chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Autopsy, Cardiac arrest, Death, Incorrect route of product administration, Respiratory arrest
Clinical narrative: Patient quit breathing at home on 06/08/19. Parents started CPR and called 911. Patient taken to hospital, arrived in asystole. Unable to be revived. Underlying medical conditions as noted above.  *Note - RotaTeq vaccine given via G-Tube*
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Resuscitation
Clinical narrative: Patient quit breathing at home on 06/08/19. Parents started CPR and called 911. Patient taken to hospital, arrived in asystole. Unable to be revived. Underlying medical conditions as noted above.  *Note - RotaTeq vaccine given via G-Tube*
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: In site of injection has a big rash and spread down his right arm
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Axillary pain, Blood immunoglobulin G, Blood immunoglobulin M, Chills, Conjunctivitis
Clinical narrative: Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Full blood count, HIV antibody, HIV antigen, Headache
Clinical narrative: Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Malaise, Measles antibody, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Mouth ulceration, Myalgia, Nausea, Pharyngitis, Photophobia
Clinical narrative: Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea, Streptococcus test
Clinical narrative: Swelling of lymph nodes behind ears, soreness both armpits, chills, Rash, fever, headache, nausea, malaise, myalgia, mild conjunctivitis, mild rhinorrhea, decreased appetite, photophobia, pharyngitis, one ulcer in mouth
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Groin pain
Clinical narrative: patient came in to pharmacy to report she began to get pain in her left hip, groin, and ankle - and both knees about about 1 an 1/2 weeks after injection - left side is worse than right side
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Chills, Pyrexia, Vomiting projectile
Clinical narrative: about 2 hours after receiving vaccine  projectile vomiting fever that went  from 99.0 to 104, developed rigors went to Emergency Room
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called back the day after (6/11/19) to report that he had gone to the doctor for severe arm pain with decreased mobility in his left arm/shoulder. Patient reported that he had seen his physician already on the morning of 6/11/19 and was being referred to Sports Medicine for follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: pain at site of injection; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On 28th March 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 2nd April 2019, the outcome of the muscle pain was resolved with sequelae. On 3rd April 2019, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. Patient's Shingrix shot resulted in pain and muscle aches which lasted for 5 days. The reporter did not consent to follow-up. There was a discrepancy with respect to the outcome date of the reported events. As per source document the outcome date was 3rd April 2019 (duration 6 days). However as per narrative description the duration was reported as 5 days. The outcome date was kept as per the structural field (3rd April 2019).
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This was a young girl brought in by her mother, they were new to the area and the had not been able to establish with a pediatrician yet. The school was requiring vaccines prior to the child being allowed to register for school. It is my understanding that mom requested the Tdap and MMR from the list the school gave her. Consents were signed for both immunizations, and VIS given. I was unaware of the age constraint of the Tdap ? the box shows ?for adolescent and adult use?, and I assumed it lined up with our other age ranges for vaccines, such as flu. This lack of knowledge has been rectified and the rest of my staff educated. We have posted the number for the health department in our nurses station so as to always have access to correct vaccine information, and to prevent any further errors in the future. Error caught at next WCC by pediatrician,  no immediate action as taken.  Patient was seen by Dr. on 6/3/19 and that's when medication error was found.  Dr. said that no harm was done to patient and that as long as it was given after 4 years of age, it is ok and DTAP was not given.  Patient's mother was informed of this error.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced pain and redness around the injection site.  very sore and swollen for 2 days.  Between yesterday and today the redness has gotten worse.  Very hot to the touch
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Chills, Feeling cold, Headache, Presyncope
Clinical narrative: The evening of the day he received both vaccines, he had a near syncopal episode that self resolved gradually. The next morning (12 June 2019), he woke up shivering and feeling very cold but no fever. He also complained of generalized joint pain and a headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient developed fever up to 100.5, chills, and malaise.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, TDAP
Symptoms: Wrong product administered
Clinical narrative: Tdap indicated but DTaP initially administered. After error was discovered, Tdap was also administered. Patient was observed, no treatment was necessary, no adverse outcomes were noted.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Myalgia
Clinical narrative: Second dose (first was not problematic). Flu-like symptoms: muscle aches, chills, weakness.
Age: 57.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Peripheral swelling, Skin warm
Clinical narrative: Vaccines given on 6-11-19 in earyl afternoon, on evening of 6-11-19 started to have slight reddness , on morning of 6-12-19 pt awoke with swelling from left upper arm progressing down left arm to elbow. Redness, and warmth to arm, pt had temp of 99.8, when seen in our office around 2:00 pm.   Redness and edema from antecubital fossa  to the top of the shoulder and halfway aroud the arm, involving only the anterior aspect. A line of demarcation was drawn.  Pt was instructed to elevate arm about heart level, take zyrtec 10mg by mouth twice daily until improves. Pt is to call  if spreading reddness. Immunizations were given at Facility in Dr. office.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Swelling from shoulder to elbow more severe, swelling from elbow to wrist, less severe, redness, unable to move arm,  Benadryl  and Cetirizine, coming in for recheck in 2 days.
Age: 50.0
Sex: F
Vaccine: ANTH
Symptoms: Dry skin, Pruritus, Rash, Skin irritation, Swelling face
Clinical narrative: Patient reports a history of eczema, and was diagnosed between the ages of 7-13. Symptoms controlled with Benadryl and creams. She never had any facial involvement until she received AVA. Denies any problems with other vaccines. She stated that approximately one week post AVA # 1 she noticed that her face was dry, irritated and swollen. She denied any new creams or products. The symptoms started to clear when she received AVA # 2 on 13 Mar. She reported that within 4 days after vaccination the facial symptoms reoccurred and persisted for about 3 wks  Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), PRURITUS, UNSPECIFIED(L299).
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Activated partial thromboplastin time, Blood immunoglobulin A, Full blood count, Headache, Henoch-Schonlein purpura
Clinical narrative: Patient got a headache, fever and broke out in a macular rash with petechiae.  He was seen two days later at ER and given steroids for 5 days with some improvement. After a couple of days patient's rash worsened so was seen in clinic again. Diagnosis given was vasculitis with differential diagnosis of drug induced purpura vs HSP.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: International normalised ratio, Metabolic function test, Petechiae, Prothrombin time, Purpura
Clinical narrative: Patient got a headache, fever and broke out in a macular rash with petechiae.  He was seen two days later at ER and given steroids for 5 days with some improvement. After a couple of days patient's rash worsened so was seen in clinic again. Diagnosis given was vasculitis with differential diagnosis of drug induced purpura vs HSP.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Rash macular, Red blood cell sedimentation rate, Urine analysis, Vasculitis
Clinical narrative: Patient got a headache, fever and broke out in a macular rash with petechiae.  He was seen two days later at ER and given steroids for 5 days with some improvement. After a couple of days patient's rash worsened so was seen in clinic again. Diagnosis given was vasculitis with differential diagnosis of drug induced purpura vs HSP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Immediate post-injection reaction
Clinical narrative: This was dose #2.  (On Dose #1, on April 3, 2019,  I had immediate pain in my arm, from shoulder to finger tips.  For a full week, I had arm tenderness, particularly near vaccination site, and very limited range of motion. Then, it subsided. That's all I remember.)  But on Dose #2, which I received yesterday afternoon, all I had initially was severe stinging, as  the vaccine was administered, followed by arm soreness + tenderness, but, by bedtime, I also had muscle aches, headache, and nausea.  The headache + nausea have continued  intermittently today, but starting this morning, I've developed a few additional side effects: some joint pain (in addition to the muscle aches), shivers, and a temperature, so far, of 100.8 F.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Myalgia, Nausea, Pain in extremity
Clinical narrative: This was dose #2.  (On Dose #1, on April 3, 2019,  I had immediate pain in my arm, from shoulder to finger tips.  For a full week, I had arm tenderness, particularly near vaccination site, and very limited range of motion. Then, it subsided. That's all I remember.)  But on Dose #2, which I received yesterday afternoon, all I had initially was severe stinging, as  the vaccine was administered, followed by arm soreness + tenderness, but, by bedtime, I also had muscle aches, headache, and nausea.  The headache + nausea have continued  intermittently today, but starting this morning, I've developed a few additional side effects: some joint pain (in addition to the muscle aches), shivers, and a temperature, so far, of 100.8 F.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This was dose #2.  (On Dose #1, on April 3, 2019,  I had immediate pain in my arm, from shoulder to finger tips.  For a full week, I had arm tenderness, particularly near vaccination site, and very limited range of motion. Then, it subsided. That's all I remember.)  But on Dose #2, which I received yesterday afternoon, all I had initially was severe stinging, as  the vaccine was administered, followed by arm soreness + tenderness, but, by bedtime, I also had muscle aches, headache, and nausea.  The headache + nausea have continued  intermittently today, but starting this morning, I've developed a few additional side effects: some joint pain (in addition to the muscle aches), shivers, and a temperature, so far, of 100.8 F.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Urticaria
Clinical narrative: Patient developed severe headache at 2:00 am day following the vaccine administration on 06/08/19 and whelps on her chest.  Tylenol and Benadryl taken on day of symptoms and symptoms completed resolved on Sunday 6/9/19.  No further treatment taken.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt. came in on 6-11-19 and was given her 2nd Varicella. On 6-12-19 pt. came in complaining redness and swelling to her left arm. Redness and swelling was in a circle and measured 55 mm x 55 mm. Pt. was instructed to monitor the areas and if it continued to swell or get bigger or have any other problems to go the ER. Dr. made aware.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hep A vaccine given was adult dose.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain and soreness in arm after coadministration of flu and Prevnar13; Pain and soreness in arm after coadministration of flu and Prevnar13; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. An elderly (over 65 years old) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization, co-administrated with influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain and soreness in arm after co-administration of influenza vaccine and pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. Events took place after use of product. The outcome of events was unknown.   No follow-up attempts are possible.  No further information is expected
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient received varicella vaccine on 5/30/19 and pt had positive pregnancy test resulted on 5/31/19. There was not a resulted pregnancy at the time of vaccine administration. Pregnancy is contraindicated with receiving live virus vaccine. Pt followed up with ObGYN doctor and referred to specialty clinic.  No signs or symptoms of the disease as of yet.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Blood pressure decreased, Presyncope
Clinical narrative: Pt had a near syncopal episode in the waiting room following her vaccinations. Went to sleep at 3am, no breakfast or food this morning and then HPV and meningococcal vaccinations. Has almost passed out once before, during cheerleading practice. Initial random BG of 93, BP of 42/27*** GIven juice, put in wheelchair and brought back to room for observation. BP improved while lying down, however continued to drop to below SBP of 80s and patient with recurrent symptoms when trying to stand up again.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Throbbing headache for two days after the injection, one of the worst headaches I have every had. Widespread muscle aches, weakness and fatigue and not localized to the injection site, began the morning after the injection and has not subsided.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Body temperature increased, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: pt reported not feeling well-nauseous, headache, vomited once before he came in on the 6/6/19. On arrival he has a temperature of 99.7. He also reported left arm swelling and pain where vaccine was given.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Vomiting
Clinical narrative: pt reported not feeling well-nauseous, headache, vomited once before he came in on the 6/6/19. On arrival he has a temperature of 99.7. He also reported left arm swelling and pain where vaccine was given.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Dizziness, Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: pt reported not feeling well-nauseous, headache, vomited once before he came in on the 6/6/19. On arrival he has a temperature of 99.7. He also reported left arm swelling and pain where vaccine was given.
Age: 47.0
Sex: M
Vaccine: TD, TD
Symptoms: Swelling, Vomiting
Clinical narrative: pt reported not feeling well-nauseous, headache, vomited once before he came in on the 6/6/19. On arrival he has a temperature of 99.7. He also reported left arm swelling and pain where vaccine was given.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain upper, Discomfort, Fatigue, Immediate post-injection reaction, Pallor
Clinical narrative: Immediate complaint of stomach pain. Patient was told to lie down, face looked pale, slightly fatigued and uncomfortable.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: 12 y/o client presented to HD Immunization Clinic for HPV #. A few moments after receiving vaccine, client experienced brief syncopal episode (1-2 seconds). MOC and RN held client upright in the chair, no fall or apparent injury. Client was aroused by MOC and RN talking to him. Upon waking, client sat in chair drinking juicebox and taking slow deep breaths. He sat in the chair for approximately 15 minutes talking to MOC and RN before stating he felt better and was ready to leave. Client declined to lie down, expressing preference to stay seated. At time of departure from the clinic, client had regained color, was alert and oriented, and walking independently.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: around injection site, abnormal oval area developed measuring 3 inches long and 2.25 inches across, area was raised, red, hot, sore, tender, inflamed with a darker bruise at point of injection - photo will be attached
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: around injection site, abnormal oval area developed measuring 3 inches long and 2.25 inches across, area was raised, red, hot, sore, tender, inflamed with a darker bruise at point of injection - photo will be attached
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Joint noise, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient to DO         5/24/19 8:16 AM  Hi,  I got my pnu23 in your office on Wednesday morning. The injection was much more painful than usual. I went home and within 2 hours my shoulder began to hurt bad enough that my ROM was effected. The injection site is really high on my left shoulder. I think that it may gave gone into my joint. It has continued to increase in pain and has been 7/10 unless I am on ibuprofen. When on ibuprofen 5/10. My ROM is pretty limited. I have intense pain if I lift my arm to shoulder height and cannot lift it further. The top of my shoulder hurts also, even the pressure of my bra strap hurts it. My shoulder is cracking and popping frequently. I am not sure what to do. Attached is a picture of the vaccine administration site. The site looks fine, it is just high. It is above my 3 freckles. The other 2 pictures are of this slightly raised red streak going from below the injection site into my armpit.this streak is tender to the touch and is super soft almost like a blister without the fluid.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient to DO         5/24/19 8:16 AM  Hi,  I got my pnu23 in your office on Wednesday morning. The injection was much more painful than usual. I went home and within 2 hours my shoulder began to hurt bad enough that my ROM was effected. The injection site is really high on my left shoulder. I think that it may gave gone into my joint. It has continued to increase in pain and has been 7/10 unless I am on ibuprofen. When on ibuprofen 5/10. My ROM is pretty limited. I have intense pain if I lift my arm to shoulder height and cannot lift it further. The top of my shoulder hurts also, even the pressure of my bra strap hurts it. My shoulder is cracking and popping frequently. I am not sure what to do. Attached is a picture of the vaccine administration site. The site looks fine, it is just high. It is above my 3 freckles. The other 2 pictures are of this slightly raised red streak going from below the injection site into my armpit.this streak is tender to the touch and is super soft almost like a blister without the fluid.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shot site was swollen and red and very tender for 3 - 4 days.  I have sick and missed work for that same amount of time.  I have a terrible headache, chills, body aches and extreme nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Pain
Clinical narrative: Shot site was swollen and red and very tender for 3 - 4 days.  I have sick and missed work for that same amount of time.  I have a terrible headache, chills, body aches and extreme nausea.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Mobility decreased, Pain, Peripheral swelling, Pyrexia
Clinical narrative: I had a fever of 104 for 4 days and the arm with the Shingrix was very very swollen like a foot ball, heavy and i was unable to move it. terrible body aches and chills along with the fever
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain, Photopsia, Pyrexia, Sensory disturbance
Clinical narrative: PATIENT IS SUFFERING FROM MIGRAINE WITH FLASHES OF LIGHTS, BODY ACHES AND PAIN, HIGH FEVER (104), AND SAID SHE WAS HAVING SENSORY ISSUES
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Generalized itching all over body. Patient received a steroid injection at dr office and a steroid dose pack to take for 6 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Patient reports two days after immunization she broke out in small, slightly itchy blisters on arms, face, upper legs, and buttocks which resolved without treatment in seven days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Had to leave work early a few hours after Shingrix vaccine.  Very weak, slightly nauseous, weird headache, whole body felt dry and achy, had trouble thinking straight.  I was out of work for 5 days.  Mostly slept and very weak with headache.  Injection site was very sore for a week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental impairment, Nausea, Pain
Clinical narrative: Had to leave work early a few hours after Shingrix vaccine.  Very weak, slightly nauseous, weird headache, whole body felt dry and achy, had trouble thinking straight.  I was out of work for 5 days.  Mostly slept and very weak with headache.  Injection site was very sore for a week.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: local reaction, swelling and redness of left thigh, cellulitis- treated with Keflex for 7 days
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Since Monday evening, patient t has been having fevers of 103.9-104.3. Both legs have been red and swollen, warm t touch. Parent is giving Tylenol and ibuprofen to help with fever. As soon as medication wears off, high fevers spike again.  Spoke with mom on 06/12/2019-instructed her to alternate giving Tylenol every 4 hours, and ibuprofen every 6 hours. Also instructed her to try cool compresses to the legs to help with the swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: patient mentioned having the following symptoms 14 hours  after vaccine:  feeling tired, possible fever, body aches
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Rash, redness, sore arm
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: PT REPORTED BLISTER TYPE RASH ALL OVER BODY AND ITCHING.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash on upper arm that began 6/7/19 and is continuously getting worse
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, 101.4 F fever, chills, tired
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Hemiparesis, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient complains of persistent weakness on the left side of the body since the administration of vaccine, also complaining of pain and inability to dress herself and other activities related to daily routine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Back pain, Fatigue, Feeding disorder
Clinical narrative: Shooting sharp pain in arm down into hand and fingers when injected. Within 4 hours other sx began and rapidly worsened. Pain, redness, heat and swelling in arm down to elbow, headache, overall muscle pain, fatigue, low grade fever, queasy, weak, unable eat. Then lower back from spine wrapping around right side to belly button severe pain, second only to childbirth. Wanted to lie down, but was afraid because I was alone. Also pain into L shoulder when tried and unable to raise L arm. Back pain, neck pain, cold hands and feet, overall limp feeling. Afraid I had another problem like gall bladder, kidney, or appendix as I had no idea I might get theses sx from Shingrix. Had only been warned about local issues. Pain continued for several days and only gradually dissipated over next week or so.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypotonia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Shooting sharp pain in arm down into hand and fingers when injected. Within 4 hours other sx began and rapidly worsened. Pain, redness, heat and swelling in arm down to elbow, headache, overall muscle pain, fatigue, low grade fever, queasy, weak, unable eat. Then lower back from spine wrapping around right side to belly button severe pain, second only to childbirth. Wanted to lie down, but was afraid because I was alone. Also pain into L shoulder when tried and unable to raise L arm. Back pain, neck pain, cold hands and feet, overall limp feeling. Afraid I had another problem like gall bladder, kidney, or appendix as I had no idea I might get theses sx from Shingrix. Had only been warned about local issues. Pain continued for several days and only gradually dissipated over next week or so.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Neck pain
Clinical narrative: Shooting sharp pain in arm down into hand and fingers when injected. Within 4 hours other sx began and rapidly worsened. Pain, redness, heat and swelling in arm down to elbow, headache, overall muscle pain, fatigue, low grade fever, queasy, weak, unable eat. Then lower back from spine wrapping around right side to belly button severe pain, second only to childbirth. Wanted to lie down, but was afraid because I was alone. Also pain into L shoulder when tried and unable to raise L arm. Back pain, neck pain, cold hands and feet, overall limp feeling. Afraid I had another problem like gall bladder, kidney, or appendix as I had no idea I might get theses sx from Shingrix. Had only been warned about local issues. Pain continued for several days and only gradually dissipated over next week or so.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Shooting sharp pain in arm down into hand and fingers when injected. Within 4 hours other sx began and rapidly worsened. Pain, redness, heat and swelling in arm down to elbow, headache, overall muscle pain, fatigue, low grade fever, queasy, weak, unable eat. Then lower back from spine wrapping around right side to belly button severe pain, second only to childbirth. Wanted to lie down, but was afraid because I was alone. Also pain into L shoulder when tried and unable to raise L arm. Back pain, neck pain, cold hands and feet, overall limp feeling. Afraid I had another problem like gall bladder, kidney, or appendix as I had no idea I might get theses sx from Shingrix. Had only been warned about local issues. Pain continued for several days and only gradually dissipated over next week or so.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Skin discolouration, Skin warm
Clinical narrative: Patient C/O pain immediately when shot given. Since then the redness and warmth has increased. The area is 12x17cm of erythematous irregularly boarded mild swelling, warm to touch. Central area 8x6cm w/faint violaceous discoloration. No drainage.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling
Clinical narrative: Patient C/O pain immediately when shot given. Since then the redness and warmth has increased. The area is 12x17cm of erythematous irregularly boarded mild swelling, warm to touch. Central area 8x6cm w/faint violaceous discoloration. No drainage.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling in upper & lower extremities
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Local reaction involving erythema 7x13cm & tenderness and induration 3x4cm of (L) upper arm, Fever 103
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Fainted after vaccine
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 1.08
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, warm to the touch.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post-Herpetic Neuralgia; Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 71-year-old male patient (pt). No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 13-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dose, vaccination site and route of administration were not provided) by a healthcare provider for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a physician at a medical center for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post-herpetic neuralgia. The outcome of the events was unknown.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy skin abnormal, Fibromyalgia, Myalgia, Small fibre neuropathy
Clinical narrative: Patient was in excellent health and totally symptom free until she received HPV immunization (Gardasil). Two days later she began to experience progressively worsening widespread muscle pain. By the time I first saw her in April 2019, she had seen her pediatrician, a rheumatologist, and had physical therapy for pain rehab. She was diagnosed with fibromyalgia. Parents were desperate because of the degree of pain and requested medical cannabis. She is now on a combination of time release tramadol (Ultram ER), neurontin and oral medical cannabis. She says this gives her 30-50% relief. Since Gardasil has been reported to cause Small Fiber Neuropathy I had her undergo skin biopsy and this diagnosis was confirmed
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Long-lasting swelling, inflammation, and hot redness that covered much of the upper right arm.  Also, dizziness, etc., developed.  Doctor examined me and said she had not seen such a reaction before.  In fact, she actually measured the effected area.  Dr. prescribed Prednisone.  Symptoms continued for weeks and finally diminished.  Met with my doctor on April 19 in this regard and other times.  Patient's notes April 22, 2019: My doctor may have filed this report.  I continue to see her since I am still recovering from the recent diagnosis of a severe allergic reaction to the Recombinant Zoster (Shingles) Vaccine, RZV.  (Incidentally, for your information, I have never had an allergic reaction to any vaccine prior to this occasion.)  On Tuesday, April 16, 2019, I had the vaccine at a local Pharmacy.  Almost immediately I developed pain, severe dark redness, soreness and swelling in my upper arm area.  A headache and weakness, odd vision and mental thinking, dizziness, off-and-on nausea, and just a plain behavioral lack of feeling to function as usual began to develop.  I am sure that I had a fever; but I did not take my temperature because of my sick state.   On Friday, April 19, I went to see my physician when I realized that this was all related to the Shingles vaccine.   And the doctor identified and diagnosed as such.  I was told by the physician that they had never seen this reaction before.  The place on my arm at the site of the injection was extremely large and extremely hot (most of the area between elbow and shoulder), and the doctor actually measured it.  My visit with the physician again on Monday, April 22, confirmed improvement; but I still was experiencing effects from the vaccine.  The physician stated that I looked better; but I was still pale and weak.  The redness was also still there (but less), and the site was still as hot.    Today, my reactions to this vaccine have not gone away; but they are diminishing, and I am beginning to feel better.    Patient's notes June 11, 2019: I continued to see my physician again yesterday.  I have now discontinued her prescription (Prednisone) for the inflammation, and I feel that I may be getting back to near-normal.    The dizziness is reducing, and is less "harsh".  I still feel some weakness, and am less active than normal; but I think that I am on the road to recovery.  Life has been a long slow-down for me because of this vaccine and shot.  I will be seeing the physician again, and am hoping that my condition is now heading for a complete recovery soon.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Long-lasting swelling, inflammation, and hot redness that covered much of the upper right arm.  Also, dizziness, etc., developed.  Doctor examined me and said she had not seen such a reaction before.  In fact, she actually measured the effected area.  Dr. prescribed Prednisone.  Symptoms continued for weeks and finally diminished.  Met with my doctor on April 19 in this regard and other times.  Patient's notes April 22, 2019: My doctor may have filed this report.  I continue to see her since I am still recovering from the recent diagnosis of a severe allergic reaction to the Recombinant Zoster (Shingles) Vaccine, RZV.  (Incidentally, for your information, I have never had an allergic reaction to any vaccine prior to this occasion.)  On Tuesday, April 16, 2019, I had the vaccine at a local Pharmacy.  Almost immediately I developed pain, severe dark redness, soreness and swelling in my upper arm area.  A headache and weakness, odd vision and mental thinking, dizziness, off-and-on nausea, and just a plain behavioral lack of feeling to function as usual began to develop.  I am sure that I had a fever; but I did not take my temperature because of my sick state.   On Friday, April 19, I went to see my physician when I realized that this was all related to the Shingles vaccine.   And the doctor identified and diagnosed as such.  I was told by the physician that they had never seen this reaction before.  The place on my arm at the site of the injection was extremely large and extremely hot (most of the area between elbow and shoulder), and the doctor actually measured it.  My visit with the physician again on Monday, April 22, confirmed improvement; but I still was experiencing effects from the vaccine.  The physician stated that I looked better; but I was still pale and weak.  The redness was also still there (but less), and the site was still as hot.    Today, my reactions to this vaccine have not gone away; but they are diminishing, and I am beginning to feel better.    Patient's notes June 11, 2019: I continued to see my physician again yesterday.  I have now discontinued her prescription (Prednisone) for the inflammation, and I feel that I may be getting back to near-normal.    The dizziness is reducing, and is less "harsh".  I still feel some weakness, and am less active than normal; but I think that I am on the road to recovery.  Life has been a long slow-down for me because of this vaccine and shot.  I will be seeing the physician again, and am hoping that my condition is now heading for a complete recovery soon.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Nausea, Pain
Clinical narrative: Long-lasting swelling, inflammation, and hot redness that covered much of the upper right arm.  Also, dizziness, etc., developed.  Doctor examined me and said she had not seen such a reaction before.  In fact, she actually measured the effected area.  Dr. prescribed Prednisone.  Symptoms continued for weeks and finally diminished.  Met with my doctor on April 19 in this regard and other times.  Patient's notes April 22, 2019: My doctor may have filed this report.  I continue to see her since I am still recovering from the recent diagnosis of a severe allergic reaction to the Recombinant Zoster (Shingles) Vaccine, RZV.  (Incidentally, for your information, I have never had an allergic reaction to any vaccine prior to this occasion.)  On Tuesday, April 16, 2019, I had the vaccine at a local Pharmacy.  Almost immediately I developed pain, severe dark redness, soreness and swelling in my upper arm area.  A headache and weakness, odd vision and mental thinking, dizziness, off-and-on nausea, and just a plain behavioral lack of feeling to function as usual began to develop.  I am sure that I had a fever; but I did not take my temperature because of my sick state.   On Friday, April 19, I went to see my physician when I realized that this was all related to the Shingles vaccine.   And the doctor identified and diagnosed as such.  I was told by the physician that they had never seen this reaction before.  The place on my arm at the site of the injection was extremely large and extremely hot (most of the area between elbow and shoulder), and the doctor actually measured it.  My visit with the physician again on Monday, April 22, confirmed improvement; but I still was experiencing effects from the vaccine.  The physician stated that I looked better; but I was still pale and weak.  The redness was also still there (but less), and the site was still as hot.    Today, my reactions to this vaccine have not gone away; but they are diminishing, and I am beginning to feel better.    Patient's notes June 11, 2019: I continued to see my physician again yesterday.  I have now discontinued her prescription (Prednisone) for the inflammation, and I feel that I may be getting back to near-normal.    The dizziness is reducing, and is less "harsh".  I still feel some weakness, and am less active than normal; but I think that I am on the road to recovery.  Life has been a long slow-down for me because of this vaccine and shot.  I will be seeing the physician again, and am hoping that my condition is now heading for a complete recovery soon.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pallor, Peripheral swelling, Thinking abnormal, Vaccination complication, Visual impairment
Clinical narrative: Long-lasting swelling, inflammation, and hot redness that covered much of the upper right arm.  Also, dizziness, etc., developed.  Doctor examined me and said she had not seen such a reaction before.  In fact, she actually measured the effected area.  Dr. prescribed Prednisone.  Symptoms continued for weeks and finally diminished.  Met with my doctor on April 19 in this regard and other times.  Patient's notes April 22, 2019: My doctor may have filed this report.  I continue to see her since I am still recovering from the recent diagnosis of a severe allergic reaction to the Recombinant Zoster (Shingles) Vaccine, RZV.  (Incidentally, for your information, I have never had an allergic reaction to any vaccine prior to this occasion.)  On Tuesday, April 16, 2019, I had the vaccine at a local Pharmacy.  Almost immediately I developed pain, severe dark redness, soreness and swelling in my upper arm area.  A headache and weakness, odd vision and mental thinking, dizziness, off-and-on nausea, and just a plain behavioral lack of feeling to function as usual began to develop.  I am sure that I had a fever; but I did not take my temperature because of my sick state.   On Friday, April 19, I went to see my physician when I realized that this was all related to the Shingles vaccine.   And the doctor identified and diagnosed as such.  I was told by the physician that they had never seen this reaction before.  The place on my arm at the site of the injection was extremely large and extremely hot (most of the area between elbow and shoulder), and the doctor actually measured it.  My visit with the physician again on Monday, April 22, confirmed improvement; but I still was experiencing effects from the vaccine.  The physician stated that I looked better; but I was still pale and weak.  The redness was also still there (but less), and the site was still as hot.    Today, my reactions to this vaccine have not gone away; but they are diminishing, and I am beginning to feel better.    Patient's notes June 11, 2019: I continued to see my physician again yesterday.  I have now discontinued her prescription (Prednisone) for the inflammation, and I feel that I may be getting back to near-normal.    The dizziness is reducing, and is less "harsh".  I still feel some weakness, and am less active than normal; but I think that I am on the road to recovery.  Life has been a long slow-down for me because of this vaccine and shot.  I will be seeing the physician again, and am hoping that my condition is now heading for a complete recovery soon.
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: breaking out in hives; increase of body temperature; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number AL545, expiry date 30th June 2019) for prophylaxis.   On 24th September 2018, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On 26th September 2018, 2 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced hives and body temperature increased. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the hives and body temperature increased to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The pharmacist reported that the patient received Fluarix and two days later he started breaking out in hives whenever he did anything that caused his body temperature to go up. He has seen multiple doctors about this problem and it was still on going. Emergency room visit was required. Related to Patient.
Age: 15.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Urticaria
Clinical narrative: breaking out in hives; increase of body temperature; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number AL545, expiry date 30th June 2019) for prophylaxis.   On 24th September 2018, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On 26th September 2018, 2 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced hives and body temperature increased. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the hives and body temperature increased to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The pharmacist reported that the patient received Fluarix and two days later he started breaking out in hives whenever he did anything that caused his body temperature to go up. He has seen multiple doctors about this problem and it was still on going. Emergency room visit was required. Related to Patient.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash on her arms and legs; Itchy rash; redness; Skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number X5XY4, expiry date 31st July 2019) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2018). Concurrent medical conditions included systemic lupus erythematosus.   On 8th March 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash, itchy rash, red rash and skin discoloration. The patient was treated with methylprednisolone and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the itchy rash, red rash and skin discoloration were unknown.   It was unknown if the reporter considered the rash, itchy rash, red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The caller was a patient who received Shingrix and sometime after she experienced rash on her arms between elbow and wrists and legs around kneecap area up to middle thigh.   The caller reported that the rash was itchy and was red in color on her arms and more purple in color on her legs.   The caller notes that itchiness flares up when her skin gets overheated. The caller reports that she has used topical over the counter steroid cream that did not help and her doctor prescribed methylprednisolone oral tablet taper that did help with the itching but rash has not resolved. The reporter consented to follow up.