chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood lactic acid, Blood magnesium, Cellulitis, Chills, Differential white blood cell count
Clinical narrative: 2/6: approx. 7pm, left arm (injection site) began feeling sore; observed light pink skin coloration approx. same size as bandaid just above that covered injection site 2/7: while at work, mild flu-like symptoms developed throughout the day (fever, mild nausea, headache); upon arrival at home, experienced severe chills; spouse assisted in covering with blankets, placing floor heater nearby, using body heat to warm; took acetaminophen for fever; chills & fever off n on throughout the night 2/8: redness tripled in size; fever, aches persist; ER approx. 9:30am, diagnosed with cellulitis; administered IV antibiotics and prescribed Keflex, informed redness may grow slightly initially; advised follow-up with primary doc 2/9:  all other flu-like symptoms resolved; redness continuing to grow, covering outer half of upper arm 2/10:  primary follow-up @ 1:15pm; Dr surprised by reaction, marks outline of redness, advises ER if progression beyond border; prescribes doxycycline in addition to Keflex, first dose taken @ 2pm, second dose with Keflex @ 6pm; ER @ 8pm due to significant expansion beyond outline; vancomycin administered in ER, admitted for observation 2/11: vancomycin effective in reducing redness, continuing IV dosage at 12hr intervals; anticipating discharge 2/12, with further Keflex/doxy treatment in out-patient status
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 2/6: approx. 7pm, left arm (injection site) began feeling sore; observed light pink skin coloration approx. same size as bandaid just above that covered injection site 2/7: while at work, mild flu-like symptoms developed throughout the day (fever, mild nausea, headache); upon arrival at home, experienced severe chills; spouse assisted in covering with blankets, placing floor heater nearby, using body heat to warm; took acetaminophen for fever; chills & fever off n on throughout the night 2/8: redness tripled in size; fever, aches persist; ER approx. 9:30am, diagnosed with cellulitis; administered IV antibiotics and prescribed Keflex, informed redness may grow slightly initially; advised follow-up with primary doc 2/9:  all other flu-like symptoms resolved; redness continuing to grow, covering outer half of upper arm 2/10:  primary follow-up @ 1:15pm; Dr surprised by reaction, marks outline of redness, advises ER if progression beyond border; prescribes doxycycline in addition to Keflex, first dose taken @ 2pm, second dose with Keflex @ 6pm; ER @ 8pm due to significant expansion beyond outline; vancomycin administered in ER, admitted for observation 2/11: vancomycin effective in reducing redness, continuing IV dosage at 12hr intervals; anticipating discharge 2/12, with further Keflex/doxy treatment in out-patient status
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test, Nausea, Pain, Pyrexia
Clinical narrative: 2/6: approx. 7pm, left arm (injection site) began feeling sore; observed light pink skin coloration approx. same size as bandaid just above that covered injection site 2/7: while at work, mild flu-like symptoms developed throughout the day (fever, mild nausea, headache); upon arrival at home, experienced severe chills; spouse assisted in covering with blankets, placing floor heater nearby, using body heat to warm; took acetaminophen for fever; chills & fever off n on throughout the night 2/8: redness tripled in size; fever, aches persist; ER approx. 9:30am, diagnosed with cellulitis; administered IV antibiotics and prescribed Keflex, informed redness may grow slightly initially; advised follow-up with primary doc 2/9:  all other flu-like symptoms resolved; redness continuing to grow, covering outer half of upper arm 2/10:  primary follow-up @ 1:15pm; Dr surprised by reaction, marks outline of redness, advises ER if progression beyond border; prescribes doxycycline in addition to Keflex, first dose taken @ 2pm, second dose with Keflex @ 6pm; ER @ 8pm due to significant expansion beyond outline; vancomycin administered in ER, admitted for observation 2/11: vancomycin effective in reducing redness, continuing IV dosage at 12hr intervals; anticipating discharge 2/12, with further Keflex/doxy treatment in out-patient status
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Reported to have stiffness to left side of neck, slight headache, and feeling nauseated. Symptoms lasted about 5-6 hours.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging, Musculoskeletal pain
Clinical narrative: Patient complained of upper shoulder pain a few months after receiving flu vaccine. He went to see a doctor where he then underwent an MRI, local steroid injection, and is currently completing 6 weeks of physical therapy. Patient still complaining of pain 4 months after vaccine administration.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Pain, Peripheral swelling
Clinical narrative: patient's husband came in this morning explaining that she had gotten prevnar yesterday and was experiencing swelling in the arm and lots of pain such that she could not sleep all night. Office was called and husband was told to make an appointment for patient to be seen by primary doctor to assess.  1pm- husband told me he would take her to urgent care. he was told to call us back with results
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Raised welted areas all over body, itchy, blistery.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac imaging procedure normal, Cardiac stress test normal, Computerised tomogram thorax normal, Cough, Fatigue
Clinical narrative: Swelling of legs and upper legs (she has to wear TED Hoses) Fatigue Coughs when laying down or when she is run down or tired
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Swelling of legs and upper legs (she has to wear TED Hoses) Fatigue Coughs when laying down or when she is run down or tired
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient came into pharmacy with red non-blister rashes on her skin all over her body. She stated they were very itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site infection, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm started swelling up, it was hot to the touch. He had a rash/infection that was going around his arm. His arm had gotten big and painful. He received the vaccines on January 21st 2020, I, his mother noticed something different January 22nd 2020. January 23rd he was taking back to the doctor, who said it was from cold compresses. On January 24th 2020 I took patient to urgent care where he received antibiotics and pain medication.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Rash
Clinical narrative: MMR vaccine administered on 01/23/2020.  Patient contacted office on 02/04/2020 stating she was feeling "achy" and her lymph nodes in the back of her neck and behind her ears were feeling swollen.  Patient stated she had an appointment to see her primary care provider on 02/05/2020.  Patient called office on 02/11/2020 stating that her face, neck and trunk were covered in a rash.  Rash started on 02/09/2020.  She states she was not seen by her primary care provider on 02/05/2020 as her appointment time was wrong.  Is being evaluated at Urgent Care on 02/11/2020.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis, Pain, Skin bacterial infection
Clinical narrative: PATIENT RECEIVED THE VACCINE ON 12-29-2019.  SHE STATED TODAY (2-11-2020) BY PHONE CALL THAT 3 DAYS AFTER RECEIVING THE VACCINE IN HER LEFT ARM, SHE DEVELOPED A SKIN BACTERIA, OR SKIN CELLULITIS.  SHE SAID THAT SHE HAS BEEN IN SEVERE PAIN SINCE SHE RECEIVED THE VACCINE AND HAS BEEN SEEN BY 2 DIFFERENT DOCTORS.  SHE ALSO STATED THAT HER HUSBAND RECEIVED THE SAME VACCINE ON THE SAME DAY WITHOUT ANY INCIDENT.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Malaise, Rash
Clinical narrative: patient reported redness and said injection site was warm to the touch; also rash on trunk, general malaise for 2-3 days
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Bradycardia, Continuous positive airway pressure, Cyanosis central, Oxygen saturation decreased
Clinical narrative: Responded to alarm for bradycardia/desaturation. Infant noted to have central cyanosis, HR in 70's initially and O2 sats in 30's, with no improvement with stimulation. Infant noted to be apneic and HR/O2 sats falling. Began PPV 20/5 at 30% FiO2 and called for RN to bedside, who notified NNP to come to bedside for apneic infant who was not responsive to stimulation and sats not improving despite PPV. FiO2 increased gradually to a max of 60% and infant suctioned with neosucker once NNP x2 arrived at bedside. Continue PPV x 3 minutes. Infant began spontaneously breathing, and PPV discontinued. CPAP of 5 given briefly, then discontinued and infant placed back on HFNC of 2L and FiO2 weaned as tolerated.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: Responded to alarm for bradycardia/desaturation. Infant noted to have central cyanosis, HR in 70's initially and O2 sats in 30's, with no improvement with stimulation. Infant noted to be apneic and HR/O2 sats falling. Began PPV 20/5 at 30% FiO2 and called for RN to bedside, who notified NNP to come to bedside for apneic infant who was not responsive to stimulation and sats not improving despite PPV. FiO2 increased gradually to a max of 60% and infant suctioned with neosucker once NNP x2 arrived at bedside. Continue PPV x 3 minutes. Infant began spontaneously breathing, and PPV discontinued. CPAP of 5 given briefly, then discontinued and infant placed back on HFNC of 2L and FiO2 weaned as tolerated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Rash vesicular, Swelling
Clinical narrative: Shingles-like rash that spread from injection site up and across shoulder approx. 6 inches. This occurs within 2-4 days post shingles vaccine. Itchiness with rash started about 2 weeks later and continued until prescribed triamcinolone (Kenalog) 0.5% cream on 2/3/20 (about 5 months later). Itchiness and rash subsided with use of triamcinolone cream.   Patient also experienced swelling and redness that subsided after a week.  Soreness subsided after 2 weeks.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Proquad given instead of MMR
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Adverse event
Clinical narrative: No event described. From the notes can only tell that the number of events had increased after vaccinations had been given.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Haemorrhage, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient reported to pharmacy on 02/11/2020. He stated he developed a rash, swelling and pain in his fingers. His fingers also bleed  occasionally.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient reported itching within a week of receiving Shingrix. Denies rash/hives/other side effects.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient came into pharmacy on 1/22/2020 complaining of long-term pain in his upper left arm/shoulder area. Patient claimed to have no pain in that area until he received a influenza vaccination at the pharmacy on 10/25/19. In the 3 months since the pain in his arm has not improved and patient believes that the pain is the direct result from the influenza vaccination being administered too high in his arm. The patient was advised to be seen by his regular physician in order for the pain to be appropriately evaluated. According to the patient his physician agreed that the pain could be caused from the vaccination and is exploring further diagnostic tests and treatments. Patient is currently controlling pain on Ibuprofen 800mg.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: PATIENT SAID VACCINE WAS GIVEN UPWARDS OF SHOULDER AND SHE'S BEEN EXPERIENCING PAIN EVER SINCE.  HER DOCTOR TOLD HER THAT THE VACCINE WAS ADMINISTERED AT THE WRONG SITE.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Pain, Pain in extremity
Clinical narrative: pt has had pain in his left arm off and on since the vaccine was given.  there is a lump under the skin where the vaccine was given. patient says lump comes and goes and changes in size.  the lump causes a throbbing pain and last night was the size of an egg.  his arm sometimes hurts when he lifts it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hallucination, auditory, Hallucination, visual, Insomnia, Nausea
Clinical narrative: insomnia, visual and auditory hallucinations, (unable to sleep the night of the sixth); slept most of the seventh; severe nausea when awake on the seventh; also severe chilling the seventh. No treatment was sought so no treatment rec'd; full recovery on the eighth. The insomnia lasted for one night only; as did the hallucinations; the nausea & chilling were worse on the seventh; but ended by the eighth.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Extreme pain in arm, fever, when checked, 101.2, usually average 97.6
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Onset of fatigue, myalgias, fever and chills about 5 hours after dose.  Fever increased to a maximum of 102.8 2-3 hours later.  Fever and other symptoms gradually resolved with a few hours by 03:00 on 11/12/2019
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: I chose Meningococcal Conjugate because the Meningococcal ACWY Vaccine is not listed. A couple of minutes after my son received the shot he fainted falling to the floor. He reports getting light headed and then he fainted
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Loss of consciousness
Clinical narrative: Patient reports headache and loss of consciousness
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Nausea, Urticaria
Clinical narrative: Hives, nausea, abdominal pain
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Left arm with numbness and tingling. Raised red area with undefined border
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Laboratory test normal, Loss of personal independence in daily activities, Panic attack
Clinical narrative: suffering from constant stomach pain; This stomech pain has caused her to have many panic attacks.; This spontaneous report has been received from a consumer (the patient's parent) via agency (VAERS ID: 809229) referring to a 12 years old female patient. The patient was allergic to amoxicillin. Concomitant therapies included melatonin 0.5 mg.   On 18-FEB-2019 at 16:00 pm, 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) (intramuscular in the left arm; dose, strength, lot # and expiration date were unknown) for prophylaxis.  On 19-FEB-2019 at 06:30 am, the patient had been suffering from constant stomach pain. This stomach pain had caused her to have many panic attacks. The patient had been in and out of the emergency room five times, pediatrician twice, gastrointestinal doctor, therapist, psychiatrist, and just had 5 days (also reported as a week) stay in the hospital. Every test had been completed and nothing had been found to be the cause. The patient had been put on many prescriptions during this time. At the time of report, the patient was on five prescriptions. The patient had been unable to participate in her normal activities. She had missed swimming championships, band concert and even her own birthday party. The doctors considered the events as coincidence.   The patient was not recovered from the adverse events. The causality assessment was considered as related by the reporter.  Follow up information has been received from a registered nurse on 11-FEB-2020. The reporter stated without more patient identifiers it was not possible to locate a chart.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hallucination, auditory, Intentional self-injury
Clinical narrative: hearing voices; hurt himself; Information has been received on request by the company of Food and Drug Administration (FDA) (agency #810104) under the Act on 11-NOV-2019  This spontaneous report was received from a physician referring to a 11-year-old male patient. Information regarding the patient's medical history, current conditions and concomitant medications was not reported. It was reported that the patient was a healthy person with no mental illness and no prior hospitalizations. On 28-SEP-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot number reported as M042583; the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) with lot number X994C; and the first dose of meningococcal acyw conj vaccine (dip toxoid (MENACTRA) with lot number U57S1AB; all administered intramuscularly for prophylaxis (dose, anatomical injection site and expiration date were not reported). The patient had no illness at the time of vaccination. In November 2017 (also reported "1-2 months later" and "around the 3rd week"), the patient complained of hearing voices (hallucination, auditory) and hurt himself (intentional self-injury) which progressively got worse. The patient required emergency room visit, and then, he was hospitalized for 3 weeks. Subsequently, he was referred to therapy with a psychiatrist, and he received outpatient psychiatric follow up and sertraline (ZOLOFT) for about 2 months. The patient's mom stated that he improved, but the physician had not seen him this year. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with auditory hallucination, and intentional self-injury was not reported.  Upon internal review, the events auditory hallucination and intentional self-injury were determined to be medically significant.   Lot number M042583 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  This is one of two reports received from the same reporter.  As per the information received on 11-FEB-2020, the registered nurse stated that, without more patient identifiers it was not possible to locate the charts.; Sender's Comments:  US-009507513-1911USA006790:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Electrocardiogram normal, Injection site pain, X-ray normal
Clinical narrative: Patient started having injection site pain that got worse by the day, with pain radiating to her back area.  She went to see her primary doctor on 2/5/20 and on 2/7/20 and they examined her, got her EKG and x-ray.  Nothing abnormal came out from  both screening tests.  She was then referred to emergency room as the primary care was unable to give further treatment for the pain.  She received muscle relaxants and pain meds (oral & topical) but stated that no medication (oral or topical) is helping to relieve pain.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: on 1/8/2020 a dose of improperly stored PROQUAD (Lot S013712 Exp 11/1/2020) was administered o a patient; This spontaneous report was received from nurse regarding a patient of unknown age and gender. The patient's medical history was not reported. The patient's concomitant therapies included sterile diluent (DILUENT MERCK).  On 08-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA))(PROQUAD) , at a dose of 0.5 milliliters (lot # S013712, has been determined to be valid, expiration date was reported as 01-NOV-2020) (strength, dose number, frequency, and anatomical site of vaccination were not reported) for prophylaxis.  The temperature was of -12.2 degrees Celsius, for a time frame of 25 minutes, without a previous temperature excursion. A digital data logger was used. The sterile diluent (DILUENT MERCK) that was used for reconstitution of varicella virus vaccine live (Oka/Merck) (VARIVAX)a was properly stored.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; dose of MMRII intramuscularly rather than subcutaneous; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date in December 2019, the pharmacist inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) one dosage form, lot number S015284, expiry date19-MAY-2021(strength was not reported) for prophylaxis intramuscularly rather than subcutaneously (incorrect route of product administration). No additional adverse effects were reported. There was no product quality complaint (PQC) present.
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: sharp tingling sensation from upper arm to fingers along with pain and tenderness; sharp tingling sensation from upper arm to fingers along with pain and tenderness; complained of pain; it was very difficult to move her arm; Information has been received from a medical assistant referring to a 27 years old female patient. The patient's historical conditions included anxiety and depression. The patient's concurrent conditions included chronic pain and allergy to amoxicillin, cephalexin, penicillin (unspecified) and potassium (unspecified). The patient's concomitant therapies included albuterol (VENTOLIN INHALER), hydrochlorothiazide, metoprolol (reported as metaprolol), diclofenac and methylprednisolone (MEDROL).  On unknown dates, the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in left deltoid. The patient tolerated the doses of vaccine well. On 17-JAN-2020, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter once, lot# S026372, expiration date of 01-APR-2022, strength was unknown) intramuscularly in right deltoid for human papilloma virus (HPV) prevention.   On 17-JAN-2020, at the time of vaccination, the patient complained of pain and was offered an ice pack and ibuprofen which she declined. The patient later that day reported to urgent care and was then referred back to the office. The patient was seen in the office on 24-JAN-2020 where no redness or swelling was detected at injection site but there were complaints of sharp tingling sensation from upper arm to fingers along with pain and tenderness. The patient called back to office on 03-FEB-2020 with continued complaints that it was very difficult to move her arm, discomfort although the arm was warm, not numb. The patient did not recover from the events. No treatment was given for the events. The nurse practitioner referred patient to a neurologist.   The relationship between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: but the patient did not return for the third dose ofGARDASIL as scheduled on an unspecified date.; No additional AE information provided; the patient did not return for the third dose of GARDASIL as scheduled on an unspecified date. Nurse reported the patient was now 29 years old and was in the physician office on 2/3/2020 to complete the HPV vaccination series with a dose of GARDAS; This spontaneous report has been received from a nurse, referring to a 20 years old female patient. The patient's historical condition, concurrent condition and concomitant therapy were not reported.  On 03-FEB-2010, the patient was administered with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot# reported as 0969Y, but upon internal validation as 663573/0969Y; expiration date: 09-OCT-2011, dose, strength, frequency and route not reported) for prophylaxis. On 14-APR-2010,  the patient was administered with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot# reported as 0969Y, but upon internal validation as 663573/0969Y; expiration date: 09-OCT-2011, dose, strength, frequency and route not reported) for prophylaxis. But the patient did not return for the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) as scheduled on an unspecified date (inappropriate schedule of vaccine administered). On 03-FEB-2020, the patient was in the physician to complete the HPV vaccination series with a dosage form of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, route, lot# and expiration date were not reported) for prophylaxis (interchange of vaccine products). No additional event provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Corneal reflex decreased, Tic
Clinical narrative: the patient began experiencing a facial tic and abnormal eye blinking; the patient began experiencing a facial tic and abnormal eye blinking; This spontaneous report has been received from a health care worker, concerning to a 25-years-old female patient who was also the reporter's daughter.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  On an unspecified date (reported as after the vaccine administration), the patient experienced facial tic (facial spasm) and abnormal eye blinking (corneal reflex decreased). At the reporting time, the patient had not recovered from the events of facial spasm and corneal reflex decreased.  The causal relationship between the events of facial spasm and corneal reflex decreased and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 06-FEB-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006017 (Expiration Date 27-FEB-2021), as prophylaxis  (dose, frequency, route of administration were not reported). It was incorrectly stored from minus (-) 14 Celsius degrees (°) to-10°C (-13.5°C) for 41 minutes and had no previous temperature excursion. The error was identified due to a data logger. The sterile diluent (lot# S031278 with expiration date 16-JUN-2022) was properly stored. No additional adverse event (AE) information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: zoster-related hearing loss; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was diagnosed with zoster-related hearing loss by a healthcare physician. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered.  Upon internal review, hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; other zoster-related injuries; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for vision loss and other zoster-related injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a medical office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: was diagnosed with cellullitis at the injection site; This spontaneous report was received from an office manager via a company representative, referring to a 69-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were unknown by reporter.  On 03-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, and anatomical location were not reported, lot number and expiration date were unknown by reporter).  On 06-FEB-2020, the patient returned to the office and was diagnosed with cellulitis at the injection site. The patient sought medical attention and was given an unspecified treatment for the adverse event. It was unknown if laboratory diagnostics or studies were performed. The outcome of injection site cellulitis was reported as not recovered.  The causality assessment between the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the aforementioned event was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 06-FEB-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date in 2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of the use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 26-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) as recommended for the long-term prevention of shingles and/or zoster-related conditions at a pharmacy.  Subsequent to pt.'s vaccination with zoster vaccine live (ZOSTAVAX), the pt. was treated by a healthcare provider at urgent care, for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care, and treatment.  As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient received medical care for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses like medical losses and cost for hospitalization, physician care, monitoring, treatment, medications and/or supplies; diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages.  The outcome of shingles was not recovered and the reporter considered this event to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was administered a dose of MMR II via the intramuscular route; No adverse events; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, frequency, lot # and expiration date were not reported) via intramuscular route (incorrect route of product administration) for prophylaxis. The reporter stated that she was not directly involved with the administration. There were no adverse effects (no adverse event) reported. No product quality complaints reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness neurosensory
Clinical narrative: significant vision loss; sensorineural hearing loss; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live, the patient suffered significant vision loss and sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events significant vision loss and sensorineural hearing loss was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events significant vision loss and sensorineural hearing loss to be disability.  Upon internal review, significant vision loss and sensorineural hearing loss were determined to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Administered both Proquad and Varivax; This spontaneous report was received from a medical assistant referring to a 12-month-old patient. The patient's concurrent condition, medical history, drug allergy/reaction and concomitant medications were not reported. On 06-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, formulation, dose/frequency, route, lot# and expiry date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, formulation, dose/frequency, route, lot# and expiry date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported. The outcome of the events was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Incorrect product storage; This spontaneous report was received from a nurse, referring to unspecified number of patients of unknown age, and gender. The patients' pertinent medical history, concurrent conditions, and previously drug reactions or allergies were not reported.   On unspecified dates since January of 2020, an unspecified number of patients were vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (lot number S021617 has been verified to be valid; expiration date: 09-JAN-2021), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number S010297 has been verified to be valid; expiration date: 03-APR-2021); both vaccines were administered as prophylaxis (strengths, doses, frequencies, and routes of administration were not reported). It was reported that the sterile diluent used to reconstitute the vaccines was properly stored.  The temperature and time frame were -9 Celsius to 8° Celsius (4.9 Celsius) for 4 hours 45 minutes, without previous temperature excursion. A digital data logger was used.  This is a non-valid case due to lack of patient identifier.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered and expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 06-FEB-2020, the patient was inadvertently vaccinated with an expired dose (expired product administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (ml) for prophylaxis (strength, frequency, route of administration, and anatomical location were not reported) (lot number R009163 had been verified to be a valid number; expiration date 06-JAN-2020).
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain upper, Blood pressure increased, Diarrhoea, Nausea
Clinical narrative: Nausea; Severe Stomach Cramps; Diarrhea; Elevated Blood Pressure; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 38-year-old female employee received her first injection of HEPLISAV-B (Lot #933621) in Jan-2020.  No concomitant vaccinations were administered.    Two to 3 hours after injection, the employee experienced severe stomach cramps, diarrhea, nausea, no fever, and elevated blood pressure 172/129 mmHg.  The employee was advised to seek medical attention if needed.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Erythema, Pain in extremity, Skin irritation
Clinical narrative: Red; Irritated; Sore Aching Arm; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported that on 21-Jan-2020, a 30-year-old female employee received the first injection of HEPLISAV-B.  No concomitant vaccinations were administered.    The employee reported red, irritated, and sore aching arm.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.    ; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache; Dizzy; Nausea; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 25-year-old male employee received the first injection of HEPLISAV-B in Nov-2019.  No concomitant vaccinations were administered.    The employee reported slight nausea, dizziness and headache.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Erythema, Feeling hot, Hyperhidrosis, Injection site rash, Nausea
Clinical narrative: Mild/Slight Rash; Itchiness; Redness due to Scratching; Feeling Nauseated; "Hot"; Sweating; Initial Report Received 30-Jan-2020 and 31-Jan-2020  On 25-Jan-2020, a physician reported that a female employee (approximate age 18 to 22 years) received her first injection of HEPLISAV-B (Lot #933621).  No concomitant vaccinations were administered.    One hour after vaccination, the employee reported mild/slight rash at injection site, itchiness, redness due to scratching, feeling nauseated, sweating, and "hot".  No treatment was administered.   On 26-Jan-2020, the events were all considered resolved.      None of the events were reported as serious.   Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Mild/Slight Rash; Itchiness; Redness due to Scratching; Feeling Nauseated; "Hot"; Sweating; Initial Report Received 30-Jan-2020 and 31-Jan-2020  On 25-Jan-2020, a physician reported that a female employee (approximate age 18 to 22 years) received her first injection of HEPLISAV-B (Lot #933621).  No concomitant vaccinations were administered.    One hour after vaccination, the employee reported mild/slight rash at injection site, itchiness, redness due to scratching, feeling nauseated, sweating, and "hot".  No treatment was administered.   On 26-Jan-2020, the events were all considered resolved.      None of the events were reported as serious.   Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.