chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Spondylitis ankylosing aggravated; Pressure in limbs; Leg pain/leg achy; Chills; Headache; Fatigue;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4161789-00 (RA).  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (TOZINAMERAN), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single and intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Pressure in limbs"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain/leg achy"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". The action taken for adalimumab was dosage not changed.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of ankylosing spondylitis flare up with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of pressure in legs and leg achy was not provided. The reporter's causality for the event(s) of chills, headache and fatigue with Humira (adalimumab) was no reasonable possibility.  Causality for BNT162B2 (TOZINAMERAN): The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   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 currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out.  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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4164537-00 (RA).  A 24-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Jul2021 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single and intramuscular, administration date 04Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Sep2021 (Batch/Lot number: unknown) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Lack of drug effect". The action taken for adalimumab was temporarily withdrawn on Sep2021. The reporter's causality for the event(s) of HUMIRA WAS NOT WORKING was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.   The reporter considered "lack of drug effect" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per information, the causal association between the event THERAPEUTIC PRODUCT EFFECT DECREASED 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: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Umbilical hernia
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168730-00 (RA).  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1141915) at CF for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UMBILICAL HERNIA (medically significant), outcome "recovered" (18Nov2021), described as "Umbilical hernia"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Low grade fever". The patient underwent the following laboratory tests and procedures: pyrexia: (2021) low. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of umbilical hernia. It was unknown if patient was enrolled in a COVID-19 vaccine trial. In Aug2021, he underwent an umbilical hernia surgery and it was successful. As of 18Nov2021, he recovered from the surgery.  The reporter's assessment of the causal relationship of the events with suspect product (Bnt162b2) was not reported.  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 events umbilical hernia, Fatigue, Pyrexia 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: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Hypertension, Nephrotic syndrome
Clinical narrative: nephrotic syndrome; hypertension; This is a literature report for the following literature source(s): "Report of three cases of minimal change disease following the second dose of mRNA SARS-CoV-2 COVID-19 vaccine".  A 41-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). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: NEPHROTIC SYNDROME (medically significant), outcome "unknown", described as "nephrotic syndrome"; HYPERTENSION (non-serious), outcome "unknown", described as "hypertension". Symptom Onset (5 days). The patient underwent the following laboratory tests and procedures: biopsy kidney: minimal change disease.  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 provided and plausible temporal association, the causality between BNT162B2 and Nephrotic syndrome, Hypertension cannot be completely 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 3 weeks after she got her second dose, she developed a golf ball size lymph node on her left arm, it was huge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Lot number: EN5318) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "foods" (unspecified if ongoing); "anaphylactic reactions" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot Number / Expiry Date: EL9261/ Unknown, Route, Anatomical Location:  Left arm, No. of Previous Doses: This was dose 1), administration date: 22Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "3 weeks after she got her second dose, she developed a golf ball size lymph node on her left arm, it was huge".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.  No further information was provided or obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID19; Tested positive for COVID19; flu like symptoms; dose number 3; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: EW0185) 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: EN6200), administration date: 23Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 24Nov2021, outcome "recovering" and all described as "Tested positive for COVID19"; IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "dose number 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Nov2021, outcome "recovering", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: Covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, influenza like illness. Clinical information: It was unknown if the patient had received any other vaccine in four weeks. It was reported that the patient had flu like symptoms, 6 weeks following booster shot. The patient tested positive for COVID19 on 24Nov2021. The patient did not suffer from covid prior vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills
Clinical narrative: Joint pain; Chills; I don't have the energy; 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 number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; CHILLS (non-serious), outcome "not recovered", described as "Chills"; ASTHENIA (non-serious), outcome "not recovered", described as "I don't have the energy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): AGN277757 (RA).  A 48-year-old female patient received bnt162b2, administration date Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Hysterectomy" (unspecified if ongoing); "double mastectomy", stop date: 2020, notes: 1 year ago. Family history included: "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; prochlorperazine maleate (COMPAZINE) taken for migraine; tizanidine hydrochloride (ZANAFLEX) taken for migraine; erenumab aooe (AIMOVIG) taken for migraine, stop date: 2021; ubrogepant (UBRELVY) taken for migraine. Past drug history included: botulinum toxin type a (BOTOX), start date: Jun2017, stop date: 2019, for Migraines, reaction(s): "Botox didn't work", notes: Route of Administration: Injection, Outcome: Ongoing.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "COVID-19". She gave permission to contact her and her doctor. She was on Botox about 2 and a half years and then it quit working for her and uh, she also had Covid in May2021 and her, she does not have the lot number, does not have the expiration date. She does not have her doctor's name since it was a pretty long time ago. She had the Covid shot, she believes it was Pfizer, first dose Apr2021 and second dose Jun2021. She stated used Botox for a few years and stopped working. Consumer provided treatment meds. She stated she is supposed to start Qulipta in a few days. Consumer stated she had a double mastectomy last year due to family history of breast cancer and she was positive for the genes for breast cancer. Consumer doesn't know the dose or lot number of the Botox. She stated she doesn't want us to contact her doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Dose received 3; My left under arm is swollen.  Looks like a baseball; This is a spontaneous report received from a contactable consumer, the patient.   A 32 year-old female patient (not pregnant) received the third (booster) dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN via an unspecified route of administration in the left arm on 24Nov2021 (Lot number: unknown) at the age of 32 years as a single dose 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 in 2021 and Dose 2 on 25May2021 for COVID-19 immunisation. The following information was reported: SWELLING (non-serious) with onset 24Nov2021, outcome "recovering", described as "My left under arm is swollen.  Looks like a baseball".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: first vaccine on 14Feb2021/second dose on 24Feb2021/tested positive for the Covid-19 virus at the end of Aug2021.; first vaccine on 14Feb2021/second dose on 24Feb2021/tested positive for the Covid-19 virus at the end of Aug2021.; had first vaccine on 14Feb2021, states she got the second dose on 24Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Lot number: EL9263) as dose 1, single and administration date 24Feb2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma, Diagnosed years ago, probably 30 years ago; "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia, Diagnosed years ago, probably 30 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Aug2021, outcome "unknown", COVID-19 (medically significant) with onset 27Aug2021, outcome "recovered" (Sep2021) and all described as "first vaccine on 14Feb2021/second dose on 24Feb2021/tested positive for the Covid-19 virus at the end of Aug2021."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Feb2021, outcome "unknown", described as "had first vaccine on 14Feb2021, states she got the second dose on 24Feb2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Aug2021) positive. Therapeutic measures were taken as a result of covid-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Lymphadenopathy, Pyrexia
Clinical narrative: Low grade fever 99.4; Swollen supraclavicular, humeral and pectoral lymph nodes of left arm; 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 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FH8027) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "autoimmune urticaria" (unspecified if ongoing); "angioedema" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL / NORETHINDRONE ACETATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose Number 3"; PYREXIA (non-serious) with onset 27Nov2021, outcome "recovering", described as "Low grade fever 99.4"; LYMPHADENOPATHY (non-serious) with onset 27Nov2021, outcome "recovering", described as "Swollen supraclavicular, humeral and pectoral lymph nodes of left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy.  Additional Information: The patient did not have covid prior to vaccination. The patient did not have covid tested post vaccination. The patient did not have known allergy.   Follow-Up (02DEC2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Dose Number 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID 19), administered in arm left, administration date 05Oct2021 (Lot number: FF2590) at the age of 59 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: El3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome "unknown", described as "Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms". Symptoms included fever 102 F, sore throat,muscle pain, headache, loss of taste all on 19Nov2021, unknown treatment. The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) 102 Fahrenheit; sars-cov-2 test: (21Nov2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Immunisation, Pain
Clinical narrative: Received third dose; Extreme fatigue; Body aches; Chills; Dizzy; Feverish; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 15:00 (Batch/Lot number: 32030BD) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "colitis ulcerative" (unspecified if ongoing), notes: ulcerative colitis; "bronchiolitis obliterans with organizing pneumonia" (unspecified if ongoing), notes: BOOP; "raynaud's syndrome" (unspecified if ongoing); "gallbladder removal" (unspecified if ongoing), notes: no gall bladder and "colectomy" (unspecified if ongoing), notes: no large intestine. Concomitant medications included: VITAMIN D and unspecified multivitamins. Vaccination history included: BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8727, Route of administration: Unspecified), administration date: on an unknown date in Mar2021, when the patient was 42 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: ER8729, Route of administration: Unspecified), administration date: on an unknown date in Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), CHILLS (non-serious), DIZZINESS (non-serious), PYREXIA (non-serious); all with onset 27Nov2021, outcome "recovering" and described as ''extreme fatigue, body aches, chills, dizzy and feverish''. Therapeutic measures were not taken as a result of fatigue, pain, chills, dizziness and pyrexia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received third dose; Extreme fatigue; Body aches; Chills; Dizzy; Feverish; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 15:00 (Batch/Lot number: 32030BD) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "colitis ulcerative" (unspecified if ongoing), notes: ulcerative colitis; "bronchiolitis obliterans with organizing pneumonia" (unspecified if ongoing), notes: BOOP; "raynaud's syndrome" (unspecified if ongoing); "gallbladder removal" (unspecified if ongoing), notes: no gall bladder and "colectomy" (unspecified if ongoing), notes: no large intestine. Concomitant medications included: VITAMIN D and unspecified multivitamins. Vaccination history included: BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8727, Route of administration: Unspecified), administration date: on an unknown date in Mar2021, when the patient was 42 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: ER8729, Route of administration: Unspecified), administration date: on an unknown date in Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), CHILLS (non-serious), DIZZINESS (non-serious), PYREXIA (non-serious); all with onset 27Nov2021, outcome "recovering" and described as ''extreme fatigue, body aches, chills, dizzy and feverish''. Therapeutic measures were not taken as a result of fatigue, pain, chills, dizziness and pyrexia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Chills; Fever 101.2; Headache; Dose received 3; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.   A 58 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 27Nov2021 at 16:00 (Batch/Lot number: 33026BD) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 13Nov2021 for immunisation and unspecified cholesterol lowering medicine and vitamins. Past drug history included: Codeine, reaction(s): "Drug allergy" and Tetracycline, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: on an unknown date in Feb2021, when the patient was 57 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE Lot number: UNKNOWN, Route of administration: Unspecified), administration date: on an unknown date in Mar2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), HEADACHE (non-serious) all with onset 28Nov2021 at 16:00, outcome "recovering" and described as ''chills, fever 101.2 and headache''. Therapeutic measures were not taken as a result of chills, pyrexia and headache. Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: The patient received other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Immunisation, Malaise
Clinical narrative: Dose number: 3; Fever; Aches; Chills / Shivers; Sweats; Migraine; Muscle aches; Loss of appetite; Arm soreness; Started feeling sick that night / Too sick to leave bed the entire day; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 27Nov2021 at 11:00 (Batch/Lot number: FH8027) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: CLARAVIS. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation and COVID-19 vaccine (DOSE 2, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), HYPERHIDROSIS (non-serious), MIGRAINE (non-serious), MYALGIA (non-serious), DECREASED APPETITE (non-serious), PAIN IN EXTREMITY (non-serious), all with onset 28Nov2021 at 04:00, outcome "recovered" (an unknown date in Nov2021), all described as "fever, aches, chills / shivers, sweats, migraine, muscle aches, loss of appetite, arm soreness"; MALAISE (non-serious) with onset an unknown date in Nov2021, outcome "recovered" (an unknown date in Nov2021), described as "started feeling sick that night / too sick to leave bed the entire day". Therapeutic measures were not taken as a result of pyrexia, pain, chills, hyperhidrosis, migraine, myalgia, decreased appetite, pain in extremity, malaise.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. This was the patient's booster shot which happened on the 27Nov2021 at 11:00, it was not until late in the night at 04:00 in which it really took a turn for the worse. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Dose number: 3; Fever; Aches; Chills / Shivers; Sweats; Migraine; Muscle aches; Loss of appetite; Arm soreness; Started feeling sick that night / Too sick to leave bed the entire day; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 27Nov2021 at 11:00 (Batch/Lot number: FH8027) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: CLARAVIS. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation and COVID-19 vaccine (DOSE 2, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; MANUFACTURER UNKNOWN), administration date: unknown, single for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), CHILLS (non-serious), HYPERHIDROSIS (non-serious), MIGRAINE (non-serious), MYALGIA (non-serious), DECREASED APPETITE (non-serious), PAIN IN EXTREMITY (non-serious), all with onset 28Nov2021 at 04:00, outcome "recovered" (an unknown date in Nov2021), all described as "fever, aches, chills / shivers, sweats, migraine, muscle aches, loss of appetite, arm soreness"; MALAISE (non-serious) with onset an unknown date in Nov2021, outcome "recovered" (an unknown date in Nov2021), described as "started feeling sick that night / too sick to leave bed the entire day". Therapeutic measures were not taken as a result of pyrexia, pain, chills, hyperhidrosis, migraine, myalgia, decreased appetite, pain in extremity, malaise.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. This was the patient's booster shot which happened on the 27Nov2021 at 11:00, it was not until late in the night at 04:00 in which it really took a turn for the worse. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: 102 Fever; Chills; Fatigue; Swollen glands under left armpit; Dose received 3 / dose number=3 of BNT162b2; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 26Nov2021 at 16:00 (Batch/Lot number: ) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; DOSE 2, SINGLE; Lot Number: 3248; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 23Mar2021, single for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; DOSE 1, SINGLE; Lot Number: 3248; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 02Mar2021, single for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), LYMPHADENOPATHY (non-serious), all with onset 27Nov2021, outcome "recovering", described as "102 fever, chills, fatigue, swollen glands under left armpit ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue and lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102 Fever; Chills; Fatigue; Swollen glands under left armpit; Dose received 3 / dose number=3 of BNT162b2; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 26Nov2021 at 16:00 (Batch/Lot number: ) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; DOSE 2, SINGLE; Lot Number: 3248; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 23Mar2021, single for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; DOSE 1, SINGLE; Lot Number: 3248; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 02Mar2021, single for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), LYMPHADENOPATHY (non-serious), all with onset 27Nov2021, outcome "recovering", described as "102 fever, chills, fatigue, swollen glands under left armpit ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue and lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right sides axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in right arm, administration date 26Nov2021 at 21:00 (Batch/Lot number: UNKNOWN) at the age of 34 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Nov2021 at 09:00, outcome "unknown", described as "Right sides axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.   Additional Information: The patient had no known allergies. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Rash, Rash macular, Vaccination site erythema
Clinical narrative: Red splotches around the injection site; Red dots over the rest of body, even as far as legs; Dose received 3, dose number: 3 of BNT162b2; Sometime between 36 and 48 hours after the vaccine developed a rash over most of body, concentrated on upper body; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Nov2021 at 09:00 (Batch/Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER2613; Route of administration: Unspecified; Anatomical Location: Left arm), administration date: 17Mar2021, when the patient was 47 years old, single for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE; Lot Number: ER8729; Route of administration: Unspecified; Anatomical Location: Left arm), administration date: 07Apr2021, when the patient was 47 years old, single for COVID-19 immunisation.  The following information was reported: RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "sometime between 36 and 48 hours after the vaccine developed a rash over most of his body, concentrated on upper body"; VACCINATION SITE ERYTHEMA (non-serious) and RASH MACULAR (non-serious) both with onset 30Nov2021, outcome "not recovered", described as "red splotches around the injection site" and "red dots over the rest of body, even as far as legs". Therapeutic measures were not taken as a result of rash, vaccination site erythema and rash macular.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "I" felt pain only on my left arm in the 1st dose and also in the 2nd dose.; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.   A 63-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date, an unknown date in Apr2021 at 14:00 (Batch/Lot number: unknown) as dose 1, single and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 20May2021 (Batch/Lot number: unknown) as dose 2; both at the age of 63 years, single for COVID-19 immunisation. The patient had no relevant medical history. The patient received unspecified concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset an unknown date in 2021, outcome "recovered" (unknown date in 2021), described as "I felt pain only on left arm in the 1st dose and also in the 2nd dose". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient had no known allergies. Pain only on left arm after the 2nd dose was reported with onset date of 21May2021 at 08:00, with outcome recovered. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle irregular (Instead of normal 28 day (4 week) cycle; it began coming every 3 weeks; This is a spontaneous report received from a non-contactable consumer, the patient.   A 35 year-old female patient (not pregnant) received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN via an unspecified route of administration in the left arm on 15Sep2021 at 14:30 (Lot number: unknown) at the age of 35 years as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: first dose of COVID-19 vaccine (Anatomical site: Left arm; Manufacturer unknown), on 18Aug2021 at 14:00 for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 24Sep2021, outcome "recovered" in 2021, described as "Menstrual cycle irregular (Instead of normal 28 day (4 week) cycle; it began coming every 3 weeks". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Myalgia, Pain
Clinical narrative: Soreness at injection site; Muscle aches; Pains throughout my body; Chills; Headache; Dose received: 3; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 38-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm, administration date 29Nov2021 at 11:00 (Batch/Lot number: FH8027) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: NASAL SPRAY, CLARITIN and METROGEL. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: EP6953, Anatomical site: Left arm, Administration time: 09:15, Route of administration: Intramuscular), administration date: 31Mar2021, and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EI3247, Anatomical site: Left arm, Administration time: 09:15, Route of administration: Intramuscular), administration date: 10Mar2021, both when the patient was 38 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 11:00, outcome "unknown", described as 'received 3rd dose of BNT162B2 Pfizer vaccine', VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 29Nov2021 at 22:00, outcome "recovering", and described as "soreness at injection site, muscle aches and pains throughout body, chills, headache". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, pain, chills and headache.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.