chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Tympanic membrane perforation
Clinical narrative: Fever, lethargy, sleeping/not eating at immediate onset of vaccines, and second occurrence of a spontaneous, double ear drum rupture (blood pouring from his ears), 48 hours after the vaccines were administered... The first time was 48 hours after his 18 month vaccines.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Painful arm lasting to current date. Pt only went to doctor recently and will be starting physical therapy to see if that will help eliminate the pain the patient is experiencing. Information only reported to pharmacy 1/19/2019.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Migraine, Peripheral swelling
Clinical narrative: Patient reported having severe migraine headache, swelling of a large area of arm, hip pain.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site. Warm to the touch, spread down the arm to the elbow of inside of left arm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Musculoskeletal pain, Pain
Clinical narrative: Shoulder injury. Pain in shoulder which is worse when using it or sleeping.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Lacrimation increased, Pneumonia, Vision blurred
Clinical narrative: Patient reported getting pneumonia after receiving vaccine. Also stated eye related issues including morning watering, itching, lack of clearness of vision in the morning (cloudy).
Age: 80.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Skeletal injury, Vibratory sense increased
Clinical narrative: Pt said that when he received his first SHINGRIX shot, employee hit his bone & his arm was "vibrating" for a little while after he received the shot.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache appeared at about noon on same day as vacinnation and continued until next day, evening. At the same time I felt weak in the muscles and had to push myself to continue on a regular schedule, lost my appetite, thinking very fuzzy, mood not good, On the next morning, woke up with blurry vision that subsided in a few hours and at the same time loud ringing in ears, mostly left ear that came and went until Thursday, Sight of injection upper right arm began to swell up on late Wednesday and then on Thursday a red wing about 2 inches started to appear about 2 inched down from the injection site then the itching began and if I did scratch the area then it began to burn so I stopped scratching very soon. Itching and redness continued until  Monday. The muscle weakness and lack of appetite and fuzzy thinking and mood change didn't really stop until Monday. At this point I'm not sure if I've had an allergic reaction or if all of the above is somewhat normal.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Mood altered, Muscular weakness, Thinking abnormal, Tinnitus
Clinical narrative: Headache appeared at about noon on same day as vacinnation and continued until next day, evening. At the same time I felt weak in the muscles and had to push myself to continue on a regular schedule, lost my appetite, thinking very fuzzy, mood not good, On the next morning, woke up with blurry vision that subsided in a few hours and at the same time loud ringing in ears, mostly left ear that came and went until Thursday, Sight of injection upper right arm began to swell up on late Wednesday and then on Thursday a red wing about 2 inches started to appear about 2 inched down from the injection site then the itching began and if I did scratch the area then it began to burn so I stopped scratching very soon. Itching and redness continued until  Monday. The muscle weakness and lack of appetite and fuzzy thinking and mood change didn't really stop until Monday. At this point I'm not sure if I've had an allergic reaction or if all of the above is somewhat normal.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Headache appeared at about noon on same day as vacinnation and continued until next day, evening. At the same time I felt weak in the muscles and had to push myself to continue on a regular schedule, lost my appetite, thinking very fuzzy, mood not good, On the next morning, woke up with blurry vision that subsided in a few hours and at the same time loud ringing in ears, mostly left ear that came and went until Thursday, Sight of injection upper right arm began to swell up on late Wednesday and then on Thursday a red wing about 2 inches started to appear about 2 inched down from the injection site then the itching began and if I did scratch the area then it began to burn so I stopped scratching very soon. Itching and redness continued until  Monday. The muscle weakness and lack of appetite and fuzzy thinking and mood change didn't really stop until Monday. At this point I'm not sure if I've had an allergic reaction or if all of the above is somewhat normal.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Patient with chronic fatigue who had improved in terms of the fatigue level reports that she developed recurrence of ongoing daily fatigue impacting daily activities approx. Dec 20, 2018.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Decreased appetite, Dehydration, Fatigue, Retinal haemorrhage, Seizure
Clinical narrative: Loss of appetite and severe fatigue began the days after vaccination. Excessive vomiting began two days after vaccination and continued for 7 days. Pt was hospitalized from 7/22 - 7/26 and treated for dehydration while they ran tests that came back inconclusive. Two weeks later, pt experienced a seizure and was rushed to the ER. She was hospitalized from August 8 - August 17th where she was found to have bilateral subdural hematomas and retinal hemorrhaging.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Subdural haematoma, Vomiting
Clinical narrative: Loss of appetite and severe fatigue began the days after vaccination. Excessive vomiting began two days after vaccination and continued for 7 days. Pt was hospitalized from 7/22 - 7/26 and treated for dehydration while they ran tests that came back inconclusive. Two weeks later, pt experienced a seizure and was rushed to the ER. She was hospitalized from August 8 - August 17th where she was found to have bilateral subdural hematomas and retinal hemorrhaging.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Nuclear magnetic resonance imaging brain normal, Trigeminal neuralgia
Clinical narrative: On September 1, 2018, 8 days after receiving the SHINGRIX Vaccine I started having intermittent sharp pains on the right side of my face. These pains worsened over the next day and I went to Urgent Care on September 2, 2018. I was diagnosed with trigeminal neuralgia and referred for follow-up in the neurology department. On September 6 I was examined by Dr. in the neurology department. Based on my symptoms, he diagnosed my condition as "classic trigeminal neuralgia" and referred my for an MRI to rule out a brain tumor. The MRI was normal. At the advice of my primary care doctor, I received the second dose on SHINGRIX in December 2018. As the symptoms are not severe (and are less server than the initial onset) I have not yet started the recommended medication. Although the timing of the onset of my condition (8 days after administration of the vaccine) could be coincidental, I strongly believe that it also may be a side effect of the SHINGRIX, as zoster herpes is nerve related.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Insomnia, Pain in extremity
Clinical narrative: Chills, Weakness, Headache, Insomnia, Arm Pain. Chills was the worst. Note nothing but some arm pain on first dose.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram, Facial paralysis
Clinical narrative: Left side of face paralysis, later diagnosed as Bell's Palsy. Diagnosed from Emergency Room visit. EKG and physical examination. Given Prednisone and an anti-viral medication
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Computerised tomogram head, Dizziness, Ear discomfort, Headache
Clinical narrative: The following day while driving I blacked out for a second then had several severe sets of dizziness then a major headache that did not go away for days. Then I had a less painful headache but pressure in the ears that lasted 3 months. I thought maybe I had a mini stroke. I did not know it was the vaccine till I had the next vaccine PREVNAR 13 in 2018. Pressure in the ears and headaches started the next morning. I have been dealing with the head issues since then. I have been to the hopital, Ear, nose and throat doctor, neurologist and regular doctor. Each several times with no relief.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness
Clinical narrative: The following day while driving I blacked out for a second then had several severe sets of dizziness then a major headache that did not go away for days. Then I had a less painful headache but pressure in the ears that lasted 3 months. I thought maybe I had a mini stroke. I did not know it was the vaccine till I had the next vaccine PREVNAR 13 in 2018. Pressure in the ears and headaches started the next morning. I have been dealing with the head issues since then. I have been to the hopital, Ear, nose and throat doctor, neurologist and regular doctor. Each several times with no relief.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Daughter called and said her father was experiencing terrible body aches, headache, and chills.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Patient had red dots that formed that night and was itchy. In the morning the itching intensified and small welts formed. Pt went to student health and was given prednisone as a treatment about 1 to 2 days later. 10 days later patient went to the Urgent Care facility and was given diflucan and recommendation to start Frojen probiotic.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dysphagia, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Severe joint pain and stiffness. Slight fever, sharp shooting pain and tingling in arms and legs. Severe muscle weakness. Difficulty swallowing.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Severe joint pain and stiffness. Slight fever, sharp shooting pain and tingling in arms and legs. Severe muscle weakness. Difficulty swallowing.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Injection site pain, Lethargy, Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received FLUAD for patients over 65 instead of FLUCELVAX for patients under 65.  On the day she received the vaccine, she was just having a little soreness in the arm where she received the injection, as expected. The next day, she came into the pharmacy complaining of shortness of breath and feeling extremely lethargic. She appeared to be doing okay at that time and did not need further medical attention but was advised to see a doctor immediately if her symptoms worsened. She has not responded to any follow-up phone calls since that time.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Extreme soreness, elliptical red and swollen rash around injection site approx. 6 inches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic, Urticaria
Clinical narrative: Patient had generalized urticaria with several itchy raised blotches present on arm and torso.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Peripheral swelling, Rash erythematous
Clinical narrative: Swollen left forearm between injection site and wrist. More swelling around the elbow with red rash. Slight pain above the elbow on the backside of the arm. Dr. at the Urgent Care diagnosed the medical condition as "Cellulitis of forearm, left" on January 19, 2019. She prescribed Cephalexin 500 mg oral capsule twice daily for 7 days, and advised me to see my physician if the swelling does not subside in 2 days. I have taken 3 capsules so far, and it appears that the swelling is decreasing. The pain is almost gone but the elbow region is now itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Very sore and red at injection site. Flu-liike symptoms (fever, chills, muscle pain, headache, malaise). Lost a whole day feeling sick. Happened with first shot and was worse with this second shot. Worst side effects of vaccine I've ever had. Told by pharmacist reaction might be worse because I I received ZOSTAVAX several years ago.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Very sore and red at injection site. Flu-liike symptoms (fever, chills, muscle pain, headache, malaise). Lost a whole day feeling sick. Happened with first shot and was worse with this second shot. Worst side effects of vaccine I've ever had. Told by pharmacist reaction might be worse because I I received ZOSTAVAX several years ago.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: All over body ache, chills, low fever, profound fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site warmth, Myalgia
Clinical narrative: Headache, fatigue, muscle aches, chills, arm soreness and increase warmth at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Headache, fatigue, muscle aches, chills, arm soreness and increase warmth at injection site.
Age: 76.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Monoplegia, Pyrexia
Clinical narrative: PT EXPERIENCED TEMPORARY PARALYSIS IN LEFT LEG BEGINNING 01/17/2019, WAS TAKEN TO ER WITH 102.4 FEVER ON 01/18/2019. WAS ADMITTED TO HOSPITAL AND WAS DISCHARGED 01/20/2019.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Extreme headache, fever, chills, nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Administration site warmth, Chills, Headache, Malaise
Clinical narrative: Patient has been experience a grade-3 type reaction since administration on 1/15/19. Patient complained about pain and soreness that occurred around the time of administration. On the same night of vaccination, patient experienced malaise, including muscle pain, headache, shivering, and fever. Within the next 24-48 hours after administration, swelling had developed at the site of administration, which spanned several inches in diameter and was warm to the touch. Patient also reported having a "rock-hard" arm with muscle pain that prevented her from being able to life her arm and use her left arm throughout the day. Note: Symptoms peaked around 24 to 48 hours after vaccine administration. Patient's symptoms have been improving as of day 4 (1/18/19) when symptoms were actually reported. Patient was able to move arm easily, but swelling and pain still existed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Patient has been experience a grade-3 type reaction since administration on 1/15/19. Patient complained about pain and soreness that occurred around the time of administration. On the same night of vaccination, patient experienced malaise, including muscle pain, headache, shivering, and fever. Within the next 24-48 hours after administration, swelling had developed at the site of administration, which spanned several inches in diameter and was warm to the touch. Patient also reported having a "rock-hard" arm with muscle pain that prevented her from being able to life her arm and use her left arm throughout the day. Note: Symptoms peaked around 24 to 48 hours after vaccine administration. Patient's symptoms have been improving as of day 4 (1/18/19) when symptoms were actually reported. Patient was able to move arm easily, but swelling and pain still existed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Extreme chills with shivering, fever of 101°, starting approximately 11 hours post vaccination, treated with Ibuprofen and lasting approximately 12 hours. Intense muscular and joint pain began approx. 17 hours post vaccination and lasted approx. 15 hours before tapering off. Treated with Ibuprofen and went away after about 2 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Pain
Clinical narrative: Painful cellulitis. Treated by Dicloxacillin 500mg 4 times a day for 7 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Painful cellulitis. Treated by Dicloxacillin 500mg 4 times a day for 7 days.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Painful cellulitis. Treated by Dicloxacillin 500mg 4 times a day for 7 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day of vaccine, patient had some soreness at injection site. This was not particularly troubling. The next day, 12/1/18, she had chills, fever to 101.3, and headache. By 12/2, her fever had resolved, but she had swelling and erythema to a diameter of 4 inches, at the injection site. The swollen, erythematous area had pruritic and stinging sensations. This continued over next few days. She contacted, me, I initially advised Benadryl at night, and Zyrtec during day, to control sx, asked her to come in, which she did on 12/7/18. Exam confirmed the presence of erythema and swelling around the injection site, which by then had begun to resolve. She was instructed to continue the antihistamines until symptoms resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Day of vaccine, patient had some soreness at injection site. This was not particularly troubling. The next day, 12/1/18, she had chills, fever to 101.3, and headache. By 12/2, her fever had resolved, but she had swelling and erythema to a diameter of 4 inches, at the injection site. The swollen, erythematous area had pruritic and stinging sensations. This continued over next few days. She contacted, me, I initially advised Benadryl at night, and Zyrtec during day, to control sx, asked her to come in, which she did on 12/7/18. Exam confirmed the presence of erythema and swelling around the injection site, which by then had begun to resolve. She was instructed to continue the antihistamines until symptoms resolved.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph nodes under arm starting at 11PM on 20 January. Still ongoing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Besides mild redness and pain at the site of injection, tiredness, muscle aches, shivering, and joint pain, especially knees. Much better today, day 4, but still have joint pain and redness and warmth at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Besides mild redness and pain at the site of injection, tiredness, muscle aches, shivering, and joint pain, especially knees. Much better today, day 4, but still have joint pain and redness and warmth at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles. Received valacyclovir 1 gm 1 tablet Q12 hours x 7 days.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site cellulitis
Clinical narrative: Symptoms started showing up either on the day of the injection or the second day after the shot but did not get noticed. On the 29th of September I, the husband, noticed that the color of her arm was deep red to pink round the edge of the muscle. Took my wife to immediate care and had her examined and they diagnosed it as cellulitis of the left upper limb. This information was originally typed by husband however he did not have the information about the facility where the vaccine was given correct so the form has been changed to list the proper site which was the health department and not the urgent care. I have advised husband that I have made that change to the form.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Malaise, Pain, Pyrexia
Clinical narrative: Localize reaction larger than a quarter. 36 hr felt feverish. Malaise, achy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Insomnia, Nausea
Clinical narrative: This spontaneous report was received from a other health care professional via Pfizer regarding a 67-year-old female patient. The patient's concurrent conditions were not reported. The patient's medical history included hyperlipidemia, diverticulum, elevated blood sugar (blood glucose increased) and palpitations. Concomitant therapies included atenolol (50 mg), cyclobenzaprine hydrochloride (10 mg), ranitidine (150 mg) and simvastatin (20 mg). The following vaccines were administered to the patient prior vaccinating with PNEUMOVAX 23. On 10-OCT-2010, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Tdap). On 14-NOV-2016, ZOSTAVAX (lot # L046293 and expiry date:17-FEB-2017) intramuscularly in left arm. On 14-NOV-2016, PREVNAR 13 (lot # N16515 and expiry date: 31-OCT-2017) 1st dose intramuscularly in left deltoid. On 15-JUN-2018 at 11:00, the patient was vaccinated with PNEUMOVAX 23 (lot # R006465 and expiry date: 24-OCT-2019) (0.5 milliliter) intramuscularly in the left deltoid for prophylaxis. On 15-JUN-2018 at 14:00, the patient experienced mild nausea, insomnia and no energy (asthenia). On 18-JUN-2018, the patient recovered from nausea, insomnia and asthenia. Causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Oropharyngeal pain, Pruritus, Swelling face, Urticaria, Wheezing
Clinical narrative: On the way home from vaccine appointment, developed facial swelling, hives, itching, pain in throat and wheezing. Family called 911, EMS gave IV BENADRYL. ER gave IV PEPCID and SOLUMEDRO; monitored and sent home. Told to F/U with PCP.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Burning sensation, Lymphadenopathy, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of urticaria (1st dose received on 21st October 2018, see case US2019004268). Concurrent medical conditions included burning rectal, rectal pain, hives and pruritus (whole scalp and stomach itching). On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, sleeplessness, pain and discomfort. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the enlargement of lymph nodes, sleeplessness and discomfort were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, sleeplessness, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced her lymph nodes swelled up and continued to have hives on her whole head and her rectum started burning 24 hours a day. The patient took a 10-day prednisone taper, which relieved her symptoms by 30 percent for about 2 to 3 hours after each dose. The patient was taking Zyrtec. The patient described the burning in her rectum as like there was chlorine inside that never got away. The patient could not sleep due to the pain and discomfort and described it as excruciating. The patient's dermatologist said it was not shingles because the hives were on both sides. The patient had been to a dermatologist and a gastroenterologist and was scheduled for a colonoscopy. The patient had consented to follow up and provided contact details of her treating physicians.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stool analysis, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of urticaria (1st dose received on 21st October 2018, see case US2019004268). Concurrent medical conditions included burning rectal, rectal pain, hives and pruritus (whole scalp and stomach itching). On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, sleeplessness, pain and discomfort. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the enlargement of lymph nodes, sleeplessness and discomfort were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, sleeplessness, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced her lymph nodes swelled up and continued to have hives on her whole head and her rectum started burning 24 hours a day. The patient took a 10-day prednisone taper, which relieved her symptoms by 30 percent for about 2 to 3 hours after each dose. The patient was taking Zyrtec. The patient described the burning in her rectum as like there was chlorine inside that never got away. The patient could not sleep due to the pain and discomfort and described it as excruciating. The patient's dermatologist said it was not shingles because the hives were on both sides. The patient had been to a dermatologist and a gastroenterologist and was scheduled for a colonoscopy. The patient had consented to follow up and provided contact details of her treating physicians.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anorectal discomfort, Condition aggravated, Discomfort, Insomnia, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of urticaria (1st dose received on 21st October 2018, see case US2019004268). Concurrent medical conditions included burning rectal, rectal pain, hives and pruritus (whole scalp and stomach itching). On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, sleeplessness, pain and discomfort. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the enlargement of lymph nodes, sleeplessness and discomfort were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, sleeplessness, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced her lymph nodes swelled up and continued to have hives on her whole head and her rectum started burning 24 hours a day. The patient took a 10-day prednisone taper, which relieved her symptoms by 30 percent for about 2 to 3 hours after each dose. The patient was taking Zyrtec. The patient described the burning in her rectum as like there was chlorine inside that never got away. The patient could not sleep due to the pain and discomfort and described it as excruciating. The patient's dermatologist said it was not shingles because the hives were on both sides. The patient had been to a dermatologist and a gastroenterologist and was scheduled for a colonoscopy. The patient had consented to follow up and provided contact details of her treating physicians.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of urticaria (1st dose received on 21st October 2018, see case US2019004268). Concurrent medical conditions included burning rectal, rectal pain, hives and pruritus (whole scalp and stomach itching). On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced enlargement of lymph nodes, sleeplessness, pain and discomfort. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the enlargement of lymph nodes, sleeplessness and discomfort were not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, sleeplessness, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient experienced her lymph nodes swelled up and continued to have hives on her whole head and her rectum started burning 24 hours a day. The patient took a 10-day prednisone taper, which relieved her symptoms by 30 percent for about 2 to 3 hours after each dose. The patient was taking Zyrtec. The patient described the burning in her rectum as like there was chlorine inside that never got away. The patient could not sleep due to the pain and discomfort and described it as excruciating. The patient's dermatologist said it was not shingles because the hives were on both sides. The patient had been to a dermatologist and a gastroenterologist and was scheduled for a colonoscopy. The patient had consented to follow up and provided contact details of her treating physicians.
Sex: F
Vaccine: HPV9
Symptoms: Injury associated with device, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a nurse regarding a female patient (who is also a nurse). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JAN-2019, patient was vaccinated with GARDASIL 9 lot # R002345 for prophylaxis with no incident. On 02-JAN-2019 when the nurse was placing the safety lock on needle post administration, the syring hub broke (Syringe issue) and needle went into nurse's hand (exposure via skin contact, occupational exposure to product and Accidental exposure to product). No adverse events were reported.
Age: 0.25
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse refers to a 3 month old patient of unknown gender. Patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JAN-2019, the patient was vaccinated with PNEUMOVAX 23 lot # N030987 (expiry date: 15-MAY-2019) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a 15 year old female patient. The patient's concurrent condition, concomitant medication and medical history were not reported. On an unknown date in October in 2018 (also reported as 3 months ago), the patient was vaccinated with GARDASIL 9 (therapy type, dose, dose unit, frequency, route of administration, lot #, expiry date unspecified) for prophylaxis. On an unknown date in October in 2018 (also reported as 3 months ago), it was reported that the patient was on therapy with an unspecified antibiotic for an unspecified reason (Adverse event). The outcome of adverse event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Muscle swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient regarding herself. Patient's medical history, concurrent conditions, and concomitant medications were not reported. On 09-JAN-2019 the patient was vaccinated with PNEUMOVAX 23, intramuscular or subcutaneous injection (dose, lot number, expiry date not provided) for pneumonia shot. Since 09-JAN-2019, the patient was experiencing soreness and swelling from her shoulder down to her elbow. Patient bicep muscle also got sore and swollen. The patient visited an unspecified physician's office and received treatment for the events. The outcome of pain in extremity and peripheral swelling was reported as not recovered. Causality assessment was not provided. No product quality complaint was present.
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 50 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on 14-JAN-2019, the patient was inadvertently vaccinated with a dose of PROQUAD 0.5 milliliter, subcutaneous, lot # N029156, expiration date:16-APR-2019 for prophylaxis, (strength and frequency was not provided) insted of a dose of M-M-R II (interchange of vaccine products) (product administered to patient of inappropriate age). Also it was stated that the dose of PROQUAD was improperly stored (inappropriate age and product storage error). The nurse explained that PROQUAD vaccine was mistored in the refrigerator with the M-M-R II vasccines and she stated that PROQUAD was during 5 days exposure to temperatures from -9°C to 8°C. data logger was positive and tehre were not previous temperature excursions. The sterile diluent used to reconstitute PROQUAD was properly stored.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. In 2014 the patient was administered ZOSTAVAX by a pharmacist (lot# and route unknown). In 2015, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 20-MAY-2013 the patient was administered ZOSTAVAX, (lot# and route unknown), by a healthcare provider. On or about 08-FEB-2016, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The patient claimed damages as a result of: injury to himself and economic losses. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 01-SEP-2014, the patient was administered ZOSTAVAX by a physician (lot# and route unknown). On or about 15-SEP-2014, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 71 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-JUL-2015, the patient was administered the ZOSTAVAX by a nurse (lot number, dosage and route of administration not provided). On or about 12-SEP-2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to himself , loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-NOV-2012, the male patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (Lot number, dosage and route of administration not provided). On or about 08-MAR-2017, the patient was treated by a physician (dermatologist) at a dermatology office for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages as a result of:  injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a 61-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-FEB-2017, the female patient was administered the ZOSTAVAX by a healthcare provider at a clinic (Lot number, dosage and route of administration not provided). On or about 17-JUL-2017, the patient was treated by a healthcare provider at the clinic for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services (not specified) and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and female patient of unknown age and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the female patient was administered the ZOSTAVAX by a healthcare provider at a medical center/hospital (Lot number, dosage and route of administration not provided).  In 2014, the patient was treated by a healthcare provider at a physician's medical group/office for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages as a result of:  injury to themselves, loss of consortium, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In November 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. In 2014, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to himself, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In September 2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On or about 18-JAN-2017, the patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-AUG-2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2014, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. On an unknown date reported as "shortly after" receiving the ZOSTAVAX vaccine, the patient developed a rash, accompanied by pain and blisters, with the pain remaining after the rash and blisters subsided. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Rash, accompanied by pain and blisters was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: Information had been received from a pharmacist referring to a female young adult. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. The patient was not pregnant. On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine administered (name and lot number not provided) (route, strength, dose, frequency and expiration date were not reported) for prophylaxis. Well after the 15 minutes obeservation period, the patient experienced a seizure. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of seizure was unknown. The causality between the event and unidentified Merck hpv vaccine administered (name and lot number not provided) was not reported. Upon internal review, seizure was determined to be medically significant.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received in October 2018) and SHINGRIX (received 1st dose on an unknown date). On 3rd January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness, fever and feeling abnormal. The patient was treated with paracetamol (Tylenol) and medication unknown (Fluids). In January 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tiredness and feeling abnormal were unknown. It was unknown if the reporter considered the tiredness, fever and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: In December 2018, the patient had complete physical examination  which was normal. The patient was fine after receiving 1st dose of SHINGRIX. After receiving 2nd dose of SHINGRIX, the patient experienced fever of 100.5 degree F for about a week and felt tired. The patient reported that she had excessive energy prior to vaccine and now felt like a truck ran over her. The patient reported that her normal temperature was 97.6 degree F. The patient did follow up with her physician and he advised her to take fluids and Tylenol. The patient asked was this within normal limits of side effects, was this a typical reaction and anything to do so that she could return to normal.