chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pain, Pupillary light reflex tests normal, Ulcerative keratitis, Visual acuity tests
Clinical narrative: Neck got incredibly stiff, got extremely dizzy and had a severe nausea.   They observed me for over an hour, prescribed Zofran, and told me to go home and rest. My eyes started getting itchy that afternoon. Over the next few days I tried ice packs and warm compress. By Tuesday it was so bad I went to the er. They numbed them and sent me home with a referral to an optometrist if it got worse. I woke up in so much pain I called them crying on Wednesday.  They referred me to my normal optometrist, whom I had seen early March and he diagnosed me with two ulcers in my left corena.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Visual field tests normal
Clinical narrative: Neck got incredibly stiff, got extremely dizzy and had a severe nausea.   They observed me for over an hour, prescribed Zofran, and told me to go home and rest. My eyes started getting itchy that afternoon. Over the next few days I tried ice packs and warm compress. By Tuesday it was so bad I went to the er. They numbed them and sent me home with a referral to an optometrist if it got worse. I woke up in so much pain I called them crying on Wednesday.  They referred me to my normal optometrist, whom I had seen early March and he diagnosed me with two ulcers in my left corena.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Angiogram, Blood test, Cardiac failure, Computerised tomogram, Echocardiogram
Clinical narrative: Heart Failure, Blood Clots in heart and other locations
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Intracardiac thrombus, Thrombosis, Ultrasound Doppler, X-ray
Clinical narrative: Heart Failure, Blood Clots in heart and other locations
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chronic respiratory disease, Computerised tomogram thorax abnormal, Echocardiogram, Electrocardiogram
Clinical narrative: Developed episodes of tachycardia and desaturation, with any normal exertion, debilitating in the months following COVID vaccines.  It took almost a year of testing (ekg, echo, labs, steroids, antibiotics, holter monitor, long walk test, PFT?s, finally Pulmonary CT scan w/contrast). ). Difficult to get in person MD appointments at that time. Finally referred to Pulmonologist. CT scan revealed innumerable pulmonary nodules with diffusion issues. Repeat CT scan unchanged. NO other explanation for this now chronic disease issue from lung lining damage.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Exercise test, Laboratory test, Oxygen saturation decreased, Pulmonary mass
Clinical narrative: Developed episodes of tachycardia and desaturation, with any normal exertion, debilitating in the months following COVID vaccines.  It took almost a year of testing (ekg, echo, labs, steroids, antibiotics, holter monitor, long walk test, PFT?s, finally Pulmonary CT scan w/contrast). ). Difficult to get in person MD appointments at that time. Finally referred to Pulmonologist. CT scan revealed innumerable pulmonary nodules with diffusion issues. Repeat CT scan unchanged. NO other explanation for this now chronic disease issue from lung lining damage.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Developed episodes of tachycardia and desaturation, with any normal exertion, debilitating in the months following COVID vaccines.  It took almost a year of testing (ekg, echo, labs, steroids, antibiotics, holter monitor, long walk test, PFT?s, finally Pulmonary CT scan w/contrast). ). Difficult to get in person MD appointments at that time. Finally referred to Pulmonologist. CT scan revealed innumerable pulmonary nodules with diffusion issues. Repeat CT scan unchanged. NO other explanation for this now chronic disease issue from lung lining damage.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a 94-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 18-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022).    This case contains information for patient 6 out of 7 involved. Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2023: Follow up received and added patient details, added dosage regimens and added event onset date and suspect start date, updated I-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body temperature, Expired product administered, No adverse event, Underdose
Clinical narrative: None.
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Feeling abnormal, Pollakiuria, Pyrexia
Clinical narrative: couldn't stop urinating; lost of feeling; she couldn't stand up; fever; Administered fourth dose of 0.05ml; fallen; she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fallen), POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and PYREXIA (she had a fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O45lz1a and 045LZ1A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Client states has breast Cancer and allergic to suffer.  Concurrent medical conditions included Breast cancer and Allergy (allergic to suffer).   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .05 milliliter. In 2021, the patient experienced PYREXIA (she had a fever). On 17-Mar-2022, the patient experienced FALL (fallen), PYREXIA (fever) and UNDERDOSE (Administered fourth dose of 0.05ml). On 18-Mar-2022, the patient experienced DYSSTASIA (she couldn't stand up). On an unknown date, the patient experienced POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling). At the time of the report, FALL (fallen) and PYREXIA (fever) was resolving, POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and UNDERDOSE (Administered fourth dose of 0.05ml) outcome was unknown and PYREXIA (she had a fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient stayed at the hospital for 5 hours, went to the emergency room on 01-Sep-2023. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-733273 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Follow up received contains updated dose details, events and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733273:Linked cases- Monovalent case (MOD-2023-733251) and Bi-balavalent case (MOD-2023-733273)
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: couldn't stop urinating; lost of feeling; she couldn't stand up; fever; Administered fourth dose of 0.05ml; fallen; she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fallen), POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and PYREXIA (she had a fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O45lz1a and 045LZ1A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Client states has breast Cancer and allergic to suffer.  Concurrent medical conditions included Breast cancer and Allergy (allergic to suffer).   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .05 milliliter. In 2021, the patient experienced PYREXIA (she had a fever). On 17-Mar-2022, the patient experienced FALL (fallen), PYREXIA (fever) and UNDERDOSE (Administered fourth dose of 0.05ml). On 18-Mar-2022, the patient experienced DYSSTASIA (she couldn't stand up). On an unknown date, the patient experienced POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling). At the time of the report, FALL (fallen) and PYREXIA (fever) was resolving, POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and UNDERDOSE (Administered fourth dose of 0.05ml) outcome was unknown and PYREXIA (she had a fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient stayed at the hospital for 5 hours, went to the emergency room on 01-Sep-2023. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-733273 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Follow up received contains updated dose details, events and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733273:Linked cases- Monovalent case (MOD-2023-733251) and Bi-balavalent case (MOD-2023-733273)
Age: 96.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt was administered vaccine in our office on 6/13/23 and than Pharmacy administered same vaccine  on 7/18/23 - no obvious issues with pt but pt is 93yrs old and there is some concern
Sex: U
Vaccine: HIBV, HPV9, MMR, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report a TE, HCP could not confirm if vaccines have been administered or not.; This spontaneous report has been received from a healthcare professional and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in 2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W007035, has been verified and considered valid for pre-filled syringe formulation, with an expiration date of 20-OCT-2023), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number W011266 has been verified and considered as valid for pre-filled syringe formulation, with an expiration date of 05-SEP-2024), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot number 028532 has been verified and considered as valid, with an expiration date of 09-MAY-2025), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number W032494 has been verified and considered as valid, with an expiration date of expiration date of 22-NOV-2023), all administered as prophylaxis, plus sterile diluent, solution for injection/infusion, (lot number W009643 has been verified and considered as valid, with an expiration date of 14-NOV-2024). All suspect therapies were reportedly administered after having suffered a temperature excursion (product storage error). No further adverse events were reported.  This case has been considered as non-valid due to lack of patient identifiers.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with caller the patient did not experience any other adverse event; The caller said the patient received a dose of MMRII on 7/7/2023, after the product was involved in a temperature excursion.; This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and drugs reactions and allergies were not provided.  On 07-JUL-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 1 dose as prophylaxis (Lot number w039699 has been verified to be a valid lot number, expiration date reported and validated as 25-MAY-2024) (strength, dose, frequency, route of administration, and anatomical location were not reported).  The vaccine was exposed to a temperature excursion of 48.8 degrees Fahrenheit (F) during a time frame of 7 hours and 45 minutes (product storage error). It was unknown if there was a previous temperature excursion. It was confirmed with caller that the patient did not experience any other adverse event (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: did not experience any other adverse event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 7/5/2023, aft; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included varicella virus vaccine live (oka/merck)(VARIVAX).          On 05-JUL-2023, the patient was vaccinated with a improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Albumin status rHA lot # w039699 with expiration date 25-MAY-2024, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was that the vaccines was exposed to a temperature excursion with a temperature of 48.8 °F for 7 hours and 45 minutes. The patient did not experience any other adverse event. It was reported that varicella virus vaccine live (oka/merck)(VARIVAX) was administered on the same date, but it did not undergo a temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HBP reporting that VARIVAX was administered after it experienced a supported temperature excursion; Varivax - Lot number W025277 expiration date 28-Sep-2022; This spontaneous report was received from a healthcare professional, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and historical drugs were nor reported. Concomitant medications included sterile diluent (manufacturer unknown).    On 12-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, 1st dose (lot number W025277 was verified to be valid, expiration date reported as 10-AUG-2024 but upon internal validation established as 28-SEP-2022 [conflicting information]) (Expired product administered), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine was given after it experienced a supported temperature excursion of -8.6 Celsius (C) degrees, during a time frame of 51 minutes. The vaccine suffered a previous temperature excursion of -11.5 C for 1 hour, 16 minutes, 0 seconds (Product storage error). No side effects were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report was received from a healthcare business professional and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions and drug reaction/allergies were not reported. Concomitant medication included sterile diluent 0.5 milliliter.   On 12-JUL-2023, the patient received vaccination with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W036940, expiration date: 19-MAY-2024, administered for prophylaxis (strength and route of administration were not provided) after it experienced a supported temperature excursion (Product storage error). The storage temperature of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was -8.6 degrees Celsius for a time frame of 51 minutes. There was previous temperature excursion, the storage temperature of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was -11.5 degrees Celsius for a time frame of 1 hour and 16 minutes. No side effects reported. No additional adverse event.
Sex: U
Vaccine: COVID19
Symptoms: CSF test, Magnetic resonance imaging, Myelopathy, Protein total
Clinical narrative: INFLAMMATORY MYELOPATHIES/UNMASKING UNDERLYING MYELOPATHIC DISEASE; This spontaneous report was received from literature. This report concerned multiple patients. The objective of this study to characterize the clinical presentations of myelitis and myelopathies following SARS-CoV2 infection (COVID-19) or vaccination for COVID-19.  The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced inflammatory myelopathies which were associated with vaccination (n equal to 3) and COVID-19 (n equal to 2). The patients had notable CSF pleocytosis, elevated protein and MRI (Magnetic resonance imaging) involvement of white matter tracts and grey matter. COVID-19 and vaccination were also associated with unmasking underlying myelopathic disease such as demyelinating or metabolic) in 4 patients. Patients with inflammatory etiologies only saw improvement in their symptoms after Plasmapheresis (PLEX) and early initiation can halt progression and improve outcomes. Among the unmasked group, patients had heterogeneous clinical presentations. Imaging in this group showed chronic lesions, unlike the other two groups.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammatory myelopathies/unmasking underlying myelopathic disease was not reported.  The authors concluded that it is critical to identify the etiological factors in subjects with myelopathies in the setting of COVID-19 or vaccination to establish an appropriate treatment.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230720785- inflammatory myelopathies/unmasking underlying myelopathic disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Electronystagmogram, Fatigue, Gait disturbance
Clinical narrative: dizziness/dizzy; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; feel exhausted/fatigued; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2022, outcome "not recovered", described as "dizziness/dizzy"; MALAISE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 2022, outcome "unknown" and all described as "I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "feel exhausted/fatigued". The events "dizziness/dizzy", "i feel like i am on a boat, staggering, i can walk in a straight line so no one on the outside can tell" and "feel exhausted/fatigued" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, malaise, fatigue, gait disturbance.  Additional Information: It was reported that patient had two vaccines and two boosters, the most recent booster was on 13Apr2022 and got dizzy on 01May2022. Happened every single day all of the time. Worsened. "It is 24 hours..well not while I am sleeping. I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell. I feel exhausted, I do not know what to do about it" (as reported). Patient was dizzy and fatigued for more than a year. She recently saw a doctor and she had heard that other people had experienced similar symptoms. She was wondering if there might be a connection between the vaccine and dizziness. If so, what could be done to cure it. Patient had many tests and tried many alternative and western therapies. Vaccine was administered to right arm just below the shoulder. No other products reported. Treatment reported was had VNG which was a medical test where hook up to different electrodes to see how inner ear was functioning. Had an MRI, CAT scan, physical therapy, osteopath, chiropractor and various practitioners.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Malaise
Clinical narrative: dizziness/dizzy; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; feel exhausted/fatigued; I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER, Lot number and expiration date not provided.), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2022, outcome "not recovered", described as "dizziness/dizzy"; MALAISE (non-serious), GAIT DISTURBANCE (non-serious) all with onset 2022, outcome "unknown" and all described as "I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "feel exhausted/fatigued". The events "dizziness/dizzy", "i feel like i am on a boat, staggering, i can walk in a straight line so no one on the outside can tell" and "feel exhausted/fatigued" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, malaise, fatigue, gait disturbance.  Additional Information: It was reported that patient had two vaccines and two boosters, the most recent booster was on 13Apr2022 and got dizzy on 01May2022. Happened every single day all of the time. Worsened. "It is 24 hours..well not while I am sleeping. I feel like I am on a boat, staggering, I can walk in a straight line so no one on the outside can tell. I feel exhausted, I do not know what to do about it" (as reported). Patient was dizzy and fatigued for more than a year. She recently saw a doctor and she had heard that other people had experienced similar symptoms. She was wondering if there might be a connection between the vaccine and dizziness. If so, what could be done to cure it. Patient had many tests and tried many alternative and western therapies. Vaccine was administered to right arm just below the shoulder. No other products reported. Treatment reported was had VNG which was a medical test where hook up to different electrodes to see how inner ear was functioning. Had an MRI, CAT scan, physical therapy, osteopath, chiropractor and various practitioners.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Psoriasis, Rash, Urticaria
Clinical narrative: Psoriasis; woke up with hives/rash on body spreading; URTICARIA(Hives); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Lot number: EW0164) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8732 LD, Location of injection: Arm Left), administration date: 03Apr2021, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 30May2021, outcome "not recovered", described as "URTICARIA(Hives)"; RASH (non-serious) with onset 30May2021, outcome "not recovered", described as "woke up with hives/rash on body spreading"; PSORIASIS (non-serious) with onset 02Jun2021, outcome "not recovered". The events "woke up with hives/rash on body spreading", "urticaria(hives)" and "psoriasis" required physician office visit.  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, psoriasis.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Apr2023 at 10:00 as dose 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 at 10:00 as dose 1, single (Lot number: ER8732), in left arm, on 26Apr2021 at 12:00 as dose 2, single (Lot number: EW0167), in left arm, on 23Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient thought had "Rebound COVID" with runny nose, muscle aches, cough, lethargic 6 days after finished last dose of Paxlovid. Paxlovid did reduce initial symptoms 2 days after starting treatment though.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 5 / Moderna, Dose: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 026B21A), on 01May2021 as dose 2, single (Lot number: 002C21A), on 29Dec2021 as dose 3 (booster), single (Lot number: 041J21A) and on 19Jul2022 as dose 4 (booster), single (Lot number: 051B22A) for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer" (unspecified if ongoing); "Known allergies: Codiene" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2022, outcome "not recovered", described as "Pfizer, Dose: 5 / Moderna, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication in 2weeks. Patient received Paxlovid as Covid-19 treatment from 06Jul2023 to 11Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Took four shots of the Pfizer Covid shots/had Covid; Took four shots of the Pfizer Covid shots/had Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 included: "Covid" (unspecified if ongoing), notes: She had Covid before about a year ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Took four shots of the Pfizer Covid shots/had Covid". The event "took four shots of the pfizer covid shots/had covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positve, notes: She got Covid; Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300252691 same patient, different product/event;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lab Notes:Nasal Swab  /Result:Positive; Lab Notes:Nasal Swab  /Result:Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 15:00 as dose 1, single (Lot number: EP7534), in left arm, on 10Apr2021 at 15:00 as dose 2, single (Lot number: EN5318), in left arm and on 27Nov2021 at 16:30 as dose 3 (booster), single (Lot number: FJ1620) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HSV2" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Eggs, Hazelnuts, lactose" (unspecified if ongoing). Concomitant medication(s) included: B12-VITAMIIN; D3; LIVALO; OMEPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; SYNTHROID. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "unknown" and all described as "Lab Notes:Nasal Swab  /Result:Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2021) Negative, notes: Nasal Swab; (13May2021) Negative, notes: Nasal Swab; (03Aug2021) Negative, notes: Nasal Swab; (01Feb2022) Positive, notes: Nasal Swab; SARS-CoV-2 RNA: (18Apr2021) Negative, notes: Nasal Swab; (13May2021) Negative, notes: Nasal Swab; (03Aug2021) Negative, notes: Nasal Swab; (01Feb2022) Positive, notes: Nasal Swab. Clinical course: Patient had no other vaccine in four weeks and Covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300252940 same reporter/patient/product, different dose/event;US-PFIZER INC-202300253096 same reporter/patient/product, different dose/event;US-PFIZER INC-2021367791 same reporter/patient/product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: pos.test; pos.test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 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 "pos.test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Pos. Therapeutic measures taken as a result of drug ineffective, covid-19 included administration of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300124971 different patient, same drug and event;
Age: 77.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: go3277) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: eh9899), in left arm, on 31Jan2021 as dose 2, single (Lot number: el9269), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: ff2589), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: fm0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2022, stop date: 18Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253665 same patient, different drug, different event;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 31 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: ER8730), in right arm, on 16Apr2021 at 15:00 as dose 2, single (Lot number: EW0164), in right arm and on 24Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FG3527), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BUPROPIONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2023, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253737 same patient, different event, different dose;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Pyrexia
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 31 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 15:00 as dose 1, single (Lot number: ER8730), in right arm, on 16Apr2021 at 15:00 as dose 2, single (Lot number: EW0164), in right arm and on 24Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FG3527), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BUPROPIONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2023, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253737 same patient, different event, different dose;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Headache; stuffy nose; low fever (38 C); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; BUPROPIONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE at 03:00 PM, Batch/lot number: ER8730, Anatomical location: Right Arm), administration date: 26Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE at 03:00 PM, Batch/lot number: EW0164, Anatomical location: Right Arm), administration date: 16Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE at 03:00 PM, Batch/lot number: FG3527, Anatomical location: Right Arm), administration date: 24Nov2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered"; PYREXIA (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered", described as "low fever (38 C)"; NASAL CONGESTION (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered", described as "stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nasal congestion, pyrexia. Clinical course: Patient denied for any other vaccine in four weeks. Patient denied for having covid prior to vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253711 Same Patient/Product, Different Dose/Event (LOE);
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Pyrexia
Clinical narrative: Headache; stuffy nose; low fever (38 C); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; BUPROPIONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE at 03:00 PM, Batch/lot number: ER8730, Anatomical location: Right Arm), administration date: 26Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE at 03:00 PM, Batch/lot number: EW0164, Anatomical location: Right Arm), administration date: 16Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE at 03:00 PM, Batch/lot number: FG3527, Anatomical location: Right Arm), administration date: 24Nov2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered"; PYREXIA (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered", described as "low fever (38 C)"; NASAL CONGESTION (non-serious) with onset 29Jun2023 at 07:00, outcome "recovered", described as "stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nasal congestion, pyrexia. Clinical course: Patient denied for any other vaccine in four weeks. Patient denied for having covid prior to vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253711 Same Patient/Product, Different Dose/Event (LOE);
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 23May2022 at 14:00 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2021 at 13:00 as dose 1, single (Lot number: 019B21A), in left arm and on 04May2021 at 13:00 as dose 2, single (Lot number: 021C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Lichen planus in mouth" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "known allergies: lg amts of shellfish" (unspecified if ongoing); "known allergies: lg amts of cheese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021 at 16:00, outcome "unknown"; 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 with Paxlovid from 05Jul2023 to 10Jul2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253697 Same patient, different drug, different event;