chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: booster; headache; nausea; chills; body aches; fatigue; This is a spontaneous report received from a contactable reporter (Other-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional information: On day 2 after receiving Pfizer Covid booster, the patient experienced headache, nausea, chills, body aches and fatigue. The patient was still experiencing headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Influenza like illness
Clinical narrative: flu-like symptoms; Chills; fatigue; headache; dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 09:30 (Lot number: FG3527) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 33 years old, for COVID-19 Immunization, reaction(s): "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ", "flu like symptoms (chills, headache and tiredness) ". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 09:30, outcome "unknown", described as "dose received: 3"; INFLUENZA LIKE ILLNESS (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "flu-like symptoms"; CHILLS (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 07Dec2021 21:30, outcome "recovering", described as "headache". Therapeutic measures were taken as a result of influenza like illness, chills, fatigue, headache. Additional information: The patient had no list of any other medications received within 2 weeks of vaccination.  Acetaminophen received as treatment for the adverse event.  The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021147534 same patient/drug, different dose/,similar vent
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: body aches for 24 hrs; COVID19 Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 14:30 (Lot number: FH8027) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 44 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP-6955, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 14:30, outcome "unknown", described as "COVID19 Booster"; PAIN (non-serious) with onset 06Dec2021 20:00, outcome "recovered" (07Dec2021 20:00), described as "body aches for 24 hrs". Therapeutic measures were not taken as a result of pain. Additional Information: The patient had no list of any other medications received within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.  The patient had no known allergies  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Gait disturbance, Swelling
Clinical narrative: barely stand and walk; Left underarm swelled up like a softball, very tender to touch; joint pain; Left underarm swelled up like a softball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Dec2021 13:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer survivor" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Allergy:  hazelnuts" (unspecified if ongoing); "Allergy: walnuts" (unspecified if ongoing); "Allergy: Pecans" (unspecified if ongoing); "Allergy: Brazil nuts" (unspecified if ongoing). The patient took concomitant medications (other unspecified medications received within 2 weeks of vaccination). Past drug history included: Keflex, reaction(s): "Allergy: Keflex"; Augmentin, reaction(s): "Allergy: Augmentin". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: Apr2021, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: Mar2021, for Covid-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  The following information was reported: GAIT DISTURBANCE (medically significant) with onset 04Dec2021, outcome "recovering", described as "barely stand and walk"; AXILLARY PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "Left underarm swelled up like a softball, very tender to touch "; ARTHRALGIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "joint pain"; SWELLING (non-serious) with onset 04Dec2021, outcome "recovering", described as "Left underarm swelled up like a softball". Patient described the clinical course of events as follows: Woke up the next day with severe joint pain. Could barely stand and walk. Left underarm swelled up like a softball, very tender to touch or even put ice on. Joint pain dissipated after 3 days, but underarm is still swollen and tender to touch. Therapeutic measures were not taken as a result of gait disturbance, axillary pain, arthralgia, swelling.  The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immunisation, Myalgia, Pyrexia
Clinical narrative: dizziness; severe fever; severe headache; severe muscle aches; booster; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 14:30 (Lot number: F63527) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 11Nov2021; and an unspecified contraception pill (received within 2 weeks of vaccination). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Right), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right), administration date: 27Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 14:30, outcome "unknown", described as "booster"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "recovered" (07Dec2021), described as "dizziness"; PYREXIA (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (06Dec2021), described as "severe fever"; HEADACHE (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (08Dec2021), described as "severe headache"; MYALGIA (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (06Dec2021), described as "severe muscle aches". Therapeutic measures were taken as a result of pyrexia, headache, myalgia and included ibuprofen 400 mg. Clinical course: The following morning after receiving the vaccine severe fever, severe headache and severe muscle aches started. 30 minutes after taking 400 mg ibuprofen, these events got better but restarted an hour later. This was repeated 3-times during that day. The following day moderate headache was still ongoing and mild dizziness started. The fever and muscle aches resolved. By the 3rd day only mild headache was ongoing, the dizziness was resolved. Recovered fully from all events by the 4th day after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Gait disturbance, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: Inappropriate schedule of vaccine administered; Fluids for dehydration after dose 2; Legs not working; Unable to stand or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included: "Diabetes" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: TRULICITY (received within 2 weeks of vaccination). Vaccination history included: Bnt162b2 (First dose (location of injection: left arm)), administration date: 23Feb2021, when the patient was 78 years old, for COVID-19 immunization. The following information was reported: DEHYDRATION (medically significant) with onset 2021, outcome "unknown", described as "Fluids for dehydration after dose 2"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Legs not working"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "Unable to stand or walk"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "fluids for dehydration after dose 2", "legs not working" and "unable to stand or walk" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dehydration. Post the vaccination, the patient has not been tested for COVID-19.  Then, on 07Dec2021 at 12:45 PM, the patient received the third dose of bnt162b2 (BNT162B2), administered in arm left, (Batch/Lot number: unknown), for covid-19 immunisation.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ataxia
Clinical narrative: ATAXIA; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 5 year-old 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: ATAXIA (hospitalization), outcome "unknown", described as "ATAXIA".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Heart rate, Heart rate increased, Myocarditis
Clinical narrative: myocarditis; chest pains; racing heart; pounding; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization more than 6 months ago. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; CHEST PAIN (non-serious) with onset 2021, outcome "recovered", described as "chest pains"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "pounding"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovered", described as "racing heart". About 14 hours after receiving the second dose, the patient developed chest pains and a pounding, racing heart. It resolved by the next day, so the patient never sought medical care. His symptoms and their presentation seem consistent with myocarditis. What was Pfizer's recommendation for someone seeking a booster shot that had myocarditis after the second shot.  The patient underwent the following laboratory tests and procedures: heart rate: (2021) racing heart. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported myocarditis, chest pain and Heart rate increased are related to BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: DOSE 3 (BOOSTER), SINGLE; Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered; Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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) all with onset 09Dec2021, outcome "unknown" and all described as "Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered"; IMMUNISATION (medically significant), outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) positive. Clinical course: The reporter mentioned that she had two patients who got their Pfizer COVID-19 vaccine including their booster, then tested positive on COVID after that.  Tested positive for COVID after a total of 3 doses of Pfizer COVID-19 vaccine had been administered. The reported event from date/to date/outcome are all unknown; but she thinks the test may have been taken today, 09Dec2021 and she believes it was a home test. She also reported that the patient reported no symptoms, only a positive result for COVID on that test. As far as caller is aware there has not been any further testing or anything done. The reporter has no information to provide regarding any further testing/investigations, treatment or medical interventions performed relative to this event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101759070 same reporter, product, events; different patients
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait inability, Illness, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Got very sick; Arthritis got worse; her body was starting to swell; she was not being able to walk; She has pain every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (ongoing), notes: She has had arthritis for a long time. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis"; ILLNESS (non-serious), outcome "unknown", described as "Got very sick"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis got worse"; SWELLING (non-serious), outcome "unknown", described as "her body was starting to swell"; GAIT INABILITY (non-serious), outcome "unknown", described as "she was not being able to walk"; PAIN (non-serious), outcome "unknown", described as "She has pain every day". She didn't know if this is a side effect from 2nd shot or not. She felt like it may have been a side effect. She had pain every day, swelling every day, can't walk, and it was hard.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Rheumatoid arthritis; Got very sick; Arthritis got worse; her body was starting to swell; she was not being able to walk; She has pain every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (ongoing), notes: She has had arthritis for a long time. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis"; ILLNESS (non-serious), outcome "unknown", described as "Got very sick"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis got worse"; SWELLING (non-serious), outcome "unknown", described as "her body was starting to swell"; GAIT INABILITY (non-serious), outcome "unknown", described as "she was not being able to walk"; PAIN (non-serious), outcome "unknown", described as "She has pain every day". She didn't know if this is a side effect from 2nd shot or not. She felt like it may have been a side effect. She had pain every day, swelling every day, can't walk, and it was hard.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: with the 2nd dose she had an anaphylactic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101758384 (Pfizer).  A 21-year-old female patient received BNT162B2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose 2 , single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1), for Covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant), outcome "unknown", described as "with the 2nd dose she had an anaphylactic reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Immunisation
Clinical narrative: Booster; Crohn's disease; This is a solicited report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4186548-00 (AbbVie).  Solicited report from the (private) by a consumer of an adult female with an event of non-serious Crohns symptoms with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Crohns Symptoms. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 27Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. On 19Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. On 28Aug2021, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer/ Biontech. The causality assessment per reporter for the event Crohn's disease with BNT162B2 was reported as reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunisation and Crohn's disease and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on covid test; tested positive on covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer [Pharmacy Technician who is also the patient] ) from medical information team and a sales representative. A 72 year-old male patient received BNT162B2 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive on covid test". Caller is a company Employee. Caller wanted to report an AE regarding consumers "they have gotten Pfizer covid-19 vaccine including booster" and apparently tested positive on covid test. Caller said that she feel like she's obligated to report it. Caller also added that she cannot share the consumers information to me, but she mentioned that the one she talked to is a woman and her husband, the wife age "about 66" and the husband age "about 72" (caller is not sure about the age and just tried to guess it). It was further reported that the patient tested positive for COVID after a total of 3 doses of Pfizer Covid-19 Vaccine had been administered. She thinks the test may have been taken on 09Dec2021 and she believes it was a home test. She also reported that the patient reported no symptoms, only a positive result for COVID on that test. As far as caller is aware there has not been any further testing or anything done. The patient underwent the following laboratory tests and procedures: COVID-19 test: (09Dec2021) positive.  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, Illness, Immunisation, Movement disorder, Pyrexia
Clinical narrative: booster shot; became terribly ill; fever; she felt numb and that she could not move.; she felt numb and that she could not move.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (COMIRNATY), administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "original Covid Virus" (unspecified if ongoing), notes: in Apr (unspecified year). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Manfacturer: Pfizer), for COVID-19 Immunization; Bnt162b2 (Dose:2, Manfacturer: Pfizer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; ILLNESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "became terribly ill"; PYREXIA (non-serious) with onset 08Dec2021, outcome "unknown", described as "fever"; HYPOAESTHESIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 08Dec2021, outcome "unknown" and all described as "she felt numb and that she could not move.".  Additional information: The patient was in her 70s. The patient got sick from the original Covid Virus in Apr. Then the patient got two Pfizer Covid Vaccines, then 08Dec2021 the patient got seriously ill when she got the booster shot. The patient had a fever and all the original symptoms she experienced with the Covid-19 virus. One serious thing was that she felt numb and that she could not move. She asked her son to bring the walker to help her site up and walk, go to the bathroom which helped her to breath and come out from that numbness. The reporter stated that it was strange that within a few hours she got sick from the booster. The reporter was asked what the test showed after getting sick and having the vaccine. The reporter was unsure of the type of test, so unable to provide an answer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Renal pain
Clinical narrative: severe kidney pain; she had her third dose of the Pfizer COVID-19 shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 08:20 (Lot number: FH8020) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose; Lot Number / Expiry Date: EW0162/ Unknown; Anatomical Location:  Left arm), administration date: 07Apr2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Second dose ; Lot Number / Expiry Date: EW0179/ Unknown; Anatomical Location: Right arm), administration date: 29Apr2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "Numbness"; Bnt162b2 (Second dose; Lot Number / Expiry Date: EW0179/ Unknown; Anatomical Location: Right arm), administration date: 29Apr2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Tingling". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "she had her third dose of the Pfizer COVID-19 shot"; RENAL PAIN (non-serious) with onset 09Dec2021 04:00, outcome "recovering", described as "severe kidney pain". Therapeutic measures were taken as a result of renal pain. Additional information: She woke up at 4 am that morning and had to take ADVIL because it (severe kidney pain) was so painful. The pain was currently dull. She would probably go to the doctor today or tomorrow depending on how the pain feels after the medicine (ADVIL) wears off.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: She got pregnant way after she received the 2 doses but experienced miscarriage; This is a spontaneous report received from a contactable reporter (nurse, a retired licensed vocational nurse) from Medical Information team.  A 31 year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown," described as "she got pregnant way after she received the 2 doses, but experienced miscarriage." The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient was the reporter's daughter-in-law and wanted to know if this might be related to the vaccine.  The batch/lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the causal association between the event miscarriage and the suspect drug BNT162B2 is assessed possibly unrelated  The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Immunisation, Pulmonary thrombosis
Clinical narrative: Booster; blood clots in both lungs; blood clots in both lungs and legs; face redness; Face swelling; dizziness; short of breath; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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 (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; PULMONARY THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs"; THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs and legs"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "face redness"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "Face swelling"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "short of breath". The events "blood clots in both lungs", "blood clots in both lungs and legs", "face redness", "face swelling", "dizziness" and "short of breath" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative x 2. Therapeutic measures were taken as a result of pulmonary thrombosis, thrombosis. Clinical course: With booster, the patient had some side effects immediately. Fortunately, the patient went to ER. The patient had no preexisting condition nor genetic cause for this and believed in the vaccine but would not want to die from it. Now the patient was on blood thinners for the rest of life as a precaution.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face, Thrombosis
Clinical narrative: Booster; blood clots in both lungs; blood clots in both lungs and legs; face redness; Face swelling; dizziness; short of breath; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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 (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; PULMONARY THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs"; THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs and legs"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "face redness"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "Face swelling"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "short of breath". The events "blood clots in both lungs", "blood clots in both lungs and legs", "face redness", "face swelling", "dizziness" and "short of breath" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative x 2. Therapeutic measures were taken as a result of pulmonary thrombosis, thrombosis. Clinical course: With booster, the patient had some side effects immediately. Fortunately, the patient went to ER. The patient had no preexisting condition nor genetic cause for this and believed in the vaccine but would not want to die from it. Now the patient was on blood thinners for the rest of life as a precaution.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Tinnitus, Vision blurred
Clinical narrative: tingling on the left side of my spine; pulsatile tinnitus very, very loud; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER -BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm right (Lot number: EN6201) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Right), administration date: 02Apr2021, for COVID-19 Immunization, reaction(s): "Pulsatile tinnitus". The following information was reported: SPINAL PAIN (disability), outcome "not recovered", described as "tingling on the left side of my spine"; TINNITUS (disability), outcome "not recovered", described as "pulsatile tinnitus very, very loud"; VISION BLURRED (disability), outcome "not recovered", described as "blurry vision". The events "tingling on the left side of my spine", "pulsatile tinnitus very, very loud" and "blurry vision" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of spinal pain, tinnitus, vision blurred.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability
Clinical narrative: severe headache; could not work the first 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2021 15:45 (Lot number: EL9264) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts, mushrooms, oranges, grapefruit" (unspecified if ongoing); "dust allergy" (unspecified if ongoing); "Allergy to molds" (unspecified if ongoing); "kidney donor" (unspecified if ongoing). The patient took concomitant medications: unspecified estrogen patch. Past drug history included: Oxycodone, reaction(s): "drug allergy". The following information was reported: HEADACHE (non-serious) with onset 27Jan2021 16:00, outcome "not recovered", described as "severe headache"; IMPAIRED WORK ABILITY (non-serious) with onset 27Jan2021 16:00, outcome "not recovered", described as "could not work the first 2 days". The events "severe headache" and "could not work the first 2 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: He did not feel good with first two Pfizer COVID vaccines; Low grade fever; muscle aches; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Dec2020 (Lot number: EH9899) at the age of 52 years as dose 1, single and intramuscular, administered in deltoid right, administration date 08Jan2021 (Lot number: EL3246, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "he dose not smoke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "He did not feel good with first two Pfizer COVID vaccines"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: He did not feel good with first two Pfizer COVID vaccines, but did not feel out of normal from what was explained would happen. He had a Low grade fever and muscle aches and nausea and headache. He was just overweight, but no medical conditions.
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Immunisation
Clinical narrative: booster; experienced loss of hearing in one ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "experienced loss of hearing in one ear".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain in extremity, Panic reaction, Stress
Clinical narrative: freaking out/panicking; short of breath/can't get a full breath in; chest was hurting; Sore arm; stressed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FC3181) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypotension/Low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PANIC REACTION (non-serious) with onset 09Dec2021, outcome "unknown", described as "freaking out/panicking"; DYSPNOEA (non-serious) with onset 09Dec2021, outcome "unknown", described as "short of breath/can't get a full breath in"; CHEST PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "chest was hurting "; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021, outcome "unknown", described as "Sore arm"; STRESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "stressed ". Therapeutic measures were taken as a result of panic reaction, stress.  Additional information: Patient stated that she was okay and was probably just freaking out for nothing. She didn't know. Patient stated, "So, I am not sitting here freaking out every 5 seconds when I noticed something. I am just like short of breath, holding out there and it just kind feels like, I can't get a full breath in. I don't know, how to explain and my chest was hurting earlier. I am fine. " Stated, "I am one of those people that panic and I like, when I can't breath, I think I am going to die and like, I didn't want to get vaccinated." Treatment: patient stated she took a 0.25 Alprazolam pill to treat the panic that she was experiencing from it because panicking can make your breathing worse. So, she took one of those and she took an  gummy it's like some sort of natural herbs, that's good for stress relief. She took those today to try to keep her from panicking or freaking out of the anything and making her breathing any worse.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Vaccination site pain
Clinical narrative: gotten covid 2; gotten covid 2; sore arm were they poked him; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (Pfizer covid 19 vaccine), administered in arm, administration date 2021 (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. Vaccination history included: Flu shot, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "gotten covid 2"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm were they poked him". The clinical course was reported as follows: He got covid 19 vaccine . The way a lot of people made it seem he was scared but his work said he needed it. He got the shots and no side effects sore arm were they poked him but nothing bad didn't feel any different . He have gotten covid 2 and if this helped you not get it he will take a shot every year like the flu shot .  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Fatigue, Immunisation
Clinical narrative: deep cough that still persists +2 weeks but is improving; significant fatigue; upset stomach for about a week; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 11:00 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "celiac disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "low thyroid: hypothyroidism" (unspecified if ongoing); "polycythemia" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "allergies to wheat, yeast, orange peel, high fructose corn syrup" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: material used in stress tests. Concomitant medication(s) included: BREO ELLIPTA; ALBUTEROL [SALBUTAMOL]; SYNTHROID; OMEPRAZOLE. Past drug history included: Morphine, reaction(s): "drug allergy"; Sensit, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose 2, lot number: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 11:15 AM), administration date: 29Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 04:15 PM), administration date: 01Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 11:00, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 26Nov2021 16:00, outcome "recovering", described as "deep cough that still persists +2 weeks but is improving"; FATIGUE (non-serious) with onset 26Nov2021 16:00, outcome "recovering", described as "significant fatigue"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Nov2021 16:00, outcome "recovering", described as "upset stomach for about a week". Therapeutic measures were not taken as a result of cough, fatigue, abdominal discomfort.  Additional Information: Concomitant Therapy included more unspecified drugs. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.