chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Chest discomfort, Dizziness, Dysgeusia, Injection site pruritus
Clinical narrative: I went for a tetanus booster due to a cut on my foot. I do not know which vaccine was administered specifically since no paperwork was provided, but the following day I had a low grade fever of 100.4 that went down to 99.5. Following that I was very dizzy and nauseous. I then started to feel faint and feel extreme pain in my neck, lower back and jaw. I looked up what I could do and started taking Tylenol. The arm where the vaccine was applied is hot, swollen and itchy.  As of today in addition to the aforementioned symptoms, I have developed a metalic taste, and mild tightness in my chest, and the dizziness has worsened.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Injection site warmth, Nausea, Neck pain, Pain in jaw
Clinical narrative: I went for a tetanus booster due to a cut on my foot. I do not know which vaccine was administered specifically since no paperwork was provided, but the following day I had a low grade fever of 100.4 that went down to 99.5. Following that I was very dizzy and nauseous. I then started to feel faint and feel extreme pain in my neck, lower back and jaw. I looked up what I could do and started taking Tylenol. The arm where the vaccine was applied is hot, swollen and itchy.  As of today in addition to the aforementioned symptoms, I have developed a metalic taste, and mild tightness in my chest, and the dizziness has worsened.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: I went for a tetanus booster due to a cut on my foot. I do not know which vaccine was administered specifically since no paperwork was provided, but the following day I had a low grade fever of 100.4 that went down to 99.5. Following that I was very dizzy and nauseous. I then started to feel faint and feel extreme pain in my neck, lower back and jaw. I looked up what I could do and started taking Tylenol. The arm where the vaccine was applied is hot, swollen and itchy.  As of today in addition to the aforementioned symptoms, I have developed a metalic taste, and mild tightness in my chest, and the dizziness has worsened.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Gait inability, Headache, Laboratory test, Muscle fatigue
Clinical narrative: THIS WAS MY 2ND OF 3 DOSES IN THE SERIES. I RECEIVED THE 1ST DOSE ON APRIL 4, 2021 AND THE 2ND ON APRIL 21, 2021. NEXT DOSE AFTER THE 2ND DOSE, I SUDDENLY DEVELOPED AN EXCRUCIATING HEADACHE (THE TYPE THAT I HAD NEVER HAD IN LIFE BEFORE AND SINCE AFTER THAT DAY) AND AT THE SAME TIME MY LEGS JUST GAVE UP ON ME THAT I COULD STAND OR WALK AND HAD TO CALL FOR ASSISTANCE FOR PEOPLE TO SUPPORT ME TO A CHAIR. THE SYMPTOMS RESOLVED AFTER A FEW MINUTES BUT SINCE THAT DAY OVER TWO YEARS AGO NOW, I HAVE BEEN HAVING PROGRESSIVELY WORSENING MUSCLE WEAKNESS/FATIGUE, CRAMPS, DEEP PAIN, AND OCCASIONAL PARESTHESIA IN THE MUSCLES OF MY LEGS FROM MY BUTTOCKS DOWN TO MY FEET.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Muscular weakness, Pain, Paraesthesia
Clinical narrative: THIS WAS MY 2ND OF 3 DOSES IN THE SERIES. I RECEIVED THE 1ST DOSE ON APRIL 4, 2021 AND THE 2ND ON APRIL 21, 2021. NEXT DOSE AFTER THE 2ND DOSE, I SUDDENLY DEVELOPED AN EXCRUCIATING HEADACHE (THE TYPE THAT I HAD NEVER HAD IN LIFE BEFORE AND SINCE AFTER THAT DAY) AND AT THE SAME TIME MY LEGS JUST GAVE UP ON ME THAT I COULD STAND OR WALK AND HAD TO CALL FOR ASSISTANCE FOR PEOPLE TO SUPPORT ME TO A CHAIR. THE SYMPTOMS RESOLVED AFTER A FEW MINUTES BUT SINCE THAT DAY OVER TWO YEARS AGO NOW, I HAVE BEEN HAVING PROGRESSIVELY WORSENING MUSCLE WEAKNESS/FATIGUE, CRAMPS, DEEP PAIN, AND OCCASIONAL PARESTHESIA IN THE MUSCLES OF MY LEGS FROM MY BUTTOCKS DOWN TO MY FEET.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: THIS WAS MY 2ND OF 3 DOSES IN THE SERIES. I RECEIVED THE 1ST DOSE ON APRIL 4, 2021 AND THE 2ND ON APRIL 21, 2021. NEXT DOSE AFTER THE 2ND DOSE, I SUDDENLY DEVELOPED AN EXCRUCIATING HEADACHE (THE TYPE THAT I HAD NEVER HAD IN LIFE BEFORE AND SINCE AFTER THAT DAY) AND AT THE SAME TIME MY LEGS JUST GAVE UP ON ME THAT I COULD STAND OR WALK AND HAD TO CALL FOR ASSISTANCE FOR PEOPLE TO SUPPORT ME TO A CHAIR. THE SYMPTOMS RESOLVED AFTER A FEW MINUTES BUT SINCE THAT DAY OVER TWO YEARS AGO NOW, I HAVE BEEN HAVING PROGRESSIVELY WORSENING MUSCLE WEAKNESS/FATIGUE, CRAMPS, DEEP PAIN, AND OCCASIONAL PARESTHESIA IN THE MUSCLES OF MY LEGS FROM MY BUTTOCKS DOWN TO MY FEET.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: THIS WAS MY 2ND OF 3 DOSES IN THE SERIES. I RECEIVED THE 1ST DOSE ON APRIL 4, 2021 AND THE 2ND ON APRIL 21, 2021. NEXT DOSE AFTER THE 2ND DOSE, I SUDDENLY DEVELOPED AN EXCRUCIATING HEADACHE (THE TYPE THAT I HAD NEVER HAD IN LIFE BEFORE AND SINCE AFTER THAT DAY) AND AT THE SAME TIME MY LEGS JUST GAVE UP ON ME THAT I COULD STAND OR WALK AND HAD TO CALL FOR ASSISTANCE FOR PEOPLE TO SUPPORT ME TO A CHAIR. THE SYMPTOMS RESOLVED AFTER A FEW MINUTES BUT SINCE THAT DAY OVER TWO YEARS AGO NOW, I HAVE BEEN HAVING PROGRESSIVELY WORSENING MUSCLE WEAKNESS/FATIGUE, CRAMPS, DEEP PAIN, AND OCCASIONAL PARESTHESIA IN THE MUSCLES OF MY LEGS FROM MY BUTTOCKS DOWN TO MY FEET.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Costochondritis, Electrocardiogram, Fibrin D dimer
Clinical narrative: Fever, aches, leading to chostochronditis (sudden onset - I had chest pains and went to ER.) They did an EKG, d-dimer, and chest CT. Eventually diagnosed chostochronditis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aches, leading to chostochronditis (sudden onset - I had chest pains and went to ER.) They did an EKG, d-dimer, and chest CT. Eventually diagnosed chostochronditis
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Tremor
Clinical narrative: The evening after vaccine the patient had chills and was shaking. Was better the next day. But 2 days later experienced shortness of breath and chest tightness. He went to the hospital and was admitted.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Ear pain, Malaise, Oropharyngeal pain, Otitis externa
Clinical narrative: During the night after receiving Prevnar 20, she developed right ear pain, right-sided throat pain, generalized bodyaches, malaise, and diarrhea. These symptoms were still persistent on 8/27/2023 when she sought evaluation at the Clinic. She was diagnosed with right otitis externa and prescribed otic antibiotic drops. She was advised to seek re-evaluation from her PCP in 1-2 days.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: During the night after receiving Prevnar 20, she developed right ear pain, right-sided throat pain, generalized bodyaches, malaise, and diarrhea. These symptoms were still persistent on 8/27/2023 when she sought evaluation at the Clinic. She was diagnosed with right otitis externa and prescribed otic antibiotic drops. She was advised to seek re-evaluation from her PCP in 1-2 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Severe tiredness and Fever 102 for days even on Tylenol (lowered the fever) starting 5-6 hours after 2nd vaccination). Hives/Rash after throughout body worsening on day 5. Went to ER with fever, rash, difficulty breathing, elevated blood pressure and pulse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Severe tiredness and Fever 102 for days even on Tylenol (lowered the fever) starting 5-6 hours after 2nd vaccination). Hives/Rash after throughout body worsening on day 5. Went to ER with fever, rash, difficulty breathing, elevated blood pressure and pulse.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Extreme fatigue and shortness of breath.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Joint lock, Joint range of motion decreased
Clinical narrative: Patient left elbow locked. She cannot fully extend, She receive the shot on 8-23-23 Started feeling adverse reaction 08-25-23
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLUR4, MMR, VARCEL
Symptoms: Dizziness, Electrocardiogram normal, Hypotension, Nausea, Syncope
Clinical narrative: Patient started feeling dizzy after the administration of 4 out of 5 vaccines scheduled. After a couple of seconds he fainted for a couple of seconds. She was still very dizzy and nauseous and her blood pressure was very low. Since patient was not recovering the paramedics were called. They performed further test and when stable she agreed to go to the hospital for further testing with them and her husband.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: *Administration error: not previously vaccinated 5 year old should have received 1 dose of 0.25ml of Dark Blue Cap, Gray Border label Moderna vaccine, Instead received 0.05ml of Dark Pink cap yellow box label Moderna. Patient was administered dose at approximately 11am and error was discovered at approximately 2:45pm same day of administration (8/24/23). No adverse side effects were reported up until 4:30pm (8/24/23)
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Breakthrough Infection
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Sex: U
Vaccine: HEPA, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; a 15-month old patient was inadvertently administered PROQUAD instead of MMR-II.  Patient then proceeded to receive VARIVAX and HAVRIX concomitantly.  Confirmed that no symptomatic adv; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter once (lot #W024980, has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 05-FEB-2024)(strength, and route of administration were not provided). The patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RII) (Wrong product administered). Then the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter once, (lot #W006412, has been verified to be a valid lot number for vaccinated with varicella virus vaccine live (oka/merck), expiration date: 23-FEB-2024) (strength, and route of administration were not provided). The patient also received hepatitis a vaccine inact (HAVRIX), 0.5 milliliter once, (lot # 2YZ9B, expiration date: 07-DEC-2023) (strength, formulation, and route of administration were not provided). All the vaccines were administered for prophylaxis. No additional adverse events were reported.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Precautionary missed dose AE being filed due to a pharmacist calling with MIL request for the following question regarding GARDASIL9. If a 24-year-old female "may have" received one dose of GARDASIL9 approximately 5 years ago, is it recommended to st; No additional AE; This spontaneous report was received from a pharmacist and refers to a 24-years-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in approximately 2018, the patient was vaccinated with 1st hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date not provided) for prophylaxis. The patient was wanting the vaccine at the time of report (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called to report a 16-year-old patient who received a first dose of GARDASIL 9 in 2018 and received a second dose of GARDASIL 9 today on 08/08/2023. Limited patient demographics provided. No additional AE/PQC.; No additional AE/PQC.; This spontaneous report was received from an pharmacist referring to a 16 years old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.   On an unknown date in 2018, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration data were unknown) as prophylaxis. On 08-AUG-2023, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration data were unknown) as prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event (AE) or product quality complaint (PQC) were provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 07-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006983, expiration date 07-MAR-2025, 0.5 milliliter, intramuscular) after temperature excursions for prophylaxis (product storage error). Temperature excursion was 18.3F for 1 hour and 5 minutes. No previous temperature excursion. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report a T/E, improperly stored VARIVAX administered to patients.; This spontaneous report was received from a Medical Assistant (C.M.A.) referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 14-AUG-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 ml, once; lot# X006983 with expiration date 07-MAR-2025; lot # X002101 with expiration date 19-JAN-2025; strength and route were not reported) for prophylaxis, which was temperature excursion (product storage error). The excursion temperature was minus 7.1 degrees Celsius with time frame of 2 hours 43 minutes 0 seconds. There was no previous temperature excursion. It was confirmed no symptoms or sided effects were reported (no adverse event).
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product selection error, Wrong product administered
Clinical narrative: not reported any adverse reaction to the accidental administration of the PROQUAD vaccine at the time of the call; the error occurred due to the trays the vaccines were handled on being accidentally switched; a dose of PROQUAD that was accidently administered to the wrong patient/ one patient was given the wrong vaccine; This spontaneous report was received from an office manager referring to a 2-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 14-AUG-2023, the patient was accidently vaccinated a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 mL / two dose series, lot#: X004368, expiration date: 02-JUN-2024; strength and route of administration were not provided), which was administered to the wrong patient (wrong product administered). This vaccine was supposed to be administered to the patient's sibling, who came into the practice at the same time for routine vaccinations. The error occurred due to the trays the vaccines were handled on being accidentally switched, not due to confusion over the vaccine appearances (product selection error).  The patient involved has not reported any adverse reaction to the accidental administration of the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no further AE; MMR administration not completed; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration was not completed. The patient turned during administration and "drops" of the vaccine fell on the "surface" (incorrect dose administered).  It was unable to specify how much of the vaccine was actually administered. No further adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and referred to a patient with unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status of recombinant human albumin [rHA]) subcutaneous injection, frequency reported as 1 dose, lot #X009733, expiration date: 02-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional AEs were reported (No adverse event).  The storage temperature was 29 Fahrenheit with time frame of 4 hours 30 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported pediatric patient received adult dose of VAQTA. See additional AE cases 02457006 and 02457034/no PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 22-AUG-2023 the pediatric patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # W023489 and expiration date 27-DEC-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).    This case contains information for the 20th of 42 patients described by the reporter.  No concomitant drug was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms off 50% or more. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches.  No adverse reactions occurred.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 20 out of 42
Sex: U
Vaccine: COVID19-2
Symptoms: Blood pressure systolic, No adverse event, Off label use, Tachycardia, Therapeutic response unexpected
Clinical narrative: Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 220. On an unknown date, Tachycardia: greater than or equal to 150..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.     This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID-19.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).      Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
Age: 80.0
Sex: M
Vaccine: COVID19, FLUA3
Symptoms: Pancreatic carcinoma
Clinical narrative: pancreatic cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PANCREATIC CARCINOMA (pancreatic cancer) in a 9-decade-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUAD) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SAG 3V (FLUAD) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC CARCINOMA (pancreatic cancer) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (pancreatic cancer) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PANCREATIC CARCINOMA (pancreatic cancer) to be related.    Concomitant medication not reported.   The patient was dying of pancreatic cancer. He never had any trouble with the pancreas before and he was almost 81. He was diagnosed with pancreatic cancer a few months after receiving the shot.  Treatment medication not reported. Company comment: This spontaneous case concerns a 9-decade-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of PANCREATIC CARCINOMA, which occurred on an unknown onset latency with an unspecified dose of mRNA-1273 vaccine. The vaccination date and the onset of the event were not reported; hence, latency could not be properly assessed. Treatment medication not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-737836, US-MODERNATX, INC.-MOD-2023-737856, US-MODERNATX, INC.-MOD-2023-737864 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737836:Same Reporter US-MODERNATX, INC.-MOD-2023-737864: (same reporter) US-MODERNATX, INC.-MOD-2023-737856: (same reporter)
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023; No adverse event; Dose were administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7644C and AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Aug-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 10-JUL-2023. Vial did not undergo any temperature excursion. Vial size was reported as 2.5 milliliter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737985, US-MODERNATX, INC.-MOD-2023-737989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737985:Patient 2 US-MODERNATX, INC.-MOD-2023-737989:Patient 3
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: two patients received expired ACT-HIB with no reported adverse event; Initial information received on 23-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender two patients who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2023, the two patients received an expired dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ796AA, expiry date- 12-AUG-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller would like to know how to proceed?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Age: 2.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No specific adverse event; GARDASIL 9 was accidently given to a 2 year 10 month old male patient this morning; This spontaneous report was received from a physician assistant  and refers to a 2-year 10 month old  male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-JUL-2023, the patient was accidently given hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W030851, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age)  No additional adverse event was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingle / uspected Vaccination failure; Sales rep submitted via CRM: Doctor has seen patients who have developed shingle post completion of the two dose series of shingrix.; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 22-AUG-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Sales rep submitted via CRM: Doctor has seen patients who have developed shingle post completion of the two dose series of shingrix.).  The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A physician reported that he/she had seen patients who had developed shingle, post completion of the two-dose series of Shingrix. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).      No concomitant drug was reported.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.  Vaccine was given to the patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms off 50% or more. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches.  No adverse reactions occurred.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more).    Concomitant medication was not reported.  Vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65. Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches. Treatment medication was not reported.  This case contains information of 21st patient out of 42 reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case