chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: She had the first and second vaccine and then got the virus.; She had the first and second vaccine and then got the virus.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had the first and second vaccine and then got the virus.": AE E-transmitting. Realized after the call ended the caller provided an AE when she said her granddaughter got the virus after getting both doses of the vaccine. Demographics not obtained due to not recognizing the AE during the call. Reported to the caller that Pfizer does not set the vaccine mandates and she would need to contact her granddaughter's college for more information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria cholinergic
Clinical narrative: administration date= 06Jun2021 administration date= 04Aug2021; Approximately 2 weeks after administration of second dose patient developed cholinergic urticaria when is still present 6 months later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 15:00 (Lot number: EW0167) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer, lot-number =FD5613,, Dose Administration time: 11:00 AM, Anatomical Location: Left Arm), administration date: 06Jun2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported: URTICARIA CHOLINERGIC (medically significant) with onset 21Aug2021 17:00, outcome "not recovered", described as "Approximately 2 weeks after administration of second dose patient developed cholinergic urticaria when is still present 6 months later"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date= 06Jun2021 administration date= 04Aug2021". The event "approximately 2 weeks after administration of second dose patient developed cholinergic urticaria when is still present 6 months later" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria cholinergic and treated with antihistamines.  Clinical Course: Patient did not administer other vaccine in four weeks. Patient did not take other medications in two weeks. It was unknown if the patient had COVID  prior vaccination. It was unknown if the patient had covid tested post vaccination. There were no Known allergies. Approximately 2 weeks after administration of second dose patient developed cholinergic urticaria when was still present 6 months later. The Adverse event was treated with antihistamines.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash, Urticaria
Clinical narrative: she became sick with the hives; extreme hives; rash outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 (Lot number: FC0007) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: ALBUTEROL HFA taken for asthma; FLOVENT taken for asthma. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she became sick with the hives"; URTICARIA (non-serious), outcome "unknown", described as "extreme hives"; RASH (non-serious), outcome "unknown", described as "rash outbreak". The events "she became sick with the hives", "extreme hives" and "rash outbreak" were evaluated at the physician office visit.  Additional information: The patient received the vaccine in early afternoon. The reporter stated that she was now having since in the last month some extreme hives and rash outbreak which did not 'itch' and the reporter sent her to her doctor twice in the last 3 weeks and they didn't know, understood where it was coming from and they were not going to change in any upper environment. Expiration date of Covid19 vaccine was reported as 11-21. On first day, the patient was put on Zertec, then was the breakthrough Benadryl and then it was breakthrough eruptions of the hives and they put her on prednisone. Prednisone expiration date was 15Jan2023, LOT# 108231003516, 5 mg, tablet. LOT# for Cetrazine was 108231001520/ HK1170 expiration date was Jan2023/ Jun2023. For asthma the patient also had 'zentol'.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: administration date=11/Feb/2021; administration date=11/Oct/2021; Development of atopic dermatitis (of the scalp) 1-2 months after second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 08:30 (Lot number: EL3248) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ORTHO TRI-CYCLEN; DUPIXENT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), for COVID-19 immunization. The following information was reported: DERMATITIS ATOPIC (medically significant) with onset Apr2021, outcome "not recovered", described as "Development of atopic dermatitis (of the scalp) 1-2 months after second dose."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=11/Feb/2021; administration date=11/Oct/2021". The event "development of atopic dermatitis (of the scalp) 1-2 months after second dose." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dermatitis atopic. It was unknown if therapeutic measures were taken as a result of inappropriate schedule of product administration.The patient had report about covid vaccine. Patient had no any other vaccine in four weeks. Ae resulted in [Doctor or other healthcare professional office/clinic visit]. Ae treatment Multiple topical steroids, oral prednisone, Dupixent. Patient had no covid prior vaccination. Patient tested covid post vaccination. covid test type post vaccination was nasal Swab.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pyrexia, Vomiting
Clinical narrative: severe vomiting; low grade fever; was unable to eat or drink anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 13:30 (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), administration date: 07Jan2022, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: VOMITING (medically significant) with onset 29Jan2022 10:30, outcome "recovering", described as "severe vomiting"; PYREXIA (non-serious) with onset 29Jan2022 10:30, outcome "recovering", described as "low grade fever"; DYSPHAGIA (non-serious) with onset 29Jan2022 10:30, outcome "recovering", described as "was unable to eat or drink anything". Therapeutic measures were not taken as a result of vomiting, pyrexia, dysphagia. Patient did not have COVID prior vaccination and didn't test COVID post vaccination. No known allergies were reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, SARS-CoV-2 test
Clinical narrative: AD flared approximately 2 months post Booster shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Lot number: EL0141) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ORTHO TRI-CYCLEN; DUPIXENT. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 11Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 11Oct2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: DERMATITIS ATOPIC (medically significant) with onset Apr2021, outcome "not recovered", described as "AD flared approximately 2 months post Booster shot.". The event "ad flared approximately 2 months post booster shot." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dermatitis atopic with Multiple topical steroids, oral prednisone, Dupixent. Clinical Course: Patient did not taken other vaccine  in four weeks. Patient taken other medication in two weeks are Ortho Tri-Cyclen, daily vitamin, dupixen.  No covid prior to vaccination. Covid test was done post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: anaphylaxis; seizure; hives; Covid test date=19Jan2022, Covid test result=Positive; Covid test date=19Jan2022, Covid test result=Positive; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: Polycystic ovarian syndrome ("PCOS") (unspecified if ongoing); Gastrooesophageal reflux disease ("GERD") (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "known allergies: nuts" (unspecified if ongoing),; "known allergies: figs" (unspecified if ongoing); "known allergies: pollen" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing), all notes: known allergies: shellfish, nuts, figs, pollen, eggs. Concomitant medications included: OMEPRAZOLE; METFORMIN. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "anaphylaxis"; SEIZURE (hospitalization, medically significant, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "seizure"; URTICARIA (hospitalization, life threatening) with onset 20Jan2021, outcome "recovered with sequelae", described as "hives"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Covid test date=19Jan2022, Covid test result=Positive". The events "anaphylaxis", "seizure" and "hives" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasal Swab: (19Jan2022) positive. Therapeutic measures were taken as a result of anaphylactic reaction, seizure, urticaria, which included epinephrine (EPIPEN). Clinical course: Facility type vaccine: Hospital. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Epigastric discomfort, Feeling hot, Rash, Skin irritation, Swelling face
Clinical narrative: major hives issues; outbreaks of hot spots; irritation on her skin; swelling of the face; So there has been rashes; Irritation on Face; Irritation on Face and Stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FC0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dry skin" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: URTICARIA (medically significant), outcome "not recovered", described as "major hives issues"; FEELING HOT (medically significant), outcome "not recovered", described as "outbreaks of hot spots"; SKIN IRRITATION (medically significant), outcome "not recovered", described as "irritation on her skin"; SWELLING FACE (medically significant), outcome "not recovered", described as "swelling of the face"; RASH (medically significant), outcome "not recovered", described as "So there has been rashes"; SKIN IRRITATION (non-serious), outcome "not recovered", described as "Irritation on Face"; EPIGASTRIC DISCOMFORT (non-serious), outcome "not recovered", described as "Irritation on Face and Stomach". The events "major hives issues", "outbreaks of hot spots", "irritation on her skin", "swelling of the face", "so there has been rashes", "irritation on face" and "irritation on face and stomach" were evaluated at the physician office visit. Treatment included Benadryl, Zyrtec, Cetirizine Hydrochloride Antihistamine, Prednisone 5mg tablets: take 4 tablets by mouth twice a day for 3 days, then 2 tablets twice a day for 3 days, then 2 tablets by mouth once daily for 2 days, then 1 tablet 1 daily for 2 days.  Clinical course: reported stated that patient was on Steroid and was done the end of last week and patient is starting to have issues with hives again. Patient did not had history of all previous immunization with the Pfizer vaccine considered as suspect and was not administered additional vaccines on Same Date of the Pfizer Suspect. Adverse Event onset time reported as 7-10 Days Later. Patient did not had Prior Vaccinations within 4 weeks. AE reported prior vaccinations are normal redness injection site and mild fever when patient was little with typical vaccines (not specified). Family Medical History Relevant to AE reported as None. No relevant tests are reported.  Follow up (31Jan2022): This is a spontaneous follow up report from a same contactable other HCP. This other HCP reported for a 10-Years-Old female patient that: Updated information: reporter phone no. mail id, patient address, RMH, Suspect product dose no, facility name Event, event outcome, physician office  No follow-up attempts are needed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: major hives issues; outbreaks of hot spots; irritation on her skin; swelling of the face; So there has been rashes; Irritation on Face; Irritation on Face and Stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FC0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dry skin" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: URTICARIA (medically significant), outcome "not recovered", described as "major hives issues"; FEELING HOT (medically significant), outcome "not recovered", described as "outbreaks of hot spots"; SKIN IRRITATION (medically significant), outcome "not recovered", described as "irritation on her skin"; SWELLING FACE (medically significant), outcome "not recovered", described as "swelling of the face"; RASH (medically significant), outcome "not recovered", described as "So there has been rashes"; SKIN IRRITATION (non-serious), outcome "not recovered", described as "Irritation on Face"; EPIGASTRIC DISCOMFORT (non-serious), outcome "not recovered", described as "Irritation on Face and Stomach". The events "major hives issues", "outbreaks of hot spots", "irritation on her skin", "swelling of the face", "so there has been rashes", "irritation on face" and "irritation on face and stomach" were evaluated at the physician office visit. Treatment included Benadryl, Zyrtec, Cetirizine Hydrochloride Antihistamine, Prednisone 5mg tablets: take 4 tablets by mouth twice a day for 3 days, then 2 tablets twice a day for 3 days, then 2 tablets by mouth once daily for 2 days, then 1 tablet 1 daily for 2 days.  Clinical course: reported stated that patient was on Steroid and was done the end of last week and patient is starting to have issues with hives again. Patient did not had history of all previous immunization with the Pfizer vaccine considered as suspect and was not administered additional vaccines on Same Date of the Pfizer Suspect. Adverse Event onset time reported as 7-10 Days Later. Patient did not had Prior Vaccinations within 4 weeks. AE reported prior vaccinations are normal redness injection site and mild fever when patient was little with typical vaccines (not specified). Family Medical History Relevant to AE reported as None. No relevant tests are reported.  Follow up (31Jan2022): This is a spontaneous follow up report from a same contactable other HCP. This other HCP reported for a 10-Years-Old female patient that: Updated information: reporter phone no. mail id, patient address, RMH, Suspect product dose no, facility name Event, event outcome, physician office  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Disease recurrence, Pain in extremity, Tinnitus
Clinical narrative: Asthma attack; Asthma attack; ringing in ears; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 10:30 (Lot number: EW0158) at the age of 63-year as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ringing ears" (ongoing); "Asthma" (ongoing), notes: Asthma severe in myself; "Reflux" (ongoing); "Eczema on skin dryness" (unspecified if ongoing). Family history included: "Thyroid issue" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: Mother cancer; "Heart attack" (unspecified if ongoing), notes: Father Heart attack. Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); FLOVENT HFA taken for asthma (ongoing); PROAIR HFA taken for asthma (ongoing); CLOBETASOL 0.05% taken for skin disorder (ongoing). Past drug history included: Estrace for Balance of body hormones. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8727, Anaomical location: Right Arm, Time: 10:30), administration date: 25Mar2021, when the patient was 63-year old, for COVID-19 immunization, reaction(s): "Asthma attack", "Ringing in my right ears", "Dizziness", "Arm pain". The following information was reported: ASTHMA (medically significant), DISEASE RECURRENCE (medically significant), outcome "not recovered" and all described as "Asthma attack"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". The events "asthma attack", "asthma attack (disease recurrence)", "ringing in ears" and "arm pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of asthma, disease recurrence. Clinical course: Patient received bnt162b2 on 18Dec2021 02:30 (Lot number: ED7218) via an unspecified route of administration administered on right arm as DOSE 3 (BOOSTER), SINGLE.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: he's still weak on his left side his injection was a year ago today; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (hospitalization), outcome "not recovered", described as "he's still weak on his left side his injection was a year ago today". Therapeutic measures were taken as a result of asthenia.  Clinical course: Patient, a year ago today, got vaccine, stayed 15 minutes after the shot, walked out and had an adverse event. They took him to hospital and was in there for nearly a month. He was sent home with some physical therapy and was still receiving it. Patient was still weak on his left side his injection was a year ago today. He was getting slightly better, but not better. He was paying for it out of pocket. He would like to know if there was any assistance. Patient was too proud to call. He does not have a lot or expiration for the product. He did not wish to provide any other details.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association , there is a possibility of causal association between the event ASTHENIA and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erectile dysfunction, Product use issue
Clinical narrative: Erectile dysfunction; Pfizer: 05Jan2022, Moderna vaccine same date: 05Jan2022; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 15:45 (Lot number: FL3198) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 05Jan2022 (Lot number: 021L21A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Vaccination history included: Moderna Dose number: 1 (Lot number: 041B21A) and Dose number: 2 (Lot number: 021L21A), both vaccine location: left arm, administration time: 12:00 PM, administration date: 17May2021 (as reported), when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: ERECTILE DYSFUNCTION (medically significant) with onset 06Jan2022, outcome "not recovered", described as "Erectile dysfunction"; PRODUCT USE ISSUE (non-serious) with onset 05Jan2022, outcome "unknown", described as "Pfizer: 05Jan2022, Moderna vaccine same date: 05Jan2022". Therapeutic measures were not taken as a result of erectile dysfunction. Patient started experiencing erectile dysfunction since Pfizer booster. He didn't have the problem on 04Jan2022. As of 31Jan2022, he was still having the same problem which never happened before 04Jan2022. He does not have Covid related or any health problem. He had 2 Moderna shots before. Also reported that other vaccine same date product was Moderna (lot number: 021L21A) on 05Jan2022 as "dose number: 2" (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He was diagnosed with Covid for the second time in Nov2021; He was diagnosed with Covid for the second time in Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02095270.  A male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2020 (unspecified if ongoing), notes: Verbatim: First time he got Covid was sometime in Jan2020 and this was before he received the Pfizer Covid-19 vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "He was diagnosed with Covid for the second time in Nov2021".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did get COVID; did get COVID; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did get COVID".  Clinical course: Reporter stated, know people who are not immunized and are in the hospital right now, also know people who are fully immunized and did get COVID except their symptoms are quite mild. Okay, so getting the vaccine will not prevent you from getting Omicron but it will prevent you from getting terribly ill. And yes, I know people who had gotten terrible ill who are not vaccinated. Reporter stating causality as related to events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Stress, Suspected COVID-19
Clinical narrative: Seizures; she had a resurgence of Covid symptoms; They get worse with stress; 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 29 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus", start date: 2013 (ongoing); "sick" (unspecified if ongoing), notes: She has had a cytokine reaction before when she gets sick.; "cytokine reaction" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; SUSPECTED COVID-19 (non-serious) with onset 2021, outcome "unknown", described as "she had a resurgence of Covid symptoms"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "They get worse with stress".  Mentioned that after getting the vaccine she experienced seizures. It was stated that she has never had seizures before and stated that she lost her job because of it. Still in the process of diagnosing her and finding out what was causing her seizures. Since her doses, she has had at least 1 seizure every day and get worse with stress and they come in waves. Recently she had a resurgence of Covid symptoms about 2 weeks ago and the seizures got worse then. Stated that this occurred with her first and second doses. She does not remember the exact dates she received her doses. Also reported that she experienced seizures on 23Sep2021 and she had a resurgence of Covid symptoms on Jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: UNK
Symptoms: Condition aggravated, Drug interaction, Psoriasis, Therapeutic product effect decreased, Therapeutic response shortened
Clinical narrative: Humira not working or not getting same effect of Humira as before, covid-19 vaccine; was wearing off; Drug effect decreased; Psoriasis flare-up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22P-163-4251468-00.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) and second regimen subcutaneous since 2021 (Batch/Lot number: unknown) for psoriatic arthropathy. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INTERACTION (medically significant), outcome "unknown", described as "Humira not working or not getting same effect of Humira as before, covid-19 vaccine"; THERAPEUTIC RESPONSE SHORTENED (medically significant), outcome "unknown", described as "was wearing off"; THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Drug effect decreased"; PSORIASIS (medically significant), outcome "unknown", described as "Psoriasis flare-up". The action taken for adalimumab was unknown. On unknown dates, the patient experienced Humira not working/not getting same effect of Humira as before, covid-19 vaccine was wearing off and psoriasis broke out in torso/front and back. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) drug effect decreased, wearing off effect, psoriasis flare-up not working/not getting same effect of HUMIRA as before, covid-19 vaccine was wearing off and psoriasis broke out in torso/front and back was not reported.   Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) drug effect decreased, wearing off effect, psoriasis flare-up was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Paranasal sinus discomfort
Clinical narrative: body aches; sinus pressure; Caller reported he was diagnosed with Covid for a third time on 23Jan2022; Caller reported he was diagnosed with Covid for a third time on 23Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 02095270. (Merck)  A male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Nov2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "Caller reported he was diagnosed with Covid for a third time on 23Jan2022"; PAIN (non-serious), outcome "unknown", described as "body aches"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure". Patient reported that he was diagnosed with Covid on 23Jan2022, and the doctor prescribed molnupiravir. Patient confirmed he has not started the molnupiravir yet. Patient stated this is the third time he has been sick with Covid and reported he has been vaccinated with two doses of the Pfizer Covid-19 Vaccine. Patient explained the first time he got Covid was sometime in Jan2020 and this was before he received the Pfizer Covid-19 vaccine. Patient said he received his first dose of the Pfizer Covid-19 Vaccine around Nov2021 and the second dose sometime in Dec2021, but he was unable to provided exact dates and stated he was diagnosed with Covid for the second time in Nov2021; Patient did not know the specific date, but he said it was after he was vaccinated with his first dose of the Pfizer Covid-19 Vaccine. Patient reported he was diagnosed with Covid for a third time on 23Jan2022 and stated again this is after he received 2 doses of the Pfizer Covid-19 Vaccine. Patient stated he has body aches and sinus pressure. Patient did not provide any further details. No additional AE or PQC reported. No additional information provided.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: Asymptomatic; Asymptomatic; This is a spontaneous report received from a non-contactable reporter(s) (Other 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 (hospitalization, medically significant), ASYMPTOMATIC COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Asymptomatic".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, Asymptomatic Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; Cough; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Lot number: 301308A) at the age of 81 years as dose 3 (booster), single, administration date 16Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Two heart stents", start date: 12Feb2020 (unspecified if ongoing), notes: Verbatim: two heart stents. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "tested positive for Covid-19"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Therapeutic measures were taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test
Clinical narrative: binex: Positive/Covid test result=Positive; breakthrough infection/Covid test result=Positive; breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "binex: Positive/Covid test result=Positive"; COVID-19 (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "breakthrough infection/Covid test result=Positive"; INFECTION (medically significant) with onset 31Jan2022 08:00, outcome "not recovered", described as "breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive, notes: covid test type post vaccination=Nasal Swab,.  Clinical course: other vaccine same date product was not known. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid, omicron I assume; got covid, omicron I assume; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid, omicron I assume". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Customer Verbatim: I had gotten my booster shot. And before the 2 weeks was up I got covid, omicron I assume. I have been wondering how this affects immunity  No follow-up attempts are needed. No further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, Inappropriate schedule of product administration, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: I got covid 28Dec2021; I got covid 28Dec2021; that time the itching moved to my front and back neck areas; Dose 2:23Jun2021/Dose 1: 04May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jun2021 (Lot number: EW0196) at the age of 41 years as dose 2, single and administered in arm left, administration date 04May2021 (Lot number: EW0167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRENA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "I got covid 28Dec2021"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Jun2021, outcome "unknown", described as "Dose 2:23Jun2021/Dose 1: 04May2021"; PRURITUS (non-serious) with onset 28Dec2021, outcome "unknown", described as "that time the itching moved to my front and back neck areas". The events "i got covid 28dec2021", "i got covid 28dec2021", "that time the itching moved to my front and back neck areas" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antibody test: (01Jun2021) 5812.3, notes: My covid antibody level is 5812.3 AU/ml; sars-cov-2 antibody test: (25Jan2022) positive, notes: covid test type post vaccination: Blood test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, pruritus.  Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination:Morena IUD.  Follow-Up (02Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I got covid 28Dec2021; I got covid 28Dec2021; that time the itching moved to my front and back neck areas; Dose 2:23Jun2021/Dose 1: 04May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jun2021 (Lot number: EW0196) at the age of 41 years as dose 2, single and administered in arm left, administration date 04May2021 (Lot number: EW0167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRENA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "I got covid 28Dec2021"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Jun2021, outcome "unknown", described as "Dose 2:23Jun2021/Dose 1: 04May2021"; PRURITUS (non-serious) with onset 28Dec2021, outcome "unknown", described as "that time the itching moved to my front and back neck areas". The events "i got covid 28dec2021", "i got covid 28dec2021", "that time the itching moved to my front and back neck areas" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antibody test: (01Jun2021) 5812.3, notes: My covid antibody level is 5812.3 AU/ml; sars-cov-2 antibody test: (25Jan2022) positive, notes: covid test type post vaccination: Blood test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, pruritus.  Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination:Morena IUD.  Follow-Up (02Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: Small fibre neuropathy positive skin biopsy; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 22-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 09:15 (Lot number: EN5319) as dose 2, single and intramuscular, administered in arm left, administration date 17Jan2021 09:00 (Lot number: EL0142) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: SMALL FIBRE NEUROPATHY (disability), outcome "not recovered", described as "Small fibre neuropathy positive skin biopsy". The event "small fibre neuropathy positive skin biopsy" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy skin: (unspecified date) positive, notes: Small -Fiber Neuropathy; COVID test: (Jan2022) negative, notes: Nasal Swab. Treatment received for the adverse event included Lyrica, Gabapentin, Cymbalta. Not diagnosed with COVID-19 prior to vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the event small fibre neuropathy  and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate