chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; Very sore arm at the injection site; Language:  Report about COVID vaccine: Yes Reporting type: AE Reporter type: Patient Patient occupation: None of the above  Dose received: More than 3 Most recent dose details: product=COVID 19, brand=Pfizer,  Brand unknown=False, Lot unknown=False,  Other vaccine same date details:other vaccine same date product=Pfizer, Other vaccine same date vaccine date=04Apr2022, Other vaccine same date  vaccine location=Left Arm  If other vaccine in four weeks: Yes Other medications in two weeks: No  If covid prior vaccination: No If covid tested post vaccination: No Known allergies: No Other medical history: NA  Start Date/Time: Pfizer 04Apr2022 10:00 AM Location of injection for vaccine received same date: Pfizer - Left Arm Location of injection for vaccine received within 4 weeks PRIOR: Tetanus  - Right Arm Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care List of any other medications the patient received within 2 weeks of vaccination:No  Reported Event: Continuing headache 30+ hours after vaccination.  Very sore arm at the injection site. Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Apr2022
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Deafness neurosensory
Clinical narrative: neurological hearing loss; deaf in one ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 2 (booster), single (Lot number: SK9895) at the age of 63 years 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: DEAFNESS (medically significant) with onset 03Apr2022, outcome "unknown", described as "deaf in one ear"; DEAFNESS NEUROSENSORY (medically significant) with onset 03Apr2022, outcome "unknown", described as "neurological hearing loss".  Clinical information: The patient had no history of any side effects with this Vaccine until now. Patient stated he wanted to report a side effect and then maybe get some guidance on what to do next? He was having neurological hearing loss after his 2nd Booster (Clarified and confirmed as Pfizer Covid-19 Vaccine). He did not have this issue before and from doing research, he thought this was somewhat of a rare side effect that had happened to him need to get medical attention immediately if he wanted it reversed. He was deaf in one ear. Site of vaccination was pharmacy.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID: (174529). The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "COVID-19 infection". It was reported that the patient was diagnosed with COVID-19 infection after being fully vaccinated with the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 10Feb2021 as dose 2, single (Lot number: EL3247) and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022, outcome "unknown" and all described as "covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive, notes: Unknown.   Additional information: It was unknown if the patient diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced symptoms as fatigue and myalgia on 05Apr2022. It was unknown if treatment to ae. It was unknown if patient COVID tested prior vaccination. Patient was COVID tested post vaccination on 05Apr2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a causal association between reported events drug ineffective, Covid-19 and suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: A little redness, soreness; a little redness, soreness; This is a spontaneous report received from non-contactable reporter(s) (Other 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: PAIN (non-serious), outcome "unknown", described as "A little redness, soreness"; ERYTHEMA (non-serious), outcome "unknown", described as "a little redness, soreness".  Additional information: It was reported that, patient age was 0- 9 years. Reports side effects from COVID vaccine among other patients in his practice. It was stated that a little redness, soreness, that type of stuff, but right, that's normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Her hair fell out as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200531842 (Pfizer Inc).  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Her hair fell out as well".  Additional information: The reporter nephew married a girl who was in her 30's. Her hair fell out as well. So, it was something with the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she caught COVID and is fully vaccinated; she caught COVID and is fully vaccinated; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she caught COVID and is fully vaccinated". 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 available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I was literally down every, like three days after every shot; This is a spontaneous report received from non-contactable reporter(s) (Other 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I was literally down every, like three days after every shot".  Additional information: Patient age: 40-44 years. Experienced side effects after COVID vaccine. Stated I was like, I was literally down every, like three days after every shot. Action taken: Unknown, Outcome: Unknown. Causality: Not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caught COVID after being fully vaccinated; Caught COVID after being fully vaccinated; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An (10-17 years) adolescent female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 caught COVID after being fully vaccinated.   Clinical course: It was reported that, the patient had COVID in January. She was due for her booster. Also reported that, she was fully inoculated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Computerised tomogram, Fibrin D dimer, Investigation
Clinical narrative: States her fingers could not close; she had problems with her wrists and her shoulders; she had problems with her wrists and her shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2022 (Batch/Lot number: unknown) at the age of 76 years 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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "States her fingers could not close"; JOINT INJURY (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "she had problems with her wrists and her shoulders". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Limb injury, Mammogram, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: States her fingers could not close; she had problems with her wrists and her shoulders; she had problems with her wrists and her shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2022 (Batch/Lot number: unknown) at the age of 76 years 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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "States her fingers could not close"; JOINT INJURY (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "she had problems with her wrists and her shoulders". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: palpitations; severe chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 2, single (Lot number: EM9810), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassemia Trait" (unspecified if ongoing), notes: other medical history: Thalassemia Trait; "Mitral Valve Prolapse" (unspecified if ongoing), notes: other medical history: Mitral Valve Prolapse. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot number: EL3247, vaccine location: Left arm), administration date: 15Jan2021, for Covid-19 Immunization. The following information was reported: PALPITATIONS (disability, medically significant) with onset 2021, outcome "unknown"; CHEST PAIN (disability, medically significant) with onset 2021, outcome "unknown", described as "severe chest pain". The events "palpitations" and "severe chest pain" required emergency room visit. Therapeutic measures were taken as a result of palpitations, chest pain.  Additional Information: No allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Adverse event: Developed tingling, burning and felt like shards of glass were being thrown inside the flesh in my lower extremities. Also had the most severe pain in my feet, felt like I was walking on my bones and there were no padding/flesh on the soles of my feet within a week of receiving the booster.Dose received: 3, Most recent dose details: product=COVID 19, brand=Pfizer, Brand unknown=False, Lot number=33036BD, Lot unknown=False, Administration date=16Feb2022, Dose number=3, Vaccine location=Left arm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Nasal congestion, Nasopharyngitis, Ophthalmological examination
Clinical narrative: nasal congestion; Slight fever 99-101; Brain fog disability; Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 73 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cataracts", start date: 2021, stop date: Feb2022; "Cataract surgery", start date: Feb2022 (unspecified if ongoing), notes: Cataracts removed, intraocular monofocal lens. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 12Oct2021 as dose number unknown, single. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 14Oct2021, outcome "recovered" (21Oct2021), described as "Cold symptoms"; FEELING ABNORMAL (disability) with onset Nov2021, outcome "recovering", described as "Brain fog disability"; NASAL CONGESTION (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever 99-101". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99?-101?; Ophthalmological examination: (03Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye; (10Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye. Therapeutic measures were not taken as a result of feeling abnormal.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nasal congestion; Slight fever 99-101; Brain fog disability; Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 73 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cataracts", start date: 2021, stop date: Feb2022; "Cataract surgery", start date: Feb2022 (unspecified if ongoing), notes: Cataracts removed, intraocular monofocal lens. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 12Oct2021 as dose number unknown, single. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 14Oct2021, outcome "recovered" (21Oct2021), described as "Cold symptoms"; FEELING ABNORMAL (disability) with onset Nov2021, outcome "recovering", described as "Brain fog disability"; NASAL CONGESTION (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever 99-101". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99?-101?; Ophthalmological examination: (03Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye; (10Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye. Therapeutic measures were not taken as a result of feeling abnormal.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: experienced an itching rash over large areas of my body. This included arm pits, waist, part of chest, palms of hands and bottom of feet.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2022 19:00 (Batch/Lot number: unknown) at the age of 74 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Other vaccine same date product= Pfizer, Other vaccine same date dose number= 1, Other vaccine same date vaccine location= Arm), for COVID-19 Immunization, reaction(s): "None"; Bnt162b2 (Other vaccine same date product= Pfizer, Other vaccine same date dose number= 2, Other vaccine same date vaccine location= Arm), for COVID-19 Immunization, reaction(s): "None"; Bnt162b2 (Other vaccine same date product= Pfizer, Other vaccine same date dose number= 3, Other vaccine same date vaccine location= Arm), for COVID-19 Immunization, reaction(s): "None". The following information was reported: RASH PRURITIC (non-serious) with onset 06Apr2022 01:00, outcome "recovering", described as "experienced an itching rash over large areas of my body. This included arm pits, waist, part of chest, palms of hands and bottom of feet.". Therapeutic measures were not taken as a result of rash pruritic.  Additional information: About a day after receiving the shot, I experienced an itching rash over large areas of my body. This included arm pits, waist, part of chest, palms of hands and bottom of feet. Other vaccine in four weeks is no. Other medications in two weeks is yes. covid prior vaccination is no. covid test post vaccination is no. Known allergies is none. Other medical history is none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had all the vaccines from Pfizer; had all the vaccines from Pfizer; 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-202200531233.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Patient" (ongoing); "Covid" (unspecified if ongoing), notes: coughing and feeling week because of the Covid. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had all the vaccines from Pfizer".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Computerised tomogram, Vaccination failure
Clinical narrative: experienced COVID-19 pneumonia; experienced COVID-19 pneumonia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing), notes: Osteopenia, unchanged osteolytic lesions, and unchanged vertebral compression fracture deformities; "osteolytic lesions" (unspecified if ongoing), notes: Osteopenia, unchanged osteolytic lesions, and unchanged vertebral compression fracture deformities; "vertebral compression fracture deformities" (unspecified if ongoing), notes: Osteopenia, unchanged osteolytic lesions, and unchanged vertebral compression fracture deformities. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 28Jan2022, outcome "unknown", COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 28Jan2022, outcome "recovered" (02Feb2022) and all described as "experienced COVID-19 pneumonia". The patient was hospitalized for covid-19 pneumonia (start date: 28Jan2022, discharge date: 02Feb2022, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: Chest X-ray: (28Jan2022) Patchy bibsilar airspace opacity concerning for pn, notes: Patchy bibsilar airspace opacity concerning for pneumonia; Computerised tomogram: (28Jan2022) New multifocal pneumonia 2., notes: New multifocal pneumonia 2. Osteopenia, unchanged osteolytic lesions, and unchanged vertebral compression fracture deformities. CT Chest without IV Contract.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 pneumonia 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.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients; her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "Caller states she is calling for stability data on the Pfizer Covid Vaccine (grey cap)? Caller states her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200531244 same reporter/AE/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: fatigue; flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms".  Additional Information: When the patient received the Pfizer for first two vaccines, experienced flu like symptoms and fatigue for two days. The patient wanted to report symptoms seeing as they were not the norm. The patient was interested in knowing if others have reported similar side effects and was looking forward to have some feedback.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: she got the Omicron variant after the 2 shots; she got the Omicron variant after the 2 shots.; she ached all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002191). The reporter is the patient.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), outcome "unknown", described as "she got the Omicron variant after the 2 shots"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "she got the Omicron variant after the 2 shots."; PAIN (non-serious), outcome "recovered", described as "she ached all over". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Caller stated that she got both her vaccines from Pfizer, but then she got the Omicron variant after the 2 shots. Caller states everyone now knows that the BA1 variant changed so much that the vaccines did not protect her. Caller states she was sure she got the Omicron variant because that what was prevalent in her area. Caller states her husband got it first and then gave it to her. Caller states she got it on a holiday, and she ached all over, but she got over it fast, it did not bother her too much and she was in her 70s. Caller states she probably now has natural immunity, which used to say was the best but now who knows what they say. This was a product complaint to report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Investigation
Clinical narrative: have recently been diagnosed with anemia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old 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: ANAEMIA (non-serious), outcome "unknown", described as "have recently been diagnosed with anemia.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient have recently been diagnosed with anemia. Patient never had this before and he was 69. Patient had many tests to find the cause, but so far nothing. Patient had question Could the vaccines/booster cause this?  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaemia
Clinical narrative: have recently been diagnosed with anemia.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old 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: ANAEMIA (non-serious), outcome "unknown", described as "have recently been diagnosed with anemia.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient have recently been diagnosed with anemia. Patient never had this before and he was 69. Patient had many tests to find the cause, but so far nothing. Patient had question Could the vaccines/booster cause this?  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Investigation
Clinical narrative: anemia; 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 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 (Dose=1, Caller is a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine), for Covid-19 Immunization; Covid 19 (Dose=2, Caller is a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine), for covid-19 immunization. The following information was reported: ANAEMIA (non-serious), outcome "unknown", described as "anemia". Therapeutic measures were taken as a result of anaemia.  Additional information: Call received from agent (withheld), NTID: (withheld), Reportum#: (withheld). Caller dropped the call while she was on hold during the warm transfer. Caller was a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine. Caller was asking if there was a correlation between the vaccine and anemia since she started experiencing anemia after taking the doses. Callback attempt made as per attached VR-Callback, no answer but was able to leave a voice message (Callback attempt #1: Wed, 06Apr2022 1:36 PM). E-transmitting to agent. Possible AE duplication. Numbers were really low; had to have 2 iron infusions. Is report related to a study or programme: No. Is Covid Vaccine a Pfizer product: Yes. Covid Vaccine manufacturer: unspecified. NDC number of Covid Vaccine: Not Provided. Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report. Expiry Date of Covid Vaccine: Not Provided. Other Products: Not Provided. Caller states that she was calling about the Pfizer Product: Covid Vaccine. Says that she has a question. States she is 69 years old and has never had this problem. She had developed anemia. States that she is wondering if there is any correlation with that and the vaccines? Caller states that she has had 2 shots and one booster dose. Says she was not sick from the anemia, but her numbers were really low and she had to have 2 iron infusions. Caller declines to complete safety report at this time. Caller declines to provide email address.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia
Clinical narrative: anemia; 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 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 (Dose=1, Caller is a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine), for Covid-19 Immunization; Covid 19 (Dose=2, Caller is a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine), for covid-19 immunization. The following information was reported: ANAEMIA (non-serious), outcome "unknown", described as "anemia". Therapeutic measures were taken as a result of anaemia.  Additional information: Call received from agent (withheld), NTID: (withheld), Reportum#: (withheld). Caller dropped the call while she was on hold during the warm transfer. Caller was a 69-year old patient who has taken both doses of the primary series and a booster dose of the Pfizer Covid 19 vaccine. Caller was asking if there was a correlation between the vaccine and anemia since she started experiencing anemia after taking the doses. Callback attempt made as per attached VR-Callback, no answer but was able to leave a voice message (Callback attempt #1: Wed, 06Apr2022 1:36 PM). E-transmitting to agent. Possible AE duplication. Numbers were really low; had to have 2 iron infusions. Is report related to a study or programme: No. Is Covid Vaccine a Pfizer product: Yes. Covid Vaccine manufacturer: unspecified. NDC number of Covid Vaccine: Not Provided. Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report. Expiry Date of Covid Vaccine: Not Provided. Other Products: Not Provided. Caller states that she was calling about the Pfizer Product: Covid Vaccine. Says that she has a question. States she is 69 years old and has never had this problem. She had developed anemia. States that she is wondering if there is any correlation with that and the vaccines? Caller states that she has had 2 shots and one booster dose. Says she was not sick from the anemia, but her numbers were really low and she had to have 2 iron infusions. Caller declines to complete safety report at this time. Caller declines to provide email address.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Headache, Hypoaesthesia, Inflammation, Peripheral swelling
Clinical narrative: swelling in legs; joints inflamation; heels and ankles inflamation; headaches; numbness in hands; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in legs"; ARTHRITIS (non-serious), outcome "unknown", described as "joints inflammation"; INFLAMMATION (non-serious), outcome "unknown", described as "heels and ankles inflammation"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in hands".  Additional Information: Patient received the primary series of Pfizer Vaccine last year and a Moderna vaccine as a booster dose in 15Dec2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Feb2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) between 4'4" and 4'6", notes: her son is between 4'4" and 4'6"; SARS-CoV-2 test: (10Feb2022) positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: body itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "body itching". Therapeutic measures were taken as a result of pruritus.  Additional Information: Reported by Consumer. Description of Event is Approx 36 hours after receiving COVID vaccine had whole body itching, no rash, resolved a few hours and after 50 mg dose of diphenhydramine. Name of Product COVID vaccine. Country of Occurrence. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: severe seasonal allergies have disappeared after receiving my Covid Booster Vaccine; 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 number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: my severe seasonal allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "severe seasonal allergies have disappeared after receiving my Covid Booster Vaccine".  Additional information: Subject: Patient Assistance. Customer Verbatim: Patient just wanted someone to know at Pfizer that patient's severe seasonal allergies had disappeared after receiving patient's COVID Booster 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: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The reporter read online about 2 different formulations of the Pfizer covid vaccine gray cap formulation, said the article came from an official site which she couldn't remember, says it might have been from the CDC but since she got the gray cap with lot# of FK9895 and says she did not have any side effect with the vaccine. The reporter wanted to know the inactive ingredients of the vaccine if there would be differences for each formulations. The reporter said the shot from gray cap vaccine went well as compared to her purple cap dose which she had some minor reaction which is headache. The reporter said the event was nothing serious and fairly mild.   Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product expiration date issue
Clinical narrative: Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FD0809, Expiration Date: Oct2021) 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: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022". Additional information; vaccine being given after expiration date. Purple top COVID vaccine lot FD0809 was set to expire on Oct2021 on original labeling and then with extended expiration date Jan2022. It was held at ultra-cold temperature, then taken out and refrigerated one week. The vaccines were given Apr1-5. Could you please tell us if there is any additional stability testing done to extend the expiration date of the product Outbound call back at 2:31 PM  The patient stated this was reported to her from another pharmacist and that 50 people total were administered the vaccines. She does not have any further details regarding patient information/demographics. Agent e-transmitting as AE, patient declined warm transfer to agent stating she didn't have any additional information. can you give us any guidance on re-vaccination for the patients who received the expired vaccine. Response: This is to confirm receipt of inquiry. Please note this case as INT-00620080. Agent will follow-up with the customer. Kind Regards,  No follow-up attempts are possible, No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Guillain-Barre syndrome
Clinical narrative: This is a literature report for the following literature source(s): "Guillain-Barre Syndrome with Rapid Onset and Autonomic Dysfunction Following First Dose of Pfizer-BioNTech COVID-19 Vaccine: A Case Report". 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "Rapid Onset and Autonomic Dysfunction". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site inflammation
Clinical narrative: Pain in the arm; inflammation around the injection site; low grade headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2022 17:30 (Lot number: FJ5383) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood, pressure; "Overweight" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: mushrooms" (unspecified if ongoing), notes: Known allergies: mushrooms. Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; ADVAIR; ALBUTEROL [SALBUTAMOL]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2022, outcome "recovered" (05Apr2022), described as "Pain in the arm"; VACCINATION SITE INFLAMMATION (non-serious) with onset 30Mar2022, outcome "recovered" (06Apr2022), described as "inflammation around the injection site"; HEADACHE (non-serious) with onset 30Mar2022, outcome "recovered" (01Apr2022), described as "low grade headache". Therapeutic measures were not taken as a result of pain in extremity, vaccination site inflammation, headache.  No follow-up attempts are possible. No further information is expected.