chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Syncope, Vertigo, Vomiting
Clinical narrative: Manufacturer= Merck Sharp & D. Innoculation was given in October, 2017. On 6/6/19 Sudden vomiting and collapse at work from extreme vertigo, was hospitalized for 6 days. Lost 2 weeks of work before returning to work, part time. I was not sick from anything for an entire year and a half prior to this incident. Vertigo is persistent 6 weeks later. (Today is 7/21/18.) I am still fighting vertigo and am going to PT sessions for the symptoms. I believe that such an extreme condition is because of the ZOSTAVAX inoculation causing nerve damage in my vestibular passages.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Heart rate increased, Pain
Clinical narrative: Patient reports later that day (7/20/18) feeling while body pain including joint pain, high pulse rate (96 bpm) and feeling very short of breath. The symptoms continued until at least this morning when he called the pharmacy at 8:30 AM (7/21/18). I suggested that he seek the help of a medical provider via a clinic or the ER. He had not as of this morning (7/21/18).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Butterfly rash, Dizziness, Fatigue, Impaired driving ability, Injected limb mobility decreased
Clinical narrative: By 4pm in the afternoon, my arm (from elbow up to my neck) became extremely painful. I couldn't lift the arm without using my right arm as a helper. I had to cancel a social engagement that evening because I wasn't capable of driving. Also, Thursday and Friday I was nauseous, light headed, and fatigued. Friday my arm felt a little better, but I still wasn't able to put a shirt on over my head. Saturday (today) the arm was sorer again, but in a more concentrated location, at the top of the shoulder. Also, by Saturday morning I'd developed a mild "butterfly" rash across my chest.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Rash
Clinical narrative: By 4pm in the afternoon, my arm (from elbow up to my neck) became extremely painful. I couldn't lift the arm without using my right arm as a helper. I had to cancel a social engagement that evening because I wasn't capable of driving. Also, Thursday and Friday I was nauseous, light headed, and fatigued. Friday my arm felt a little better, but I still wasn't able to put a shirt on over my head. Saturday (today) the arm was sorer again, but in a more concentrated location, at the top of the shoulder. Also, by Saturday morning I'd developed a mild "butterfly" rash across my chest.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Injection site swelling, Pain, Rash erythematous
Clinical narrative: Bright red rash and swelling all over upper arm and around injection site with severe body aches and pains and fatigue.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Insomnia, Malaise
Clinical narrative: A few hours after the shot, I developed a headache and my arm was sore at the injection site.  About 15 hours after the shot, I had chills, muscle aches, headache, sore arm, and felt sick. Symptoms woke me up, and I couldn't fall back to sleep because I felt unwell and ached.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: A few hours after the shot, I developed a headache and my arm was sore at the injection site.  About 15 hours after the shot, I had chills, muscle aches, headache, sore arm, and felt sick. Symptoms woke me up, and I couldn't fall back to sleep because I felt unwell and ached.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Pain in right leg hamstrings causing limping; lasting weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Somnolence
Clinical narrative: Felt light headed and very tired day after second dose was received. Did not experience this after first dose 4 months ago. I had to go to bed and slept all afternoon.....very unusual! But I was fine the next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Headache, Pyrexia
Clinical narrative: Two hours after injection I felt like passing out. About 12 hours after the vaccine I developed a fever...first was 99.7 and about 3 hours later had gone up to 100.7 at which point I took a Naproxen followed by TYLENOL because the Naproxen was not reducing my headache. By about 7AM that morning I felt much relief. I must note here that the pharmacist did warn me that having a bad reaction was quite common even though I have never had reactions to other types of immunizations. He told me that apparently this one is different.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Continuous Moderate Pain in left arm which radiates down forearm to wrist/hand, severe swelling, redness, tenderness, itching, warmth since 7/21/2018 @ 11:00 am. Area of redness and swelling  has increased in size. I have tried topical rubbing alcohol and witch hazel in hopes of providing some relief. Symptoms have progressively worsened since receiving SHINGRIX. Plan to return to  pharmacy today.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Continuous Moderate Pain in left arm which radiates down forearm to wrist/hand, severe swelling, redness, tenderness, itching, warmth since 7/21/2018 @ 11:00 am. Area of redness and swelling  has increased in size. I have tried topical rubbing alcohol and witch hazel in hopes of providing some relief. Symptoms have progressively worsened since receiving SHINGRIX. Plan to return to  pharmacy today.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, minor chills and fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: Chills, fever, aching, loss of appetite, tired, upset stomach for approximately 27 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, aching, loss of appetite, tired, upset stomach for approximately 27 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: 11 x 2 cm of erythema on LT upper arm; fever x 1 day
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Woke on July 2 with swollen lips. Called pharmacist, was instructed to take BENADRYL and if I couldn't breath or it got worse, go to the ER. Lips got more swollen and eyes became swollen on July 4. All swelling was gone by July 6.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Arm at injection site swelled and at present is 31/2 inches by 1 1/3 inches. It doesn't hurt, but doctor recommended cutting it out. Scheduled for surgery. Have decided to have a biopsy, Xray / ET scan before that happens.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, chills, fatigue, stomach pain. Lasted one day.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Neuralgia
Clinical narrative: Neuropathic pain commencing left lateral lower chest wall area and gradually progressing across the left upper abdominal wall to the midline. Pain is not improving.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood pressure decreased, Cold sweat, Disorientation, Heart rate decreased
Clinical narrative: 10 minutes after her immunization, Patient was standing next to her father. She had a glazed over look on her face, I asked her father to grab onto her. He eased her down to the ground and she lost conciousness for about 10 seconds. When she woke up, she was disoriented. Her father carried her to the bench where I checked her blood pressure. It was 76/31 p51. 2 minutes later it rose to 111/81 p 92. Pt was diaphoretic and clammy. Medical services came and she was monitored. Her BP stabilized and her blood glucose was 91. She refused transport to the hospital and left under the supervision of her parents.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: 10 minutes after her immunization, Patient was standing next to her father. She had a glazed over look on her face, I asked her father to grab onto her. He eased her down to the ground and she lost conciousness for about 10 seconds. When she woke up, she was disoriented. Her father carried her to the bench where I checked her blood pressure. It was 76/31 p51. 2 minutes later it rose to 111/81 p 92. Pt was diaphoretic and clammy. Medical services came and she was monitored. Her BP stabilized and her blood glucose was 91. She refused transport to the hospital and left under the supervision of her parents.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Headache, Myalgia, Neuralgia
Clinical narrative: Every bone and muscle in my body hurts, low grade fever, chills, severe headache, triage I also nerve on left side (where I have had shingles) hurts so bad I feel like I need root canals in every tooth.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Toothache
Clinical narrative: Every bone and muscle in my body hurts, low grade fever, chills, severe headache, triage I also nerve on left side (where I have had shingles) hurts so bad I feel like I need root canals in every tooth.
Age: 45.0
Sex: F
Vaccine: FLUR3
Symptoms: Gastrooesophageal reflux disease, Injection site erythema, Injection site pain, Nausea, Pruritus
Clinical narrative: Pain and erythema in her right deltoid--Nausea with reflux--Tachycardia--itching BENADRYL 25 mg IV push twice PEPCID 20 mg IV push once ZOFRAN 8mg IV push.
Age: 45.0
Sex: F
Vaccine: FLUR3
Symptoms: Tachycardia
Clinical narrative: Pain and erythema in her right deltoid--Nausea with reflux--Tachycardia--itching BENADRYL 25 mg IV push twice PEPCID 20 mg IV push once ZOFRAN 8mg IV push.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Histamine intolerance, Injection site erythema, Injection site warmth
Clinical narrative: Second shot of SHINGRIX. First shot had no reaction. Second shot caused histamine reaction approximately 24 hours later. Patient said she had been outside in the heat all day when the reaction was noted. The injection site was red and warm to touch. Patient used ice packs over night and it lessened the size of the redness area. Patient is allergic to BENADRYL. She may try using a different antihistamine and continue to use icing the area.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: Patient reported pain at the sight of injection a few hours after immunization was given. She reported extreme fatigue the day after immunization. She went to the doctor on July 22, 2018 and reported swelling of the arm and unable to move her left arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Peripheral swelling, Swelling
Clinical narrative: PATIENT STATES PNEUMOVAX 23 VACCINE CAUSED HER INJECTION SITE TO SWELL UP. PAIN WAS HARD TO BARE. THE SWELLING TRAVELED TO HER PALMS THE FOLLOWING DAY. SWELLING HAS ALSO REACHED HER BODY.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Peripheral swelling, Swelling
Clinical narrative: PATIENT STATES PNEUMOVAX 23 VACCINE CAUSED His INJECTION SITE TO SWELL UP. PAIN WAS HARD TO BARE. THE SWELLING TRAVELED TO HIS PALMS THE FOLLOWING DAY. SWELLING HAS ALSO REACHED HIS BODY.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever (days 1, 2, Tylenol); Spotty rash all over body except neck and face/head (day5 and still has it).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Secure message to MD 07/20/2018 @ 2:17 p.m. : Pt has some significant redness around the vaccine that was placed in his muscle. He doesn't have a fever and he is acting normally, but the redness has grown over the last few hours to about 3 inches. Call center RN advise notes 07/20/2018 @ 2:57p.m: Call Notes: KEY SYMPTOMS: site of IM immunization now redness with 3 inches in diameter warm to touch, itching, denies pain. ONSET/DURATION/INTENSITY: last night, getting worse. PERTINENT HISTORY: vaccines yesterday, mom allergic to adhesive tapes. TRIED (BETTER/WORSE): none.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Disorientation, Syncope, Vomiting
Clinical narrative: Employee was standing in the reception area 30 minutes after the injection and fainted for about 10 seconds. She felt disoriented and soon after she had two episodes of emesis. About 20 minutes after the event, employee stated that she was fine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Ear pain, Fatigue, Feeling abnormal
Clinical narrative: 07/18/18: 1 hour after shot: Dizziness, pain in right arm, spread to right shoulder. 07/18/18: 2 hours after shot: Right side neck pain, right ear pain, headache. Symptoms persisted until 07/19/18. 07/19/18: Fever, fatigue, red blotches and swollen injection area on right arm, warm to touch, general feeling of feeling unwell, listlessness, brain fog, stomach upset. Persisted to 07/20/18: Fever continues, red blotches and swelling continues on injection site, warmness to touch, stomach upset. 07/22/18: Fever diminishes, red blotches decrease but still remain somewhat, swelling decreases but still remains, some stomach upset, hives develop on inner right thigh area, 0723/18: Fever gone, redness gone, some soreness remains in injection site area, hives almost gone, stomach improves. Still persistent unwell feeling, but improved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 07/18/18: 1 hour after shot: Dizziness, pain in right arm, spread to right shoulder. 07/18/18: 2 hours after shot: Right side neck pain, right ear pain, headache. Symptoms persisted until 07/19/18. 07/19/18: Fever, fatigue, red blotches and swollen injection area on right arm, warm to touch, general feeling of feeling unwell, listlessness, brain fog, stomach upset. Persisted to 07/20/18: Fever continues, red blotches and swelling continues on injection site, warmness to touch, stomach upset. 07/22/18: Fever diminishes, red blotches decrease but still remain somewhat, swelling decreases but still remains, some stomach upset, hives develop on inner right thigh area, 0723/18: Fever gone, redness gone, some soreness remains in injection site area, hives almost gone, stomach improves. Still persistent unwell feeling, but improved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Listless, Malaise, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: 07/18/18: 1 hour after shot: Dizziness, pain in right arm, spread to right shoulder. 07/18/18: 2 hours after shot: Right side neck pain, right ear pain, headache. Symptoms persisted until 07/19/18. 07/19/18: Fever, fatigue, red blotches and swollen injection area on right arm, warm to touch, general feeling of feeling unwell, listlessness, brain fog, stomach upset. Persisted to 07/20/18: Fever continues, red blotches and swelling continues on injection site, warmness to touch, stomach upset. 07/22/18: Fever diminishes, red blotches decrease but still remain somewhat, swelling decreases but still remains, some stomach upset, hives develop on inner right thigh area, 0723/18: Fever gone, redness gone, some soreness remains in injection site area, hives almost gone, stomach improves. Still persistent unwell feeling, but improved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Urticaria
Clinical narrative: 07/18/18: 1 hour after shot: Dizziness, pain in right arm, spread to right shoulder. 07/18/18: 2 hours after shot: Right side neck pain, right ear pain, headache. Symptoms persisted until 07/19/18. 07/19/18: Fever, fatigue, red blotches and swollen injection area on right arm, warm to touch, general feeling of feeling unwell, listlessness, brain fog, stomach upset. Persisted to 07/20/18: Fever continues, red blotches and swelling continues on injection site, warmness to touch, stomach upset. 07/22/18: Fever diminishes, red blotches decrease but still remain somewhat, swelling decreases but still remains, some stomach upset, hives develop on inner right thigh area, 0723/18: Fever gone, redness gone, some soreness remains in injection site area, hives almost gone, stomach improves. Still persistent unwell feeling, but improved.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: 5 DAYS AGO (07/17/2018) PARENTS NOTICED ERYTHEMATOUS, HARDENED KNOT ON RIGHT THIGH AT SITE OF INJECTION. NOT WARM TO TOUCH BUT DOES APPEAR TENDER TO TOUCH. AREA OF INDURATION AT VACCINATION SITE ONLY ON RIGHT THIGH. LOW GRADE TEMP ONCE 3 DAYS AGO HIGHEST 100.4. PT HAS BEEN MORE FUSSY LATELY & DECREASED APPETITE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pain, Irritability
Clinical narrative: 5 DAYS AGO (07/17/2018) PARENTS NOTICED ERYTHEMATOUS, HARDENED KNOT ON RIGHT THIGH AT SITE OF INJECTION. NOT WARM TO TOUCH BUT DOES APPEAR TENDER TO TOUCH. AREA OF INDURATION AT VACCINATION SITE ONLY ON RIGHT THIGH. LOW GRADE TEMP ONCE 3 DAYS AGO HIGHEST 100.4. PT HAS BEEN MORE FUSSY LATELY & DECREASED APPETITE.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Influenza like illness, Pain
Clinical narrative: Pain, red, hot, felt flu-ish (achey, headache) lasting 4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Muscle tightness
Clinical narrative: The patient became very tired after the vaccine and the next day she had a 2 inch red band around her arm where the injection was given. It felt sore. 2 days later she has experienced diarrhea, neck tightness and the area is hot to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The patient became very tired after the vaccine and the next day she had a 2 inch red band around her arm where the injection was given. It felt sore. 2 days later she has experienced diarrhea, neck tightness and the area is hot to touch.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Arm had large red area- about 6 by 6 inches, started small and enlarged by the 2nd day Sunday, 7/22/2018, warm to touch per patient. Patient states he has no other symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Anxiety, Balance disorder, Blood test, Dizziness
Clinical narrative: Dizziness, major anxiety, felt completely off balance, upset easily, paranoid.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranoia
Clinical narrative: Dizziness, major anxiety, felt completely off balance, upset easily, paranoid.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient states that a couple of hours after receiving the injection she experienced severe nausea and a fever. She states she felt better the morning after the injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Patient experiencing extreme pain that is radiating down the arm. Her pain was at an 11 last night (07/21/18). She had a hard time sleeping due to the pain and couldn't sleep on the side the injection was administered. Today her pain is at an 8. I told her to take TYLENOL and apply lidocaine to the arm to help manage the pain. I told her to follow up with her doctor in one weeks time if the pain doesn't subside.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives all over the back side of his body. Resembled poison ivy but knew it was not that because the patient has not been outside/exposed to that.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Headache for 12 hours, starting at 8pm on night of injection; Shivering for 10 hours, starting at 10pm on night of injection; Severe fatigue for 20 hours, starting at 8pm on night of injection.  Unable to perform normal activities during that time, including difficulty sleeping and working the next day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash erythematous, Vaccination site reaction
Clinical narrative: Patient came back to the pharmacy on July 11, 2018 with a large red rash by the vaccination site. She said her arm still hurt a week after the shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: - Severe pain at injection site; inability to move arm; pain lasted 48 hours with site still red, swollen, and hot (over 53 hours post shot). - Severe flu symptoms: body aches, headache, fever, nausea: lasted 52 hours with the exception of fever which lasted 24 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: - Severe pain at injection site; inability to move arm; pain lasted 48 hours with site still red, swollen, and hot (over 53 hours post shot). - Severe flu symptoms: body aches, headache, fever, nausea: lasted 52 hours with the exception of fever which lasted 24 hours.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient said she is having pain at the site of injection, swelling, a bump and she feels like it is feverish and warm at the site of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient said she is having pain at the site of injection, swelling, a bump and she feels like it is feverish and warm at the site of injection.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Excruciating pain, significant bruising from shoulder to elbow, swelling from shoulder to elbow, unable to move arm, fingers tingly. Symptoms started Thursday soon after vaccination and have improved through today. Bruising, swelling, and pain still present.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: Patient indicated that she felt fine after the vaccine was adminsitered. For the next 2 days she experienced body ache, fever and pain on her lower back.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Urticaria
Clinical narrative: Patient contacted pharmacy concerning a red welt the size of a half dollar that started to develop aprroximately 24 hours after her vaccination. The deltiod muscle is tender. Recommended ice and diphenhydramine to the patient. If continues to worsen to contact her PCP.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Bone pain, Chest pain, Headache, Myalgia
Clinical narrative: Muscles and bone pain, headache and elevated blood pressure (maybe due to the pain), chest pain and no fever. Taking TYLENOL to reduce pain. Currently patient said the pain is getting better, advised her to see doctor if she still experiencing these side effects.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Raised bump near site of injection. Painful when touched. Not red. No rash. Recommended Benadryl, ice, or cool compress. To contact MD if gets worse and that we will follow up with patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Vision blurred
Clinical narrative: Dark cloudy vision deep eye pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Middle insomnia, Mobility decreased, Musculoskeletal discomfort, Myalgia
Clinical narrative: About 12 hours after the vaccine, I awoke in the night, aching joints and muscles throughout the night, hard to turn over, had the urge to stretch and tense my muscles. In the morning I got in the hot tub, took Naproxen, and walked 3 miles to pump the pain out of my muscles. I began feeling better throughout the day, and 24 hours later I felt quite normal again with the exception of soreness in the injected arm. 48 hours later the soreness is nearly gone.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: About 12 hours after the vaccine, I awoke in the night, aching joints and muscles throughout the night, hard to turn over, had the urge to stretch and tense my muscles. In the morning I got in the hot tub, took Naproxen, and walked 3 miles to pump the pain out of my muscles. I began feeling better throughout the day, and 24 hours later I felt quite normal again with the exception of soreness in the injected arm. 48 hours later the soreness is nearly gone.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: After receiving the shot at 8:30 am on 7/20, my son's left shoulder began to swell and was hard and red around the injection site. He complained of itching throughout the day, but seemed otherwise fine. Throughout the day on 7/20, 7/21 and 7/22, his arm became so swollen and hard and the redness and swelling moved down to his elbow and around the back of his shoulder and arm. I took him to the Urgent Care to have him evaluated. It was determined that it was a significant negative reaction but there was no infection or cellulitis. They advised me to give him some Benadryl.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Swelling
Clinical narrative: Severe neck stiffness with severe pain (9-10 on 10 pt scale) and swelling on left side from base of neck to bottom of shoulder blade. Ibuprofen 800mg every 8 hrs, ice packs, bed rest without pillow. Lasting 3 days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Occult blood negative
Clinical narrative: Watery loose stools W/O mucus or blood started approximately 4 hours after rotavirus vaccine was given orally. Continues with increased watery stools now 3 days later. No fever, fussiness, emesis or other signs of illness. No ill contacts. Breastfeeding with no new food given, Mom has not made any changes to her die which might have effected baby.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Cardiac discomfort, Dizziness, Dyspnoea, Seizure
Clinical narrative: Patient felt light-headed, had a mild seizure (hands and legs contorted), breathing difficulty, and heart discomfort.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Incomplete course of vaccination
Clinical narrative: Patient took 1 capsule of VIVOTIF EC and experienced stomach pain for the next day. Patient's mother contacted Prescriber who discontinued the remaining doses upon hearing about the adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-JUN-2008, the patient was treated for a persistent vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: CSF test normal, Computerised tomogram head normal, Electroencephalogram, Endotracheal intubation, Laboratory test normal
Clinical narrative: Seizure requiring intubation approximately 4-6 hours later. Stabilized in PICU and discharged.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Lethargy, Seizure
Clinical narrative: Seizure requiring intubation approximately 4-6 hours later. Stabilized in PICU and discharged.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Computerised tomogram normal, Endotracheal intubation, Intensive care, Lumbar puncture normal, Seizure
Clinical narrative: Seizure requiring intubation approximately 4-6 hours later. Stabilized in PICU and discharged.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Seizure requiring intubation approximately 4-6 hours later. Stabilized in PICU and discharged.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of itching, pain, and a small lump at the injection site.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient complained of itching, pain, and a small lump at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-OCT-2013, the patient was inoculated with ZOSTAVAX, (lot # and route unknown), at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-APR-2015, the patient was treated by a certified physician assistant (PA-C) at a healthcare facility, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed VALTREX and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 02-JUN-2011, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-SEP-2014, the patient was treated at a clinic by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, HIBICLENS, mupirocin and clotrimazole topical for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-AUG-2013, the patient was treated by a physician at a clinic for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician at a clinic for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a public health as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician/MD at a medical facility/office, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-FEB-2015, the patient was treated by the same physician, at the medical facility/office for a blistering vesicular outbreak, which was diagnosed as shingles with post herpetic neuralgia, a condition which affects the nerve fibers and skin. The patient was prescribed gabapentin and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient reports fever of 100.5 F and Chills. Patient reports aches and flu like symptoms. Patient reports 5-6 bouts of light diarrhea.
Age: 47.0
Sex: F
Vaccine: IPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient came in for 2nd IPOL vaccination. About 1 week after injection patient noticed itchy rash on arm. Informed the pharmacy another week later 7/19/2018 and said that it has not gotten any better and has spread down leg. No pain or inflammation-Just itchy rash.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Differential white blood cell count, Full blood count, Headache, Hypoaesthesia
Clinical narrative: The new shingles vaccine, my first dosage, had the commonly reported reddness at site of injection, pain in arm radiating down to my hand causing numbness, nausea and mild headache for about 3 days.    My concern is a blood panel taken by my endocrinologist on July 10th, revealing an abnormal  liver ensyme, ALT (SGPT) of 55 IU/L.  I would have not thought anything about the shingles vaccine if I had not had a blood panel done on June 25, 2018 at my annual physical with primary care doctor, showing the same liver ensyme at 25.  My doctor regulary does liver panels due to the statin drugs I take.  I can't help but think the shingles vaccine on top of my regular medications sent this ensyme above normal range.  Hopefully it will go back within normal range given time.  I will not be taking the second dose of this vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Pain, Pain in extremity
Clinical narrative: The new shingles vaccine, my first dosage, had the commonly reported reddness at site of injection, pain in arm radiating down to my hand causing numbness, nausea and mild headache for about 3 days.    My concern is a blood panel taken by my endocrinologist on July 10th, revealing an abnormal  liver ensyme, ALT (SGPT) of 55 IU/L.  I would have not thought anything about the shingles vaccine if I had not had a blood panel done on June 25, 2018 at my annual physical with primary care doctor, showing the same liver ensyme at 25.  My doctor regulary does liver panels due to the statin drugs I take.  I can't help but think the shingles vaccine on top of my regular medications sent this ensyme above normal range.  Hopefully it will go back within normal range given time.  I will not be taking the second dose of this vaccine.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Lymphadenopathy, Pyrexia, White blood cell count decreased
Clinical narrative: Lymph node swelling behind left ear and left posterior neck area developed 7/19; developed fever 101.5 on 7/21. CBC done on 7/21 - sl. low wbc ct, possible viral suppression. Watch for S/Sxs viral illness, also discussed S/Sxs of adenitis,
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Loss of control of legs, Monoparesis, Neuropsychological test
Clinical narrative: Patient lost all control of his lower extremities.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from the medical assistant refers to 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On 01-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot # N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from the medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 30-MAY-2018 (also reported as 25-MAY-2018), the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 07-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to the patient included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 04-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.