chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022) 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 (Pharmacist inadvertently administered with bivalent that was past 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 16Sep2022, and vial was first punctured on 19Sep2022 at 15:15 administered on 20Sep2022). No concomitant medication was provided. Number of doses were 2 Doses. It was reported that vial was initially stored in the refrigerator on 16 Sep 22 in the morning. Vial was first punctured on 19 Sep 22 at 15:15 (3:15pm). Post punctured vial was stored at room temperature. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius equals to 46 degree to 77 degree Fahrenheit) was approximately 18 hours. The patient had received Moderna vaccine first dose on 02 Feb 21, second dose  on 03 Mar 21, first booster dose on 15 Nov 21 and second booster dose on 21 Apr 22, Moderna bivalent booster 1 on 20 Sep 2022. No treatment medication was provided. This case was linked to MOD-2022-648558 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2022: Significant follow up- patient details, dose number and narrative updated.
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Therapeutic response changed
Clinical narrative: The nurse attempted to vaccinate the client and did not observe a wheel form upon administration. No signs or symptoms noted after the unsuccessful attempt.
Age: 68.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Wrong technique in product usage process
Clinical narrative: The nurse attempted to vaccinate the client and did not observe a wheel form. No signs or symptoms noted after the unsuccessful attempt.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted
Age: 28.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: No adverse event, Vaccination error
Clinical narrative: The nurse attempted to vaccinate the client and did not observe a wheel form. No signs or symptoms noted after the unsuccessful attempt.
Age: 28.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dizziness, Panic attack
Clinical narrative: The nurse attempted to vaccinate the client and did not observe a wheel form. No signs or symptoms noted after the unsuccessful attempt.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Blindness unilateral, Blood test, Dyspnoea
Clinical narrative: 2 hrs after vaccine  all my joints. Where hot and in pains from last Aug im still in pains my breathing been a struggle  my one eye went blind  the Dr..  Gave me meds drops. Memory  is bad  stomach  bloating   always tired
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Joint warmth, Memory impairment, Pain in extremity
Clinical narrative: 2 hrs after vaccine  all my joints. Where hot and in pains from last Aug im still in pains my breathing been a struggle  my one eye went blind  the Dr..  Gave me meds drops. Memory  is bad  stomach  bloating   always tired
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test, Urine analysis
Clinical narrative: 2 hrs after vaccine  all my joints. Where hot and in pains from last Aug im still in pains my breathing been a struggle  my one eye went blind  the Dr..  Gave me meds drops. Memory  is bad  stomach  bloating   always tired
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: The nurse attempted to vaccinate the client and did not observe a wheel form. No signs or symptoms noted after the unsuccessful attempt.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Symptoms on my right arm big rash around the injection site and hot and itchiness is still occurring
Age: 25.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Amnesia, Migraine, Seizure
Clinical narrative: Migraines, sezuires,memory loss
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Axillary pain, Back pain, Cough, Fatigue
Clinical narrative: Itching and lump at injection site was immediate.   Sore shoulder.  Woke up with upset stomach, armpit pain and swelling, tenderness side of left breast, back pain left side, nausea, headache, cough with tingly feeling in chest, foggy brain, extreme fatigue.   Did not have a reaction to the two Pfizer Covid shots from the previous vaccine.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Headache, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Itching and lump at injection site was immediate.   Sore shoulder.  Woke up with upset stomach, armpit pain and swelling, tenderness side of left breast, back pain left side, nausea, headache, cough with tingly feeling in chest, foggy brain, extreme fatigue.   Did not have a reaction to the two Pfizer Covid shots from the previous vaccine.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Paraesthesia, Swelling, Tenderness
Clinical narrative: Itching and lump at injection site was immediate.   Sore shoulder.  Woke up with upset stomach, armpit pain and swelling, tenderness side of left breast, back pain left side, nausea, headache, cough with tingly feeling in chest, foggy brain, extreme fatigue.   Did not have a reaction to the two Pfizer Covid shots from the previous vaccine.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMRV
Symptoms: Blood iron normal, Blood thyroid stimulating hormone normal, Decreased appetite, Differential white blood cell count normal, Exercise tolerance decreased
Clinical narrative: For 3 weeks following receipt of the vaccine, patient exhibited fatigue (required naps when she previously did not), exercise intolerance, decreased appetite, and sudden insatiable desire for sweets when she previously did not ask for sweets. Symptoms resolved after 9/14/22.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMRV
Symptoms: Fatigue, Food craving, Full blood count normal, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: For 3 weeks following receipt of the vaccine, patient exhibited fatigue (required naps when she previously did not), exercise intolerance, decreased appetite, and sudden insatiable desire for sweets when she previously did not ask for sweets. Symptoms resolved after 9/14/22.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPHEPBIP, MMRV
Symptoms: Red blood cell sedimentation rate normal, Serum ferritin normal
Clinical narrative: For 3 weeks following receipt of the vaccine, patient exhibited fatigue (required naps when she previously did not), exercise intolerance, decreased appetite, and sudden insatiable desire for sweets when she previously did not ask for sweets. Symptoms resolved after 9/14/22.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine. The vaccine expired on 9/13 and was administered on 9/20.  A report with Pfizer was filed (Pfizer case number - 8X40L61H) and the Patient's parent was called and informed. As per CDC guidelines the patient will return to site to received a dose of the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Alopecia, Alopecia universalis, Blood thyroid stimulating hormone normal, COVID-19
Clinical narrative: 2 weeks after receiving 1st dose in May 2021, my hair started shedding. After 2nd dose hair loss increased. Saw Dermatologist in Sept and we did steroid injections for 5 months, no improvements. Saw primary care doctor, did a ton of lab work, nothing abnormal. Caught covid in Jan 2022 and was sick for 3 weeks. Saw a Rheumatologist, nothing he could do for me. Saw a different Derm, started oral steroids. They made me sick, discontinued treatment. Now with Immunologist/Derm at Clinic. She had me do more labs. All normal. Wants to start me on Xeljanz (an inhibitor) but I am concerned about all the side effects. I have had total body hair loss as of June 2022. I am now Alopecia Univeralis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Culture urine negative, Full blood count normal, Glycosylated haemoglobin normal, HIV test negative
Clinical narrative: 2 weeks after receiving 1st dose in May 2021, my hair started shedding. After 2nd dose hair loss increased. Saw Dermatologist in Sept and we did steroid injections for 5 months, no improvements. Saw primary care doctor, did a ton of lab work, nothing abnormal. Caught covid in Jan 2022 and was sick for 3 weeks. Saw a Rheumatologist, nothing he could do for me. Saw a different Derm, started oral steroids. They made me sick, discontinued treatment. Now with Immunologist/Derm at Clinic. She had me do more labs. All normal. Wants to start me on Xeljanz (an inhibitor) but I am concerned about all the side effects. I have had total body hair loss as of June 2022. I am now Alopecia Univeralis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Helicobacter test negative, Hepatitis B core antibody negative, Hepatitis C antibody negative, Laboratory test normal, Lipids normal
Clinical narrative: 2 weeks after receiving 1st dose in May 2021, my hair started shedding. After 2nd dose hair loss increased. Saw Dermatologist in Sept and we did steroid injections for 5 months, no improvements. Saw primary care doctor, did a ton of lab work, nothing abnormal. Caught covid in Jan 2022 and was sick for 3 weeks. Saw a Rheumatologist, nothing he could do for me. Saw a different Derm, started oral steroids. They made me sick, discontinued treatment. Now with Immunologist/Derm at Clinic. She had me do more labs. All normal. Wants to start me on Xeljanz (an inhibitor) but I am concerned about all the side effects. I have had total body hair loss as of June 2022. I am now Alopecia Univeralis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test normal, Rheumatoid factor negative, Thyroxine free normal, Urine analysis normal
Clinical narrative: 2 weeks after receiving 1st dose in May 2021, my hair started shedding. After 2nd dose hair loss increased. Saw Dermatologist in Sept and we did steroid injections for 5 months, no improvements. Saw primary care doctor, did a ton of lab work, nothing abnormal. Caught covid in Jan 2022 and was sick for 3 weeks. Saw a Rheumatologist, nothing he could do for me. Saw a different Derm, started oral steroids. They made me sick, discontinued treatment. Now with Immunologist/Derm at Clinic. She had me do more labs. All normal. Wants to start me on Xeljanz (an inhibitor) but I am concerned about all the side effects. I have had total body hair loss as of June 2022. I am now Alopecia Univeralis.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast cancer stage III, Chemotherapy, Magnetic resonance imaging
Clinical narrative: Diagnosed with Breast Cancer - Type: Triple Negative - Stage 3C - large tumor measures 7 cm in August 2022 by biopsy after physical breast exam by doctor in July 2022. History of dense breast tissue so cancer was undetected in mammograms in May 2022 and July 2021. NO CANCER detected in ultrasound in December 2021 just 3 months before vaccine. Treatment Plan - 6 months of chemotherapy then mastectomy and radiation (just started chemotherapy). NO FAMILY HISTORY OF BREAST CANCER. Due to the size of the largest tumor and statistical data about how Triple Negative tumors grow, the date of the vaccine corresponds with the origin of the tumor. I have never tested positive for COVID.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram normal, Positron emission tomogram, Triple negative breast cancer
Clinical narrative: Diagnosed with Breast Cancer - Type: Triple Negative - Stage 3C - large tumor measures 7 cm in August 2022 by biopsy after physical breast exam by doctor in July 2022. History of dense breast tissue so cancer was undetected in mammograms in May 2022 and July 2021. NO CANCER detected in ultrasound in December 2021 just 3 months before vaccine. Treatment Plan - 6 months of chemotherapy then mastectomy and radiation (just started chemotherapy). NO FAMILY HISTORY OF BREAST CANCER. Due to the size of the largest tumor and statistical data about how Triple Negative tumors grow, the date of the vaccine corresponds with the origin of the tumor. I have never tested positive for COVID.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Back pain, Balance disorder, Chest X-ray, Chest pain
Clinical narrative: Roughly 7 hours after injection, began experiencing severe chest pain, followed shortly by fever ranged (101-104 during duration), severe back pain, much increased urination throughout the night.  Sleep was impossible.  By early morning (roughly 6 am) my wife hard to help me to bathroom due to lack if energy and balance.  At 8:30 AM I called my family physician when their office opened, they directed me to the hospital.  By then, I was so sick my wife had to drive me.  I don't remember the drove in and only vaguely recall By memory the events at the hospital.  According to my wife, I was given an EKG, chest xray, and urine test.  After, they injected me with a steroid, benadryl, and an anti nausea medication.  After roughly 4-5 hours, I began to feel slightly better.  At the time of me writing this, I am still not fully recovered.  I am still experiencing lack if energy, nausea, and some schest pain.  I believe it is also worth noting that I had a similar, though less severe and untreated event with the second pfizer vaccine (of the first 2 original shots).  in that instance, my fever also went to 104, though I did not have the chest pains or frequent urination.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Impaired driving ability, Insomnia, Malaise, Memory impairment
Clinical narrative: Roughly 7 hours after injection, began experiencing severe chest pain, followed shortly by fever ranged (101-104 during duration), severe back pain, much increased urination throughout the night.  Sleep was impossible.  By early morning (roughly 6 am) my wife hard to help me to bathroom due to lack if energy and balance.  At 8:30 AM I called my family physician when their office opened, they directed me to the hospital.  By then, I was so sick my wife had to drive me.  I don't remember the drove in and only vaguely recall By memory the events at the hospital.  According to my wife, I was given an EKG, chest xray, and urine test.  After, they injected me with a steroid, benadryl, and an anti nausea medication.  After roughly 4-5 hours, I began to feel slightly better.  At the time of me writing this, I am still not fully recovered.  I am still experiencing lack if energy, nausea, and some schest pain.  I believe it is also worth noting that I had a similar, though less severe and untreated event with the second pfizer vaccine (of the first 2 original shots).  in that instance, my fever also went to 104, though I did not have the chest pains or frequent urination.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mobility decreased, Nausea, Pollakiuria, Pyrexia, Urine analysis
Clinical narrative: Roughly 7 hours after injection, began experiencing severe chest pain, followed shortly by fever ranged (101-104 during duration), severe back pain, much increased urination throughout the night.  Sleep was impossible.  By early morning (roughly 6 am) my wife hard to help me to bathroom due to lack if energy and balance.  At 8:30 AM I called my family physician when their office opened, they directed me to the hospital.  By then, I was so sick my wife had to drive me.  I don't remember the drove in and only vaguely recall By memory the events at the hospital.  According to my wife, I was given an EKG, chest xray, and urine test.  After, they injected me with a steroid, benadryl, and an anti nausea medication.  After roughly 4-5 hours, I began to feel slightly better.  At the time of me writing this, I am still not fully recovered.  I am still experiencing lack if energy, nausea, and some schest pain.  I believe it is also worth noting that I had a similar, though less severe and untreated event with the second pfizer vaccine (of the first 2 original shots).  in that instance, my fever also went to 104, though I did not have the chest pains or frequent urination.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PROQUAD was administered after a temperature excursion to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  There were two temperature excursions, with the same time/temp on different days. The temperature excursions for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin [rHA]) occurred at -14.2 degrees Celsius for 1 hour 11 minutes on 13-JUN-2022 and 24-JUN-2022, respectively. On 20-JUL-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin [rHA]) subcutaneous injection, once, lot #U002535, expiration date: 24-JUL-2022, administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported.  Follow-up information was received from a nurse on 16-SEP-2022 referring to a 4-year-old female patient. The suspect vaccine was administered subcutaneously at right arm. Patient information and additional information about vaccination related were updated.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE reported; a dose of M-M-R II and VARIVAX were both administered to the patient intramuscularly; Information was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-AUG-2022, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin)(M-M-R II) (0.5 ml, lot # U028162, expiration date 09-SEP-2023) and varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot # T032322, expiration date 22-SEP-2022) were both administered to the patient intramuscularly for prophylaxis (incorrect route of product administration). No additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; refrigerated products administered to the patient; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). There was no previous temperature excursion. No additional adverse event details were available (no adverse event). ; Sender's Comments:  US-009507513-2209USA002722:02242138 US-009507513-2209USA002779:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported an adverse event. Caller explained PROQUAD was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.     ?    Names of vaccines involved (including lot/exp): PROQUAD lot W0065; This spontaneous report was received from medical assistant and refers to an identifiable patient with unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W006585, expiration date: 23-AUG-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).  The vaccine was stored at the temperature that was reported as 1.6 degrees of Celsius for 2 hours and 10 minutes. There was no previous temperature excursion reported.  No additional adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with caller no other AE occurred; Customer reported an AE for VARIVAX and MMRII. The caller said these products were administered to the patient after two temperature excursions occurred; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, two temperature excursions occurred for varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with a temperature of 5.9 and 8.8 degrees Celsius, for a time frame of 10 and 8 hours. No previous temperature excursions were reported.  On 31-AUG-2022, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U028164, expiration date 09-SEP-2023; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA])  (M-M-R II) 1 dose, lot # U019291 expiration date 18-JUN-2023 (route of administration and anatomical location were not provided) both as prophylaxis (product storage error). No other events were reported (no adverse event).; Sender's Comments:  US-009507513-2209USA003954: US-009507513-2209USA004005:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant reporting AE for improperly stored vaccine administered. No additional AE information reported. No PQC reported. See case 02244271.     ?    Names of vaccines involved: PROQUAD (U039955 11/03/2022)    ?    Temperature: 9.3F; Temperature: 9.3F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 01-SEP-2022, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U039955, expiration date: 14-JUN-2023, administered for prophylaxis (strength, site, and route of administration were not provided) after temperature excursion (9.3 degrees Fahrenheit (F) for 0 hour 5 minutes 0 seconds and 14 degrees F up to 46 degrees F (25.9 F) for 1 hour 20 minutes 0 seconds) (product storage error). No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's; The nurse stated that an expired dose of PNEUMOVAX 23 vaccine was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T039322, expiration date: 09-SEP-2022, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details available.; Nurse calling states an expired dose of GARDASIL 9 was inadvertently administered to a patient that was past expiry. The product expired 9/6/2022 and was administered 9/14/2022.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 14-SEP-2022, the patient was inadvertently vaccinated with a expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number 1787290 is an invalid lot number, expiration date reported as 06-SEP-2022) (exact dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis (expired product administered). It was reported that the product had not experienced any temperature excursions through the date of administration. No additional adverse events were reported.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Renal disorder
Clinical narrative: developed cellulitis; it hit my kidney; This spontaneous report was received from an 80-year-old female patient reporting on herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, route and site of administration were not provided).  On an unspecified date, the patient developed cellulitis.   On an unknown date, the patient reported "it hit my kidney" (unspecified renal disorder).  At the time of reporting, the outcome of the event it hit my kidney was not known.   The outcome of the event developed cellulitis was recovering (reported as "did well, only had redness in arm).   The reporter did not provide the causal relationship between suspect therapy and the events.  Upon internal review, the event developed cellulitis was determined to be medically significant.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Anaemia, Arrhythmia, Crohn's disease, Inappropriate schedule of product administration
Clinical narrative: first dose was on 14-AUG-20220 and second on 17-AUG-2021; Crohn's disease (stomach cramps, anemia, weight loss); arrythmias; sepsis; Information has been received via company representative from a Physician regarding her 11-year-old daughter with drug allergy (to adalimumab). No other information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 14-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after", side effects began.     On 17-AUG-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after",  the patient went to the emergency room for stomach cramps, arrhythmias, "noclasum," anemia, weight loss, sepsis, and later diagnosed with Crohn's disease. Side effects continued for 6 months after dose. The caller stated the patient was "in recovery" (conflicting information, also reported as "outcome: not recovered").  The patient sought medical attention and was prescribed holistic treatments including "like 30 different vitamins". It was unknown if any laboratory test was performed.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.  Upon internal review, Crohn's disease, sepsis and arrhythmia were determined medically significant.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Sepsis, Weight decreased
Clinical narrative: first dose was on 14-AUG-20220 and second on 17-AUG-2021; Crohn's disease (stomach cramps, anemia, weight loss); arrythmias; sepsis; Information has been received via company representative from a Physician regarding her 11-year-old daughter with drug allergy (to adalimumab). No other information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 14-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after", side effects began.     On 17-AUG-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) intramuscularly for prophylaxis (dose, site of administration, lot number and expiration date were not reported).   On an unspecified date, reported as "shortly after",  the patient went to the emergency room for stomach cramps, arrhythmias, "noclasum," anemia, weight loss, sepsis, and later diagnosed with Crohn's disease. Side effects continued for 6 months after dose. The caller stated the patient was "in recovery" (conflicting information, also reported as "outcome: not recovered").  The patient sought medical attention and was prescribed holistic treatments including "like 30 different vitamins". It was unknown if any laboratory test was performed.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.  Upon internal review, Crohn's disease, sepsis and arrhythmia were determined medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report was received from a vaccine coordinator concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U015678, expiration date: 18-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided) after experiencing a temperature excursion at a temperature of 51 Fahrenheit degrees (product storage error).   The reporter stated that the vaccine was accidentally placed and stored since 15-NOV-2021, in a refrigerator that had a temperature excursion. No previous temperature excursions and no additional adverse events were reported.   This is one of several report received form the same source.; Sender's Comments:  US-009507513-2209USA006115:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: Pharmacist reported that a patient came in telling her that her doctor recommend GARDASIL 9 even though she is over 45 years of age.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, the doctor's patient recommended her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number, expiration date, dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported) as prophylaxis, even though the patient was over 45 years of age (product prescribing issue). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Customer reports that she has an interruption in schedule pertaining to GARDASIL 9. Customer reports that she is passed her 2 month mark for receiving her 2nd dose of GARDASIL 9.; No additional AEs reported.; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided). The patient reported that she had an interruption in schedule pertained to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient reported that she was passed her two month mark for receiving her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Blister, Herpes zoster, Vaccination failure
Clinical narrative: Had the two injections, still getting outbreaks/suspected vaccination failure; Shingles many times; Had the blisters biopsied; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had the two injections of Shingrix and still got the shingles many times. The patient had shingles before the shots and still getting outbreaks.  The patient did blisters biopsied. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shots didn't give you shingles?/suspected vaccination failure; Shingles/ has had it what three, four times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked are you sure that the shots did not give you shingles. The patient stated that everyone he knew that had gotten them, had gotten either the jab or the Covid jab(known side effect look up the documents) and everyone he knew that had gotten the vid had been jabbed, no one that have not had gotten them. The patient himself have had them what three to four times. The case was linked with case US2022AMR134291, reported by same reporter. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR134291:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Some who got the shot for Shingles they still got it (shingles)/Suspected vaccination failure; They still got it (shingles) but not bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter knows some who got the shot for shingles and they still got the shingles but not bad. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was one of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR134920:Same reporter/ husband US-GSK-US2022AMR134931:Same reporter/ inavlid case
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included allergic rhinitis (had Allergic rhinitis since 26th February 2018).   On 25th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 25th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient stated that, still trying to reach to the schedule. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. RNS to check all vials for vaccines prior to administration. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR131200:Same reporter US-GSK-US2022AMR131228:Same reporter US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131240:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Large redness (significant reactions); Swelling (significant reactions); This case was reported by a nurse via sales rep and described the occurrence of erythema in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva723z, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Menveo.     Additional Information: GSK Receipt Date: 12-SEP-2022  Reporter's Comment:  Nurse reported that event is related to product, reported several patients had significant reactions with large redness and swelling to dose 2.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Pain around back (still experiencing sympstoms/ sought physical therapy); This case was reported by a other health professional via sales rep and described the occurrence of back pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced back pain. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-Sep-2022 Reporter's Comment: Patient reported that had pain for 2 months following administration of Shingrix on right arm, had physical therapy and pain around back.  The patient still experiencing pain. The reporter agrees to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe myalgia to the left arm; This case was reported by a pharmacist via other manufacturer and described the occurrence of myalgia upper extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was unknown.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.     Additional Information: GSK receipt date: 12 Sep 2022 Reporters comment: The caller is the reporter and he reported that the patients received the shingrix vaccine and experienced severe myalgia to the left arm. The reporter did not provide the lot number OR expiry date or any additional information for this report, no additional information provided.  No additional adverse event reported.  No PQC reported. .
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 10 months since first, got second; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November2021(10 months ago)).   On 12th September 2022, the patient received the 2nd dose of Shingrix. On 12th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK receipt date: 12th September 2022 Reporters comment: This case was reported by a patient via interactive digital media  It has been 10 months since patient's first Shingrix.  The patient got my second on the reporting day. The patient asked would he/she need another. Additional Supportive information: The patient received the 2nd dose of Shingrix late which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aching (mild side effects); Tired (mild side effects); This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and tiredness. On an unknown date, the outcome of the muscle pain and tiredness were unknown.   It was unknown if the reporter considered the muscle pain and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient asked how long after the Shingrix vaccine would patient start to have mild side effects (muscle aching and tired). Additional supportive information: The follow-up would not possible, as no contact, details were available.