chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral, Influenza like illness, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: sudden hearing loss in right ear; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2019).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant) and influenza-like symptoms. On an unknown date, the outcome of the hearing loss unilateral and influenza-like symptoms were unknown.   It was unknown if the reporter considered the hearing loss unilateral and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient made note to himself/herself to get the 2nd dose of Shingrix on 10th March 2019, but could not find it until June 2019. The patient expereinced alot of flu like symptons and had sudden hearing loss in right ear.  The patient had been to a ear-nose-throat (ENT) specialist and done an magnetic resonance imaging (MRI) and there was no reason for the hearing loss. The patient asked if hearing loss was a side effect from Shngrix.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient presented to the pharmacy on 9/3 around 11am.  She presented with a hot, red rash on her upper left arm.  She had no fever, full range of motion.  She states the rash had not radiated elsewhere.  I drew a circle around the rash for her to reference and see if it were radiating.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Pain
Clinical narrative: Aching, chilling, temp 99.8, dizzy.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states that their arm was swollen, warm to the touch, painful, and have pinkish spot around the arms injection site
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Nausea, sweating, dizziness.  Low blood pressure and actually passed out and 911 called. Malaise and tiredness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: Nausea, sweating, dizziness.  Low blood pressure and actually passed out and 911 called. Malaise and tiredness
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Nausea, Vertigo
Clinical narrative: Severe fatigue, flu-like symptoms, vertigo, lightheadedness, nausea
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: arm swelled up and very sore. Still sore. Saturday night got flu like symptoms: chills, fever, sweats, aches. Same Sunday night. Felt like hit by a truck Sunday day. Tired, weak, sore, fatigued. Same as Monday day. Felt little better Monday Night
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm swelled up and very sore. Still sore. Saturday night got flu like symptoms: chills, fever, sweats, aches. Same Sunday night. Felt like hit by a truck Sunday day. Tired, weak, sore, fatigued. Same as Monday day. Felt little better Monday Night
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Episode of syncope approximately 4 minutes after adminstration of vaccine. Pt assessed by provider, O2 remained 97-98. Pt observed for 15 minutes laying down, and 10 minutes sitting up. Pt reassessed by provider.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Weakness with very sore upper arm 5 hours after injection; dizzyness 8 hours after injection. Next day weakness with redness and some swelling on outer upper arm below injection site down to elbow, no dizzyness. Redness and swelling spread to bicep, less muscle soreness. Second day after injection, less sore, still red upper arm, with swelling; swelling and redness spread to elbow and forearm halfway to wrist and later into inside of arm from bend in elbow half way to wrist; in evening redness turned to yellow and swelling subsided.  Today, third day after injection still feeling some weakness, but able to go about normal business; swelling and soreness subsided, still yellow but less pronounced.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling, Yellow skin
Clinical narrative: Weakness with very sore upper arm 5 hours after injection; dizzyness 8 hours after injection. Next day weakness with redness and some swelling on outer upper arm below injection site down to elbow, no dizzyness. Redness and swelling spread to bicep, less muscle soreness. Second day after injection, less sore, still red upper arm, with swelling; swelling and redness spread to elbow and forearm halfway to wrist and later into inside of arm from bend in elbow half way to wrist; in evening redness turned to yellow and swelling subsided.  Today, third day after injection still feeling some weakness, but able to go about normal business; swelling and soreness subsided, still yellow but less pronounced.
Age: 0.17
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient is 2 months old and was given and HPV vaccine instead of the PCV13. Staff noticed error when  putting vaccines in EMR.  Local state agency was made aware of event.
Age: 0.17
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 2 months old and was given and HPV vaccine instead of the PCV13. Staff noticed error when  putting vaccines in EMR.  Local state agency was made aware of event.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Periorbital pain, Pyrexia, Rash
Clinical narrative: on 8/31/19 developed a fever of 100.8 which lasted 24 hours.  Followed by a non pruritic rash on face, followed by trunk and then extremities .  Denies any  cough or sneezing.  c/o periorbital pain when moving eyes which resolved.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Electroencephalogram normal, Full blood count normal
Clinical narrative: approx. 1 hr after vaccines, was fussy. 11pm had 4 episodes of shaking 30 seconds each. approx. 10-15min apart. temp 100.1 taken  to EE. baby was calm. temp 100.6 (r) transferred to other for futher eval. BMP/CBC/UA, BCx and UCx. all neg. admitted overnight for neuro w/u (7/20-7/21/19) which was negative. discharged to home with PCP f/u. baby is to f/u with neuro in 3 mon
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Metabolic function test normal, Neurological examination normal, Tremor, Urine analysis normal
Clinical narrative: approx. 1 hr after vaccines, was fussy. 11pm had 4 episodes of shaking 30 seconds each. approx. 10-15min apart. temp 100.1 taken  to EE. baby was calm. temp 100.6 (r) transferred to other for futher eval. BMP/CBC/UA, BCx and UCx. all neg. admitted overnight for neuro w/u (7/20-7/21/19) which was negative. discharged to home with PCP f/u. baby is to f/u with neuro in 3 mon
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever started 7hrs after vaccine administration, rising above 102 degrees. Fever lasted 24 hours from onset of fever. Per Dr, we tried lukewarm baths, skin to skin, tylenol, and damp cloth on babys forehead.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: drug allergy: Pneumovax; This spontaneous report was received from a nurse via Pfizer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis. (strength, formulation, dose number, anatomical location vaccination, lot number and expiration date were not provided).       On an unspecified date, the patient experienced a drug allergy to vaccine, polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity). At the time of this report, the outcome of event drug hypersensitivity was unknown.  The causality assessment of the reported event drug hypersensitivity was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).; Sender's Comments:  US-PFIZERINC-2019343499 :
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer and th epatient regarding a case in litigation, concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 07-OCT-2014, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a health care provider at a health care department, and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose of GARDASIL 9 was administered; No adverse effect reported; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 28-AUG-2019, the patient was vaccinated with a second dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot number 1614897 and expiration date on 20-SEP-2020 (dose, route of administration and anatomical injection site were not reported) for prophylaxis.  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion of 48.5 Fahrenheit (F) degrees for 4 hours and 15 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report, because the alarm went off. No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 24-APR-2019, the patient was vaccinated with an improperly stored vaccine of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) one dose, with lot number R021078 and expiration date on 12-JUN-2021 (dose number, route of administration and anatomical injection site were not reported) for prophylaxis; or rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral vaccine, with lot number R028189 and expiration date on 06-JUN-2020 (dose and dose number were not reported) for prophylaxis.  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion of 52.5 Fahrenheit (F) degrees for 4 hours and 40 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; an improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 28-AUG-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614897, expiration date 20-SEP-2021 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 48.5 degree fahrenheit during 4 hours and 15 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of improperly stored PROQUAD; No adverse effect reported; This spontaneous report was received from a medical assistant referring  to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 21-AUG-2019, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number S003863 and expiration date on 08-AUG-2020 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis.     It was reported that on an unknown date, the vaccine was exposed to a temperature excursion between -14 Celsius (C) degrees and -10 C degrees (-14.4 C degrees) for 18 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report, since it was on calibration. No adverse effects were reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Fatigue, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Flu-like symptoms that evening and following day.  After 4 days my lower face and front of neck were numb.  Not so numb that I couldn't feel them but still numb.  That symptom persists.   Chronic headache and fatigue has increased.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: patient  was feeling under the weather over the weekend.  patient had body aches and headaches and her right arm was sore and swollen and a rash developed and was really hot.  pt went to urgent care and pt was told it was cellulitis and was given an antibiotics.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: patient  was feeling under the weather over the weekend.  patient had body aches and headaches and her right arm was sore and swollen and a rash developed and was really hot.  pt went to urgent care and pt was told it was cellulitis and was given an antibiotics.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Rash
Clinical narrative: upset stomach and headache the evening of injection the next day. 2 days later - rash/bumps on abdomen
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt explained that her arm was sore on Saturday and a little red, but nothing too bad she thought it was normal. Then on Saturday evening into Sunday morning her arm had swollen up to 3 times its size and she couldn't lift it above her head without pain. Pt continued to work it so she could go to work. It was red and hot too. Pt did not take any medication and was aware of this possibility because she has been sensitive to medications her whole life. Now her arm is normal size and just a little warm and pink, but she believes the reaction is mostly over.
Age: 66.0
Sex: F
Vaccine: TYP
Symptoms: Blood pressure increased, Dizziness, Headache
Clinical narrative: Patient took one Vivotif capsule in the evening on 8/28/2019.  She developed headache, dizziness, and she had blood pressure go up to 200 in 8/30/2019 in the morning.  She went to ER and was treated for comfort.  Her husband and she could not remember what she had in the hospital.  He called Pharmacy in the afternoon on 8/30/2019.  A pharmacist, asked him not to give his wife any more Vivotif and instructed him to monitor her symptoms until she could see her primary care doctor.    Her husband and she came to Pharmacy on 9/3/2019.  He said they just left her primary care doctor who asked Patient to discontinue Vivotif.  She was advised to take Tylenol for her headache and Meclizine for her dizziness.  Patient gave patient a list of facilities where patient could have her Vivotif disposed.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Irritability
Clinical narrative: Pt was fussy after giving vaccination, and L thigh was red. Pt's mother was given ice pack for effected area.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient started to develop a rash on 8/31/2019.  The rash was spreading down his right arm.  He was seen by an instacare provider, which prescribed him triamcinolone cream.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Within 24 hours of receiving the Shingrix vaccine the patient noticed that approximately 3 inches below the vaccine site a red and hot band had formed across the width of her arm. She presented to the pharmacy to day to show me. Her arm was still red and hot, but the area had decreased to only the front  portion of her arm. She had not taken any anti-inflammatory medications to help with the symptoms
Age: 16.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Malaise
Clinical narrative: Seen in ED on 8/27/19 for malaise, general body aches and swollen, tender and red left upper arm. No cellulitis noted. Localized reaction only.
Age: 16.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Pain
Clinical narrative: Seen in ED on 8/27/19 for malaise, general body aches and swollen, tender and red left upper arm. No cellulitis noted. Localized reaction only.
Age: 72.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Blister, Inflammation, Injection site erythema, Injection site pain, Nausea
Clinical narrative: soreness and redness at the site site of the shot, nausea and low grade fever for 4 days. On fourth day, large painful blisters appeared on both hands- Right thumb, and right middle finger as well as left ring finger
Age: 72.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: soreness and redness at the site site of the shot, nausea and low grade fever for 4 days. On fourth day, large painful blisters appeared on both hands- Right thumb, and right middle finger as well as left ring finger
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Severe dizziness, two days
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Dry skin, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Next morning patient reported noting a 2.5X2.5 area with soreness, swelling, erythema and "roughness" of the skin at the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: general tiredness on first day of vaccine.  Second-third day, large rash at injection site:  1"  red center with 3: concentric pink circle--raised, hard, and warm to the touch.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: general tiredness on first day of vaccine.  Second-third day, large rash at injection site:  1"  red center with 3: concentric pink circle--raised, hard, and warm to the touch.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: general tiredness on first day of vaccine.  Second-third day, large rash at injection site:  1"  red center with 3: concentric pink circle--raised, hard, and warm to the touch.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient is complaining of still having arm pain and a bruise in her arm - now 2 weeks later after the immunization. She may not be able to visually see herself what the arm looks like but did report this reaction over the phone.
Age: 85.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain
Clinical narrative: Patient went to the ER with chest pains.  He was treated and encouraged not to have his second shot.  They did not find anything that the patient was aware of.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Ulcer
Clinical narrative: Patient came in for FLU shot at Pharmacy complaining of "sore on arm from shot at other pharmacy".  After reviewing Shots Registry, he received shot on 5/6/19. Appears to be a nickel-sized sore on arm. Referred to dermatologist or PCP.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hot flush, Rash, Rash pruritic
Clinical narrative: Caregiver reported possible HIVES , raised red itchy patches, on the left side of her body (arm, torso, and leg). No shortness of breath. No chest pains. The red areas reported began to present on 08/21/2019 sometime post Hep B vaccination. CG states she was experiencing "hot flashed on 08/21/2019 as well. This writing nurse did not physically assess this report.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eye pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports while driving home she began experiencing pain pens and needles type sensation all over her body, including pain behind her eye and in feet.  The symptoms lasted about an hour, patient took two aspirins.  The pains were improving when patient contacted the pharmacy. Patient was advised to take benadryl and seek medical attention if symptoms persisted.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site rash, Nausea
Clinical narrative: Local rash and inflammation at site of injection and nausea
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Rash all over body, fever up to 102, muscle aches x 3 days
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Patient got edema in the feet and legs on 9/1 and hasn't resolved as of 9/3/19
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Within a few hours (about 5-6) after the vaccine was given a golfball sized knot appeared at the injection site.  It was red and hot and the swelling/knot is still very apparent 5 days later.  Very painful, unable to lift arm without causing severe pain.  Cannot sleep on left arm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Within a few hours (about 5-6) after the vaccine was given a golfball sized knot appeared at the injection site.  It was red and hot and the swelling/knot is still very apparent 5 days later.  Very painful, unable to lift arm without causing severe pain.  Cannot sleep on left arm.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Headache, Lip pruritus, Oral pruritus, Paraesthesia oral
Clinical narrative: Shortness of breath, tingly, itchy lips, itchy mouth, tachycardia, headache onset approximately two minutes after injection. 50 mg Benadryl p.o administered within 15 min of onset stopped all but the tingly lips approximately 2 hours after administration.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Tachycardia
Clinical narrative: Shortness of breath, tingly, itchy lips, itchy mouth, tachycardia, headache onset approximately two minutes after injection. 50 mg Benadryl p.o administered within 15 min of onset stopped all but the tingly lips approximately 2 hours after administration.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling, Pain, Peripheral swelling
Clinical narrative: Patient recieved vaccine on Friday. Complained about knees swelling on Saturday morning and then hand swelling on Sunday.  Patient would take some Tylenol to help with the pain and it helped alleviate the pain.  Came in on Tuesday Sept 3rd and showed the hands and knees which looked like it was a little swollen.  Advised patient to take some ibuprofen as it would help bring down some of the swelling and also to call his doctor.  I also told him that I would also contact his doctor as well.  But that he should call his doctor if the pain and swelling continues.  I also told him that I would report this incident to VAERS.  Doctors office was closed when we tried reaching out as it was already past thier hours when he came in.  Will reach out to them tomorrow.
Age: 7.0
Sex: M
Vaccine: HEP, IPV, TD
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Mother of child states that the child had a rash on arms the day after receiving vaccine, that itched & some whelps. Mother applied OTC ointment, which has helped.
Age: 11.0
Sex: M
Vaccine: HEP, IPV, TD
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Mother of child states that the child had a rash on arms the day after receiving vaccine, that itched & some whelps. Mother applied OTC ointment, which has helped.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, TD
Symptoms: Rash, Rash pruritic, Swelling, Urticaria
Clinical narrative: Mother of child states that the child had a rash on arms the day after receiving vaccines, that itched & some whelps. Some raised areas/rash on legs, as well. Mother applied OTC ointment which has helped.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hours redness, induration + warmth Seen 8/31/19 5 x 5.5 cm area redness warmth tenderness (L) humeral area
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Within 24 hours redness, induration + warmth Seen 8/31/19 5 x 5.5 cm area redness warmth tenderness (L) humeral area
Age: 10.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Computerised tomogram normal, Contusion, Loss of consciousness, Muscle rigidity, Staring
Clinical narrative: Immunizations were given without incident. After administration client walked to the front office area, where (per mother) client passed out and an ambulance was called. (Another nurse was at the front and did not seen client fall but did see client right after and states that her arms and legs were rigid and eyes wide open with no blinking). Follow up phone call with mom on 8/16; mom states that the ER did CT scan to rule out seizure activity but they think that she just got overwhelmed and passed out. Mom states client is fine now other than bruise on her cheek.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported a 2 to 3 inch rash around the injection site. Patient will follow up with doctor to see if any additional care is needed. She will hold off on getting second vaccination until she sees if this clears on it's own.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Rash, Urticaria
Clinical narrative: pain + inflammation at site up to shoulder down to elbow. Could not raise arm. Other Rash + Hives
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction however 4 yr old patient given Adacel instead of Dtap vaccine - SP to mfg and since it is Dose 5 & no reaction no re vacciation requirred. Spoke to Sanofi Pasteur re: wrong vaccine of Tdap instead of Dtap given to pt they advised since 5th in series that valid vaccine & no need to reimmunize. Patient mother notified and patient had no adverse reaction from Tdap & patient should have had Dtap.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV4, MENB, MNQ
Symptoms: Headache
Clinical narrative: None stated.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV4, MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Maternal exposure during breast feeding, Pruritus, Vaccination complication
Clinical narrative: Pt called on 9/3/19 at 7:15pm, reporting adverse reaction to flu shot (administered at 5:30pm on 9/1/19). She first noticed symptoms at around 3:00am on 9/2/19 when she got up to nurse her infant. Injection site was red and swollen (welt-like per pt), area around eyes was itchy. Also reports of itching on forehead, neck and elbows. As of now, itching and redness has started to subside. No new medications or foods recently, per pt. Pt has received flu shot in previous years without any issues/allergic reactions.
Age: 61.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: per pt she developed a flat rash about 3-4 inch area. she is also experiencing  pain and fever. She has experience it for a few days
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Bacterial test negative, Biopsy skin abnormal, Culture tissue specimen negative, Erythema, Fungal test negative
Clinical narrative: Thebiopsy resultswere positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction(RT-PCR)/were positive for vaccine-derived rubella virus (VDRV); the patient was immunodeficiency and received measles, mumps, and rubella (MMR) vaccine; This literature market report has been received from authors of a published article, titled as below, referring to a currently 11 years old male patient with Nijmegen breakage syndrome, cutaneous granulomatous disease and immunodeficiency. The patient's medical history and concomitant medication were not provided.   On unknown dates, the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, route, batch/lot number and expiration date were not provided) for prophylaxis at ages 1 and 5 years (product use issue).   On an unknown date when the patient was 10 years old  (reported as 1 year history), the patient presented with an erythematous plaque on the right cheek. Skin biopsy was performed and demonstrated sarcoidal granulomas. Tissue cultures were negative for bacteria, fungi and mycobacteria. The biopsy results were positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction (RT-PCR) (vaccine-derived rubella virus (VDRV)). Infectious virus was recovered from the biopsy by cell culture. Whole-genome sequencing of the isolated virus showed 2% nucleotide divergence from the sequence of the RA27/3 vaccine strain. A nasopharyngeal swab tested negative for rubella virus by RT-PCR. At last follow-up, the lesion remained untreated. The outcome of VDRV was considered as not recovered. The reporter considered rubella was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature(linked case# 1909USA000868).; Sender's Comments:  US-009507513-1909USA000868:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Granuloma, Immunohistochemistry, Mycobacterium test, Polymerase chain reaction positive, Rubivirus test positive
Clinical narrative: Thebiopsy resultswere positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction(RT-PCR)/were positive for vaccine-derived rubella virus (VDRV); the patient was immunodeficiency and received measles, mumps, and rubella (MMR) vaccine; This literature market report has been received from authors of a published article, titled as below, referring to a currently 11 years old male patient with Nijmegen breakage syndrome, cutaneous granulomatous disease and immunodeficiency. The patient's medical history and concomitant medication were not provided.   On unknown dates, the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, route, batch/lot number and expiration date were not provided) for prophylaxis at ages 1 and 5 years (product use issue).   On an unknown date when the patient was 10 years old  (reported as 1 year history), the patient presented with an erythematous plaque on the right cheek. Skin biopsy was performed and demonstrated sarcoidal granulomas. Tissue cultures were negative for bacteria, fungi and mycobacteria. The biopsy results were positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction (RT-PCR) (vaccine-derived rubella virus (VDRV)). Infectious virus was recovered from the biopsy by cell culture. Whole-genome sequencing of the isolated virus showed 2% nucleotide divergence from the sequence of the RA27/3 vaccine strain. A nasopharyngeal swab tested negative for rubella virus by RT-PCR. At last follow-up, the lesion remained untreated. The outcome of VDRV was considered as not recovered. The reporter considered rubella was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature(linked case# 1909USA000868).; Sender's Comments:  US-009507513-1909USA000868:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Skin plaque
Clinical narrative: Thebiopsy resultswere positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction(RT-PCR)/were positive for vaccine-derived rubella virus (VDRV); the patient was immunodeficiency and received measles, mumps, and rubella (MMR) vaccine; This literature market report has been received from authors of a published article, titled as below, referring to a currently 11 years old male patient with Nijmegen breakage syndrome, cutaneous granulomatous disease and immunodeficiency. The patient's medical history and concomitant medication were not provided.   On unknown dates, the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, route, batch/lot number and expiration date were not provided) for prophylaxis at ages 1 and 5 years (product use issue).   On an unknown date when the patient was 10 years old  (reported as 1 year history), the patient presented with an erythematous plaque on the right cheek. Skin biopsy was performed and demonstrated sarcoidal granulomas. Tissue cultures were negative for bacteria, fungi and mycobacteria. The biopsy results were positive for rubella virus by immunohistochemical analysis and reverse transcriptasepolymerasechainreaction (RT-PCR) (vaccine-derived rubella virus (VDRV)). Infectious virus was recovered from the biopsy by cell culture. Whole-genome sequencing of the isolated virus showed 2% nucleotide divergence from the sequence of the RA27/3 vaccine strain. A nasopharyngeal swab tested negative for rubella virus by RT-PCR. At last follow-up, the lesion remained untreated. The outcome of VDRV was considered as not recovered. The reporter considered rubella was related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature(linked case# 1909USA000868).; Sender's Comments:  US-009507513-1909USA000868:
Sex: U
Vaccine: MMRV, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects were reported.; The patient was administered a dose of PROQUAD by intramuscular injection; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not provided.  On 17-AUG-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, intramuscular route (incorrect route of product administration) as prophylaxis (concentration, dose, dose number, and anatomical location of vaccination were not provided); lot number was reported as R009616 and has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; (expiration date: 30-SET-2019). Also a sterile diluent (DILUENT MERCK) was used (concentration, dose, and indication was not reported), lot number was reported as R036399 and has been verified to be valid for sterile diluent; (expiration date: 20-JUL-2021). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Urticaria
Clinical narrative: lip swelling and hives; lip swelling and hives; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2019 (reported as recently), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, batch/lot#, expiration date and route were not reported) for prophylaxis.   On an unspecified date in 2019 (reported as recently), the patient had lip swelling and hives after received zoster vaccine live (ZOSTAVAX). Then the patient had oral sex wife on an unspecified date and his wife thought she had herpes simplex 2 (captured in MARRS# 1909USA000568). The outcome of lip swelling and hives was not reported.  Causality between the events and zoster vaccine live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-1909USA000568:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; two year old received improperly stored Vaqta; This spontaneous report was received from a nurse and refers to a 2-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) injection, lot # S007770 and expiration date 24-JUL-2020 (dose and route of administration were not reported) for prophylaxis. The total time and the highest temperature was above 47°F (46.8F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; One patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager (also reported as healthcare business professional) referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and drug reactions/allergies and concomitant therapies were not reported.  On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713 and expiration date 20-JUN-2020 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). The temperature excursion was reported as total time and lowest temperature below 36 degree Fahrenheit (F) (33.9 F) for 40 minutes. No additional doses were administered. No adverse effects and no product quality complaint (PQC) were reported. The call was because of data logger.  The previous excursions were reported as total time and lowest temperature below 36 degree F (30.3 F) for 90 hours and 7 minutes, total time and lowest temperature below 36 degree F (30.5 F) for 1 hour 45 minutes and total time and lowest temperature below 36 degree F (35.2 F) for 2 hours 5 minutes.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). No information about the patient's pertinent medical history, and drug reactions or allergies was provided.   On 23-AUG-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003085 with expiration date of 29-JUL-2019 (route and frequency were not reported) and, on the same date, the patient also received a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot # S005084 with expiration date of 19-FEB-2021 (route and frequency were not reported). No further information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Facial paralysis, Headache, Hypoaesthesia, Pain
Clinical narrative: vision loss/issues with his vision; Bell's palsy/numbness on the left side of his face; The vaccine did not prevent; pain; headache; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. Shortly after receive zoster vaccine live (ZOSTAVAX), the patient developed headaches, numbness on the left side of his face and issues with his vision. It was stated that the vaccine did not prevent shingles(vaccination failure), but rather caused to the patient contract pain, vision loss and Bell's palsy. In response to these symptoms, the patient went to the physician and continue under his/her care. At the time of the report, the patient continued suffering significant medical expenses, pain and other damages. The outcome of facial paralysis, headache, vaccination failure and blindness was unknown.   The reporter considered all the events to be related with zoster vaccine live (ZOSTAVAX).  Upon internal review, the events facial paralysis  and blindness were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: vision loss/issues with his vision; Bell's palsy/numbness on the left side of his face; The vaccine did not prevent; pain; headache; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. Shortly after receive zoster vaccine live (ZOSTAVAX), the patient developed headaches, numbness on the left side of his face and issues with his vision. It was stated that the vaccine did not prevent shingles(vaccination failure), but rather caused to the patient contract pain, vision loss and Bell's palsy. In response to these symptoms, the patient went to the physician and continue under his/her care. At the time of the report, the patient continued suffering significant medical expenses, pain and other damages. The outcome of facial paralysis, headache, vaccination failure and blindness was unknown.   The reporter considered all the events to be related with zoster vaccine live (ZOSTAVAX).  Upon internal review, the events facial paralysis  and blindness were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blindness, Diarrhoea, Eye operation, Headache
Clinical narrative: vision loss in both eyes; severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen/multiple shingles outbreaks; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 04-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   Shortly after receiving the Zoster Vaccine Live (ZOSTAVAX), on or about 24-AUG-2015, the patient experienced a severe outbreak of a rash and shingles on her left leg, back and the side of her abdomen, tremendous pain in her ankle as well as a sickness that included headaches, vomiting, and diarrhea. The shingles and associated injuries eventually resulted in vision loss In both eyes resulting in a surgery on her right eye in May 2016. She suffered multiple shingles outbreaks as a result of the Zoster Vaccine Live (ZOSTAVAX). As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).    Outbreak of shingles and vision loss were considered to be disabling.  Upon internal review vision loss was considered to be medically significant.