chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain, Wheezing
Clinical narrative: Pain and redness at injection site. Wheezing, chills, can?t get warm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain
Age: 2.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Ataxia, Blood glucose increased, Blood ketone body increased, Blood lactic acid normal, C-reactive protein normal
Clinical narrative: Patient started with repeated episodes of vomiting, looking pale and felt cold - mom measured his temp of 96 degrees rectally. He was taken to ER with slight elevation in glucose, ketones; normal CBC, CMP, lactate, CRP. From that point he was lethargic and couldn't walk right. Admitted to peds unit. Head CT, abd ultrasound, EKG, drug screen normal. Lumbar puncture normal, including protein, HSV and enterovirus PCR. MRI brain normal. He was ataxic for several days, but after 3-4 days his gait and activity returned to normal. Saw neurology and ID while hospitalized, assisting with his care.
Age: 2.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: CSF protein normal, Computerised tomogram head, Drug screen negative, Electrocardiogram normal, Enterovirus test negative
Clinical narrative: Patient started with repeated episodes of vomiting, looking pale and felt cold - mom measured his temp of 96 degrees rectally. He was taken to ER with slight elevation in glucose, ketones; normal CBC, CMP, lactate, CRP. From that point he was lethargic and couldn't walk right. Admitted to peds unit. Head CT, abd ultrasound, EKG, drug screen normal. Lumbar puncture normal, including protein, HSV and enterovirus PCR. MRI brain normal. He was ataxic for several days, but after 3-4 days his gait and activity returned to normal. Saw neurology and ID while hospitalized, assisting with his care.
Age: 2.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Feeling cold, Full blood count normal, Gait disturbance, Herpes simplex test negative, Lethargy
Clinical narrative: Patient started with repeated episodes of vomiting, looking pale and felt cold - mom measured his temp of 96 degrees rectally. He was taken to ER with slight elevation in glucose, ketones; normal CBC, CMP, lactate, CRP. From that point he was lethargic and couldn't walk right. Admitted to peds unit. Head CT, abd ultrasound, EKG, drug screen normal. Lumbar puncture normal, including protein, HSV and enterovirus PCR. MRI brain normal. He was ataxic for several days, but after 3-4 days his gait and activity returned to normal. Saw neurology and ID while hospitalized, assisting with his care.
Age: 2.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Metabolic function test, Pallor, Polymerase chain reaction
Clinical narrative: Patient started with repeated episodes of vomiting, looking pale and felt cold - mom measured his temp of 96 degrees rectally. He was taken to ER with slight elevation in glucose, ketones; normal CBC, CMP, lactate, CRP. From that point he was lethargic and couldn't walk right. Admitted to peds unit. Head CT, abd ultrasound, EKG, drug screen normal. Lumbar puncture normal, including protein, HSV and enterovirus PCR. MRI brain normal. He was ataxic for several days, but after 3-4 days his gait and activity returned to normal. Saw neurology and ID while hospitalized, assisting with his care.
Age: 2.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Ultrasound abdomen normal, Urine ketone body present, Vomiting
Clinical narrative: Patient started with repeated episodes of vomiting, looking pale and felt cold - mom measured his temp of 96 degrees rectally. He was taken to ER with slight elevation in glucose, ketones; normal CBC, CMP, lactate, CRP. From that point he was lethargic and couldn't walk right. Admitted to peds unit. Head CT, abd ultrasound, EKG, drug screen normal. Lumbar puncture normal, including protein, HSV and enterovirus PCR. MRI brain normal. He was ataxic for several days, but after 3-4 days his gait and activity returned to normal. Saw neurology and ID while hospitalized, assisting with his care.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Blood test normal, Electrocardiogram normal, Magnetic resonance imaging normal, Neisseria test, Seizure
Clinical narrative: Complex seizures (2) lasting >15 minutes.  Resulted in Emergency Room visit and 2-day inpatient stay.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Started with itching  all over my body, then tiny spots/vesicles appeared that when scratching bursts. Rash all over my body except the thorax. Vesicle like spots or rashes on all extremities, lower back, thighs and legs...itching. drying up now with use of hydrocortisone cream but still itchy.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: During the vaccination, I felt immediate pain and paresthesias. The LPN administering the shot stated, "that felt like it hurt". The pain initially subsided, but 2-3 hours later I began experiencing severe right shoulder pain. I also had the inability to fully abduct my and had limited range of motion.  I went back to the employee health clinic and was sent to the occupational health clinic. Once there, I saw, ARNP. She examined my arm. She gave me a shot of Toradol for the pain and prescribed a Medrol dose pack. A follow-up appointment was scheduled for 12/23/19. I have continued to have severe pain and intermitted tingling in my hand, as well as limited range of motion.
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: left shoulder/upper arm red hot swollen and painful to move that started 1 day after vaccination
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: after getting the vaccine on 11-13-19, pt stopped by on sunday at 9:30 am before the pharmacy was officially open and told me that he had cellulitis after receiving both pneumovax and fluzone shot in the same arm and he was on antibiotics for three days. He had a line of demarcation on his right arm showing redness that is about 5 inches long.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Acupuncture, Injection site pain
Clinical narrative: Developed severe pain at injection site on RIGHT upper arm starting one day after vaccination administration. Persisted at severe level for 3 weeks and is still present as of 12/20/19.  Began to slightly decrease in severity about 3 weeks after administration but still present as f 12/20/19.  Physical therapy and acupuncture seem to have helped.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Somnolence
Clinical narrative: exhaustion, 4-hour nap needs the day after first Shingrix  shot.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Feeling abnormal
Clinical narrative: shot ~11 AM. Chills began ~11 hours after shot, temp ~21 hours after shot was 101. Too tired to get out of bed the day after the shot until ~8 PM. Felt draggy for ~ days after, but it is possible that cragginess was one of the many bugs going around.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Sensory loss
Clinical narrative: arm froze immediately.   patient went to physcian and recommended physical therapy, muscle relaxant, and chiropractic therapy. feeling has just returned in past few days.  patient wasnt upset.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Myalgia
Clinical narrative: Persistent Muscle Ache/Pain reported by the patient. No treatment sought from anywhere, however pain has been uncomfortable for over one month. Patient reports discomfort when trying to raise arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient described development of rash the size of a quarter on the back of one leg. Rash resolved on its own after 3 days. was no painful, itchy or bothersome
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: CELLULITIS - ARM DOUBLING IN SIZE BY 5 HOURS AFTER VACCINE, TRAVELED TO MIDFOREARM BY 48 HOURS, AND TO WRIST BY 3RD DAY
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Injection site inflammation, Injection site swelling
Clinical narrative: Patient received IM Pneumovax and a baseball size swelling occurred at the injection site and the inflammation continued down the entire arm. It did not progress to any other part of the body, and the patient saw his PCP 3 days after and was not given any further treatment. Patient came back to the pharmacy and reported the event on 12/21/2019 and his arm was getting better. He said the swelling peaked around the 16th of December.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Hard lump at injection site and patch of red, somewhat itchy skin several inches in diameter, continuing 1 week after injection. Had fatigue and muscle pain for several days after the injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Hard lump at injection site and patch of red, somewhat itchy skin several inches in diameter, continuing 1 week after injection. Had fatigue and muscle pain for several days after the injection.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: GAVE SHINGRIX FIRST - THEN FLUZONE QUAD ABOUT AN INCH DOWN FROM SHINGRIX - AS SOON AS I GAVE THE FLU SHOT PT STARTED TO BLEED AND AREA AROUND INJECTION SITE BEGAN TO SWELL AND BRUISE (ABOUT A QUARTER IN DIAMETER) - PT STATED THAT THE SHOT DID NOT HURT AND THE INJECTION SITE DID NOT HURT EITHER.  HAD PT SIT FOR 10 MINUTES AND MONITORED FOR DIFFICULTY BREATHING OR OTHER REACTIONS INCLUDING DIZZINESS - PTS REACTION DID NOT PROGRESS FURTHER AND PT STATED THEY WERE NOT DIZZY AND WERE NOT IN ANY PAIN - ADVISED PT TO LET DOCTOR KNOW AND MADE A NOTE IN PTS PROFILE - TOLD PT TO GIVE US A CALL IF ANYTHING CHANGES
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema infectiosum, Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Rash
Clinical narrative: Pt developed fever, sore throat, tachycardia and rash the following day. Diagnosed with fifth disease.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Streptococcus test, Tachycardia
Clinical narrative: Pt developed fever, sore throat, tachycardia and rash the following day. Diagnosed with fifth disease.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Magnetic resonance imaging, Neuritis, Neurological examination, Vestibular disorder
Clinical narrative: 3 cases of Zoster Sine Herpete in 9 months since vaccine administered. First of the 3 episodes (left side V 3)  resulted in hospitalization with viral vestibular neuritis, which has caused ongoing significant disequilibrium.  2nd of 3 was in right face V3 & V4 nerve tracts with complete resolution. 3rd of 3 was in same nerve tract as 1st (left V3) and has not completely resolved after 14 days of valacyclovir treatment. I had received a high strength flu vaccine 2 days before episode 3.  Prior to Shingrix I had mild, rare (every few years) episodes of ZSH with no significant symptoms and no ongoing problems related to the ZSH.
Age: 34.0
Sex: M
Vaccine: JEV1, MNQ, YF
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Injection site is swollen, red, and tender to touch.  Arm feels numb, and tingly
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood magnesium, Full blood count, Metabolic function test, Muscular weakness
Clinical narrative: Weakness to legs
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Gastric dilatation, Gastrointestinal disorder
Clinical narrative: On 12/17/19, patient said she had fever and chills, aches, headache, pain and redness at the injection site, and fatigue. On 12/18/19, she said she had severe diarrhea and vomiting. On 12/19 and 12/20, she said her stomach felt distended and she was unable to eat solid food, but she began to have normal bowel movements.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: On 12/17/19, patient said she had fever and chills, aches, headache, pain and redness at the injection site, and fatigue. On 12/18/19, she said she had severe diarrhea and vomiting. On 12/19 and 12/20, she said her stomach felt distended and she was unable to eat solid food, but she began to have normal bowel movements.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: On 12/17/19, patient said she had fever and chills, aches, headache, pain and redness at the injection site, and fatigue. On 12/18/19, she said she had severe diarrhea and vomiting. On 12/19 and 12/20, she said her stomach felt distended and she was unable to eat solid food, but she began to have normal bowel movements.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Burning sensation, Headache, Injection site pain, Oral herpes
Clinical narrative: dizziness; shingles type rash developed only on the right side of the spine; itchy; fever blister on lip; tinnitus on the ear; burning when I scratched it; scratched; injection site on my arm was very sore; injection site on my arm was very red; headache; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 6 years ago).   On 19th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain, injection site erythema and headache were recovered/resolved and the outcome of the dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the injection site on my arm was very sore and red for at least 7 days. The patient had a severe headache for a week, also dizziness and a shingles type rash developed only on the right side of spine. This rash was itchy and burning when scratched it. After several doses of Valtrex it subsided and is now starting to disappear. The patient developed a fever blister on my lip. But the worst symptom since the shot is the tinnitus in my ears. It was constant and very loud. My right ear was worse than the left. The patient did not have any adverse reaction to that vaccine. The patient concerned that and had some sort of systemic reaction to a component of this vaccine and hesitant to receive the second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Tinnitus
Clinical narrative: dizziness; shingles type rash developed only on the right side of the spine; itchy; fever blister on lip; tinnitus on the ear; burning when I scratched it; scratched; injection site on my arm was very sore; injection site on my arm was very red; headache; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 6 years ago).   On 19th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain, injection site erythema and headache were recovered/resolved and the outcome of the dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the injection site on my arm was very sore and red for at least 7 days. The patient had a severe headache for a week, also dizziness and a shingles type rash developed only on the right side of spine. This rash was itchy and burning when scratched it. After several doses of Valtrex it subsided and is now starting to disappear. The patient developed a fever blister on my lip. But the worst symptom since the shot is the tinnitus in my ears. It was constant and very loud. My right ear was worse than the left. The patient did not have any adverse reaction to that vaccine. The patient concerned that and had some sort of systemic reaction to a component of this vaccine and hesitant to receive the second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: dizziness; shingles type rash developed only on the right side of the spine; itchy; fever blister on lip; tinnitus on the ear; burning when I scratched it; scratched; injection site on my arm was very sore; injection site on my arm was very red; headache; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 6 years ago).   On 19th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain, injection site erythema and headache were recovered/resolved and the outcome of the dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the injection site on my arm was very sore and red for at least 7 days. The patient had a severe headache for a week, also dizziness and a shingles type rash developed only on the right side of spine. This rash was itchy and burning when scratched it. After several doses of Valtrex it subsided and is now starting to disappear. The patient developed a fever blister on my lip. But the worst symptom since the shot is the tinnitus in my ears. It was constant and very loud. My right ear was worse than the left. The patient did not have any adverse reaction to that vaccine. The patient concerned that and had some sort of systemic reaction to a component of this vaccine and hesitant to receive the second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Rash pruritic, Rash vesicular, Scratch, Tinnitus
Clinical narrative: dizziness; shingles type rash developed only on the right side of the spine; itchy; fever blister on lip; tinnitus on the ear; burning when I scratched it; scratched; injection site on my arm was very sore; injection site on my arm was very red; headache; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 6 years ago).   On 19th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain, injection site erythema and headache were recovered/resolved and the outcome of the dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, headache, dizziness, vesicular rash, itchy rash, fever blister, tinnitus, burning sensation and scratch to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and the injection site on my arm was very sore and red for at least 7 days. The patient had a severe headache for a week, also dizziness and a shingles type rash developed only on the right side of spine. This rash was itchy and burning when scratched it. After several doses of Valtrex it subsided and is now starting to disappear. The patient developed a fever blister on my lip. But the worst symptom since the shot is the tinnitus in my ears. It was constant and very loud. My right ear was worse than the left. The patient did not have any adverse reaction to that vaccine. The patient concerned that and had some sort of systemic reaction to a component of this vaccine and hesitant to receive the second dose.
Age: 54.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: Are soreness, tissue necrosis
Age: 54.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Pain in extremity, Soft tissue necrosis
Clinical narrative: Are soreness, tissue necrosis
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: My arm became red & swollen and it hurt. It also became itchy. The lasted for close to 2 weeks.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: My arm became red & swollen and it hurt. It also became itchy. The lasted for close to 2 weeks.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Tongue swelling; This case was reported by a other health professional via call center representative and described the occurrence of swollen tongue in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced swollen tongue. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swollen tongue was recovered/resolved.   It was unknown if the reporter considered the swollen tongue to be related to Shingrix.  Additional details were provided as follows:  After receiving a dose of Shingrix at 1.45pm in the afternoon, the patient started tongue swelling at evening. The patient reported they took Benadryl and that helped. It was resolved, but exact date of resolution was unknown. Consent to follow up was provided.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling; This case was reported by a other health professional via call center representative and described the occurrence of swollen tongue in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced swollen tongue. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swollen tongue was recovered/resolved.   It was unknown if the reporter considered the swollen tongue to be related to Shingrix.  Additional details were provided as follows:  After receiving a dose of Shingrix at 1.45pm in the afternoon, the patient started tongue swelling at evening. The patient reported they took Benadryl and that helped. It was resolved, but exact date of resolution was unknown. Consent to follow up was provided.
Age: 0.92
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was administered the first dose of VAQTA ten days before the patient turned one year old.; This spontaneous report as received from a physician concerning to a 11-month-old patient of unknown gender and ethnicity. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications were reported.  On 06-OCT-2011, ten days before the patient turned one year old, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) with lot number reported as 1068AA which has been verified to be a valid lot number for hepatitis A vaccine, inactivated, and with an expiration date not reported, but upon internal validation established as 09-MAY-2014 (strength, dose, route of administration, and injection site were not provided) for prophylaxis (product administered to patient of inappropriate age). No product quality complaint was involved.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a male patient received improperly stored VAQTA; on 11/5/2019, a male Patient received improperly / expiration date was validated to be 05-MAY-2019; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored, expired dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 (units not provided), lot # S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019, for prophylaxis. No additional adverse effect was reported.  The vaccine was stored in 47 degrees Fahrenheit (F) for 1.39 h. The previous temperature excursion was in above 47 F for 13.35 h. The improper storage was recorded by Digital Data Logger.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse events; patient received V AQTA pediatric dose instead of adult dose.; patient received V AQTA pediatric dose instead of adult dose.; This spontaneous report as received from a nurse refer to a patient of unknown age. No information regarding the patient's medical history, concomitant medication and concurrent conditions was provided. On 21-NOV-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S021092 for prophylaxis. The patient received pediatric dose instead of adult dose. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adver event; Patient was administered an improperly stored PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.       On 21-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S021324, with an expiration date in 05-JAN-2021), for prophylaxis (strength, dose, frequency and route were not provided), that underwent two temperatures excursions, the first from 6 degrees Fahrenheit to 14  degrees Fahrenheit , during a time frame of 11 hours and 30 minutes, and the second, from 6  degrees Fahrenheit to 14  degrees Fahrenheit, during a time frame of 18 hours. The dose was reconstituted with properly stored sterile diluent. digital data logger was not involved, and no additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: patient has reported no symptoms; patient received unspecified dose in VAQTA series that was improperly stored; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.     On 30-OCT-2019, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # S009562 has been verified to be a valid lot number for hepatitis A vaccine, inactivated (VAQTA), expiration date was reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019; route, unknown) ; unspecified dose in series for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was 48 degrees Fahrenheit for a time frame of 30 minutes. Previous temperature excursions were 50.4 degrees Fahrenheit for 30 minutes and 47.3 degrees Fahrenheit for 30 minutes. The call was because of a data logger. The patient had no symptoms. No product quality complaint presented.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional symptoms reported; patient received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a medical assistant and it refers to a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-NOV-2019, the patient was vaccinated with unspecified dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #S002497, expiration date: 23-JUL-2020 for prophylaxis (dose number and route of administration were not reported). Albumin status has been verified as recombinant human albumin (rHA). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with a properly stored diluent. Administered dose of vaccine experienced the temperature excursion of 6.5 degrees Fahrenheit for 20 minutes, previous temperature excursion included 8.1 degrees Fahrenheit for 25 minutes. Digital Data Logger was involved. There was no additional symptoms reported.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; a set of twins were "likely both" administered a dose of MMRll past the expiration date; This spontaneous report was received from a nurse referring to a 13 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 28-OCT-2014, the patient (one of a set of twins) was likely administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) (lot # H018948, expiration date 18-OCT-2014; strength, dose and route were not reported) which past the expiration date for prophylaxis (expired product administered). No additional adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA006949:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: she may have been vaccinated with "an HPV vaccine" previously; the patient had a pap smear done, which showed that the patient had a ''high risk type of HPV".; This spontaneous report was received from a nruse referring to a 24 year old female patient. The patient had no pertinent medical history, concomitant medication and drug reactions/allergies.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for disease prevention (product origin unknown). On 30-OCT-2019, the patient had done a pap smear, which showed that the patient had a high risk type of human papillomavirus (HPV) (human papilloma virus infection). There was no treatment to the patient. Medical attention had been sought. The outcome of human papilloma virus infection was reported as not recovered.   The causality between human papilloma virus infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Facial paresis, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; suffered left-sided facial weakness/diagnosed with Bell's Palsy; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 06-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered left-sided facial weakness and was diagnosed with Bell's Palsy as well as suffered an upper respiratory infection. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, 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 the vaccination, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.  The events of Bell's Palsy and upper respiratory infection were considered to be disabling. Upon internal review, the event of Bell's Palsy was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Diplopia, VIth nerve paralysis
Clinical narrative: double vision / diagnosed with sixth nerve palsy; hearing loss / diagnosed with sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 27-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered double vision and was diagnosed with sixth nerve palsy and also suffered hearing loss and was diagnosed with sensorineural hearing loss. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, 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 patient had not recovered from the events. The reporter considered sixth nerve palsy and sensorineural hearing loss to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, sixth nerve palsy and sensorineural hearing loss were determined to be medically significant and to be disabling.
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: The nurse mentioned that her son developed cellulitis after receiving VARIVAX; This spontaneous report was received from a registered nurse regarding her son of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, (dose, route of administration, anatomical site of injection, lot number, and expiration date was not reported).   On an unspecified date, the patient developed cellulitis after receiving varicella virus vaccine live (Oka/Merck) (VARIVAX). The outcome of cellulitis was not reported. It was unknown if he sought medical attention or if performed any laboratories or studies.   The causal relationship between the event cellulitis and varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine was not provided.   Upon internal review, the event cellulitis was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; vaccinated with a first dose of GARDASIL 9 on 12-AUG-2019 and the patient wanted to receive her second dose yesterday on 17-DEC-2019; This spontaneous report was received from a pharmacist referring to a 19 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 12-AUG-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and on 17-DEC-2019 (reported as " the patient wanted to receive her second dose yesterday"), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (inappropriate schedule of product administration); for prophylaxis (strength, dose, route, anatomical location, lot number and expiry date were not reported). No adverse event was reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; patient was inadvertently adminstered a dose of MMR II which expired on 04-DEC-2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 18-DEC-2019 the patient was inadvertently vaccinated a dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot number N034002 and expiry date 04-DEC-2019 (strength, route and anatomical location were not reported) (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored PROQUAD was administered to patient; No adverse event; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 18-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, formulation, dose/frequency, route were unknown) lot # S003176, expiry date: 30-JUL-2020 for prophylaxis (product storage error). The vaccine was stored at a temperature of 3.4 degree Celsius(minus 9 degree Celsius to minus 8 degree Celsius) for 98 hours 45 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient eas administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 17-DEC-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S013711 with expiration date on 01-NOV-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  There was a previous temperature excursion from -14 to -10 degrees Celsius (C) (-10.9 C) for 15 minutes. Then, administered doses of vaccine experienced a temperature excursion from -14 to -10 C (-11.8 C) for 1 hour 30 minutes. Digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient was administered an improperly stored of MMR II; This spontaneous report was received from a health professional (medical assistant) referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. Concomitant therapies included sterile diluent. On 17-DEC-2019, the patient was vaccinated with an improperly stored dose (1 dosage form) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S006647 and expiry date 05-MAR-2021, for prophylaxis (strength, route and anatomical location were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 9.4 degree Celsius for 25 minutes, as recorded by a data logger. No previous temperature excursion was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Brain stem infarction, Cerebrovascular accident, Dizziness
Clinical narrative: stroke involving basilar artery and a small pontine infarct; Information has been received from lawyers referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or around 20-DEC-2019, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).    On an unknown date in December 2019 (three days after vaccination), the patient experienced dizziness, aphasia and generalized weakness. The patient was diagnosed with a stroke involving basilar artery and a small pontine infarct. The patient did not recover from the event. As per the reporter, 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. The event was disabling.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine in use; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.     The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. On 18-DEC-2019, the patient was vaccinated with the improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # S004399, expiry date: 06-NOV-2020) (strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis.      It was reported that the vaccine was exposed to a temperature of 9.4 Celsius (C) for a time frame of 25 minutes (product storage error). There was previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report. The outcome of product storage error was unknown.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine in use; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.    The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. On 18-DEC-2019, the patient was vaccinated with the improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004399, expiry date: 06-NOV-2020) (strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis.      It was reported that the vaccine was exposed to a temperature of 9.4 Celsius (C) for a time frame of 25 minutes (product storage error). There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: myalgia; malaise; arm pain that lasted 24 hours; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, myalgia and malaise. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the myalgia and malaise were unknown.   It was unknown if the reporter considered the pain in arm, myalgia and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of Shingrix. He did not had any reactions with 1st dose. With 2nd dose, he reports, myalgia, malaise, arm pain that lasted 24 hours. He said it did not interfere with daily activities.