chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: administration of an adult Engerix-B dose to a 9 year-old female patient; administration of an adult Engerix-B dose to a 9 year-old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old female patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23-NOV-2023) for prophylaxis.   On 18-JUL-2023, the patient received Engerix B adult. On 18-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administration of an adult Engerix-B dose to a 9 year-old female patient) and adult product administered to child (Verbatim: administration of an adult Engerix-B dose to a 9 year-old female patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter called to report the administration of an adult Engerix-B dose to a 9-year-old female patient.  The reporter asked for safety information and recommendations on this situation. The reporter consented to follow up. The reporter called to report the administration of an adult Engerix-B dose to a 9 year-old female patient, which led to overdose and adult product administered to child.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: first dose of SHINGRIX in December, 2019. The patient received the second dose of SHINGRIX yesterday (July 27, 2023); very sore arm (Left); This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on December 2019, and felt achy reference case US2023103539).   On 27-JUL-2023, the patient received the 2nd dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: very sore arm (Left)). On 27-JUL-2023, the patient experienced drug dose administration interval too long (Verbatim: first dose of SHINGRIX in December, 2019. The patient received the second dose of SHINGRIX yesterday (July 27, 2023)). The outcome of the pain in arm was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023103539   Additional Information: GSK receipt date: 28-Jul-2023 The patient received the 2nd dose of Shingrix yesterday (the day before reporting) and had a very sore arm (left). The patient received 2nd dose after the schedule date, which led to lengthening of vaccination schedule. The reporter consented to follow up with the health care professionals (HCP) of pharmacy.; Sender's Comments:  US-GSK-US2023103539:Case for 1st dose
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 21-JUL-2022, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced hives (Verbatim: Broke out in hives). The outcome of the hives was resolved.   It was unknown if the reporter considered the hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JUL-2023 The reporter stated that a patient that had a reaction to Bexsero. He stated that the Healthcare Professional reported to him that an 18 year old female broke out in hives when she received her first dose of BEXSERO last year. So there was some concern about her getting her second dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose had not yet been given; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 10 months ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Second dose had not yet been given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Formication, Pruritus, Scab
Clinical narrative: feels like something is crawling on her skin; forming a crust; fluid filled vesicles began to pop up; very tired; vesicles as extremely itchy and forming a crust on the top very much like chickenpox; This non-serious case was reported by a consumer via call center representative and described the occurrence of vesicle in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when she was a child).   On 22-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 27-JUL-2023, 35 days after receiving Shingrix, the patient experienced vesicle (Verbatim: fluid filled vesicles began to pop up), tiredness (Verbatim: very tired), pruritus (Verbatim: vesicles as extremely itchy and forming a crust on the top very much like chickenpox) and crust (Verbatim: forming a crust). On an unknown date, the patient experienced crawling sensation (Verbatim: feels like something is crawling on her skin). The outcome of the vesicle, tiredness, pruritus and crust were not resolved and the outcome of the crawling sensation was not reported.   It was unknown if the reporter considered the vesicle, tiredness, pruritus, crawling sensation and crust to be related to Shingrix.     It was unknown if the company considered the vesicle, tiredness, pruritus, crawling sensation and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter was the patient who reported she received her first Shingrix vaccine on 22 jun 2023, in the left arm. After 5 weeks little fluid filled vesicles began to pop up all over her body. The reporter described the vesicles as extremely itchy and forming a crust on the top very much like chickenpox and new ones were popping up each day.  The reporter was very tired.  She felt like something was crawling on her skin and when she looked down ,nothing was there. The reporter had a severe case of chickenpox when she was a child. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: erythema  greater than 100 mm; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: erythema greater than 100 mm). The outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.     It was unknown if the company considered the erythema to be related to Shingrix.   Additional Information: GSK receipt date: 01-AUG-2023 The physician would like information regarding Shingrix.  The reporter enquired that if a patient had experienced erythema greater than 100 millimeter, when they received their first Shingrix dose 100 mm, should they receive their second dose? Medical Information Agent decided reported the current adverse event (AE) just to stay on the safe side and due the specific description of erythema mentioned by the physician. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient inadvertently received an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 31-JAN-2023) for prophylaxis.   On 01-AUG-2023, the patient received Havrix. On 01-AUG-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received an expired dose of Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Aug-2023 The reporter consented to follow-up. The patient received an expired dose of Havirx, which led to expired vaccine used.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of only the liquid component; Administration of only the liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA910a, expiry date 28-FEB-2025) for prophylaxis.   On 18-JUL-2023, the patient received Menveo. On 18-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid component) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-AUG-2023 The healthcare professional asked when they could administer a proper reconstituted dose to this patient. The reported did not provide patient initials. The reporter consented to follow up. The reporter called to report the administration of only the liquid component of Menveo to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Drug ineffective
Clinical narrative: Adverse event/severe side effects; Lack of effect/0 Zero antibodies; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies). At the time of the report, ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up information included no new information On 26-Aug-2021: Translation received on 31-AUG-2021 contain significant information that include Event added. On 26-Aug-2021: Translation received on 31-AUG-2021 contain significant information that include Event added. On 26-Aug-2021: Upon internal review on 02-AUG-2023, significant correction was performed to delete the event of immunodeficiency and merge it in the verbatim of the event of Lack of drug effect and also to update the report type in the case
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    This case was for patient no.14, who experienced Myocarditis after first dose of Moderna vaccine.  No concomitant or treatment medications were reported.  This study is based on a cohort evaluation of all adults administered =1 mRNA COVID-19 vaccine, including boosters, in the Health Administration between 14 December 2020 and 9 October 2022. From 14 December 2020 to 9 October 2022, 2 184 449 first and 2 036 948 second doses of mRNA-1273 (Moderna) were administered. In addition, 1 156 160 mRNA-1273 booster doses were administered. Among vaccine recipients in our cohort aged 1839 (predominately male, as expected in a based cohort), estimated incidence rates of confirmed myocarditis/pericarditis ranged from 0.46 cases per million (for Moderna dose 1, all ages) to 19.76 (Pfizer dose 2, ages 1839). Of the 178 potential safety events identified by the RA, only 33 were ultimately confirmed following an mRNA vaccine. Potential cases were ruled out after chart review for various reasons.  In summary, the incidence of myocarditis or pericarditis in patients was low across >10 million doses of mRNA COVID-19 vaccines (primary or booster doses) administered in the clinic.   This case was linked to MOD-2023-734758 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow up received by safety on 27-JUL-2023 has email that contains significant information: Reporter information, literature information, suspect information and event details were updated.; Sender's Comments: Company comment: This is a literature non-study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant AESI myocarditis. The event occurred after receiving the first dose of mRNA-1273 vaccine (event and vaccine dates were not provided). Concomitant and treatment medications were not reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MOD-2023-734758:Same literature (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Eye swelling, Illness, Migraine, SARS-CoV-2 test
Clinical narrative: Could not open eyes and kept bigger and bigger and were swollen; Was really sick.; Covid has made migraine so much worse; Had covid twice this year but doesn't know how; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had covid twice this year but doesn't know how), EYE SWELLING (Could not open eyes and kept bigger and bigger and were swollen), ILLNESS (Was really sick.) and MIGRAINE (Covid has made migraine so much worse) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (Had covid twice this year but doesn't know how). On an unknown date, the patient experienced EYE SWELLING (Could not open eyes and kept bigger and bigger and were swollen), ILLNESS (Was really sick.) and MIGRAINE (Covid has made migraine so much worse). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Had covid twice this year but doesn't know how), EYE SWELLING (Could not open eyes and kept bigger and bigger and were swollen) and ILLNESS (Was really sick.) outcome was unknown and MIGRAINE (Covid has made migraine so much worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2023, SARS-CoV-2 test: Positive.         Concomitant medication was not provided. Patient had second episode of covid on 23rd of June of this year. Patient was terrified of getting it again. It was reported that patient received all of the Covid vaccines except the 2nd bivalent vaccine. Patient confirmed that all the vaccines were from Moderna. Also reported that patient probably had Covid twice this year but doesn't know how it came because patient wears a mask always. The first round was back in March but did not get any antibodies or anything. Patient had gone to hospital and called doctor because patient knew it was covid but doctor told it was cold and later tested positive and was given Paxlovid.  Patient took Paxlovid again from the evening of 23-Jun for second episode.   Reporter did not allow further contact
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023; No adverse event; HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Patient was healthy.  Previously administered products included for Product used for unknown indication: pfizer (Dose 1) on 05-Mar-2022. Past adverse reactions to the above products included No adverse event with pfizer.    On 31-Jul-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 31-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose beyond use date on 31JUL2023. BUD was 29JUL2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29 Jun 2023, beyond use date was 29 Jul 2023 and administered 31 Jul 2023).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
Age: 0.83
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.; no adverse event; Dose administered after 30-day Use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event) in a 10-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.).    Concomitant product use was not provided by the reporter.  Vial was 2.5 ml. Vial did not undergo any temperature excursions. Suspect vaccine expiry date was reported as 06-Sep-2023.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: depression; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEPRESSION (depression) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no health issues. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSION (depression). At the time of the report, DEPRESSION (depression) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received the 1st 2 doses of Moderna COVID-19 Vaccine when the vaccine just came out, the caregiver does not remember the exact date but mentioned it was maybe on 2020. The lot number was unknown. The patient started feeling depressed after receiving the vaccines, the patient fell into a big depression that progressed slowly and felt out of space, and this had been going on for 2 years now, and it's getting worse, the patient was oblivious to everything. The patient needed to visit the doctor and they gave medications for depression but caller did not remember names. Previous to this situation, the patient was a healthy man.
Age: 53.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid from 23Jul2023 to 28Jul2023 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265196 Same patient, different drug/ AE;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Human papilloma virus test, Human papilloma virus test positive
Clinical narrative: HPV APTIMA positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Lot number: EN6208) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZITHROMAX. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number EN6203), administration date: 22Feb2021, for COVID-19 immunisation. The following information was reported: HUMAN PAPILLOMA VIRUS TEST POSITIVE (non-serious) with onset 06Oct2021, outcome "recovered" (2022), described as "HPV APTIMA positive test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Something significant Pfizer should know was she tested positive for HPV and that was why she will no longer take the booster. It was either after first or second dose of Covid vaccination. It had been way many too years of fidelity in marriage to be testing positive for HPV. Likely it was in her system and something stimulated it. Her HPV APTIMA positive test was on 29Sep from Labcorp. She got her two boosters and went in September for annual GYN. That was when she tested positive. Had never tested positive before. She had two test. One was positive and then a year later with no mRNA in her system a negative test. She was looking up her Labcorp test. Caller clarified the one on 29Sep2021 had report date of 06Oct2021 and she tested positive. She had two doses of Covid vaccine by then. She got that information in Oct2021. Took third dose because of where they were in pandemic. Her doctor died during Covid. 04Dec2020 was plain bloodwork. Trying to figure out when she got the negative test. She had been tested every year before and never had HPV. The body just does not start testing positive for HPV. After so many years in a monogamous marriage something stimulated the HPV virus in her body. After the Sep2021 positive she has had a negative HPV test the following year. Why would she stimulate that in her body again, she would not. Patient reported the weight: was 121 pounds before this started a week ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265759 same reporter/patient, different product/AE;US-PFIZER INC-202300076238 same reporter, different patient/product/AE;US-PFIZER INC-202300265890 same reporter/patient/product, different AE/dose (LOE);
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Weight, Weight decreased
Clinical narrative: decreased appetite; weight loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "weight loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The Caller stated that she took both shot and she wanted to know the side effects and list of inactive ingredients of the vaccine. Upon providing response, Caller clarified whether decreased appetite was same as lack of appetite. She also stated that due to this it may potentially cause weight loss and confirmed that she was currently experiencing weight loss and had all four doses.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient experienced numbness on the side of her body where she received the shot; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, 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: HYPOAESTHESIA (non-serious), outcome "recovered", described as "Patient experienced numbness on the side of her body where she received the shot". It was unknown if therapeutic measures were taken as a result of hypoaesthesia.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid (24Jul2023 to 28Jul2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265882 same patient, different drug/event;
Age: 56.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 as dose 2, single (Lot number: EW0177) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 22Jul2023 to 26Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266008 Same patient, different drug/AE.;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Investigation
Clinical narrative: heart is messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "heart is messed up". The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart is messed up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Skin reaction
Clinical narrative: Skin reaction; allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "food allergies" (unspecified if ongoing), notes: Has food allergies; "external allergies" (unspecified if ongoing), notes: external allergies.; "allergic to antibiotics" (unspecified if ongoing), notes: allergic to antibiotics and sulfur; "allergic to sulfur" (unspecified if ongoing), notes: allergic to antibiotics and sulfur; "allergies to medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SKIN REACTION (non-serious) with onset 2021, outcome "unknown"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergy". The events "skin reaction" and "allergy" required physician office visit. Therapeutic measures were taken as a result of skin reaction, hypersensitivity. Additional information: Has a lot of allergies to medications, amongst other things. Also had allergist for majority of the time. Treatment: Lots of things. Patient doesn't want to take another shot if, it is going to bring back the allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Granuloma annulare
Clinical narrative: Granuloma Annulare; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acne" (unspecified if ongoing), notes: Never had problem with skin except, slight amount of acne when younger. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Location: Left arm), administration date: 07Jan2021, for COVID-19 immunization. The following information was reported: GRANULOMA ANNULARE (medically significant) with onset 2021, outcome "not recovered". The event "granuloma annulare" required physician office visit. Therapeutic measures were taken as a result of granuloma annulare. Therapeutic measures were taken as a result of granuloma annulare which included Corticosteroid injection (Hydrocortisone injections), Cortisone cream USP 2.5%, Betamethasone cream .05%, Triamcinolone 0.025% cream. Clinical Course: Patient believed that about 6 months or less after, can't be sure but, didn't start reporting to doctor until then. Started having effects of auto immune disease, later diagnosed as granuloma annulare, an auto immune disease of the skin. Clarified, it was 3 to 6 months after second Covid vaccine that the symptoms started. They tried treating with several products, cortisone injections, several different types of creams. It spread on body in several places, nothing has been effective. They are going to try something else in about 8 days. They will be putting him on another product. Patient Visited to different doctor for this and was getting no results. Now going to be seeing a different dermatologist. Never had problem with skin except, slight amount of acne when younger.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of suspect drug cannot be completely excluded for the reported event, GRANULOMA ANNULARE.  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 RAs, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300266222 same reporter/patient,different drug/Event;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had received Paxlovid treatment from 20Jul2023 to 24Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265914 same patient/reporter, different drug/event;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Skin reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Highly allergic to antibiotics " (unspecified if ongoing); "Has food allergies" (unspecified if ongoing); "Has a lot of allergies to medications" (unspecified if ongoing); "Has a lot of allergies to amongst other things / external allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Highly allergic". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Right arm), administration date: 11Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "Skin reaction"; BNT162b2 (DOSE 2, SINGLE, Right arm), administration date: 10Mar2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "Skin reaction". The following information was reported: SKIN REACTION (non-serious) with onset 2021, outcome "recovered" (2023). The event "skin reaction" required physician office visit. Therapeutic measures were taken as a result of skin reaction.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 18:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient was given Paxlovid from 22Jul2023 to 27Jul2023 for the treatment of Covid-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Yellow fever
Clinical narrative: Had yellow fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 15-year-old female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: YELLOW FEVER (medically significant), outcome "unknown", described as "Had yellow fever".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events YELLOW FEVER and The suspected drug 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-202300265006 Same reporter/patient/drug, different dose/event.;