chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Aches, low fever, joint pain began on the evening of the shot.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Palpitations, Pyrexia
Clinical narrative: Uncontrollable chills, high temp around 102 F, and racing heart, and some slight difficulty breathing.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH ON FACR LOWER LEFT QUADRANT OF FACE---AND VALTREX WAS GIVEN.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient broke out in rash of hands...diagnosed as shingles.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red bump under injection site per mother of patient.
Age: 4.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Drug administered to patient of inappropriate age, Wrong patient received medication
Clinical narrative: Patient should not have received these immunizations. She is only 4 years old. The patient's sister (12 years old) was also in the clinic today, and she was receiving her shots. The shots the patient received were meant for the sibling. They were on the same tray as the patient's 4 year immunizations (KINRIX, PROQUAD). The mother opted not to have patient receive her 4 year immunizations after I advised her of the accidental mix-up.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had swelling on the right arm the day after his vaccines that ended up in an urgent care visit and treatment for cellulitis. Mother called me over the weekend reporting swelling of the extremity where the vaccine had been given. Told her to apply ice 10 minutes on and the rest of the hour off as much as she could, to outline the erythema, and to give ibuprofen. Told her to FU with our office or urgent care if it became worse. Notes from urgent care were sent to our office today stating they placed the child on cephalexin and told to FU with our office. Patient has not FU with us yet.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and pain at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccine 8-4-18. On 8-6-18 patient called pharmacy and said shortly after vaccination had dime size area that latter grew to half dollar size area that was red and swollen, and had heat in area and pain. She also experienced pain that went down her arm. As of Monday the pain going down the arm had subsided but still had red, swollen, hot area on arm. This was her first dose of SHINGRIX. I Spoke with one employee, then transfered to another and then to another at GlaxoSmith Kline and was told that these symptoms were common. I asked if patient should receive second dose of SHINGRIX and was told cdc recommends completion of the series if reaction was Grade 1 to 3. However, if reaction was Allergic reaction then second dose contraindicated. Manufacturer recommended consulting primary care provider. I spoke with Nurse at Dr's office who said patient would need to be seen for them to determine if was allergy or not. I spoke to patient regarding all of this. Patient thought was getting better not worse and did not want to call doctor office.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient received vaccine 8-4-18. On 8-6-18 patient called pharmacy and said shortly after vaccination had dime size area that latter grew to half dollar size area that was red and swollen, and had heat in area and pain. She also experienced pain that went down her arm. As of Monday the pain going down the arm had subsided but still had red, swollen, hot area on arm. This was her first dose of SHINGRIX. I Spoke with one employee, then transfered to another and then to another at GlaxoSmith Kline and was told that these symptoms were common. I asked if patient should receive second dose of SHINGRIX and was told cdc recommends completion of the series if reaction was Grade 1 to 3. However, if reaction was Allergic reaction then second dose contraindicated. Manufacturer recommended consulting primary care provider. I spoke with Nurse at Dr's office who said patient would need to be seen for them to determine if was allergy or not. I spoke to patient regarding all of this. Patient thought was getting better not worse and did not want to call doctor office.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Loss of consciousness, Posture abnormal
Clinical narrative: Patient was given vaccine to Right deltoid at 4:22pm (3rd dose) with no previous reaction to vaccine. At approx. 4:23pm patients mom started yelling for staff and patient was observed with head down to chin seemingly "passed out" patient was laid back and upon touching his chest to check respirations the patient then lounged forward with his eyes open. Patient said "I blacked out". Nursing staff checked his Pulse and it was 58 and oxygen level was 98%. Patient was given juice incase a blood sugar issue but blood glucose checked and it was 85. Patient has no known previous medical history. Patient was alert and orientated to person and place but was unable to say it was August but did say the month before September so was orientated to time. There is a language barrier as patient is Spanish speaking as well an English speaking.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Left arm: big circular skin rash, covers 1/4 of his arm. Right cheek: dark purple, shingle-like spots, as big as an eraser with 2 addition smaller spots. Lower right back: big birthmark-like rash, covers 1/4 of his back, skin is raised.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Feeling cold, Headache, Influenza virus test, Insomnia
Clinical narrative: Fever higher than 102, chills, headache. Left underarm got swollen after two days and stayed for 4 days. Was hard to sleep due to sharp pain in the underarm.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, Urine analysis
Clinical narrative: Fever higher than 102, chills, headache. Left underarm got swollen after two days and stayed for 4 days. Was hard to sleep due to sharp pain in the underarm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient 1st noticed when she went to take a bath morning following vaccination. Redness and dark red dots extending from deltiod injection site diagonally towards inner arm -  approximately 4 inch wide red striation from deltoid to axillary region is swollen. Patient says it is tender entire arm from elbow to shoulder is warm to the touch. Muscle spasms in the bicep area. She had the PREVNAR vaccine 2 years ago, flu shot every year and has never had such a reaction similar to this which is why she decided to report this denies pain, denies itching, denies shortness of breath.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Muscle spasms
Clinical narrative: Patient 1st noticed when she went to take a bath morning following vaccination. Redness and dark red dots extending from deltiod injection site diagonally towards inner arm -  approximately 4 inch wide red striation from deltoid to axillary region is swollen. Patient says it is tender entire arm from elbow to shoulder is warm to the touch. Muscle spasms in the bicep area. She had the PREVNAR vaccine 2 years ago, flu shot every year and has never had such a reaction similar to this which is why she decided to report this denies pain, denies itching, denies shortness of breath.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Culture, Gait disturbance, Injection site warmth, Irritability
Clinical narrative: Temperature of 100.6 on 07/28/18, increasing fussiness and stumbling when walking. 07/30/18 right thigh warm to touch, 07/31/18 mother took to ER and was told to massage area while also applying warm, moist, heat to right thigh. Per mother on medical record.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Streptococcus test negative
Clinical narrative: Temperature of 100.6 on 07/28/18, increasing fussiness and stumbling when walking. 07/30/18 right thigh warm to touch, 07/31/18 mother took to ER and was told to massage area while also applying warm, moist, heat to right thigh. Per mother on medical record.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around the injection site hours after vaccine was administered.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: Patient reports numbing pain at injection site. Patient was unable to lift arm above head. Pain persisted through the night and went to the ER.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Condition aggravated, Myalgia, Rheumatoid arthritis
Clinical narrative: Started to have joint/muscle/bone pain - felt like a RA flair. The worst day was Saturday and slowly subsided. Has RA.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex test, Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: VALTREX 1g 3 times daily x 7 days. Rash over upper rt. buttock area that appeared within the last 24 hrs. after receiving vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: 3d after vaccine noted (L) clavicle area sore then spread to (L) anterior clavicle area. Pain 8/10. ADVIL helped total 7d with decreased ROM and pain 5/10.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Paraesthesia
Clinical narrative: Patient reports tingling sensation to area administered. Patient noted with erythema to back left upper arm to site of ZOSTAVAX administered 7/25/18, presents with redness, inflammation 6cm wide and 10cm length, noted to be warm to touch, no pain on palpation.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Gait disturbance, Headache, Lethargy
Clinical narrative: Patient state he received the vaccine on 7/31/18 from the pharmacy. Pt. states that evening he began to feel weak, low grade fever, HA, cough, and lethargic, and trouble walking w/o assistance.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient state he received the vaccine on 7/31/18 from the pharmacy. Pt. states that evening he began to feel weak, low grade fever, HA, cough, and lethargic, and trouble walking w/o assistance.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to injection site occurring on 7/26/18 (Left shoulder). 7-30-18 Spoke with client - better but still some soreness swelling and little warmth.
Age: 16.0
Sex: F
Vaccine: HEP, MENB, MNQ
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid quarter size bump, hard, swollen, hot to the touch, pain to touch.
Sex: U
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client reported on 7/25/18 that pt. had redness, heat, softball size raised area on (R) upper arm. Saw Nurse Practitioner on 7/25/18. Dx w/cellulitis. Given Clindamycin 300 mg TID x 10 days. 7/25/18 mother called to report child had seen nurse practitioner on 7/25/18. Child had raised 5 in. x 5 in. area on (R) upper arm - red, swollen, and hot to touch. Prescribed Clindamycin 300 mg TID x 10 days for cellulitis of (R) upper arm.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: Throwing up, low-grade fever, diarrhea, fatigue.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site cellulitis, Pain in extremity, Swelling
Clinical narrative: Extreme pain in arm. Next day swelling and redness, nurse practitioner diagnosed as cellulitis at side of injection on 7-11. Immediately put on an antibiotic (Cephalexin).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Uncontrollable shaking, fever, severe headache, muscle and joint pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Somnolence, Vaccination site pain
Clinical narrative: Beginning that evening the patient experienced headache causing nausea and very sore arm where vaccine was administered. Headache continued thru the next morning. After headache subsided patient experienced daytime fatigue/sleepiness which is not normal for him. All side effects had subsided by noon today, just some arm soreness remaining.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Pain, Swelling
Clinical narrative: Patient described major swelling, and body aches. Also complains of major pain "in the ankles."  Body aches increased over the course of 2 days. When asked if patient has been using anything to help with the aches, did not mention taking any other medications. Patient was referred to Urgent Care to be seen by physician.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Limb discomfort, Pain, Pyrexia
Clinical narrative: Achy body tired, sore arm, fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Patient called clinic the evening of receiving her vaccination complaining of localized swelling to the injection site, and the area had swelled up to the size of her hand. Patient stated she had been icing the area, but was advised to take BENADRYL and TYLENOL or ibuprofen for the swelling, and to return to clinic or ER with worsening of symptoms. The next day the patient reported low grade fever and nausea when she was called to check on her.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Rash, Swelling face
Clinical narrative: Rash on face, swelling on face, headache, fatigue. All went away by Monday 8-6-18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient woke up with localized swelling, redness and pain around the injection site. Treating with ice packs applied in 20 minute cycles.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Pt called stating that she is having severe pain after her booster SHINGRIX vaccine today. States that she feels like it was given in the bursa or to close to the bursa. States that the pain is severe to the point that she can't move her arm. States that she got the injection by RN at 11:30 and the pain started at 12:45 with stiffness/pain that has escalated. States that it was given about 1.5 inches below the shoulder bone and she is concerned it is maybe to close to the bursa after speaking with her daughter who works in the health care field.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Anxiety, Emotional distress, Loss of consciousness, Nausea
Clinical narrative: Pharmacist gave vaccines to patient and they were very anxious, recommended to pt and mom that pt sit there until she calmed down. Pt was upset and wanted to get up and walk around. About 10mins later patient felt nauseous and passed out. The patient and her mom were counseled that, fainting can happen due to the relief of being done with the vaccines if they are really anxious. EMS came and said that the patient was good to go. After sitting for about 15mins patient had recovered.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: Body aches, fever, shingles, loss of range of motion in right arm.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: Choking, Dyskinesia, Gaze palsy, Resuscitation, Unresponsive to stimuli
Clinical narrative: 5 days after pt received his 2 month old vaccines. Pt out of a sudden became unresponsive in my mothers arms. My 15 year old brother witnessed pt feet, hands jerking and eyes rolled back. My mom gave pt mouth to mouth, by the time the ambulance arrived pt was responsive and pt was rushed to the hospital. Dr. did not know what had happened to him since he was responsive, an x-ray was taken but the Dr. could not read it because it was fuzzy. The hospital reports state pt  choked but that's not what the hospital said since they didn't know what happened to pt and its obvious when somebody chokes. its still unclear what happened to pt that day.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: X-ray
Clinical narrative: 5 days after pt received his 2 month old vaccines. Pt out of a sudden became unresponsive in my mothers arms. My 15 year old brother witnessed pt feet, hands jerking and eyes rolled back. My mom gave pt mouth to mouth, by the time the ambulance arrived pt was responsive and pt was rushed to the hospital. Dr. did not know what had happened to him since he was responsive, an x-ray was taken but the Dr. could not read it because it was fuzzy. The hospital reports state pt  choked but that's not what the hospital said since they didn't know what happened to pt and its obvious when somebody chokes. its still unclear what happened to pt that day.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient complains of extreme muscle pain originating from shoulder. States that it still hurts after one month, especially when he lifts his arm above his head. States that it feels painful in what might be considered the synovial fluid.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Redness, heat, swelling at injection site; nausea and lightheadedness (not sure if related).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient states that she has been experiencing a painful tingling sensation since receiving the vaccine and that sometimes she has to wear a sling because her arm hurts to that extent.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Antinuclear antibody positive, Blood test, Blood testosterone decreased, Cognitive disorder, Condition aggravated
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Depression, Fibromyalgia, Myalgia, Rheumatoid arthritis, Type 2 diabetes mellitus
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Allergic reaction to excipient, Amnesia, Antinuclear antibody positive, Anxiety, Autoimmune disorder
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Back pain, Bedridden, Blood glucose increased, Blood testosterone decreased, Condition aggravated
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Depression, Diabetes mellitus, Heart rate increased, Hypersomnia, Immunology test
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Impaired work ability, Influenza like illness, Limb crushing injury, Loss of personal independence in daily activities, Muscle strain
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pharyngeal oedema, Throat irritation
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Tremor, Vision blurred
Clinical narrative: Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: SHINGRIX vaccine administered at approximately 09:45 am on 7/30/2018. Patient reports having fever of 103 degrees with chills around 9pm that same day. Patients reports feeling better by 10 am the next day 7/31/2018.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Diffuse rash from shoulders to ankles, no itch or burning.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Myalgia, Bilateral neck pain/shoulder pain, chills, no fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Edema, pruritus, increased local temp at the injection site both arms.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: Several hours after injection into left arm my left arm became paralyzed. I could not move it at all. The pain was unbearable (throbbing at sight of injection). I took an ibuprofen to help but it did nothing. It got a little better each day but on the seventh day Pharmacist told me to go to the emergency room. I did (copies attached). Arm still in pain to this day. I have not recovered from this vaccination. My left arm hurts all the time when I move it a certain way. I cannot lift with my left arm w/out pain. I cannot sleep on my left arm behind my back or lift it above my head. I am sick to death of the pain and kept hoping it would get better with time (as I am greatly apposed to taking pain medication because of the side effects). I took pain pills after visit to emergency room and my husband said I was a "drooling idiot" from them an my speech was slurred also I could not drive to work if I took the pills. I plan to see a "pain specialist" w/in the coming month to see if he can help...My life is pure misery from this damn shot! P.S. I have used the heating pad and alternating w/ice packs in the beginning but that did not help either.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abnormal behaviour, Dysarthria, Impaired driving ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Several hours after injection into left arm my left arm became paralyzed. I could not move it at all. The pain was unbearable (throbbing at sight of injection). I took an ibuprofen to help but it did nothing. It got a little better each day but on the seventh day Pharmacist told me to go to the emergency room. I did (copies attached). Arm still in pain to this day. I have not recovered from this vaccination. My left arm hurts all the time when I move it a certain way. I cannot lift with my left arm w/out pain. I cannot sleep on my left arm behind my back or lift it above my head. I am sick to death of the pain and kept hoping it would get better with time (as I am greatly apposed to taking pain medication because of the side effects). I took pain pills after visit to emergency room and my husband said I was a "drooling idiot" from them an my speech was slurred also I could not drive to work if I took the pills. I plan to see a "pain specialist" w/in the coming month to see if he can help...My life is pure misery from this damn shot! P.S. I have used the heating pad and alternating w/ice packs in the beginning but that did not help either.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Monoplegia, Pain, Pain in extremity
Clinical narrative: Several hours after injection into left arm my left arm became paralyzed. I could not move it at all. The pain was unbearable (throbbing at sight of injection). I took an ibuprofen to help but it did nothing. It got a little better each day but on the seventh day Pharmacist told me to go to the emergency room. I did (copies attached). Arm still in pain to this day. I have not recovered from this vaccination. My left arm hurts all the time when I move it a certain way. I cannot lift with my left arm w/out pain. I cannot sleep on my left arm behind my back or lift it above my head. I am sick to death of the pain and kept hoping it would get better with time (as I am greatly apposed to taking pain medication because of the side effects). I took pain pills after visit to emergency room and my husband said I was a "drooling idiot" from them an my speech was slurred also I could not drive to work if I took the pills. I plan to see a "pain specialist" w/in the coming month to see if he can help...My life is pure misery from this damn shot! P.S. I have used the heating pad and alternating w/ice packs in the beginning but that did not help either.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Migraine, Pain
Clinical narrative: Immediately after the injection my upper arm swelled up, turned red, extremely painful. 2 hours later I felt tired, woozy, arm was extremely painful. 6 hrs later I went to sleep and was up all night with chills, severe headache, body aches, stomach ache. The headache my arm was so painful it kept waking me up that night. The head ache continued into the next day with throbbing and pulsating headache. I was still woozy and off balance. There side effects cleared up 36 hrs after the shot. Today is 5 days post injection and my arm is still a little red and tender to the touch put no where as painful as at the beginning. I was not able to work for 24 hours after the injection due to the headache, fatigue, arm pain.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Balance disorder, Chills, Dizziness, Erythema
Clinical narrative: Immediately after the injection my upper arm swelled up, turned red, extremely painful. 2 hours later I felt tired, woozy, arm was extremely painful. 6 hrs later I went to sleep and was up all night with chills, severe headache, body aches, stomach ache. The headache my arm was so painful it kept waking me up that night. The head ache continued into the next day with throbbing and pulsating headache. I was still woozy and off balance. There side effects cleared up 36 hrs after the shot. Today is 5 days post injection and my arm is still a little red and tender to the touch put no where as painful as at the beginning. I was not able to work for 24 hours after the injection due to the headache, fatigue, arm pain.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: Immediately after the injection my upper arm swelled up, turned red, extremely painful. 2 hours later I felt tired, woozy, arm was extremely painful. 6 hrs later I went to sleep and was up all night with chills, severe headache, body aches, stomach ache. The headache my arm was so painful it kept waking me up that night. The head ache continued into the next day with throbbing and pulsating headache. I was still woozy and off balance. There side effects cleared up 36 hrs after the shot. Today is 5 days post injection and my arm is still a little red and tender to the touch put no where as painful as at the beginning. I was not able to work for 24 hours after the injection due to the headache, fatigue, arm pain.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Immediately after the injection my upper arm swelled up, turned red, extremely painful. 2 hours later I felt tired, woozy, arm was extremely painful. 6 hrs later I went to sleep and was up all night with chills, severe headache, body aches, stomach ache. The headache my arm was so painful it kept waking me up that night. The head ache continued into the next day with throbbing and pulsating headache. I was still woozy and off balance. There side effects cleared up 36 hrs after the shot. Today is 5 days post injection and my arm is still a little red and tender to the touch put no where as painful as at the beginning. I was not able to work for 24 hours after the injection due to the headache, fatigue, arm pain.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Dysphagia, Feeling abnormal, Hypoaesthesia
Clinical narrative: About 1 to 2 minutes after vaccination, patient stated she felt like something from the right arm radiated up to her head, ear, nose, throat, and cheekbone. She also stated a metal taste in her mouth, then numbness on the right side of her face. I alerted the PA next door at express care to take a look at her. About 3 to 5 minutes later, patient stated having a little trouble swallowing, then the PA called 911.
Age: 0.83
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: C/O rash, vomiting, diarrhea for 2 weeks.
Age: 4.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: None. Pt. tolerated well.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Headache
Clinical narrative: Information has been received from a physician via a field employee referring to a 14 year old female patient. The patient's concurrent condition and medical history were reported as none. Information about drug reactions/allergies was unknown by the reporter. The patient was vaccinated with either GARDASIL or GARDASIL 9 (unidentified Merck hpv vaccine) (strength, batch/lot number and expiration date unknown; every dose of 0.5ml, first dose on 14-OCT-2014, second dose on 23-DEC-2014, third 15-APR-2015 respectively) intramuscularly for prophylaxis. On an unknown date (reported as after a few weeks after the first shot, also reported as the patient was 14 years old), the patient had headaches that persisted. The patient self-treated with ibuprofen and naproxen sodium (ALEVE). There was no sought medical attention. The outcome of headache was reported as continued to this day (not recovered). The causality assessment was not provided by reporter.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Off label use
Clinical narrative: This spontaneous report was received from a physician (who had read an article in "JAMA (unspecified abbreviation)" network for dermatology) via pharmacy technician refers to a female patient in her 60's. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date since March of 2016 (reported as "6 weeks apart"), the patient was vaccinated with two doses of GARDASIL 9, intramuscularly for multiple squamous cell tumors (off label use). Then 3 weeks after, 2nd Intramuscular dose, patient took the 3 largest tumors and injected GARDASIL 9 directly into tumors 4 times over the next 9 months (inappropriate schedule of vaccine administered). The doses were given from March of 2016 through February of 2017. By time of the article in May of 2018, the patient was tumor free. No product quality complaint (PQC) was involved.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a currently 17 year old female patient reporting on herself. The patient had no pertinent medical history, concurrent conditions or drug reactions/allergies. There was no concomitant medication. On 17-JUL-2018, the patient was vaccinated with VARIVAX for prevention of chickenpox, while she was pregnant. The patient became pregnant with last menstrual period of 23-JUN-2018, estimated date of conception of 07-JUL-2018 and estimated delivery date of 30-MAR-2019. The patient was informed she was pregnant by the physician's office after they reviewed her blood work from 17-JUL-2018. The pregnancy outcome was pending. No adverse experiences were reported. No treatment was given.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 18 year old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 25-JUL-2018, the patient was vaccinated with an adult dose of VAQTA (dose, frequency and route were unknown) lot # N028743 for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications were not provided. On 26-JUL-2018, the patient was inadvertently vaccinated with an expired unspecified dose of VARIVAX, lot number: M033906 with expiration date on 20-JUL-2018 (strength, dose number, anatomical location and route of administration were not reported), for prophylaxis (expired product administered). No adverse effect was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered registered nurse and refers to a 12 months patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 30-JUL-2017, the patient was supposed to receive M-M-R II and VARIVAX but BY mistake and not a confusion,  the patient received vaccination for prophylaxis with PROQUAD, 0.5 ml once, subcutaneous, lot number N014948 with expiration date on 11-NOV-2018 (strength, dose number and anatomical location were not reported) and with VARIVAX lot Number N017394 and expiration date on 07-JUN-2019 (strength, dose number, anatomical location and route of administration were not reported). The lot number and expiration date of the sterile diluent used for reconstitution was unknown. There was no adverse effect reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 25-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589:
Age: 1.08
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 13 month old male patient. On 05-JUL-2018 the patient was vaccinated with VAQTA lot # N030286 dose 1, intramuscular in the left thigh for prophylaxis. On 05-JUL-2018 the patient was vaccinated with VARIVAX lot # R002051 dose 1, subcutaneous in the left thigh and pneumococcal 13v conj vaccine (CRM197) intramuscular in the right thigh from lot T78675. Concomitant therapies included sterile diluent. No adverse effects reported.; Sender's Comments: US-009507513-1807USA007589:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored PNEUMOVAX 23 for prophylaxis, lot number R012501 and expiration date on 08-JAN-2020  (dose, route of administration and anatomical location were not reported). The dose of PNEUMOVAX 23 was exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (18 °C), during a time frame of 1 hour and 9 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Dyspnoea, Pallor, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 14 year old patient of unknown gender. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies, or concomitant medications. On 31-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N025429 (expiration date: 21-JUL-2020) for prophylaxis (strength, dose, frequency, and route of administration were not reported). Subsequently, about two minutes after the administration, of GARDASIL 9, the patient became "unresponsive, shortness of breath and looked pale in the color" (unresponsive to stimuli, dyspnea, and pallor, respectively). Subsequently, the emergency medical service was called and the patient was taken to an unspecified hospital emergency room. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. By the time of the report, the outcome of unresponsive to stimuli, dyspnoea and pallor was unknown. The causality relationship between the aforementioned events and GARDASIL 9 was not reported. Upon internal review, unresponsive event was determined to be medically significant. All telephone attempts to obtain follow up information had been unsuccessful and additional information has been requested. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA000591: US-009507513-1808USA000592:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Dyspnoea, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 11 year old patient of unknown gender. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies, or concomitant medications. On 31-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N025429 (expiration date: 21-JUL-2020) for prophylaxis (strength, dose, frequency, route of administration were not reported). Almost immediately after being vaccinated, the patient "shook a bit", and then, about two minutes after the administration, of GARDASIL 9, the patient became "unresponsive, shortness of breath and looked pale in the color". Subsequently, the emergency medical service was called and the patient was taken to an unspecified hospital emergency room. No laboratory diagnostic studies and no intervention to prevent serious criteria were performed. By the time of the report, the outcome of unresponsive to stimuli, dyspnoea, pallor, and tremor was unknown. The causality relationship between the aforementioned events and GARDASIL 9 was not reported. Upon internal review, unresponsive event was determined to be medically significant. All telephone attempts to obtain follow up information had been unsuccessful and additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA000589: US-009507513-1808USA000592.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Dyspnoea, Pallor, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 16 year old patient of unknown gender. The patient had no pertinent medical history, concurrent conditions, drug reactions/allergies, or concomitant medications. On 31-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N025429 (expiration date: 21-JUL-2020) for prophylaxis (strength, dose, frequency, route of administration were not reported). Subsequently, about two after the administration, of hpv GARDASIL 9, the patient became "unresponsive, shortness of breath and looked pale in the color" (unresponsive to stimuli, dyspnea, and pallor, respectively). Subsequently, the emergency medical service was called and the patient was taken to an unspecified hospital emergency room. No laboratory diagnostic studies were performed. By the time of the report, the outcome of unresponsive to stimuli, dyspnoea and pallor was unknown. The causality relationship between the aforementioned events and GARDASIL 9 was not reported. Upon internal review, unresponsive event was determined, to be medically significant. All telephone attempts to obtain follow up information have been unsuccessful and additional information has been requested. This is one of several reports received from the same reporter.; Sender's Comments: US-1009507513-1808USA000591: US-1009507513-1808USA000589:
Sex: M
Vaccine: HPV9
Symptoms: Antinuclear antibody negative, Dysphagia, Dyspnoea, Exaggerated startle response, Facial paresis
Clinical narrative: This spontaneous report was received from a company representative and refers to a 25 year old male patient. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown. On 02-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9; on 02-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9. Both doses were administered for prophylaxis (strength, route of administration, frequency, lot# and expiration date were unknown). On April 2018, the patient experienced gradual onset of generalized extremity and facial weakness (muscular weakness)(facial paresis) with muscle fasciculations (muscle contractions involuntary), hypnic jerks (myoclonus), hypersalivation (salivary hypersecretion), startle reflex (exaggerated startle response), spasticity (muscle spasticity), gas (flatulence), trouble swallowing (dysphagia), and difficulty breathing (dyspnoea) ongoing over last few months. On an unknown date, the patient had lab test results of ANA 1:640 and an MRI of brain and spine that were reported as normal. The patient has been evaluated by a primary health physician, a neurologist and a rheumatologist with inconclusive results. Causality between GARDASIL 9 and the mentioned events was unknown.