chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Ear pain, Facial paralysis, Facial paresis, Foreign body sensation in eyes
Clinical narrative: left ear pain/numbness and tingling on right side of face and left side facial weakness.  starting several hours after vaccination. sensation of FB when laying on that side. initially treated with otc advil/tylenol and cortisporin drops. five drops three times a day for seven day in affected ear. Right side paresthesias resolved bit left side facial weakness persisted. Pt seen the next day at an urgent care clinic and diagnosed with Bell's Palsy. Pt given steroids there and completed course (dose, strength and length of course unknown). It did not help. Primary doctor called in valtrex for her, no change in sx. On patient follow up 8/14/2020 complains of left 4th and 5th fingers numbness. Pt uses artificial eye drops every three hours. blurry vision at times, sometimes L eye feels dry and gritty.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Vision blurred
Clinical narrative: left ear pain/numbness and tingling on right side of face and left side facial weakness.  starting several hours after vaccination. sensation of FB when laying on that side. initially treated with otc advil/tylenol and cortisporin drops. five drops three times a day for seven day in affected ear. Right side paresthesias resolved bit left side facial weakness persisted. Pt seen the next day at an urgent care clinic and diagnosed with Bell's Palsy. Pt given steroids there and completed course (dose, strength and length of course unknown). It did not help. Primary doctor called in valtrex for her, no change in sx. On patient follow up 8/14/2020 complains of left 4th and 5th fingers numbness. Pt uses artificial eye drops every three hours. blurry vision at times, sometimes L eye feels dry and gritty.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: patient called today c/o redness and very painful right arm even 8 days after immunization.
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Dizziness, Feeling abnormal, Mydriasis, Tremor, Unresponsive to stimuli
Clinical narrative: patient received Shingrix first, then the Fluad. moments after the Fluad was given she mentioned her left arm felt odd and she began to feel faint. Moments after that, her pupils dilated slightly, she had small tremors and became unresponsive for about 10-15 seconds. She then regained composure and marked that she wasn't expecting this to happen. I asked if she had a known seizure disorder and she confirmed she has had absence seizures in the past, but that these last occurred more than 5 years ago, and she was on no medication to control them. While questioning her and attempting to make her more comfortable, she seized again for another 15 seconds, requiring me to give her support to prevent falling out of the chair. Once that was resolved she was given water.  I allowed her to sit as long as she desired while she recovered which ended up being around 10 minutes. When I went to check on her she had stood up and collected her things. I asked if she would like emergency medical services, and she declined, she indicated she would ask her husband to come pick her up from the pharmacy. She then thanked me for helping her and left on her own accord. This is the last interaction with the patient as of documenting the event.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Electroencephalogram, Epilepsy, Magnetic resonance imaging, Neurological decompensation, Seizure
Clinical narrative: This child was diagnosed with advanced epilepsy at the Clinic after progressive neurologic decline, starting 2 weeks after these 2 vaccinations were given. She was ultimately started on anti-epileptic drugs to stop the 10+ seizures she was having daily.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, Flatulence
Clinical narrative: Discovered after vaccine given that it was past expiration date of 06/26/2020. Informed mother by phone,. Mother said child had some increase in intestinal gas that night. Denies other changes or concerns.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient came to the pharmacy and reported that her injection site was read and sore.
Age: 69.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Epistaxis, Headache, Injected limb mobility decreased, Lacrimation increased, Limb discomfort
Clinical narrative: Patient reported got vaccine on 8/27/2020, the symptoms start within 24 hours included skin rash on the portion of his right forehead (rash seems red, swelling and itchy), needle like pain in the head, eye watery, eye blurry if concentrate for approximate 5 minutes. Left arm felt heavy, and had hard time to lift, but it got better after 2 days. On 9/1/2020, Patient noticed there were a spot of bleeding nose once, and then it went away. Patient described on Tuesday 9/1/2020, the symptoms were worse, and today 9/3/2020 he came in to the pharmacy and he stated it gets better. The rashes on forehead is still swelling and red.
Age: 69.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Swelling, Vision blurred
Clinical narrative: Patient reported got vaccine on 8/27/2020, the symptoms start within 24 hours included skin rash on the portion of his right forehead (rash seems red, swelling and itchy), needle like pain in the head, eye watery, eye blurry if concentrate for approximate 5 minutes. Left arm felt heavy, and had hard time to lift, but it got better after 2 days. On 9/1/2020, Patient noticed there were a spot of bleeding nose once, and then it went away. Patient described on Tuesday 9/1/2020, the symptoms were worse, and today 9/3/2020 he came in to the pharmacy and he stated it gets better. The rashes on forehead is still swelling and red.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Skin warm
Clinical narrative: Pt reported with large painful rash, warm to touch on arm. approximately- 6X4 inches. developed less than 24 hours after vaccination. denies anaphylaxis, fever. Pt is calling md and will start antihistamines and H1blockers while icing the area.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong immunization for patient based on age.
Age: 29.0
Sex: M
Vaccine: FLU4, HEPAB, TDAP
Symptoms: Abdominal discomfort, Asthenia, Headache, Nausea, Pain in extremity
Clinical narrative: Headache, Fever, Pain in Extremities, nausea/stomach upset, weakness
Age: 29.0
Sex: M
Vaccine: FLU4, HEPAB, TDAP
Symptoms: Pyrexia
Clinical narrative: Headache, Fever, Pain in Extremities, nausea/stomach upset, weakness
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling cold, Pollakiuria
Clinical narrative: - urinated 6 times every hour throughout the night - at 3am she got cold - went to sleep early at 8pm
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PATIENT CALLED TO THE PHARMACY TODAY. HE REPORTED FEELING PAINS IN HIS JOINT OF THE KNEE,LEGS, FEET, AND HIPS. THE PAIN STARTED 4 DAYS AFTER THE VACCINATIONS AND IS STILL ONGOING. HE REPORTED THAT HE HAS TO TAKE IBUPROFEN TO CONTROL THE PAIN. PATIENT MADE A DOCTOR'S APPOINTMENT ON 9/4/20 TO SEE THE  DOCTOR REGARDING THE PAIN.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness
Clinical narrative: PATIENT CALLED TO THE PHARMACY TODAY. HE REPORTED FEELING PAINS IN HIS JOINT OF THE KNEE,LEGS, FEET, AND HIPS. THE PAIN STARTED 4 DAYS AFTER THE VACCINATIONS AND IS STILL ONGOING. HE REPORTED THAT HE HAS TO TAKE IBUPROFEN TO CONTROL THE PAIN. PATIENT MADE A DOCTOR'S APPOINTMENT ON 9/4/20 TO SEE THE  DOCTOR REGARDING THE PAIN.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered
Clinical narrative: unknown
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Immediate post-injection reaction, Malaise
Clinical narrative: Immediate bruise then to red hot swollen mark about the size of a baseball.   Aches chills fever malaise migraine headache    Still achy headache today 9/3 with red tender soar arm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Immediate bruise then to red hot swollen mark about the size of a baseball.   Aches chills fever malaise migraine headache    Still achy headache today 9/3 with red tender soar arm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Immediate bruise then to red hot swollen mark about the size of a baseball.   Aches chills fever malaise migraine headache    Still achy headache today 9/3 with red tender soar arm
Age: 79.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Arthralgia, Dyspnoea, Pain, Pyrexia
Clinical narrative: patient was experiencing low grade fever 99.5 F and all over body aches and joint pain. She said she had trouble breathing in the evening while asleep but she was better when I spoke with her today and she said she had experienced difficult breathing in the past. Resolved at the moment. She is able to complete day to day tasks/activities. Discussed with her to try acetaminophen for fever, and to inform us of any worsening of reactions and to seek medical care if adverse reactions worsen or do not improve.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: 6 hours after injection, mild headache, painful injection site and fatigue.  18 hours after vaccination, fever of 99.8, sore muscles, very painful injection site, extremely fatigued.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Chills, due like symptoms, achy into 2 day
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: Had severe pain in arm, extremely tired and could not get up, shivering, headache. Later in day had a fever and light headed.  By day 4 I had a rash on arm that was hot and my arm was extremely painful I could barely lift it.  Rash is still on arm and hot on day 6.  I hope it will be gone soon(Dr recommended cold packs and tylenol)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash, Skin warm
Clinical narrative: Had severe pain in arm, extremely tired and could not get up, shivering, headache. Later in day had a fever and light headed.  By day 4 I had a rash on arm that was hot and my arm was extremely painful I could barely lift it.  Rash is still on arm and hot on day 6.  I hope it will be gone soon(Dr recommended cold packs and tylenol)
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Nodule, Pain in extremity
Clinical narrative: THE PATIENT EXPRESSED PAIN IN HER LEFT ARM AND FELT A KNOT ON HER COLLAR BONE FROM RECEIVING FLU VACCINE ON 9/1/20. SHE WAS UNABLE TO LIFT HER ARM HIGHER THAN SHOULDER HEIGHT WHEN SHE CAME TO THE PHARMACY ON 9/3/20. SHE EXPRESSED AS NUMBNESS IN HER ARM. SHE INITIALLY FELT THE PAIN ON THE DAY AFTER RECEIVING THE FLU VACCINE ON 9/2/20. SHE RESTED HOME BUT THE PAIN BECAME WORSE THE NEXT DAY. THE PATIENT HAD POSSIBLE TEAR ON LEFT BICEPS ABOUT 2 MONTHS AGO, WHICH SHE NEVER SAW A DR AND DID NOT RECOVER FULLY. THE PATIENT HAS AN IMPLANT IN HER RIGHT ARM AND INJECTION IN THE ARM WAS NOT AN OPTION. THE PATIENT WAS ADVISED TO ICE AND REFRAIN FROM USING HER LEFT ARM.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient received a dose after saying he completed series. no known abnormalities
Age: 67.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Significant arm soreness and tenderness to the touch on arm that pneumovax 23 was injected into.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: pt reported fever, chills nausea from 9pm til 5am. at 10am on 9/2/2020 she reports being fine now
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Irregular breathing, Loss of consciousness, Paraesthesia
Clinical narrative: Received flu shot during shift at hospital. Started with prickly feeling in face and arms less than 1 minute after injection. Notified coworker. Lost awareness. When regaining awareness, was surrounded by coworkers who asked me to get into the gurney and gave me water. Per my coworkers, my skin flushed very red, was staring straight ahead, arms were shaking, breathing was irregular. They said it looked like seizure activity. As I started to look better, they said I was talking but have no recollection of saying anything. They said it lasted less than 1 minute. I noticed I was dripping in sweat when I became more aware.   Manufacturer: GlaxoSmithKline (Flulaval)
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure like phenomena, Staring, Tremor
Clinical narrative: Received flu shot during shift at hospital. Started with prickly feeling in face and arms less than 1 minute after injection. Notified coworker. Lost awareness. When regaining awareness, was surrounded by coworkers who asked me to get into the gurney and gave me water. Per my coworkers, my skin flushed very red, was staring straight ahead, arms were shaking, breathing was irregular. They said it looked like seizure activity. As I started to look better, they said I was talking but have no recollection of saying anything. They said it lasted less than 1 minute. I noticed I was dripping in sweat when I became more aware.   Manufacturer: GlaxoSmithKline (Flulaval)
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Peripheral swelling, Skin discolouration
Clinical narrative: immediately after administering the fluzone flu vaccine IM left arm, patient's upper arm (deltoid) began to swell to about the size of a golf ball.  red and purple in color .  the swelling was instant and did not worsen after a few minutes
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Feeling hot, Pain
Clinical narrative: Patient reported feeling feverish and very tired.  She has been achy all over her body all day.  She feels very hot and likes she's been dragging all day.  She did admit to not eating very much at all.  She may try and take some tylenol and eat some food for nourishment.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported feeling feverish and very tired.  She has been achy all over her body all day.  She feels very hot and likes she's been dragging all day.  She did admit to not eating very much at all.  She may try and take some tylenol and eat some food for nourishment.
Age: 29.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site bruising, Myalgia
Clinical narrative: Bilateral arm myalgias and bilateral lower extremity myalgias. Bruise at injection site
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Patient reported eating and having a beer after getting his vaccine.  A couple of hours later he experienced difficulty breathing (shortness of breath/tightness).  He said it lasted for about an hour and then went away.  He has since been fine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Severe tinnitus in both ears,  hissing, high pitched whine Nausea Chills Body aches  Joint pain in hips and knees  Headache Fatigue  Diarrhea  Malaise
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Tinnitus
Clinical narrative: Severe tinnitus in both ears,  hissing, high pitched whine Nausea Chills Body aches  Joint pain in hips and knees  Headache Fatigue  Diarrhea  Malaise
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Irritability, Lethargy, Rash, Vomiting projectile
Clinical narrative: Rash. Dehydration. Yellow projectile vomiting 3 times within 4 hours. Irritable. Lethargic.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: X-ray gastrointestinal tract abnormal
Clinical narrative: Rash. Dehydration. Yellow projectile vomiting 3 times within 4 hours. Irritable. Lethargic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Pain at inject site, muscle pain, tiredness, flu like symptoms
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site urticaria, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: 24 hrs after vaccines given patient came back to office with, redness, swelling, itchy & sore to touch (L) arm upper wheal 30 x 20 mm & (L) arm lower wheal 10 x 12 mm. 48 hrs from IZ L upper 40x60mm - used benadryl & IBU
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 24 hrs after vaccines given patient came back to office with, redness, swelling, itchy & sore to touch (L) arm upper wheal 30 x 20 mm & (L) arm lower wheal 10 x 12 mm. 48 hrs from IZ L upper 40x60mm - used benadryl & IBU
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling & pain in arm & down to hand. Noticed the next morning after getting the shot.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Abnormal behaviour, Computerised tomogram, Electrocardiogram, Syncope, Vomiting
Clinical narrative: 1415 Patient's mom called stating he had fainted at work & he Kept asking her the same question over & over. I asked her to take him to the ER immediately. I asked her to Please call back. 1615 called & spoke with Patient he seemed show to respond to question. He did say he Just vomited. Mom Not there spoke with Aunt they had not taken him to ER. Encouraged Them again, Told Them he could have concussion. 9/3 spoke with patient he states he is doing really good. He reports in ER give IV (which really helped) CT & EKG done.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: patient had syncopal event after admin of all 3 vaccines. Easy to arouse but took approx 45-60 min to recover
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: redness, swelling , 3 inch diameter
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient having stiff neck, not able to get out of bed
Age: 76.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dizziness
Clinical narrative: Within 2 minutes of vaccination, patient was light headed. Patient was asked to sit - water and orange juice give to patient EMS called, however patient declined
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Lower body joint swelling; Stiffness; pain in hips, knees and ankles; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced swollen joints, stiffness and pain in hip. The patient was treated with ibuprofen. On an unknown date, the outcome of the swollen joints and stiffness were not recovered/not resolved and the outcome of the pain in hip was unknown.   It was unknown if the reporter considered the swollen joints, stiffness and pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix about 5 weeks ago and have had severe lower body joint swelling and stiffness starting about 5 days after the vaccine and it has not gotten better.  The patient also reported severe pain in hips, knees and ankles. The patient took ibuprofen.  The reporter asked how much longer it would last. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Lower body joint swelling; Stiffness; pain in hips, knees and ankles; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced swollen joints, stiffness and pain in hip. The patient was treated with ibuprofen. On an unknown date, the outcome of the swollen joints and stiffness were not recovered/not resolved and the outcome of the pain in hip was unknown.   It was unknown if the reporter considered the swollen joints, stiffness and pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix about 5 weeks ago and have had severe lower body joint swelling and stiffness starting about 5 days after the vaccine and it has not gotten better.  The patient also reported severe pain in hips, knees and ankles. The patient took ibuprofen.  The reporter asked how much longer it would last. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Large 3in x 2 in reddened area, hard, tender, hot to the touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Severe headache, alternating chills and sweats, lack of appetite and 3 x 5 inch redness on skin at site of the injection, limited to contour of the bicep injected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: Hot/cold, cold sweats, dizzy, nauseous, body aches, lethargic, headache, loss of appetite, injection sight pain, lower back and shoulder pain, not thinking clearly, unable to do daily routine  functions.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Injection site pain, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Hot/cold, cold sweats, dizzy, nauseous, body aches, lethargic, headache, loss of appetite, injection sight pain, lower back and shoulder pain, not thinking clearly, unable to do daily routine  functions.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental impairment, Nausea, Pain
Clinical narrative: Hot/cold, cold sweats, dizzy, nauseous, body aches, lethargic, headache, loss of appetite, injection sight pain, lower back and shoulder pain, not thinking clearly, unable to do daily routine  functions.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer and an elderly female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) in a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of the event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, (dosage regimen and route of administration were not provided), lot number S036635, expiration date 14-NOV-2021, as prophylaxis.   The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -16.07 degree Fahrenheit (F) for a period of less than 25 minutes (reported as -25 minutes), without previous temperature excursion. The call was because a digital data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: acute herpes zoster neuropathy; acute herpes zoster neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a pharmacist. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for acute herpes zoster neuropathy. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will 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 acute herpes zoster neuropathy was considered as not recovered. The causality was assessed as related by the lawyer.  Upon internal review, acute neuropathy was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; tempreature excursion that was intermittent beginning 28-JUL-2020/there have been administered doses; This spontaneous report as received from an nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not reported.   On 28-JUL-2020, varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T002843 verified to be valid with expiration date of 23-JAN-2022, and lot number S032357 verified to be with expiration date 14-OCT-2021) were exposed to a temperature excursion that was intermittent; these doses of vaccine were stored between -14 degrees Celsius (C) to -10 C for a 38 hours and 30 min. There was not a previous temperature excursion. Digital data logger was involved (product storage error).  On an unknown dates, the patient was vaccinated with the improperly storage varicella virus vaccines live (oka/merck) (VARIVAX) reported above at a dose of 0.5 mL (vaccination scheduled, route of administration, and anatomical location was not provided). No adverse event was reported.; Sender's Comments:  US-009507513-2008USA014711: US-009507513-2008USA014701:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 29-NOV-2012 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a healthcare provider. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for shingles. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will 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 shingles was considered as not recovered. The causality was assessed as related by the lawyer.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 27-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 24-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 (also reported as TOO2843) and expiration date reported as 23-JAN-2022) (strength, frequency and route of administration were not reported)  The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was previous temperature excursion.   A digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine that was administered to a patient after temperature excursion occured; This spontaneous report has been received from a nursing assistant concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.        On 13-AUG-2020,  the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX)  formulation not provided but defaulted to subcutaneous injection, Lot # T002846 and  expiration date 23-JAN-2022  for prophylaxis (dosage regimen was not provided). The storage temperature was reported to had been at  -10.2°C for 1 hour and 53 minutes.            There was digital data logger involved and  no previous temperature excursion was reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950:AE case # 01697219 US-009507513-2008USA014798:AE case #01697207 US-009507513-2008USA014951:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: TEMPERATURE EXCURSION INVOLVING VARIVAX; This spontaneous report has been received from a registered nurse concerning  a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.        On 28-JUL-2020, the vaccine varicella virus vaccine live (oka/merck)(VARIVAX)  experienced intermittent temperature excursion.  On 03-AUG-2020, the patient was vaccinated with  a dose of  the aforementioned varicella virus vaccine live (oka/merck)(VARIVAX) Lot # S032357, expiration date 14-OCT-2021, .5 milliliter for prophylaxis (frequency and patient route of administration was not provided). Lot # was also reported as T002843 with expiration date 23-JAN-2022. The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.          There was digital data logger involved and  no previous temperature excursion was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose administered; This spontaneous report was received from a registered nurse concerning to patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 28-AUG-2020, the patient was vaccinated with an expired dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ML dose which had a lot# R009162 expiration date 06-JAN-2020 (route of administration and anatomical location of administration were not informed) for prophylaxis. However, at the reporting time the patient had not experienced any adverse event.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R009162; expirationdate: 06-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered.; This spontaneous report was received from a Nurse, referring to a female patient of unknown age. The patients concurrent conditions, pertinent medical history and concomitant medications were not provided.     On 31-JUL-2020 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(VARIVAX). The patient was administered again with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on 07-AUG-2020 (inappropriate schedule of product administration).  No further Adverse events or Product quality complaint were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 20-MAR-2009 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a healthcare provider. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for shingles. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will 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 shingles was considered as not recovered. The causality was assessed as related by the lawyer.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A 12 year old female patient received first dose of GARDASIL 9 6 months to a year ago; The patient is not experiencing any side effects.; Was brought in for her second dose by one parent but 10 days later, the other parent brought her into the HCP's office and the second dose was administered again; This spontaneous report was received from a health professional via company representative, concerning a 12 year old female patient. There was no information about the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  In approximately 2019, (reported as "6 months to a year ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 18-AUG-2020, the patient was brought to get her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), but 10 days later (also reported as 28-AUG-2020), the other parent brought the patient into the health care professional's office and the second dose was administered again. All vaccinations for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided for none of the vaccinations).  At the reporting time, the patient was not experiencing any side effects.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination
Clinical narrative: She received VARIVAX 15 years ago but did not receive the full round; This spontaneous report was received from a pharmacist, referring to an 18-year-old, female patient. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On an unspecified date approximately in 2005, (reported as "15 years ago"), the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX)  (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis but did not receive the full round.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; patient received as part of routine vaccination on 9/1/2020 a dose of VARIVAX that expired on 8/22/2020; This spontaneous report was received from a nurse referring to a 15-year-old female patient. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.   The nurse reported that on 01-SEP-2020, the patient received as part of routine vaccination  a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) that had expired on 22-AUG-2020, lot # R024023 (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported). This was human error as the nurse that administered the varicella virus vaccine live (Oka/Merck) (VARIVAX) did not check the expiration date. The varicella virus vaccine live (Oka/Merck) (VARIVAX) had been properly stored prior to administration. The sterile diluent (MERCK STERILE DILUENT) used to reconstitue the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored and not past it's expiration date but the lot # and expiration date of the sterile diluent (MERCK STERILE DILUENT) were unknown at the time of reporting. No Additional adverse events reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE information provided.; administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T002845 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (10.56 F), during a time frame of 50 minutes, as recorded by a digital data logger. There was a previous temperature excursion of 6 F to 14 F (8.47 F), during a time frame of 30 minutes. No further adverse event information was provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000710: US-009507513-2009USA000749: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000736:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 2-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 27-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T002848, which have been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error). The use of a sterile diluent was reported (dose, lot number and expiration date were unknown by the reporter).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000699:
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistance, referring to a 16 year old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. Concomitant therapies included Merck sterile diluent.  On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# S024364 and expiration date 06-AUG-2021, for prophylaxis (strength, dose, route and frequency were not reported).   The temperature excursion was of -14 Centigrade degrees (°C) to -10°C (-13.04°C) during 45 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 5-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 27-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S021326 has been verified to be valid, expiration date reported and validated as 05-JAN-2021) as prophylaxis (product storage error). The use of a sterile diluent was reported (dose, lot number and expiration date were unknown by the reporter).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE information provided.; HCP notes with patient details on administration of improperly stored vaccines.; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). Concomitant therapies included the sterile diluent (lot number and expiration date were not provided).  Additionally, it was reported that the suspect vaccines was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a time frame of 50 minutes, as recorded by the digital data logger. There was a previous temperature excursion reported as between 6 degrees F to 14 degrees F (8.47 degrees F) for a time frame of 30 minutes. No further adverse event information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000777: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000826: US-009507513-2009USA000894: US-009507513-2009USA000971: US-009507513-2009USA000976: US-009507513-2009USA001003: US-009507513-2009USA001123: US-009507513-2009USA001194:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 12-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 27-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T002845, which have been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error). The use of a sterile diluent was reported (dose, lot number and expiration date were unknown by the reporter).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: