recovered", described as "radiating pain along her arm/it was even more intense after the 3rd shot". The event "radiating pain along her arm/it was even more intense after the 3rd shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: radiating pain along her arm/it was even more intense after the 3rd shot; it was even more intense after the 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 (Lot number: EW0185) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE MONONITRATE. Vaccination history included: Bnt162b2 (first dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm"; Bnt162b2 (second dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm". The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "it was even more intense after the 3rd shot"; PAIN (non-serious) with onset 23Oct2021, outcome "not recovered", described as "radiating pain along her arm/it was even more intense after the 3rd shot". The event "radiating pain along her arm/it was even more intense after the 3rd shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Condition aggravated
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Injury" (ongoing); "arthritis" (ongoing); "antibody count lowered" (ongoing); "Fell" (ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "antibody count lowered". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Ocular vascular disorder
Clinical narrative: redness on her face; swollen eye; stroke in her eye; This is a spontaneous report received from a contactable reporter (consumer, patient's husband) from medical information team for a Pfizer sponsored program (159558).  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Feb2021 (Lot number: EN6202) at the age of 75 years as dose 1, 0.3 ml single for COVID-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (blood pressure medicine). The following information was reported: ERYTHEMA (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "redness on her face"; EYE SWELLING (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "swollen eye"; OCULAR VASCULAR DISORDER (non-serious) with onset 2021 (also reported as 40 days after vaccination), outcome "not recovered", described as "stroke in her eye". The patient was advised by her allergist not to get the second dose so she didn't.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Muscle disorder, Myalgia, Nerve injury
Clinical narrative: Muscle pain after first vaccine; Increased pain of her fibromyalgia after the first vaccine; having issues with her nerves; having issues with her muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 46 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: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain after first vaccine"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Increased pain of her fibromyalgia after the first vaccine"; NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "having issues with her nerves"; MUSCLE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "having issues with her muscles". Additional information: The patient stated that she got her first Covid 19 vaccine almost 5.5 weeks prior to the report. Her doctor told her not to get the second dose. She stated that she wanted to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypersensitivity, Illness, Speech disorder, Vision blurred
Clinical narrative: developed Bell's palsy/face is not straightened out; it got a form of allergic reaction; I became ill; vision on right side is slightly blurry; It's also messing with my speech a little /it's messing up with the 'teeth' a little like talking; This is a spontaneous report received from a contactable consumer or other non HCP from medical information team. The reporter is the patient. A 54 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 22Oct2021 (Lot number: FM2588) at the age of 54 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medications included: AMLODIPINE; METFORMIN. Vaccination history included: Bnt162b2 (first dose), administration date: 2021, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 30Oct2021, outcome "not recovered", described as "developed Bell's palsy/face is not straightened out"; HYPERSENSITIVITY (non-serious) with onset 30Oct2021, outcome "unknown", described as "it got a form of allergic reaction"; MALAISE (non-serious) with onset 30Oct2021, outcome "unknown", described as "I became ill"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "vision on right side is slightly blurry"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "It's also messing with my speech a little /it's messing up with the 'teeth' a little like talking". The events were evaluated at the emergency room visit. Therapeutic measures were taken as the result of the events. The patient thought he had a heart attack but it was determined that he had developed Bell's palsy and his face has not straightened out. It was also reported that his vision on right side was slightly blurry and messing with his speech a little. The patient would like to know if Bell's palsy is related to the Pfizer Covid 19 vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Presyncope, Syncope
Clinical narrative: he said he was going where he didn't want to go and darkness in front of his eyes; I saw him swaying back and forth in the shower and about to fall; he was conscious but his lips were pale; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 5-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The vaccine was administered in pharmacy or drug store. There were no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid-19 prior vaccination, was not tested for Covid-19 post vaccination. He had no known allergies and no other medical history. The following information was reported: SYNCOPE (medically significant) with onset 23Nov2021 08:30, outcome "recovered", described as "he said he was going where he didn't want to go and darkness in front of his eyes"; PRESYNCOPE (non-serious) with onset 23Nov2021 08:30, outcome "recovered", described as "I saw him swaying back and forth in the shower and about to fall"; PALLOR (non-serious) with onset 23Nov2021 08:30, outcome "recovered", described as "he was conscious but his lips were pale". The parent reported that patient took vaccine yesterday evening. He was okay. In the morning, he woke up around 8:30 am and went to shower. After 15-20 minutes in shower, the parent saw him swaying back and forth in the shower and about to fall. The parent picked patient up, he was conscious but his lips were pale. The parent asked him what happened and he said "he was going where he didn't want to go" and darkness in front of his eyes. Therapeutic measures were not taken as a result of syncope, presyncope, pallor.   Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Stomatitis
Clinical narrative: sores in his mouth; diagnosed with Covid-19 via a PCR test with symptom (fever); This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the parent. An 8-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly administered in the left arm on 11Nov2021 19:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient has no relevant family history. The patient had no predisposing factors. There were no concomitant medications. There are no other vaccines administered on same date with the Pfizer vaccine considered as suspect. The parent reported that her 8-year-old son who received the first dose of the orange cap Pfizer Covid-19 vaccine on 11Nov2021 and was diagnosed with Covid-19 via a PCR test on 21Nov2021. The parent stated that her son is scheduled to receive his second dose of the orange cap Pfizer Covid-19 vaccine on 02Dec2021 and inquired if her son receives the second dose of the orange cap Pfizer Covid-19 vaccine, will it overwhelm his system with antibodies. She also inquired if myocarditis be more likely or any other issues with having too many antibodies after receiving the Pfizer Covid-19 vaccine and diagnosis of Covid-19 after receiving the vaccine and if it is not recommended for him to get the second dose of the orange cap Pfizer Covid-19 vaccine while being symptomatic with Covid-19. The reporter added that the patient had onset of COVID on 18Nov2021, with COVID PCR Test performed on 21Nov2021 which verified diagnosis as positive for COVID. She further described symptoms to include onset of fever on 18Nov2021 and he got sores in his mouth today (23Nov2021). She thinks the event is getting worse, symptoms getting worse. She has not heard of sores in the mouth being a symptom of COVID but does not know what else that would be related to. The patient underwent the following laboratory tests and procedures was sars-cov-2 test: (21Nov2021) positive with notes of no other testing or investigations performed other than COVID PCR Test which was performed as throat swab. The adverse events did not require emergency room visit or physician office visit. The patient was not hospitalized. The outcome of the events was not recovered.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Throat irritation
Clinical narrative: she developed a rash; her throat was itching; her face was bright red all over her face and chest; 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 (159558). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Dose:1st, lot number EN6205.), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 immunization and did not have any side effects.  The following information was reported: RASH (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "she developed a rash"; THROAT IRRITATION (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "her throat was itching"; ERYTHEMA (medically significant) with onset 22Mar2021, outcome "recovering", described as "her face was bright red all over her face and chest". The events "she developed a rash", "her throat was itching" and "her face was bright red all over her face and chest" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, throat irritation, erythema which included Benadryl injection, Solumedrol, Pepcid and Famotidine injection.  Clinical course: She had both of the Pfizer covid 19 vaccines in Mar2021. The patient stated she did not have any side effects after the first dose but 30 minutes after the second dose she had a reaction. She developed a rash and her throat was itching and her face was bright red all over. The patient reported she was sent to the hospital and got a couple of injections and it got better. They gave her a Benadryl injection. She is wondering if she is okay to get the COVID booster. She was doing fine. They made her sit there for 30 minutes. She left, and got to her car. Then she developed an immense heath scratching in throat. She looked in the rear view mirror and her face was bright red all over her face and chest. So she went back in. They wouldn't let her leave. She had a scratching in her throat. They sent her to the emergency room. In the ambulance they gave her Benadryl and Solumedrol. When she got to the Emergency room they gave her Pepcid on arrival. She saw improvement and everything. Everything started resolving right after. They gave her one more injection of Famotidine. She was only there a half of and hour and went home.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Tinnitus
Clinical narrative: Whooshing sound in left ear with pain and pressure; Whooshing sound in left ear with pain and pressure; Whooshing sound in left ear with pain and pressure; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 35 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 01Oct2021 (Lot number: FC31fz) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, lot number=FF2588, dose 1 on 10Sep2021, at 35 years old, in the right arm, for Covid-19 Immunization. The patient did not receive other vaccine in four weeks. The patient received the vaccine at a Pharmacy or Drug Store. The following information was reported: EAR PAIN (medically significant), EAR DISCOMFORT (medically significant), TINNITUS (medically significant) all with onset 15Oct2021, outcome "not recovered" and all described as "Whooshing sound in left ear with pain and pressure".  The event "whooshing sound in left ear with pain and pressure", was evaluated at the physician office visit.  Therapeutic measures were taken as a result of ear pain, ear discomfort, tinnitus. Treatment included antibiotics and anti-inflammatory drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer - patient's husband) from medical information team and product quality group.  A 56-year-old female patient received BNT162B2, administration date 05Mar2021 (Lot number: EN6198) at the age of 55 years as dose 2, single and administration date 2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: ADVIL for Headache. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient has contracted COVID on 23Nov2021, testing positive after receiving both the Pfizer COVID vaccines. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Product Quality Group provided investigational results on 24Nov2021 for BNT162B2: Conclusion of Previously Completed Investigation:The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: stroke during surgery; TIA; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 70 year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), administered in arm (unsure if in the left arm), administration date 30Mar2021 (Lot number: ER8733) at the age of 70 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "She is a heart patient" (unspecified if ongoing); "TAVR Surgery, Heart Valve Replaced", start date: 12Apr2021 (unspecified if ongoing). The patient had no allergies. The patient had unspecified concomitant medications (reported as "No, any medication she has had is a daily medication that she has been taking"). Vaccination history included: BNT162B2 (Lot number: EN6205, administered in the arm), administration date: 02Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 12Apr2021, outcome "unknown", described as "stroke during surgery"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset of 2021 (reported as either in Jun2021 or Jul2021) outcome "unknown", described as "TIA". The patient did not have testing for what just happened, but for the scans and stuff that she had would have been back in Apr2021, she also had a stroke then, but the stroke was during the surgery on 12Apr2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647058 Same patient, different events, different vaccine dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Lymphadenopathy
Clinical narrative: Chest pain; Shortness of breath; Full lymph nodes under her left arm; This is a spontaneous report received from a contactable Consumer or other non HCP for a Pfizer sponsored program (159558). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: 3302680) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First vaccine: , Date: 01Nov2021, Lot: FH8020, Site: left arm), administration date: 01Nov2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Shortness of breath"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Full lymph nodes under her left arm".
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash pruritic
Clinical narrative: inflammation; rashes all over her face/ rash is on both sides to the neck and chest, it itched; 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 50 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 14Oct2021 (Lot number: FF8841) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer (ongoing). The following information was reported: RASH PRURITIC (medically significant) with onset Oct2021, outcome "not recovered", described as "rashes all over her face/ rash is on both sides to the neck and chest, it itched"; INFLAMMATION (medically significant), outcome "unknown", described as "inflammation". Therapeutic measures were taken as a result of rash pruritic, inflammation which included steroid shot for inflammation, desonide cream, and hydroxyzine tablets (LOT-155909). Clinical course was described as follows: the rash started 2-3 days after the first dose, it was on both sides to the neck and chest, it itched. The rash is still visible. The patient got the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: FJ1620) on 23Nov2021.  Follow-up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure has been increasing so much and it is now at stage 3; 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 male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood pressure condition" (ongoing), notes: preexisting prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "blood pressure has been increasing so much and it is now at stage 3". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) increasing so much and it is now at stage 3. It was further reported that the patient has preexisting blood pressure condition prior to the vaccine but it was never like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac disorder, Immunisation, Visual impairment
Clinical narrative: arrhythmia; the issue I am having now currently with my heart; issue with my vision; I would see these like a squiggly line sometimes they are more than one and they are separate/one big circular squiggly line; booster; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "macular degeneration in one eye " (unspecified if ongoing); "cataract" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "arrhythmia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "the issue I am having now currently with my heart"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "I was also having issue with my vision; I would see these like a squiggly line sometimes they are more than one and they are separate another time there is just one big circular squiggly line and that''s kind of what I was seeing"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". Patient stated that the Pfizer vaccine that she got was causing arrhythmia and the issue she was having now currently with her heart. Patient was reporting that she had some side effects. Questioned as to whether or not the Pfizer vaccine that she got was causing arrhythmia and the issue she was having now currently with her heart. She had issue the night before the report with her heart and she also had issue with her vision as well. Stated that she does have macular degeneration in one eye and trying to develop cataract (Intent history) in both and so periodically 'I will see'. In the past she would see these like a squiggly line sometimes they were more than one and they are separate another time there was just one big circular squiggly line and that's kind of what she was seeing the night before the report. It stayed with her for good hour, hour and half and then finally stopped and just few minutes ago before she was doing a phone call those smaller squiggly line came back in to her vision and  that was she just remembered when she was on hold that also being going on but that started back just the night before the report and few minutes ago. Stated that she got the COVID 19 Vaccine booster on the 19th (as reported).    The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electric shock sensation, Immunisation, Pulmonary oedema
Clinical narrative: shocks thru body; booster; compromised breathing/fluid around lungs; compromised breathing/fluid around lungs; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (060820).  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PULMONARY OEDEMA (medically significant), DYSPNOEA (non-serious) all with onset Nov2021, outcome "recovering" and all described as "compromised breathing/fluid around lungs"; ELECTRIC SHOCK SENSATION (non-serious) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "shocks thru body"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster". The reported covid booster on 16Nov2021, felt shocks thru body 16Nov2021, resolved on own. reported compromised breathing/fluid around lungs when walking pre existing-breathing improved while walking since start. MD was unaware. Encouraged to discuss with MD.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID after their primary series of Pfizer-COVID 19 vaccine; This is a spontaneous report received from a non-contactable consumer (patient) from medical information team for a Pfizer sponsored program (159558).   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "COVID after their primary series of Pfizer-COVID 19 vaccine". The patient inquired if someone had COVID after their primary series of Pfizer-COVID 19 vaccine, when can they get the booster dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: put the patient down; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: twice before Jan2021. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "mild reaction". The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "put the patient down". Additional information: The event lasted for about 36 hours (as reported).  The lot number for BNT162B2 was not provided and will be requested during follow up.