chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007d21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Allergy to antibiotic (amoxicillin) and Sulfonamide allergy (sulfa medication gives her a rash).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication included two thyroid medication and two hormone medication.  It was reported that every time the patient had a procedure she needed to take a COVID test.  No treatment medication was provided.   This case was linked to MOD-2022-611799 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Coating in mouth, Illness, Oral discomfort, Paraesthesia oral
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007d21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Allergy to antibiotic (amoxicillin) and Sulfonamide allergy (sulfa medication gives her a rash).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication included two thyroid medication and two hormone medication.  It was reported that every time the patient had a procedure she needed to take a COVID test.  No treatment medication was provided.   This case was linked to MOD-2022-611799 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18-Jul-2022. Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.  Vaccine administered 30 days after beyond use date.  Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient was administered with second booster dose.  Number of doses/vials were 6 doses from the same vial. On 16-Jun-2022, the vial was initially stored in the refrigerator and the patient received dose from the same vial lot.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18 Jul 2022.  Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16 Jun 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   6 patients received dose from affected vial. No concomitant product reported by reporter. Vial did not undergone any temperature excursion issue. The vial was first put into refrigerator on 16 Jun 2022. No treatment medication reported by reporter.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, HIBV, MNQ, TD, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion with no adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA290846.  This case involves a patient (unknown age and gender) who reported temperature excursion with no adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HIB (PRP/T) VACCINE [ActHIB].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE llot C5873AA; Expiration: 30-Jun-2023 ), ODIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7249AB; Expiration: 11-Mar-2024 ), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ613AA; Expiration: 25Feb2023 ), DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE , DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT l(strength, dose, formulation, route, lot number: not reported) all for immunization.  On an unknown date the patient reported temperature excursion with no adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE,  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event temperature excursion with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administering FLUBLOK to under 18 years of age, instead of FLUZONE with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves Adolescent under 18 years of age and unknown gender patient to whom administering flublok instead of fluzone with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 19-Jul-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, frequency, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On 19-JUL-2022 the patient developed a non-serious  event of administering flublok to under 18 years of age, instead of fluzone with no reported adverse event (wrong product administered) (latency:  1 day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Treponema test false positive
Clinical narrative: false positive syphilis test; Initial information received on 21-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old male patient who had false positive syphilis test after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine.  The patient's past vaccination(s) included FLUARIX. The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7283AA; strength and expiry date not reported) via intramuscular route in the left arm for Immunization. Patient states that he received a Sanofi Tdap vaccination on 16-Jun-2022 from his doctor and was not certain of the brand name of the vaccine.  On 04-Jul-2022 the patient states that when he attempted to donate blood and he received false positive syphilis test (treponema test false positive) (latency:18 days). Patient states that this also happened to him approximately 2 years ago after he received a FLUARIX vaccine from GSK and received a false positive syphilis test when attempting to donate blood. Patient asked if there was any way to compare these two vaccines and was any information available regarding the Sanofi Tdap vaccine that he received causing false positive syphilis tests;  Relevant laboratory test results included: Treponema test - On 04-Jul-2022:  [false positive syphilis test]  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (false positive syphilis test).  At time of reporting, the outcome was Unknown for the event false positive syphilis test.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Contusion, Erythema, Hypersensitivity, Joint swelling
Clinical narrative: Lots of red, itchy bumps, looked like bug bites on day one, more bruise like on day 2, quantity doubled between day 1 and day 2, ankles and hands swollen on day two, pt. indicated her ankles were painful to touch, further swelling in face on day three, more bumps on face. Visited Urgent Care, allergic reaction diagnosed as hives and started Benadryl on day three. PCP indicated the rash could be Erythema Multiforme.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling, Rash, Rash pruritic, Swelling face, Urticaria
Clinical narrative: Lots of red, itchy bumps, looked like bug bites on day one, more bruise like on day 2, quantity doubled between day 1 and day 2, ankles and hands swollen on day two, pt. indicated her ankles were painful to touch, further swelling in face on day three, more bumps on face. Visited Urgent Care, allergic reaction diagnosed as hives and started Benadryl on day three. PCP indicated the rash could be Erythema Multiforme.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain, Spinal X-ray
Clinical narrative: I had the vaccine on Friday afternoon then woke up on Saturday morning with severe neck pain on the right side that is still going on...day 9 now.. I was unable to put my head back in my neck to insert eye drops and am having a hard time looking up and down and left and right. Pain is radiating down side of my neck into my upper shoulder blade. I am aware that pain normally lasts only 2-3 days but was wondering if it can last longer.  Thank you.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received J&J vaccine on 4/2021, Moderna COVID vaccine on 5/12/2022, and Pfizer COVID vaccine on 5/25/22. No adverse effects noted.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Anxiety, Chest pain, Headache
Clinical narrative: Left sided chest pain, anxiety, headache.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR II was given on 05-JUL-2022 after expiration date of 30-JUN-2022.; no adverse event; This spontaneous report was received from a certified medical assistant referring to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions previous drug reactions or allergies, and concomitant therapies were not reported.   On 05-JUL-2022, the patient was vaccinated with a fist dose of an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter (ml), with and expiration date: 30-JUN-2022, administered subcutaneously for prophylaxis (strength, anatomical site and lot number were not provided) (expired product administered).  No additional adverse event (AE) information was provided.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Never got 3rd dose; got 1st dose Nov 2016, 2nd Jan 2017; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in Novemebr 2022).   In January 2017, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In January 2017, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: The reporter was a pharmacist. Patient received two doses of Twinrix. Patient never received third dose of Twinrix. The reporter did consent to follow up. No other information was available. The health care professional did not have time to provide further details of event. Additional supportive information: Patient received second dose of Twinrix late than recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix which led to incomplete course of vaccination. Note : As two schedule was provided for Twinrix conservatively too long event was coded as 2nd dose was reported as suspect.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: stored at 30.7F x 3 hours 49 minutes, vaccines administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number H4Y3G, expiry date 12th March 2024) for prophylaxis, DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) (batch number 3PA37, expiry date 23rd February 2024) for prophylaxis.   In July 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comments: The reporter stated administration of Bexsero, Boostrix, Infanrix, Engerix-B to unknown number of patients that were stored at 30.7 degree F for 3 hours and 49 minutes on 13 July 2022. Reporter reported that these vaccines was administered to the patients from 13 July 2022 to 19 July 2022. The reporter stated that the temperature excursion was potentially due to thermometer touching metal in refrigerator and not a true temperature excursion. The reporter consented to follow up. Additional supported information: Bexsero, Boostrix, Infanrix and Engerix-B these vaccines was stored at 30.7 degree Fahrenheit for 3 hours and 49 minutes which led to incorrect storage of vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: BOOSTER DOSE WAS NO LONGER IN THEIR SYSTEM; This spontaneous report received from a pharmacist concerned a patient of an unspecified age, sex. Initial information was processed along with the additional information received on 20-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: transplant, and concurrent conditions included: immunocompromised. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 1, primary dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. On an unspecified date, the patient experienced primary dose was no longer in their system following vaccination with primary dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose 2, booster dose, dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced booster dose was no longer in their system (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of booster dose was no longer in their system was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242725. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220735351.; Sender's Comments: V0:20220742370-covid-19 vaccine ad26.cov2.s-  booster dose  was no longer in their system. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (immunocompromised), SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Oedema peripheral
Clinical narrative: My left underarm is swallen even as of today Monday 7/252022 Te swallen area feels uncomfortable slightly painful which worries me .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Adrenal disorder, Anxiety, Autonomic nervous system imbalance, Blood test normal
Clinical narrative: 2021 04 24 Severe headaches, tinnitus, hearing loss, sfn, fatigue, disautomia, anxiety, adrenal rushes  DRUG TREATMENTS: Nimesil ? 2 weeks Nalgesin ? 2 weeks Paracetamol ? 2 weeks Ibumetin ? 2 weeks Ibuprofen ? 2 weeks Mydocalm? 4 weeks Sirdalud ? 2 weeks Amitriptyline ? 6 weeks Kodeine Ultracod ? 2 weeks Brexin ? 2 weeksArcoxia ? 1 week Gabapentine - 4 weeks Piroksikam ? 2 weeks Meldonio dihidrate since 2021-12 - now Kalio aspartate/Magnio aspartate ? 2 weeks Betahistino dihidrochloride ? since 2022-02 - now Piracetam/Cinarizin since 2022-02 - now B12 vitamins - 4 weeks Vitamin D - 4 weeks Ginkgo biloba - since 2022-03 - now Pentoksifiline- since 2022-03 - now Kvetiapine - since 2022-03 - now Mirtazapine - since 2022-03 - now Pregabaline ? since 2021 09 ? now Neurorubine injections - 2 weeks NON DRUG TREATMENTS: Ozone therapy - 2 weeks Acupuncture - 4 weeks Massages ? 4 weeks
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Fibrin D dimer normal, Headache, Magnetic resonance imaging head normal
Clinical narrative: 2021 04 24 Severe headaches, tinnitus, hearing loss, sfn, fatigue, disautomia, anxiety, adrenal rushes  DRUG TREATMENTS: Nimesil ? 2 weeks Nalgesin ? 2 weeks Paracetamol ? 2 weeks Ibumetin ? 2 weeks Ibuprofen ? 2 weeks Mydocalm? 4 weeks Sirdalud ? 2 weeks Amitriptyline ? 6 weeks Kodeine Ultracod ? 2 weeks Brexin ? 2 weeksArcoxia ? 1 week Gabapentine - 4 weeks Piroksikam ? 2 weeks Meldonio dihidrate since 2021-12 - now Kalio aspartate/Magnio aspartate ? 2 weeks Betahistino dihidrochloride ? since 2022-02 - now Piracetam/Cinarizin since 2022-02 - now B12 vitamins - 4 weeks Vitamin D - 4 weeks Ginkgo biloba - since 2022-03 - now Pentoksifiline- since 2022-03 - now Kvetiapine - since 2022-03 - now Mirtazapine - since 2022-03 - now Pregabaline ? since 2021 09 ? now Neurorubine injections - 2 weeks NON DRUG TREATMENTS: Ozone therapy - 2 weeks Acupuncture - 4 weeks Massages ? 4 weeks
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Massage, Ozone therapy, Small fibre neuropathy, Tinnitus
Clinical narrative: 2021 04 24 Severe headaches, tinnitus, hearing loss, sfn, fatigue, disautomia, anxiety, adrenal rushes  DRUG TREATMENTS: Nimesil ? 2 weeks Nalgesin ? 2 weeks Paracetamol ? 2 weeks Ibumetin ? 2 weeks Ibuprofen ? 2 weeks Mydocalm? 4 weeks Sirdalud ? 2 weeks Amitriptyline ? 6 weeks Kodeine Ultracod ? 2 weeks Brexin ? 2 weeksArcoxia ? 1 week Gabapentine - 4 weeks Piroksikam ? 2 weeks Meldonio dihidrate since 2021-12 - now Kalio aspartate/Magnio aspartate ? 2 weeks Betahistino dihidrochloride ? since 2022-02 - now Piracetam/Cinarizin since 2022-02 - now B12 vitamins - 4 weeks Vitamin D - 4 weeks Ginkgo biloba - since 2022-03 - now Pentoksifiline- since 2022-03 - now Kvetiapine - since 2022-03 - now Mirtazapine - since 2022-03 - now Pregabaline ? since 2021 09 ? now Neurorubine injections - 2 weeks NON DRUG TREATMENTS: Ozone therapy - 2 weeks Acupuncture - 4 weeks Massages ? 4 weeks
Sex: F
Vaccine: YF
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Women who were pregnant when first vaccinated with no reported adverse event; Initial information received from on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine YELLOW FEVER VACCINE [YF-VAX] in context of women who were pregnant when first vaccinated with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Women who were pregnant when first vaccinated with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of women who were pregnant when first vaccinated with no reported adverse event (exposure during pregnancy) (latency: Unknown) following the administration of YELLOW FEVER VACCINE. Reportedly they were asking if women who were pregnant when first vaccinated are recommend to receive another vaccine. What would be the vaccine schedule. Do we wait 10 years or give the additional dose during the next travel and possible exposure.  Action taken: not applicable.  Outcome: Unknown  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: PENTACEL was administered to one patient 4 days after the expiration date with no reported adverse event; Initial information received on 20-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered to one patient 4 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 18-Jul-2022, the patient received a 0.5ml (dose 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength not provided) (lot UJ495AA; expiry date: 14-Jul-2022)  via intramuscular route in the left vastus lateralis for immunization 4 days after the expiration date with no reported adverse event (expired product administered).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Epistaxis, Headache, Menstruation irregular
Clinical narrative: Chills, rigors,fever with TMax 104.2 Headache Dizziness, near syncope Nose bleed Menstrual period for first time in approx 5 yes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: Chills, rigors,fever with TMax 104.2 Headache Dizziness, near syncope Nose bleed Menstrual period for first time in approx 5 yes
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: Pt developed lymph node swelling under shoulder on same side as vaccine (left).  pt has discussed with dr and dr is monitoring
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Caregiver went limp following the vaccine and fainted, for report 10 seconds. Patient was clenching hand and looked to be having a mild seizure. No history of seizure or adverse effects of to any vaccines Patient did not fall or hit head. Patient states felt disease and began to black out. After 10mins patinet reported felt shaky and had a small headache
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Seizure, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Caregiver went limp following the vaccine and fainted, for report 10 seconds. Patient was clenching hand and looked to be having a mild seizure. No history of seizure or adverse effects of to any vaccines Patient did not fall or hit head. Patient states felt disease and began to black out. After 10mins patinet reported felt shaky and had a small headache
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: the patient experienced swelling 7 to 10 days after injection. then on 7-4-22 she got a rash and then rash on mid section. Rash went away on 7-15-22. on 7/21/22 she got her second shot and has the redness at the site only.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: the patient experienced swelling 7 to 10 days after injection. then on 7-4-22 she got a rash and then rash on mid section. Rash went away on 7-15-22. on 7/21/22 she got her second shot and has the redness at the site only.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Nervous system disorder
Clinical narrative: There has been so much long term affects from cardiac to neurology contacting my primary care doctor would be best. I've seen every specialist there is in the medical field
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypoxia, Malaise
Clinical narrative: Patient hypoxic and diagnosed with symptomatic COVID infection. Admitted to hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID infection leading to hospitalization
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Catheter directed thrombolysis, Computerised tomogram, Echocardiogram, Intensive care, Laboratory test abnormal
Clinical narrative: On the morning of 6/11/22 I was experiencing symptoms of heart attack and went to ER in my town. They confirmed "silent" heart attack and transported me to the nearest hospital with a cardiologist. After tests it was confirmed that I had a blood clot lodged in my lungs. They performed the EKOS procedure. I was in the hospital until 6/15-3 days in ICU.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Pulmonary thrombosis
Clinical narrative: On the morning of 6/11/22 I was experiencing symptoms of heart attack and went to ER in my town. They confirmed "silent" heart attack and transported me to the nearest hospital with a cardiologist. After tests it was confirmed that I had a blood clot lodged in my lungs. They performed the EKOS procedure. I was in the hospital until 6/15-3 days in ICU.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid pt who was fully vaccinated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, Musculoskeletal pain, Painful respiration
Clinical narrative: I had a pain in my left shoulder blade that made it hard to breathe it was there for about a week or so and then moved to what I think is my left lung area. I never put two and two together till just in the last week. Every time I sneeze, cough, or breath deep or sye it hurts in my upper chest and lower lung area.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, X-ray
Clinical narrative: I had a pain in my left shoulder blade that made it hard to breathe it was there for about a week or so and then moved to what I think is my left lung area. I never put two and two together till just in the last week. Every time I sneeze, cough, or breath deep or sye it hurts in my upper chest and lower lung area.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Hyperaesthesia, Lethargy
Clinical narrative: High Fever, muscle pain and Joint pain throughout body, super sensitivity to touch, nausea, headache, weakness.  To put this in perspective, I have had kidney stones 11 times in my life which is painful.  This was worse.  I contemplated going to the ER, but I did not have the money to spend.  So I used tylenol, cool compresses, a hot bath with essential oils, and tried to keep hydrated with water and pedialyte.  After about 24 hours I thought I was feeling a bit better.  I attempted to get showered, and run a few errands.  After about 2 hours, the headache returned and I had muscle and joint discomfort which was not as severe as the pain the day before.  I had intermittent fever like symptons as on and of nausea. Today I am starting the day with a headache, and general lethargy.  But the day is still young.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: High Fever, muscle pain and Joint pain throughout body, super sensitivity to touch, nausea, headache, weakness.  To put this in perspective, I have had kidney stones 11 times in my life which is painful.  This was worse.  I contemplated going to the ER, but I did not have the money to spend.  So I used tylenol, cool compresses, a hot bath with essential oils, and tried to keep hydrated with water and pedialyte.  After about 24 hours I thought I was feeling a bit better.  I attempted to get showered, and run a few errands.  After about 2 hours, the headache returned and I had muscle and joint discomfort which was not as severe as the pain the day before.  I had intermittent fever like symptons as on and of nausea. Today I am starting the day with a headache, and general lethargy.  But the day is still young.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines ; Moderna 11/22/21 Lot# 034F21A;  Moderna 12/22/21 Lot# 067H21A;  Moderna 6/20/22 Lot# 014B22A
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 5/5/21 Lot# 016C21A;  Moderna 6/5/21 Lot# 036C21A
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mobility decreased, Nausea, Pain
Clinical narrative: Symptoms: fever 101, body aches, chills, extreme fatigue, nausea.  Treatment: bed rest, intermittent Ibuprofen 600mg &  Tylenol 700mg.  Symptoms began around 10pm, 12 hours post injection & lasted until 10pm the next day, 24 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Symptoms: fever 101, body aches, chills, extreme fatigue, nausea.  Treatment: bed rest, intermittent Ibuprofen 600mg &  Tylenol 700mg.  Symptoms began around 10pm, 12 hours post injection & lasted until 10pm the next day, 24 hours.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: On the evening on 07/08/2022 I had a little bit of a sore throat and my voice dropped a bit. On the next day, I noticed some sneezing and a runny nose. Later in the day, I developed a significant headache which is unusual for me. I took 2 aspirin that night which got rid of the headache. I continued with common cold like symptoms and my husband seemed to be coming down with the same thing. At the suggestion of a friend, we tested for COVID-19 on 07/11/2022 with a PCR test and the results were positive the next day. I called my doctor after receiving the results and he prescribed PAXLOVID. After beginning the PAXLOVID, my symptoms continued to improve although I feel that they were progressing well on their own.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sick relative, Sneezing
Clinical narrative: On the evening on 07/08/2022 I had a little bit of a sore throat and my voice dropped a bit. On the next day, I noticed some sneezing and a runny nose. Later in the day, I developed a significant headache which is unusual for me. I took 2 aspirin that night which got rid of the headache. I continued with common cold like symptoms and my husband seemed to be coming down with the same thing. At the suggestion of a friend, we tested for COVID-19 on 07/11/2022 with a PCR test and the results were positive the next day. I called my doctor after receiving the results and he prescribed PAXLOVID. After beginning the PAXLOVID, my symptoms continued to improve although I feel that they were progressing well on their own.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after two vaccines Pfizer 12/16/21 Lot# 33130BA;  Pfizer 1/6/22 Lot# 33130BA
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines  Pfizer 3/15/21 Lot# EP7534;  PFIZER 4/5/21 lOT# EW0153;  PFIZER 10/31/21 lOT# FF8841
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received the 2nd dose of Moderna COVID vaccine on 7-23-22 in the afternoon.. The next evening, 7-24-22, he started experiencing hives on his neck and abdomen.  He took benadryl tablets and went to sleep. Monday morning, 7-25-22, the hives were still there, and maybe a little worse.  He called pharmacy to inform and also called his doctor.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate increased, Tryptase
Clinical narrative: On November 18, 2021 I developed severe itching in my palms and feet.  This spread over several days into a rash and itching throughout my entire body unrelieved by Benadryl.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose error. Patient was to receive 0.3 ml IM and was administered 0.5 ml. IM
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after two vaccines  Moderna 3/4/21 Lot# 030L20A;  Moderna 4/1/21 Lot# 017B21A
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blood test abnormal, Varicella, Varicella virus test positive
Clinical narrative: Patient tested positive for VARICELLA when being vaccinated on 10/14/21
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Injection site swelling, Pruritus, Tongue disorder, Urticaria
Clinical narrative: I had swelling at the injection site. Then saturday, i started itching a welp which was on the opposite arm of the injection site. I started feeling like I had a bite, or i was bitten by something, an ant or mosquito. I was in a weird part of my arm. I went to a movie t about noon, and all down my arm and down the side of my back started to itch. At that point, I was sitting next to someone, nothing weird about that. When I got home, it started to spread down the back of my leg, my butt cheek and down my thigh, it spread over to the other leg in the same area. and by evening, it went to my calves. So I took benadryl to go to sleep, cause it was unbareable. I didnt really know what hives were, so I looked it up. Woke up on Sunday morning, it was activated all over everywhere. I couldnt take benadryl , so i went and brought allegra and I took that. By the time I took that, it had gotten so much worst. In my feet, between my toes, my palms, my face, I can feel my tongue get a little thick. I started to get nervous. By then I had already taken allegra, soon as it kicked in, it went away. This morning, it was worst. I was welted everywhere, but my torso is not welted.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after two vaccines  Pfizer 6/26/21 Lot# EW0180;  Pfizer 7/29/21 Lot# FA7485
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient developed COVID after vaccinations administered.
Age: 55.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Pt admit with Covid related diagnosis.  Vaccinated from Covid
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 26.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Had Covid Vaccine.  Diagnosed with Covid.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE