chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain/mild chest pain; 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 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Apr2021 (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 (Dose: 1), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset Apr2021, outcome "recovered", described as "chest pain/mild chest pain". Additional Information: The patient received his 2nd dose of Covid vaccine on 13Apr. He then experienced mild chest pain and it lasted for two weeks. He ended up going to the hospital on the 27th overnight advised by his physician. The patient said his chest pain symptom is "more significant this time than the second shot", which he received in Apr2021. Wondering if this is a side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Extreme fatigue; Extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 13:15 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE QUADRIVALENT, administration date 23Sep2021; LOSARTAN; ATORVASTATIN; AMLODIPINE; METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 12Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), ARTHRALGIA (non-serious) all with onset 25Oct2021 13:30, outcome "recovering" and all described as "Extreme fatigue". Therapeutic measures were not taken as a result of fatigue, arthralgia.  Additional information included: Patient received Fluzone 65+ HD Pf 2021-22 -Left arm, within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Events did not result in prolongation of hospitalization. Device Date: 26Oct2021.    No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain, all joints but mostly hips, knees, elbows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:30 (Lot number: EP7533) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 12:30), administration date: 09Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "Joint pain, all joints but mostly hips, knees, elbows". The event "joint pain, all joints but mostly hips, knees, elbows" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient didn't receive any other vaccines within 4 weeks. Prior to the COVID vaccine other medications in two weeks included Thyroid. The patient didn't have known allergies. The treatment received for the adverse event included Anti-inflammatory meds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Headache; fatigue; tenderness at injection site; low-grade fever; sore throat; stuffy nose; achy muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Dose vaccine location: Left arm, lot/batch number, expiry date and route of administration unspecified), administration date: 20Mar2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Dose vaccine location: Right arm, lot/batch number, expiry date and route of administration unspecified), administration date: 10Apr2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "tenderness at injection site"; PYREXIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "low-grade fever"; OROPHARYNGEAL PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "stuffy nose"; MYALGIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "achy muscles". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain, pyrexia, oropharyngeal pain, nasal congestion, myalgia.  Additional information: It was reported that the patient did not receive any other vaccine in four weeks. Reportedly the patient did not have covid prior vaccination and was not covid tested post vaccination. The patient also did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Headache; fatigue; tenderness at injection site; low-grade fever; sore throat; stuffy nose; achy muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Dose vaccine location: Left arm, lot/batch number, expiry date and route of administration unspecified), administration date: 20Mar2021, when the patient was 50 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Dose vaccine location: Right arm, lot/batch number, expiry date and route of administration unspecified), administration date: 10Apr2021, when the patient was 50 years old, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "tenderness at injection site"; PYREXIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "low-grade fever"; OROPHARYNGEAL PAIN (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "stuffy nose"; MYALGIA (non-serious) with onset 26Oct2021 01:00, outcome "recovering", described as "achy muscles". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain, pyrexia, oropharyngeal pain, nasal congestion, myalgia.  Additional information: It was reported that the patient did not receive any other vaccine in four weeks. Reportedly the patient did not have covid prior vaccination and was not covid tested post vaccination. The patient also did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: I started feeling itchy. I have no redness or bumps, but terrible itchiness wherever my skin folds. Armpits, across the top and under my breasts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 10:00 (Lot number: 30155ba) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fc3183, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Sep2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 21Oct2021, outcome "not recovered", described as "I started feeling itchy. I have no redness or bumps, but terrible itchiness wherever my skin folds. Armpits, across the top and under my breasts.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus.  Additional information: Patient was not pregnant at the time of vaccination. Patient had no Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Allergy shots within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 reported as yes. Patient reported as started feeling itchy, have no redness or bumps, but terrible itchiness wherever her skin folds. Armpits, across the top and under the breasts. Around the waistband area, the creases of legs, and tops of the feet. It was still itchy at the time of report. Seriousness reported as No.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Low grade fever; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 26Mar2021 11:00 (Lot number: EN9208) at the age of 38 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:1st, Time:11:00, Anatomical site of injection: Shoulder, Route of administration: Intramuscular, Batch/Lot number: EM9809 EUA 12-2020), administration date: 05Mar2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "Low grade fever"; CHILLS (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "chills"; HEADACHE (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, headache.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Investigation, Magnetic resonance imaging, Peripheral swelling, Ultrasound scan
Clinical narrative: Right leg swelled from knee to foot; Right Front of leg turns red and outside of ankle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101458025 (Pfizer).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diagnosed 8 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot EN6203; Injected on left arm unable to confirm if given in the muscle.), administration date: 01Mar2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right leg swelled from knee to foot"; ERYTHEMA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right Front of leg turns red and outside of ankle". The events "right leg swelled from knee to foot" and "right front of leg turns red and outside of ankle" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema.  Additional information: The adverse event had not gone away and it has been 6 months now. She went to a walk in clinic. Her PCP sent her for an x-ray and it only showed a little bit of fluid. Then she went to a walk in clinic and they sent her for Ultrasound and that did not show anything. Then, she ended up going to the Emergency. They did an MRI and did not know what it was and treated her for Cellulitis. They gave her an antibiotic and it did nothing. She does not know the name or have the lot or expiration for it. Rheumatologist said it was not arthritis.  End of April, her right leg swelled from her knee to her foot, the right front of her leg turned red, as well as the outside of her ankle on the right side. Per caller, she was seen by several doctors, several tests were done but all were negative and her condition is unknown.    No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Right leg swelled from knee to foot; Right Front of leg turns red and outside of ankle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101458025 (Pfizer).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diagnosed 8 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot EN6203; Injected on left arm unable to confirm if given in the muscle.), administration date: 01Mar2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right leg swelled from knee to foot"; ERYTHEMA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right Front of leg turns red and outside of ankle". The events "right leg swelled from knee to foot" and "right front of leg turns red and outside of ankle" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema.  Additional information: The adverse event had not gone away and it has been 6 months now. She went to a walk in clinic. Her PCP sent her for an x-ray and it only showed a little bit of fluid. Then she went to a walk in clinic and they sent her for Ultrasound and that did not show anything. Then, she ended up going to the Emergency. They did an MRI and did not know what it was and treated her for Cellulitis. They gave her an antibiotic and it did nothing. She does not know the name or have the lot or expiration for it. Rheumatologist said it was not arthritis.  End of April, her right leg swelled from her knee to her foot, the right front of her leg turned red, as well as the outside of her ankle on the right side. Per caller, she was seen by several doctors, several tests were done but all were negative and her condition is unknown.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  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: URTICARIA (non-serious), outcome "unknown", described as "hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101352990 same reporter, drug and event/ different patient.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood creatine phosphokinase, Body temperature, Chills, Myalgia
Clinical narrative: low grade fever of 99.9 degrees; rigors; muscle soreness; extreme knee joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 27Feb2021 14:00 (Lot number: EN6203) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "enlarged descending colon", start date: 2016 (unspecified if ongoing), notes: In 2016 patient was hospitalized with diff and an enlarged descending colon.; "right ear pain" (unspecified if ongoing), notes: In 2019/2020 patient was seeing ENT for right ear pain; "Eustachian tube balloon sinuplasty" (unspecified if ongoing), notes: ultimately undergoing a Eustachian tube balloon sinuplasty; "mild herniation", start date: 2012 (unspecified if ongoing), notes: In 2012 patient had a mild herniation; "lumbar pain" (unspecified if ongoing), notes: the patient had a mild herniation at L5/S1 causing lumbar pain and neurological symptoms in left outer calve taking approximately 2 years to resolve; "Depression" (ongoing); "slight tear sustained to a sagittal band of the third metacarpophalangeal joint" (unspecified if ongoing), notes: In 2020 patient saw an orthopedist for a slight tear sustained to a sagittal band of the third metacarpophalangeal joint. Concomitant medication(s) included: WELLBUTRIN taken for depression, start date: 20Apr2020 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 06Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: EL9264), administration date: 06Feb2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "low grade fever of 99.9 degrees"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "rigors"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "muscle soreness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "extreme knee joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever of 99.9 degrees; rigors; muscle soreness; extreme knee joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 27Feb2021 14:00 (Lot number: EN6203) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "enlarged descending colon", start date: 2016 (unspecified if ongoing), notes: In 2016 patient was hospitalized with diff and an enlarged descending colon.; "right ear pain" (unspecified if ongoing), notes: In 2019/2020 patient was seeing ENT for right ear pain; "Eustachian tube balloon sinuplasty" (unspecified if ongoing), notes: ultimately undergoing a Eustachian tube balloon sinuplasty; "mild herniation", start date: 2012 (unspecified if ongoing), notes: In 2012 patient had a mild herniation; "lumbar pain" (unspecified if ongoing), notes: the patient had a mild herniation at L5/S1 causing lumbar pain and neurological symptoms in left outer calve taking approximately 2 years to resolve; "Depression" (ongoing); "slight tear sustained to a sagittal band of the third metacarpophalangeal joint" (unspecified if ongoing), notes: In 2020 patient saw an orthopedist for a slight tear sustained to a sagittal band of the third metacarpophalangeal joint. Concomitant medication(s) included: WELLBUTRIN taken for depression, start date: 20Apr2020 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 06Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: EL9264), administration date: 06Feb2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "low grade fever of 99.9 degrees"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "rigors"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "muscle soreness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "extreme knee joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Malaise, Pain
Clinical narrative: Headache; fever; chills; aches and pains; painful underarm; malaise/feeling really sick; painful underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 12:30 (Lot number: FF8841) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma mild" (unspecified if ongoing), notes: other medical history: Asthma mild; "Known allergies:Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: CITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "aches and pains"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Oct2021 12:00, outcome "not recovered" and all described as "painful underarm"; MALAISE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "malaise/feeling really sick". Therapeutic measures were not taken as a result of headache, pyrexia, chills, pain, pain in extremity, malaise, axillary pain.  Additional information: adverse event Headache, fever , chills , aches and pains, painful underarm , malaise, feeling really sick and under the weather. If other vaccine in four weeks: No. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; fever; chills; aches and pains; painful underarm; malaise/feeling really sick; painful underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 12:30 (Lot number: FF8841) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma mild" (unspecified if ongoing), notes: other medical history: Asthma mild; "Known allergies:Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: CITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "aches and pains"; PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Oct2021 12:00, outcome "not recovered" and all described as "painful underarm"; MALAISE (non-serious) with onset 27Oct2021 12:00, outcome "not recovered", described as "malaise/feeling really sick". Therapeutic measures were not taken as a result of headache, pyrexia, chills, pain, pain in extremity, malaise, axillary pain.  Additional information: adverse event Headache, fever , chills , aches and pains, painful underarm , malaise, feeling really sick and under the weather. If other vaccine in four weeks: No. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle ache; Redness; Soreness Injection site; Fever; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Lot number: Fc3183) at the age of 15 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for allergy, notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Sep2021, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Muscle ache"; ERYTHEMA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Redness"; INJECTION SITE PAIN (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Soreness Injection site"; PYREXIA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Body ache". The events "muscle ache", "redness", "soreness injection site", "fever" and "body ache" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of myalgia.  Additional information: Vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up (02Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lichen planus, Nodule, Rash
Clinical narrative: my Lichen planus condition has aggravated with nodules appearing in several other parts of my body; nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area; have rash on his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lichen planus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 07Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset Mar2021, outcome "not recovered", described as "my Lichen planus condition has aggravated with nodules appearing in several other parts of my body"; NODULE (non-serious) with onset Mar2021, outcome "not recovered", described as "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area"; RASH (non-serious) with onset 2021, outcome "unknown", described as "have rash on his body". The events "my lichen planus condition has aggravated with nodules appearing in several other parts of my body" and "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lichen planus, nodule.  Additional information: No seriousness criteria were reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. It was reported that patient did not see the nodules before where they appear after vaccination with second dose. Patient applied Clobetasol Propionate Ointment, USP 0.05% to the affected areas twice a day but the growing number of spots and slow recovery this might not be as effective the manage the condition. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies reported. It was reported that patient had an adverse event for Covid vaccine after the second shot and began to have rash on his body. It was reported that patient had lichen planus condition for many years, which was a chronic condition that affects his legs and hands sometimes. Stated that he was treated with Betamethasone twice a day. Stated that he has them on his back, scalp, hands, legs and groin area.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lichen planus, Pruritus, Skin mass
Clinical narrative: my Lichen planus condition has aggravated with nodules appearing in several other parts of my body; nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area; have rash on his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lichen planus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 07Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset Mar2021, outcome "not recovered", described as "my Lichen planus condition has aggravated with nodules appearing in several other parts of my body"; NODULE (non-serious) with onset Mar2021, outcome "not recovered", described as "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area"; RASH (non-serious) with onset 2021, outcome "unknown", described as "have rash on his body". The events "my lichen planus condition has aggravated with nodules appearing in several other parts of my body" and "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lichen planus, nodule.  Additional information: No seriousness criteria were reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. It was reported that patient did not see the nodules before where they appear after vaccination with second dose. Patient applied Clobetasol Propionate Ointment, USP 0.05% to the affected areas twice a day but the growing number of spots and slow recovery this might not be as effective the manage the condition. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies reported. It was reported that patient had an adverse event for Covid vaccine after the second shot and began to have rash on his body. It was reported that patient had lichen planus condition for many years, which was a chronic condition that affects his legs and hands sometimes. Stated that he was treated with Betamethasone twice a day. Stated that he has them on his back, scalp, hands, legs and groin area.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: fever; nausea; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: FH8020) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301451A), administration date: 05Oct2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "fever"; NAUSEA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "nausea"; MYALGIA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "muscle pain". Therapeutic measures were not taken as a result of pyrexia, nausea, myalgia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; the injection site was sore, red, and swollen; Besides that, the most concerning side effect which was the itchiness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 13:00 (Lot number: FH8020) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Alport Syndrome" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; LAMICTAL; TRAZODONE; FISH OIL; VIT D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (lot umber=EP6955, dose number=1, vaccine location=Left Arm), administration date: 01Apr2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (lot umber=EP7533, dose number=2, vaccine location=Left Arm), administration date: 22Apr2021, when the patient was 44 years old, for COVID-19 immunization; Flu, administration date: 13Oct2021.  The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 23Oct2021 14:00, outcome "recovering" and all described as "the injection site was sore, red, and swollen"; VACCINATION SITE PRURITUS (non-serious) with onset 23Oct2021 14:00, outcome "recovering", described as "Besides that, the most concerning side effect which was the itchiness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site pruritus.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: No. After receiving the booster on 23Oct2021 the injection site was sore, red, and swollen. Unlike the previous two injections, this third dose was noticeably more swollen and more painful than the other two. It has been 5 days and arm still shows signs of swelling and pain. Besides that, the most concerning side effect was the itchiness at the injection site which was very uncomfortable, almost as itchy as a mosquito bite. The itchiness was only on the injection site, the swollen area, and maybe an inch outside of the swollen area. It has also lasted 5 days. No medication was used for this symptom.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Chills; Low fever; Left lymph node under left arm is sore and slightly swollen; Left lymph node under left arm is sore and slightly swollen; Headache; Left lymph node under left arm is sore and slightly swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Oct2021 13:00 (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 12Oct2021, stop date: 12Oct2021; TDAP, start date: 28Sep2021. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: Bnt162b2 (Dose Number: 2, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 17Mar2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 25Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Low fever"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "Left lymph node under left arm is sore and slightly swollen"; HEADACHE (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, lymph node pain, lymphadenopathy, headache, pain in extremity.  Additional information: The patient was not diagnosed with prior vaccination and not tested with covid post vaccination. The patient received birth control within two weeks of vaccination. On 27Oct2021, the patient had chills and low fever. About 12 hours after and still ongoing on two days later, left lymph node under left arm was sore and slightly swollen. The patient continue to have a headache. The issues returned to normal.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; Low fever; Left lymph node under left arm is sore and slightly swollen; Left lymph node under left arm is sore and slightly swollen; Headache; Left lymph node under left arm is sore and slightly swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Oct2021 13:00 (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 12Oct2021, stop date: 12Oct2021; TDAP, start date: 28Sep2021. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: Bnt162b2 (Dose Number: 2, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 17Mar2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Anatomical site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN0203 Jun2021), administration date: 25Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Low fever"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "Left lymph node under left arm is sore and slightly swollen"; HEADACHE (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, lymph node pain, lymphadenopathy, headache, pain in extremity.  Additional information: The patient was not diagnosed with prior vaccination and not tested with covid post vaccination. The patient received birth control within two weeks of vaccination. On 27Oct2021, the patient had chills and low fever. About 12 hours after and still ongoing on two days later, left lymph node under left arm was sore and slightly swollen. The patient continue to have a headache. The issues returned to normal.  No follow-up attempts are possible. No further information is expected.