chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immunisation, Interchange of vaccine products, Loss of consciousness
Clinical narrative: vomited several times; nauseous; headache; passed out; dizziness; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8762) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's 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. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. Past drug history included: Allergies: zpack, reaction(s): "Drug allergy". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 006C21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 41 years old, for COVID-19 immunization; Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 017B21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Dec2021 08:30, outcome "recovering", described as "passed out"; IMMUNISATION (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "Interchange of vaccine products"; DIZZINESS (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 14Dec2021 10:45, outcome "recovering", described as "vomited several times"; NAUSEA (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "nauseous"; HEADACHE (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "headache". Around 8:30AM on 14Dec2021 during hand PT the patient passed out. Made it home and then around 10:45AM she vomited several times. Still feeling nauseous, headache, and dizziness. Therapeutic measures were taken as a result of loss of consciousness, dizziness, vomiting, nausea, headache, treatment received at PT office which got her legs up and cold compress.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomited several times; nauseous; headache; passed out; dizziness; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8762) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's 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. The patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. Past drug history included: Allergies: zpack, reaction(s): "Drug allergy". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 006C21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 41 years old, for COVID-19 immunization; Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 017B21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 14Dec2021 08:30, outcome "recovering", described as "passed out"; IMMUNISATION (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Dec2021 09:00, outcome "unknown", described as "Interchange of vaccine products"; DIZZINESS (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "dizziness"; VOMITING (non-serious) with onset 14Dec2021 10:45, outcome "recovering", described as "vomited several times"; NAUSEA (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "nauseous"; HEADACHE (non-serious) with onset 14Dec2021 08:30, outcome "recovering", described as "headache". Around 8:30AM on 14Dec2021 during hand PT the patient passed out. Made it home and then around 10:45AM she vomited several times. Still feeling nauseous, headache, and dizziness. Therapeutic measures were taken as a result of loss of consciousness, dizziness, vomiting, nausea, headache, treatment received at PT office which got her legs up and cold compress.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Headache, Immunisation, Pain in jaw, Photosensitivity reaction
Clinical narrative: Started with headache within 24 hrs of/HA all over/ Throbbing and sharp; some sensitivity to light; sore in jaw; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other healthcare professional: Nurse). The reporter is the parent.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Dec2021 13:15 (Lot number: FE3594) at the age of 17 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "known allergies: environmental allergies" (unspecified if ongoing); "known allergies: seasonal allergies" (unspecified if ongoing); "Cramps" (unspecified if ongoing). 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 been tested for COVID-19. Concomitant medication(s) included: ADVIL [IBUPROFEN], 200 mg, as needed, orally, taken for muscle spasms; CETRIZINE, 10 mg, 1x/day, orally; SERTRALINE, 12.5 mg, 1x/day, orally. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Apr2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 09Dec2021 13:15, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Started with headache within 24 hrs of/HA all over/ Throbbing and sharp"; PHOTOSENSITIVITY REACTION (non-serious) with onset 10Dec2021, outcome "unknown", described as "some sensitivity to light"; PAIN IN JAW (non-serious) with onset 10Dec2021, outcome "unknown", described as "sore in jaw". The events "started with headache within 24 hrs of/ha all over/ throbbing and sharp", "some sensitivity to light" and "sore in jaw" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram head: (Dec2021) unknown results.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Vaccination site pain
Clinical narrative: sore arm at injection site; headache; fatigue; booster; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 13:15 (Lot number: fh8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Time of administration: 13:00, Anatomical location: Arm Left, Batch/Lot No: ep6955), administration date: 31Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "muscle aches", "chills"; Bnt162b2 (Dose Number: 1, Batch/Lot No: el3247), administration date: 10Mar2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 13:15, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 14Dec2021 06:30, outcome "recovering", described as "sore arm at injection site"; HEADACHE (non-serious) with onset 14Dec2021 06:30, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 14Dec2021 06:30, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered was noted as workplace clinic. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine and list of any other medications, the patient received within 2 weeks of vaccination was noted as no.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymph node pain, Pain, Pyrexia
Clinical narrative: booster; Sore underarm (lymph node); Chills; Fever; Body ache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection) (Lot number: FH8030) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; LYMPH NODE PAIN (non-serious), outcome "recovered", described as "Sore underarm (lymph node)"; CHILLS (non-serious), outcome "recovered", described as "Chills"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Body ache". Therapeutic measures were not taken as a result of lymph node pain, chills, pyrexia, pain.  Additional information: The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Infection, Nasopharyngitis
Clinical narrative: infection; cold; Second Dose: Date 08Mar2021; 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 male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; First Dose: Date 26Feb2021 Lot EN6205), administration date: 26Feb2021, for Covid-19 immunization. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "infection"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second Dose: Date 08Mar2021". Clinical course: The patient was scheduled to get his booster tomorrow and mentioned that he had an infection and cold, and was going to get a Z Pak. He was confused if he should still continue with the shot tomorrow, in other words was it still okay to get the booster.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fall, Hypotension, Loss of consciousness, Rib fracture
Clinical narrative: black-outs; syncope; contusions; hypotension; fallen four times; five broken ribs; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program .  A 85 year-old male patient received bnt162b2 (COMIRNATY) (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), for Covid-19 Immunization, reaction(s): "melanoma carcinoma on his scalp"; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "black-outs"; SYNCOPE (medically significant), outcome "unknown", described as "syncope"; CONTUSION (medically significant), outcome "unknown", described as "contusions"; HYPOTENSION (medically significant), outcome "unknown", described as "hypotension"; FALL (non-serious), outcome "unknown", described as "fallen four times"; RIB FRACTURE (non-serious), outcome "unknown", described as "five broken ribs". Clinical course: After his booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap), the patient developed a series of serious adverse events like black-outs, contusions, hypotension, and syncope. The patient has fallen four times and currently has five broken ribs. They cannot find a reason of why he is dropping, other than he received his booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: black-outs; syncope; contusions; hypotension; fallen four times; five broken ribs; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program .  A 85 year-old male patient received bnt162b2 (COMIRNATY) (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), for Covid-19 Immunization, reaction(s): "melanoma carcinoma on his scalp"; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "black-outs"; SYNCOPE (medically significant), outcome "unknown", described as "syncope"; CONTUSION (medically significant), outcome "unknown", described as "contusions"; HYPOTENSION (medically significant), outcome "unknown", described as "hypotension"; FALL (non-serious), outcome "unknown", described as "fallen four times"; RIB FRACTURE (non-serious), outcome "unknown", described as "five broken ribs". Clinical course: After his booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap), the patient developed a series of serious adverse events like black-outs, contusions, hypotension, and syncope. The patient has fallen four times and currently has five broken ribs. They cannot find a reason of why he is dropping, other than he received his booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever; Body aches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: PYREXIA (non-serious) with onset Mar2021, outcome "recovered", described as "Fever"; PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: bilateral pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose No:1), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "not recovered", described as "bilateral pulmonary embolism". Caller reported an adverse event following the second dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Caller stated that I am calling on behalf of a patient who received her primary series of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and within a week of her second dose she developed bilateral pulmonary embolism. The patient would like to receive her booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). The reporter questioned Do they had any information of post-authorization reports of patients that received a subsequent dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) after developing bilateral pulmonary embolism. Caller requested escalation on her specific question: "Post-authorization reports of patients that received a subsequent dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) after developing bilateral pulmonary embolism", as this information is needed to make a medical decision on whether the patient can safely receive her booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap).  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event pulmonary embolism and suspect drug BNT162B2 cannot be excluded. 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: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 06Dec2021 19:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 15Dec2021 07:00, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: Yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm / Became severe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm / Became severe".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland/lymph node in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 16:00 (Lot number: FD7218) at the age of 32 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 Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 04May2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "recovering", described as "Swollen gland/lymph node in left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Vaccination site pain
Clinical narrative: Covid 19 booster; injection site arm pain; minor shoulder pain; minor headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid 19 booster"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site arm pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "minor shoulder pain"; HEADACHE (non-serious), outcome "unknown", described as "minor headache".  Additional information: Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Immunisation
Clinical narrative: Booster; I'm having issues with my balance right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient 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), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "I'm having issues with my balance right now". Therapeutic measures were taken as a result of balance disorder.  Additional information: Patient called in to place a refill for the medication Premarin. During the call patient stated that the patient was having issues with balance right now. Patient later stated on the call. The patient got the Pfizer Vaccine, got three of them knew. Patient was going to physical therapy they said they were looking into that being related to the vaccine, cause patient having some really bad ones.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: booster; Arm pit pain 24 hours after 3rd booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: Covid-19 vaccine (DOSE:1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; AXILLARY PAIN (non-serious), outcome "unknown", described as "Arm pit pain 24 hours after 3rd booster".  Additional information: Arm pit pain started 24 hours after 3rd booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Immunisation, Muscle fatigue, Myalgia
Clinical narrative: achy joints/deep joint pain; achy joints/muscles; breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough).; Normal muscle fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 18:30 (Lot number: 32030BD) at the age of 35 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8780, Location of injection: Arm Right), administration date: 07Apr2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:30, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/deep joint pain"; MYALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/muscles"; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "recovering", described as "breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough)."; MUSCLE FATIGUE (non-serious) with onset 18Nov2021, outcome "recovering", described as "Normal muscle fatigue". Therapeutic measures were not taken as a result of immunisation, arthralgia, myalgia, dyspnoea, muscle fatigue.  Additional information: It was reported that beyond that 48 hour after the booster (3rd) shot, the patient continues to have achy joints, muscles plus some minor breathing issues. Normal muscle fatigue was normal with working out etc. However, the deep joint pain, difficulty breathing heavily during exercise (lungs don't feel like they expand or breath in enough). The patient reported that the events are nothing severe however it was persistent and not normal based on her body before the booster vaccine. No issues persisting after initial, or 2nd dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: developed bilateral PE 1 week after her second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received COVID-19 Vaccine - Manufacturer Unknown (BNT162B2), administration date 2021 (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: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 2021, outcome "unknown", described as "developed bilateral PE 1 week after her second dose". The reporter stated that the query was about the COVID vaccine. The reporter had a patient who developed bilateral PE 1 week after her second dose about 9, 10 months ago and the patient want to get a booster dose and they were just wondering if we have information in that regard. The reporter did not specify which vaccine the patient received.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit of injection arm (left arm); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FH830) at the age of 62 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 1, SINGLE, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 08:00), administration date: 11Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 09:00, outcome "recovering", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021 20:00, outcome "recovering", described as "Swollen lymph node in armpit of injection arm (left arm)". Therapeutic measures were not taken as a result of immunisation, lymphadenopathy.  Additional information: Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. Device Date : 15Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: fever began at 99.3 and that was ongoing, It was gotten higher. She took Tylenol about 2 hours before when it was 101.7. She would say the fever has worsened because it went up to 101.7.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Immunisation, SARS-CoV-2 test
Clinical narrative: booster shot; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 301358A) at the age of 67 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia. Concomitant medication(s) included: ATORVASTATIN; PROPRANOLOL; LISINOPRIL; OMEPRAZOLE. Past drug history included: Ibuprofen, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262 5121, Location of injection: Arm Left), administration date: 06Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203 6121, Location of injection: Arm Right), administration date: 26Feb2021, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Oct2021, outcome "unknown", described as "booster shot"; DIARRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "diarrhea". The event "diarrhea" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medication patient received within 2 weeks of vaccination: Atorvastatin, Propranolol, Lisinopril, Omeprazole. The patient reported that the patient did not have adverse effects from either of the first two doses of the Covid vaccines. However in late Aug2021 the patient started experiencing diarrhea. It continued even after booster shot (3rd overall shot). The Patient doctors has done a lot of blood work but everything came back normal (coloscopy is pending in Jan2022). The patients symptoms had not gotten any better. The patients diarrhea symptoms are anywhere from 3-8 times per day. The patient was not diagnosed with covid-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Immunisation, Malaise, Throat tightness, Vaccination site pain
Clinical narrative: Throat tightness; difficulty swallowing; Slight feeling of general malaise; Slight arm soreness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose number unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset 15Dec2021 09:00, outcome "unknown", described as "Slight feeling of general malaise"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 09:00, outcome "unknown", described as "Slight arm soreness"; THROAT TIGHTNESS (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "Throat tightness"; DYSPHAGIA (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "difficulty swallowing". Follow-up on (15Dec2021 ) information included.  Updated Information : New Events Throat tightness, difficulty swallowing added. Additional information :Yesterday, after sending the report below, I also experienced throat tightness and difficulty swallowing (around 11:30am on 15Dec2021).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Frequent bowel movements, Haematochezia, Immunisation, Sleep disorder
Clinical narrative: Booster; Blood in her stool; Stress; Increase abdominal pain; Interrupted sleep; Bowel movement frequency; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer, Dose number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "Booster"; HAEMATOCHEZIA (medically significant) with onset 2021, outcome "not recovered", described as "Blood in her stool"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "Stress"; ABDOMINAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Increase abdominal pain"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Interrupted sleep"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 2021, outcome "not recovered", described as "Bowel movement frequency". Clinical course: Patient reported when she got the Covid booster back in Oct2021, she had an adverse effect while on Xeljanz. after the booster, developed and increase with blood in her stool. md is aware. she also reported having "flare ups," most recently 2-3 days after the holidays. her flare ups, caused by stress, worsened her symptoms. symptoms consisted of increase abdominal pain, blood in her stool, and interrupted sleep because of bowel movement frequency. patient reported it has been improving with spots of blood in her stool and able to sleep 5 hours straight. md is aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event Haematochezia and other reported events and the suspect drug BNT162B2 cannot be excluded.   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: Stress
Clinical narrative: Booster; Blood in her stool; Stress; Increase abdominal pain; Interrupted sleep; Bowel movement frequency; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer, Dose number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "Booster"; HAEMATOCHEZIA (medically significant) with onset 2021, outcome "not recovered", described as "Blood in her stool"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "Stress"; ABDOMINAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Increase abdominal pain"; SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Interrupted sleep"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 2021, outcome "not recovered", described as "Bowel movement frequency". Clinical course: Patient reported when she got the Covid booster back in Oct2021, she had an adverse effect while on Xeljanz. after the booster, developed and increase with blood in her stool. md is aware. she also reported having "flare ups," most recently 2-3 days after the holidays. her flare ups, caused by stress, worsened her symptoms. symptoms consisted of increase abdominal pain, blood in her stool, and interrupted sleep because of bowel movement frequency. patient reported it has been improving with spots of blood in her stool and able to sleep 5 hours straight. md is aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event Haematochezia and other reported events and the suspect drug BNT162B2 cannot be excluded.   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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Malaise
Clinical narrative: Chills; headache; injection site pain; tiredness; feeling unwell; Dose number: 3; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 16:00 (Lot number: FJ8762) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Cats" (unspecified if ongoing), notes: known allergies: Cats and mold; "known allergies: mold" (unspecified if ongoing), notes: known allergies: Cats and mold. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Vaccine Administration Time: 11:00 AM), administration date: 16Apr2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208, Vaccine Administration Time: 01:30 PM), administration date: 15Mar2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 16:00, outcome "unknown", described as "Dose number: 3"; CHILLS (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 14Dec2021 11:00, outcome "recovering", described as "feeling unwell". Therapeutic measures were not taken as a result of chills, headache, vaccination site pain, fatigue, malaise.  No follow-up attempts are possible. No further information is expected.