chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Urinary retention
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, Vomiting.
Age: 68.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediately after Tdap was given the shot site swelled up about the size of a marble the nurse said it was a reaction and I should report it Later that nite the area went down just tender to touch
Age: 0.25
Sex: M
Vaccine: IPV
Symptoms: Rash
Clinical narrative: Patient received the first dose of Polio 1/8/2020. Patient's father notified a rash on patient's head. back and stomach when giving him a bath that evening after patient received the shot. Patient's father  was notified to take patient to the ER for evaluation.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in the left arm
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itchy
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Pt reported pain and significant swelling/warmth from shoulder down to elbow and pain in her back, started about two hours after vaccine was administered. Pt states symptoms are better upon notifying clinic today, but still has some swelling and tenderness.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site vesicles, Spinal pain
Clinical narrative: Injection was at the top of the left arm/shoulder area.  Within hours I had severe pain and itching in the entire left biceps area.  My left arm biceps swelled and had blisters on the skin.  I went to bed that night and upon awakening I had SEVERE burning pain throughout my spinal cord area.  The spinal pain went away the day after the injection.  The rash and itching of the left bicep area skin lasted for less than one week.   I reported to my primary care physician at my annual exam, and the pharmacist when the second dose was due.  Due to the reaction we (the pharmacist and I) concluded I should not take the second dose.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming
Clinical narrative: He slept after the vaccinations for 2 hours then woke up screaming inconsolably for 5 hours.  No fever but clearly in pain.  Unlike anything we had ever seen before with our newborn son
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Lymph node pain
Clinical narrative: Pt came in 01/08 @ 5:08 pm to tell us that her MD states we should open report her adverse reaction on her Shingrix.  Pt states that she had redness, swelling, sore glands in arm on right side where shot was given, and a bruise for around 7 days
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: Local reaction, Wrong product administered
Clinical narrative: Patient was given Flublok instead of Flucelvax. Per patients mother only a local reaction was noticed. However, mother states this happens with all vaccines that she receives. No other symptoms or signs noted. Patient is well and not experiencing any trouble.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Bursa removal, Bursitis, Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: The patient received a flu shot in her left arm and a Prevnar 13 shot in her right arm on the same day. Both shots caused expected soreness soon after. In the following days the pain in the left arm went away and the pain in the right arm worsened with limited range of motion of the right arm. She saw an orthopedic surgeon and had an MRI. It indicated an inflamed bursa which was subsequently removed. She has since been doing physical therapy. Her main purpose for reporting this incident was to ensure that our personnel are properly trained in order to prevent any future incidents.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: The patient received a flu shot in her left arm and a Prevnar 13 shot in her right arm on the same day. Both shots caused expected soreness soon after. In the following days the pain in the left arm went away and the pain in the right arm worsened with limited range of motion of the right arm. She saw an orthopedic surgeon and had an MRI. It indicated an inflamed bursa which was subsequently removed. She has since been doing physical therapy. Her main purpose for reporting this incident was to ensure that our personnel are properly trained in order to prevent any future incidents.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Infection, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Vaccine given 1/2/20. On 1/4/20 AM Mother reports that L arm was red, swollen with a lump. Was taken to After hours Clinic. Mother states she was told he had an infection and was put on abx. Mother called our clinic on 1/8/20. Staff attempted to return call and left message. Message passed to another staff member and Mother was reached. States today, 1/9 , the reaction/infection is "almost gone".
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Inflammation
Clinical narrative: Minimal, self-resolving local inflammation to DTAP
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Petechiae, Rash erythematous, Rash papular, Urticaria
Clinical narrative: Pink papular rash to trunk with some areas that appeared more whelpy with petechial rash on bilateral arms that started on 1/1/20 and lasted 3-4 days with no other symptoms.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hypersomnia, Impaired work ability, Myalgia
Clinical narrative: Per patient: "Severe enough weakness, myalgias, lightheadedness and fever the next day that I had trouble working (had to lie down myself during clinic)?. I went home and slept for 16 hrs. By Saturday (2 days after vaccine), able to function fairly well.  By Sunday (3 days after), near 100%."
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Per patient: "Severe enough weakness, myalgias, lightheadedness and fever the next day that I had trouble working (had to lie down myself during clinic)?. I went home and slept for 16 hrs. By Saturday (2 days after vaccine), able to function fairly well.  By Sunday (3 days after), near 100%."
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient had complaint of sore arm 1 week post immunization.  Patient reports today (01/09/2020) that underside of arm is still stiff and had limited mobility without pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Patient went to the hospital the day after Flu vaccine being administered.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Insomnia, Neck pain, Pain
Clinical narrative: PT CALLED TODAY AFTER RECEIVING THE INJECTION YESTERDAY. STATED SHEHAD EXCRUCIATING PAIN  FROM NECK TO ELBOW OF RIGHT ARM LAST NIGHT AND THUS COULD NOT SLEEP EITHER.  IT WAS 4 PM WHEN WE SPOKE AND SHE SAID IT HAD SUBSIDED COMPARED TO LAST NIGHT BUT IT STILL HURTS TO MOVE HER ARM.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain when moving, no swelling or rash but feel like the whole right arm as charley horse. the pain radiates from injection site and slowly goes down.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pyrexia
Clinical narrative: Weakness, High fever(102 F)
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fever of 100.7 chills muscle aches flu like symptoms run down fatigued
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the adult dose and not the 65+ dose.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complains of general soreness of injection site
Age: 63.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Burning sensation, Paraesthesia, Rash erythematous, Rash pruritic
Clinical narrative: Chest covered in red itchy spots, red eruptions over chest onto shoulders, Itchy slight burning - treated with topical hydrocortisone 1% and oral Benadryl.  11/14/2019 Re eruption same pattern only very itchy and increase in burning and hurting.  Overall skin feels like tiny pin pricks.  Sought medical treatment by dermatologist who prescribed oral prednisone for 10 days, tapering dose along with prescription topical hydrocortisone cream twice a day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pyrexia
Clinical narrative: A patient called today to state that she had a reaction and was not sure if it was related to the Shingrix vaccine she received yesterday (01/08/2020).  She described the reaction as redness on cheeks, whole face feels hot, low grade fever (Temperature 99.1 Degree Fahrenheit). Patient stated that her temperature usually runs around 97.5 Degree Fahrenheit.  I asked her if she wanted us to contact her PCP. Patient said that she does not want us to follow up with her PCP.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Patient received her second dose. After her second dose she starting itching right away. When she woke up the next morning it was swollen and warm to the touch. As the day went on patient stated it spread and still warm to the touch. Patient was told to go to urgent care because it looked like it could be infected
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Diarrhoea, Dizziness, Facial pain, Headache
Clinical narrative: Immediate: achy, dizzy and weak, low grade fever 48 hours - day 5: achy, dizzy, nausea, diarrhea, congestion, extreme headaches, fever 102 1 week later:  bad Headache, stiff neck, bad congestion, sinus infection, facial pain, achy and fever
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Immediate: achy, dizzy and weak, low grade fever 48 hours - day 5: achy, dizzy, nausea, diarrhea, congestion, extreme headaches, fever 102 1 week later:  bad Headache, stiff neck, bad congestion, sinus infection, facial pain, achy and fever
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Respiratory tract congestion, Sinusitis
Clinical narrative: Immediate: achy, dizzy and weak, low grade fever 48 hours - day 5: achy, dizzy, nausea, diarrhea, congestion, extreme headaches, fever 102 1 week later:  bad Headache, stiff neck, bad congestion, sinus infection, facial pain, achy and fever
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dysgraphia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Within a few hours of receiving the Bexsero vaccine Friday late afternoon, his right arm was in extreme pain (not normal vaccine ache/tenderness like his left arm was having) to the point of not being able to lift his right arm. It continued to hurt so badly he was taking 2 advil several times a day to help. Ice did not help alleviate any of the pain. There was no redness, swelling or marked heat in the area of the vaccine. On Monday, Tuesday, Wednesday, and Thursday of that week he could barely write to get through school. Thursday, Friday and Saturday the following week he continued to have pain but it began to decrease each day. There was still intermittent pain for at least 2 full weeks after he received the vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Vomiting
Clinical narrative: Chills (flu-like symptoms) about 12 ours after injection, followed by nausea and vomiting the following morning.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling cold
Clinical narrative: Pt reports feeling overly cold, even after a warm shower. Also reports a sore back. This started in the morning.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Pain, Pruritus, Pustule
Clinical narrative: Initially the worst (large, painful) red swelling I've ever experienced after an injection. Within two days I began to get what looked like pox all through the large red area. That lasted well over two weeks and at first was extremely painful, than so itchy that I couldn't sleep. Eventually the "pox" (large raised bumps close together) formed scabs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Swelling
Clinical narrative: Initially the worst (large, painful) red swelling I've ever experienced after an injection. Within two days I began to get what looked like pox all through the large red area. That lasted well over two weeks and at first was extremely painful, than so itchy that I couldn't sleep. Eventually the "pox" (large raised bumps close together) formed scabs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration
Clinical narrative: firm Erythema from mid-arm to elbow lasting 2-3 days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: Pt noticed rash at site of flu vaccine 48 hours after being given. Rash consistent with urtical reaction which then spread to abdomen, arms, legs & face
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Aphonia, Bedridden, Ear pain, Headache, Oropharyngeal pain
Clinical narrative: One hour after patient received hi dose flu shot he experienced sore throat, lost voice, earache, headache, runny nose. This symptoms are still persisting after 3 days. Patient had been bed ridden for 3 days.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: One hour after patient received hi dose flu shot he experienced sore throat, lost voice, earache, headache, runny nose. This symptoms are still persisting after 3 days. Patient had been bed ridden for 3 days.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient came into pharmacy stating he had an adverse reaction to the flu shot he had received one month prior. Patient said he developed lesions/welts by the site and on his back. He took 7 benadryl tabs and the site went away.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibrin D dimer increased
Clinical narrative: Apparently a spike in D Dimer score, though Dr. will be making further assessments.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient came to health department on 1-6-2020 to have tb skin test results read. She showed me her back of the left arm. Reddness noted there it measured 50 x 28 mm. I drew out line with a marker. I asked her to apply Ice packs and take Ibuprofen. I followed up with a phone call today (1-9-2020) & she said she was okay now.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: 2 mo male developed abdominal, frontal, back and extremity rash within 48' of injection. ROS (-) fever, not fussy, feeling normally.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Client is taking Imuran 250mg daily. It is an immune suppressing medication for treating clients ulcerative colitis. Immune Suppressing drugs are a contraindication to getting STAMARIL (a live virus vaccine) There have been no adverse events at time of this report
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Grunting, Irritability, Mood altered, Pyrexia
Clinical narrative: Fussiness, diarrhea, grunting, fever (Mood alteration)
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced a sore arm and joint as well as fever and chills the night the vaccine was administered. The fever and chills resolved by the next day, but her arm was very sore and she was unable to move it for about 4 days. She has since gone to see a doctor because her symptoms have not fully resolved and her arm has not gone back to baseline. She still has joint pain and has to rest her arm down even while working at a desk and cannot lift or hold her arm u for a length of time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Fatigue, Inflammation, Injection site pain, Pain
Clinical narrative: Original vaccine date 9/28/19.  Initially VERY painful, but had been warned of such.  Reduced somewhat within about 3-4 days.  Noted that within about a week, that I was having pain in the outer aspect of my  mid upper left arm (similar pain location  as when I had a rotator cuff injury YEARS ago in my RIGHT ARM. )  Initially thought it might be "something to do with rotator cuff".  Did exercises simple that would be in line with that type of "injury".  There was NO apparent redness at injection site, NO apparent  fever, I did experience some fatigue, but not clear if directly related to vaccine??? FYI, I am an RN & had given vaccines in the past in hospital.  November 6th had appointmt already scheduled with my primary Dr. As an incidental comment, she looked at my arm very briefly.  Gave me an order for  Physical Therapy if I didn't improve plus a very recommendation of name of a well respected Accupuncturist.. First 2 weeks of  December noted increasing pain with mobility of left ARM.  VERY Painful (8-9/10) as well as pain shooting down into my elbow & intermittently into hands/fingers.  Since unable to get into PT until 12/17 for workup/evaluation; I connected with the Accupuncturist on  12/16/19 and 12/17/19.  After detailed review by both   and brief eval by  PT  with Rehab  BOTH noted  no primary issue with rotator cuff, but extensive  INFLAMMATORY response.  Continuing with PT only at this time.  Have as of today, had 2  ,1 hour PT sessions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Original vaccine date 9/28/19.  Initially VERY painful, but had been warned of such.  Reduced somewhat within about 3-4 days.  Noted that within about a week, that I was having pain in the outer aspect of my  mid upper left arm (similar pain location  as when I had a rotator cuff injury YEARS ago in my RIGHT ARM. )  Initially thought it might be "something to do with rotator cuff".  Did exercises simple that would be in line with that type of "injury".  There was NO apparent redness at injection site, NO apparent  fever, I did experience some fatigue, but not clear if directly related to vaccine??? FYI, I am an RN & had given vaccines in the past in hospital.  November 6th had appointmt already scheduled with my primary Dr. As an incidental comment, she looked at my arm very briefly.  Gave me an order for  Physical Therapy if I didn't improve plus a very recommendation of name of a well respected Accupuncturist.. First 2 weeks of  December noted increasing pain with mobility of left ARM.  VERY Painful (8-9/10) as well as pain shooting down into my elbow & intermittently into hands/fingers.  Since unable to get into PT until 12/17 for workup/evaluation; I connected with the Accupuncturist on  12/16/19 and 12/17/19.  After detailed review by both   and brief eval by  PT  with Rehab  BOTH noted  no primary issue with rotator cuff, but extensive  INFLAMMATORY response.  Continuing with PT only at this time.  Have as of today, had 2  ,1 hour PT sessions.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry eye, Eye swelling, Fatigue, Headache
Clinical narrative: 2 hours after shot - fatigue, numbness & swelling (L) sife of face/eyes. HA for 5 days & achy with chills. She was started on Prednisone & Valtrex Saw the eye doctor & possible Speech therapy for numbness in face. 69 y.o. female presents with complaints of headache and chills, achiness Monday several hours after getting Shingrix vaccine at pharmacy.  2 hours ago she was not able to blow the motor of the sauna and was only able to rattle her mouth also developed numbness andl and swelling to left side of face/eye;Denies any change in speech.   Pt has tried Tylenol and ASA without improvement. Normally takes 1 asa in the am, added 2 more about 2 hours ago  She got the shot , has not felt good since HA for 5 days and achy since the shot HA 6/10 , left side as well, achy  Then face noticed at noon , odd, felt funny Then could whistle and blow Eye funny , feels dry and something in it feeling  Vision ok No other neuro, talk and thinking fine Can move everything but the face , she did not know was not moving it  Chewing felt odd/wrong
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging brain, Mastication disorder, Ocular discomfort, Pain
Clinical narrative: 2 hours after shot - fatigue, numbness & swelling (L) sife of face/eyes. HA for 5 days & achy with chills. She was started on Prednisone & Valtrex Saw the eye doctor & possible Speech therapy for numbness in face. 69 y.o. female presents with complaints of headache and chills, achiness Monday several hours after getting Shingrix vaccine at pharmacy.  2 hours ago she was not able to blow the motor of the sauna and was only able to rattle her mouth also developed numbness andl and swelling to left side of face/eye;Denies any change in speech.   Pt has tried Tylenol and ASA without improvement. Normally takes 1 asa in the am, added 2 more about 2 hours ago  She got the shot , has not felt good since HA for 5 days and achy since the shot HA 6/10 , left side as well, achy  Then face noticed at noon , odd, felt funny Then could whistle and blow Eye funny , feels dry and something in it feeling  Vision ok No other neuro, talk and thinking fine Can move everything but the face , she did not know was not moving it  Chewing felt odd/wrong
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: 2 hours after shot - fatigue, numbness & swelling (L) sife of face/eyes. HA for 5 days & achy with chills. She was started on Prednisone & Valtrex Saw the eye doctor & possible Speech therapy for numbness in face. 69 y.o. female presents with complaints of headache and chills, achiness Monday several hours after getting Shingrix vaccine at pharmacy.  2 hours ago she was not able to blow the motor of the sauna and was only able to rattle her mouth also developed numbness andl and swelling to left side of face/eye;Denies any change in speech.   Pt has tried Tylenol and ASA without improvement. Normally takes 1 asa in the am, added 2 more about 2 hours ago  She got the shot , has not felt good since HA for 5 days and achy since the shot HA 6/10 , left side as well, achy  Then face noticed at noon , odd, felt funny Then could whistle and blow Eye funny , feels dry and something in it feeling  Vision ok No other neuro, talk and thinking fine Can move everything but the face , she did not know was not moving it  Chewing felt odd/wrong
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Limb discomfort, Shoulder injury related to vaccine administration
Clinical narrative: on an unspecified date after vaccination, developed "discomfort in left shoulder", "decreased mobility in left shoulder" and was diagnosed with "SIRVA (Shoulder Injury from Vaccine)"; This spontaneous report was received from a nurse via a representative company referring to a 16 years old female patient. Pertinent medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). Drug allergy included allergy to amoxicillin.      On 21-OCT-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) (strength and vaccine dosage detail were not reported; lot # 1621926, expiration date not reported, but upon internal validation established as 28-NOV-2021) intramuscularly in the left arm for prophylaxis.      On an unknown date in 2019 (reported as after vaccination), the patient developed discomfort in left shoulder, decreased mobility in left shoulder and was diagnosed with shoulder injury related to vaccine administration (SIRVA) (shoulder injury from vaccine). On 09-DEC-2019, the patient came to physician's office. It was unknown if treatment was given or lab diagnostics was performed for the event. The outcome of the event was not recovered.  The reporter considered the event was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Aspiration bursa, Bursal fluid accumulation, Injection site pain, Magnetic resonance imaging normal, Nerve block
Clinical narrative: on an unspecified date after vaccination, developed "discomfort in left shoulder", "decreased mobility in left shoulder" and was diagnosed with "SIRVA (Shoulder Injury from Vaccine)"; This spontaneous report was received from a nurse via a representative company referring to a 16 years old female patient. Pertinent medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). Drug allergy included allergy to amoxicillin.      On 21-OCT-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) (strength and vaccine dosage detail were not reported; lot # 1621926, expiration date not reported, but upon internal validation established as 28-NOV-2021) intramuscularly in the left arm for prophylaxis.      On an unknown date in 2019 (reported as after vaccination), the patient developed discomfort in left shoulder, decreased mobility in left shoulder and was diagnosed with shoulder injury related to vaccine administration (SIRVA) (shoulder injury from vaccine). On 09-DEC-2019, the patient came to physician's office. It was unknown if treatment was given or lab diagnostics was performed for the event. The outcome of the event was not recovered.  The reporter considered the event was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Neuralgia, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: on an unspecified date after vaccination, developed "discomfort in left shoulder", "decreased mobility in left shoulder" and was diagnosed with "SIRVA (Shoulder Injury from Vaccine)"; This spontaneous report was received from a nurse via a representative company referring to a 16 years old female patient. Pertinent medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). Drug allergy included allergy to amoxicillin.      On 21-OCT-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) (strength and vaccine dosage detail were not reported; lot # 1621926, expiration date not reported, but upon internal validation established as 28-NOV-2021) intramuscularly in the left arm for prophylaxis.      On an unknown date in 2019 (reported as after vaccination), the patient developed discomfort in left shoulder, decreased mobility in left shoulder and was diagnosed with shoulder injury related to vaccine administration (SIRVA) (shoulder injury from vaccine). On 09-DEC-2019, the patient came to physician's office. It was unknown if treatment was given or lab diagnostics was performed for the event. The outcome of the event was not recovered.  The reporter considered the event was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site discomfort, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: on an unspecified date after vaccination, developed "discomfort in left shoulder", "decreased mobility in left shoulder" and was diagnosed with "SIRVA (Shoulder Injury from Vaccine)"; This spontaneous report was received from a nurse via a representative company referring to a 16 years old female patient. Pertinent medical history included attention deficit/hyperactivity disorder (ADHD). Concomitant therapy included methylphenidate hydrochloride (CONCERTA). Drug allergy included allergy to amoxicillin.      On 21-OCT-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) (strength and vaccine dosage detail were not reported; lot # 1621926, expiration date not reported, but upon internal validation established as 28-NOV-2021) intramuscularly in the left arm for prophylaxis.      On an unknown date in 2019 (reported as after vaccination), the patient developed discomfort in left shoulder, decreased mobility in left shoulder and was diagnosed with shoulder injury related to vaccine administration (SIRVA) (shoulder injury from vaccine). On 09-DEC-2019, the patient came to physician's office. It was unknown if treatment was given or lab diagnostics was performed for the event. The outcome of the event was not recovered.  The reporter considered the event was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering Fever Upset stomach
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering Fever Upset stomach
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches 6 hours after vaccine and shivering without temperature 10  hours after vaccine
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Insomnia
Clinical narrative: Headache, pain at injection site, inability to sleep
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In January 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, 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), patient suffered postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and 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. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Postherpetic neuralgia was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    On or about 18-FEB-2014 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength. batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. On or about 18-FEB-2014 the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.  On an unknown date, reported as subsequent to the vaccination, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the 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 unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).     The event shingles was serious due to hospitalization and life threatening.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength. batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively in 2015, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.  On an unknown date, reported as subsequent to the vaccination, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the 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 unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).     The event shingles was serious due to hospitalization and life threatening.   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    On or about 12-OCT-2012 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength. batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively on or about 12-OCT-2012, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.  On an unknown date, reported as subsequent to the vaccination, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the 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 unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).     The event shingles was serious due to hospitalization and life threatening.   Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthroscopy, Blood culture, C-reactive protein, Chills, Culture
Clinical narrative: sweating; limited mobility in left shoulder; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; chills; This spontaneous report has been received from a pharmacist, referring to a 77-year-old male patient. The patient's concurrent conditions included hypertension, esophagitis and hyperlipidemia. The patient had no drug reaction or allergy. The patient's concomitant medication included vitamin D.   On 13-MAY-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S018405 with expiration date 28-MAR-2021; strength, dose, frequency were not reported) intramuscularly in the left deltoid for prophylaxis.  On 31-DEC-2019, the patient developed chills, sweating, limited mobility in left shoulder, left arm pain, warmth and fatigue. The patient had sought for medical attention. On 02-JAN-2020, the patient was admitted. On the same day, the patient had a left shoulder arthroscopic irrigation and debridement. On unknown dates, the patient had following tests (result not provided): complete blood count (CBC); C-reactive protein (CRP); comprehensive metabolic panel (CMP); basic metabolic panel (BMP); blood culture and culture of fluid from shoulder. At the time of the report, the patient was still in the hospital receiving intravenous vancomycin. The outcome of events was reported as recovering. The causality assessment was not provided by the reporter. The pharmacist was requesting a lot check for this lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   Upon internal review, all the events (required left shoulder arthroscopic irrigation and debridement) were considered to be medically significant.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Feeling hot, Full blood count, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: sweating; limited mobility in left shoulder; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; chills; This spontaneous report has been received from a pharmacist, referring to a 77-year-old male patient. The patient's concurrent conditions included hypertension, esophagitis and hyperlipidemia. The patient had no drug reaction or allergy. The patient's concomitant medication included vitamin D.   On 13-MAY-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S018405 with expiration date 28-MAR-2021; strength, dose, frequency were not reported) intramuscularly in the left deltoid for prophylaxis.  On 31-DEC-2019, the patient developed chills, sweating, limited mobility in left shoulder, left arm pain, warmth and fatigue. The patient had sought for medical attention. On 02-JAN-2020, the patient was admitted. On the same day, the patient had a left shoulder arthroscopic irrigation and debridement. On unknown dates, the patient had following tests (result not provided): complete blood count (CBC); C-reactive protein (CRP); comprehensive metabolic panel (CMP); basic metabolic panel (BMP); blood culture and culture of fluid from shoulder. At the time of the report, the patient was still in the hospital receiving intravenous vancomycin. The outcome of events was reported as recovering. The causality assessment was not provided by the reporter. The pharmacist was requesting a lot check for this lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   Upon internal review, all the events (required left shoulder arthroscopic irrigation and debridement) were considered to be medically significant.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Joint debridement, Joint irrigation, Metabolic function test, Pain in extremity
Clinical narrative: sweating; limited mobility in left shoulder; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; left arm pain, warmth and fatigue; chills; This spontaneous report has been received from a pharmacist, referring to a 77-year-old male patient. The patient's concurrent conditions included hypertension, esophagitis and hyperlipidemia. The patient had no drug reaction or allergy. The patient's concomitant medication included vitamin D.   On 13-MAY-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S018405 with expiration date 28-MAR-2021; strength, dose, frequency were not reported) intramuscularly in the left deltoid for prophylaxis.  On 31-DEC-2019, the patient developed chills, sweating, limited mobility in left shoulder, left arm pain, warmth and fatigue. The patient had sought for medical attention. On 02-JAN-2020, the patient was admitted. On the same day, the patient had a left shoulder arthroscopic irrigation and debridement. On unknown dates, the patient had following tests (result not provided): complete blood count (CBC); C-reactive protein (CRP); comprehensive metabolic panel (CMP); basic metabolic panel (BMP); blood culture and culture of fluid from shoulder. At the time of the report, the patient was still in the hospital receiving intravenous vancomycin. The outcome of events was reported as recovering. The causality assessment was not provided by the reporter. The pharmacist was requesting a lot check for this lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   Upon internal review, all the events (required left shoulder arthroscopic irrigation and debridement) were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to male patient of an unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a healthcare provider. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.