chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tinnitus, Ultrasound pelvis, Ultrasound scan
Clinical narrative: A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient came in for a wellness visit with Dr. on 4/20/23. She ordered the patient a DTaP (#3) and an IPV (#2) but was administered Kinrix. GSK was called for advisement and the patients mother was notified. Dr. let the patients mother know of what signs and symptoms to look out for. Dr. spoke again with patients mother 4/24/23 to follow up and he is not experiencing any adverse reaction.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No AE; HCP calling to report that 2 doses from PROQUAD lot, which expired on 4/6/2023, were administered on 4/11/2023. No further information provided, no additional AEs, no PQCs. (LOT U031564 EXP 4/6/2023); This spontaneous report was received from a site coordinator (also reported as medical assistant ), concerning to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 11-APR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/once, (lot #U031564, pending validation expiration date: 06-APR-2023) administered for prophylaxis (strength, and route of administration were not provided).  This is one of the two cases created from the same reporter; Sender's Comments:  US-009507513-2304USA005904:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; HCP calling to report that 2 doses from PROQUAD lot, which expired on 4/6/2023, were administered on 4/11/2023. No further information provided, no additional AEs, no PQCs. (LOT U031564 EXP 4/6/2023); This spontaneous report was received from a site coordinator (also reported as medical assistant ), concerning to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 11-APR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/once, (lot #U031564, pending lot validation expiration date: 06-APR-2023) (albumin status recombinant human albumin) administered for prophylaxis (strength, and route of administration were not provided).  This is one of the two cases created from the same reporter.; Sender's Comments:  US-009507513-2304USA003834:
Sex: F
Vaccine: TYP
Symptoms: Chlamydia test positive, Chlamydial infection, Sexually transmitted disease test
Clinical narrative: Tested positive for Chlamydia; A spontaneous report was received from a pharmacist on 13APR2023 regarding a 19-year-old female patient who was "tested positive for chlamydia" (PT: Chlamydial infection) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.    The patient's medical history, concomitant medications, or known allergies were reported as none.  On 12APR2023 the patient received one dose of Vivotif and was tested positive for chlamydia during an unrelated sexually transmitted disease (STD) screen. Reportedly, the patient was asymptomatic and did not receive any treatment for chlamydia. Additionally, it was reported that the patient has not decided whether she would continue the Vivotif or would stop the medication.  The outcome of the reported event was unknown, at the time of this report.   The action taken with Vivotif with respect to the reported event was unknown.    No additional information was reported.  Company comment: It was reported that a 19-year-old female patient tested positive for chlamydia (chlamydial infection) following the administration of first dose of Vivotif for immunisation. Considering the information reported, it seems to be an incidental finding on STD screening and the patient was asymptomatic, the causality for the event chlamydial infection is assessed as not related to Vivotif. The case is considered serious due to the medical significance of the event.  Updated Company Comment: A spontaneous case report regarding a 19-year-old female consumer with no reported medical history, and concomitant medications, who tested positive for chlamydia, during an unrelated sexually transmitted disease screen following the first dose of Vivotif. The patient was asymptomatic and did not receive any treatment for chlamydia. It is unknown if Vivotif will be continued. The outcome of the event was not reported. The causality of the incidental event is assessed as not related to Vivotif given the lack of biological plausibility.; Sender's Comments: A spontaneous case report regarding a 19-year-old female consumer with no reported medical history, and concomitant medications, who tested positive for chlamydia, during an unrelated sexually transmitted disease screen following the first dose of Vivotif. The patient was asymptomatic and did not receive any treatment for chlamydia. It is unknown if Vivotif will be continued. The outcome of the event was not reported. The causality of the incidental event is assessed as not related to Vivotif given the lack of biological plausibility.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Apr-2023, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Batch number for vaccine was reported as 066H22A OR 0S5FF22B. Patient had completed fatigue. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Trigger finger
Clinical narrative: Trigger thumb; This spontaneous case was reported by a patient and describes the occurrence of TRIGGER FINGER (Trigger thumb) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    It was reported that patient had no history of COVID diagnosis. It was also reported that patient did receive other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Trigger thumb (had for 30-40 yrs ago).   On 12-Sep-2022, 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 April 2023, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRIGGER FINGER (Trigger thumb). The patient was treated with IBUPROFEN in February 2023 at an unspecified dose and frequency. At the time of the report, TRIGGER FINGER (Trigger thumb) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that patient was a recipient of all Moderna vaccine and was supposed to receive second bivalent dose. Patient received Shingrix vaccine 2 to 3 weeks ago.  It was also reported that the previous condition of trigger thumb which was almost completely resolved was triggered with another episode due to use of iPhone and editing pictures. Patient saw the doctor on 10-Feb-2023 and took ibuprofen which continued on 24-Feb-2023 too. Four weeks ago on 24-Mar-2023, patient received steroid injection in the tendon surrounding the thumb.
Age: 1.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given a single monovalent Moderna vaccine in the past. Today the patient was administered a 0.2mL dose of the vial presentation of the dark pink cap and yellow label boarder vaccine) and NO ADVERSE EVENT (no adverse event) in a 1-year-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. 215K22A) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Apr-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) .2 milliliter. On 21-Apr-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Given a single monovalent Moderna vaccine in the past. Today the patient was administered a 0.2mL dose of the vial presentation of the dark pink cap and yellow label boarder vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given a single monovalent Moderna vaccine in the past. Today the patient was administered a 0.2mL dose of the vial presentation of the dark pink cap and yellow label boarder vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Given a single monovalent Moderna vaccine in the past. Today the patient was administered a 0.2mL dose of the vial presentation of the dark pink cap and yellow label boarder vaccine). Patient was 21 months old.  Patient had single monovalent Moderna vaccine in the past as first dose. No concomitant medications were reported. No symptoms reported. No additional doses medications or treatments. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19-2
Symptoms: Euphoric mood, Pain
Clinical narrative: Brother also had less pain after receiving this vaccine.; Brother also had euphoric feeling with less pain after receiving this vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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. On an unknown date, the patient experienced PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.). At the time of the report, PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.    Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 61 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's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. 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 included Paxlovid, treatment start date: 01Apr2023, and treatment stop date: 05Apr2023.   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZERBION-TECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 010M20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 030M20A) and on 01Feb2022 as dose 3 (booster), single (Lot number: 037F21A), in left arm 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Jan2023, outcome "unknown"; 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: (17Apr2023) Negative, notes: Tested negative for 2 days after treatment course ended; (19Apr2023) Positive, notes: Tested positive on day 4 after treatment course ended. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 10Apr2023 to 15Apr2023.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot GJ3274 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ3274, bulk and fill lots GJ2419, and GJ2425. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163470 Same reporter/patient, different drug, different event.;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site ulcer
Clinical narrative: Half inch diameter redness; non healing sore at the inoculation site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "Gout" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia; "Anemia" (unspecified if ongoing), notes: Other medical history: COPD, High Blood Pressure, Gout, Anemia. Concomitant medication(s) included: IRON; CALCIUM; LOSARTAN; B-12; SIMVASTATIN; ALLOPUR. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization; Bnt162b2 (product: Pfizer-BioNTech,, lot number: 30/4s8a,, dose number: DOSE 3 (BOOSTER), SINGLE, vaccine location: left arm), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", described as "Half inch diameter redness"; VACCINATION SITE ULCER (non-serious), outcome "not recovered", described as "non healing sore at the inoculation site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site ulcer.  Additional information: Half inch diameter redness and non healing sore at the inoculation site since the day of the third booster on Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: fatigue; arm soreness; injection site soreness in the arm soreness; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6204) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness in the arm soreness".  Additional information: Caller wanted to know if the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was wearing off and the shelf life for the Pfizer COVID-19 Bivalent Vaccine and if there was safety information for the Pfizer COVID-19 Bivalent Vaccine administered after its beyond use date. if the side effects he experienced with the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was working and if the Pfizer COVID-19 Bivalent Vaccine is different from the Monovalent. Caller got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness. He wanted to know if someone else has experienced this for this long and what to do to feel better. If there was a difference in the formulation that could have caused this. He also mentioned that he didn't have any COVID-19 symptoms, but that if one could get the vaccine with a previous infection of COVID-19 in case he had the infection without being aware. He also wanted to know why sometimes the expiry was placed as 6 months and other times as 10 weeks, given that his vaccine expires on 14May2023. He also wanted to know if his side effects meant that the vaccine was working and if the fact that we're constantly needing boosters means that the vaccine is wearing off. Typically with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. Fatigue lasting into the next day which happened with prior shots. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300164781 same patient, different vaccine dose/event;US-PFIZER INC-202300164778 same patient/event, different vaccine dose;US-PFIZER INC-202300164780 same patient/event, different vaccine dose;US-PFIZER INC-202300164779 same patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: fatigue; arm soreness; Injection site soreness in the arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 4 booster, single (Lot number: FN2908, Expiration Date: 14May2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site soreness in the arm soreness".  Additional information: Caller wanted to know if the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was wearing off, the shelf life for the Pfizer COVID-19 Bivalent Vaccine, if there was safety information for the Pfizer COVID-19 Bivalent Vaccine administered after its beyond use date, if the side effects he experienced with the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was working and if the Pfizer COVID-19 Bivalent Vaccine is different from the Monovalent. Per agent, caller got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness for a while. He wanted to know if someone else has experienced this for this long and what to do to feel better. If there was a difference in the formulation that could have caused this. He also mentioned that he didn't have any COVID-19 symptoms, but that if one could get the vaccine with a previous infection of COVID-19 in case he had the infection without being aware. He also wanted to know why sometimes the expiry was placed as 6 months and other times as 10 weeks, given that his vaccine expires on 14May2023. He also wanted to know if his side effects meant that the vaccine was working and if the fact that we're constantly needing boosters means that the vaccine is wearing off. Typically, with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. Sender's Comments: Linked Report(s): US-PFIZER INC-202300163844 same patient/event, different vaccine dose;
Age: 57.0
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) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2022 as dose 4 (booster), single (Lot number: 057M21A) at the age of 57 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 included: "Mild seasonal allergies (rhinitis)" (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: (11Apr2023) Negative; (15Apr2023) Positive, notes: tested (strongly) positive again on 15Apr2023; (20Apr2023) Positive, notes: (20Apr2023), still testing (faint-to-moderate) positive.  Clinical information: Tested negative on 11Apr2023 after increasingly faint readings (one week after starting Paxlovid course); tested (strongly) positive again on 15Apr2023. As of today (20Apr2023), still testing (faint-to-moderate) positive. (All testing using at-home antigen tests.) Symptoms since rebound positive test were minor to nonexistent (congestion and mild fatigue, could have been due to allergies and lack of sleep from worry about the positive test). Other medication in 2weeks.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 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 included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Rebound covid symptoms (cough, rhinorrhea) after 6 days of testing negative; (13Apr2023) Negative, notes: Negative with symptom resolution starting 13Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient was treated with Paxlovid covid-19, treatment start date: 11Apr2023, Treatment stop date: 16Apr2023.  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: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE , COVID-19 and The suspected drug cannot be ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech Dose Number 4 ... Moderna Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer survivor 2x" (unspecified if ongoing); "inflammatory arthritis" (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 "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech Dose Number 4 ... Moderna Dose Number 3". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date 10Apr2023, Treatment stop date 15Apr2023, Indication-Treatment of COVID-19, No Known allergies.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines); infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines); This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 13-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "infected one of them (pertaining to her grandsons), he's also vaccinated (with Pfizer covid-19 vaccines)". Clinical course: Caller was a retired Registered Nurse. She stated that she had infected one of her grandsons, he was also vaccinated with Pfizer covid-19 vaccines. He did not had a long positive with a fever, missed an important musical piece, 13 years old.  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 information currently available, there is a reasonable possibility of a causal association between the reported adverse events drug ineffective, Covid-19 and the suspect product BNT162b2.,Linked Report(s) : US-PFIZER INC-202300165347 same reporter/product, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective "; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical course: After initial dose, the patient and his wife both got COVID.  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-PV202300072700 same reporter/drug, different patient/event;
Age: 75.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 08Nov2022 as dose number unknown, single (Lot number: 010422A) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: Covid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient was treated for COVID-19 with Paxlovid from 05Apr2023 to 06Apr2023 having lot number GE3011. After taking Paxlovid, patient had one negative covid home test. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165379 Same patient, different product;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248), on 11Feb2021 as dose 2, single (Lot number: EN6201), on 18Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: CAD with stent placement; "CAD with stent placement" (unspecified if ongoing), notes: CAD with stent placement; "Achilles tendon discomfort" (unspecified if ongoing), notes: Definite familial hyper cholesterol Emil with Achilles tendon xanthoma; "Xanthoma" (unspecified if ongoing), notes: Definite familial hyper cholesterol Emil with Achilles tendon xanthoma; "Mild type 1 Von Willebrand disease" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Familial hypercholesterolemia" (unspecified if ongoing), notes: Definite familial hypercholesterolemia with Achilles tendon xanthoma. Concomitant medication(s) included: EZETIMIBE, start date: 06May2021, stop date: 08Apr2023; ROSUVASTATIN, start date: 06May2022, stop date: 08Apr2023; COLCHICINE, start date: 18Aug2022, stop date: 08Apr2023; MIRABEGRON, start date: 15Apr2020; ACETYLSALICYLIC ACID; TYLENOL; AREDS. Past drug history included: Nitrofurantoin monohyd/m-cryst, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Apr2023 to 13Apr2023.   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-202300165569 same patient different drug/event;
Sex: M
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). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2023) Positive. Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19.  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-202300165846 same patient; different drug;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; 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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right 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: "Seasonal Allergies" (unspecified if ongoing); "Penicilin" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: Tested positive again after 4 days from 2nd negative test; (20Apr2023) Positive, notes: Tested positive again after 4 days from 2nd negative test; (Apr2023) Negative, notes: Tested positive again after 4 days from 2nd negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: COVID 19 Treatment brand: Pfizer from 09Apr2023 to 13Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid on 20Apr2023.  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-202300165872 Same patient, different product, different event;
Age: 65.0
Sex: M
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 7 (booster), single (batch/lot number: unknown) at the age of 65 years, in left arm for covid-19 immunization; 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), as dose 4 (booster), single (batch/lot number: unknown), as dose 5 (booster), single (batch/lot number: unknown) and as dose 6 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "myasthenia gravis" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "sulfa allergy" (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 " treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Covid-19 test: negative, notes: rebound after 2 negative rests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid which started from 03Apr2023 to 07Apr2023.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid three times and was hospital twice; got covid three times and was hospital twice; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), SUSPECTED COVID-19 (caused and prolonged hospitalization, medically significant), outcome "unknown" and all described as "got covid three times and was hospital twice".  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-PV202300073218 Same patient/event; different dose;
Age: 67.0
Sex: M
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 (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4989) and on 10Oct2022 at 16:00 as DOSE 5 (BOOSTER), SINGLE (lot number: GJ3277) at the age of 67 years, administered in the right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 20Feb2021 as DOSE 1, SINGLE (lot number: EN6201), on 16Mar2021 as DOSE 2, SINGLE (lot number: EN6208) and on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE (lot number: FF2587) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Simvastatin, reaction(s): "known allergies: Simvastatin." The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Mar2023) Positive. Therapeutic measures were taken as a result of Vaccination failure, Covid-19.
Age: 56.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1283), on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic Type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: positive home antigen test after completing 5 days of treatment of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.Paxlovid was taken from 13Apr2023 to 17Apr2023.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand other=Moderna/ Vaccine administration date=06Nov2021/ Vaccine dose number=2; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 2, single (Lot number: 091D21A), in left arm and on 13May2022 at 13:00 as dose 3 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 041A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: Aug2016; LEVOTHYROXINE, start date: Jul1999; LOSARTAN POTASSIUM, start date: Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine administration date=06Nov2021/ Vaccine dose number=2". Therapeutic measures were taken as a result of drug ineffective, covid-19.