chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium decreased, Blood test, Body temperature increased, Chills, Differential white blood cell count abnormal
Clinical narrative: I got achy, headache chills, racing hearr. Took temp it was 100.7, took a half hour later it was 101.9. Got a hold of triage nurse. She said to go to ER. Temp over 102 at ER, heart rate 117. Blood tests given. White blood cells elevated, potassium was low. Given IV fluids, tylenol, ibuprofen. Had me stay until midnight. Temp down to 99, heart rate down to 100. Today 8/25, temp 100 @ 2pm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count abnormal, Headache, Metabolic function test abnormal, Monocyte count increased, Neutrophil count increased
Clinical narrative: I got achy, headache chills, racing hearr. Took temp it was 100.7, took a half hour later it was 101.9. Got a hold of triage nurse. She said to go to ER. Temp over 102 at ER, heart rate 117. Blood tests given. White blood cells elevated, potassium was low. Given IV fluids, tylenol, ibuprofen. Had me stay until midnight. Temp down to 99, heart rate down to 100. Today 8/25, temp 100 @ 2pm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Palpitations, White blood cell count increased
Clinical narrative: I got achy, headache chills, racing hearr. Took temp it was 100.7, took a half hour later it was 101.9. Got a hold of triage nurse. She said to go to ER. Temp over 102 at ER, heart rate 117. Blood tests given. White blood cells elevated, potassium was low. Given IV fluids, tylenol, ibuprofen. Had me stay until midnight. Temp down to 99, heart rate down to 100. Today 8/25, temp 100 @ 2pm.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Large purple area with blisters around injection site. Patient complained of area feeling hot and hard around the injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Headache, Injection site reaction, Nausea, Neck pain
Clinical narrative: Headache, neck pain, nausea, body aches, shakes, and  Erythema multiforme. Beaches and neck pain began in the am on 8/20. Lesions began that evening with severe shakes. The lesions started in the elbow crease of left arm and armpit. Then to the right elbow crease. Then to the right groom area and left armpit. Then the left deltoid. Top of right foot and left calf. Dermatology visit 8/22. Told to take antihistimibe for itching and the swelling and steroid cream.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Skin lesion, Tremor
Clinical narrative: Headache, neck pain, nausea, body aches, shakes, and  Erythema multiforme. Beaches and neck pain began in the am on 8/20. Lesions began that evening with severe shakes. The lesions started in the elbow crease of left arm and armpit. Then to the right elbow crease. Then to the right groom area and left armpit. Then the left deltoid. Top of right foot and left calf. Dermatology visit 8/22. Told to take antihistimibe for itching and the swelling and steroid cream.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Severe fatigue-continually tried to get up and stay up out of bed longer than 10 minutes just kept feeling faint and had to get back to bed. Once there sleepy 1-2 hours at a time. This lasted about 28-30 hour, weakness and not able to keep soft up right or do light cleanin. Tookmany naps and stayed in bed. This lasted about 28-30 hours. Head ache, dizziness, injection site pain for two days. Took pain reliever, Tylenol, and used a hot pad on injection site.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Loss of personal independence in daily activities, Somnolence
Clinical narrative: Severe fatigue-continually tried to get up and stay up out of bed longer than 10 minutes just kept feeling faint and had to get back to bed. Once there sleepy 1-2 hours at a time. This lasted about 28-30 hour, weakness and not able to keep soft up right or do light cleanin. Tookmany naps and stayed in bed. This lasted about 28-30 hours. Head ache, dizziness, injection site pain for two days. Took pain reliever, Tylenol, and used a hot pad on injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: At about 10 hours after injection, chills, fever (101.7), swollen lymph glands under left arm, aches in all joints. Lasted 2 1/2 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Borrelia test, C-reactive protein, Full blood count, Groin pain
Clinical narrative: Within a week (3 days) after the SHINGRIX vaccine and the flu shot (pharmacist said he could have them both together) my husband developed extreme pain running down both legs to feet with tingling and weakness, lower back pain. And stabbing pain in groin area. Could not sleep in any position. Had to walk around to feel better. Took a long walk outside in the middle of the night to try to feel better. Pain got so bad I brought my husband to ER at 4:30am because his legs felt so weak. He does not normally have any leg pain and is very active (plays hockey regularly, plays tennis and sails, walks aggressively weekly) His legs still feel painful but slowly dissipating. He does not have any neurological issues, no herniated disc or any other related problems.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Within a week (3 days) after the SHINGRIX vaccine and the flu shot (pharmacist said he could have them both together) my husband developed extreme pain running down both legs to feet with tingling and weakness, lower back pain. And stabbing pain in groin area. Could not sleep in any position. Had to walk around to feel better. Took a long walk outside in the middle of the night to try to feel better. Pain got so bad I brought my husband to ER at 4:30am because his legs felt so weak. He does not normally have any leg pain and is very active (plays hockey regularly, plays tennis and sails, walks aggressively weekly) His legs still feel painful but slowly dissipating. He does not have any neurological issues, no herniated disc or any other related problems.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Dry skin, Rash, Rash erythematous
Clinical narrative: Trunk rash, face rash. Slight red color. Bumpy, rough. All over face and trunk.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site movement impairment, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Injection site hot to touch, fever, aches, soreness, loss of movement, swelling, rash, tight/hard feeling in thigh.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Skin tightness
Clinical narrative: Injection site hot to touch, fever, aches, soreness, loss of movement, swelling, rash, tight/hard feeling in thigh.
Age: 4.0
Sex: F
Vaccine: UNK, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Gait disturbance, Pain, Skin warm, Swelling
Clinical narrative: Large (double the size of a half dollar) red ring with bullseye in the center. Hot to the touch and very swollen. She is extremely sore and is limping. She had her shots yesterday where she was given 3 and this morning work up do large red spot and continued to double in size.
Age: 4.0
Sex: F
Vaccine: UNK, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large (double the size of a half dollar) red ring with bullseye in the center. Hot to the touch and very swollen. She is extremely sore and is limping. She had her shots yesterday where she was given 3 and this morning work up do large red spot and continued to double in size.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Red skin and painful big hard lump on left and right leg where vaccine was administered.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Acute disseminated encephalomyelitis, Antibody test positive, Headache, Immunoglobulin therapy, Intracranial pressure increased
Clinical narrative: Presented with headache on 5/3/18 and vision changes on 5/22/18. Hospitalized on 5/25/18 for papilledema, increased ICP and ADEM. Hospitalized 5/25/18 to 6/5/18. Treatment included IV SOLU-MEDROL and IVIG.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Nuclear magnetic resonance imaging abnormal, Papilloedema, Visual impairment
Clinical narrative: Presented with headache on 5/3/18 and vision changes on 5/22/18. Hospitalized on 5/25/18 for papilledema, increased ICP and ADEM. Hospitalized 5/25/18 to 6/5/18. Treatment included IV SOLU-MEDROL and IVIG.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red and swollen and painful continuing 3 days after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth in (R) peroneal area 24 hours after given PROQUAD. No fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash vesicular
Clinical narrative: Vesicular rash: 7.5 cm area of erythema.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site induration, Injection site irritation, Injection site reaction
Clinical narrative: Headache for first 24 hrs. with low grade temp. Hardness at injection site, large wide area of rash/redness and irritation down upper arm almost to elbow. Duration of more than 2 weeks until finally rash/redness faded to lowest area.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Headache for first 24 hrs. with low grade temp. Hardness at injection site, large wide area of rash/redness and irritation down upper arm almost to elbow. Duration of more than 2 weeks until finally rash/redness faded to lowest area.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Inflammation
Clinical narrative: PATIENT SAID SHE EXPLAINED SHORTNESS OF BREATH AND DIFFICULTY BREATHING A DAY AFTER THE SHOT. AS SHE WAS SLEEPING, HER CHEST WAS TIGHT AND FELT AS IF AN ELEPHANT WAS SITTING ON HER CHEST.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: PATIENT SAID SHE EXPLAINED SHORTNESS OF BREATH AND DIFFICULTY BREATHING A DAY AFTER THE SHOT. AS SHE WAS SLEEPING, HER CHEST WAS TIGHT AND FELT AS IF AN ELEPHANT WAS SITTING ON HER CHEST.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain in extremity
Clinical narrative: 48 hours of pain in arm. Flu-like malaise for 36 hours (without fever).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: First day I was extremely fatigued, had headache and went to bed early. Next morning, the 25th, my left arm hurt at injection site, and I was unable to raise my arm up to shoulder level because of extreme muscle pain. No swelling or rash. Horrible headache, very fatigued. Took ALEVE in morning. By afternoon, I had a 102 degree fever. By evening, the injection site had swollen a lot, and had red lines and spots on it. Took 2 ALEVE again that night and iced the site. Next morning (today), the fever is gone, but I still have intense headache and the injection site is still swollen. I can raise my arm slightly higher, but not much.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: First day I was extremely fatigued, had headache and went to bed early. Next morning, the 25th, my left arm hurt at injection site, and I was unable to raise my arm up to shoulder level because of extreme muscle pain. No swelling or rash. Horrible headache, very fatigued. Took ALEVE in morning. By afternoon, I had a 102 degree fever. By evening, the injection site had swollen a lot, and had red lines and spots on it. Took 2 ALEVE again that night and iced the site. Next morning (today), the fever is gone, but I still have intense headache and the injection site is still swollen. I can raise my arm slightly higher, but not much.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging, Quadriplegia
Clinical narrative: Transverse Myelitis, resulting in quadriplegia.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site mass, Injection site swelling, Neck pain, Rash
Clinical narrative: Patient recieved dose 1 of the SHINGRIX in the right arm. Complains of swollen lump near injection site. Neck pain along with a small rash.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Shivering fever, joint pain, headache, medicated with TYLENOL and Ibuprofen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fatigue - persisting on day 3. Chills and fever (1 degree or so) - persisting on day 3. Nausea - first 24 hours - one episode at night. Pain, itching, swelling and hardness, and redness 2 inches out around the injection site - persisting on day 3.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fatigue - persisting on day 3. Chills and fever (1 degree or so) - persisting on day 3. Nausea - first 24 hours - one episode at night. Pain, itching, swelling and hardness, and redness 2 inches out around the injection site - persisting on day 3.
Age: 70.0
Sex: M
Vaccine: FLUR4, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Syncope
Clinical narrative: Pt was leaving facility, began having dizziness, and had sycopal episide causing him to fall and hit head on floor. Sent to ED via PV for possible concussion. CT scan normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received the first dose on SHINGRIX on Friday, 8/24/18. On Saturday, 8/25/18, she developed a rash on her legs from ankle to knee without any pain or itchiness. The rash continued on 8/26/18, when she called the pharmacy to report the event.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen hot area at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Nodule, Pyrexia, Swelling
Clinical narrative: Swollen knot, fever, cellulitis under skin over 12 Centimeters in diameter.
Age: 33.0
Sex: F
Vaccine: DT
Symptoms: Decreased appetite, Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in bicep for 48 hrs not able to move arm. Committing fever flu like symptoms. No appetite. Cloudy thoughts.
Age: 33.0
Sex: F
Vaccine: DT
Symptoms: Thinking abnormal
Clinical narrative: Severe pain in bicep for 48 hrs not able to move arm. Committing fever flu like symptoms. No appetite. Cloudy thoughts.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Asthenia, Blood culture, Blood test, Chills, Crying
Clinical narrative: Started crying a lot, she was irritable, then high fever appeared up to 104.5 but never low than 102. She stop eating, crawl and when you call her she barely open her eyes. The eyes looked teary, the nose and cheeks red, chills, tremors, she was so weak.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Culture urine, Decreased appetite, Erythema, Hyporesponsive to stimuli, Inability to crawl
Clinical narrative: Started crying a lot, she was irritable, then high fever appeared up to 104.5 but never low than 102. She stop eating, crawl and when you call her she barely open her eyes. The eyes looked teary, the nose and cheeks red, chills, tremors, she was so weak.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Irritability, Lacrimation increased, Pyrexia, Tremor, Urine analysis
Clinical narrative: Started crying a lot, she was irritable, then high fever appeared up to 104.5 but never low than 102. She stop eating, crawl and when you call her she barely open her eyes. The eyes looked teary, the nose and cheeks red, chills, tremors, she was so weak.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Chills, shivers, muscle aches, headache (especially in right eye), vague nausea, flu-like symptoms peeked approx. 17 hrs. after vaccination and gradually receded until approx. two days after vaccination.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Fever beginning about 24 hours later. Rose to 100.6. Sore arm. Fatigue. Big red circle around site 30 plus hours later.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Malaise, Muscular weakness
Clinical narrative: Moderately severe headache, Dizziness, Sore arm (8/10), Rigors, Fever by touch, Nausea, malaise, muscle weakness. I couldn't have worked. Lasted 4 days. Worse on day 1 and 2. I did have similar symptoms with the first dose 2.5 months earlier but not nearly as severe. Would not get another immunization with SHINGRIX if it was recommended.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Skin warm
Clinical narrative: Moderately severe headache, Dizziness, Sore arm (8/10), Rigors, Fever by touch, Nausea, malaise, muscle weakness. I couldn't have worked. Lasted 4 days. Worse on day 1 and 2. I did have similar symptoms with the first dose 2.5 months earlier but not nearly as severe. Would not get another immunization with SHINGRIX if it was recommended.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site (upper left arm) whenever arm is raised. Worse upon arising but never goes away. Topical remedies (Skinners Salve, Blue EMU) did not give relief. It has been over a month and the second shot will be due soon.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Musculoskeletal chest pain
Clinical narrative: Mid thoracic area became painful. The pain worked itself around the ribs on the right to the front right side of my chest. Soon after the blisters started to appear from the back to the front. Several spots observed especially on the outside area of right breast. After doctor visit I was placed on  Valacyclovir 1gm for a week. It was still quite painful so doctor prescribed Gabapentin 100 Mg. I am still taking this.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Arm very sore, red around injection site, itching.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness from shoulder to elbow.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports swelling, redness, warmth, and pain the day after vaccination on the whole upper part of the arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: PT RECEIVED SECOND DOSE ON 8/18/2018 AND DEVELOPED SHINGLE-LIKE RASH ON BACK ON 8/25. SHE WAS SEEN BY DOCTOR ON 8/26--AT THIS TIME IT HAS BEEN CONFIRMED THAT THE PATIENT HAS SHINGLES. SHE WAS PRESCRIBED ACYCLOVIR 800MG AND NORCO (FOR PAIN RELATED TO SHINGLES).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Back pain, Feeling abnormal, Hyperhidrosis, Nightmare
Clinical narrative: 1009: tdap and meningitis vaccine were administered. At that time, pt appeared to be in NAD. I instructed pt and MOC to remain in exam room for 20 minutes after administration of vaccine for monitoring. 1020: pt states "I don't feel ok", pt was seated in exam room chair near her mother. Pt set her head on her mother's shoulder and experienced a syncopal episode. I immediately began to wake pt up- pt was unconscious for about 10 seconds, and did not incur any physical injury. I was able to keep pt upright in chair during entire syncopal episode. Vitals were taken at that time, and pt seemed to be fully alert within 20 seconds. Pt was alert and oriented appx 5 minutes later- was able to tell me her first/last name, DOB, today's date, the reason for today's visit. Pt was visibly anxious and tearful. Pt appeared to be diaphoretic and cool to touch. Pt stated she had a "nightmare" during syncopal episode. PERRL, S1S2 ausculated with no gallops, clicks, murmurs or rubs. No rashes. No hives. Pt denied cp, sob or trouble breathing. No tongue/lip swelling noted. Pt reported sharp back pain and tingling in her fingers at this time. Since pt had syncopal episode nearly 10 minutes after immunization, and was now experiencing back pain/tingling of fingers, I instructed MOC to call 911. EMS arrived appx 10 minutes later. Pt was able to walk to gurney and was transported to ER by EMS.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia, Peripheral coldness, Syncope, Tearfulness
Clinical narrative: 1009: tdap and meningitis vaccine were administered. At that time, pt appeared to be in NAD. I instructed pt and MOC to remain in exam room for 20 minutes after administration of vaccine for monitoring. 1020: pt states "I don't feel ok", pt was seated in exam room chair near her mother. Pt set her head on her mother's shoulder and experienced a syncopal episode. I immediately began to wake pt up- pt was unconscious for about 10 seconds, and did not incur any physical injury. I was able to keep pt upright in chair during entire syncopal episode. Vitals were taken at that time, and pt seemed to be fully alert within 20 seconds. Pt was alert and oriented appx 5 minutes later- was able to tell me her first/last name, DOB, today's date, the reason for today's visit. Pt was visibly anxious and tearful. Pt appeared to be diaphoretic and cool to touch. Pt stated she had a "nightmare" during syncopal episode. PERRL, S1S2 ausculated with no gallops, clicks, murmurs or rubs. No rashes. No hives. Pt denied cp, sob or trouble breathing. No tongue/lip swelling noted. Pt reported sharp back pain and tingling in her fingers at this time. Since pt had syncopal episode nearly 10 minutes after immunization, and was now experiencing back pain/tingling of fingers, I instructed MOC to call 911. EMS arrived appx 10 minutes later. Pt was able to walk to gurney and was transported to ER by EMS.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient had no reaction until the next evening after the administration. There is a tennis ball sized bruising and swelling around the injection site. It is hot to the touch and painful and the swelling and pain has been progressively getting bigger and worse. Patient tried icing with ice bag, taken TYLENOL and MOTRIN. Patient was at the hospital but not for this reaction, asked the doctor about the arm but the doctor said that it's an adverse reaction to the vaccination but did not do any further check-up. Urged patient to seek urgent care or call PCP if no relief in few more days and to continue icing the area and taking OTC for pain relief and swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Patient had severe vertigo, she was admitted to the hospital for 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient broke out in rash 2.5 weeks post vaccination that covered upper torso, both arms and starting on both legs. The rash is very itchy but patient had not tried to take anything over the counter for it yet, will try BENADRYL. Patient states she has no known med allergies and has not ever had a reaction to a vaccine before. She did get this years flu vaccination from someplace else on 8/19/2018.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site pain, Lethargy, Pain
Clinical narrative: Patient reports low grade fever, slight headache, body aches, stomach pain, and soreness at injection site. Patient states was very lethargic and slept for most of the day. Soreness at site lasted 4 days, but other symptoms resolved in about 8 hours after onset. Patient says when symptoms resolved he felt back to normal with no lasting effects.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence
Clinical narrative: Patient reports low grade fever, slight headache, body aches, stomach pain, and soreness at injection site. Patient states was very lethargic and slept for most of the day. Soreness at site lasted 4 days, but other symptoms resolved in about 8 hours after onset. Patient says when symptoms resolved he felt back to normal with no lasting effects.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Pyrexia
Clinical narrative: Patient indicated that she experienced fever and generalized joint pain and swelling.
Age: 63.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient experienced extreme pain (in the left arm where the SHINGRIX was given) that lasted through the night after the administration and resulted in her being admitted into the ED for pain management the next morning. The pain subsided after medical intervention. Patient was released from the hospital and continued oral pain medication until 08-25-2018. There were no external signs (ie. No erythema, rash, fever). As of 08-26-2018 she has limited range of motion but can hold a book up for short periods as well as let her arm dangle. She is using her other arm to help move the affected arm and still has moderate to severe pain. She received vaccinations in both arms, the other arm had no issues reported other than standard post IM injection.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Blister, Rash
Clinical narrative: Patient received the vaccine on 08/21/2018 and started feeling pain in her back, Upon checking she found blisters, bumps and rash on her back. She came to pharmacy today and mentioned about the same on 8/26/2018. I have advised her to call her Dr. and see him ASAP for a proper diagnosis.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: Within 3 hours I started to have a headache, achy muscles, fatigue, achy joints, nausea and moderate pain at injection site. This went on for 4 days. I was weak and the HA came and went. I had a similar reaction to the first shot in the series but not as severe. Only 2 days of these symptoms, I never react to shots in the past.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Within 3 hours I started to have a headache, achy muscles, fatigue, achy joints, nausea and moderate pain at injection site. This went on for 4 days. I was weak and the HA came and went. I had a similar reaction to the first shot in the series but not as severe. Only 2 days of these symptoms, I never react to shots in the past.
Age: 66.0
Sex: U
Vaccine: PNC13
Symptoms: Full blood count, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient developed large red, swollen, hot area in upper arm of injection site. Redness covered outer arm from shoulder to elbow. On day 3 of event, center of area cleared but 1-2 inches of the edges formed angry, red blisters, which was very itchy. On day 4, patient saw PA, and began taking two OTC oral antihistamines, and applying prescription topical steroid cream to blisters. On day 5, patient developed id reaction on inner forearms. On day 8, patient saw PA again and bloodwork was ordered. By day 12, blisters had disappeared and skin was no longer swollen or itchy. On day 14, skin is still reddish in area of blisters but not hot or itchy. Pics available.
Age: 66.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Metabolic function test
Clinical narrative: Patient developed large red, swollen, hot area in upper arm of injection site. Redness covered outer arm from shoulder to elbow. On day 3 of event, center of area cleared but 1-2 inches of the edges formed angry, red blisters, which was very itchy. On day 4, patient saw PA, and began taking two OTC oral antihistamines, and applying prescription topical steroid cream to blisters. On day 5, patient developed id reaction on inner forearms. On day 8, patient saw PA again and bloodwork was ordered. By day 12, blisters had disappeared and skin was no longer swollen or itchy. On day 14, skin is still reddish in area of blisters but not hot or itchy. Pics available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On day of vaccination (8/22/2018) pt reported minimal pain, swelling. 8/25/2018, pt reported size up to mosquito bite. Today area was swollen, red, inflamed, painful, warm to touch & about 6 inches by 4 inches in a rough oval shape. Could be ADR (25-35% of recipients) or infection, such as cellulitis. Advised to consult physician if does not resolve on own by tomorrow.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction, Pruritus
Clinical narrative: Local site reaction to left leg, increasing redness and warmth for several days, some hardness to skin reported by family but not noted in clinic. Pt came to me 3 days s/p vaccine, still with local redness and warmth, almost with bulls-eye appearance as a few rings of light and dark redness. No induration. Pt reports itching but no pain. Family has tried BENADRYL and TYLENOL. I gave BACTRIM antibiotic for 5 day course, instructed to use ibuprofen for swelling and inflammation. Mark borders and watch closely, and follow-up if not improving.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abdominal distension, Dyspnoea, Fatigue, Lung disorder, Pain
Clinical narrative: "Symptoms common to pneumonia"-barely able to breathe, tightness in lungs, nose running constantly, gurgling in lungs, achingly tired, mucus, severely bloated.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pneumonia, Rhinorrhoea
Clinical narrative: "Symptoms common to pneumonia"-barely able to breathe, tightness in lungs, nose running constantly, gurgling in lungs, achingly tired, mucus, severely bloated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph at collar bone on the right side.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Headache, Injection site pain, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: Spouse called stating that she has been tired feeling with headache not able to perform activities of daily living. Also, stated that both sites were very sore and hot feeling.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 8/20 PT REC'D VACCINE, FELT FINE. 8/22 PT WOKE UP NOT FEELING WELL; FATIGUE, MALAISE, ACHE, FEVER, CHILLS, SLEEPY. 8/23 INJECTION SITE STARTED TO HURT, FELT HOT, ITCHY, RED, TENDER TO TOUCH. TOOK TYLENOL FOR PAIN. 8/26 PT CAME TO PHARMACY STATED TO REPORT; ADVISED PT TO CALL MD IN THE MORNING.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Malaise, Pain, Pyrexia, Somnolence
Clinical narrative: 8/20 PT REC'D VACCINE, FELT FINE. 8/22 PT WOKE UP NOT FEELING WELL; FATIGUE, MALAISE, ACHE, FEVER, CHILLS, SLEEPY. 8/23 INJECTION SITE STARTED TO HURT, FELT HOT, ITCHY, RED, TENDER TO TOUCH. TOOK TYLENOL FOR PAIN. 8/26 PT CAME TO PHARMACY STATED TO REPORT; ADVISED PT TO CALL MD IN THE MORNING.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, X-ray limb abnormal
Clinical narrative: My arm was somewhat sore for a couple of weeks, but then it got out of control. The pain was excruciating. My doctor took an X-ray on August 20th and saw a shadow around my rotator cuff. He feels that the serum was stuck in the bursa at the rotator cuff. I was given a MEDROL DOSEPAK and sent for physical therapy for my shoulder.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Patient came in to the pharmacy on 8/25/18 and asked pharmacist to look at her arm from her flu shot. The area directly around the injection site looked fine except for a tiny bruise, however the area was very red and warm down the arm from the mid upper shoulder to the wrist. Pharmacist told the patient to go to the urgent care to rule out cellulitis. Patient was seen in urgent care and prescribed a MEDROL DOSEPAK. She was told that she had an allergic reaction and that she should no longer get a flu vaccine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Patient came in to the pharmacy on 8/25/18 and asked pharmacist to look at her arm from her flu shot. The area directly around the injection site looked fine except for a tiny bruise, however the area was very red and warm down the arm from the mid upper shoulder to the wrist. Pharmacist told the patient to go to the urgent care to rule out cellulitis. Patient was seen in urgent care and prescribed a MEDROL DOSEPAK. She was told that she had an allergic reaction and that she should no longer get a flu vaccine.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Agitation, Crying, Electroencephalogram, Facial paralysis, Monoparesis
Clinical narrative: Patient was outside with class peers and staff. While sitting and having snack, she was observed by her teacher to suddenly stop eating. Her head dropped forward with Left side of her mouth pulled downward and arm dropped to her lap. This lasted approximately 2-3 seconds. When patient "woke", she was agitated - crying but calmed after climbing into teacher's lap. Patient was taken to school nurse's office, and once she appeared to be back at baseline. I (Mom) was called. I picked patient up from school, called her neurologist, and made an appointment for her to be seen.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Posture abnormal
Clinical narrative: Patient was outside with class peers and staff. While sitting and having snack, she was observed by her teacher to suddenly stop eating. Her head dropped forward with Left side of her mouth pulled downward and arm dropped to her lap. This lasted approximately 2-3 seconds. When patient "woke", she was agitated - crying but calmed after climbing into teacher's lap. Patient was taken to school nurse's office, and once she appeared to be back at baseline. I (Mom) was called. I picked patient up from school, called her neurologist, and made an appointment for her to be seen.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Had vaccines 08/21/18. Today, 8/24/18, muscle on RT has a hard, pinkish lump about the size of half dollar. When mom rubs it she says "ouwy". She is happy, playful. Slightly feverish. She is sitting in warm bath currently which seems to give some relief.
Age: 85.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Stabbing pain in legs that night.
Age: 65.0
Sex: M
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red, tenderness at site of injection. B/P 136/88.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site indentation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a day after receiving Shingrix, the patient experienced pain localized, local swelling and localized erythema. On an unknown date, the patient experienced muscle degeneration. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved and the outcome of the muscle degeneration was not recovered/not resolved and the outcome of the localized erythema was recovering/resolving. It was unknown if the reporter considered the pain localized, local swelling, muscle degeneration and localized erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within 24 hours of receiving the vaccine, the patient stated that she had pain, redness, and swelling that was a couple of inches below the injection site. The patient stated that the area was big, huge and red and was about 3 inches in diameter that lasted for about 4 weeks. It began to dissipate, and then she noticed a "big dent" in the area. The patient stated it was like her muscle deteriorated in that area. The physician was aware and informed her that there was nothing that she could do as this was just the way that her body reacted to the vaccine. The patient stated that her pharmacist recommended that the 2nd dose be given in her hip but she cannot find a facility that would administer it in the hip due to privacy reasons. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a day after receiving Shingrix, the patient experienced pain localized, local swelling and localized erythema. On an unknown date, the patient experienced muscle degeneration. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved and the outcome of the muscle degeneration was not recovered/not resolved and the outcome of the localized erythema was recovering/resolving. It was unknown if the reporter considered the pain localized, local swelling, muscle degeneration and localized erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within 24 hours of receiving the vaccine, the patient stated that she had pain, redness, and swelling that was a couple of inches below the injection site. The patient stated that the area was big, huge and red and was about 3 inches in diameter that lasted for about 4 weeks. It began to dissipate, and then she noticed a "big dent" in the area. The patient stated it was like her muscle deteriorated in that area. The physician was aware and informed her that there was nothing that she could do as this was just the way that her body reacted to the vaccine. The patient stated that her pharmacist recommended that the 2nd dose be given in her hip but she cannot find a facility that would administer it in the hip due to privacy reasons. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site indentation, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a day after receiving Shingrix, the patient experienced pain localized, local swelling and localized erythema. On an unknown date, the patient experienced muscle degeneration. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved and the outcome of the muscle degeneration was not recovered/not resolved and the outcome of the localized erythema was recovering/resolving. It was unknown if the reporter considered the pain localized, local swelling, muscle degeneration and localized erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within 24 hours of receiving the vaccine, the patient stated that she had pain, redness, and swelling that was a couple of inches below the injection site. The patient stated that the area was big, huge and red and was about 3 inches in diameter that lasted for about 4 weeks. It began to dissipate, and then she noticed a "big dent" in the area. The patient stated it was like her muscle deteriorated in that area. The physician was aware and informed her that there was nothing that she could do as this was just the way that her body reacted to the vaccine. The patient stated that her pharmacist recommended that the 2nd dose be given in her hip but she cannot find a facility that would administer it in the hip due to privacy reasons. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle atrophy, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received Shingrix for prophylaxis. On 16th May 2018, the patient received the 1st dose of Shingrix. In May 2018, less than a day after receiving Shingrix, the patient experienced pain localized, local swelling and localized erythema. On an unknown date, the patient experienced muscle degeneration. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved and the outcome of the muscle degeneration was not recovered/not resolved and the outcome of the localized erythema was recovering/resolving. It was unknown if the reporter considered the pain localized, local swelling, muscle degeneration and localized erythema to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Within 24 hours of receiving the vaccine, the patient stated that she had pain, redness, and swelling that was a couple of inches below the injection site. The patient stated that the area was big, huge and red and was about 3 inches in diameter that lasted for about 4 weeks. It began to dissipate, and then she noticed a "big dent" in the area. The patient stated it was like her muscle deteriorated in that area. The physician was aware and informed her that there was nothing that she could do as this was just the way that her body reacted to the vaccine. The patient stated that her pharmacist recommended that the 2nd dose be given in her hip but she cannot find a facility that would administer it in the hip due to privacy reasons. The patient had denied permission to contact their physician.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, DTAPIPVHIB, HEP, HEPA
Symptoms: Dermatitis allergic, Injection site cellulitis
Clinical narrative: Was not aware that my daughter was given a HEP B shot until she had an adverse reaction, asked nurse specifically to not give it to her, she persisted to anyways. Her leg swelled up almost double in size from the knee up and had red and white pattern. Doctor initially thought cellulitis but because of finding out she was given shot not listed on her vaccine symptom pain decided that it was a reaction.  Swelling took several days to go down and an emergency room visit and follow up at urgent care and with regular doctor. She was given course of Cephalexin for 10 days and prednisone.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, DTAPIPVHIB, HEP, HEPA
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: Was not aware that my daughter was given a HEP B shot until she had an adverse reaction, asked nurse specifically to not give it to her, she persisted to anyways. Her leg swelled up almost double in size from the knee up and had red and white pattern. Doctor initially thought cellulitis but because of finding out she was given shot not listed on her vaccine symptom pain decided that it was a reaction.  Swelling took several days to go down and an emergency room visit and follow up at urgent care and with regular doctor. She was given course of Cephalexin for 10 days and prednisone.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to an 88-year old non-pregnant female patient. The patient's concurrent conditions included hypertension (HTN), atrial fibrillation (Afib), coronary artery disease (CAD) and hyperlipidaemia. The patient's concomitant therapies included atorvastatin, COREG, cholecalciferol, valsartan and low dose aspirin. The patient had no known allergies. The patient had no illnesses at the time of vaccination and up to one month prior. On 11-JUL-2018 at 10:44, the patient was vaccinated with first dose of PNEUMOVAX 23, lot # N034525 (expiry date: 13-JUN-2019), intramuscularly in the right arm for prophylaxis (dose was not reported). On 12-JUL-2018 at 14:40, the patient experienced erythema, swelling, heat left arm and soreness beginning evening following vaccination. The patient visited doctor's office and received antibiotics for the events. The patient did not experience these events previously. The outcome of events was reported as recovered on an unknown date in 2018. The reporter did not provide any causality assessment for the events. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA006915.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old male patient who received Shingrix for prophylaxis. On 6th August 2018, the patient received the 1st dose of Shingrix. In August 2018, several days after receiving Shingrix, the patient experienced rash. The patient was treated with acyclovir, triamcinolone and prednisone. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: In August 2018, within a couple of days after vaccination, the patient broke out into a rash which was on his left shoulder to his elbow. On 15th August 2018, the patient was seen in the emergency room and was prescribed prednisone by mouth, Acyclovir and Triamcinolone 0.5 percent. On 16th August 2018, the patient reported that the rash began to spread and was across his chest.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old male patient who received Shingrix for prophylaxis. On 6th August 2018, the patient received the 1st dose of Shingrix. In August 2018, several days after receiving Shingrix, the patient experienced rash. The patient was treated with acyclovir, triamcinolone and prednisone. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: In August 2018, within a couple of days after vaccination, the patient broke out into a rash which was on his left shoulder to his elbow. On 15th August 2018, the patient was seen in the emergency room and was prescribed prednisone by mouth, Acyclovir and Triamcinolone 0.5 percent. On 16th August 2018, the patient reported that the rash began to spread and was across his chest.