chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: had a case of break-through covid, confirmed today via rapid test at home.; had a case of break-through covid, confirmed today via rapid test at home.; fever up to 100 degrees; running nose; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and administration date 05Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jan2022, outcome "not recovered" and all described as "had a case of break-through covid, confirmed today via rapid test at home."; PYREXIA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "fever up to 100 degrees"; RHINORRHOEA (medically significant) with onset 07Jan2022, outcome "not recovered", described as "running nose"; FATIGUE (medically significant) with onset 07Jan2022, outcome "not recovered", described as "exhaustion". The events "had a case of break-through covid, confirmed today via rapid test at home.", "had a case of break-through covid, confirmed today via rapid test at home.", "fever up to 100 degrees", "running nose" and "exhaustion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (07Jan2022) upto 100 degree; sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, rhinorrhoea, fatigue. Consumer reported that, the patient received any other vaccines within 4 weeks prior to the COVID vaccine and patient received any other medications within 2 weeks of vaccination was unknown. Consumer stated that, the patient did not diagnosed with COVID-19 prior to vaccination and patient had been tested for COVID-19, since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Uveitis
Clinical narrative: uveitis; Eye pain evaluated by a dr.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "uveitis"; EYE PAIN (non-serious), outcome "unknown", described as "Eye pain evaluated by a dr.". The event "eye pain evaluated by a dr." was evaluated at the physician office visit. Eye pain was reported "weird and had never happened before.: Eye pain evaluated by a dr. For uveitis, but did not have.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller also reported AE for herself that she contracted the COVID 19 virus after her primary series before getting the booster dose of Pfizer BioNtech covid 19 vaccine.; Caller also reported AE for herself that she contracted the COVID 19 virus after her primary series before getting the booster dose of Pfizer BioNtech covid 19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller also reported AE for herself that she contracted the COVID 19 virus after her primary series before getting the booster dose of Pfizer BioNtech covid 19 vaccine."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Pain in extremity
Clinical narrative: receiving covid vaccine/ and 3 days recently due to covid; receiving covid vaccine/ and 3 days recently due to covid; pain in left calf since 05Jan2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a sponsored program (141003).  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral since Aug2021 (ongoing) (Batch/Lot number: unknown) at 5 mg 2x/day for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "receiving covid vaccine/ and 3 days recently due to covid"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022, outcome "recovered" (Jan2022), described as "pain in left calf since 05Jan2022". The action taken for tofacitinib citrate was unknown. Clinical Course: It was reported that missed therapy for 3 days (date unknown) prior to receiving covid vaccine, and 3 days due to covid (resumed Xeljanz today). No adverse events due to the missed doses of Xeljanz. Prescription per dispensing system states to take Xeljanz 5 mg two tablets by mouth one time a day, however patient was advised by md to take one 5mg tablet twice a day and no adverse events reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, the events COVID-19 and drug ineffective are assessed as possibly related to BNT162B2 and are unlikely related to tofacitinib. Given the current SARS-COV-2 pandemic in the country of incidence, there is an inherently higher risk of COVID-19 infection regardless of tofacitinib treatment. The case will be reassessed when additional information becomes available.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cutaneous lupus erythematosus, Gait disturbance, Immunisation, Memory impairment
Clinical narrative: Boostered; discoid Lupus; autoimmune deficient; I'm unable to walk that far; I can't remember if I started a whole new form all over again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the patient.  A 85 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 85 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: Covid- 19 vaccine (Dose 1 unknown manufacture), for Covid-19 immunization; Covid-19 vaccine (Dose 2 unknown manufacture), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Boostered"; CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "discoid Lupus"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune deficient"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I'm unable to walk that far"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I can't remember if I started a whole new form all over again".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: After both COVID vaccinations and booster, patient  tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough; After both COVID vaccinations and booster, patient  tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Lot number: FJ1620) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After both COVID vaccinations and booster, patient tested positive for COVID using PCR/symptoms of fatigue, sore throat, low grade fever and cough"; IMMUNISATION (medically significant) with onset 23Nov2021, outcome "unknown", described as "Booster dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Additional information: After both COVID vaccinations and booster, patient tested positive for COVID using PCR. Patient has symptoms of fatigue, sore throat, low grade fever and cough. Booster dose was 23Nov2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction, Inappropriate schedule of product administration, Throat tightness
Clinical narrative: Anaphylactic reaction; her throat begin to close; 1st:Sep2021,On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller also reports patient has history of asthma and allergies.; "Allergies" (unspecified if ongoing), notes: Caller also reports patient has history of asthma and allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Sep2021, when the patient was 18 years old, for Covid-19 immunization, reaction(s): "Anaphylactic reaction". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction"; THROAT TIGHTNESS (non-serious), outcome "unknown", described as "her throat begin to close"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st:Sep2021,On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine". The event "her throat begin to close" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: allergy test: (14Dec2021) she was not allergic to peg and polysorbate. Therapeutic measures were taken as a result of anaphylactic reaction, throat tightness. Clinical Course: On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine. Following the second dose within 35-40 min after they left the facility and got home her throat begin to close and again required an epi pen and went to the ER for treatment to open her throat. Caller reports no residual side effects. Her allergist thinks maybe it is a combination of PEG and polysorbate together. Patient mother reported that her daughter had experienced anaphylaxis after both doses due to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Nerve injury, Spinal cord injury
Clinical narrative: Nerve issues, spinal issues, joint issues; Nerve issues, spinal issues, joint issues; Nerve issues, spinal issues, joint issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: SPINAL CORD INJURY (disability, medically significant), NERVE INJURY (disability), JOINT INJURY (disability), outcome "unknown" and all described as "Nerve issues, spinal issues, joint issues". The event "nerve issues, spinal issues, joint issues", "nerve issues, spinal issues, joint issues" and "nerve issues, spinal issues, joint issues" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of spinal cord injury, nerve injury, joint injury. The patient had no other vaccine in four weeks. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient did not have Covid prior to vaccination, the patient was not tested for covid-19 post vaccination. If treatment ae: No The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Patient tested positive on 06Jan2022.; Patient tested positive on 06Jan2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cold urticaria" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks prior to vaccination. Vaccination history included: Covid19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "Patient tested positive on 06Jan2022.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 / covid test result=Positive; COVID-19 / covid test result=Positive; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 10:00 (Lot number: 33036BD) at the age of 31 years as dose 3 (booster), single, administered in arm left, administration date 23Apr2021 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 02Apr2021 (Lot number: EW0151) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "not recovered" and all described as "COVID-19 / covid test result=Positive"; IMMUNISATION (medically significant) with onset 03Jan2022 10:00, outcome "unknown", described as "dose received: 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Patient did not take other vaccine in four weeks and no covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Positive antigen tests for COVID-19; Positive antigen tests for COVID-19; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 31Dec2021 (Lot number: EF3594) as dose 3 (booster), single, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive antigen tests for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive; (09Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036498 Same reporter/drug/event, different patient
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: I tested positive for the coronavirus; I tested positive for the coronavirus; throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: GW0183) at the age of 26 years as dose 2, single and (Lot number: EEW0183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovering" and all described as "I tested positive for the coronavirus"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 05Jan2022, outcome "recovering", described as "throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive; (unspecified date) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, oropharyngeal discomfort. Clinical course: The patient had no taken other vaccine in four weeks and no other mediation in two weeks. The patient had no covid prior vaccination. The patient was tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Immunisation, Off label use, Product use issue
Clinical narrative: breakthrough covid-19 infection; breakthrough covid-19 infection; Dose number 3; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 14:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Mar2021 13:30 (Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 13:30 (Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 04Nov2021 13:30 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; LEVOTHYROXINE; VITAMIN D 2000; BABY ASPIRIN; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022 22:00, outcome "recovering" and all described as "breakthrough covid-19 infection"; IMMUNISATION (medically significant) with onset 04Nov2021 14:00, outcome "unknown", described as "Dose number 3"; PRODUCT USE ISSUE (medically significant), OFF LABEL USE (medically significant) all with onset 04Nov2021, outcome "unknown" and all described as "BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021". The patient underwent the following laboratory tests and procedures: covid-19 immunisation: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: breakthrough covid-19 infection; breakthrough covid-19 infection; Dose number 3; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 14:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Mar2021 13:30 (Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 11Feb2021 13:30 (Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 04Nov2021 13:30 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; LEVOTHYROXINE; VITAMIN D 2000; BABY ASPIRIN; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022 22:00, outcome "recovering" and all described as "breakthrough covid-19 infection"; IMMUNISATION (medically significant) with onset 04Nov2021 14:00, outcome "unknown", described as "Dose number 3"; PRODUCT USE ISSUE (medically significant), OFF LABEL USE (medically significant) all with onset 04Nov2021, outcome "unknown" and all described as "BNT162B2, administration date 04Nov2021/FLU VACCINE VII, administration date 04Nov2021". The patient underwent the following laboratory tests and procedures: covid-19 immunisation: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Muscle spasms, Muscle twitching
Clinical narrative: booster; left eye is constantly twitching; my lung is constantly spasm; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 070H21H) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "lung surgery" (unspecified if ongoing); "Langerhans cell Histiocytosis" (unspecified if ongoing); "sick" (unspecified if ongoing); "infected and had a severe lung problem" (unspecified if ongoing); "two type of pneumonia" (unspecified if ongoing); "rising of first type of COVID and I have" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE:1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization, reaction(s): "swelling at injection site"; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "left eye is constantly twitching"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "my lung is constantly spasm; muscle spasm". Therapeutic measures were not taken as a result of muscle twitching, muscle spasms.  Additional Information: The patient had a concern about what happened after she had her booster shot and her son first shot. They think they had the same thing that happened with little bit odd on both. When asked if you both had the shot patient stated, Yes, she have been fully vaccinated with the first booster and her son had his first shot. When asked want to anything about it patient stated, was this normal to all of this sudden like her left eye was constantly twitching or had like muscle spasm in her body. Patient stated, It was also due to the fact that she had the lung surgery right before COVID and she mean, she had been in a breakout and she had her surgery and her lung was constantly spasm. The patient stated, she got sick right before COVID broke out, infected and had a severe lung problem, two type of pneumonia and all this kind of surgery before from the rising of first type of COVID. The patient stated, she had, she was not sure. When probed for any further help patient further stated, no, that was just it, she was just wonder if this was one normal to have like that muscle spasm they know in her body and because her eye or same eye her both of her eye constantly twitching and it has still not stopped.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036315 Same patient and drug, different event separated in time;US-PFIZER INC-202200036495 Same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: when she was given a dose of the Pfizer vaccine for Covid-19, her throat closed.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "when she was given a dose of the Pfizer vaccine for Covid-19, her throat closed."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, SARS-CoV-2 test
Clinical narrative: started  having symptoms on 30DEC2021/tested positive on 01 Jan 2022; lightheaded/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: FL0007) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 30Dec2021, outcome "not recovered", described as "started having symptoms on 30DEC2021/tested positive on 01 Jan 2022"; DIZZINESS (non-serious) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "lightheaded/dizzy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19, dizziness.  Additional information: The patient started symptoms on 30Dec2021 and tested positive on 01Jan2022. The patient was scheduled for his second dose on 21Jan2022. Reporter was asking if patient needs to test negative before getting the second dose.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has tested positive for the virus twice. And have received both vaccine doses.; she has tested positive for the virus twice. And have received both vaccine doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: positive for covid 19 for the second time. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she has tested positive for the virus twice. And have received both vaccine doses.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; positive. Clinical course reported as my girlfriend is positive for COVID 19 for the second time, she has tested positive for the virus twice and have received both vaccine doses.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID; Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive antigen tests for COVID-19/ had 2 Pfizer/BionTech vaccines-has COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200035829 Same reporter/RA, Different patient/AE
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; Acute Respiratory Failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FH8028) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tape" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; APIXABAN; PREDNISONE; ALLOPURINOL. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol". Vaccination history included: Bnt162b2 (Dose number: 02, Administration Date: 21Jan2021, Lot No.: EL8982), administration date: 21Jan2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Acute respiratory failure", "Multiple unprovoked bilateral Pulmonary embolisms"; Bnt162b2 (Dose number: 01, Administration Date: 07Jan2021, Lot No.: EL3246), administration date: 07Jan2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization, life threatening) with onset 11Dec2021, outcome "not recovered", described as "Acute Respiratory Failure"; IMMUNISATION (medically significant) with onset 03Dec2021, outcome "unknown", described as "booster". The patient was hospitalized for acute respiratory failure (start date: 11Dec2021, hospitalization duration: 16 day(s)). The event "acute respiratory failure" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Dec2021) negative; (26Dec2021) negative. Therapeutic measures were taken as a result of acute respiratory failure. No other vaccine in four weeks. Clinical course: I received my last vaccine (injection #02) on 21Jan2021. On 27Jan2021 I was admitted to the hospital with acute respiratory failure. In Jul2021 I was admitted for multiple unprovoked bilateral Pulmonary embolisms. On 03Dec2021 I received my booster (injection #03). On 11Dec2021 I was again admitted to the hospital for Acute Respiratory Failure. Prior to the vaccines, I have never had any lung or respiratory issues. Now, I have to have supplemental O2. Adverse event start date: 27Jan2021. Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. No days hospitalization: 16. AE treatment: Supplemental O2 at home, Lifetime Eliquis for PE's. No covid prior vaccination. Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: fully vaccinated and tested Covid positive; fully vaccinated and tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Clinical Course: The patient was fully vaccinated. She tested negative three times in the last week (Jan2022). On 03Jan2022, she tested negative after the two minute rapid test. On 05Jan2022, she thinks that she had the PCR test and that was negative. She stated that she was not feeling good. On 06Jan2022, she took another rapid 15 minute test that was negative. She stated that over the weekend she was feeling sick and had an appointment today (10Jan2022) at 9:45 and got her results where she tested Covid positive today (10Jan2022). She inquired when is the soonest she can schedule for a booster dose of the Pfizer covid vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "fully vaccinated and tested Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: the 2-minute rapid test on Monday was negative; (06Jan2022) negative, notes: the 15-minute rapid test on Thursday was negative; (10Jan2022) positive, notes: Covid positive after she tested negative three times in the last week; (05Jan2022) negative, notes: PCR test on Wednesday was negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; 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 male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported he was due for his second dose on 13Jan2022 and stated he recently tested positive for COVID. The patient wanted to know if he tested negative before or by the date of the second vaccine could he get the second dose or should he wait longer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: My period was irregular; It lasted for 10-14 days since first day of period; delayed for  more than 7 days, about 10 days; my period completely stooped; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 18:00 (Lot number: EN8727) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Postpatum Depression, depression" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 18:00), administration date: 01Mar2021, when the patient was 45-years-old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (disability) with onset 31Mar2021, outcome "not recovered", described as "My period was irregular"; HEAVY MENSTRUAL BLEEDING (disability) with onset 31Mar2021, outcome "not recovered", described as "It lasted for 10-14 days since first day of period"; MENSTRUATION DELAYED (disability) with onset 31Mar2021, outcome "not recovered", described as "delayed for  more than 7 days, about 10 days"; AMENORRHOEA (disability) with onset 31Mar2021, outcome "not recovered", described as "my period completely stooped". The patient reported her period was irregular since Mar2021, the month she had her COVID-19 vaccine. It lasted for 10-14 days since first day of period; sometimes lasted for 5 days. It was delayed for more than 7 days, about 10 days. Six months after injection, her period completely stopped. Her mom had menopause at 52-years-old. The patient didn't have other menopause symptoms besides stopped period. The events "my period was irregular", "it lasted for 10-14 days since first day of period", "delayed for  more than 7 days, about 10 days" and "my period completely stooped" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, menstruation delayed, amenorrhoea. Since the vaccine, the patient was not tested for COVID-19.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough case of Covid-19 infection; Breakthrough case of Covid-19 infection; mild sore throat; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EL3247) at the age of 44 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, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 10Feb2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 10Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 10Jan2022, outcome "not recovered" and all described as "Breakthrough case of Covid-19 infection"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jan2022, outcome "not recovered", described as "mild sore throat"; PAIN (non-serious) with onset 10Jan2022, outcome "not recovered", described as "aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab; (10Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain, pain.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pulmonary embolism
Clinical narrative: acute respiratory failure; Pulmonary embolisms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Jan2021 (Lot number: EL8982) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tape" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; APIXBAN; PREDNISONE; ALLOPURINOL. Past drug history included: Known allergies: demerol, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose: 1, product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EL3246,, lot unknown=False,, administration date=07Jan2021,, dose number=1,, vaccine location=Left arm), administration date: 07Jan2021, for COVID-19 immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization, life threatening) with onset 27Jan2021, outcome "not recovered", described as "acute respiratory failure"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 27Jan2021, outcome "not recovered", described as "Pulmonary embolisms". The patient was hospitalized for acute respiratory failure (start date: 11Dec2021, hospitalization duration: 16 day(s)); for pulmonary embolism (start date: Jul2021, hospitalization duration: 16 day(s)). The events "acute respiratory failure" and "pulmonary embolisms" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of acute respiratory failure, pulmonary embolism. Clinical course: No other vaccine in four weeks. I received my last vaccine (injection #02) on 21Jan2021. On 27Jan2021 I was admitted to the hospital with acute respiratory failure. In Jul2021 I was admitted for multiple unprovoked bilateral Pulmonary embolisms. On 03Dec2021 I received my booster (injection #03). On 11Dec2021 I was again admitted to the hospital for Acute Respiratory Failure. Prior to the vaccines, I have never had any lung or respiratory issues. Now, I have to have supplemental O2. Adverse event start date: 27Jan2021. Ae resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No days hospitalization: 16. Patient was not Recovered. AE treatment included Supplemental O2 at home, Lifetime Eliquis for PE's. No covid prior vaccination. Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Feeling abnormal
Clinical narrative: feels weird; feelings of anxiousness; blood pressure it's a little high 143/92; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA410476.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose number known, single for covid-19 immunisation; dupilumab (DUPILUMAB), administration date 03Dec2021 (Batch/Lot number: unknown) as 300 mg. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feels weird"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "feelings of anxiousness"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "blood pressure it's a little high 143/92". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was unknown.  Additional information: As per the reporter on 03Nov2021 the patient developed a non-serious event feels weird (feeling abnormal), feeling of anxiousness (anxiety), blood pressure and it was a little high 143/92 (blood pressure increased). Action taken with Dupilumab (Dupixent) and Tozinameran (Pfizer BioNTech Covid-19 vaccine) was unknown for all events (feels weird, feelings of anxiousness, blood pressure and it's a little high 143/92). It was not reported if the patient received a corrective treatment for the events (feels weird, feelings of anxiousness, blood pressure and it's a little high 143/92).  The lot number for bnt162b2 was not provided and will be requested during follow up.