chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Feeling of body temperature change, Hand deformity, Headache
Clinical narrative: aches and felt like something was taking over her body and she was going to die; Hands locked up, knuckles could not straighten; Painful when knuckles straightened; Felt red and hot, than felt cold; she could not move, and could not get up; aches: in her head, neck, face, arms, hands, neck, shoulder, and back; Felt red and hot, than felt cold; Could not sleep; Fever; aches: in her head, neck, face, arms, hands, neck, shoulder, and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 67 years 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: NEAR DEATH EXPERIENCE (medically significant) with onset Dec2021, outcome "unknown", described as "aches and felt like something was taking over her body and she was going to die"; HAND DEFORMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Hands locked up, knuckles could not straighten"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Painful when knuckles straightened"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Felt red and hot, than felt cold"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "she could not move, and could not get up"; BACK PAIN (non-serious), HEADACHE (non-serious) all with onset Dec2021, outcome "unknown" and all described as "aches: in her head, neck, face, arms, hands, neck, shoulder, and back"; INSOMNIA (non-serious) with onset Dec2021, outcome "unknown", described as "Could not sleep"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fever". Clinical course: The patient was fine and she has not missed work in 17years, patient do not want to take next dose. The patient experienced painful when knuckles straightened. Reporter seriousness for hands locked up, knuckles could not straighten, Painful when knuckles straightened, Aches, Could not sleep, Does not want to take second shot, Fever, Felt red and hot, than felt cold: unspecified.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Movement disorder, Near death experience, Pain, Pyrexia
Clinical narrative: aches and felt like something was taking over her body and she was going to die; Hands locked up, knuckles could not straighten; Painful when knuckles straightened; Felt red and hot, than felt cold; she could not move, and could not get up; aches: in her head, neck, face, arms, hands, neck, shoulder, and back; Felt red and hot, than felt cold; Could not sleep; Fever; aches: in her head, neck, face, arms, hands, neck, shoulder, and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 67 years 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: NEAR DEATH EXPERIENCE (medically significant) with onset Dec2021, outcome "unknown", described as "aches and felt like something was taking over her body and she was going to die"; HAND DEFORMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Hands locked up, knuckles could not straighten"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Painful when knuckles straightened"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Felt red and hot, than felt cold"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "she could not move, and could not get up"; BACK PAIN (non-serious), HEADACHE (non-serious) all with onset Dec2021, outcome "unknown" and all described as "aches: in her head, neck, face, arms, hands, neck, shoulder, and back"; INSOMNIA (non-serious) with onset Dec2021, outcome "unknown", described as "Could not sleep"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fever". Clinical course: The patient was fine and she has not missed work in 17years, patient do not want to take next dose. The patient experienced painful when knuckles straightened. Reporter seriousness for hands locked up, knuckles could not straighten, Painful when knuckles straightened, Aches, Could not sleep, Does not want to take second shot, Fever, Felt red and hot, than felt cold: unspecified.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Just come down with Covid/has 2 shots & no booster; Just come down with Covid/has 2 shots & no booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male 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. Relevant medical history included: "overweight" (unspecified if ongoing), notes: he is overweight. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Just come down with Covid/has 2 shots & no booster".  Clinical course: It was reported that, his doctor said, Paxlovid is not yet commercially available. Since time is of the essence (he is overweight and told me that if the symptoms did not subside in a day or two, he may need hospitalization. Is there any way I can get the medicine to him while he Ts still ambulatory?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: i have known 3 people who have had heart attacks, and one is in rough shape; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "i have known 3 people who have had heart attacks, and one is in rough shape".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Nausea, Vomiting
Clinical narrative: Unable to keep any food / drink down; severe nausea; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date May2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tourette syndrome" (unspecified if ongoing), notes: tourette syndrome - mild case; "anxiety" (unspecified if ongoing), notes: anxiety; "depression" (unspecified if ongoing), notes: depression under control with meds; "penicillin - trunk rash" (unspecified if ongoing), notes: known allergies penicillin - trunk rash. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Pfizer COVID 19, lot unknown reason=Not available/provided to reporter at the time of report completion.), administration date: Apr2021, when the patient was 22 years old, for Covid-19 immunization. Prior vaccination, patient did not have covid and not tested for covid post vaccination. The following information was reported: IMPAIRED GASTRIC EMPTYING (medically significant), outcome "not recovered", described as "Unable to keep any food / drink down"; NAUSEA (non-serious), outcome "not recovered", described as "severe nausea"; VOMITING (non-serious), outcome "not recovered", described as "Vomiting". The event "unable to keep any food / drink down" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of impaired gastric emptying, nausea, vomiting. Clinical course: after the 2nd dose and now the booster, reporter daughter has had severe nausea, vomiting and is unable to keep any food / drink down.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Positive test result to COVID-19 and developed symptoms; Positive test result to COVID-19 and developed symptoms; still sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Positive test result to COVID-19 and developed symptoms"; ILLNESS (non-serious), outcome "unknown", described as "still sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional Information: consumer stated she and her husband are still sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19.; Tested positive for Covid 19.; Other vaccine same date vaccine date 27Nov2021/Off label use; Other vaccine same date vaccine date 27Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 27Nov2021 (Batch/Lot number: unknown) as unk, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient was tested positive post vaccination for COVID-19. Covid test type post vaccination was reported as Nasal Swab. Covid test name post vaccination was reported as BinaxNOW. Patient was tested as negative on 27Dec2021 and positive on 29Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 21:30, outcome "recovering" and all described as "Tested positive for Covid 19."; OFF LABEL USE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 27Nov2021/Off label use"; PRODUCT USE ISSUE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 27Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative, notes: Nasal swab; (29Dec2021) positive, notes: Nasal swab positive at 21:30. Adverse event was reported as Tested positive for Covid Virus. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She mentioned that she was just diagnosed with COVID yesterday; She mentioned that she was just diagnosed with COVID yesterday; 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 54 year-old female patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 30Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "She mentioned that she was just diagnosed with COVID yesterday". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: she was just diagnosed with COVID. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he tested positive for Covid-19; 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 male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (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: COVID-19 (non-serious) with onset Dec2021, outcome "unknown", described as "he tested positive for Covid-19". 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: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: Was diagnosed with covid; Was diagnosed with covid; Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Was diagnosed with covid"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold symptoms". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19, nasopharyngitis. It was reported that patient barely had any symptoms, cold symptoms, isolated for 10 days. The patient had his health having come in, and he thought he would just get blood check, to check out what he's doing and got an antibody infusion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Paralysis
Clinical narrative: she is now blind; paralized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: BLINDNESS (medically significant), outcome "unknown", described as "she is now blind"; PARALYSIS (medically significant), outcome "unknown", described as "paralized".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Heart rate increased, Hyperthyroidism, Pyrexia
Clinical narrative: Thyroditis; thyroid went hyper; hyperthyroid; High fever; Fast heartbeat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in hand left, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The following information was reported: HYPERTHYROIDISM (medically significant) with onset Mar2021, outcome "unknown", described as "Thyroditis; thyroid went hyper; hyperthyroid"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "High fever"; HEART RATE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "Fast heartbeat". The patient underwent the following laboratory tests and procedures: blood test: (2021) hyperthyroid. Therapeutic measures were taken as a result of hyperthyroidism, pyrexia included Prednisone, Ibuprofen and Tylenol. clinical course: Basically 2 weeks after the vaccine patient had thyroiditis. The thyroid went hyper, all blood test (Further not clarified) on thyroid came like patient had a hyperthyroid, which patient never had before so that's why patient never had the 2nd vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Interchange of vaccine products, Pain
Clinical narrative: Booster; he got the Pfizer COVID-19 Vaccine. He got the first two doses and his booster dose was Moderna COVID-19 Vaccine.; Mild pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "he got the Pfizer COVID-19 Vaccine. He got the first two doses and his booster dose was Moderna COVID-19 Vaccine."; PAIN (non-serious), outcome "recovered" (2021), described as "Mild pain". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883265 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Pain
Clinical narrative: recently diagnosed with Covid as a breakthrough case; recently diagnosed with Covid as a breakthrough case; aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Failure" (unspecified if ongoing), notes: I am a Heart Failure patient. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "recently diagnosed with Covid as a breakthrough case"; PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "chills". Customer Verbatim: I personally wanted to say thank you for the time & effort put into the Covid Vaccine. I received 2 doses & I am a Heart Failure patient and was recently diagnosed with Covid as a breakthrough case. I literally had 1 bad day during my whole quarantine and that day overall was still mild! Just some aches & chills. I am a true believer in your vaccine & have told everyone I can & will continue pushing for people to get vaccinated. Maybe it didn't prevent it but it sure did make it mild.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bone pain, Chills, Cough
Clinical narrative: Booster; I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021; feeling not good; diarrhea; pain in my bones; chills; no smell; no taste; sinus congestion; major coughing; upper respiratory problem; 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) (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: Johnson & johnson (Dose:1), administration date: May2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021"; MALAISE (non-serious) with onset Dec2021, outcome "not recovered", described as "feeling not good"; DIARRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "diarrhea"; BONE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my bones"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; ANOSMIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no smell"; AGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no taste"; SINUS CONGESTION (non-serious) with onset Dec2021, outcome "not recovered", described as "sinus congestion"; COUGH (non-serious) with onset Dec2021, outcome "not recovered", described as "major coughing"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "upper respiratory problem".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Malaise, Respiratory disorder
Clinical narrative: Booster; I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021; feeling not good; diarrhea; pain in my bones; chills; no smell; no taste; sinus congestion; major coughing; upper respiratory problem; 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) (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: Johnson & johnson (Dose:1), administration date: May2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021"; MALAISE (non-serious) with onset Dec2021, outcome "not recovered", described as "feeling not good"; DIARRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "diarrhea"; BONE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my bones"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; ANOSMIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no smell"; AGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no taste"; SINUS CONGESTION (non-serious) with onset Dec2021, outcome "not recovered", described as "sinus congestion"; COUGH (non-serious) with onset Dec2021, outcome "not recovered", described as "major coughing"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "upper respiratory problem".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Booster; I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021; feeling not good; diarrhea; pain in my bones; chills; no smell; no taste; sinus congestion; major coughing; upper respiratory problem; 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) (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: Johnson & johnson (Dose:1), administration date: May2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "I took the Johnson & Johnson shot earlier this year in May I took the Pfizer booster shot Dec2021"; MALAISE (non-serious) with onset Dec2021, outcome "not recovered", described as "feeling not good"; DIARRHOEA (non-serious) with onset Dec2021, outcome "not recovered", described as "diarrhea"; BONE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my bones"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "chills"; ANOSMIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no smell"; AGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "no taste"; SINUS CONGESTION (non-serious) with onset Dec2021, outcome "not recovered", described as "sinus congestion"; COUGH (non-serious) with onset Dec2021, outcome "not recovered", described as "major coughing"; RESPIRATORY DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "upper respiratory problem".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Pyrexia, Suspected COVID-19
Clinical narrative: Caller added he was diagnosed with COVID-19 infection last week.; Caller added he was diagnosed with COVID-19 infection last week.; sick; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FF8839) at the age of 40 years as DOSE 1, SINGLE for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 21Dec2021, outcome "not recovered", SUSPECTED COVID-19 (hospitalization, medically significant) with onset 21Dec2021, outcome "not recovered" and all described as "Caller added he was diagnosed with COVID-19 infection last week."; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever".  Follow-up (30Dec2021): This is a spontaneous follow-up report from same contactable consumer.  Updated information: patient details include age, height, weight, 1st dose details and events was added. Additional information: N/A  Follow-up (03JAN2022): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EP7533) at the age of 29 years as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "PCOS" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies or history of hearing damage or previous tinnitus prior to receiving the vaccine. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (disability) with onset 06Apr2021 23:30, outcome "not recovered", described as "Tinnitus". The event "tinnitus" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) negative, notes: Nasal Swab. Therapeutic measures Steroid taper from ENT were taken as a result of tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: extreme pain on my throat; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; headaches; high fever; cough; congestion; 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), administration date 18Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 04Jul2021 (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), SUSPECTED COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron"; HEADACHE (non-serious) with onset 26Dec2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "high fever"; COUGH (non-serious) with onset 26Dec2021, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "unknown", described as "congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "extreme pain on my throat". Addition information: It was reported that: The vax clinician told me to come back in 6 months to get the booster. Fast Forward to 25Dec2021. Right after the holidays I started experiencing a breakthrough infection, likely from the new COVID-19 strain Omicron. Typed on 3rd.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: extreme pain on my throat; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron; headaches; high fever; cough; congestion; 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), administration date 18Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 04Jul2021 (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), SUSPECTED COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "experiencing a  breakthrough infection, likely from the new COVID-19 strain Omicron"; HEADACHE (non-serious) with onset 26Dec2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "high fever"; COUGH (non-serious) with onset 26Dec2021, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "unknown", described as "congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "extreme pain on my throat". Addition information: It was reported that: The vax clinician told me to come back in 6 months to get the booster. Fast Forward to 25Dec2021. Right after the holidays I started experiencing a breakthrough infection, likely from the new COVID-19 strain Omicron. Typed on 3rd.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: my brother has a friend who is paralyzed now after getting vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  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: PARALYSIS (medically significant), outcome "unknown", described as "my brother has a friend who is paralyzed now after getting vaccinated".  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, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (she received Moderna initially, DOSE 1), for Covid-19 immunization; Moderna (she received Moderna initially, DOSE 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec)"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. The patient son tested positive for Covid with a home test on 24Dec and his wife had now tested positive too last night that was 29Dec and filling another AE report today (that his wife moderna initially but did received the Pfizer booster). Regarding the report for withheld, the patient intended to file his report within 24 hours but candidly with everything happening in his home and with Christmas holiday it inadvertently slipped.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster; she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (she received Moderna initially, DOSE 1), for Covid-19 immunization; Moderna (she received Moderna initially, DOSE 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster/ tested positive too last night (29Dec)"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "she received Moderna initially but did receive the Pfizer booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. The patient son tested positive for Covid with a home test on 24Dec and his wife had now tested positive too last night that was 29Dec and filling another AE report today (that his wife moderna initially but did received the Pfizer booster). Regarding the report for withheld, the patient intended to file his report within 24 hours but candidly with everything happening in his home and with Christmas holiday it inadvertently slipped.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after having both Pfizer vaccinations/symptoms included fever of about 101.5 and muscles aches; tested positive for Covid after having both Pfizer vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2, Solution for injection) (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: COVID-19 (medically significant) with onset 27Dec2021, outcome "unknown", described as "tested positive for Covid after having both Pfizer vaccinations/symptoms included fever of about 101.5 and muscles aches"; DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "tested positive for Covid after having both Pfizer vaccinations". The patient underwent the following laboratory tests and procedures: pyrexia: (27Dec2021) about 101.5; sars-cov-2 test: (27Dec2021) positive.  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-202101884945 same reporter/drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Myalgia, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after having both Pfizer vaccinations; Tested positive for Covid after having both Pfizer vaccinations; muscles aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male 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) all with onset 24Dec2021, outcome "unknown" and all described as "Tested positive for Covid after having both Pfizer vaccinations"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "muscles aches". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) about 101.5; COVID-19: (24Dec2021) positive. Clinical course: His symptoms included fever of about 101.5 and muscles aches.   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-202101884897 same reporter/drug/AE, different patient
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered; SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered; received the third dose of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: ff2593) at the age of 33 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 26Jan2021 (Lot number: EL1686) as dose 2, single and intramuscular, administered in arm left, administration date 03Jan2021 (Lot number: EL0140) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; BUSPIRONE; ONDANSETRON; EMGALITY [GALCANEZUMAB]; WELLBUTRIN; BACLOFEN; LILETTA. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered"; IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "received the third dose of BNT162B2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: third test; all within 24 hrs and at different sites; (30Dec2021) negative, notes: second test; all within 24 hrs and at different sites; (30Dec2021) negative, notes: first test; all within 24 hrs and at different sites. Therapeutic measures were not taken as a result of covid-19, vaccination failure. Addition information: The patient had COVID prior vaccination. Known allergy was none. The patient had COVID test post vaccination.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; 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 parent.  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: ANAPHYLACTIC REACTION (hospitalization), outcome "unknown", described as "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: Diarrhoea, Nausea, Retching
Clinical narrative: nausea to the point of dry heaving; nausea to the point of dry heaving; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6199) via an unspecified route of administration in the arm left on 05Mar2021 at 10:45 (at the age of 32-year-old) as dose 1, single for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), coffee allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date in Mar2021, the patient experienced nausea to the point of dry heaving and diarrhea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment:  This follow-up report is being submitted to amend previous information: updated medical history "polycystic ovarian syndrome(PCOS)" and "coffee allergy" and added event 'dry heaves' per reported 'nausea to the point of dry heaving'.