chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Feeling cold, Inflammation, Pain, SARS-CoV-2 test
Clinical narrative: Feeling cold; Body inflamed; COVID-19; COVID-19; Pain/Sore; FACILITATED COLLECT  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): 22K-163-4255170-00.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Aug2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154253) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovering" and all described as "COVID-19"; PAIN (non-serious) with onset 01Jan2022, outcome "recovered" (07Jan2022), described as "Pain/Sore"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold"; INFLAMMATION (non-serious), outcome "unknown", described as "Body inflamed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. The action taken for adalimumab was dosage permanently withdrawn.   The reporter's causality for the events covid-19, feeling cold, pain, body inflamed with BNT162B2 was not reported. The reporter's causality for the event of felt cold and body inflamed with Humira was not provided. The reporter's causality for the event of covid-19 with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of pain/sore with Humira (adalimumab) was a reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE, covid-19, PAIN, INFLAMMATION, and FEELING COLD and BNT162B2.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination failure
Clinical narrative: Feeling cold; Body inflamed; COVID-19; COVID-19; Pain/Sore; FACILITATED COLLECT  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): 22K-163-4255170-00.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Aug2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154253) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovering" and all described as "COVID-19"; PAIN (non-serious) with onset 01Jan2022, outcome "recovered" (07Jan2022), described as "Pain/Sore"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold"; INFLAMMATION (non-serious), outcome "unknown", described as "Body inflamed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. The action taken for adalimumab was dosage permanently withdrawn.   The reporter's causality for the events covid-19, feeling cold, pain, body inflamed with BNT162B2 was not reported. The reporter's causality for the event of felt cold and body inflamed with Humira was not provided. The reporter's causality for the event of covid-19 with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of pain/sore with Humira (adalimumab) was a reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE, covid-19, PAIN, INFLAMMATION, and FEELING COLD and BNT162B2.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up/patient's toes were bothering; had stiffness in toes and feet; just tired due first covid shot.; 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-163-4142785-00 (AbbVie).  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up/patient's toes were bothering"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "had stiffness in toes and feet"; FATIGUE (non-serious), outcome "unknown", described as "just tired due first covid shot.". The action taken for upadacitinib was unknown. The patient's toes were bothering, thoughts might be having rheumatoid arthritis flare and had stiffness in toes and feet. He also experienced achy due to second Covid shot and just tired due first Covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare due to Covid-19 vaccination with Rinvoq (UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare due to Covid-19 vaccination with bnt162b2 (BNT162B2) was reported as possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2 .The impact of this report on the benefit/risk profile of the Pfizer drug 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: Blindness unilateral, Deafness
Clinical narrative: can't hear; she can't see with one eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "can't hear"; BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "she can't see with one eye". It was mentioned that the patient had an adverse event in the brain, that she could not see with one eye and could not hear, but not specified if it was regarding the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Heavy menstrual bleeding, Urinary incontinence
Clinical narrative: heavy menstrual bleeding; cant control her bladder; can't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 12 year-old female patient received bnt162b2 (BNT162B2), intramuscular (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: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "heavy menstrual bleeding"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "cant control her bladder"; GAIT INABILITY (non-serious), outcome "unknown", described as "can't walk".  Additional information: The reporter wasn't an HCP and called regarding Pfizer Covid-19 Vaccine. she spoke about a girl 12 years old who was in clinical trials, and presented an heavy menstrual bleeding, cant control her bladder, was in tube feeding, and can't walk. The reporter mentioned that a study had released animal trials with mice that had bioaccumulation in the ovaries; and she was concerned about reproductive harm.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: was diagnosed yesterday at the hospital with COVID; She was very sick all week long; was diagnosed yesterday at the hospital with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female 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: DRUG INEFFECTIVE (medically significant) with onset 05Dec2021, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 05Feb2022, outcome "unknown" and all described as "was diagnosed yesterday at the hospital with COVID"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick all week long". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Feb2022) positive. Therapeutic measures were taken as a result of covid-19, illness. Does Pfizer know how long it lasts before it wears out? Like with the flu vaccine every year you have to have a flu vaccine so does Pfizer know how long it lasts. Product clarified to be the COVID vaccine. Inquired if caller has received the COVID vaccine and she did not answer the question but states that she was diagnosed yesterday at the hospital with COVID. She was very sick all week long and then realized that's what the problem was, yesterday morning, early, she found out that she has COVID 19. They gave her Paxlovid because of her age, the pills, she is a senior, but she is just curious about the vaccine itself.  Caller mentioned having concerns/ questions regarding if Pfizer know how long the COVID vaccine lasts before it wears out? Like with the flu vaccine every year you have to have a flu vaccine so does Pfizer know how long it lasts. Inquired if caller has received the COVID vaccine and she did not answer the question but states that she was diagnosed yesterday at the hospital with COVID. She was very sick all week long and then realized that's what the problem was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Laboratory test, Lung infiltration, SARS-CoV-2 test
Clinical narrative: hypoxemia; BL pulmonary infiltrates; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DM2" (unspecified if ongoing); "COVID-19", start date: Dec2020 (not ongoing), notes: diagnosed with mild COVID infection in Dec2020, completely recovered after 1 week. Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 25Jan2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: HYPOXIA (hospitalization) with onset Feb2021, outcome "recovering", described as "hypoxemia"; LUNG INFILTRATION (hospitalization) with onset Feb2021, outcome "recovering", described as "BL pulmonary infiltrates". The patient was hospitalized for hypoxia, lung infiltration (hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result; laboratory test: negative. Therapeutic measures were taken as a result of hypoxia, lung infiltration. Clinical course: Patient diagnosed with mild COVID infection in Dec2020, completely recovered after 1wk. Then received 2 doses BNT162b2 in Jan/Feb2021, 2 weeks after second dose subsequently developed hypoxemia and BL pulmonary infiltrates requiring hospital admission, improved with steroids and treatment for CAP. Infectious workup negative. Sx and radiographic findings gradually resolved over 8wks. She then received a booster vaccination Dec2021. 3d later, developed dyspnea and hypoxemia which progressed over the following week. She was again admitted to hospital with hypoxemia and BL pulmonary infiltrates, again improved with steroids and CAP tx. Concern this may represent a pneumonitis or other inflammatory process related to vaccination given time course and recurrence. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The causal association of reported events in relation to BNT162B2 cannot be excluded on the basis of temporal relation.   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,Linked Report(s) : US-PFIZER INC-202200212386 same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Illness, SARS-CoV-2 test
Clinical narrative: Covid 28Jul2021; Covid 28Jul2021; Sick 3 weeks; brain fog two months; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2021, outcome "unknown" and all described as "Covid 28Jul2021"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick 3 weeks"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog two months"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jul2021) positive. The patient took the BOOSTER dose on Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Covid 28Jul2021; Covid 28Jul2021; Sick 3 weeks; brain fog two months; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2021, outcome "unknown" and all described as "Covid 28Jul2021"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick 3 weeks"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog two months"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jul2021) positive. The patient took the BOOSTER dose on Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: positive Covid test; positive Covid test; congestion; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid test"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; HEADACHE (non-serious), outcome "unknown", described as "slight headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: I have a positive Covid test. Minimal symptoms, but they include congestion and a slight headache. Received all 3 Pfizer vaccines. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, PPV, VARZOS
Symptoms: Plasma cell myeloma
Clinical narrative: multiple myeloma; This is a spontaneous report received from contactable physician from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation; pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunization; varicella zoster vaccine (VARICELLA ZOSTER VACCINE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLASMA CELL MYELOMA (medically signiifcant), outcome "unknown", described as "multiple myeloma". The physician stated that this was reported during a conversation that patient received vaccines at local pharmacies, including Covid vaccine, pneumococcal vaccine, and perhaps shingles vaccine, and patient subsequently was diagnosed with multiple myeloma. The reporter did not know whether any of the vaccines were Pfizer products and did not have much information available but wanted to report because the doctor expressed concern regarding administration of concomitant vaccines.  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 limited information provided, there is not sufficient evidence to support a causal relationship between the event "multiple myeloma" and COVID-19 Vaccine, PCV13. This case will be re-assessed when additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200239418 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19, PPV, VARZOS
Symptoms: Plasma cell myeloma
Clinical narrative: Multiple myeloma; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; pneumococcal 13-val conj vac (dipht crm197 protein) (MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; varicella zoster vaccine (MANUFACTURER UNKNOWN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLASMA CELL MYELOMA (medically significant), outcome "unknown", described as "Multiple myeloma". The physician stated that this was reported during a conversation that patient received vaccines at local pharmacies, including Covid vaccine, pneumococcal vaccine, and perhaps shingles vaccine, and patients subsequently were diagnosed with multiple myeloma. The reporter did not know whether any of the vaccines were Pfizer products and did not have much information available but wanted to report because the doctor expressed concern regarding administration of concomitant vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event plasma cell myeloma is assessed as likely an intercurrent condition that is unrelated to the use of BNT162B2 and pneumococcal 13-val conjugate vaccine. This assessment will be updated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200239390 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: Vomiting; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: she is in the hospital"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well". Clinical course was reported as, the reporter stated, "my fiance (patient) could not beat it and now she is stuck there, and we took the risk of taking your damn vaccine even though she did not need it and now she cannot even speak for herself, and she is in the hospital (further clarification unknown; captured as per verbatim) vomiting, not feeling well, etc. Reporter seriousness for all the events were, unspecified.  QR Comment: This case might be a split however further clarifications were unknown hence, split not made.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache
Clinical narrative: After receiving 3rd dose of vaccine in the morning, individual described it as if head was burning overnight with the back of head (near neck) still painful in the morning.; After receiving 3rd dose of vaccine in the morning, individual described it as if head was burning overnight with the back of head (near neck) still painful in the morning.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An adult male patient received bnt162b2 (BNT162B2), administration date 09Feb2022 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown), for COVID-19 immunisation.  The following information was reported: BURNING SENSATION (non-serious), HEADACHE (non-serious) all with onset 09Feb2022, outcome "unknown", and all described as "After receiving 3rd dose of vaccine in the morning, individual described it as if head was burning overnight with the back of head (near neck) still painful in the morning.".   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. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received treatment for the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: she felt something was wrong with the left side of her face. She described it as "numbing and swelling".; she felt something was wrong with the left side of her face. She described it as "numbing and swelling".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Jan2022 (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: SWELLING FACE (medically significant), HYPOAESTHESIA (non-serious) all with onset 30Jan2022, outcome "recovered" (Jan2022) and all described as "she felt something was wrong with the left side of her face. She described it as "numbing and swelling".".  Clinical information: The female patient stated that she received her first dose last 30Jan2022 and on the way home, she felt something was wrong with the left side of her face on same day(30Jan2022). She described it as numbing and swelling. She said that it lasted between 1hr to 1hr and 30 mins (Jan2022). She mentioned that she spoke with her doctor and was told to call Pfizer MI for information. She wanted to know, should she take her scheduled second dose after experiencing the mentioned side effects. Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1. Signs of a severe allergic reaction can include as Swelling of your face. Referred to her HCP for appropriate recommendations.  The lot number for bnt162b2 was not provided. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Colonoscopy, Computerised tomogram, Lymphadenopathy, Positron emission tomogram
Clinical narrative: Enlarged lymph nodes; Pain in abdomen; 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), intramuscular, administered in arm, administration date 26Jan2021 11:00 (Lot number: EL3302) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "NHL Lymphoma", start date: 2013, stop date: 2014, notes: Stop date: 2014 , Pertinent details: Rituxan as tx; "Lyme disease", start date: 2004, stop date: 2004, notes: Stop date: 2004; "Bell's Palsy", start date: 2004, stop date: 2004, notes: Stop date: 2004; "Possible recurrence of lymphoma", start date: 2021 (ongoing), notes: Stop date: Ongoing checked, Pertinent details: still waiting for final diagnosis; "Spinal tap", start date: 2004 (unspecified if ongoing); "colonoscopy", start date: 2013 (unspecified if ongoing), notes: Polyps. Family history included: "Pancreatic cancer" (unspecified if ongoing), notes: Mother: Pancreatic cancer, died 1996 at age 69; "Heart problems" (unspecified if ongoing), notes: Father: Heart problems, died 2015 at 88. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Jan2021, outcome "unknown", described as "Enlarged lymph nodes"; ABDOMINAL PAIN (non-serious) with onset 31Jan2021, outcome "unknown", described as "Pain in abdomen". The events "enlarged lymph nodes" and "pain in abdomen" 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 pain.  Additional Information: Vaccination Facility Type was Hospital. No prior vaccination (within 4 weeks).   Follow-Up (14Feb2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Swelling, Thrombosis
Clinical narrative: blood clots; calf pain; headaches/head pain; swelling; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "calf pain"; HEADACHE (non-serious), outcome "unknown", described as "headaches/head pain"; SWELLING (non-serious), outcome "unknown", described as "swelling". Additional information: Patient stated that her job requested booster vaccine or she will lose her job. Due to the adverse reactions that she had with the first 2 vaccines, and now calf pain and blood clots ruled out, she felt that Pfizer should hold her exempt from receiving this injection (Booster). She was fully vaccinated. She had swelling, head pain, and when she gets headaches it was so severe that she had to call out of work.    The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200249143 same patient/drug, different dose/AE
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jun2021 (Lot number: EW0185) at the age of 12 years as dose 2, single and administration date 13May2021 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Feb2022 21:30, outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Feb2022) negative, notes: Nasal Swab; (06Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 (Lot number: FH8030) at the age of 44 years as dose 3 (booster), single, administration date 25Mar2021 (Lot number: EK5730) as dose 2, single and administration date 04Mar2021 (Lot number: EJ1685) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; LISINOPRIL; ZOLMITRIPTAN. Past drug history included: Injectible cortisone, reaction(s): "Known allergies: Injectible Cortisone", notes: Known allergies: Injectible Cortisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022 08:00, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient received no other vaccine in four weeks. Prior to vaccination patient was not Covid-19 positive.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Lot number: FK5127) at the age of 11 years as dose 2 (tris), single and administration date 13Nov2021 (Lot number: FI0007) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022 21:00, outcome "recovering" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) negative, notes: Nasal Swab; (07Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: No other vaccine in four weeks, No covid prior vaccination and covid tested post vaccination was reported as yes.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Lot number: FJ1611) at the age of 40 years as dose 3 (booster), single, administration date 25Mar2021 (Lot number: EK5730) as dose 2, single and administration date 04Mar2021 (Lot number: EJ1685) 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 09Feb2022 08:00, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Feb2022) negative, notes: Nasal Swab, iHealth Covid-19 Antigen Rapid Test; (09Feb2022) positive, notes: Nasal Swab, iHealth Covid-19 Antigen Rapid Test. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course was reported as, Facility type vaccine was Pharmacy or Drug Store. Patient not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke at the hospital after the second Pfizer Covid-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant, hospitalization), outcome "unknown", described as "had a stroke at the hospital after the second Pfizer Covid-19 vaccine.".  Clinical Course: The reporter states that her son had a stroke at the hospital after the second Pfizer Covid-19 vaccine and her son's school wanted him to get the booster. The reporter would like to know how to go about getting a letter that he should not get the booster. The reporter states her son's HCP referred her to us and her son was 15 years old but was 14 years old when he received the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal.; Menstruation (period) cycle lasting longer than normal/Bleeding has gone on for 8 days now, when "my" normal cycle is 3-4 days.; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Lot number: FL3209) at the age of 25 Year(s) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs; "Food allergy" (unspecified if ongoing), notes: Known allergies: Mushrooms and "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8727; Anatomical Location: Left arm), administration date: 26Mar2021, when the patient was 24 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE;  Lot Number: EW0164; Anatomical Location: Left arm), administration date: 16Apr2021, when the patient was 24 years old, for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation (period) cycle lasting longer than normal/Bleeding has gone on for 8 days now, when "my" normal cycle is 3-4 days. Therapeutic measures were not taken as a result of menstruation irregular and heavy menstrual bleeding.  Additional information: It was reported that the patient's menstruation (period) cycle started 4 days earlier than normal and lasting longer than normal. Bleeding started while she was still taking the pills that have the active medication. Bleeding had gone on for 8 days at the time of reporting, when the normal cycle was 3-4 days. 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, it was unknown if the patient had 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: drug ineffective; COVID-19; 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): 22K-163-4269969-00 (AbbVie).  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jul2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single and intramuscular, administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN) The reporter's causality for the event(s) of COVID-19 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN was no reasonable possibility.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up of lower back pain and left hip pain; Early stage osteoarthritis; Severe fatigue; Rheumatoid arthritis flare up of lower back pain and left hip pain; Rheumatoid arthritis flare up of lower back pain and left hip pain; Sore arm; FACILITATED COLLECT  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): 22K-163-4250457-00 (AbbVie), US-PFIZER INC-202200230136 (Pfizer).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1154505) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", OSTEOARTHRITIS (non-serious), outcome "not recovered" and all described as "Early stage osteoarthritis"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Severe fatigue"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "Rheumatoid arthritis flare up of lower back pain and left hip pain". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of early stage osteoarthritis and sore arm after receiving covid-19 pfizer brand with rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up of lower back pain and left hip pain with rinvoq (upadacitinib) was a reasonable possibility.  The reporter's causality for the event vaccination site pain with Vaccination site pain with pfizer biontech covid-19 vaccine (tozinameran) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Suspect Adverse Reaction.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.