chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Attention deficit hyperactivity disorder, Body temperature, Chills, Feeling abnormal, Hyperhidrosis
Clinical narrative: Acceleration of ADHD; Hives were all over mostly torso; Fever 103.2; Chills; Sweats; Brain fog; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 11:00 (Lot number: EW0772) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time: 10 am, Anatomical site of injection: Left upper arm, Batch/Lot number: EW0172), administration date: 20May2021, for Covid-19 immunization.  The following information was reported: ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Acceleration of ADHD"; URTICARIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "Hives were all over mostly torso"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Fever 103.2"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Sweats"; FEELING ABNORMAL (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Brain fog". The events "acceleration of adhd", "hives were all over mostly torso", "fever 103.2", "chills", "sweats" and "brain fog" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of attention deficit hyperactivity disorder, urticaria, pyrexia, chills, hyperhidrosis, feeling abnormal.  Additional information: No prior vaccination. The patient received the treatment for the events was Steroids, Hydroxyzine. Acceleration of ADHD which has continued. No family Medical history relevant to AE. Really, just wanted to let you know I self the odd brainthing after second shot. Then with this covid whatever it was, it does to brain, never went away. Thought may help with your studies as this goes forward. I am sure you know at this point there is no cure. Just control.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: Acceleration of ADHD; Hives were all over mostly torso; Fever 103.2; Chills; Sweats; Brain fog; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 11:00 (Lot number: EW0772) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time: 10 am, Anatomical site of injection: Left upper arm, Batch/Lot number: EW0172), administration date: 20May2021, for Covid-19 immunization.  The following information was reported: ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Acceleration of ADHD"; URTICARIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "Hives were all over mostly torso"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Fever 103.2"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Sweats"; FEELING ABNORMAL (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Brain fog". The events "acceleration of adhd", "hives were all over mostly torso", "fever 103.2", "chills", "sweats" and "brain fog" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of attention deficit hyperactivity disorder, urticaria, pyrexia, chills, hyperhidrosis, feeling abnormal.  Additional information: No prior vaccination. The patient received the treatment for the events was Steroids, Hydroxyzine. Acceleration of ADHD which has continued. No family Medical history relevant to AE. Really, just wanted to let you know I self the odd brainthing after second shot. Then with this covid whatever it was, it does to brain, never went away. Thought may help with your studies as this goes forward. I am sure you know at this point there is no cure. Just control.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Inappropriate age at vaccine administration; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 03Dec2021 (Lot number: FL0007) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right), administration date: 10Nov2021, for COVID-19 Immunization.The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration"; ILLNESS (non-serious) with onset 03Jan2022, outcome "recovering", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111485 Same patient/different dose/different events
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 03Dec2021 (Lot number: FL0007) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right), administration date: 10Nov2021, for COVID-19 Immunization.The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration"; ILLNESS (non-serious) with onset 03Jan2022, outcome "recovering", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111485 Same patient/different dose/different events
Age: 33.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Pain, Urticaria
Clinical narrative: Allergic reaction; hives; Lip swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: 330368D) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Polycystic ovaries" (unspecified if ongoing), notes: Verbatim: Polycystic ovarian syndrome. Concomitant medication(s) included: IBUPROFEN [IBUPROFEN SODIUM]. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization.  The following information was reported: HYPERSENSITIVITY (non-serious) with onset 23Jan2022, outcome "recovering", described as "Allergic reaction"; URTICARIA (non-serious) with onset 23Jan2022, outcome "recovering", described as "hives"; LIP SWELLING (non-serious) with onset 23Jan2022, outcome "recovering", described as "Lip swelling". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient stated that, patient believe to be an allergic reaction to it, had hives covering majority of body and lip swelling about 42 hours after the vaccine. Patient stated, patient got the hives and went to urgent care and was given a steroid shot of  Decadron and Benadryl. Patient stated, events were improving still having hives its been 5 days.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: Allergic reaction; hives; Lip swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: 330368D) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Polycystic ovaries" (unspecified if ongoing), notes: Verbatim: Polycystic ovarian syndrome. Concomitant medication(s) included: IBUPROFEN [IBUPROFEN SODIUM]. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization.  The following information was reported: HYPERSENSITIVITY (non-serious) with onset 23Jan2022, outcome "recovering", described as "Allergic reaction"; URTICARIA (non-serious) with onset 23Jan2022, outcome "recovering", described as "hives"; LIP SWELLING (non-serious) with onset 23Jan2022, outcome "recovering", described as "Lip swelling". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient stated that, patient believe to be an allergic reaction to it, had hives covering majority of body and lip swelling about 42 hours after the vaccine. Patient stated, patient got the hives and went to urgent care and was given a steroid shot of  Decadron and Benadryl. Patient stated, events were improving still having hives its been 5 days.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Allergic reaction; hives; Lip swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: 330368D) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Polycystic ovaries" (unspecified if ongoing), notes: Verbatim: Polycystic ovarian syndrome. Concomitant medication(s) included: IBUPROFEN [IBUPROFEN SODIUM]. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization.  The following information was reported: HYPERSENSITIVITY (non-serious) with onset 23Jan2022, outcome "recovering", described as "Allergic reaction"; URTICARIA (non-serious) with onset 23Jan2022, outcome "recovering", described as "hives"; LIP SWELLING (non-serious) with onset 23Jan2022, outcome "recovering", described as "Lip swelling". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient stated that, patient believe to be an allergic reaction to it, had hives covering majority of body and lip swelling about 42 hours after the vaccine. Patient stated, patient got the hives and went to urgent care and was given a steroid shot of  Decadron and Benadryl. Patient stated, events were improving still having hives its been 5 days.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia, Rash
Clinical narrative: developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0170) at the age of 20 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: ER8729) 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: RASH (non-serious) with onset 02Apr2021, outcome "recovered", described as "developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines". Therapeutic measures were not taken as a result of rash.  Additional Information: Vaccine Facility type was reported as, School or Student Health Clinic. If other vaccine in four weeks was unknown. The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) as dose 3, single for covid-19 immunisation. Patient stated that, he developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines-stated symptoms/rash cleared on its own after couple days or so. Patient was given claritin 10mg tab prior to his Pfizer covid 'booster' and watched for 30min-no problems-I called Patient today 31Jan2022 to see if any rash developed over the weekend and he said no-no rash developed this time however stated he did feel feverish and achy for 1-2days (feels fine now). No treatment received for Events. It was unknown If patient had covid prior vaccination and If covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0170) at the age of 20 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: ER8729) 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: RASH (non-serious) with onset 02Apr2021, outcome "recovered", described as "developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines". Therapeutic measures were not taken as a result of rash.  Additional Information: Vaccine Facility type was reported as, School or Student Health Clinic. If other vaccine in four weeks was unknown. The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) as dose 3, single for covid-19 immunisation. Patient stated that, he developed a rash on his torso proportional to 24hrs after his 1st and 2nd pfizer covid vaccines-stated symptoms/rash cleared on its own after couple days or so. Patient was given claritin 10mg tab prior to his Pfizer covid 'booster' and watched for 30min-no problems-I called Patient today 31Jan2022 to see if any rash developed over the weekend and he said no-no rash developed this time however stated he did feel feverish and achy for 1-2days (feels fine now). No treatment received for Events. It was unknown If patient had covid prior vaccination and If covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever over 100 deg f; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2022 08:30 (Lot number: FK5618) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=PFIZER, prev dose brand unknown=False,, Batch/Lot No: FK5618, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 21Jan2022 21:00, outcome "recovered", described as "Fever over 100 deg f"; PAIN (non-serious) with onset 21Jan2022 21:00, outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Fever over 100deg f, body aches lasting 24 hours. Ae resulted in: None of the above. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever over 100 deg f; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2022 08:30 (Lot number: FK5618) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=PFIZER, prev dose brand unknown=False,, Batch/Lot No: FK5618, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 21Jan2022 21:00, outcome "recovered", described as "Fever over 100 deg f"; PAIN (non-serious) with onset 21Jan2022 21:00, outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain.  Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Fever over 100deg f, body aches lasting 24 hours. Ae resulted in: None of the above. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Parasthesias in arms and legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm right, administration date 12Feb2022 11:00 (Lot number: FE3594) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASPIRIN (E.C.); TAMSULOSIN; VITAMIN B12 & FOLIC ACID. Past drug history included: Levaquin, reaction(s): "Drug Allergy". The following information was reported: PARAESTHESIA (non-serious) with onset 12Feb2022 16:00, outcome "not recovered", described as "Parasthesias in arms and legs". Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient did not have other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not have covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: extreme fatigue; 24 hours vomiting; several weeks of hives; left shoulder pain; jaw pain; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, shoulder pain, jaw pain, vomiting and hives. On an unknown date, the outcome of the fatigue and vomiting were unknown and the outcome of the shoulder pain, jaw pain and hives were recovered/resolved.   It was unknown if the reporter considered the fatigue, shoulder pain, jaw pain, vomiting and hives to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced extreme fatigue, left shoulder and jaw pain for 24 hours. The patient also experienced vomiting and several weeks of hives. The nurse did not recommend 2nd dose of Shingrix currently to the patient. This report was already reported to VAERS.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Pain in jaw, Urticaria, Vomiting
Clinical narrative: extreme fatigue; 24 hours vomiting; several weeks of hives; left shoulder pain; jaw pain; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, shoulder pain, jaw pain, vomiting and hives. On an unknown date, the outcome of the fatigue and vomiting were unknown and the outcome of the shoulder pain, jaw pain and hives were recovered/resolved.   It was unknown if the reporter considered the fatigue, shoulder pain, jaw pain, vomiting and hives to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced extreme fatigue, left shoulder and jaw pain for 24 hours. The patient also experienced vomiting and several weeks of hives. The nurse did not recommend 2nd dose of Shingrix currently to the patient. This report was already reported to VAERS.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis reactive, Inappropriate schedule of product administration, Rash
Clinical narrative: I developed a rash on my legs / Rash eventually covered most of my extremities; administration date=28Jan2021/dose number=2; developed joint pain that migrated from one joint until another; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 11:45 (Lot number: EL0140) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN; LOSARTAN POTASSIUM/HCTZ. Vaccination history included: Bnt162b2 ([{prev dose product=COVID 19,, prev dose brand=Pfizer-BioNTech,, prev dose brand unknown=False,, prev dose lot number=EL0140,, prev dose lot unknown=False,, prev dose administration date=11Jan2021,, prev dose administration time=01:45,, PM, prev dose dose number=1,, prev dose vaccine location=Right arm}]), administration date: 11Jan2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Jan2021 11:45, outcome "unknown", described as "administration date=28Jan2021/dose number=2"; RASH (non-serious) with onset Feb2021, outcome "not recovered", described as "I developed a rash on my legs / Rash eventually covered most of my extremities"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "developed joint pain that migrated from one joint until another". The events "administration date=28jan2021/dose number=2", "i developed a rash on my legs / rash eventually covered most of my extremities" and "developed joint pain that migrated from one joint until another" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, arthralgia. No follow-up attempts are possible. No further information is expected.  Additional information: Patient developed a rash on my legs approximately two weeks after second vaccine. Rash eventually covered most of my extremities. About 4 months later she developed joint pain that migrated from one joint until another (rash subsided). Joint pain was resolved 8 months after vaccine, but rash returned and continues and it has now been 1 year since side effects began. Patient did not have COVID prior vaccination. Patient tested positive after vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Rash, SARS-CoV-2 test
Clinical narrative: I developed a rash on my legs / Rash eventually covered most of my extremities; administration date=28Jan2021/dose number=2; developed joint pain that migrated from one joint until another; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 11:45 (Lot number: EL0140) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN; LOSARTAN POTASSIUM/HCTZ. Vaccination history included: Bnt162b2 ([{prev dose product=COVID 19,, prev dose brand=Pfizer-BioNTech,, prev dose brand unknown=False,, prev dose lot number=EL0140,, prev dose lot unknown=False,, prev dose administration date=11Jan2021,, prev dose administration time=01:45,, PM, prev dose dose number=1,, prev dose vaccine location=Right arm}]), administration date: 11Jan2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Jan2021 11:45, outcome "unknown", described as "administration date=28Jan2021/dose number=2"; RASH (non-serious) with onset Feb2021, outcome "not recovered", described as "I developed a rash on my legs / Rash eventually covered most of my extremities"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "developed joint pain that migrated from one joint until another". The events "administration date=28jan2021/dose number=2", "i developed a rash on my legs / rash eventually covered most of my extremities" and "developed joint pain that migrated from one joint until another" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, arthralgia. No follow-up attempts are possible. No further information is expected.  Additional information: Patient developed a rash on my legs approximately two weeks after second vaccine. Rash eventually covered most of my extremities. About 4 months later she developed joint pain that migrated from one joint until another (rash subsided). Joint pain was resolved 8 months after vaccine, but rash returned and continues and it has now been 1 year since side effects began. Patient did not have COVID prior vaccination. Patient tested positive after vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Pruritus, Rash erythematous
Clinical narrative: Red rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 3rd January 2022, had a headache and arm soreness in the arm she got her vaccine in (right). For tolerance to 1st dose, refer case US2022AMR046820).   On 7th March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th March 2022, 1 days after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2022AMR046820  Additional details were provided as follows: The patient self-reported this case. The patient stated that, she got her second Shingrix vaccine in the right arm at her local pharmacy and the next day broke out with a red, itchy rash on both sides of her neck and torso. The rash was still present. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046820:Same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 3rd January 2022, had a headache and arm soreness in the arm she got her vaccine in (right). For tolerance to 1st dose, refer case US2022AMR046820).   On 7th March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th March 2022, 1 days after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2022AMR046820  Additional details were provided as follows: The patient self-reported this case. The patient stated that, she got her second Shingrix vaccine in the right arm at her local pharmacy and the next day broke out with a red, itchy rash on both sides of her neck and torso. The rash was still present. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046820:Same reporter.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Erythema, Peripheral swelling, Thrombosis
Clinical narrative: THREE BLOOD CLOTS ON LEFT ARM; SWELLING; REDNESS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 813490) concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, allergy to lidocaine, morphine and Ativan, gastro-esophageal reflux disease, arthritis, and chronic pain issues. Patient was not pregnant at the time of reporting. Patient never had any adverse event following any previous vaccine. There was no genetic/Hereditary pre-disposition to blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 11-MAR-2021 13:30 for an unspecified indication. Concomitant medications included alprazolam, fentanyl, hydrochlorothiazide/triamterene, immunoglobulin cytomegalovirus, and montelukast sodium.  On 19-APR-2021 at 15:00 the patient noticed three blood clots on left arm, swelling, and redness. The patient went to urgent care, at urgent care blood clots were diagnosed by sonogram. Laboratory data included: CT scan (Computed tomography) (NR: not provided) blood clots, and Sonogram (NR: not provided) blood clots. Treatment medications included: rivaroxaban (Xarelto). On 20-JAN-2022, patient visited the hematologist. Laboratory data included: Blood test (extensive blood testing) (NR: not provided) not reported. On an unspecified date, patient stopped taking Xarelto 20 mg (rivaroxaban) as per hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from three blood clots on left arm, swelling, and redness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220327363- covid-19 vaccine ad26.cov2.s-Three blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: THREE BLOOD CLOTS ON LEFT ARM; SWELLING; REDNESS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 813490) concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, allergy to lidocaine, morphine and Ativan, gastro-esophageal reflux disease, arthritis, and chronic pain issues. Patient was not pregnant at the time of reporting. Patient never had any adverse event following any previous vaccine. There was no genetic/Hereditary pre-disposition to blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 11-MAR-2021 13:30 for an unspecified indication. Concomitant medications included alprazolam, fentanyl, hydrochlorothiazide/triamterene, immunoglobulin cytomegalovirus, and montelukast sodium.  On 19-APR-2021 at 15:00 the patient noticed three blood clots on left arm, swelling, and redness. The patient went to urgent care, at urgent care blood clots were diagnosed by sonogram. Laboratory data included: CT scan (Computed tomography) (NR: not provided) blood clots, and Sonogram (NR: not provided) blood clots. Treatment medications included: rivaroxaban (Xarelto). On 20-JAN-2022, patient visited the hematologist. Laboratory data included: Blood test (extensive blood testing) (NR: not provided) not reported. On an unspecified date, patient stopped taking Xarelto 20 mg (rivaroxaban) as per hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from three blood clots on left arm, swelling, and redness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220327363- covid-19 vaccine ad26.cov2.s-Three blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Erythema, Swelling, Thrombosis
Clinical narrative: THREE BLOOD CLOTS ON LEFT ARM; SWELLING; REDNESS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 813490) concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, allergy to lidocaine, morphine and Ativan, gastro-esophageal reflux disease, arthritis, and chronic pain issues. Patient was not pregnant at the time of reporting. Patient never had any adverse event following any previous vaccine. There was no genetic/Hereditary pre-disposition to blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 11-MAR-2021 13:30 for an unspecified indication. Concomitant medications included alprazolam, fentanyl, hydrochlorothiazide/triamterene, immunoglobulin cytomegalovirus, and montelukast sodium.  On 19-APR-2021 at 15:00 the patient noticed three blood clots on left arm, swelling, and redness. The patient went to urgent care, at urgent care blood clots were diagnosed by sonogram. Laboratory data included: CT scan (Computed tomography) (NR: not provided) blood clots, and Sonogram (NR: not provided) blood clots. Treatment medications included: rivaroxaban (Xarelto). On 20-JAN-2022, patient visited the hematologist. Laboratory data included: Blood test (extensive blood testing) (NR: not provided) not reported. On an unspecified date, patient stopped taking Xarelto 20 mg (rivaroxaban) as per hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from three blood clots on left arm, swelling, and redness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220327363- covid-19 vaccine ad26.cov2.s-Three blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: THREE BLOOD CLOTS ON LEFT ARM; SWELLING; REDNESS; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 813490) concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, allergy to lidocaine, morphine and Ativan, gastro-esophageal reflux disease, arthritis, and chronic pain issues. Patient was not pregnant at the time of reporting. Patient never had any adverse event following any previous vaccine. There was no genetic/Hereditary pre-disposition to blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 11-MAR-2021 13:30 for an unspecified indication. Concomitant medications included alprazolam, fentanyl, hydrochlorothiazide/triamterene, immunoglobulin cytomegalovirus, and montelukast sodium.  On 19-APR-2021 at 15:00 the patient noticed three blood clots on left arm, swelling, and redness. The patient went to urgent care, at urgent care blood clots were diagnosed by sonogram. Laboratory data included: CT scan (Computed tomography) (NR: not provided) blood clots, and Sonogram (NR: not provided) blood clots. Treatment medications included: rivaroxaban (Xarelto). On 20-JAN-2022, patient visited the hematologist. Laboratory data included: Blood test (extensive blood testing) (NR: not provided) not reported. On an unspecified date, patient stopped taking Xarelto 20 mg (rivaroxaban) as per hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from three blood clots on left arm, swelling, and redness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220327363- covid-19 vaccine ad26.cov2.s-Three blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Burning sensation, Contusion, Dysphonia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Jul2021 15:00 (Lot number: EW0164) at the age of 57 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: she has allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose#1 Pfizer Covid 19 vaccine on 20Jun2021 in her right arm likely, around 3pm. lot EW0172, Route of administration: intramuscular), administration date: 20Jun2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "weird feeling in my mouth"; Flu shot (I got flu shot in Nov2020), administration date: Nov2020. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles"; CONTUSION (non-serious) with onset Jul2021, outcome "unknown", described as "I had bruising on top of both feet"; BACK PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 06Jan2022, outcome "recovering" and all described as "My R side upper back hurt & burned"; PYREXIA (non-serious) with onset 06Jan2022, outcome "recovered" (Jan2022), described as "Had a fever 101.00 for a day & half"; DYSPHONIA (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Then my voice was slow losing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster, back pain, burning sensation, dysphonia. Additional information: Caller states she has the Pfizer Covid-19 vaccine done at the hospital because she has allergies and her doctor said to go to the hospital and ended up with internal shingles 3 weeks ago. No prior vaccinations. (06Jan2022) My R side upper back hurt & burned. There was no bumps. Had a fever 101.00 for a day & half. The pain was ongoing. Then my voice was slow losing. Then I went to an urgent care on (10Jan2022). The Dr. diagnosed me with internal shingles. Dr. treated me with prednisone 20 and valacyclovir 1gm #21. After taking the meds for 2 days my voice came back. My pain in my back was going away slowly. Now I still have pain but not all the time. I think the shingles did nerve damage. I looked online and saw articles that people were getting shingles from getting the Covid shot. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Jul2021 15:00 (Lot number: EW0164) at the age of 57 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: she has allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose#1 Pfizer Covid 19 vaccine on 20Jun2021 in her right arm likely, around 3pm. lot EW0172, Route of administration: intramuscular), administration date: 20Jun2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "weird feeling in my mouth"; Flu shot (I got flu shot in Nov2020), administration date: Nov2020. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles"; CONTUSION (non-serious) with onset Jul2021, outcome "unknown", described as "I had bruising on top of both feet"; BACK PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 06Jan2022, outcome "recovering" and all described as "My R side upper back hurt & burned"; PYREXIA (non-serious) with onset 06Jan2022, outcome "recovered" (Jan2022), described as "Had a fever 101.00 for a day & half"; DYSPHONIA (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Then my voice was slow losing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster, back pain, burning sensation, dysphonia. Additional information: Caller states she has the Pfizer Covid-19 vaccine done at the hospital because she has allergies and her doctor said to go to the hospital and ended up with internal shingles 3 weeks ago. No prior vaccinations. (06Jan2022) My R side upper back hurt & burned. There was no bumps. Had a fever 101.00 for a day & half. The pain was ongoing. Then my voice was slow losing. Then I went to an urgent care on (10Jan2022). The Dr. diagnosed me with internal shingles. Dr. treated me with prednisone 20 and valacyclovir 1gm #21. After taking the meds for 2 days my voice came back. My pain in my back was going away slowly. Now I still have pain but not all the time. I think the shingles did nerve damage. I looked online and saw articles that people were getting shingles from getting the Covid shot. No follow-up attempts are possible. No further information is expected.