chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 11-year-old female patient. Concomitant therapies included MENACTRA and ADACEL. The patient had no pertinent medical history or drug reactions/ allergies.   On 29-MAR-2021 the patient was vaccinated with the first dose of GARDASIL 9 (lot # T026954, expiration date 13-APR-2022, 0.5 milliliter, once) via intramuscular for vaccination.   On 29-MAR-2021, the patient experienced seizure like tonic-clonic movement with syncope after receiving first dose of GARDASIL 9 along with MENACTRA and ADACEL. The patient recovered after 15 minutes (on 29-MAR-2021). The patient was given cool compress and maintained a supine position as treatment. No lab diagnostics/studies were performed. The patient had sought medical attention. The events were not cancer, and the patient was not overdose. Device was not available for evaluation (obtain was false).  The causality between GARDASIL 9 and the events was not reported.  Upon internal review, seizure like tonic-clonic movement with syncope were determined to be medically significant. Combination product report: Yes; Brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: T026954; expiration date: 13-APR-2022; device age and unit: 0 ; malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 11-year-old female patient. Concomitant therapies included MENACTRA and ADACEL. The patient had no pertinent medical history or drug reactions/ allergies.   On 29-MAR-2021 the patient was vaccinated with the first dose of GARDASIL 9 (lot # T026954, expiration date 13-APR-2022, 0.5 milliliter, once) via intramuscular for vaccination.   On 29-MAR-2021, the patient experienced seizure like tonic-clonic movement with syncope after receiving first dose of GARDASIL 9 along with MENACTRA and ADACEL. The patient recovered after 15 minutes (on 29-MAR-2021). The patient was given cool compress and maintained a supine position as treatment. No lab diagnostics/studies were performed. The patient had sought medical attention. The events were not cancer, and the patient was not overdose. Device was not available for evaluation (obtain was false).  The causality between GARDASIL 9 and the events was not reported.  Upon internal review, seizure like tonic-clonic movement with syncope were determined to be medically significant. Combination product report: Yes; Brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: T026954; expiration date: 13-APR-2022; device age and unit: 0 ; malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Angiogram cerebral normal, Angiogram normal, Computerised tomogram head normal, Condition aggravated, Facial paralysis
Clinical narrative: Patient received 1st dose of Pfizer COVID-19 vaccine 03/23/2021. Patient tested positive for COVID-19 03/29/2021. Patient currently admitted for COVID-19 infection.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Magnetic resonance imaging head normal, Neuropathy peripheral
Clinical narrative: Patient received 1st dose of Pfizer COVID-19 vaccine 03/23/2021. Patient tested positive for COVID-19 03/29/2021. Patient currently admitted for COVID-19 infection.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: COVID-19
Clinical narrative: Patient received 1st dose of Pfizer COVID-19 vaccine 03/23/2021. Patient tested positive for COVID-19 03/29/2021. Patient currently admitted for COVID-19 infection.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Fatigue, Malaise
Clinical narrative: Shortness of breath immediately after receiving vaccine while at administering facility (not Facility). Shortness of breath persisted for 1 week. Patient was seen by PCP, MD, on 3/26/21 with basic physical examination and blood testing, but not referred for emergency evaluation. Patient on 3/29/21 collapsed at home, EMS was called and performed resuscitation without success. Patient perished on 3/29/21.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood chloride increased, Blood creatinine increased, Blood test, Carbon dioxide decreased, Death
Clinical narrative: Shortness of breath immediately after receiving vaccine while at administering facility (not Facility). Shortness of breath persisted for 1 week. Patient was seen by PCP, MD, on 3/26/21 with basic physical examination and blood testing, but not referred for emergency evaluation. Patient on 3/29/21 collapsed at home, EMS was called and performed resuscitation without success. Patient perished on 3/29/21.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Glomerular filtration rate, Immediate post-injection reaction, N-terminal prohormone brain natriuretic peptide increased, Syncope
Clinical narrative: Shortness of breath immediately after receiving vaccine while at administering facility (not Facility). Shortness of breath persisted for 1 week. Patient was seen by PCP, MD, on 3/26/21 with basic physical examination and blood testing, but not referred for emergency evaluation. Patient on 3/29/21 collapsed at home, EMS was called and performed resuscitation without success. Patient perished on 3/29/21.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Stood up after receiving the vaccine and immediately got dizzy and felt like I could faint.  As the morning the dizziness got worse and had nausea, this continued for 4-5 days before it seemed to get a little better.  It has now been 7 days and although it is better I still have some dizziness.  For the last 4 days I have been taking 2 meclizine.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lip swelling, Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: Initially told MD had localized itching at injection site, then stated to Dr. per MD that her lips felt tingly
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Paraesthesia oral
Clinical narrative: Initially told MD had localized itching at injection site, then stated to Dr. per MD that her lips felt tingly
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Electrocardiogram normal, Headache, Heart rate normal, Nausea
Clinical narrative: Completely unable to move my body and mouth for a couple of hours. Severe headache, severe tingling in my legs.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Palpitations
Clinical narrative: Completely unable to move my body and mouth for a couple of hours. Severe headache, severe tingling in my legs.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Paraesthesia, Paralysis
Clinical narrative: Completely unable to move my body and mouth for a couple of hours. Severe headache, severe tingling in my legs.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Injection site paraesthesia, Paraesthesia oral, Swelling
Clinical narrative: Began experiencing right side of tongue and lips tingling within 30 minutes after receiving vaccine. Took oral diphenhydramine but it did not improve.  Visited urgent care the next day. No treatment was given, and patient was advised to follow up with primary physician. Four days later patient states she feels like her mouth is swollen on one side.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Mouth swelling, Paraesthesia oral
Clinical narrative: Began experiencing right side of tongue and lips tingling within 30 minutes after receiving vaccine. Took oral diphenhydramine but it did not improve.  Visited urgent care the next day. No treatment was given, and patient was advised to follow up with primary physician. Four days later patient states she feels like her mouth is swollen on one side.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: Within minutes  of my injection I had a hot flushing of heat fill and stay in my chest and throat. The sensation was similar to receiving contrast dye for something like a CT scan. I was given Benadryl and my vitals were checked. I stayed at the clinic for a total of an hour. The sensation was fully gone about 90min after injection.  I never felt short of breath or struggled to breath.   I am experiencing pretty standard flu like symptoms within 12-24hrs after my  second dose. Biggest and perhaps strangest side effect I feel now is all the lymph nodes in my right armpit are swollen and very sore.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Lymphadenopathy
Clinical narrative: Within minutes  of my injection I had a hot flushing of heat fill and stay in my chest and throat. The sensation was similar to receiving contrast dye for something like a CT scan. I was given Benadryl and my vitals were checked. I stayed at the clinic for a total of an hour. The sensation was fully gone about 90min after injection.  I never felt short of breath or struggled to breath.   I am experiencing pretty standard flu like symptoms within 12-24hrs after my  second dose. Biggest and perhaps strangest side effect I feel now is all the lymph nodes in my right armpit are swollen and very sore.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rash, Syncope, Vomiting
Clinical narrative: 3 hours after vaccination the following symptoms presented: vomiting, diarrhea, chills, light headedness, dehydration.  overnight after vaccination: labored breathing next morning 8am after vaccination: itchy, irritated rash on face and neck. significant swelling of vaccinated arm front top of elbow to top of shoulder area. These symptoms had to be treated by oral corticosteroids.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: 3 hours after vaccination the following symptoms presented: vomiting, diarrhea, chills, light headedness, dehydration.  overnight after vaccination: labored breathing next morning 8am after vaccination: itchy, irritated rash on face and neck. significant swelling of vaccinated arm front top of elbow to top of shoulder area. These symptoms had to be treated by oral corticosteroids.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site swelling, Pruritus, Rash, Vomiting
Clinical narrative: 3 hours after vaccination the following symptoms presented: vomiting, diarrhea, chills, light headedness, dehydration.  overnight after vaccination: labored breathing next morning 8am after vaccination: itchy, irritated rash on face and neck. significant swelling of vaccinated arm front top of elbow to top of shoulder area. These symptoms had to be treated by oral corticosteroids.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; sore where the pacemaker was put in; sore at the injection site; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Left on 31Jan2021 14:30 (Batch/Lot Number: PAA156051) as SINGLE DOSE for covid-19 immunization.  Medical history included thyroid disorder (reported as thyroid) from an unknown date and unknown if ongoing. It was not provided if there were prior vaccinations (within 4 weeks), if there was any patient's Medical History (including any illness at time of vaccination) and if there was any family history. The patient is vaccinated at a medical office (reported as). There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. Concomitant medication included levothyroxine taken for thyroid disorder (reported as thyroid) at 75mg; take once daily by mouth from an unspecified start date (reported as taking for 10 years) and ongoing. It was reported that the patient had the first vaccine 31Jan2021 at 14:30PM in the left arm. She was scheduled for the second dose 21Feb2021 but she had a heart attack and a pacemaker put in and had to cancel the appointment. She is trying to reschedule the second dose. It was mentioned she doesn't know who to call. Adds she called the number and was transferred here. Advised caller this is Pfizer DSU and we document our patient's experience with our products. Caller agreed to report. Mentions her daughter is a teacher and set up the first dose for the caller because the caller is her mother-in-law; so the caller plans to contact her daughter about getting the second dose. The patient stated that she did have a very bad reaction to the vaccine, she noticed after an hour after the shot on 31Jan2021, it was very sore at the injection site for about 10 minutes and then she got the same thing the next day. The pain came and went for 5 to 10 minutes at a time. They don't know if she was getting a heart attack or if it was the vaccine. The pain at the injection site went away when she went to the emergency room on 15Feb2021 and the put oxygen on her. She was admitted 15Feb2021 for a heart attack and then had a pacemaker put in. She was discharged 25Feb2021. Adds she is slowly recovering but the site where they put in the pacemaker is still sore on Feb2021. The outcome of the event heart attack was recovered with sequelae on 15Feb2021, for the event sore at the injection site was recovered on 15Feb2021 and for the event sore where the pacemaker was put in was not recovered. The patient did required a visit to emergency room for the event heart attack. The patient was hospitalized, for 10 days (from 15Feb2021 to 25Feb2021) for heart attack.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Localized hives left arm where PNEUMOVAX 23 injection was given by; swelling at the injection site; Redness at the injection site; Muscle soreness at injection site; The consumer also reported having hives, on the upper left arm, as well.; Indication: "Pneumococcal Disease"; This spontaneous report was received from a medical assistant and refers to a 70 year old female patient, her concurrent conditions included  seasonal allergy. The patient's concomitant therapies included fluticasone propionate(FLONASE) and cetirizine hydrochloride(ZYRTEC). The patient's histórical conditions were not provided.     On 23-FEB-2021, the patient was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  intramuscular in the left arm (dose and lot # were not reported), for pneumococcal infection.    On 23-FEB-2021, the patient experienced severe swelling (vaccination site swelling), redness (vaccination site erythema), soreness in the muscle (vaccination site pain), at the injection site and having hives, on the upper left arm (urticaria) and localized hives left arm where pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was injected (vaccination site urticaria).   On 26-FEB-2021, the patient had recovered from vaccination site urticaria, urticaria, vaccination site pain, vaccination site erythema and vaccination site swelling. The reporter considered vaccination site swelling, vaccination site urticaria, urticaria, vaccination site pain and vaccination site erythema to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered
Clinical narrative: patient was confirmed by Medicas Assistant to be fine with no signs or complications; co-administered pedvaxhib/pentecel; Inappropriate dose of vaccine administered; This spontaneous report was received from a medical assistant and refers to a 2-month-old male patient. The patient was a full term baby. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-MAR-2021 "at around 3", the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S031500, expiration date 21-APR-2022; strength, dose and route of administration were not provided) in combination with hib conj vaccine (tet toxoid) (+) diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (mrc-5) (+) tetanus toxoid (PENTACEL) (strength, dose, route of administration, lot # and expiration date were not provided). The patient supposed to be vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX). Prior to and at reporting time, the patient was confirmed to be full term, at a healthy weight, fine with no signs of complications, feeding normal, and sleeping normal. Poison Control Representative suggested Tylenol be used in case of fever occurrence. The patient did not experience any adverse events. The present status was reported as recovered.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date in 2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot number S021456 with expiration date of 25-FEB-2022 (route of administration and anatomical location were not provided) for prophylaxis, that on 06-JAN-2021 was exposed to a temperature of 1.6 degree Celsius (°C) during a time frame of 8 hours. Data logger was not involved. There were no previous excursions reported. No adverse events were reported.  As of 18-MAR-2021, no further information was available..
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Unevaluable event
Clinical narrative: Priori adjuvant therapy: Subepithelial bevacizumab, HPV vaccination; Priori adjuvant therapy: Subepithelial bevacizumab, HPV vaccination;   This literature marketed report has been received from authors of published article as stated above, referring to a 47 years old female patient who had hypertension, pancytopenia and systemic lupus erythematosus(SLE).   On an unknown date, the patient received HPV vaccination(hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot # and expiration date were not reported) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, dose, frequency, route, lot # and expiration date were not reported) as prior adjuvant medical therapy for severe recurrent respiratory papillomatosis (RRP)(product use in unapproved indication and product origin unknown).The disease of recurrent respiratory papillomatosis (RRP) distribution included supraglottic, glottic, subglottic, cervical and thoracic trachea, pulmonary.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other information reported.; VARlVAX was administered to a patient prior to discovering the temperature excursion; This spontaneous report was received from a nurse practitioner, referring to a 9-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 (ml) by subcutaneous (SQ) route (lot number T022314 which has been verified to be valid, expiration date reported and validated as 30-JUN-2022) (vaccination scheme and anatomical site of injection were not reported) as prophylaxis (product storage error). On 14-MAR-2021 (conflicting information onset date also reported as 15-MAR-2021), the nurse reported a temperature excursion involving their varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines. The administered dose of the vaccine was stored at a temperature of 31.8 degrees Fahrenheit (F), during a time frame of 5 hours and 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No other information was reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Chronic inflammatory demyelinating polyradiculoneuropathy, Gait disturbance, Hypoaesthesia
Clinical narrative: Paresthesia, Pain in Limb, Foot Arm and Hand,chronic inflammatory demyelinating polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 17-JUL-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered numbness in legs and hands, trouble walking, balance issues, pain in the left hip that radiated to the left leg, pain in fingers of right hand, and motor weakness. The pt was diagnosed with paresthesia, pain in limb, foot, arm and hand, and chronic inflammatory demyelinating polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experiences 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), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was unknown. Causality assessment was related.  The reporter considered the event to be disability. Upon internal review, chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Motor dysfunction, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Paresthesia, Pain in Limb, Foot Arm and Hand,chronic inflammatory demyelinating polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 17-JUL-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered numbness in legs and hands, trouble walking, balance issues, pain in the left hip that radiated to the left leg, pain in fingers of right hand, and motor weakness. The pt was diagnosed with paresthesia, pain in limb, foot, arm and hand, and chronic inflammatory demyelinating polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experiences 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), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was unknown. Causality assessment was related.  The reporter considered the event to be disability. Upon internal review, chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Economic problem, Incomplete course of vaccination
Clinical narrative: I got shingle shot on 28-JAN-2016, just found out a week ago. I may not have been protected.; I could not afford another shot; This spontaneous report was received from a 65 years old female patient referring to herself. The patient's concomitant medications included metformin, venlafaxine hydrochloride, methimazole, buspirone hydrochloride, vitamins (unspecified) and procaterol hydrochloride (PROAIR). The patient's pertinent medical history included chronic obstructive pulmonary disease (COPD), diabetes and disability. The patient's drug reactions/allergies was not reported.   On 28-JAN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and expiration date were not provided; route: injection) to prevent shingles.  On approximately 15-MAR-2021 (reported as a week ago), the patient said she might not have been protected. She had pay a lot of money for shot which made her annoyed. The patient needed another shot and would like to reimbursement. The patient was disabled and by the time she got another shot, it would cost her another bunch of money. She stated that she could not afford another shot with her disability payment.   The outcome of vaccination failure was not provided. The causality assessment between vaccine zoster vaccine live (ZOSTAVAX) with the aforementioned event was related.; Sender's Comments:  US-009507513-2103USA002742:
Sex: F
Vaccine: PNC13, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Per caller Pneumovax was admin but the name charted for the medication given was Prevnar 13.; This spontaneous report was received from a licensed practical nurse and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unspecified date in 2016, the patient was supposed to received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # reported as 165N56, expiration date reported as an unknown date in October 2017, however the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) lot # reported as 165N56, expiration date reported as an unknown date in October 2017 (dose, route and site of administration were not reported), for prophylaxis. No additional adverse event was reported.  Lot number 165N56 is an invalid lot number for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23. Lot number 165N56 does not match any Company product as confirmed by Lot Verification team.
Sex: F
Vaccine: COVID19, MMR
Symptoms: Allergy to chemicals, Stevens-Johnson syndrome, Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 20-year-old female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported. On an unspecified day in 2006, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), one dosage form for prophylaxis (frequency, strength, route of administration, lot number, and expiry date were not reported). Other suspect therapies included sars-cov-2 vaccine (unspecified) (dose, frequency, strength, administration route, lot number, indication, and expiry date were not reported). On an unknown date, the patient experienced severe hives (urticaria), Stevens-Johnson syndrome, polyethylene glycol allergy (allergy to chemicals), and anaphylactic reaction. The outcome of an anaphylactic reaction, allergy to chemicals, and urticaria was unknown. The outcome of the Stevens-Johnson syndrome was reported as recovered/resolved. The reporter did not assess a causality relationship between the events and the suspect therapies. Upon internal review, the events of the Stevens-Johnson syndrome and anaphylactic reaction were determine to be medically significant.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: inadvertently administered PEDVAX subcutaneously in patient's thigh as opossed to intramuscularly; No additional ; This spontaneous report as received from a medical assistant, concerning a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was inadvertently vaccinated subcutaneously in the patient's thigh with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter, lot number T026959 with expiration date 11-MAR-2023 (frequency was not provided) for prophylaxis. No additional adverse event.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's; the administration of an expired VAQTA vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-MAR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), 1 dose, lot # S037821 has been verified to be a valid lot#, expiry date: 07-JAN-2021 (formulation, strength, route of administration were not provided) for prophylaxis. There was no adverse event reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; incorrect product storage; This spontaneous report was received from a nurse concerning a 4-year-old patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-MAR-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T030479, expiration date 03-JUL-2022) at a dose 0.5 milliliter for prophylaxis, which had a temperature excursion of 8 degree Fahrenheit for 15 minutes. the reporter stated that the temperature excursion was not detected by a data logger and that the vaccine had no previous temperature excursions. No additional adverse event were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No sign or symptoms reported; temperature excursion on MMR-11 and Varivax.Both products were given. MMR-11 was stored in recommended range; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025942, expiration date: 30-JUL-2022, 0.5 milliliter (formulation, route of administration and strength were not reported) for prophylaxis.  On an unknown dates, the doses of the vaccine were exposed to temperature excursion at 5.9 Celsius degrees (C) for 20 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Booster dose missed, No adverse event
Clinical narrative: Consumer missed dose of GARDASIL 9; No additional AE; have restarted the dosing schedule on 26-MAR-2021; This spontaneous report was received from the patient's mother, who was referring to her daughter (the patient's age was unknown). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-NOV-2019, the patient received her first shot of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. Due to coronavirus disease (COVID) restrictions, she did not get the remaining dose regime (reported also as missed dose) and have restarted the dosing schedule on 26-MAR-2021 (described as today). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's noted; temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T003017, expiration date 25-JUL-2021 (formulation, route of administration, strength and dose were not reported) for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 8.8 Fahrenheit degrees (F) for 45 minutes. There was previous temperature excursion at 8.71 F for 15 minutes. The call was due to digital data logger. No additional adverse event was reported.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was "fine" / No additional AE reported; the patient received four total doses of GARDASIL 9; the patient received 1st dose on 27-JUN-2016, 2nd dose on 07-SEP-2017, 3rd dose on 15-OCT-2019; This spontaneous report was received from a certified medical assistant and refers to a 15-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUN-2016, 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) lot # L016428, expiration date was not reported but upon internal validation was established as 30-JUL-2017 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 07-SEP-2019, the second dose of the vaccine was administered (lot # N004798, expiration date was not reported but upon internal validation was established as 31-OCT-2019; exact dose, route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). On 15-OCT-2019, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1614898, expiration date was not reported but upon internal validation was established as 15-NOV-2021 (exact dose, route of administration and anatomical location were not provided) and on 22-MAR-2021, the fourth dose was administered (lot # 1687292, expiration date was not reported but upon internal validation was established as 25-AUG-2022; exact dose, route of administration and anatomical location were not provided) (extra dose administered). The reporter stated that her office had been unaware that the patient had received the first two doses at other clinics, so they had restarted the series for him. At the time of report, he was fine (no adverse event (AE) was reported), but the medical assistant was wondering what to tell him to expect. 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: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: HIVES; SHORTNESS OF BREATH; RASH; A spontaneous report has been received from a consumer. The report concerns a male patient.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number CH2023) 0.2 ml once/single administration, via nasal route, during 2014.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced mild hives (preferred term: Urticaria). On an unknown date, the patient experienced mild shortness of breath (preferred term: Dyspnoea). On an unknown date, the patient experienced mild rash (preferred term: Rash).     The patient recovered from the event(s) of shortness of breath on an unspecified date. The outcome of the event(s) of hives and rash was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Butterfly rash, Erythema, Eye swelling, Incomplete course of vaccination
Clinical narrative: Butterfly rash on face/  and neck/continual rash; Burning / still get unexplained / burning on right eye sporadically; Raw Swollen eyes / still get unexplained swelling / on right eye sporadically; Raw Swollen lids / and under eyes; Welt developed under right eye / welt allergy under my right eye; Sensitivity to any facial product; Redness; discoloration under eyes; Resembled lupus; Date of vaccine. June 19, 2019; Rash; Was miserable for over 1 1/2 years; This case was reported by a consumer and described the occurrence of butterfly rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration, rash lupus-like and incomplete course of vaccination. On an unknown date, the outcome of the butterfly rash, burning sensation, eye swelling, swelling of eyelid, sensitive skin, skin discoloration and rash lupus-like were recovered/resolved and the outcome of the welts, erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration and rash lupus-like to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient experienced butterfly rash on face and neck. The rash resembled lupus, burning.  The patient also experienced raw Swollen eyes and lids continual rash redness discoloration under eyes still sensitivity to any facial product for few months. The patient had welt developed under right eye. The patient was attended by dermatologist and ophthalmologist for extended period of time. Some side effects lasted over 1 year. The patient would not take the second dose because of this reaction, which led to incomplete course of vaccination.  Up until now, the patient did not see where to report adverse effects to but the patient was reporting now for your data. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Sensitive skin, Skin discolouration, Skin erosion, Swelling of eyelid, Systemic lupus erythematosus rash
Clinical narrative: Butterfly rash on face/  and neck/continual rash; Burning / still get unexplained / burning on right eye sporadically; Raw Swollen eyes / still get unexplained swelling / on right eye sporadically; Raw Swollen lids / and under eyes; Welt developed under right eye / welt allergy under my right eye; Sensitivity to any facial product; Redness; discoloration under eyes; Resembled lupus; Date of vaccine. June 19, 2019; Rash; Was miserable for over 1 1/2 years; This case was reported by a consumer and described the occurrence of butterfly rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration, rash lupus-like and incomplete course of vaccination. On an unknown date, the outcome of the butterfly rash, burning sensation, eye swelling, swelling of eyelid, sensitive skin, skin discoloration and rash lupus-like were recovered/resolved and the outcome of the welts, erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration and rash lupus-like to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient experienced butterfly rash on face and neck. The rash resembled lupus, burning.  The patient also experienced raw Swollen eyes and lids continual rash redness discoloration under eyes still sensitivity to any facial product for few months. The patient had welt developed under right eye. The patient was attended by dermatologist and ophthalmologist for extended period of time. Some side effects lasted over 1 year. The patient would not take the second dose because of this reaction, which led to incomplete course of vaccination.  Up until now, the patient did not see where to report adverse effects to but the patient was reporting now for your data. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Butterfly rash on face/  and neck/continual rash; Burning / still get unexplained / burning on right eye sporadically; Raw Swollen eyes / still get unexplained swelling / on right eye sporadically; Raw Swollen lids / and under eyes; Welt developed under right eye / welt allergy under my right eye; Sensitivity to any facial product; Redness; discoloration under eyes; Resembled lupus; Date of vaccine. June 19, 2019; Rash; Was miserable for over 1 1/2 years; This case was reported by a consumer and described the occurrence of butterfly rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration, rash lupus-like and incomplete course of vaccination. On an unknown date, the outcome of the butterfly rash, burning sensation, eye swelling, swelling of eyelid, sensitive skin, skin discoloration and rash lupus-like were recovered/resolved and the outcome of the welts, erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the butterfly rash, burning sensation, eye swelling, swelling of eyelid, welts, sensitive skin, erythema, skin discoloration and rash lupus-like to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient experienced butterfly rash on face and neck. The rash resembled lupus, burning.  The patient also experienced raw Swollen eyes and lids continual rash redness discoloration under eyes still sensitivity to any facial product for few months. The patient had welt developed under right eye. The patient was attended by dermatologist and ophthalmologist for extended period of time. Some side effects lasted over 1 year. The patient would not take the second dose because of this reaction, which led to incomplete course of vaccination.  Up until now, the patient did not see where to report adverse effects to but the patient was reporting now for your data. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Chills, Hypersensitivity, Paraesthesia, Tachycardia
Clinical narrative: ALLERGIC REACTION; chills; TACHYCARDIA; TINGLING; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included lymphatic disorder (problem in the leg) and drug allergy (Ibuprofen or an inactive ingredients in the Ibuprofen).   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced allergic reaction, chills, tachycardia and tingling. On an unknown date, the outcome of the allergic reaction, chills, tachycardia and tingling were unknown.   It was unknown if the reporter considered the allergic reaction, chills, tachycardia and tingling to be related to Engerix B.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient experienced severe allergic reaction to the hepatitis B vaccine specifically Engerix B. The allergic reaction was further described as tachycardia, chills and tingling. The patient reported this information prior to receiving Pfizer Covid 19 Vaccine. The reporter refused to provide an address.