chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain
Clinical narrative: Bad abdominal pain starting roughly 24 hours after the injection and lasting about 2 days. The pain would settle down if I lay in one position for a while, but would start up again if I moved into a different position.   There were no GI symptoms with it--no gas or diarrhea. I didn't notice any other symptoms except the pain. Pain went from just under the breastbone down to the groin. It felt very much like I'd gone through a crushing ab workout and was sore.  Walking, changing position, or pressing anywhere on the abdomen caused pain.  The first day I could barely walk with the pain, and spent most of it in bed. The second day it was more of an annoyance. It seemed to improve with rest.  I've previously had mild flu-like symptoms after the vaccine, but never this particular symptom, and not for over 48 hours.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Once I inserted the needle for IM injection for the flu shot, the patient complained about the pain. I asked her if she was OK. She said yes. So I continued. After I finished the injection, she complained that her whole left arm from shoulder to the tip of her fingers were numbed. She suspected that I hit her nerve. A few minutes later, she complained that her right temple hurt and just did not feel right. I offered to call 911 for her but she declined and left. She threatened to file a lawsuit if it caused permanent damage. I contacted Incident Reporting Hotline and received a claim# should I decide to file a lawsuit.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling of glands under left armpit (same side as injection). Symptoms are raised red bumps that are sore and tender to the touch. Next day a glad in the right armpit also swelled. Glad under left jaw bone has also been tender.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Influenza like illness, Lymphadenopathy, Rhinorrhoea
Clinical narrative: Pt reported feeling like he was coming down with a cold, including flu-like symptoms such as coughing, runny nose, and swollen glands. Pt states he usually gets swollen glands as a precursor to getting a cold. When patient reported to pharmacy, stated that symptoms were slowly resolving.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Shivers. Headache
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Night sweats, Pain
Clinical narrative: patient experienced aches, chills, and nightsweat lasting a day starting a few hours following receipt of influenza immunization.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Nausea, Neuralgia
Clinical narrative: Had fever of 101 and chills for 3 days; severe headache; body ache; sore throat; weakness; nausea neuralgia in feet and legs for 2 days
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Had fever of 101 and chills for 3 days; severe headache; body ache; sore throat; weakness; nausea neuralgia in feet and legs for 2 days
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient reported to urgent care for redness and swelling in her entire arm, not just at injection site. Urgent care MD prescribed an antibiotic for cellulitis that she subsequently filled at our pharmacy and reported the adverse event.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Screaming
Clinical narrative: Screaming (inconsolable), diarrhea Review by ER Doctors believed it may be due to vaccine administration. Orders were to monitor.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: The following day after the vaccine, client had hive reaction localized under the flu-shot site on his left arm.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pt had swallening. Redness on whole left arm & painful also. Started 2nd day after vaccine. Dr inject steroid and pt was ok after.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Hypotonia, Pyrexia, Skin discolouration
Clinical narrative: Pt had fever of 101 Turned purple and flaccid for few seconds 911 was called it took few minutes for pt to be completely back  to normal
Age: 4.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mom spoke to provider had fever last eve 102 & vomited x1 today. Afebrile now
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Papule, Vaccination site rash
Clinical narrative: Mild rash at site of varicella vaccine 5-8 sl - raised pink papules -2mm in diameter, with surrounding pink skin, no warmth, no vesicles no signs of discomfort
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed urticaria s/p infuenza vaccine 1 day priar
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient experienced severe soreness at site of injection, loss of range in motion in arm, and unresolved pain with NSAIDs and ice.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Induration, Swelling
Clinical narrative: HARD BUMPS after 4 month vaccines took about one month to Resolve.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Patient called and stated that her arm sores and it is difficult to lift it. She mentioned that the pharmacist who administered vaccine initially missed ( poked with needle but unable to inject) and on the second try was able to properly administer the vaccine. The patient mentioned that the arm is not swollen or bruised but it sores still 10 days after the vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient exhibited syncope immediately after immunization. Patient moved to supine position. Patient remained in pharmacy for addl 15 min for observation & provided orange juice. Patient left independently & reported no addl symptoms
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site swelling, Pyrexia
Clinical narrative: chills, headache, & fever, (L) arm swelling/swollen where shot given.
Age: 86.0
Sex: M
Vaccine: FLUC4, PNC
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Numb/Pain in the left arm (Flucelvax) and wrist. Cant close hand as of today 9/30/20. Pt consulted PCP, and was told it is probably not a vaccine adverse effect and to ice the area plus take APAP. As of now, pt has some relief.
Sex: F
Vaccine: FLU4, FLU4, PPV, PPV, PPV
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: fever; injection site started to become red; injection site started to become blotchy; chills; loss of appetite; orange pee; weak; "incredible pain" in her arm; could not move it; soreness at the injection site; This spontaneous report was received from a 31 years old female patient with allergies to citrus fruits referring to herself. Concomitant medications included morphine, ibuprofen (ADVIL) and acetaminophen (+)hydrocodone bitartrate (NORCO).  The patient's current condition included asthma.    At 9:30 AM on 17-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, strength, frequency, route, lot# and expiration date were not reported).    At around noon on 17-SEP-2020, the patient started to feel soreness at the injection site and at 11 PM that same night the patient started to feel weak and had "incredible pain" in arm. The patient could not move it to put a shirt on and had to go to the hospital. The doctors at the emergency room (ER) noted that there was no fever, no swelling and told the patient to take ibuprofen (ADVIL) and let it rest. The pain was intense and she took acetaminophen (+) hydrocodone bitartrate (NORCO) and went back to sleep. The patient woke up the next morning with "extreme pain and chills" and throughout the day she had a "loss of appetite and orange pee". The patient continued to use acetaminophen (+) hydrocodone bitartrate (NORCO) until she had to go back to the ER on 19-SEP-2020 for "unbearable pain and a fever". At the ER the doctors noted the patient had fever of 102 degrees Fahrenheit and the injection site and started to become "blotchy and red". Due to all the events, the patient was admitted in hospital on an unknown date in September 2020. The patient returned home and had started to recover (outcome of the events was recovering).  The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  All the events was considered as medically significant and disability by the patient.
Sex: F
Vaccine: FLU4, FLU4, PPV, PPV, PPV
Symptoms: Vomiting
Clinical narrative: fever; injection site started to become red; injection site started to become blotchy; chills; loss of appetite; orange pee; weak; "incredible pain" in her arm; could not move it; soreness at the injection site; This spontaneous report was received from a 31 years old female patient with allergies to citrus fruits referring to herself. Concomitant medications included morphine, ibuprofen (ADVIL) and acetaminophen (+)hydrocodone bitartrate (NORCO).  The patient's current condition included asthma.    At 9:30 AM on 17-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, strength, frequency, route, lot# and expiration date were not reported).    At around noon on 17-SEP-2020, the patient started to feel soreness at the injection site and at 11 PM that same night the patient started to feel weak and had "incredible pain" in arm. The patient could not move it to put a shirt on and had to go to the hospital. The doctors at the emergency room (ER) noted that there was no fever, no swelling and told the patient to take ibuprofen (ADVIL) and let it rest. The pain was intense and she took acetaminophen (+) hydrocodone bitartrate (NORCO) and went back to sleep. The patient woke up the next morning with "extreme pain and chills" and throughout the day she had a "loss of appetite and orange pee". The patient continued to use acetaminophen (+) hydrocodone bitartrate (NORCO) until she had to go back to the ER on 19-SEP-2020 for "unbearable pain and a fever". At the ER the doctors noted the patient had fever of 102 degrees Fahrenheit and the injection site and started to become "blotchy and red". Due to all the events, the patient was admitted in hospital on an unknown date in September 2020. The patient returned home and had started to recover (outcome of the events was recovering).  The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  All the events was considered as medically significant and disability by the patient.
Sex: F
Vaccine: FLU4, FLU4, PPV, PPV, PPV
Symptoms: Asthenia, Chills, Chromaturia, Decreased appetite, Injection site erythema
Clinical narrative: fever; injection site started to become red; injection site started to become blotchy; chills; loss of appetite; orange pee; weak; "incredible pain" in her arm; could not move it; soreness at the injection site; This spontaneous report was received from a 31 years old female patient with allergies to citrus fruits referring to herself. Concomitant medications included morphine, ibuprofen (ADVIL) and acetaminophen (+)hydrocodone bitartrate (NORCO).  The patient's current condition included asthma.    At 9:30 AM on 17-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, strength, frequency, route, lot# and expiration date were not reported).    At around noon on 17-SEP-2020, the patient started to feel soreness at the injection site and at 11 PM that same night the patient started to feel weak and had "incredible pain" in arm. The patient could not move it to put a shirt on and had to go to the hospital. The doctors at the emergency room (ER) noted that there was no fever, no swelling and told the patient to take ibuprofen (ADVIL) and let it rest. The pain was intense and she took acetaminophen (+) hydrocodone bitartrate (NORCO) and went back to sleep. The patient woke up the next morning with "extreme pain and chills" and throughout the day she had a "loss of appetite and orange pee". The patient continued to use acetaminophen (+) hydrocodone bitartrate (NORCO) until she had to go back to the ER on 19-SEP-2020 for "unbearable pain and a fever". At the ER the doctors noted the patient had fever of 102 degrees Fahrenheit and the injection site and started to become "blotchy and red". Due to all the events, the patient was admitted in hospital on an unknown date in September 2020. The patient returned home and had started to recover (outcome of the events was recovering).  The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  All the events was considered as medically significant and disability by the patient.
Sex: F
Vaccine: FLU4, FLU4, PPV, PPV, PPV
Symptoms: Injection site pain, Injection site reaction, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: fever; injection site started to become red; injection site started to become blotchy; chills; loss of appetite; orange pee; weak; "incredible pain" in her arm; could not move it; soreness at the injection site; This spontaneous report was received from a 31 years old female patient with allergies to citrus fruits referring to herself. Concomitant medications included morphine, ibuprofen (ADVIL) and acetaminophen (+)hydrocodone bitartrate (NORCO).  The patient's current condition included asthma.    At 9:30 AM on 17-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, strength, frequency, route, lot# and expiration date were not reported).    At around noon on 17-SEP-2020, the patient started to feel soreness at the injection site and at 11 PM that same night the patient started to feel weak and had "incredible pain" in arm. The patient could not move it to put a shirt on and had to go to the hospital. The doctors at the emergency room (ER) noted that there was no fever, no swelling and told the patient to take ibuprofen (ADVIL) and let it rest. The pain was intense and she took acetaminophen (+) hydrocodone bitartrate (NORCO) and went back to sleep. The patient woke up the next morning with "extreme pain and chills" and throughout the day she had a "loss of appetite and orange pee". The patient continued to use acetaminophen (+) hydrocodone bitartrate (NORCO) until she had to go back to the ER on 19-SEP-2020 for "unbearable pain and a fever". At the ER the doctors noted the patient had fever of 102 degrees Fahrenheit and the injection site and started to become "blotchy and red". Due to all the events, the patient was admitted in hospital on an unknown date in September 2020. The patient returned home and had started to recover (outcome of the events was recovering).  The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  All the events was considered as medically significant and disability by the patient.
Sex: F
Vaccine: FLU4, FLU4, PPV, PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: fever; injection site started to become red; injection site started to become blotchy; chills; loss of appetite; orange pee; weak; "incredible pain" in her arm; could not move it; soreness at the injection site; This spontaneous report was received from a 31 years old female patient with allergies to citrus fruits referring to herself. Concomitant medications included morphine, ibuprofen (ADVIL) and acetaminophen (+)hydrocodone bitartrate (NORCO).  The patient's current condition included asthma.    At 9:30 AM on 17-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, strength, frequency, route, lot# and expiration date were not reported).    At around noon on 17-SEP-2020, the patient started to feel soreness at the injection site and at 11 PM that same night the patient started to feel weak and had "incredible pain" in arm. The patient could not move it to put a shirt on and had to go to the hospital. The doctors at the emergency room (ER) noted that there was no fever, no swelling and told the patient to take ibuprofen (ADVIL) and let it rest. The pain was intense and she took acetaminophen (+) hydrocodone bitartrate (NORCO) and went back to sleep. The patient woke up the next morning with "extreme pain and chills" and throughout the day she had a "loss of appetite and orange pee". The patient continued to use acetaminophen (+) hydrocodone bitartrate (NORCO) until she had to go back to the ER on 19-SEP-2020 for "unbearable pain and a fever". At the ER the doctors noted the patient had fever of 102 degrees Fahrenheit and the injection site and started to become "blotchy and red". Due to all the events, the patient was admitted in hospital on an unknown date in September 2020. The patient returned home and had started to recover (outcome of the events was recovering).  The relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  All the events was considered as medically significant and disability by the patient.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP, FLU4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Brief syncopal episode following administration of vaccines.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP, FLU4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Brief syncopal episode following administration of vaccines.
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Burning sensation, Chest pain, Electrocardiogram, Hypoaesthesia, Swelling
Clinical narrative: patient reported pain, tightness in chest, and lymph node irritation for days, interfering with sleep
Age: 54.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Chest discomfort, Pain, Skin irritation, Sleep disorder
Clinical narrative: patient reported pain, tightness in chest, and lymph node irritation for days, interfering with sleep
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Pneumonia
Clinical narrative: I got the flu last year; weakness; that I am allergic to eggs; Initial information received on 17-Sep-2020 regarding an unsolicited valid non serious case received from a consumer non-healthcare professional.  This case is linked with case 2020SA264795 (same reporter).   This case involves a 72-years-old female patient who got the flu last year (influenza) and has weakness (asthenia) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included smallpox, pneumonia and allergy to eggs due to which she had the reactions of abdominal pain, peripheral swelling and rash macular.  The patient's past vaccination included smallpox vaccine (when studied abroad and came down with cowpox) and Influenza vaccine(Unknown manufacturer).  The patient's past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food allergy(egg allergy).  Concomitant medications included two part and booster PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  In 2019, the patient received a once 0.5 mL standard strength dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu last year (influenza) and has weakness (asthenia) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was also allergic to eggs(contraindication to vaccination).   It was case of contraindication to vaccination since the patient had egg allergy and was administered Fluzone High Dose quadrivalent.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza and asthenia.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Contraindication to vaccination, Influenza
Clinical narrative: I got the flu last year; weakness; that I am allergic to eggs; Initial information received on 17-Sep-2020 regarding an unsolicited valid non serious case received from a consumer non-healthcare professional.  This case is linked with case 2020SA264795 (same reporter).   This case involves a 72-years-old female patient who got the flu last year (influenza) and has weakness (asthenia) while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included smallpox, pneumonia and allergy to eggs due to which she had the reactions of abdominal pain, peripheral swelling and rash macular.  The patient's past vaccination included smallpox vaccine (when studied abroad and came down with cowpox) and Influenza vaccine(Unknown manufacturer).  The patient's past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food allergy(egg allergy).  Concomitant medications included two part and booster PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  In 2019, the patient received a once 0.5 mL standard strength dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu last year (influenza) and has weakness (asthenia) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was also allergic to eggs(contraindication to vaccination).   It was case of contraindication to vaccination since the patient had egg allergy and was administered Fluzone High Dose quadrivalent.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza and asthenia.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt had hives all over her body few hours after received this vaccine on 9/24/20 at 1:10pm.  Hives was developed around 6-7pm with itchiness and worse around 9pm.  Hives started fading around 3am and gone by 5-6am.  Then hives repeated with the same pattern for 4 days around the same time.  Hives finally resolved on 9/28/20.
Age: 34.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Neck pain, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Right shoulder pain specifically subacromial, right sided neck pain. Significant pain with active ROM of right shoulder. Suspected SIRVA.
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Neck pain
Clinical narrative: sore shoulder, sore neck muscle
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Emergency room/department or urgent care; This initial information has been received on request by the Company from the agency on 18-AUG-2020, concerning an 18-year-old female patient. Information about medical history and concurrent conditions was not provided. Concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO).     On 16-AUG-2019 at 10:25, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029512, expiration date not reported, upon internal validation established as 08-JUL-2021, intramuscular in the right arm; strength and dose were not reported) for prophylaxis.    On 16-AUG-2019 at 10:30, the patient went to emergency room/department or urgent care (ill-defined disorder). The outcome of the event was recovered on the same day. The causality assessment was not reported.  Follow-up information has been received from the nurse practitioner on 28-SEP-2020. It was stated that the nurse practitioner could not identify this patient. She stated she will look at her patients for the vaccination date and see if she can identify this patient. No further information was available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029512; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Titers test showed the patient required a booster dose of MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.      Pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #, dose and route not reported) as booster for measles, mumps and rubella.     Subsequently, on an unspecified date, the patient had their titers tested during a pre-employment screening, which showed the patient required a "booster dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  At the time of reporting the patient's outcome was unknown.  The relatedness between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the aforementioned event was not reported.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumoccocal conjugate PCV 13 on 24-MAR-2015 and pneumoccocal polysaccgaride PPV23 and pneumococcal, unspecified formula on 16-MAY-2016; This spontaneous report was received from a physician, referring a 68-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-MAY-2015, the patient was vaccinated with pneumococcal conj vaccine (unspecified) (reported as pneumococcal conj PCV 13) and on 16-MAY-2016 the patient was vaccinated with two pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumococcal  polysaccharide PPV 23 and pneumococcal unspecified formula) for prophylaxis (strengths, doses, routes of administration, anatomical locations, lots numbers  and expirations date were not provided) (inappropriate schedule of product administration).  This is one of three reports received from the same patient.; Sender's Comments:  US-009507513-2003USA003815:
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccinated with PPSV 23 on 30-SEP-2013 and PCV 13 on 20-OCT-2015; Information has been received from a nurse referring to a 67 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 16-APR-2008 and 30-SEP-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not reported) separately for prophylaxis. However, on 20-OCT-2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) for prophylaxis (inappropriate schedule of product administration).   This is one of two cases about the same patient (split from legal case).; Sender's Comments:  US-009507513-1801USA002424:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; improperly stored vaccine administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 09-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live(PROQUAD) (lot # T013537, expiration date: 17-OCT-2021)(dose, route of administration were not provided) for prophylaxis.  The vaccine was stored from  15 Fahrenheit degrees (F) to 46 Fahrenheit degrees (36.5 Fahrenheit degrees) for a time frame of 3 hours and 15 minutes. There was no previous temperature excursions. Digital data logger was involved.  The outcome of product storage error was unknown. There was no additional adverse events (AE) details available.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects.; On 09/17/2020, a patient received a dose of VARIVAX that was reconstituted with an expired diluent.; On 09/17/2020, a patient received a dose of VARIVAX that was reconstituted with an expired diluent.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions, or allergies and concomitant medications were not reported.   On 17-SEP-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S019461, which has been verified to be valid, expiration date reported and validated as 24-JUN-2021) as prophylaxis, however; it was reconstituted (medication dilution) with an expired sterile diluent(MERCK STERILE DILUENT) (formulation, strength, dose, frequency and route of administration were not reported; lot number N029881, which has been verified to be valid, expiration date reported and validated as 24-MAY-2020) (expired product administered and product preparation issue). It was not known any adverse effect.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AE/PQC to report; Consumer stated the pharmacist did not agitate the vaccine; Information has been received from a female patient of unknown age concerning herself. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-FEB-2020, the patient was vaccinated with the first of 3 scheduled doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  It was reported that before administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) the pharmacist did not agitate the vaccine (product preparation issue).  Consumer stated she did not have any side effects.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter and refers to a currently 1-year old patient of unknown gender and race. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # S038702, expiration date 01-DEC-2021 for prophylaxis (frequency and route of administration not reported) (product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (°C) for 8 hours and 53 minutes, and -10.1°C for 6 hours and 40 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2009USA008377: US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from a "purchasing assistant" and refers to a currently 4-year old patient of unknown gender and race. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date, the patient was vaccinated withan improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter, lot # T005406, expiration date 12-AUG-2021 for prophylaxis (frequency and route of administration not reported) (product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (°C) for 8 hours and 53 minutes, and -10.1°C for 6 hours and 40 minutes. The call was made due to a digital data logger. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2009USA008520: US-009507513-2009USA008353: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored administered PROQUAD AE; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 21-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live(PROQUAD) (lot # T013540, expiration date: 17-OCT-2020)(dose, route of administration were not provided) for prophylaxis.  The vaccine was stored from  6 Fahrenheit degrees (F) to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 min. There was no previous temperature excursions. Digital data logger was involved.  The outcome of product storage error was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No known adverse effects; patient received an expired dose of PNEUMOVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 22-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # R024025 was confirmed to be valid, expiration date was 02-SEP-2020 (dose, route of administration, anatomical location were not reported) for prophylaxis.  No known adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Localised infection, Mobility decreased
Clinical narrative: she had an infection; her arm was swollen; her arm was red; her arm was very painful; had a temperature of 99 degrees; couldn't move her arm for a couple of days; Information has been received from a 67 years old female patient referring to herself. The patient's pertinent medical history was not provided. The patient's drug reactions/allergies included antibiotics, erythromycin and amocacillion sulfa type. The patient's concomitant medications included antibiotic, gliponide for heart rhythms and raloxifene hydrochloride (EVISTA) for bone density. The patient also received a flu shot and a pneumonia shot on the same day with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  On approximately 16-SEP-2020 (reported as about a week ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose/frequency 1 (unit not provided), route of administration: injection; strength, lot # and expiration date were unknown) because she worked in healthcare and wanted to be careful with not getting sick, and wanted to keep her immune system strong.      On an unknown date in September 2020 (reported as last week), the patient had an extreme reaction to the vaccine. The patient had an infection and her arm was swollen and red, very painful, had a temperature of 99 degrees, and could not move her arm for a couple of days. The patient stated the pain and swelling was from the injection site all the way down to her wrist. The patient had to go to urgent care because of the side effects she was experiencing worsened, and while she was admitted they gave her an antibiotic to help with the reaction. The patient was wanting to know if there was certain ingredients in the vaccine that would be an indication that this was an allergic reaction or if it could have been cellulitis. All the events recovered in September 2020. The causality between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: she had an infection; her arm was swollen; her arm was red; her arm was very painful; had a temperature of 99 degrees; couldn't move her arm for a couple of days; Information has been received from a 67 years old female patient referring to herself. The patient's pertinent medical history was not provided. The patient's drug reactions/allergies included antibiotics, erythromycin and amocacillion sulfa type. The patient's concomitant medications included antibiotic, gliponide for heart rhythms and raloxifene hydrochloride (EVISTA) for bone density. The patient also received a flu shot and a pneumonia shot on the same day with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  On approximately 16-SEP-2020 (reported as about a week ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose/frequency 1 (unit not provided), route of administration: injection; strength, lot # and expiration date were unknown) because she worked in healthcare and wanted to be careful with not getting sick, and wanted to keep her immune system strong.      On an unknown date in September 2020 (reported as last week), the patient had an extreme reaction to the vaccine. The patient had an infection and her arm was swollen and red, very painful, had a temperature of 99 degrees, and could not move her arm for a couple of days. The patient stated the pain and swelling was from the injection site all the way down to her wrist. The patient had to go to urgent care because of the side effects she was experiencing worsened, and while she was admitted they gave her an antibiotic to help with the reaction. The patient was wanting to know if there was certain ingredients in the vaccine that would be an indication that this was an allergic reaction or if it could have been cellulitis. All the events recovered in September 2020. The causality between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was assessed as related.
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: developed an unspecified rash; This spontaneous report has been received from a physician via company representative. concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided.  In September 2013 (reported as 7 years ago), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (frequency, route, lot number and expiration date were not provided) for prophylaxis.         In September 2013 (reported as 7 years ago), the patient developed unspecified rash shortly after received the dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). The reporter stated that the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) during a different office visit on an unknown date.   The outcome of rash was reported as resolved. The causal relationship between rash and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A 20-year-old patient received a pediatric dose of VAQTA; A 20-year-old patient received a pediatric dose of VAQTA; This spontaneous report has been received from a pharmacist, regarding to a 20-year-old patient of unknown gender. On an unknown date, the patient was vaccinated with a pediatric dose (product administered to patient of inappropriate age and incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (mL) (scheme vaccine, route of administration, anatomical location, lot number and expiration date were not reported), as prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles rash on her buttocks and side of leg that was extremely painful; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or around 25-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date not reported) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving the vaccine), the patient suffered a shingles rash on her buttocks and side of leg that was extremely painful. The patient was diagnosed with herpes zoster. As a direct and proximate result of the vaccine, patient's symptoms resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX),  she sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of PROQUAD on 9/21/2020; This spontaneous report was received from a nurse, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 21-SEP-2020, the patient received an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S021617, expiration date: 09-JAN-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (DILUENT MRK) used to reconstitute the vaccine was properly stored.  The vaccine underwent a temperature excursion of minus 3.1 degrees Celsius (C) for 12 hours and 10 minutes, and -7.4 C for 4 hours and 20 minutes. There was no previous temperature excursion. The call was not because of a data logger.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Three doses of the MMR-II that were not supported in that temp stability case were inadvertently administered; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. Information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHa) (M-M-R II) lot # S025155, expiration date 13-AUG-2021, once (dosage regimen and route of administration were not provided) for prophylaxis.   The improperly store vaccine experienced a temperature above 47-degrees Fahrenheit (71.92 F) for 4 hours and 55 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA010584:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Three doses of the MMR-II that were not supported in that temp stability case were inadvertently administered in the ensuing time since that case; This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 18-SEP-2020, the patient was vaccinated once with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S025155, which have been verified to be valid, expiration date reported and validated as 13-AUG-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit (F): 71.92 degrees F for 4 hours and 55 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one from several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of VARIVAX; No known adverse effects.; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 18-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, dose, frequency and route of administration were not reported; lot number R024023 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck) with an expiration date on 22-AUG-2020) (expired vaccine used ). No known adverse effects were reported. The outcome of expired vaccine used was unknown.