chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, head ache, extreme Nausea, throwing up
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Hunger, Lethargy, Pallor
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient was seen lying on his side and appeared pale. Patient stated he was hungry, dehydrated and sleepy due to lack of food and sleep. Paramedics were called with no abnormal findings of vitals. Patient left pharmacy after 15 minute observation period with a caregiver.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient was seen lying on his side and appeared pale. Patient stated he was hungry, dehydrated and sleepy due to lack of food and sleep. Paramedics were called with no abnormal findings of vitals. Patient left pharmacy after 15 minute observation period with a caregiver.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Headache, muscle soreness, body aches.  It?s been about 90 minutes.  Took some ibuprofen and am going to face the day.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: On Day 3 started a Rash on the back and has spread to other areas of the body.  Severity is not bad,  Itchy
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN DILUTED DOSE/SALINE SOLUTION AT APPOINTMENT TIME. PT WAS GIVEN NEW APPOINTMENT 3/21 TO GET THEIR VACCINE AGAIN FOR CORRECT DOSE.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Erythema, Flushing, Injection site rash, Ocular hyperaemia
Clinical narrative: Petechiae  (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate,  flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Petechiae
Clinical narrative: Petechiae  (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate,  flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: about 2 days after vaccination of first dose, pt has noticed prolonged dizziness. comes in waves, especially when pt has been sitting or laying down for prolonged time. will notice dizziness upon standing which lasts about a couple seconds and then goes away. has been occuring regularly starting two days after vaccination and continues to occur now, 3 weeks later.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 8 hours after receiving the vaccine, I started to experience fever, chills, and headache. Upon waking the following morning, I had body aches, headaches, and chills.  The 2nd day after receiving the vaccine, one of my lymph nodes, along my left collar bone (left arm injection) became swollen. Now is the third day and I have woken up with a headache. Still don?t feel completely back to normal.  No treatment taken to date. Going to see my PCP on 3/23.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Skin laceration, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Two (2) days after receiving the 1st vaccine shot I began having  pulse irregularities being detected when taking my blood pressure. The detection has occurred 4 times in the last 2 weeks. I have never received this detection previously.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Systemic: Death. Unknow cause as of reporting date. -Severe, Additional Details: PT caregiver called to report that the Pt passed away on 3/8/21 2 days post vaccince, Caregiver was distrot and not very able to provided more details due to reccent nature of report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. Went to bed and the following day was just feeling very fatigued. Then around 6 o?clock I started getting horrible chills bodyaches and a low-grade fever. A large red rash appeared and my arm was incredibly sore and the skin was burning. I have experienced body chills off and on since the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. Went to bed and the following day was just feeling very fatigued. Then around 6 o?clock I started getting horrible chills bodyaches and a low-grade fever. A large red rash appeared and my arm was incredibly sore and the skin was burning. I have experienced body chills off and on since the vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain, Tenderness, Urticaria
Clinical narrative: Welts appeared around injection site approximately 12 hours after vaccination and have remained for 36 hours. The welts were in 2 major patches within 5 inches of the injection site and were approximately half-dollar sized. They are painful and tender.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: 1st shot: Same day: aches and fogginess for 24 hours  2nd shot: Same day: aches, fogginess, fatigue, and growing SOB, heaviness and tightness in chest, frighteningly forceful occasional heart beat, irregular heart rhythm over the next couple of weeks. Aches gone in 24 hours. Fogginess, fatigue. SOB, chest and heart symptoms significantly subsided 19 days after 2nd shot.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate irregular, Pain, Palpitations
Clinical narrative: 1st shot: Same day: aches and fogginess for 24 hours  2nd shot: Same day: aches, fogginess, fatigue, and growing SOB, heaviness and tightness in chest, frighteningly forceful occasional heart beat, irregular heart rhythm over the next couple of weeks. Aches gone in 24 hours. Fogginess, fatigue. SOB, chest and heart symptoms significantly subsided 19 days after 2nd shot.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Injection site pain, Nasopharyngitis, Pain
Clinical narrative: Woke up in the morning and my tinnitus was a lot louder than usual.  (I also had that symptom when I had Covid in late October.)  I felt really tired even though I just woke up.  Also tired throughout the day. I was cold all day. Had a fever. I was sore/achy on sides of my body from under my arms to my waist. Sore arm at injection site. I took Tylenol in the early evening and that made me start feeling better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Woke up in the morning and my tinnitus was a lot louder than usual.  (I also had that symptom when I had Covid in late October.)  I felt really tired even though I just woke up.  Also tired throughout the day. I was cold all day. Had a fever. I was sore/achy on sides of my body from under my arms to my waist. Sore arm at injection site. I took Tylenol in the early evening and that made me start feeling better.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Breast mass, Breast pain, Breast swelling
Clinical narrative: Headache and stuffy head night of vaccine.  took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump.  by evening could feel pain down into left breast.  following morning--could see little "lumps"/swollen areas on left side of left breast.  Armpit still swollen and sore
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: Headache and stuffy head night of vaccine.  took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump.  by evening could feel pain down into left breast.  following morning--could see little "lumps"/swollen areas on left side of left breast.  Armpit still swollen and sore
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Flatulence, Hypoaesthesia
Clinical narrative: 03:40 pm..Numbness in right cheek into lower jaw.  similar to when you are coming out of novicane from dental appt. Lasted about 15 minutes but subtle feeling for 24 hours.    Friday morning: reaction to my BP meds of heavy head, weak hands that other meds caused me in past.   Never had previously.  Been on this med brand for over 3 years.   The symptoms passed after 5 hours when med wore off.  My BP seems lower than before shot. So reduced med to half dose 2x day and full dose once a day.   Seems to have helped reduce symptoms, but they reappear less intense now.  Also have heartburn and much more gas than ever had in past.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left armpit (not in the arm pit) kind of near side of breast.  About 3 inches around.  It showed up yesterday around 3 or 4 pm  -and I have taken naproxen.  Too soon for outcome.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: 24 hours after injection site sore and warm  this is 4 days later still feel it
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Headache, Rash
Clinical narrative: severe rash on both lower legs, asthma, headache
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: I had no issues before the shot.  After I took the shot, I developed a rash on my stomach the next day. I did not pay attention and I thought it was the rash they were talking about.   It started to hurt the next day and was still red and not getting better.  I went to urgent care and I told them that I took the COVID-19 shot.  They said that I had shingles.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Nose bleed followed by fatigue, muscle aches, headache, and fever.  Symptoms started 5 hours after injection and lasted approximately 15 hours.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema - lip
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Extremity contracture, Vision blurred
Clinical narrative: episodic shortness of breath, blurred vision, dizziness, episodic finger contractures to bilater hands
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Received shot around 230pm - chills began around 11pm, pounding headache and body aches kicked in around 230am. Took some pain meds around 7am the next day - was okay til the afternoon when the chills seemed to come back along with the body aches and slight headache not as bad as the night before though. As of March 21 I still feel a bit tired and legs ache quite a bit but Pain meds help
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Burning sensation, Dysgeusia, Flushing
Clinical narrative: A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oral discomfort
Clinical narrative: A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional adverse events/product quality complaints reported.; Caller is inquiring if administered expired VARlVAX is viable.; This spontaneous report was received from a other health professional concerning to a patient of unknown age and gender. The patient's current conditions, medical history and historical drug were not reported. No concomitant therapies were provided.      On an unknown date the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002740 and expiration date since it makes match with the autopopulated expiration date expiration date:20-JAN-2021) (dose, strength, vaccination scheme, anatomical site of injection, route of administration and indication were not reported).         On 02-FEB-2021, the reporter was inquiring if administered expired varicella virus vaccine live (oka/merck) (VARIVAX) was viable.   No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's; Customer calling to report a temperature excursion on V ARlV AX. Customer does note the vaccine was administered; This spontaneous report as received from a other refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.      On 19-FEB-2021, the patient was vaccinated with first dose varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025910 and expiration date since it makes match with the autopopulated expiration date 20-AUG-2021) dose 1(indication, route, and anatomical location were not reported) which where stored at temperature excursion. The temperature excursion was 7.1 degrees Fahrenheit for a time frame of 45 minutes, and 6.9 degrees Fahrenheit for 45 minutes, as recorded by a data logger. The previous temperature excursion was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 45 minutes.   No additional adverse events was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information; 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 22-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin)   (PROQUAD) lot # S027465, expiration date of 02-MAR-2021, 0.5 milliliter  for prophylaxis  (strength, dose, route, frequency, and anatomical location were not provided).   The vaccine was exposed to multiple temperature excursions since 01-NOV-2020 through the end of February 2021.  The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2103USA000947: US-009507513-2103USA000942: US-009507513-2103USA000993: US-009507513-2103USA001343:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No further AE; a temperature excursion/Improperly stored and administered; This spontaneous report was received from an other healthcare professional referring to a patient of an unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not provided.    On 26-FEB-2021, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose: 1 (unit unknown), lot # T026156, expiration date 22-MAY-2022, route and strength were not provided) for prophylaxis (product storage error). No adverse events reported.   Administered dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion above 49.3 Fahrenheit (F) for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; the vaccine was going through  temperature excursions; 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 15-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin)   (PROQUAD) lot # S027465, expiration date of 02-MAR-2021, 0.5 milliliter  for prophylaxis  (strength, dose, route, frequency, and anatomical location were not provided).   The vaccine was exposed to multiple temperature excursions since 01-NOV-2020 through the end of February 2021.  The call was made due to a digital data logger. No additional adverse effect reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2103USA000942: US-009507513-2103USA001024: US-009507513-2103USA000993: US-009507513-2103USA000947:
Age: 55.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: no additional adverse effects; she is over 45 years of age and was administered the first dose of the vaccine; This spontaneous report as received from a consumer refers to a 55-year-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.     The consumer reported that she is over 45 year old  and on 04-MAR-2020,she was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).No additional adverse effects reported.
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: a patient developed facial nerve palsy after receiving gardasil; This spontaneous report was received from a consumer after GARDASIL vaccine administration", referring a 15-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (strength, dose, frequency, route of administration, lot #, expiration date were not provided) as prophylaxis.   The abstract of the article stated that, on an unspecified date, after vaccine administration the patient developed peripheral facial nerve palsy. At the report time, the outcome of the event was unknown.  The causal relationship between the aforementioned event and the suspect vaccine was not provided.  Upon internal review, the event of peripheral facial nerve palsy was considered medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: painful outbreak of shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-SEP-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) at the direction of his primary physician for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) being administered, in 2017 (reported as within a week), the pt developed a painful outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the product. The pt also experienced 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, 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 had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the the pt. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event painful outbreak of shingles to be disability.
Age: 10.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Injection site swelling
Clinical narrative: Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen; Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen; This spontaneous report has been received from a nurse regarding a 10-years-old female patient. the patient's concurrent conditions included anxiety and mild asthma. Historical conditions were not reported. The patient had no drug reactions or allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine and lamotrigine (LAMICTAL).   On 22-FEB-2021, the patient was vaccinated the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 injection intramuscular (IM) as human papillomavirus (HPV) prophylaxis (lot # 1691180, expiration date 15-NOV-2022). On the same date, she was also vaccinated with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 injection as prophylaxis (dose, frequency, route of administration were not reported).   Since this date (reported as since the vaccine administration), the patient had been dizzy and the injections site had been significantly swollen. She sought for medical attention. No laboratory diagnostics and studies were performed. No treatment was given for the events. On 24-FEB-2021, the patient's mother called the clinic to report the events. On 09-MAR-2021, the events were recovering (also reported as recovery date, conflicting information). The patient did not experience any additional adverse symptoms.   The causality between the events and the suspect therapies was unknown. 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: 1691180; expirationdate: 12-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Tendonitis
Clinical narrative: chronic tendonitis; I am allergic to/ MMR vaccine; joint pain; This spontaneous report  was received from a health care professional, via other company and refers to a female patient of unknown age. The patient's concurrent conditions included allergy to eggs, milk, beef, yeast, corn, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) and environmental allergies to all the trees, grasses, pollens, rag weeds, molds, cat dander, dust mites and roaches.  In 1994, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (dose, route of adminstration, lot number and expiration date were not reported). That year, the patient had a severe generalized arthritic reaction to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) which resulted in chronic tendonitis and joint pain. The outcome of the events was not reported.  The patient considered the events to be related to vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: suspected vaccination failure; Shingles after dose two; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 91-year-old female patient who received Herpes zoster (Shingrix) (batch number B334Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number EY93J, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer and shingles.   On 17th July 2018, the patient received the 1st dose of Shingrix. On 22nd October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced shingles after the 1st and 2nd dose of Shingrix. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012493:Same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Insomnia, Paraesthesia, Sleep disorder
Clinical narrative: burning pins and needles in my hands and feet; burning pins and needles in my hands and feet; woke me with their intensity; This case was reported by a consumer and described the occurrence of pins and needles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included menopause. Concurrent medical conditions included allergy to antibiotic (allergies are vibramiacin and gantrin).   In October 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced pins and needles, burning sensation and sleeplessness. In December 2020, the outcome of the pins and needles, burning sensation and sleeplessness were recovered/resolved.   It was unknown if the reporter considered the pins and needles, burning sensation and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient had no other underlying health issues other than menopause muffin top. The patient received Shingrix in pharmacy and had developed intermittent burning pins and needles in hands and feet, these occasionally woke up the patient with their intensity and then subsided. For tolerances of 2nd dose, refer case US2021AMR025923, reported by same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025923:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Mobility decreased, Vaccine positive rechallenge
Clinical narrative: she was in bed for 3 days / is not feeling well since she got the vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of mobility decreased in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of mobility decreased (received 1st dose on unknown date, refer case US2021AMR043056).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient was in bed for 3 days after receiving shingrix vaccine and then she was fine. On 21th January 2021, the patient received Pfizer BioNtech covid vaccine on left upper arm intramuscularly and experienced headache, profound fatigue and felt unwell. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043056:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: First shot / It was extremely painful; Received the first shot / about two years ago / didn't get part two; This case was reported by a consumer and described the occurrence of pain in a adult 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. The patient received 1st dose of shingrix two years ago, and it was very painful. The patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. Patient questioned that need to get one and part two again considering the time span between doses.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Most recently, the patient had a shot of Shingles and got the side effects which led to sickness. Batch number and expiration date was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore arm at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that he had no side effect after the administration of Shingrix vaccination just had injection site soreness.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019080481:Same country, Same product.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt like I had the flu for a day; This case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of no adverse event (had single shot version with no problems).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient felt like the flu for a day after vaccination. The patient already had Shingles in past and never want again. For tolerence with 2nd dose refer case US2021AMR048218.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048218:same patient same reporter 2nd dose
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood pressure increased, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: immobilizing pain in my left hip; full body muscle spasms; hip pain was almost unbearable; 101.5 temp; blood preassure was 155/110 / my blood pressure was 168/130, 165/128, and 171/130; swelling at injection site; soreness at injection site; pain muscle of my right hip; major night sweating; a bit of fatigue late in the afternoon; This case was reported by a consumer and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced fatigue. On 9th February 2021, the patient experienced mobility decreased and muscle spasm. In February 2021, the patient experienced fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating and pain in hip. The patient was treated with tramadol and ibuprofen (Advil). On an unknown date, the outcome of the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue were recovered/resolved.   The reporter considered the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm at around 2:00 pm and five hours later had a 101.5 temperature, blood pressure was 155/110, swelling and soreness at injection site. The patient had a 10 level pain in the muscle of right hip.  These symptoms persisted for four days and included major night sweating, continued immobilizing pain in left hip and full body muscle spasms. The patient reported after each of these spasms blood pressure was 168/130, 165/128 and 171/130 and the hip pain was almost unbearable.  The patient took two 50mg Tramadol and Advil and went to sleep.  The patient when woke up on Saturday and it was like nothing ever happened.  The hip pain was completely gone, blood pressure was normal (128/90), the swelling at the injection site was gone and the fever was down to 99. The patient had X-rays of hip that showed no ortho problems and did not had any lingering effects except a bit of fatigue. The doctor was not convinced that the issues are related to Shingrix, but there were no underlying issues and the symptoms all showed up on the day of the vaccination and all pretty much went away on the same day. The patient experience was less than perfect and wanted to share it in hopes that the patient at least confirm that my health issues side effects are related to vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Mobility decreased, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: immobilizing pain in my left hip; full body muscle spasms; hip pain was almost unbearable; 101.5 temp; blood preassure was 155/110 / my blood pressure was 168/130, 165/128, and 171/130; swelling at injection site; soreness at injection site; pain muscle of my right hip; major night sweating; a bit of fatigue late in the afternoon; This case was reported by a consumer and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced fatigue. On 9th February 2021, the patient experienced mobility decreased and muscle spasm. In February 2021, the patient experienced fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating and pain in hip. The patient was treated with tramadol and ibuprofen (Advil). On an unknown date, the outcome of the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue were recovered/resolved.   The reporter considered the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm at around 2:00 pm and five hours later had a 101.5 temperature, blood pressure was 155/110, swelling and soreness at injection site. The patient had a 10 level pain in the muscle of right hip.  These symptoms persisted for four days and included major night sweating, continued immobilizing pain in left hip and full body muscle spasms. The patient reported after each of these spasms blood pressure was 168/130, 165/128 and 171/130 and the hip pain was almost unbearable.  The patient took two 50mg Tramadol and Advil and went to sleep.  The patient when woke up on Saturday and it was like nothing ever happened.  The hip pain was completely gone, blood pressure was normal (128/90), the swelling at the injection site was gone and the fever was down to 99. The patient had X-rays of hip that showed no ortho problems and did not had any lingering effects except a bit of fatigue. The doctor was not convinced that the issues are related to Shingrix, but there were no underlying issues and the symptoms all showed up on the day of the vaccination and all pretty much went away on the same day. The patient experience was less than perfect and wanted to share it in hopes that the patient at least confirm that my health issues side effects are related to vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: immobilizing pain in my left hip; full body muscle spasms; hip pain was almost unbearable; 101.5 temp; blood preassure was 155/110 / my blood pressure was 168/130, 165/128, and 171/130; swelling at injection site; soreness at injection site; pain muscle of my right hip; major night sweating; a bit of fatigue late in the afternoon; This case was reported by a consumer and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021 14:00, the patient received the 1st dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced fatigue. On 9th February 2021, the patient experienced mobility decreased and muscle spasm. In February 2021, the patient experienced fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating and pain in hip. The patient was treated with tramadol and ibuprofen (Advil). On an unknown date, the outcome of the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue were recovered/resolved.   The reporter considered the fever, increased blood pressure, injection site swelling, injection site pain, muscle pain, sweating, mobility decreased, muscle spasm, pain in hip and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm at around 2:00 pm and five hours later had a 101.5 temperature, blood pressure was 155/110, swelling and soreness at injection site. The patient had a 10 level pain in the muscle of right hip.  These symptoms persisted for four days and included major night sweating, continued immobilizing pain in left hip and full body muscle spasms. The patient reported after each of these spasms blood pressure was 168/130, 165/128 and 171/130 and the hip pain was almost unbearable.  The patient took two 50mg Tramadol and Advil and went to sleep.  The patient when woke up on Saturday and it was like nothing ever happened.  The hip pain was completely gone, blood pressure was normal (128/90), the swelling at the injection site was gone and the fever was down to 99. The patient had X-rays of hip that showed no ortho problems and did not had any lingering effects except a bit of fatigue. The doctor was not convinced that the issues are related to Shingrix, but there were no underlying issues and the symptoms all showed up on the day of the vaccination and all pretty much went away on the same day. The patient experience was less than perfect and wanted to share it in hopes that the patient at least confirm that my health issues side effects are related to vaccination.