chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Product administered to patient of inappropriate age; Wrong product administered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1788308. The original narrative from the sender is the following:  "Administered Rotavirus vaccine IM instead of PO as specified by manufacturer. No adverse effects were reported by parent".  The causal relationship between Vaxelis and the events "Product administered to patient of inappropriate age and Wrong product administered" were assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather Rotavirus vaccine. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Decreased appetite, Diarrhoea, Malaise, Vomiting
Clinical narrative: Patient vomiting+diarrhea at time of visit; Patient vomiting+diarrhea at time of visit; Feeling sick, not eating; Feeling sick, not eating; An incorrect administration of an unnecessary vaccine Vaxelis; This non-serious spontaneous safety report with Agency reference #02102374 and interaction #02102370 was received by a partner on 03-Feb-2022 from a Nurse, and forwarded to Agency on 04-Feb-2022.  The reporter did not assess the causal relationship between Vaxelis and the events 'Feeling sick' and 'Not eating'. It was unknown if the events were due to the vaccine administration since the patient already had similar symptoms prior to vaccine administration. Furthermore, the causality between Vaxelis and the reported event  'An incorrect administration of an unnecessary vaccine Vaxelis' was not applicable, due to the nature of the event.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 09-Feb-2022 from a nurse, and forwarded to Agency on 10-Feb-2022.  No medical history was reported.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events: Patient vomiting and diarrhea at time of visit. An intercurrent gastrointestinal infection needs to be taken into consideration.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: VAXELIS was administered to an 11-year-old; This non-serious spontaneous safety report with Agency Case ID # 02123715 was received by a partner on 07-MAR-2022 and forwarded to Agency on 09-MAR-2022 from a health care professional.   This case was considered off label use due to product use in unapproved population (VAXELIS was administered to an 11-year-old).  Due to the nature of the event, the causality between Vaxelis and the reported event of "VAXELIS was administered to an 11-year-old" is not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis was given to a 11 year old patient; This non-serious spontaneous safety report with reference number 2022SA085058 (and inquiry # 01012639), was received by a partner on 09-MAR-2022 and forwarded to Agency on 11-MAR-2022, from a Non-Health Care Professional .  The causal relationship between Vaxelis and the reported event "Vaxelis was given to a 11 year old patient" was assessed as not applicable due to the nature of this event (off-label use since Vaxelis was administered in unapproved population).  No further information is expected given that the reporter did not give consent to be contacted.
Age: 11.0
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old receiving Vaxelis; This spontaneous safety report was received by the partner on 14-Mar-2022 and forwarded to Agency on 15-Mar-2022 from an other health care professional.  Due to the nature of the event, the causality between the event "11 year old receiving Vaxelis" and the product is not applicable.  Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased
Clinical narrative: Her mom is having issues and it's very frustrating; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is patient daughter.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Her mom is having issues and it's very frustrating".  Additional information: The reporter stated that the patient was having issues and it was very frustrating.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (25Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021572104 Different patient, same drug/event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Pain in extremity, Ultrasound scan
Clinical narrative: fatigue; headache; severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 13:19 (Lot number: EL8982) at the age of 68 years as dose 1, 0.3 ml single and intramuscular, administered in arm left, administration date 08Feb2021 14:49 (Lot number: EL9269) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "R arm had torn Rotator cuff muscles requiring surgery" (unspecified if ongoing), notes: R arm had torn Rotator cuff muscles requiring surgery; "R arm had damaged muscles" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Hormone replacement therapy" (unspecified if ongoing); "Lung scarring" (unspecified if ongoing), notes: lung scarring (pneumonia sx); "Hypothyroidism" (unspecified if ongoing); "Fluid retention" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for hypercholesterolaemia (ongoing); ESTRADIOL taken for hormone replacement therapy (ongoing); MONTELUKAST taken for lung disorder (ongoing); LEVOTHYROXIN taken for hypothyroidism (ongoing); SPIROLACTON taken for hypothyroidism (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "severe arm pain". The events "fatigue", "headache" and "severe arm pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional Information: The patient reported that the AE required Rheumatologist (2 visitis) and Physician office PCP. The patient's relevant medical history was reported as none. On 08Oct2021 the patient received other vaccine Pfizer 301358A, with expiration date as Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: fatigue; headache; severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 13:19 (Lot number: EL8982) at the age of 68 years as dose 1, 0.3 ml single and intramuscular, administered in arm left, administration date 08Feb2021 14:49 (Lot number: EL9269) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "R arm had torn Rotator cuff muscles requiring surgery" (unspecified if ongoing), notes: R arm had torn Rotator cuff muscles requiring surgery; "R arm had damaged muscles" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Hormone replacement therapy" (unspecified if ongoing); "Lung scarring" (unspecified if ongoing), notes: lung scarring (pneumonia sx); "Hypothyroidism" (unspecified if ongoing); "Fluid retention" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for hypercholesterolaemia (ongoing); ESTRADIOL taken for hormone replacement therapy (ongoing); MONTELUKAST taken for lung disorder (ongoing); LEVOTHYROXIN taken for hypothyroidism (ongoing); SPIROLACTON taken for hypothyroidism (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "severe arm pain". The events "fatigue", "headache" and "severe arm pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.  Additional Information: The patient reported that the AE required Rheumatologist (2 visitis) and Physician office PCP. The patient's relevant medical history was reported as none. On 08Oct2021 the patient received other vaccine Pfizer 301358A, with expiration date as Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, SARS-CoV-2 test
Clinical narrative: Chills; sudden onset right arm weakness less than 24 hours after pfizer booster; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 73-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2022 09:45 (Lot number: FK9895) at the age of 73 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Htn" (unspecified if ongoing); "DM" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN; AMARYL; METFORMIN; ASPIRINE; TAMSULOSIN. Vaccination history included: Covid-19 vaccine (Primary series of vaccination completed., Manufacturer name unknown.), for COVID-19 immunization. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient was tested for COVID prior and post vaccination. The following information was reported: CHILLS (hospitalization) with onset 17Mar2022 03:00, outcome "recovered with sequelae", described as "Chills"; MUSCULAR WEAKNESS (hospitalization) with onset 17Mar2022 03:00, outcome "recovered with sequelae", described as "sudden onset right arm weakness less than 24 hours after pfizer booster". The patient was hospitalized for chills, muscular weakness (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Mar2022) negative. Therapeutic measures were taken as a result of chills, muscular weakness which included Aspirin.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the onset of chills and muscular weakness 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: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Gait disturbance, Transient ischaemic attack
Clinical narrative: TIA; stroke; trouble walking; feeling like my left side of body is being stung all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "trouble walking"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling like my left side of body is being stung all the time".  Clinical course: "I believe with all my heart. I got the 3rd shoot booster, I was healthy, within 2 1/2 weeks after getting the shot, I had TIA's and then a stroke. I am now left trouble walking, feeling like my left side of body is being stung all the time, plus other issues I never had before. I wish I never had gotten the shots."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Experienced some sort of paralysis after receiving vaccine; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 64 year-old male patient received bnt162b2 (COMIRNATY) (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: PARALYSIS (medically significant), outcome "unknown", described as "Experienced some sort of paralysis after receiving vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin G decreased, Deep vein thrombosis, Lymphocytosis, Pain in extremity
Clinical narrative: Plantar fasciitis; Lymphocytosis; White blood cell 130,000; sore heel; Deep vein thrombosis; Lower immunoglobulin G/Lower (20); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4316223-00.  A 75-year-old male patient received bnt162b2 (BNT162B2), intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 1, single, intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 2, single and intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 3 (booster), single for covid-19 immunisation; jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown, single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral at an unspecified date (Batch/Lot number: unknown) for chronic lymphocytic leukaemia. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "Deep vein thrombosis"; BLOOD IMMUNOGLOBULIN G DECREASED (medically significant) with onset 2022, outcome "unknown", described as "Lower immunoglobulin G/Lower (20)"; PLANTAR FASCIITIS (medically significant), outcome "unknown", described as "Plantar fasciitis"; LYMPHOCYTOSIS (medically significant), outcome "unknown", described as "Lymphocytosis"; WHITE BLOOD CELL COUNT ABNORMAL (medically significant), outcome "unknown", described as "White blood cell 130,000"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "sore heel". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g (Immunoglobulin G): (2022) lower (20); sars-cov-2 antibody test (COVID-19 antibody test): (unspecified date) negative; white blood cell count (White Blood Cell): (unspecified date) 130000, notes: no units. The action taken for ibrutinib was unknown. Therapeutic measures (Eliquis and Medrol) were taken as a result of deep vein thrombosis, blood immunoglobulin g decreased, plantar fasciitis, lymphocytosis, white blood cell count abnormal, pain in extremity. The reporter's causality between the suspect drug ibrutinib (IMBRUVICA) and the events was not provided. The reporter's causality between the suspect drugs jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) and bnt162b2 (BNT162B2) and the events was not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Plantar fasciitis, SARS-CoV-2 antibody test, White blood cell count, White blood cell count abnormal
Clinical narrative: Plantar fasciitis; Lymphocytosis; White blood cell 130,000; sore heel; Deep vein thrombosis; Lower immunoglobulin G/Lower (20); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4316223-00.  A 75-year-old male patient received bnt162b2 (BNT162B2), intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 1, single, intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 2, single and intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose 3 (booster), single for covid-19 immunisation; jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), intramuscular at an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown, single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral at an unspecified date (Batch/Lot number: unknown) for chronic lymphocytic leukaemia. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "Deep vein thrombosis"; BLOOD IMMUNOGLOBULIN G DECREASED (medically significant) with onset 2022, outcome "unknown", described as "Lower immunoglobulin G/Lower (20)"; PLANTAR FASCIITIS (medically significant), outcome "unknown", described as "Plantar fasciitis"; LYMPHOCYTOSIS (medically significant), outcome "unknown", described as "Lymphocytosis"; WHITE BLOOD CELL COUNT ABNORMAL (medically significant), outcome "unknown", described as "White blood cell 130,000"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "sore heel". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g (Immunoglobulin G): (2022) lower (20); sars-cov-2 antibody test (COVID-19 antibody test): (unspecified date) negative; white blood cell count (White Blood Cell): (unspecified date) 130000, notes: no units. The action taken for ibrutinib was unknown. Therapeutic measures (Eliquis and Medrol) were taken as a result of deep vein thrombosis, blood immunoglobulin g decreased, plantar fasciitis, lymphocytosis, white blood cell count abnormal, pain in extremity. The reporter's causality between the suspect drug ibrutinib (IMBRUVICA) and the events was not provided. The reporter's causality between the suspect drugs jnj 78436735 (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) and bnt162b2 (BNT162B2) and the events was not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Platelet count, Platelet count decreased
Clinical narrative: blood platelets went down; dehydration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (hospitalization), outcome "unknown", described as "blood platelets went down"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydration". The patient underwent the following laboratory tests and procedures: platelet count: blood platelets went down. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, Blood test, Investigation, Pruritus
Clinical narrative: The blood work showed a high ANA (thyroid); After I go my second dose on 14Feb2021 about 1 month later, I started to get intermittent itching on skin,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200449767 (Pfizer).  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 61 years 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 number: 1, Manufacture: Unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "unknown", described as "After I go my second dose on 14Feb2021 about 1 month later, I started to get intermittent itching on skin,"; ANTINUCLEAR ANTIBODY INCREASED (non-serious), outcome "unknown", described as "The blood work showed a high ANA (thyroid)". The events "after i go my second dose on 14feb2021 about 1 month later, i started to get intermittent itching on skin," and "the blood work showed a high ana (thyroid)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200449766 similar report from same reporter
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: The blood work showed a high ANA (thyroid); After I go my second dose on 14Feb2021 about 1 month later, I started to get intermittent itching on skin,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200449767 (Pfizer).  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 61 years 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 number: 1, Manufacture: Unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "unknown", described as "After I go my second dose on 14Feb2021 about 1 month later, I started to get intermittent itching on skin,"; ANTINUCLEAR ANTIBODY INCREASED (non-serious), outcome "unknown", described as "The blood work showed a high ANA (thyroid)". The events "after i go my second dose on 14feb2021 about 1 month later, i started to get intermittent itching on skin," and "the blood work showed a high ana (thyroid)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200449766 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Quality of life decreased, SARS-CoV-2 test
Clinical narrative: Autonomic dysfunction; taking the shot my life has forever altered my life; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "Autonomic dysfunction"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "taking the shot my life has forever altered my life". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was stated that, the patient was developed autonomic dysfunction since getting first pfizer shot. It was tested multiple times prior and during for covid and tested negative on multiple occasions, have lots of medical bills now and had not worked as a registered nurse for over 6 months. It was heartbreaking that for taking the shot for patient life has forever altered patient's life.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I had an allergic reaction to the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  An adult 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I had an allergic reaction to the Pfizer Covid-19 vaccine". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: The patient stated had an allergic reaction to the Pfizer Covid-19 vaccine. Had to take a lot of diphenhydramine. Other medications (Including over-the-counter medications, nutritional and herbal supplements, etc), past medical history, family history and social history (Including occupational history, use of alcohol, tobacco, or recreational drugs) were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Memory impairment, Pyrexia
Clinical narrative: his mind seemed to be forgetful; 2 days fever; weakness and tiredness for 2-3 months; weakness and tiredness for 2-3 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200464133 (Pfizer).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: FF8841) 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), administration date: Jan2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 immunization. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "his mind seemed to be forgetful"; PYREXIA (non-serious), outcome "unknown", described as "2 days fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "weakness and tiredness for 2-3 months".  Additional information: Patient stated that he had his 2 shots and booster last fall and had bad reactions with the Pfizer COVID vaccine. At first he did not associate it with the shot and stated that he had 2 days fever, weakness and tiredness for 2-3 months, it probably was a lingering effect of the vaccination and ell couple times and his mind seemed to be forgetful, he did not think it is dementia. Patient scared about taking another boster shot. NDC, UPC number of Covid-19 vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Sinus tachycardia
Clinical narrative: palpitations and inappropriate sinus tachycardia after your 2nd covid 19 vax and again after booster; sinus tachycardia; 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 bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "palpitations and inappropriate sinus tachycardia after your 2nd covid 19 vax and again after booster"; SINUS TACHYCARDIA (non-serious), outcome "unknown", described as "sinus tachycardia".  Additional information: It was reported that, the patient (mom) was being evaluated for palpitations and inappropriate sinus tachycardia after her 2nd Covid 19 vax and again after the booster. Stated that, no history of true myopericarditis.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200463172
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Investigation, Lymphadenopathy, Pain, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Lot number: FF2590) at the age of 26 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "oral allergy syndrome" (unspecified if ongoing); "allergy to birch trees" (unspecified if ongoing); "certain foods make her throat itch" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot No: EN6205), administration date: Mar2021, for Covid-19 immunization, reaction(s): "stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for Covid-19 immunization, reaction(s): "arm and stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "arm and stomach swelling". The following information was reported: LYMPHADENOPATHY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Terrible pain and swollen lymph nodes under her arm"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "belly was swollen"; RASH (non-serious), outcome "unknown", described as "Rash"; URTICARIA (non-serious), outcome "unknown", described as "small hives". The events "terrible pain and swollen lymph nodes under her arm", "belly was swollen", "rash", "terrible pain and swollen lymph nodes under her arm" and "small hives" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, abdominal distension, rash, pain, and urticaria. Additional Information: The rash disappears and comes back somewhere else. She was on antihistamines for 6 weeks and has gone to dermatologist and allergist. She said that her daughter had a extreme reaction after the vaccine. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200463199 similar report from same reporter; US-PFIZER INC-202200463200 similar report from same reporter.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Lot number: FF2590) at the age of 26 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "oral allergy syndrome" (unspecified if ongoing); "allergy to birch trees" (unspecified if ongoing); "certain foods make her throat itch" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot No: EN6205), administration date: Mar2021, for Covid-19 immunization, reaction(s): "stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for Covid-19 immunization, reaction(s): "arm and stomach swelling"; Bnt162b2 (DOSE 2, Lot No: EN6205), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "arm and stomach swelling". The following information was reported: LYMPHADENOPATHY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Terrible pain and swollen lymph nodes under her arm"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "belly was swollen"; RASH (non-serious), outcome "unknown", described as "Rash"; URTICARIA (non-serious), outcome "unknown", described as "small hives". The events "terrible pain and swollen lymph nodes under her arm", "belly was swollen", "rash", "terrible pain and swollen lymph nodes under her arm" and "small hives" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, abdominal distension, rash, pain, and urticaria. Additional Information: The rash disappears and comes back somewhere else. She was on antihistamines for 6 weeks and has gone to dermatologist and allergist. She said that her daughter had a extreme reaction after the vaccine. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200463199 similar report from same reporter; US-PFIZER INC-202200463200 similar report from same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200463210 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "unknown", described as "Rash". Therapeutic measures were taken as a result of rash.  Additional information: It was reported that the patient got the booster in Jan2022 and she had a rash and she has been taking Benadryl 3 times a day and Caladryl.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Oropharyngeal pain, SARS-CoV-2 test, Sinus congestion
Clinical narrative: two positive Ag tests; two positive Ag tests; mild ST; sinus congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single, administration date 01May2021 (Lot number: EW0172) as dose 2, single and administration date 10Apr2021 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Mar2022, outcome "unknown" and all described as "two positive Ag tests"; OROPHARYNGEAL PAIN (non-serious) with onset 23Mar2022, outcome "unknown", described as "mild ST"; SINUS CONGESTION (non-serious) with onset 23Mar2022, outcome "unknown", described as "sinus congestion"; FATIGUE (non-serious) with onset 23Mar2022, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) positive, notes: COVID test type post vaccination: Unknown; (23Mar2022) positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, sinus congestion, fatigue.  Clinical course: It was reported that, on 23Mar2022, the patient had been tested two Ag tests for COVID-19 since the vaccination and both time tests were positive after partying on the week end.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the information provided there is a reasonable possibility of causal association between the events oropharyngeal pain, sinus congestion and fatigue with the suspect product bnt162b2.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: two positive Ag tests; two positive Ag tests; mild ST; sinus congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single, administration date 01May2021 (Lot number: EW0172) as dose 2, single and administration date 10Apr2021 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Mar2022, outcome "unknown" and all described as "two positive Ag tests"; OROPHARYNGEAL PAIN (non-serious) with onset 23Mar2022, outcome "unknown", described as "mild ST"; SINUS CONGESTION (non-serious) with onset 23Mar2022, outcome "unknown", described as "sinus congestion"; FATIGUE (non-serious) with onset 23Mar2022, outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) positive, notes: COVID test type post vaccination: Unknown; (23Mar2022) positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, sinus congestion, fatigue.  Clinical course: It was reported that, on 23Mar2022, the patient had been tested two Ag tests for COVID-19 since the vaccination and both time tests were positive after partying on the week end.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the information provided there is a reasonable possibility of causal association between the events oropharyngeal pain, sinus congestion and fatigue with the suspect product bnt162b2.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; + COVID Ag; HA; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) at the age of 28 years as dose 3 (booster), single, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Mar2022, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 23Mar2022, outcome "unknown", described as "+ COVID Ag"; HEADACHE (non-serious) with onset 23Mar2022, outcome "unknown", described as "HA"; FATIGUE (non-serious) with onset 23Mar2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, headache, fatigue.  Clinical course: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown and unknown diagnosed with COVID-19 Prior to vaccination. Device Date: 23Mar2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE)  headache and fatigue 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got sick with covid / covid test result: Positive; got sick with covid / covid test result: Positive; got sick with covid / covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Apr2021 (Lot number: EW0158) at the age of 23 years as dose 2, single and intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing); "cleft lip and pallet" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (disability, medically significant), COVID-19 (disability, medically significant), ILLNESS (disability) all with onset Jan2022, outcome "not recovered" and all described as "got sick with covid / covid test result: Positive". The event "got sick with covid / covid test result: positive", "got sick with covid / covid test result: positive" and "got sick with covid / covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (May2021) 100 bpm, notes: over 100 bpm at rest and without activity; sars-cov-2 test: (Dec2021) negative; (Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness. Clinical course: Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient had not diagnosed with COVID-19.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events vaccination failure, Covid-19, Illness and suspect 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: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: had the first dose of Pfizer & a week later, I started losing my hair; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200468208 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "had the first dose of Pfizer & a week later, I started losing my hair".  Additional information included: The reporter stated that people keep telling me that there were conditions that caused hair loss. The patient found it funny that all of the sudden the patient had a condition. The only thing that changed in patient's life was the vaccine. The patient was mandated for the second dose just 4 weeks after the 1st one, which was April 2 and was terrified.  The lot number for bnt162b2 was not provided and will be requested during follow up.