chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cerebral atrophy, Myelopathy
Clinical narrative: have an atrophied brain stem and spinal cord; have an atrophied brain stem and spinal cord; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL ATROPHY (have an atrophied brain stem and spinal cord) and MYELOPATHY (have an atrophied brain stem and spinal cord) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBRAL ATROPHY (have an atrophied brain stem and spinal cord) (seriousness criterion medically significant) and MYELOPATHY (have an atrophied brain stem and spinal cord) (seriousness criterion medically significant). At the time of the report, CEREBRAL ATROPHY (have an atrophied brain stem and spinal cord) and MYELOPATHY (have an atrophied brain stem and spinal cord) outcome was unknown.            Concomitant medication was not provided.  Patient received two injections of the Moderna Covid vaccine a couple of years ago and have an atrophied brain stem and spinal cord. Otherwise, very healthy.   Treatment information was not reported.  Company comment: This spontaneous case concerns a patient of unknown gender with no relevant medical history, who experienced the unexpected serious (medically significant) events of cerebral atrophy and myelopathy. The events occurred on an unknown date after a dose of SPIKEVAX NOS (dose number not provided). As reported, patient received two injections of the Moderna Covid vaccine a couple of years ago and have an atrophied brain stem and spinal cord; otherwise, very healthy. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: we were tested and we were both  positive for COVID; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (we were tested and we were both  positive for COVID) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (we were tested and we were both  positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at a dose of 20 packs of Paxlovid 150mg renal pills and 100mg. At the time of the report, COVID-19 (we were tested and we were both  positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that came down with the virus first. Had it about 4 to 5 days as of Monday, yesterday. Patient had all the vaccination including booster dose. Patient thought it was a bad cold and it was not getting any better. Patient thought it might have something else either COVID and RSV. Patient went to a walk in clinic and tested positive for COVID. The symptoms at that point were not overwhelming. Still felt stuffed up, had a little productive cough, joint hurt a little but not incredibly. The nurse practitioner gave a prescription of paxlovid renal but patient thought it was a paxlovid. Patient thought either gave that because have a renal problem which patient has not and did not take any history.   It was mentioned that the patient got 20 packs of paxlovid 150mg renal pills and 100mg and has no history of renal problems. It has been informed to patient that treatment medication should only be taken twice a day for 5 consecutive days.  This case contains information about patient 1 out of 2 who tested positive for COVID.   This case was linked to US-MODERNATX, INC.-MOD-2024-757196 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757196:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID vaccine: received a total of 4 doses of the Moderna COVID vaccine; COVID positive; This spontaneous case was reported by a medical assistant and describes the occurrence of COVID-19 (COVID vaccine: received a total of 4 doses of the Moderna COVID vaccine; COVID positive) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID vaccine (Dose 1) on 11-Jan-2021 and Moderna COVID vaccine (Dose 2) on 08-Feb-2021. Past adverse reactions to the above products included No adverse reaction with Moderna COVID vaccine and Moderna COVID vaccine.   On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID vaccine: received a total of 4 doses of the Moderna COVID vaccine; COVID positive). At the time of the report, COVID-19 (COVID vaccine: received a total of 4 doses of the Moderna COVID vaccine; COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  The patient was the reporter.  Patient received a total of 4 doses of the Moderna COVID vaccine. Patient was COVID positive prior to getting Paxlovid. Patient did not have really any symptoms, only went in because had sinusitis and came out positive with COVID, but was having a cold, had a little cough, checked lungs and was told to be fine. Patient had not started taking Paxlovid yet, and was trying to get Paxlovid, but knew nothing about it.  The physician prescribed the medication, patient took it to pharmacy and was told at the pharmacy that the patient did not have it and was asked to go to another pharmacy. The patient went to another pharmacy which also said that they did not have the medication, and just had the old one, but patient could not get the new one because insurance needed Rx number and group number from Pfizer to receive it. The patient stated that patient did not need to take the medication.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient had mild flu symptoms.; Patient had a sore injection site arm.; Arm was also swollen; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Patient had mild flu symptoms.), VACCINATION SITE PAIN (Patient had a sore injection site arm.) and VACCINATION SITE SWELLING (Arm was also swollen) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA (Patient had mild flu symptoms.), VACCINATION SITE PAIN (Patient had a sore injection site arm.) and VACCINATION SITE SWELLING (Arm was also swollen). At the time of the report, INFLUENZA (Patient had mild flu symptoms.), VACCINATION SITE PAIN (Patient had a sore injection site arm.) and VACCINATION SITE SWELLING (Arm was also swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.   The patient received her second dose of the Moderna Covid-19 vaccine on 1 Mar 2023 lot number 013A21A expiration date was not provided. She did not remember which arm she received the vaccine in. She had mild flu symptoms. She received her third Moderna Covid-19 vaccine on 2 Nov 2021 lot number 071F21A expiration date was not known. She did not remember which arm she received the vaccine in. She had wife had no side effects. She received her next Moderna Covid-19 vaccine on 20 Apr 2022 lot number 048L21A expiration date was not provided. She did not remember which arm she received the vaccine in. She had no adverse reactions.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-757304 (E2B Linked Report). This case was linked to MOD-2024-757311 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757304:Husband case
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Patient had 5 nights of being drenched in sweats; fever; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (Patient had 5 nights of being drenched in sweats) and PYREXIA (fever) in an 81-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Patient had 5 nights of being drenched in sweats) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (Patient had 5 nights of being drenched in sweats) and PYREXIA (fever) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Incorrect dose administered
Clinical narrative: headache; lightheadedness; fatigue; patient receiving 2 doses 0.3 ml at one time; This is a spontaneous report received from a Pharmacist from medical information team.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 14:22 as dose 1, 0.3 ml single (Lot number: HG2282, Expiration Date: 06Dec2023), in right arm (right deltoid) and on 27Oct2023 at 14:23 as dose 2, 0.3 ml single (Lot number: HG2282, Expiration Date: 06Dec2023) at the age of 66 years, in right arm (right deltoid), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Hypothyroidism" (ongoing); "Pain" (ongoing); "GERD" (ongoing); "diabetes type ii" (ongoing); "depression or anxiety disorder" (ongoing); "anxiety" (ongoing); "Thyroid" (ongoing); "Depression" (ongoing); "Diabetes" (ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension, start date: 21Aug2023 (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing); NORCO oral taken for pain, start date: May2022 (ongoing); SYNTHROID oral taken for hypothyroidism, start date: 07Dec2023 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing); OZEMPIC subcutaneous taken for type 2 diabetes mellitus, start date: 07Dec2023 (ongoing); SERTRALINE oral taken for depression (ongoing); ROSUVASTATIN oral taken for cardiovascular event prophylaxis (ongoing); VIIBRYD taken for depression, start date: 11Dec2023 (ongoing); ABILIFY oral taken for depression, anxiety, start date: 13Dec2023 (ongoing). The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 26Oct2023, outcome "unknown", described as "patient receiving 2 doses 0.3 ml at one time"; FATIGUE (non-serious) with onset 27Oct2023, outcome "recovered" (Oct2023); HEADACHE (non-serious) with onset 27Oct2023, outcome "recovered" (Oct2023); DIZZINESS (non-serious) with onset 27Oct2023, outcome "recovered" (Oct2023), described as "lightheadedness".  Additional information: Reporter had a patient who came in for her annual Covid vaccine and the technician who administered the vaccine administered 2 doses of 0.3mL so she got 0.6mL. Norco: On an altered dose due to the 10mg not being available, now taking the 7.5mg. As of 16Jan2024, patient received 2 (0.3mL) doses of COMIRNATY 12+ Covid vaccine at the same time on 27Oct2023 in error. She received the dose intended for her and the one intended for her husband. She reported headache, lightheadedness and fatigue that night (27Oct2023) and the following day (28Oct2023). She reported feeling normal about 2 days later (Oct2023).  Follow-up (21Nov2023): Follow-up attempts are completed. No further information is expected.  Follow-up (16Jan2024): This is a spontaneous follow up report received from a Pharmacist. Updated information: medical history, concomitant medications, suspect drug data (vaccination date), new events (headache, lightheadedness and fatigue).
Sex: U
Vaccine: PNC20
Symptoms: Device safety feature issue
Clinical narrative: went to close the safety on the needle and it busted off from the end the PFS; The initial case was missing the following minimum criteria: a reportable adverse event. Upon receipt of follow-up information on 08Jan2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from a sales representative and product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HE6175) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "went to close the safety on the needle and it busted off from the end the PFS".  Additional information: They had an issue with one of our Prevnar 20 PFS. After the employee gave the injection, she went to close the safety on the needle and it busted off from the end the PFS.  Causality for "went to close the safety on the needle and it busted off from the end the pfs" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Now that they have Covid; Now that they have Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, UNKNOWN MANUFACTURER, did get all the Covid shots), for Covid-19 Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Now that they have Covid".  Additional information: The patient was calling in for Paxlovid, saying that the doctor prescribed Paxlovid, the wife also tested positive, did get all the Covid shots and the booster that was put out by the government and wondered whether this drug is good to take now that they have Covid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose number unknown (boosters), Manufacturer Unknown), for Covid-19 Immunization; Flu, for Immunization; Rsv, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". It was reported that the patient took all the doses and the patient was sick.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016267 Same reporter/vaccine/events, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebral disorder, Vaccination failure
Clinical narrative: Covid; Covid; Covid brain; This is a spontaneous report and received from Other HCPs from medical information team, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jan2024 as dose 1, single (Lot number: HM7010) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Covid"; CEREBRAL DISORDER (non-serious) with onset Jan2024, outcome "unknown", described as "Covid brain". Clinical course: Patient was a psychologist calling in regard to Pfizer covid19 vaccine and need to find the dosage the she got on 03Jan2024 using the lot number and NDC number (NDC-00069237710). She and her husband are participating in research relating to RSV vaccinations and flu vaccinations. They have to be able to tell them if they get any other medications. They got a Pfizer vaccine, the newest one and got permission to get it on 03Jan. The researchers needed to know the dose of the Pfizer vaccines. The patient stated she has Covid and has Covid brain.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY 2023-2024 FORMULA can not be fully excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 10:00 as dose 1, single (Lot number: HG4629) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Olmesartan, start date: 03Jul2023, notes: lot number: M2212201. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment).
Age: 69.0
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 Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment started on 04Jan2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Lot number: HD9876) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "tuna allergy" (unspecified if ongoing); "Scallops allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen COVID-19 vaccine (Dose 1, Single, Batch/Lot No: 1805022, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2 (Booster), Single, Batch/Lot No: 32030BD, Location of injection: Arm Right), administration date: 21Dec2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Batch/Lot No: FP7150, Location of injection: Arm Right), administration date: 29Jul2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 4 (Booster), Single, Batch/Lot No: GJ5342, Location of injection: Arm Right), administration date: 02Jan2023, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received Paxlovid form 08Jan2024 to 12Jan2024 for the treatment of COVID-19. Other medical history reported as no.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old patient received BNT162b2 (COMIRNATY), on 05Feb2021 as dose 2, single (Lot number: EL9262, Expiration Date: May2021) at the age of 76 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (dose 1, administered intramuscularly in the right shoulder, Lot number: EL3246), administration date: 15Jan2021, when the patient was 76-year-old, for COVID-19 immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189575 same patient/product, different dose number/event;
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old patient received BNT162b2 (BNT162B2), on 22Jul2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 77 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE on right shoulder. EXP May2021), administration date: 15Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE on right shoulder), administration date: 05Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189575 Same patient/product different dose/AE;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non-HCP.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 4 (booster), single (Lot number: FJ5683) intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: E1346, Route of administration: Intramuscular; Anatomical location: Right shoulder), administration date: 15Jan2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9262, Expiry date: May2021; Route of administration: Intramuscular, Anatomical location: Right shoulder), administration date: 05Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 3 (BOOSTER) SINGLE; Lot number: FC3182, Route of administration: Intramuscular; Anatomical location: Right shoulder), administration date: 22Jul2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "sore arm".
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 78 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; intramuscularly into right shoulder, Lot: E13246), administration date: 15Jan2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "sore arm"; BNT162b2 (Dose 2, single; intramuscularly into right shoulder, Lot: EL9262 expiry: May2021), administration date: 05Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3 (booster), single; intramuscularly into right shoulder, Lot: FC3182), administration date: 22Jul2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "sore arm"; BNT162b2 (Dose 4 (booster), single; intramuscularly into right shoulder, Lot: FJ5683), administration date: 09Feb2022, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189575 Same patient/vaccine, different dose/AE;
Age: 77.0
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 Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 14:00 as dose 1, single (Lot number: HG4629) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 5; Manufacturer Unknown), for Covid-19 immunization. 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing); "known allergies: hazelnut allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Single), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Single), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from  07Jan2024 to 12Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
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 Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 06Jan2024 to 10Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine dose number: 5, vaccine brand: Pfizer ; vaccine dose number: 6, vaccine brand other: Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2023 at 15:00 as dose 6 (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "CKD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE/VALSARTAN, start date: Jun2020 (ongoing); ZOLPIDEM, start date: May2010 (ongoing). Past drug history included: Telmisartan, reaction(s): "Known allergies: Telmisartan". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2023 at 15:00, outcome "unknown", described as "vaccine dose number: 5, vaccine brand: Pfizer ; vaccine dose number: 6, vaccine brand other: Moderna"; 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: SARS-CoV-2 test: Positive; Negative; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 05Jan2024 to 10Jan2024. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Dec2023 as dose 1, single (Lot number: HM7009) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Known allergies: zithromax reaction" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY ELLIPTA, start date: 01May2023; ALBUTEROL [SALBUTAMOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccine lot number: Er8730, Vaccine dose number: 1), administration date: 01Apr2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Vaccine lot number: EW0153, Vaccine dose number: 2), administration date: 22Apr2021, when the patient was 42-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number: FG3527, Vaccine dose number:3, Vaccine location: Left arm), administration date: 05Nov2021, when the patient was 42-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: GR2524, Vaccine dose number: 4, Vaccine location: Left arm), administration date: 13Sep2022, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from  09Jan2024 to 14Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report and received from Consumer or other non HCPs from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1), for COVID-19 immunization; Moderna (Dose 2), for COVID-19 immunization; Moderna (Dose 3), for COVID-19 immunization; Moderna (Dose 4), for COVID-19 immunization; Moderna (Dose 5), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE;  , Manufacturer Unknown), for COVID-19 immunization. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 04Jan2024 to 09Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Lot number: HGH4675) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: ATORVASTATIN, start date: 18Apr2015. Vaccination history included: Covid-19 vaccine  as DOSE 1, SINGLE, DOSE 2, SINGLE, DOSE 3 (BOOSTER), SINGLE all from Manufacturer: Unknown all for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures including Paxlovid from 08Jan2024 to 12Jan2024 were taken as a result of drug ineffective, covid-19.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures including Paxlovid from 04Jan2024 to 08Jan2024 were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162b2 omi xbb.1.5  administration.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Spikevax Dose 1, 2,3, 5/BNT162B2, BNT162B2 OMI BA.4-5 dose 4; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2023 as dose 4 (booster), single (Lot number: GH9702) at the age of 35 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 026B21A), in right arm, on 30Apr2021 as dose 2, single (Lot number: 017C21A), in right arm, on 12Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in right arm and on 22Oct2023 as dose 5 (booster), single (Lot number: 3031632), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2023, outcome "not recovered", described as "Moderna Spikevax Dose 1, 2,3, 5/BNT162B2, BNT162B2 OMI BA.4-5 dose 4"; 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: (31Dec2023) Negative, notes: First negative; (16Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment included Paxlovid from 28Dec2023 to 01Jan2024.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0160), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 55 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative 2 days after that; Positive, notes: tested positive 2 days after that. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 06Jan2024 to 10Jan2024.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 17:00 as dose 1, single (Lot number: HG4628) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Slight allergy to Honeydew melon" (unspecified if ongoing); "Itchy tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (15Jan2024) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 05Jan2024 until 10Jan2024.   No follow-up attempts are possible.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive for Covid. Clinical course: They have been administered all the shots and booster shots for Covid, was able to get all the Covid shot vaccine and booster however, just several days ago they got Covid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400007124 same reporter/vaccine/events, different patients;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP . Reporter is the patient.   A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 4 (booster), single (Lot number: 301253A) at the age of 64 years intramuscular, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in arm, on 09Apr2021 as dose 2, single (Lot number: EW0162), in arm and on 20Jun2021 as dose 3 (booster), single (Lot number: FM0173), in arm, all intramuscular 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), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Covid". Clinical course: Vaccine was not administered at  facility. Patient told physician that he had COVID 3 months earlier from 08Nov2023. This was at annual physical where he was told he was in excellent health.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414971 same patient, similar vaccine, different event;