chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Injection site bruising, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pt stated this began as a knot to injection site (left deltoid) almost immediately/the following day the injection was given. Started bruising, swelling and was painful. The bruise started spreading to left bicep and to lower arm. Pt applied ice which decreased swelling. Pt seen 8/10/2020 and was told to ice area and take ibuprofen for pain. Will return to office if it does not improve
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Feeling abnormal, Pyrexia, Scab
Clinical narrative: All of a sudden I had chills (couldn?t get warm), low grade fever and felt miserable.  I also had a a sudden appearance of a rather large  blister on my face near the left side of my mouth.  The bister reminded me of a core sore type of thing and it had clear fluid in it. The symptoms lasted for a couple of days..  Today feeling much better and the blister has scabbed over.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: Vomitted 5 times after breakfast the day after receiving the shot. VIOLENT! also had a headache for 3 days.
Age: 38.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Gastrointestinal haemorrhage, Intussusception, Ultrasound scan, X-ray
Clinical narrative: 7/13/20 GI bleed -> hospitalized for intussusception reduced with enema
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Hypophagia, Pyrexia, Tremor
Clinical narrative: Tremors fever unsteady gait not eating
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Extreme soreness, swelling and welts covered most of upper arm, hot and itchy.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Culture urine negative, Electroencephalogram normal, Febrile convulsion, Full blood count, Leukocytosis
Clinical narrative: 2 complex febrile seizures. First one lasted 9 minutes and resolved by itself. Second one was inside the ambulance, lasted 2 minutes and it was treated with .4mL of Versed. She was taken to Hospital.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: SARS-CoV-2 test negative, Urine analysis normal, Viral test negative, White blood cell count increased
Clinical narrative: 2 complex febrile seizures. First one lasted 9 minutes and resolved by itself. Second one was inside the ambulance, lasted 2 minutes and it was treated with .4mL of Versed. She was taken to Hospital.
Age: 44.0
Sex: M
Vaccine: FLUN4
Symptoms: Dizziness
Clinical narrative: This happened a long time ago but this is the only time I found out about this adverse event reporting system. I was still in active duty service and they gave us this "Flu Mist" thru the nasal passage at around 2013 and 2014  Few days after this flu mist, I felt so dizzy every time I lay down or in supine position. There was a time that I can still feel the dizziness even when I was half awake in bed. It was a really frightening experience. I am a very healthy person and this is the first time I ever experienced that. I really felt the vaccine latched in to my brain thru the nasal passage and messed it up.  After so many years it the symptoms disappeared then lately this year, the symptoms came back. I am not 100% sure if that vaccine was directly causing my dizziness or it made me more vulnerable to become dizzy after being triggered by another mechanism.   I was so mad at that time because I think we were used as a guinea pig for that new "Flu Mist" vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine give
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain
Clinical narrative: Patient called today said that her left leg  doesn't fell the same as before the 2 nd IMZ of the Shingrix.  She got the 1 st shot on 02/29/20 and the 2 nd one on 07/25/20. She noticed after the  2 nd shot. She said maybe swelling, little pain and she said she will contact her Dr's office to see if anything else going on.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Pain in extremity, Skin warm
Clinical narrative: Child received immunization on 8/5/2020 during a vaccination clinic per County Public Health.  Mother called County Public Health office Friday AM 8/7/2020 reporting child's arm was very redden, warm to touch and painful.   Public Health nurse instructed mother to take child into the clinic  and have arm evaluated.   Child was seen by FNP in clinic 8/7/2020 @10:30 AM. Diagnosis was allergic reaction to vaccine .   Treatment: prenisolONE 15 mg/15 ml solution 1 tsp. by mouth BID for 5 days and  DiphenhydraAMINE 12.5mg / 5ml Take 2.5 ml by mouth  every 4 hours as needed for itching or allergies.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Decreased appetite, Dizziness, Impaired driving ability, Influenza like illness
Clinical narrative: I received the shot at the pharmacy at 3 PM and was told mild flu like symptoms might occur but since I had only a loss of appetite for a day with the first dose the pharmacist and I believed the same would be true this time.  I returned to work for the evening and had a 1/2 hour drive after that.  5-6 hours later I was OVERCOME with dizziness. I was not able to drive and once at home I continued with dry heaves, extreme dizziness, nausea for 4 hours. I was unable to move off a chair with out assistance.  The nausea subsided about 16-18 hours after the shot.  I did not feel 100% until at least 6 days later.  I had limited appetite and aches in my upper back.  The suddeness of this reaction was extremely scary and no warning from the provider other than " the usual" symptoms is very concerning because I could have been driving.  No indication that the 2nd dose could be worse than the first is also scary to individuals that had a mild time with #1 and falsely believed everything would be fine.  I have heard many of my friends have had this overwhelming nausea experience and others say they would rather have the shingles.   I hope the vaccine can be adjusted in some way to prevent this reaction and more education can be given to the person receiving it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Retching
Clinical narrative: I received the shot at the pharmacy at 3 PM and was told mild flu like symptoms might occur but since I had only a loss of appetite for a day with the first dose the pharmacist and I believed the same would be true this time.  I returned to work for the evening and had a 1/2 hour drive after that.  5-6 hours later I was OVERCOME with dizziness. I was not able to drive and once at home I continued with dry heaves, extreme dizziness, nausea for 4 hours. I was unable to move off a chair with out assistance.  The nausea subsided about 16-18 hours after the shot.  I did not feel 100% until at least 6 days later.  I had limited appetite and aches in my upper back.  The suddeness of this reaction was extremely scary and no warning from the provider other than " the usual" symptoms is very concerning because I could have been driving.  No indication that the 2nd dose could be worse than the first is also scary to individuals that had a mild time with #1 and falsely believed everything would be fine.  I have heard many of my friends have had this overwhelming nausea experience and others say they would rather have the shingles.   I hope the vaccine can be adjusted in some way to prevent this reaction and more education can be given to the person receiving it.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site inflammation, Injection site streaking, Injection site warmth, Lymphadenopathy
Clinical narrative: Pt had fever of 101f and red streak from vaccine site about 6-8 inches down arm. Pt went to doctor to see if she had covid. Dr thought she had infection and prescribed 2 antibiotics including amoxicillin and benadryl. Red streak became more topically inflamed and warm with more swollen lymph nodes per patient assessment. Pt called pharmacy to report. Pharmacist filed vaers and referred pt to primary provider.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt had fever of 101f and red streak from vaccine site about 6-8 inches down arm. Pt went to doctor to see if she had covid. Dr thought she had infection and prescribed 2 antibiotics including amoxicillin and benadryl. Red streak became more topically inflamed and warm with more swollen lymph nodes per patient assessment. Pt called pharmacy to report. Pharmacist filed vaers and referred pt to primary provider.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Patient had a vaso vagal response to HPV #2. Patient responded well after nasal stimulant was introduced. Patient was made to lie die and take sips of room temperature water. Safely discharged home per provider.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Erythema
Clinical narrative: Patient presented to office for well child exam.  Patient recieved Pentacel in RIght Deltoid.  Late that night/early the next morning patients arm started getting red, not to touch.  Area continued growing bigger and on 8/7/20 was seen back in office by Nurse Practitioner.  Patient was given Rocephen, and given script for Keflex to start if area didn't get any better. Patient reported 8/10/20 patients arm is much better.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Gait disturbance, Hypophagia, Laboratory test normal, Pyrexia, Tremor
Clinical narrative: Tremors fever and unsteady gait and not eating
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Laboratory test
Clinical narrative: Patient complained of extreme dizziness lasting for 3 days (Fri-Mon).  Came to see PCP on Monday 8/10/2020.  Lab work completed.  Patient will follow up later in week.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Feeling of body temperature change, Headache, Injection site pain, Injection site swelling
Clinical narrative: Received Trumenba injection on 8/ 4/20.  Later that day she felt "hot and cold ".  She then  developed some diarrhea, said she had a headache and her ears were ringing at one point.  No fever nasal drainage or cough. She also had nausea  and swelling and soreness of left upper arm at the injection site, since later in the day on 8/ 4/20. Patient was treated with Zofran and ibuprofen for the swelling and pain in her arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Tinnitus
Clinical narrative: Received Trumenba injection on 8/ 4/20.  Later that day she felt "hot and cold ".  She then  developed some diarrhea, said she had a headache and her ears were ringing at one point.  No fever nasal drainage or cough. She also had nausea  and swelling and soreness of left upper arm at the injection site, since later in the day on 8/ 4/20. Patient was treated with Zofran and ibuprofen for the swelling and pain in her arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: patient has large red lump that appeared at the injection site accompanied by soreness
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: patient developed fever the night of receiving vaccination as well as red macular rash on face and ears.  Rash was nonpruritic and nonpainful.  mother gave Motrin and Benadryl which did not help improve symptoms. Resolved after 24 hours.  Subsequently developed swelling, firmness and redness with tenderness to left deltoid area for 3 days afterwards.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash macular
Clinical narrative: patient developed fever the night of receiving vaccination as well as red macular rash on face and ears.  Rash was nonpruritic and nonpainful.  mother gave Motrin and Benadryl which did not help improve symptoms. Resolved after 24 hours.  Subsequently developed swelling, firmness and redness with tenderness to left deltoid area for 3 days afterwards.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Rash pruritic
Clinical narrative: 2 days after shots received, infant was covered from head to toe in a very itchy rash that lasted 3 days. 2 days after shots received, infant would cry inconsolably for 4 hours straight every 2 hours that last for 3 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red band about 1.5-2" thick on upper arm covering about half the circumference of the arm. Appearance is blotchy and irregular. Location is about 2" below injection site. Pt reports it is very painful and hot. She reports that it first developed the following night after receiving the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Armpit swollen/ lymph nodes swollen with a rash in the inside of my armpit and right breast.  I went to urgent care on Saturday (08/08/2020) Dr proscribed Cephalexin.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Epistaxis, Head injury, Lip haemorrhage, Loss of consciousness, Moaning
Clinical narrative: 2-5 min after vaccine patient stood up to leave exam room and patient fainted and hit head on exam table. Drop of blood to nose and lip. Patient immediate moan. Rolled patient on side and held c-spine while PCT came BP110/65 HR69. LOC less than 10 seconds
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: 2-5 min after vaccine patient stood up to leave exam room and patient fainted and hit head on exam table. Drop of blood to nose and lip. Patient immediate moan. Rolled patient on side and held c-spine while PCT came BP110/65 HR69. LOC less than 10 seconds
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Depressed level of consciousness, Hyperhidrosis, Muscle rigidity, Pallor, Posture abnormal
Clinical narrative: Patient lost consciousness (semi-conscious yet not completely out like syncope) and was able to stay upright in chair with balance provided by myself.  Patient upper arms and body became rigid with yet both arms moved up and down with hands hanging down from wrists.  It really seemed like more of a seizure to me.  Patient  snorted and snored with head tilted slightly to left side.  The episode lasted about 30 to 45 seconds.  Patient became very pale and diaphoretic.  Patient took about 15 to 20 minutes to recover to the point of being able to be escorted to a car to be transported home.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Snoring
Clinical narrative: Patient lost consciousness (semi-conscious yet not completely out like syncope) and was able to stay upright in chair with balance provided by myself.  Patient upper arms and body became rigid with yet both arms moved up and down with hands hanging down from wrists.  It really seemed like more of a seizure to me.  Patient  snorted and snored with head tilted slightly to left side.  The episode lasted about 30 to 45 seconds.  Patient became very pale and diaphoretic.  Patient took about 15 to 20 minutes to recover to the point of being able to be escorted to a car to be transported home.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Aphasia, Communication disorder, Discomfort, Spinal pain
Clinical narrative: Patient was administered the vaccine and was talking to the pharmacist asking about the nationality etc. and all of a sudden he stopped talking for 3 to 4 seconds and was feeling uncomfortable and was not able to communicate properly.  Asked if he was able to breathe,  he said he is not having any difficulty breathing but was complaining of pain down the spine in his back .  Called 911 and the EMT arrived quickly, patient  got up and walked with them. Later he was checked for his vitals, not admitted to hospital.  I spoke with the patient  over phone after 2 and 1/2 hours post incident. Patient said he was resting and I advised him to see a Doctor as soon as possible as a follow-up.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: none
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Joint range of motion decreased
Clinical narrative: Patient's right arm was red and flush above elbow.  Her arm had limited range of motion after the injection.  She did not have redness at the site of injection but was red below until elbow
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient walked into clinic on 8/10/2020 to report allergic reaction to vaccine. Her left upper arm was red, swollen and hot to the touch. Patient reported that arm was also painful. She had been using ice on arm without any relief of symptoms.  Redness was about 7 inches long and about 4-5 inches wide.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient walked into clinic on 8/10/2020 to report allergic reaction to vaccine. Her left upper arm was red, swollen and hot to the touch. Patient reported that arm was also painful. She had been using ice on arm without any relief of symptoms.  Redness was about 7 inches long and about 4-5 inches wide.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUA3, IPV, MMRV
Symptoms: Anxiety, Dyskinesia, Encephalitis, Hallucination, Mental disorder
Clinical narrative: He started having Encephalitis such as hallucinations, anxiety, stop talking , screaming ,   lost his mind, weird movements . I took him to many doctor, but no one can help him . Until I took him to a neurologist that can provided him a treatment .
Age: 4.0
Sex: M
Vaccine: DTAP, FLUA3, IPV, MMRV
Symptoms: Screaming, Speech disorder
Clinical narrative: He started having Encephalitis such as hallucinations, anxiety, stop talking , screaming ,   lost his mind, weird movements . I took him to many doctor, but no one can help him . Until I took him to a neurologist that can provided him a treatment .
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Lip swelling, Pyrexia, Rash
Clinical narrative: fever to 102 with joint pain, swelling, lip swelling, vesicles on gums, diffuse Steven Johnson rash
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Stevens-Johnson syndrome, Swelling
Clinical narrative: fever to 102 with joint pain, swelling, lip swelling, vesicles on gums, diffuse Steven Johnson rash
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Erythema, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: fever to 102 with joint pain, swelling, lip swelling, vesicles on gums, diffuse Steven Johnson rash
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Vision blurred
Clinical narrative: fever to 102 with joint pain, swelling, lip swelling, vesicles on gums, diffuse Steven Johnson rash
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: Left sided Chest wall and rib pain 2 days after immunization.  Seen in local ED and dx'd as possible pleurisy, then possible Pneumonia
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: After I administered the vaccines when patient stood up he became faint and started to fall. I caught him and got him to a chair and then the floor with his feet up. He never lost consciousness. He was nervous about getting the vaccines, but actually did well and was surprised that it was done and he did not realize it. He did not eat this morning, so that probably contributed too. After laying on the floor for about 15 minutes with his feet elevated,  I helped him get to a chair and gave him orange juice and a breakfast bar. He stayed another 15 minutes and was feeling back to normal when he left.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site cellulitis, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, painful, warm to touch. Patient diagnosed with cellulitis of upper, left arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Inappropriate schedule of product administration
Clinical narrative: Patient was given a 3rd dose of Gardasil which was not needed. Patient had previously Received 1st dose at age 12 and 2nd dose at age 13. On Saturday 8/8 patient c/o lower back pain which did not subside til Sunday (8/9) evening
Age: 2.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site nodule
Clinical narrative: Small nodule over left thigh
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient tolerated both vaccines at first. She was standing, walking and chatting. About 10 minutes after the vaccines she had a syncopal episode. I was not witness to this but another nurse reports seeing it. Patient did not hit her head. The patient was assessed by a Provider
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Diffuse Urticarial rashes to chest and extremities 45 mins after application Tx: Solumedrol 40mg IM to Left gluteal area Benadryl 25mg PO x1 given
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Very bad pain in night, woke me up, from back of head aLL way down body but not Feet. Hurt too bad to arise and take medication so as Long as still, not too bad so went to sleep. Morning too bad to get up sot stayed still until 8AM. As Day went on-got better. ARM hurt for 2 wks were shot site was (oFF and on.)
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Restlessness
Clinical narrative: 7/22/20 6:30 - pain @ site; 9:30 Fever T- 98.9 -F. RESTLESS & SHIVERING IN BED ALL NIGHT. TOOK ACETAMINOPHEN, DIPHENHYDRAMINE 1x 7/23/20 8:30 AM T - 94.8 Felt better but more pain in R shoulder radiating down arm from injection site. 7/24/20 Felt better but pain persisted 4-6 days.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Rash macular
Clinical narrative: 8/10/20 1910 - Diffuse macular erythema in large patches
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hypotension, Seizure
Clinical narrative: Unwittnessed seizure activity per pts mother RN, within 10 min after inj. Pt was found to be hypotensive. Pts sxs/v/s stable w/fluids 30 min after incident.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Tic
Clinical narrative: Tic left side of face (twitch); This spontaneous report was received from healthcare professionals via FDA referring to a 11 years old male patient. The patient had no other illnesses at the time of vaccination and no pre-existing diagnosis. Information about the concomitant therapy was not provided.  On 18-JUL-2019, 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# 1602281 expiration date not reported, but upon internal validation established as 21-JUL-2021; strength, route and dose detail were not provided) in the right arm for prophylaxis. On the same day, the patient also received diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine (lot# 2774D, dose 1; strength, route and dose detail were not provided) and meningococcal conj vaccine (unspecified) (MCV4) (lot# AMVA113A dose 1; strength, route and dose detail were not provided) both in the left arm for prophylaxis. On 19-JUL-2019, the patient experienced tic left side of face (twitching). No relevant diagnosis tests or lab data was performed. For the last four days, the event had been improved. The outcome of the event was considered as recovering (also reported that it was unknown if the patient was recovered).   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Follow up information has been received from a health professional via telephone call on 30-JUL-2020. The reporter wished to identify origin of this report. It was explained that the report was generated from VAERS report and would be requested additional information if possible. The date of administration, gender and age of patient were provided. The reporter stated that she would fax this form back upon completion. 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: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported.; patient was administered an expired dose of GARDASIL 9.; This spontaneous report was received from a medical assistant referring to a 12 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not provided.   On 21-JUL-2020, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N023952, expiration date 12-JUL-2020, strength, exact dose and route were not provided) for prophylaxis. No additional adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Nurse reported GARDASIL 9 administered to patient after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 23-JUL-2020, after a temperature excursion, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, for prophylaxis, non-valid lot #163741, expiration date reported on 16-FEB-2022. Vaccine was stored at a temperature of 8.83°C, during a time frame of 20 hours. There was no additional adverse experiences neither previous temperature excursion reported. The call was because of a data logger.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; The nurse stated on 7/28/2020 she administered and expired VAQTA; This spontaneous report as received from a nurse via company representative and refers to a 2-year-old patient of unknown gender. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.  On 28-JUL-2020, the patient was vaccinated with and expired dose of hepatitis a vaccine, inactivated (VAQTA), expiration date on 26-JUL-2020 as prophylaxis. (strength, dose, frequency, route of administration, anatomical location, and lot number not reported). No additional adverse event reported.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Side effects experienced: None; Inappropriate schedule of vaccine administered; This spontaneous report was received from a lawyer and a consumer, reporting on a 61-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-OCT-2009, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 13-NOV-2012, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 17-JUN-2016, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and site of administration were not reported for any of the vaccines) (inappropriate schedule of vaccine administered). No adverse effects were reported.   On 15-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and experienced shingles, anxiety, depression, loss of balance, bell's Palsy and enlarged aorta/cardiac aneurysm (case # 1803USA001121).  This is one of two cases from the same patient.; Sender's Comments:  US-009507513-1803USA001121:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported.; Pharmacist reported that VARIVAX which had undergone a temp excursion, had been administered to a patient.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, and previous drug reactions or allergies were not reported.     On 03-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) vial, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number S003447, which has been verified to be valid, and expiration date reported and validated as 04-FEB-2021) (product storage error) (dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). The suspect vaccine was reconstituted with 0.5 ml of Merck sterile diluent (lot number S003447, which has been verified to be valid, expiration date reported and validated as 09-NOV-2021).   The varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 18 degrees Fahrenheit (F), for a time frame of 5 hours, as recorded by the digital data logger. There was no previous temperature provided. No other adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Genital rash, Herpes zoster, Penile rash, Rash
Clinical narrative: suffered a painful rash on the penis, testicles and anus. patient was diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 17-APR-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered a painful rash on the penis, testicles and anus. The pt was diagnosed with herpes zoster. 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 the vaccine. The patient 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster on the penis, testicles and anus was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event herpes zoster on the penis, testicles and anus to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: sensorineural hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 23-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered a sudden left-sided hearing loss and was diagnosed with sudden  onset sensorineural hearing loss. 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 the vaccine. The patient 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event sensorineural hearing loss was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event sensorineural hearing loss to be disability.  Upon internal review, the event sensorineural hearing loss was determined to be medically significant.
Sex: F
Vaccine: PPV, UNK
Symptoms: Local reaction, Vaccination complication
Clinical narrative: had a localized reaction to Pneumovax 23/ vaccine related adverse reaction; potentially contaminated; This spontaneous report was received from a pharmacist, via other company, concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S024808, expiration date 02-JUN-2020) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis.    On an unknown date, the patient experienced a vaccination related reaction, she went to the emergency room (ER) and had localized reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). They were requesting to send off the needle or the vaccine box to see if it was potentially contaminated (suspected product contamination). The outcome of the event was not reported.   The reporter considered the event to be related to the suspect vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry:; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Loss of consciousness, Syncope
Clinical narrative: fainted/passed out in the doctor's office after administration of the vaccine; This spontaneous report was received from a consumer, which is also a company representative, and the patient's mother, regarding a 12-year-old female patient. The patient's medical history, concomitant medications and drug reactions or allergies were not provided.   On 03-AUG-2020, the patient had no eaten breakfast and was vaccinated with the second and last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration date were not provided). It was unknown if the patient received any other vaccinations at the same time.  On 03-AUG-2020,after administration of the vaccine, the patient fainted/passed out (syncope) in the doctor's office and sought medical attention. No treatment was needed. Later, the patient was perfectly fine and she was able to leave the doctor's office. The patient's mother wondered if as the patient had not had breakfast, this was the reason why she fainted.   On the same date, the patient had blood drawn, however no test or results were mentioned.   The reporter did not assess the relatedness between fainted/passed out and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review, the event faint/passed out was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Right sided facil droop / diagnosed with Bell's palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 21-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 25-AUG-2017, four days after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right-sided facial droop. Subsequently, on an unspecified date in August 2017, the pt was hospitalized and diagnosed with Bell's Palsy. It was also specified that 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. The event was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, Bell's Palsy was considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Dizziness, Sudden hearing loss, Tinnitus
Clinical narrative: Vertigo; Sudden idiopathic hearing loss of left ear; Sensorineural hearing loss of left ear; Tinnitus; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 23-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden left ear hearing loss and dizziness. Pt was diagnosed with sudden idiopathic, sensorineural hearing loss of left ear, tinnitus and vertigo. It was also specified that 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. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness neurosensory and sudden hearing loss were considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo; Sudden idiopathic hearing loss of left ear; Sensorineural hearing loss of left ear; Tinnitus; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 23-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden left ear hearing loss and dizziness. Pt was diagnosed with sudden idiopathic, sensorineural hearing loss of left ear, tinnitus and vertigo. It was also specified that 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. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness neurosensory and sudden hearing loss were considered medically significant.
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site rash, Injection site reaction, Rash
Clinical narrative: "a lump on her upper arm at the injection site with a rash that is now travelling down her arm".; the patient experienced an "injection site reaction"; "a lump on her upper arm at the injection site with a rash that is now travelling down her arm"; "a lump on her upper arm at the injection site with a rash that is now travelling down her arm"; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported), as prophylaxis. Following the administration of the vaccine the patient experienced an "injection site reaction", she called the pharmacist, and the pharmacist described the reaction as "a lump on her upper arm at the injection site, with a rash that was travelling down her arm" (injection site mass, injection site rash and rash).   The outcome of the events injection site reaction, injection site mass, injection site rash and rash were reported as not recovered. The causal relationship between the aforementioned events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a dose of VAQTA, which expired on 07-JUL-2020, and was inadvertently administered on 06-AUG-2020; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On 06-AUG-2020, the patient was inadvertently vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, one dosage form as prophylaxis; lot number S012250 with an expiration date on 07-JUL-2020 (expired product administrated) (strength, anatomical location and route of administration were not provided). No adverse effects reported, nor product quality complain involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received Heplisav-B Instead of Hepatitis A Vaccine; Initial Report Received on 04-Aug-2020.  A certified medical assistant (CMA) reported that an 18 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) instead of Hepatitis A immunization.  No medical history or known drug allergies were reported.   No concomitant medications were reported.  On 04-Aug-2020, the patient went into the clinic to receive Hepatitis A immunization, but instead received a dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # not reported) in the left deltoid from an advanced registered nurse practitioner.  At the time of the report, the patient did not have any adverse reactions to the injection.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: fever; fatigue; chills; nausea; headache; head spinning; left arm painful at site of injection; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the day after the vaccination, the patient experienced fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection. The clinical outcomes of fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia, Vertigo
Clinical narrative: fever; fatigue; chills; nausea; headache; head spinning; left arm painful at site of injection; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the day after the vaccination, the patient experienced fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection. The clinical outcomes of fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.