chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: He basically got alopecia areata after receiving the vaccine; His son experienced alopecia areata or hair loss after the first dose and second dose; Upon receipt of follow-up information on 10Aug2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BIOTIN; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "He basically got alopecia areata after receiving the vaccine"; ALOPECIA (non-serious), outcome "unknown", described as "His son experienced alopecia areata or hair loss after the first dose and second dose". Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: The patient used topical cream for the AA which is Alopecia areata, it is Fluocinolone acetonide (treatment). He also used a previous cream called Tofacitinib topical cream (treatment) and he also used Clobetasol Propionate topical solution (treatment). Today he also received a shot, injection steroid today and that is called Kenalog and expected to receive that once a month. No other medical condition. No investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Covid symptoms continues even after tested negative after taken Paxlovid; (08Aug2022) Positive, notes: tested again with a home kit on 08Aug, and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient reported his Covid symptoms continued even after being tested negative after taking Paxlovid. Because of the symptoms, he tested again with a home kit on 8Aug2022, and it was positive. He had four doses of vaccines over the last 1 and 1/2 years. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Why the pediatrician would have such old/expired vaccines on hand that are being administered to youth, rather than being discarded; This case has been considered invalid as info not qualifying for AE reporting.  This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team, Program ID: The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose number unknown, single (Lot number: FL2757, Expiration Date: 30Sep2022) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 04Aug2022, outcome "unknown", described as "Why the pediatrician would have such old/expired vaccines on hand that are being administered to youth, rather than being discarded".  Follow-up (11Aug2022): This case has been considered invalid as info not qualifying for AE reporting. This is a spontaneous follow-up report from same contactable consumer. Updated information included: Case invalid. The updated expiry date upon follow up was 30Sep2022 and therapy start and stop date was 04Aug2022. Sender's Comments: Linked Report(s) : PFIZER INC-202201053812 similar report from same reporter;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm, on 26Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Excessive stomach acid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levofloxacin, reaction(s): "Drug Allergy"; Likely many fluoroquinolones, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On the second day, I had a strongly positive Covid rapid test; Negative, notes: The day I took the last pills, I felt very good and had a negative Covid rapid test; Positive, notes: Four days later I had another strong positive rapid test and symptoms similar to a head cold returned for several days; Positive, notes: still have a significant positive rapid test and minor symptoms; Positive, notes: 4 days after start of Covid symptoms, I tested positive and was prescribed Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: 4 days after start of Covid symptoms, the patient tested positive and was prescribed Paxlovid. He completed the full course of Paxlovid tablets as prescribed. His condition improved, although it was already improving slightly when I received the pills. Over the next few days nearly all symptoms disappeared. On the second day, he had a strongly positive Covid rapid test. The day he took the last pills, he felt very good and had a negative Covid rapid test. Four days later he had another strong positive rapid test and symptoms similar to a head cold returned for several days. Yesterday, 8 days after finishing Paxlovid, he still have a significant positive rapid test and minor symptoms. he understand that this is not an unusual event. He report this just in case they are trying to get a variety of input on this. He does not consider this to be so much an adverse event as an unexpected event. He does not need any response. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Biopsy, Blister, Diarrhoea, Dysstasia
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 patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "lupus" (unspecified if ongoing); "allergic to Gluten" (unspecified if ongoing). The patient's 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 "she had all the symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: she tested negative for COVID-19 with the test kits. Clinical Course: Patient stated that patient had the primary 2-dose series of Pfizer COVID-19 vaccine in 2021 (in (state withheld)). They explained to her that patient might have fever or pain in the injection area up to one day to two days or possibly three days. Stated that patient had lupus, fibromyalgia, diabetes, Raynaud disease, and cancer, patient had been on the cancer medication for 4 years with which she only had nausea and headache, patient asked her doctor if she could take it at night, and patient did so, to avoid those symptoms during the day and be an active person. Pfizer had supplied to her the medication AROMASIN Exemestane 25 mg tablets, for 4 years, and patient had an appointment scheduled for Oct at local Cancer Center. Patient had all the symptoms of COVID-19, but patient tested negative for COVID-19 with the test kits that patient purchased at the (pharmacy name withheld) inside (state name withheld)). Patient was diabetic and had been taking her medications and injecting insulin, without issues, until the day after patient received the booster dose of Pfizer COVID-19 vaccine (in (place name withheld)) lot number FL3209 on 04Jan2022. Since then, patient stated that patient fell in bed, and patient still has symptoms to this day 11Aug2022, the booster messed up her life, it is still the same, it harmed her system and patient wonders if the vaccine altered her immune system. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Influenza virus test, Insulin resistance, Monkeypox, Myalgia
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 patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "lupus" (unspecified if ongoing); "allergic to Gluten" (unspecified if ongoing). The patient's 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 "she had all the symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: she tested negative for COVID-19 with the test kits. Clinical Course: Patient stated that patient had the primary 2-dose series of Pfizer COVID-19 vaccine in 2021 (in (state withheld)). They explained to her that patient might have fever or pain in the injection area up to one day to two days or possibly three days. Stated that patient had lupus, fibromyalgia, diabetes, Raynaud disease, and cancer, patient had been on the cancer medication for 4 years with which she only had nausea and headache, patient asked her doctor if she could take it at night, and patient did so, to avoid those symptoms during the day and be an active person. Pfizer had supplied to her the medication AROMASIN Exemestane 25 mg tablets, for 4 years, and patient had an appointment scheduled for Oct at local Cancer Center. Patient had all the symptoms of COVID-19, but patient tested negative for COVID-19 with the test kits that patient purchased at the (pharmacy name withheld) inside (state name withheld)). Patient was diabetic and had been taking her medications and injecting insulin, without issues, until the day after patient received the booster dose of Pfizer COVID-19 vaccine (in (place name withheld)) lot number FL3209 on 04Jan2022. Since then, patient stated that patient fell in bed, and patient still has symptoms to this day 11Aug2022, the booster messed up her life, it is still the same, it harmed her system and patient wonders if the vaccine altered her immune system. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Swelling
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 patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "lupus" (unspecified if ongoing); "allergic to Gluten" (unspecified if ongoing). The patient's 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 "she had all the symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: she tested negative for COVID-19 with the test kits. Clinical Course: Patient stated that patient had the primary 2-dose series of Pfizer COVID-19 vaccine in 2021 (in (state withheld)). They explained to her that patient might have fever or pain in the injection area up to one day to two days or possibly three days. Stated that patient had lupus, fibromyalgia, diabetes, Raynaud disease, and cancer, patient had been on the cancer medication for 4 years with which she only had nausea and headache, patient asked her doctor if she could take it at night, and patient did so, to avoid those symptoms during the day and be an active person. Pfizer had supplied to her the medication AROMASIN Exemestane 25 mg tablets, for 4 years, and patient had an appointment scheduled for Oct at local Cancer Center. Patient had all the symptoms of COVID-19, but patient tested negative for COVID-19 with the test kits that patient purchased at the (pharmacy name withheld) inside (state name withheld)). Patient was diabetic and had been taking her medications and injecting insulin, without issues, until the day after patient received the booster dose of Pfizer COVID-19 vaccine (in (place name withheld)) lot number FL3209 on 04Jan2022. Since then, patient stated that patient fell in bed, and patient still has symptoms to this day 11Aug2022, the booster messed up her life, it is still the same, it harmed her system and patient wonders if the vaccine altered her immune system. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "lupus" (unspecified if ongoing); "allergic to Gluten" (unspecified if ongoing). The patient's 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 "she had all the symptoms of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: she tested negative for COVID-19 with the test kits. Clinical Course: Patient stated that patient had the primary 2-dose series of Pfizer COVID-19 vaccine in 2021 (in (state withheld)). They explained to her that patient might have fever or pain in the injection area up to one day to two days or possibly three days. Stated that patient had lupus, fibromyalgia, diabetes, Raynaud disease, and cancer, patient had been on the cancer medication for 4 years with which she only had nausea and headache, patient asked her doctor if she could take it at night, and patient did so, to avoid those symptoms during the day and be an active person. Pfizer had supplied to her the medication AROMASIN Exemestane 25 mg tablets, for 4 years, and patient had an appointment scheduled for Oct at local Cancer Center. Patient had all the symptoms of COVID-19, but patient tested negative for COVID-19 with the test kits that patient purchased at the (pharmacy name withheld) inside (state name withheld)). Patient was diabetic and had been taking her medications and injecting insulin, without issues, until the day after patient received the booster dose of Pfizer COVID-19 vaccine (in (place name withheld)) lot number FL3209 on 04Jan2022. Since then, patient stated that patient fell in bed, and patient still has symptoms to this day 11Aug2022, the booster messed up her life, it is still the same, it harmed her system and patient wonders if the vaccine altered her immune system. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "mild coronary artery disease" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: IMDUR; PRAVACHOL. The patient received other medication in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: treatment I test negative for Covid on Day 11 and 12; (2022) Positive, notes: I tested positive with an antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received anti-viral treatment for COVID-19, treatment start date 24Jul2022 and treatment stop date 28Jul2022. Clinical course: After completing Paxlovid 5-day treatment the patient test negative for Covid on Day 11 and 12. On Day 13, the patient began feeling achy, very tired, return of sore throat and runny nose. The patient tested positive with an antigen test and resumed second period of isolation and quarantine. Adverse event start date reported as 04Aug2022 at 17:00. The adverse event was not resulted in physician office or emergency room visit. Sender's Comments: Based on the information given in narrative, the causal relationship between the events vaccination failure and COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pyrexia, Vaccination site discomfort
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 patient. A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Gluten" (unspecified if ongoing). Concomitant medication(s) included: AROMASIN. Vaccination history included: Bnt162b2 (Dose 1, Single, (Lot # not provided)), administration date: 2021, for COVID-19 immunization, reaction(s): "discomfort at site of injection", "fever", "pain in the injection area". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "discomfort at site of injection". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She received the first and second doses in 2021. The ones (doses) received, she was aware about side effects like fever, discomfort at site of injection. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201053803 Same patient, same drug/different dose, different AEs; PFIZER INC-202201053843 Same patient, same drug, similar events, different dose;
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), at the age of 5 years on 09Nov2021 as dose 1, single (Lot number: FK5127) and on 02Dec2021 as dose 2, single (Lot number: FK5127) at the age of 6 years, all intramuscular for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included multivitamin with iron. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "patient tested positive for COVID-19 on 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) positive. Sender's Comments: Linked Report(s): US-PFIZER INC-202201053004 same patient, different vaccine dose/AE.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the parent. A 7-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 2, single (Lot number: FK5127) at the age of 7 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BIOTIN; MULTIVITAMIN [VITAMINS NOS]. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 16Nov2021, when the patient was 7-year-old, for COVID-19 Immunization, reaction(s): "His son experienced alopecia areata or hair loss after the first dose and second dose", "His son experienced alopecia areata or hair loss after the first dose and second dose". The following information was reported: ALOPECIA AREATA (non-serious), ALOPECIA (non-serious) all with onset 2021, outcome "unknown" and all described as "His son experienced alopecia areata or hair loss after the first dose and second dose". Therapeutic measures were taken as a result of alopecia areata, alopecia. Additional information: Reporter stated that my son had an adverse reaction to the Pfizer vaccine and trying to get some answers and some help regarding his issue. Reporter stated his son got the Pfizer Covid 19 vaccine the first dose was 16Nov2021, second dose was 07Dec2021 and his son experienced alopecia areata or hair loss after the first dose and second dose. He would like to know if we had any information regarding that. Reporter did not know his height, but believe his weight was 90 pounds (reporter was unsure about height and weight). Expiration date: Reporter stated, the only date it shows was 16Nov2021. That was the date of the shot. Other medical condition: Reporter stated, no, not that we are aware of. Other medications: Reporter stated, at the time of vaccine or to fix the issue, at the time of vaccine or after, he was using a topical cream at this time for the AA which was Alopecia areata, it was fluocinolone acetonide (treatment). He also used a previous cream called Tofacitinib topical cream (treatment) and he also used Clobetasol Propionate topical solution (treatment). Today, he also received a shot, injection steroid today and that was called Kenalog, and he was expected to received that once a month. He also takes a multi vitamin and Biotin. Prior vaccination (within 4 weeks): Reporter stated no. Vaccination facility details: Reporter stated, "I am not quite sure if this will be it, it says health care professional or clinic site was ADRN, was that right". He did not go to a pharmacy, and thought that the lot number. It was showing  Pfizer. Reporter further stated, give me just one moment. Investigations: No.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Already have all the shots. Two shots and two boosters, Pfizer vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She already had all vaccines but recently became positive twice; Positive, notes: She already had all vaccines but recently became positive twice. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 at 13:00 as dose 4 (booster), single (Lot number: 30155BA) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I got COVID again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment as Paxlovid drug from 31Jul2022 to 04Aug2022 (Lot number: XV0001) for COVID-19. Other medication in 2 weeks was reported as no. No Known allergies. Other medical history was reported as no.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 contracted at airport; COVID-19 contracted at airport; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for Covid-19 Treatment, reaction(s): "COVID-19/ Negative Reaction on Paxlovid", notes: Paxlovid (Nirmatrelvir; Ritonavir), Route of administration: Unknown. Therapy Dates/Duration: 2022-2022.; Paxlovid for Covid-19 Treatment, reaction(s): "Influenza", notes: Paxlovid (Nirmatrelvir; Ritonavir), Route of administration: Unknown. Therapy Dates/Duration: 2022-2022.; Paxlovid for Covid-19 Treatment, reaction(s): "Feeling bad", notes: Paxlovid (Nirmatrelvir; Ritonavir), Route of administration: Unknown. Therapy Dates/Duration: 2022-2022; Humira for Psoriatic Arthritis, reaction(s): "Influenza", notes: Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab), 1160837. Daily Dose: 1) Citrate free (40 mg, 1 in 2 wk), Route of admin: Subcutaneous. Therapy Dates/Duration: Unk-2022; Humira for Psoriatic Arthritis, reaction(s): "Feeling bad", notes: Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab), 1160837. Daily Dose: 1) Citrate free (40 mg, 1 in 2 wk), Route of admin: Subcutaneous. Therapy Dates/Duration: Unk-2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 30Jun2022, outcome "recovered" (2022) and all described as "COVID-19 contracted at airport". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive. Clinical Course: This is a solicited report by a consumer of a 36-year-old female with events of non-serious influenza, COVID-19 contracted at airport, feeling badly and negative reaction on Paxlovid with Humira (Adalimumab). There was no reported medical history. In 2022, the patient experienced negative reaction on Paxlovid. On 29May2022, the patient experienced Influenza. In Jun2022, the patient experienced COVID-19 contracted at airport and feeling badly. On 05Jun2022, the influenza resolved. In 2022, the COVID-19 contracted at airport resolved. Paxlovid (Nirmatrelvir; Ritonavir) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1284), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: 003K21A) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RAD" (unspecified if ongoing); "OSA" (unspecified if ongoing); "CPAP" (unspecified if ongoing); "HTN" (unspecified if ongoing); "BPH" (unspecified if ongoing); "TURP" (unspecified if ongoing); "Hayfever" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure and covid 19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she gets COVID again; she gets COVID again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "she gets COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: she gets COVID again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201054880 Same reporter/drug/patient, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: had problems with their periods they started get them again after they had the Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "had problems with their periods they started get them again after they had the Pfizer".  Clinical Course: The patient was upset because it happened with her mother in law and two of her friends they had problems with their periods they started get them again after they had the Pfizer (further clarifications unknown split not made by CH). She also heard your CEO he is like. She was going be selfish, she was not going to get the vaccine. She will give it to everybody else and he just flew to Israel and you let him go and he was not vaccinated that's pretty bad and she did not get one not because of Pfizer her brother in law used to work for you. She didn't get because the government said we are getting involved. All government in the United States involved she knew, she didn't want part of it because they haven't done anything constructed for our country an over 80 years. So, she knew not to do it. So, she didn't want the four year old to die and also what she heard from other doctor like, he said you may as well put a damn pistol to the child head because as soon you shoot them with a vaccine not only Pfizer but any of them (not clarified) it will kill their immune system and while you are growing up, you build an immune system or any germs that comes on child's way she will have no protection against. So, she just wanted to know, how you all have no more ethics or all about the money.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown, single (Lot number: FD0809) at the age of 53 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Iodine, reaction(s): "allergic to iodine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Patient received Anti-viral COVID 19 Treatment with Paxlovid from 02Aug2022 to 04Aug2022, lot number: 19119252A.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Cytomegalovirus test, Epstein-Barr virus test, Physical examination, Vulval ulceration
Clinical narrative: Vulvar aphthous ulcers; Vulvar aphthous ulcers; This is a literature report.  An adolescent patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bnt162b2 for COVID-19 immunisation, reaction(s): "Without complications", notes: Dose 1, Single.  The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Vulvar aphthous ulcers". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Physical exam: Was consistent with a diagnosis of vulvar aphthous, notes: ulcers with no exceptional characteristics. There were multiple ulcerations with fibrinous exudate and some with necrotic islands.; Sender's Comments: Based on the information in the case, an association between the reported events ulceration of vulva and aphthous ulcer and the suspect product BNT162B2 cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-PV202200042326 Same article/drug/event and different patient;US-PFIZER INC-202201056246 Same article/drug/event and different patient:;
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EL1040), in left arm, on 14Jan2021 as dose 2, single (Lot number: EL1283), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Other medical history: Depression. Concomitant medication(s) included: WELLBUTRIN; ATORVASTATIN; VITAMIN D NOS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medications i.e., Wellbutrin, Atorvastatin Vitamin D, in two weeks of vaccination. Patient had received Paxlovid for adverse event treatment (Treatment start date was 10Jun2022 & Treatment stop date was 14Jun2022). Patient had no known allergies reported.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible". Therapeutic measures were not taken as a result of illness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201056342 same patient, different product and event; PFIZER INC-202201056719 same patient and product, different dose; PFIZER INC-202201056720 same patient and product, different dose;
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 27Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 32 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cutaneous lymphoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 03Aug2022 to 07Aug2022.  Clinical information: The patient had no known allergies. Other medication in 2 weeks was reported as none.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient was not received other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details reported, the patient received Paxlovid (Lot number: YHF) for COVID-19 treatment from 02Aug2022 to 07Aug2022. BNT162B2 lot number was not reported because lot number was obscured by other product labelling. On 11Aug2022 20:00, the patient was re-infected. Adverse event was not resulted in physician office or emergency room visit. The patient was not received treatment for adverse event (as reported). The patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 antigen test positive; COVID-19 antigen test positive; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 21Sep2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 045L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: Other medical history= Osteoporosis. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "COVID-19 antigen test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: having had 2 negative antigen tests; (unspecified date) Negative, notes: having had 2 negative antigen tests; (10Aug2022) Positive, notes: positive antigen test 7 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.