chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid after being boosted; got covid after being boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid after being boosted". Clinical course Reporter husband's brother and his wife also got covid after being boosted. No further details, she doesn't know if they would want to report. Declines to complete a report for her husband's bother and his wife. PC also filed on Reports 1, 2, and 3, of 4. Is there a product complaint to report? Yes. Description of Product Complaint: Description of complaint: Got covid after being boosted with the covid-19 vaccine. Not provide Product strength and count size dispensed. Not provide Additional lot numbers.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200469651 same reporter/drug/AE, different patient
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 antigen: Positive; Covid 19 antigen: Positive; Alopecia areata; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 10:00 (Lot number: FJ1620) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "low testosterone" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Covid 19 antigen: Positive"; ALOPECIA AREATA (non-serious) with onset 14Dec2021 18:00, outcome "not recovered", described as "Alopecia areata". The event "alopecia areata" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of alopecia areata.  Clinical course: The Alopecia areata was treated with products that are supposed. The patient did not receive any other vaccine in four weeks and not having Covid prior vaccination. He tested Covid post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive 24Mar Ag both asymptomatic; Tested positive 24Mar Ag both asymptomatic; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 63 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 04Feb2021 (Lot number: EL3247) 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 24Mar2022, outcome "unknown" and all described as "Tested positive 24Mar Ag both asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Mar2022) positive, notes: Covid test type post vaccination: Nasal Swab; (22Mar2022) negative, notes: Covid test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19. It was unknown if patient had covid prior vaccination and take other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Vaccination failure, Asymptomatic COVID-19 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated and tested positive for COVID today; Patient was fully vaccinated and tested positive for COVID today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Mar2022, outcome "unknown" and all described as "Patient was fully vaccinated and tested positive for COVID today". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Mar2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Condition aggravated, Fatigue, Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 56-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown),  and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced illness/sick, nausea, with outcome of unknown; fatigue/tired (no energy has been getting worse), asthenia and aggravated condition, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The patient took the first and second dose of the Pfizer COVID-19 vaccine. It made him sick, nausea and tired (no energy has been getting worse). He wanted to know what he can do about his energy getting worse. He has seen doctors. They do not know what was going on with him. His blood work came back normal, but he still has lack of energy and fatigue, which keeps getting worse and worse. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 56-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown),  and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced illness/sick, nausea, with outcome of unknown; fatigue/tired (no energy has been getting worse), asthenia and aggravated condition, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The patient took the first and second dose of the Pfizer COVID-19 vaccine. It made him sick, nausea and tired (no energy has been getting worse). He wanted to know what he can do about his energy getting worse. He has seen doctors. They do not know what was going on with him. His blood work came back normal, but he still has lack of energy and fatigue, which keeps getting worse and worse. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 56-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown),  and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced illness/sick, nausea, with outcome of unknown; fatigue/tired (no energy has been getting worse), asthenia and aggravated condition, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The patient took the first and second dose of the Pfizer COVID-19 vaccine. It made him sick, nausea and tired (no energy has been getting worse). He wanted to know what he can do about his energy getting worse. He has seen doctors. They do not know what was going on with him. His blood work came back normal, but he still has lack of energy and fatigue, which keeps getting worse and worse. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold-like symptoms; got Covid-19 after Covid-19 vaccination; got Covid-19 after Covid-19 vaccination; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "got Covid-19 after Covid-19 vaccination"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Patient was infected with Omicron variant and he had some cold-like symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
Clinical narrative: AG 25Mar2022, 26Mar2022; AG 25Mar2022, 26Mar2022; severe cold symptoms; myalgia; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 30Mar2021 (Lot number: EP6955) as dose 2, single and administration date 11Mar2021 (Lot number: EN5318) 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 25Mar2022, outcome "unknown" and all described as "AG 25Mar2022, 26Mar2022"; NASOPHARYNGITIS (non-serious) with onset 25Mar2022, outcome "unknown", described as "severe cold symptoms"; MYALGIA (non-serious) with onset 22Mar2022, outcome "unknown", described as "myalgia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Mar2022) positive; (26Mar2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasopharyngitis, myalgia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: + sx and covid test on 26Mar22.; + sx and covid test on 26Mar22.; congestion no loss of taste or smell; fever; body aches; cough; sweats; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 43 years 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 Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 42 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Mar2022 22:00, outcome "unknown" and all described as "+ sx and covid test on 26Mar22."; NASAL CONGESTION (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "congestion no loss of taste or smell"; PYREXIA (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "cough"; HYPERHIDROSIS (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "sweats"; HEADACHE (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "Headache". The events "+ sx and covid test on 26mar22.", "+ sx and covid test on 26mar22.", "congestion no loss of taste or smell", "fever", "body aches", "cough", "sweats" and "headache" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, pain, cough, hyperhidrosis, headache.  Clinical course: + sx and covid test on 26Mar2022. Some St late on 25Mar2022 then HA fever body aches cough sweats congestion no loss of taste or smell. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: + sx and covid test on 26Mar22.; + sx and covid test on 26Mar22.; congestion no loss of taste or smell; fever; body aches; cough; sweats; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 43 years 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 Number: 2, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 42 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Mar2022 22:00, outcome "unknown" and all described as "+ sx and covid test on 26Mar22."; NASAL CONGESTION (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "congestion no loss of taste or smell"; PYREXIA (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "cough"; HYPERHIDROSIS (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "sweats"; HEADACHE (non-serious) with onset 25Mar2022 22:00, outcome "unknown", described as "Headache". The events "+ sx and covid test on 26mar22.", "+ sx and covid test on 26mar22.", "congestion no loss of taste or smell", "fever", "body aches", "cough", "sweats" and "headache" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, pain, cough, hyperhidrosis, headache.  Clinical course: + sx and covid test on 26Mar2022. Some St late on 25Mar2022 then HA fever body aches cough sweats congestion no loss of taste or smell. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia areata, Deep vein thrombosis
Clinical narrative: DVT in upper left arm; Alopecia Areata - sudden loss of patches of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ALLEGRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (disability, life threatening) with onset Jun2021, outcome "not recovered", described as "DVT in upper left arm"; ALOPECIA AREATA (disability, life threatening) with onset Jun2021, outcome "not recovered", described as "Alopecia Areata - sudden loss of patches of hair". The events "dvt in upper left arm" and "alopecia areata - sudden loss of patches of hair" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, alopecia areata and included treatment with steroid shots for alopecia and apixaban (ELIQUIS Rx) for DVT (deep vein thrombosis). The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed as COVID-19. The facility type vaccine was Pharmacy or Drug Store. It was unknown whether the patient had been tested for COVID-19 since the vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: 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 parent. A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. Relevant medical history included: "Not sexually active" (unspecified if ongoing), notes: she is not sexual active. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; Manufacturer: unknown), for Covid-19 immunisation. The mother's vaccination history included: Covid-19 vaccine (Dose no -2, Manufacturer- unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose no -1, Manufacturer- unknown), for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I don't have my menstrual period". Additional information: Reporter received her three doses of Covid-19. After her third dose she don't have her menstrual period and she was not pregnant. Reporter asking whether any statistics about this problem. Reporter daughter received the third dose, and she has the same problem and she is not sexual active. She was not pregnant she was virgin. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Arthralgia, Decreased appetite, Depressed mood, Dyspnoea
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 69 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: 1, Anatomical location: Left arm, No problem), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "No Problem"; Bnt162b2 (Dose:2, Arm Left), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "So tired"; Bnt162b2 (Dose:2), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "stiffness and soreness especially on knees and hips", "stiffness and soreness especially on knees and hips", "little shortness of breath", "Fatigue", "stiffness and soreness especially on knees and hips". The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2022, outcome "recovering" and all described as "Soreness in knees and hips"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "extreme fatigue"; ECZEMA (non-serious) with onset 2022, outcome "unknown", described as "Eczema on top of hands"; DECREASED APPETITE (non-serious) with onset 2022, outcome "unknown", described as "does not want to eat"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath"; ANGER (non-serious) with onset 2022, outcome "unknown", described as "makes her angry"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tired"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "itches especially at night"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 2022, outcome "unknown", described as "frustrating"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "exhausted"; DEPRESSED MOOD (non-serious) with onset 2022, outcome "unknown", described as "super depressed". Additional information: Booster shot was on 07Jan2022. She does not have her vaccine card to produce a lot expiration or date for the first two vaccines or this booster dose. She confirmed that all 3 were Pfizer COVID vaccines. She noticed getting back to normal after 3-4 months after getting it. She got the flu shot and it was somewhere between the 2nd vaccine and booster. She does not have a date, manufacturer, lot or expiration for it. Patient was taken hydrocortisone and Neosporin for the treatment of eczema. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Fatigue, Frustration tolerance decreased, Pruritus
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 69 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: 1, Anatomical location: Left arm, No problem), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "No Problem"; Bnt162b2 (Dose:2, Arm Left), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "So tired"; Bnt162b2 (Dose:2), administration date: Jun2021, when the patient was 68 years old, for Covid-19 Immunization, reaction(s): "stiffness and soreness especially on knees and hips", "stiffness and soreness especially on knees and hips", "little shortness of breath", "Fatigue", "stiffness and soreness especially on knees and hips". The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2022, outcome "recovering" and all described as "Soreness in knees and hips"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "extreme fatigue"; ECZEMA (non-serious) with onset 2022, outcome "unknown", described as "Eczema on top of hands"; DECREASED APPETITE (non-serious) with onset 2022, outcome "unknown", described as "does not want to eat"; DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "shortness of breath"; ANGER (non-serious) with onset 2022, outcome "unknown", described as "makes her angry"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tired"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "itches especially at night"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 2022, outcome "unknown", described as "frustrating"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "exhausted"; DEPRESSED MOOD (non-serious) with onset 2022, outcome "unknown", described as "super depressed". Additional information: Booster shot was on 07Jan2022. She does not have her vaccine card to produce a lot expiration or date for the first two vaccines or this booster dose. She confirmed that all 3 were Pfizer COVID vaccines. She noticed getting back to normal after 3-4 months after getting it. She got the flu shot and it was somewhere between the 2nd vaccine and booster. She does not have a date, manufacturer, lot or expiration for it. Patient was taken hydrocortisone and Neosporin for the treatment of eczema. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Mar2022, outcome "unknown", described as "Got rash on his stomach, back and groin areas/ just miscellaneous rash around his back, his torso and then his, in between his legs". Additional Context: Reporter stated, "Well myself and my 14-year-old son (Age was not further clarified hence, not captured in tab) got the Pfizer Booster shot so that would be our third shot, booster shot and I was reading the reaction paper, paper work with the reactions and all that and he's got a reaction to it, we got it last Friday so that I guess 10 days now and now he got rash on his stomach, back and groin areas but its not raised bumps or anything like that, but it is just miscellaneous rash around his back, his torso and then his, in between his legs but he said that it doesn't itch, its not sticking up, its not like a chicken pox or anything its, we just know if that reaction from the shot vaccine and if it is how long it is going to last?" Reporter stated, "No not right now." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Glaucoma, Visual impairment
Clinical narrative: my glaucoma has increased and I'm partially blind now; my glaucoma has increased and I'm partially blind now; 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 68 year-old 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: "glaucoma" (ongoing); "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GLAUCOMA (medically significant), VISUAL IMPAIRMENT (medically significant), outcome "unknown" and all described as "my glaucoma has increased and I'm partially blind now".  Clinical Course: I am a 68 year old man who has taken my first and second vaccine as well the booster. Does your company have records of your vaccine worsening/amplifying any underlying conditions from your users and are you keeping this type of feedback to evaluate for further patient awareness. I ask this because I was borderline glaucoma and had minimal tinnitus. After my first 2 injections, my glaucoma has increased and I'm partially blind now. After my booster my tinnitus has become unbearable.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Death
Clinical narrative: The reporter did not know what the patient died from; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DEATH (death) with onset 28Oct2021, outcome "fatal", described as "The reporter did not know what the patient died from". The patient date of death was 28Oct2021. The reported cause of death was "Unknown cause of death". The reporter reported that her sister had 2 of her COVID-19 vaccines and the flu shot. Her sister died on 28Oct2021. The reporter reported that she did not know what kind of condition she had and she could not talk about her sister's stuff because she did not know. The reporter reported she hadn't seen her sister in 5 years and she did not know what she died from. The report was not related to a study or programme.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Skin test
Clinical narrative: 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 74 year-old patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "allergic to nickel, leather, rubber products and numerous chemicals in everyday products" (unspecified if ongoing); "allergic to nickel, leather, rubber products and numerous chemicals in everyday products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), administration date: Feb2021, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema"; PRURITUS (non-serious), outcome "unknown", described as "itch". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received both shots. Prior to that, patient never even had a flu shot, yet 9 months later, patient developed serious eczema conditions covering 80 percent of patient's body. Patient finally got a patch test the week of 3/14. Patient body continues to itch and sometimes feels like it was on fire. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Sender's Comments: Linked Report(s): US-PFIZER_INC-202200489858 same patient, different dose of vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Erythema, Rash
Clinical narrative: 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. The reporter is the patient. A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Lot number: FF8841, Expiration Date: 30Dec2021) at the age of 67 years as dose 3 (booster ), single for Covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "eye infection" (unspecified if ongoing); "it was a diuretic" (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN taken for anxiety; LISINOPRIL taken for blood pressure abnormal, start date: Mar2010; NIFEDIPINE taken for blood pressure abnormal, start date: Mar2010; LABETALOL taken for diuretic therapy. Vaccination history included: Bnt162b2 (Second dose: given on 17Mar2021, manufacturer: Pfizer, lot number: EP7534. Information is on a sticker on the card for second dose. Expiry: unknown. NDC: unknown. Given at the (Facility name) at drive thru in right arm.), administration date: 17Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (First dose:  manufacturer: Pfizer, lot number: EL9266, expiration: unknown. NDC: unknown. Information for first dose is handwritten on the card. Given at the (Facility name) at drive thru in right arm), administration date: 22Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Flu vaccine (He usually get flu vaccine but he was late getting to it and the flu season was over so he didn't get flu vaccine). The following information was reported: RASH (non-serious), outcome "not recovered", described as "He indicates that a couple of months after the booster dose he noticed that both of his palms are bright red"; ERYTHEMA (non-serious), outcome "not recovered", described as "Caller's got red/all of a sudden right to the finger tips is shiny red". The events "he indicates that a couple of months after the booster dose he noticed that both of his palms are bright red" and "caller's got red/all of a sudden right to the finger tips is shiny red" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient noticed it two months ago. He had a doctor's appointment lined up so he followed up there. The doctor said it looked like a chemical burn, but caller wouldn't have a chemical burn for 2 months.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Condition aggravated, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 51-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE3594), at the age of 51, in left arm, on Dec 8, 2021, single dose, for COVID-19 immunization. No medical history or concomitant medications reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0150), at the age of 50, in left arm, on Apr 12, 2021, for COVID-19 immunization; reaction(s): pressure in ears, felt like she couldn't hear as well. She also received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#  EW0164), at the age of 50, in the right arm, on May 3, 2021, for COVID-19 immunization; reaction: ringing in ears. The patient experienced tinnitus, with outcome of not recovered; and aggravated condition (ringing in her ears/it has gotten a little worse), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: Reporter stated she received all three of the Pfizer COVID-19 vaccines, the first two and a booster. Reporter reported she has had issues with her ears since having the first one. After the second one, she stated she has more ringing in her ears. Reporter clarified after first shot she had pressure in her ears, felt like she couldn't hear as well. Reporter stated it faded a little but after second shot she has been having ringing in her ears that has gotten worse. The pressure started either day after or even the same day like they were clogged a little bit after the first vaccine. It subsided a little bit and she didn't notice it as much. She would open her jaw to clear out her ears. The ringing has been really bothersome, and started almost immediately after the second shot, on the same day. It is more bothersome now, and has gotten a little worse. At first, she could hear it when it is quiet but now she can hear it during a conversation. She had an auditory test done. It was a little off. Exact readings or details unknown. Her husband told her to go get tested. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 13:00 (Lot number: FJ1620) at the age of 19 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Ashwagandha. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER 8734, Location of injection: Arm Left, Vaccine Administration Time: 13:15 PM), administration date: 27Mar2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 6206, Location of injection: Arm Left, Vaccine Administration Time: 16:15 PM), administration date: 05Mar2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Dec2021 13:00, outcome "not recovered", described as "Brain Fog that began within 18 -24 hours of vaccination and has continued"; ALOPECIA (non-serious) with onset 29Dec2021 13:00, outcome "not recovered", described as "Possible hair loss correlation". The events "brain fog that began within 18 -24 hours of vaccination and has continued" and "possible hair loss correlation" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, alopecia. Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Ashwagandha within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient was not tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Illness, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Sick; Cough; Runny nose; Classic cold; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 years 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 Number: 2, Batch/Lot No: EL3247), administration date: 24Feb2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 03Feb2021, when the patient was 37 years old, for COVID-19 Immunization.  The following information was reported: ILLNESS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Sick"; COUGH (non-serious) with onset 28Mar2022, outcome "unknown", described as "Cough"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Runny nose"; NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Classic cold"; PYREXIA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Fever". The events "sick", "cough", "runny nose", "classic cold" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sick; Cough; Runny nose; Classic cold; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 years 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 Number: 2, Batch/Lot No: EL3247), administration date: 24Feb2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 03Feb2021, when the patient was 37 years old, for COVID-19 Immunization.  The following information was reported: ILLNESS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Sick"; COUGH (non-serious) with onset 28Mar2022, outcome "unknown", described as "Cough"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Runny nose"; NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Classic cold"; PYREXIA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Fever". The events "sick", "cough", "runny nose", "classic cold" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: the PCP did an antigen test and that was positive 29Mar2022; the PCP did an antigen test and that was positive 29Mar2022; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single, administration date 24Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) 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 29Mar2022, outcome "unknown" and all described as "the PCP did an antigen test and that was positive 29Mar2022". The event "the pcp did an antigen test and that was positive 29mar2022" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Mar2022) negative, notes: Unknown; (29Mar2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical Information: It was reported that the patient was Sick on 28Mar fever cough ST runny nose "classic cold" tested with at home ag all neg but the PCP did an antigen test and that was positive 29Mar2022. Prior to vaccination, the patient was not diagnosed with COVID-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available and known safety profile of suspect product the casual association between the reported events vaccination failure and covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palmar erythema
Clinical narrative: palms are bright red; sore arm; 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 parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALMAR ERYTHEMA (non-serious), outcome "unknown", described as "palms are bright red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Caller stated that, he does not know that the events were from vaccine or not. He said that all three that live in the household had two Pfizers and the booster. Their palms were bright red. They had the shots and they all had the minor side effect of sore arm. Caller clarified that he, his wife, and his son all have bright palms. Caller's got red and then he looked at theirs's and their palms were red also. Caller was not sure if this was a long term thing.  The lot number for bnt162b2 was not provided and will be requested during follow up.