chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: high fever of 103; body aches; joint aches; Lymph in right armpit were swollen; rash all over body; odd pain in hands; ghost pain in injection site; always tired; foggy brain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Jan2022 12:00 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: Unknown. N/a, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown. N/a, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "high fever of 103"; PAIN (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "body aches"; ARTHRALGIA (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "Lymph in right armpit were swollen"; RASH (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "rash all over body"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "odd pain in hands"; VACCINATION SITE PAIN (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "ghost pain in injection site"; FATIGUE (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "always tired"; FEELING ABNORMAL (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "foggy brain". Therapeutic measures were not taken as a result of pyrexia, pain, arthralgia, lymphadenopathy, rash, pain in extremity, vaccination site pain, fatigue, feeling abnormal.  Additional information: Patient had not received any other vaccines within 4 weeks before COVID vaccine. Patient had not diagnosed with COVID-19 before and after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash, Vaccination site pain
Clinical narrative: high fever of 103; body aches; joint aches; Lymph in right armpit were swollen; rash all over body; odd pain in hands; ghost pain in injection site; always tired; foggy brain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Jan2022 12:00 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: Unknown. N/a, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 12Mar2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown. N/a, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "high fever of 103"; PAIN (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "body aches"; ARTHRALGIA (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "Lymph in right armpit were swollen"; RASH (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "rash all over body"; PAIN IN EXTREMITY (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "odd pain in hands"; VACCINATION SITE PAIN (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "ghost pain in injection site"; FATIGUE (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "always tired"; FEELING ABNORMAL (non-serious) with onset 21Jan2022 12:00, outcome "recovered with sequelae", described as "foggy brain". Therapeutic measures were not taken as a result of pyrexia, pain, arthralgia, lymphadenopathy, rash, pain in extremity, vaccination site pain, fatigue, feeling abnormal.  Additional information: Patient had not received any other vaccines within 4 weeks before COVID vaccine. Patient had not diagnosed with COVID-19 before and after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she started itching all over her body.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "she started itching all over her body.".  Additional information: Caller said she had her Pfizer covid vaccine last Sep2021, then after 3 months, on Dec2021 she started itching all over her body. Caller would want to know if it's normal to take that long for the side effects to manifest. Also states, it turned out to be No more tomatoes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4564946 (Genentech, Inc.).  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: rash; immense pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "not recovered", described as "rash"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "immense pains".  Additional information: The COVID vaccine had immense side effect to the patient's health humanity since last year the patient had been in talks to send letters to the office.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Exposure via breast milk, Irritability, Lethargy, Nasopharyngitis
Clinical narrative: My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; He is also displaying signs of lethargy and irritability; He is also displaying signs of lethargy and irritability; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 03Mar2022 13:15 (Lot number: FK 9729) as dose 2, single for covid-19 immunisation. The mother of the patient was 30 years old at the time of vaccination. The mother's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK 9729, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 10Feb2022. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), PYREXIA (non-serious), NASOPHARYNGITIS (non-serious) all with onset 04Mar2022, outcome "recovering" and all described as "My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination"; LETHARGY (non-serious), IRRITABILITY (non-serious) all with onset 04Mar2022, outcome "recovering" and all described as "He is also displaying signs of lethargy and irritability". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of exposure via breast milk, pyrexia, nasopharyngitis, lethargy, irritability.  Additional information: No seriousness criteria resulted in death and was not life threatening not caused/prolonged hospitalization. Had no disabling/incapacitating and no congenital anomaly/birth defect. Reporter breastfed son following the vaccination with cdc and hcp recommendations saying it was safe to do so. Had not taken treatment prior vaccination not tested covid post vaccination. Had no known allergies and no medical history.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200364278 mother/baby.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination; He is also displaying signs of lethargy and irritability; He is also displaying signs of lethargy and irritability; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 03Mar2022 13:15 (Lot number: FK 9729) as dose 2, single for covid-19 immunisation. The mother of the patient was 30 years old at the time of vaccination. The mother's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK 9729, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 10Feb2022. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), PYREXIA (non-serious), NASOPHARYNGITIS (non-serious) all with onset 04Mar2022, outcome "recovering" and all described as "My 10 month old breastfed son acquired a 102.4 fever the 2nd day following the 2nd dose of my Pfizer vaccination along with cold symptoms that were present upon the 1st day following the 2nd dose of Pfizer vaccination"; LETHARGY (non-serious), IRRITABILITY (non-serious) all with onset 04Mar2022, outcome "recovering" and all described as "He is also displaying signs of lethargy and irritability". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of exposure via breast milk, pyrexia, nasopharyngitis, lethargy, irritability.  Additional information: No seriousness criteria resulted in death and was not life threatening not caused/prolonged hospitalization. Had no disabling/incapacitating and no congenital anomaly/birth defect. Reporter breastfed son following the vaccination with cdc and hcp recommendations saying it was safe to do so. Had not taken treatment prior vaccination not tested covid post vaccination. Had no known allergies and no medical history.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200364278 mother/baby.
Sex: U
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: rash; felt like rope burn; fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles once" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer/BioNTech Covid-19 Vaccine Details: , Dose: 1, Date: 08Mar2021, Time: Noon, Site and Route of administration: Right arm, Route of administration: Intramuscular, Batch/Lot Number: EN6199), administration date: 08Mar2021, for Covid-19 immunization, reaction(s): "throat was closing", "couldn't swallow". The following information was reported: RASH (non-serious), outcome "unknown", described as "rash"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "felt like rope burn"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: I provided all test dates/times on Pfizer website. 1st vaccine in (City, State). Felt like throat was closing pulled over onside of road. I was driving could not swallow that was after waiting 15 min in the Pharmacy. 2nd vaccine (Name) ended up with a rash photo enclosed. Felt like rope burn. Had a fever and chills. Contacted my Physician(Name). 3rd vaccine Booster same types of hives on head. Hair fall- out on the top of head- went to derm. Prescribed foam topical steroid. My hair was always extremely thick- no gray. Before getting booster I asked my GP/FP an Internal medicine to take blood and let me know what my levels were. I believe he said 380, (Name), My affiliated with (Name) Hospital. Before going in May I am supposed to get another booster. I didn't see to do well with mRNA.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: rash; felt like rope burn; fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles once" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer/BioNTech Covid-19 Vaccine Details: , Dose: 1, Date: 08Mar2021, Time: Noon, Site and Route of administration: Right arm, Route of administration: Intramuscular, Batch/Lot Number: EN6199), administration date: 08Mar2021, for Covid-19 immunization, reaction(s): "throat was closing", "couldn't swallow". The following information was reported: RASH (non-serious), outcome "unknown", described as "rash"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "felt like rope burn"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: I provided all test dates/times on Pfizer website. 1st vaccine in (City, State). Felt like throat was closing pulled over onside of road. I was driving could not swallow that was after waiting 15 min in the Pharmacy. 2nd vaccine (Name) ended up with a rash photo enclosed. Felt like rope burn. Had a fever and chills. Contacted my Physician(Name). 3rd vaccine Booster same types of hives on head. Hair fall- out on the top of head- went to derm. Prescribed foam topical steroid. My hair was always extremely thick- no gray. Before getting booster I asked my GP/FP an Internal medicine to take blood and let me know what my levels were. I believe he said 380, (Name), My affiliated with (Name) Hospital. Before going in May I am supposed to get another booster. I didn't see to do well with mRNA.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: He has been complaining about nausea; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2022 (Lot number: 33036bd) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: NAUSEA (non-serious) with onset Feb2022, outcome "not recovered", described as "He has been complaining about nausea"; FATIGUE (non-serious) with onset Feb2022, outcome "not recovered", described as "Fatigue". The events "he has been complaining about nausea" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, fatigue.  Additional Information: Pfizer Safety hopes that the child is feeling much better. Thank you for reporting the below information to safety on (SRD) 10Mar2022, with the first Pfizer Awareness Date (PRD) 23Feb2022. Since the information was reporting outside of the 24-hour compliance period for AE reporting we are actioned to follow-up on the delayed AE report. Please provide a reason for the delay in reporting and confirm completion of AE reporting training. Please also confirm understanding reporting responsibilities and the compliance timelines. We file this in the event that the documentation is required during an audit.  Response: Something I didn't specifically say in the report is that (Name) is my son. The reason for the delay is distinguishing between expected immune response to the vaccine and an adverse event. So while I listed the date he got the vaccination as the date of the adverse event I did not view it as that on 23Feb. I viewed what was happening as the expected immune response. Defining the date when I first became aware of the event wasn't straight forward so I just picked the day he got the 2nd dose of the vaccine. What triggered me to report it as an adverse event is when he came home on 10Mar and told me about his sharp pain because that seemed to be going the wrong way in recovering.  Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not received any other vaccine within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Ibuprofen. Treatment received for adverse event was prescribed antacid and referral to GI specialist. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. No medical history.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: pediatric dose undiluted was given to an adult; pediatric dose undiluted was given to an adult; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 10Mar2022 (Lot number: FL0007, Expiration Date: 28Mar2022) as dose 1, 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant), PRODUCT  PREPARATION ERROR (medically significant) all with onset 10Mar2022 and all described as "pediatric dose undiluted was given to an adult".  Additional Information: The pharmacist made a mistake yesterday and gave a pediatric dose to an adult. They got 0.3 ml for pediatric dose but it was undiluted. The pharmacist was thinking it was Pfizer adult vial that doesn't need to be diluted so the pharmacist was just calling to see what recommendation Pfizer has if that happened.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: recently diagnosed with a small case of pulmonary embolism; This is a spontaneous report received from non-contactable reporter (Consumer) from a sales representative. A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that her mother was recently diagnosed with a small case of pulmonary embolism (medically significant) with outcome of unknown. She's fine and the doctors seem to have overreacted a bit, but it gave us a scare for a little while. The reporter knows the chance of this being related to the vaccine is infinitesimally small, but just in case, the reporter inquired it Pfizer has done any analysis of the vaccine related thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 89 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 89 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), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "she developed a blood clot in her leg 2 months ago". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Urticaria
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 (Lot number: ER8735) at the age of 51 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Poultry" (unspecified if ongoing). The patient took concomitant medications which included birth control. Vaccination history included: Bnt162b2 (Dose 1, single, Lot No: FO7218, administered in Arm Left), administration date: 23Apr2021, when the patient was 51 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot No: EW0182, administered in Arm Left), administration date: 14May2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (medically significant) with onset 01Feb2022, outcome "not recovered", described as "broke out in hives"; INSOMNIA (medically significant) with onset 01Feb2022, outcome "not recovered", described as "sleeping 3-4 hours a day". The events "broke out in hives" and "sleeping 3-4 hours a day" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, insomnia which included Benadryl and prednisone. Course of events: A few weeks after her booster, the patient broke out in hives. The hives have not stopped and have gotten severe now every day. They are on her forehead, face, eye lids, ears, entire neck and all the way both arms/hands/palms, her back/bottom, her chest all the way to her lady parts, entire legs/ feet and bottom of her feet. She was rushed to the ER on Wednesday this week and had to get it to give Benadryl and prednisone. This is her 3rd round of prednisone during the 7 weeks. The medicine is not enough to get her through 24 hours, so she was sleeping 3-4 hours a day. She took 2 Benadryl pills at night but that gives her about 3 hours to sleep before that wears off and she woke up half covered again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Aldolase, Biopsy muscle, Blood creatine phosphokinase, Blood immunoglobulin G, Eosinophil count
Clinical narrative: This is a literature report for the following literature source(s): "EARLY DIAGNOSIS OF EOSINOPHILIC FASCIITIS IN A 16 YEAR-OLD FEMALE", Annals of Allergy, Asthma and Immunology., 2021; Vol:127 (5 Suppl.), pgs:S119, DOI:10.1016/j.anai.2021.08.378. A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing); "food allergies" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EOSINOPHILIC FASCIITIS (medically significant), outcome "recovering", described as "Eosinophilic fasciitis". The patient underwent the following laboratory tests and procedures: aldolase: 15.6 IU/l, notes: elevated, biopsy muscle: demonstrated inflammatory myofasciitis consistent, notes: with EF; blood creatine phosphokinase: normal; blood immunoglobulin g: positive, notes: positive Toxocara serology; eosinophil count: 2130 cells/uL, notes: eosinophilia; investigation: was unremarkable; laboratory test: remarkable for eosinophilia, notes: (2130 cells/uL), elevated aldolase (15.6 U/L), and normal creatinine kinase; magnetic resonance imaging: showed fasciitis. Therapeutic measures were taken as a result of eosinophilic fasciitis. Sender's Comments: Based on the currently available information the possibility of causal association between the event Eosinophilic fasciitis and the suspect drug BNT162B2 cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Eosinophilic fasciitis, Investigation, Laboratory test, Magnetic resonance imaging
Clinical narrative: This is a literature report for the following literature source(s): "EARLY DIAGNOSIS OF EOSINOPHILIC FASCIITIS IN A 16 YEAR-OLD FEMALE", Annals of Allergy, Asthma and Immunology., 2021; Vol:127 (5 Suppl.), pgs:S119, DOI:10.1016/j.anai.2021.08.378. A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing); "food allergies" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EOSINOPHILIC FASCIITIS (medically significant), outcome "recovering", described as "Eosinophilic fasciitis". The patient underwent the following laboratory tests and procedures: aldolase: 15.6 IU/l, notes: elevated, biopsy muscle: demonstrated inflammatory myofasciitis consistent, notes: with EF; blood creatine phosphokinase: normal; blood immunoglobulin g: positive, notes: positive Toxocara serology; eosinophil count: 2130 cells/uL, notes: eosinophilia; investigation: was unremarkable; laboratory test: remarkable for eosinophilia, notes: (2130 cells/uL), elevated aldolase (15.6 U/L), and normal creatinine kinase; magnetic resonance imaging: showed fasciitis. Therapeutic measures were taken as a result of eosinophilic fasciitis. Sender's Comments: Based on the currently available information the possibility of causal association between the event Eosinophilic fasciitis and the suspect drug BNT162B2 cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Blood pressure measurement, Fatigue, Headache, Hypotension
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Jul2021 16:00 (Lot number: EW0217) at the age of 19 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Adhesive allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. There were no concomitant medications. Past drug history included: Ubrelvy, reaction: "drug allergy". Vaccination history included: BNT162B2 (dose 1, single, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 25Jun2021, when the patient was 19 years old, for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 28Oct2021, outcome "not recovered", described as "neuropathy"; HYPOTENSION (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Low blood pressure"; TACHYCARDIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "tachycardia"; HEADACHE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "headaches"; FATIGUE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "fatigue"; TEMPERATURE INTOLERANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "temperature intolerance"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "dysautonomia". The events "neuropathy", "low blood pressure", "tachycardia", "headaches", "fatigue", "temperature intolerance" and "dysautonomia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 PCR test: (08Feb2022) negative, notes: Nasal Swab; blood pressure: (28Oct2021) low. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, hypotension, tachycardia, headache, fatigue, temperature intolerance, autonomic nervous system imbalance. Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test, Tachycardia, Temperature intolerance
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Jul2021 16:00 (Lot number: EW0217) at the age of 19 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Adhesive allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. There were no concomitant medications. Past drug history included: Ubrelvy, reaction: "drug allergy". Vaccination history included: BNT162B2 (dose 1, single, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 25Jun2021, when the patient was 19 years old, for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 28Oct2021, outcome "not recovered", described as "neuropathy"; HYPOTENSION (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Low blood pressure"; TACHYCARDIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "tachycardia"; HEADACHE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "headaches"; FATIGUE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "fatigue"; TEMPERATURE INTOLERANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "temperature intolerance"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "dysautonomia". The events "neuropathy", "low blood pressure", "tachycardia", "headaches", "fatigue", "temperature intolerance" and "dysautonomia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 PCR test: (08Feb2022) negative, notes: Nasal Swab; blood pressure: (28Oct2021) low. It was unknown if therapeutic measures were taken as a result of neuropathy peripheral, hypotension, tachycardia, headache, fatigue, temperature intolerance, autonomic nervous system imbalance. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Neck pain, Omphalitis
Clinical narrative: Infection in belly button; Fatigue; Muscle pain; Neck pain; Chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 14:00 (Lot number: FJ1614) as dose 1, single and administered in arm left, single for covid-19 immunisation, administered at Pharmacy or Drug Store.  The patient had no relevant medical history. Known allergies: None. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) received within 2 weeks of vaccination included: Multi vitamins, CALCIUM; OMEPRAZOLE. The following information was reported: OMPHALITIS (medically significant) with onset 16Feb2022, outcome "recovered" (2022), described as "Infection in belly button"; FATIGUE (non-serious) with onset 16Feb2022, outcome "not recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 16Feb2022, outcome "not recovered", described as "Muscle pain"; NECK PAIN (non-serious) with onset 16Feb2022, outcome "not recovered", described as "Neck pain"; CHILLS (non-serious) with onset 16Feb2022, outcome "recovered" (2022), described as "Chills". Therapeutic measures were taken as a result of omphalitis, fatigue, myalgia, neck pain, chills: treatment received with OTC Tylenol and anti fungal cream. Since the vaccination, the patient has not been tested for COVID-19. The patient further received bnt162b2 (BNT162B2), administration date 07Mar2022 13:00 (Lot number: FK9896) as dose 2, single for covid-19 immunisation. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer) from Medical Information Team. The reporter is the parent. A 68-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) as dose 3 (booster), single (lot number unknown), as dose 2, single (lot number unknown) and as dose 1, single (lot number unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot in the right leg". Clinical course: It was reported that the patient was diagnosed with a blood clot in the right leg, and he had just found out. The patient had all three doses. The reporter (patient's mother) stated that they have heard of several people getting blood clots after getting this vaccine; and then asked if Pfizer COVID-19 vaccine causes blood clots. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea
Clinical narrative: Stomach ache; sharp pain in his chest; couldn't breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 21Feb2022 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; CHEST PAIN (non-serious), outcome "unknown", described as "sharp pain in his chest"; DYSPNOEA (non-serious), outcome "unknown", described as "couldn''t breathe". The events "stomach ache", "sharp pain in his chest" and "couldn't breathe" were evaluated at the emergency room visit.Reporter had to call the 911 and they came and they took patient to the hospital and that was like around probably 06:30 pm. They took him to the hospital and was released like 11 or 11:30 pm. Reporter stated that when they took him to the hospital, they gave him something to drink medicine but reporter was not sure what it was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Headache, Hypersomnia, Malaise
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: SOKS16, Expiration Date: 31Aug2021) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHANTIX taken for smoking cessation therapy. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "First shot didn't hurt him that bad. It didn't really affect him". The following information was reported: CEREBRAL DISORDER (medically significant), outcome "unknown", described as "His brain just burned"; HEADACHE (non-serious), outcome "recovered", described as "headache"; MALAISE (non-serious), outcome "unknown", described as "He was just sick"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Couldn't stop sleeping and sleeping". Course of events: The second shot he got was when he was taking the Chantix as well. He got a headache that last about 3 days. He was like sick but not sick. He was just sick. It is hard to explain. His brain just burned for like 3 days after the second COVID shot. That is when he was taking the Chantix pills too. All of it burned his brain. The whole thing screwed him up. He couldn't stop sleeping and sleeping.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Frustration tolerance decreased, Investigation, Pulmonary embolism, Scan
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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, lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot number: unknown), for Covid-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "Pulmonary embolisms in both lungs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad for many days"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "very frustrated". The patient underwent the following laboratory tests and procedures: investigation: unknown results; scan: unknown results. Therapeutic measures were taken as a result of pulmonary embolism, feeling abnormal, frustration tolerance decreased. Clinical course: "I received both vaccines and a booster. After the booster I felt bad for many days and a few weeks later was diagnosed with pulmonary embolisms in both lungs. I had not had COVID and after many tests and scans, there are no reasons for me to have them. It appears I got them because of the booster. I am very frustrated and could have had a stroke or died. I have spent thousands of dollars for treatment." The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: partial paralysis of the right side of my face/Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6200) at the age of 22 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; lot EL9265), administration date: 08Feb2021, when the patient was 22 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (disability) with onset 01Mar2021, outcome "recovered with sequelae", described as "partial paralysis of the right side of my face/Bells Palsy". The event "partial paralysis of the right side of my face/bells palsy" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy included doxycycline, and methylprednisolone.  Additional information: It was reported that the patient had no covid prior vaccination and was not covid tested post vaccination. Patient had no known allergies. It was reported that after her second dose, she had partial paralysis of the right side of her face. The day after she got the second dose, she called her dermatologist and they told her to go to the ER. Once she arrived, the stroke team ruled out having a stroke. She was diagnosed with having Bells Palsy and the doctors believed it was caused by the Pfizer vaccine. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. The patient received 3rd dose of Pfizer vaccine on 28Dec2021 (lot FJ1611).  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: Rare spotting in between periods; No period for 3+ months; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: Ew0187) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PANTOPRAZOLE; CETIRIZINE. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Rare spotting in between periods"; AMENORRHOEA (non-serious), outcome "unknown", described as "No period for 3+ months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that no other vaccine received in four weeks. The patient did not have covid prior vaccination. The patient had been on birth control for 15 years with very regular periods, rare spotting in between periods on continuous method after no period for 3+ months. She was bleeding 2 weeks after her last period. Still on birth control and always had been taken regularly with no problems in 15 years.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Condition aggravated, Dyspnoea
Clinical narrative: On 5/5/21 I went to the Emergency Room because I was experiencing non stop heart palpitations with a shortness of breath.  The palpitations woke me from my sleep.  I had experienced the shortness of breath before receiving the vaccine.   However, I had never felt heart palpitations as intense and frightening as this before.  My heart was racing non stop when I was lying still in bed, for several hours and after awakening.  I then was advised to go to the ER.